US CDC and FDA recommend US pause Johnson & Johnson vaccine use over blood clot concerns “out of an abundance of caution.” The six reported cases were among more than 6.8 million doses of the vaccine administered in the US.
Cases in India are surging during a steep second wave, as millions gather for a religious festival.
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FDA: Decision to authorize Pfizer vaccine for 12- to 15-year-olds could be made "in a couple of weeks"
From CNN's Lauren Mascarenhas
Erendira Natalie receives her first dose of the Pfizer Covid-19 vaccine from a health care worker at a clinic targeting minority community members at St. Patrick's Catholic Church on April 9, in Los Angeles.
Mario Tama/Getty Images
A decision on whether to extend emergency use of the Pfizer/BioNTech Covid-19 vaccine to people ages 12 to 15 could be made in “a couple of weeks,” Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said Tuesday.
Pfizer recently asked the FDA to expand the emergency use authorization of the vaccine to include people ages 12 to 15 years.
Right now, the emergency use authorization for the Pfizer vaccine is for people 16 and older.
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College campuses are feeling the fallout from J&J interruption
From CNN's Jeff Zeleny
The interruption of the Johnson & Johnson vaccination could have a significant impact on college students, who were key targets for getting one shot before leaving school at the end of the spring semester.
While the White House downplayed the significance of the Johnson & Johnson pause, saying the Moderna and Pfizer vaccines were the predominant vaccinations being offered, officials in two states tell CNN that the fallout on college campuses was concerning.
An official in another Midwestern state also said Tuesday that college campuses had been planning vaccination clinics for students in the remaining two weeks of April. The pause on the Johnson & Johnson vaccination makes those plans highly uncertain, the official said, depending on how long the interruption takes place.
The timeline: The US Centers for Disease Control and Prevention will hold an emergency meeting of its Advisory Committee on Immunization Practices from 1:30 to 4 p.m. ET Wednesday to review “rare and severe” blood clot cases.
The CDC and the US Food and Drug Administration have recommended that the United States pause the use of the Johnson & Johnson vaccine until the review is complete.
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Johnson & Johnson pausing vaccinations in all clinical trials
From CNN’s Amanda Sealy
Johnson & Johnson has decided to pause vaccinations in all of its clinical trials while they “update guidance for investigators and participants,” according to a statement from the company on Tuesday.
The announcement follows a recommendation from US Centers for Disease Control and Prevention and the US Food and Drug Administration to pause the use of the Johnson & Johnson vaccine over blood clot concerns out of an “abundance of caution.”
The company also announced earlier that it would “proactively delay the rollout of our vaccine in Europe.”
The company currently has several ongoing trials including an ongoing Phase 2a trial and a Phase 3b trial in South Africa.
The Phase 2a trial has been ongoing since September and was initially designed to study single-dose and two-dose regimens of the vaccine, at different dose levels and schedules, in healthy adults ages 18 to 55 and 65 and older. The study expanded this study to adolescents age 12 to 17 on April 2.
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Don't dismiss men who have symptoms of an adverse event after J&J vaccine, FDA says
From CNN’s Lauren Mascarenhas
Prepared doses of the Johnson & Johnson COVID-19 vaccine sit in a box on March 6 in Thornton, Colorado.
Michael Ciaglo/Getty Images
Though the cases of severe blood clots after vaccination with Johnson & Johnson’s Covid-19 vaccine were among women, men who received the vaccine should also watch carefully for symptoms of adverse events, Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said Tuesday.
The US Centers for Disease Control and Prevention and FDA has recommended a pause on use of Johnson & Johnson’s coronavirus vaccine, following six reported US cases of a rare and severe type of blood clot.
Marks noted that the one case of this rare clotting event observed in the clinical trial was in a man.
“There was one instance of cerebral vein thrombosis with thrombocytopenia in the clinical trial – so that’s one in 20,000, approximately with Janssen – and that was in a man.”
For context: The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
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Moderna says its Covid-19 vaccine is more than 90% effective for at least six months
From CNN’s Lauren Mascarenhas
A nurse prepares the Moderna Covid-19 vaccine at the West Wales General Hospital on April 7 in Carmarthen, Wales.
Jacob King/WPA Pool/Getty Images
The Moderna Covid-19 vaccine remains more than 90% effective for at least six months, the company announced in a statement Tuesday.
Moderna cited preliminary results from its Phase Three trial showing the vaccine has been more than 90% effective against all cases of the virus and more than 95% effective against severe disease.
Research published recently in The New England Journal of Medicine showed robust antibody levels in people vaccinated with Moderna’s vaccine six months out.
Pfizer will deliver Covid-19 vaccines to the US ahead of schedule
From CNN's Michael Nedelman
Pfizer has boosted production of its Covid-19 vaccine and “can deliver 10% more doses to the US by the end of May than previously agreed,” Pfizer CEO Dr. Albert Bourla said in a tweet Tuesday.
This means the company will deliver 220 million doses by the end of next month – 20 million more than previously expected. The company had previously expected to fulfill its US contract for 300 million doses by the end of July. Bourla said the company would also hit that deadline two weeks early.
The US has purchased 300 million doses from Moderna, as well. In a statement Tuesday, Moderna noted it “remains on track to deliver the second 100 million doses to the U.S. government by end of May 2021 followed by another 100 million additional doses by end of July 2021.”
Prior to the recommended pause of Johnson & Johnson’s US rollout Tuesday, the US had purchased 200 million doses of its vaccine, 100 million of which the company had committed to providing by the end of May.
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Protection from mRNA Covid-19 vaccines likely lasts at least nine months, FDA official says
From CNN’s Lauren Mascarenhas
Protection from mRNA Covid-19 vaccines likely lasts at least nine months, Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said Tuesday.
Current research on mRNA Covid-19 vaccines has shown that the vaccines likely provide protection for at least six months.
Marks said that researchers will need to watch for whether immunity is dropping off more quickly for older and immunocompromised individuals. He added that it is possible the vaccines will require boosters.
“With each month, we’ll get more certainty about when that might be necessary,” said Marks.
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Variants account for about 78% of recent Covid-19 cases in New York City, data shows
From CNN’s Deidre McPhillips
Covid-19 variants account for about 78% of recent Covid-19 cases in New York City, according to data published by the city’s health department on Monday.
Nearly 1,500 virus specimens were collected between March 22 and March 28 and genetically sequenced by the New York City Pandemic Response Laboratory. Of those specimens, about 30% were identified to be B.1.1.7, the variant first identified in the U.K. Another 45% of the genetically sequenced samples were identified to be B.1.526, the variant first discovered in New York City.
B.1.1.7 is classified as a variant of concern by the US Centers for Disease Control and Prevention, as it has been found to be more transmissible and cause more severe infections. B.1.526 is a variant of interest, with ongoing studies regarding its effects on disease severity and vaccine effectiveness.
The prevalence of both of these variants has increased quickly in New York City. In the second half of February, B.1.1.7 accounted for about 10% of genetically sequenced specimens and B.1.526 accounted for about 35% of those sampled.
About 5% of confirmed cases have been genetically sequenced, and both B.1.1.7 and B.1.526 have been identified in all five of the city’s boroughs, according to the city’s health department.
“The proportion of variants of concern and variants of interest is increasing,” according to the report, suggesting that the “spread of specific variants, potentially due to their greater infectiousness, which is one reason why COVID-19 cases in NYC remain at a high plateau of between 3,000 to 4,000 new cases each day.”
Over the past seven days, New York City has reported more than 15,000 new cases of Covid-19, an improvement from the average of nearly 19,000 cases per week in recent weeks, according to data published by the city’s health department. However, New York City ranks 20th for the most new Covid-19 cases per capita among US metropolitan areas in the past week, according to data the data from the White House Covid-19 Team
Nationally, B.1.1.7 accounted for about 44% of samples collected between March 14 and March 27 and B.1.526 accounted for about 6% of samples, according to data published by the CDC.
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Covid-19 cases among US children increased slightly last week
From CNN's Jamie Gumbrecht
At least 73,192 new child Covid-19 cases were identified through testing last week, according to the American Academy of Pediatrics, a slight increase in new reported cases from the week before
Children represented 13.5% of all cases in the United States. More than 3.54 million children in the United States have tested positive for Covid-19 as of April 8.
Children made up between 6% and 18.9% of those who were tested for Covid-19, and 5.3% to 32.3% of children tested were positive for the coronavirus, depending on the state.
Children are still considered much less likely than adults to develop severe symptoms of Covid-19 or to die from the disease. Children represented 1.3% to 3.1% of total reported hospitalizations for Covid-19, based on the information provided by 24 states and New York City. Only 0.1% to 1.9% of all cases of Covid-19 in children required hospitalization.
Ten states reported zero child deaths among the 43 states that provided data on Covid-19 mortality.
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Arkansas governor will pause use of J&J vaccine to better understand reactions
From CNN’s Chris Boyette
AK Governor's Office/Youtube
Arkansas Gov. Asa Hutchinson told reporters he has “confidence” in the Johnson & Johnson vaccine, but the state will pause its use of the vaccine to allow the medical community to better prepare for the rare reactions that have been documented.
The governor added that Arkansas has enough supply of the vaccine to meet the demands of the state.
“We will continue our vaccination program, uninterrupted. It continues at a rapid pace and no one should delay getting a vaccination, because of the pause on one part of the vaccination. We have the supply currently on hand in Arkansas, to meet the demand needs of our state,” he said.
“No one should slow down and say, ‘Well because of this, I’m going to wait.’ Don’t wait, get the vaccine now, it is critically important,” the governor added.
The state’s health secretary, Dr. José R. Romero, said he supports Arkansas’ pause of the Johnson & Johnson vaccine.
“We believe it is prudent, at this time to pause in our administration of the Janssen [Johnson & Johnson] vaccine, until we have more information and in particular, because this is an unusual manifestation of thrombosis, we want physicians to understand that this treatment for this particular disease is not your standard treatment,” Romero said.
Previously scheduled state clinics that were planning to use the Johnson & Johnson vaccine will now use the Pfizer and Moderna vaccines, according to Colonel Robert Ator, program manager for Arkansas Vaccine Distribution.
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Canada reports first case of rare blood clot with AstraZeneca's Covid-19 vaccine
From CNN’s Paula Newton in Ottawa
Canada confirmed Tuesday its first case of a rare blood clot complication after a woman received the AstraZeneca vaccine.
The statement released from Health Canada says that the person “experienced a very rare adverse event involving blood clots with low platelets following immunization,” adding that the person is now recovering at home.
Quebec later confirmed that it was a woman who had been administered the vaccine in that province.
“I think that the good news is that the lady in question has been cared for and she is doing well and what we are doing now involves hyper-vigilance,” said Christian Dube, Quebec’s health minister in French during a news conference Tuesday.
Health Canada says it continues to investigate and is also monitoring reports of similar adverse events in Europe.
Canada first approved the AstraZeneca vaccine in February but recently updated its recommendation on using the vaccine to exclude younger Canadians under the age of 55.
Canada has received more than 2 millions doses of the AstraZeneca vaccine including 1.5 million sent by the Biden administration in recent days. The US has not yet authorized the AstraZeneca vaccine.
The European Medicines Agency (EMA), meanwhile, said earlier this month that a particular combination of unusual blood clots with low blood platelet counts should be listed as a side effect of the vaccine, but stopped short of recommending its use be limited. The benefits of the shot outweigh the risks and Covid-19 is a “very serious disease,” it added.
UK regulators took a more cautious approach, saying healthy adults under 30 should be offered other vaccines. Officials described the move as a “course correction” that would not derail the country’s rapid inoculation program.
CNN’s Angela Dewan and Sharon Braithwaite contributed reporting to this post.
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CDC vaccine advisers will meet about Johnson & Johnson's vaccine tomorrow
From CNN's Ashley Ahn
A dose is drawn from a vial of the Johnson & Johnson COVID-19 vaccine at an event put on by the Thornton Fire Department on March 6 in Thornton, Colorado.
Michael Ciaglo/Getty Images
The US Centers for Disease Control and Prevention will hold an emergency meeting of its Advisory Committee on Immunization Practices, or ACIP, from 1:30 to 4 p.m. ET Wednesday to review “rare and severe” blood clot cases among people who received the Johnson & Johnson Covid-19 vaccine.
The meeting will be virtual with no in-person attendance.
The CDC and the US Food and Drug Administration have recommended that the United States pause the use of the Johnson & Johnson vaccine until the review is complete.
The FDA will also review the ACIP’s analysis as it investigates the cases, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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Turkey announces partial lockdown as daily Covid-19 cases hit record high
From CNN's Gul Tuysuz
Turkish President Recep Tayyip Erdogan announced a partial lockdown for the first two weeks of the Muslim holy month of Ramadan as Turkey continues to post record numbers of coronavirus cases and increasing daily deaths.
Turkey reported 273 deaths and 59,187 new coronavirus cases in the last 24 hours— hitting a record high in daily cases, according to Turkish health ministry.
Under the partial lockdown, pre-school and students in grades 8 to 12 will continue in-person education but all other grades will be required to do distance learning, according to the Turkish president.
Cafes, tea houses, and gyms will be closed with restaurants only offering delivery services. Wedding, engagement parties and all other indoor activities are prohibited until the end of Ramadan.
The weekday curfew has been extended by two hours and will be from 7 p.m. to 5 a.m. local time, but the weekend curfew, will continue as is.
Government workers will be put on limited work hours. Those who are pregnant, have pre-existing health conditions and women who have kids under the age of 10, are exempt from work, Erdogan said. The private sector will be encouraged to adopt more “work from home.”
If these tightened measures do not bring down the spread of the virus, stricter measures will be implemented, he added.
Erdogan also said intercity travel will be restricted but did not provide specifics. A detailed list of new measures which will go into effect on Wednesday will be provided by the interior ministry, Erdogan said.
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Biden reacts to J&J vaccine pause and says there is enough vaccine for every American
From CNN's Allie Malloy
President Joe Biden speaks before a meeting in the Oval Office of the White House on April 13 in Washington, DC.
Brendan Smialowski/AFP/Getty Images
President Biden said Tuesday that there is enough vaccine that is “basically 100% unquestionable for every single solitary American” when asked about the recommended pause in the use of the Johnson & Johnson Covid-19 vaccine.
Biden did not further comment or answer questions on the recommendation or on Americans who have received the Johnson & Johnson vaccine.
The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
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South Africa suspends rollout of Johnson & Johnson Covid-19 vaccine
From CNN’s David McKenzie in Johannesburg
A healthcare worker takes out the Johnson & Johnson COVID-19 coronavirus vaccine from a temperature controlled fridge at the Klerksdorp Hospital in South Africa on February 18.
Phil Magakoe/AFP/Getty Images
South Africa’s Health Minister Zweli Mkhize on Tuesday evening announced the suspension of South Africa’s rollout of the Johnson & Johnson vaccine, stressing that South African scientists believe it will only be a temporary suspension.
Mkhize said the decision was made after the US Food and Drug Administration (FDA) recommended the United States pause its rollout of the single dose vaccine because of six reported cases of a rare and severe form of blood clot among more than 6.8 million doses of the vaccine administered in the US.
The minister said that they had not received any reports of blood clots in the more than 250,000 health care workers already vaccinated with the Johnson & Johnson vaccine, as part of a large-scale trial in South Africa. Full rollout of the vaccine is yet to commence.
South Africa has banked heavily on the Johnson & Johnson vaccine after the Oxford-AstraZeneca vaccine was shown to be less effective against mild and moderate cases of a strain of the virus discovered in South Africa.
At least 30 million doses of the Johnson & Johnson vaccine have been secured, the minister said, adding that the country has also secured 30 million doses of the Pfizer vaccine this fiscal year.
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Pregnant and postpartum women who wish to get vaccinated encouraged to receive Pfizer or Moderna vaccines
From CNN's Jacqueline Howard
A nurse fills up a syringe with the Moderna Covid-19 vaccine at a vaccination site at a senior center on March 29 in San Antonio, Texas.
Sergio Flores/Getty Images
The American College of Obstetricians and Gynecologists (ACOG) announced on Tuesday that pregnant and postpartum women who wish to get vaccinated against Covid-19 are encouraged to receive either the Pfizer/BioNTech or Moderna vaccines rather than the Johnson & Johnson.
The announcement follows the US Centers for Disease Control and Prevention’s and the US Food and Drug Administration’s recommendation to pause the use of the Johnson & Johnson vaccine over blood clot concerns out of an “abundance of caution.”
“Individuals who have been vaccinated with the Johnson & Johnson vaccine within the last 21 days who experience severe headache, abdominal pain, leg pain, or shortness of breath should seek immediate evaluation,” the statement said.
“They should be certain to communicate that they have received the Johnson & Johnson vaccine to prompt appropriate evaluation. Given the elevated risk for thrombosis experienced by women during pregnancy or the postpartum period and while using birth control pills, evaluation of acute thrombosis is commonly performed in our specialty,” the statement continued.
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Nearly 23% of US population is fully vaccinated against Covid-19, CDC data shows
From CNN's Deidre McPhillips
A shot of the Johnson & Johnson COVID-19 vaccine is administered at Delaware County's drive through clinic at Delaware County Community College in Marple, Pennsylvania, on April 10.
Pete Bannan/MediaNews Group/Daily Times/Getty Images
More than 192 million doses of Covid-19 vaccine have been administered in the United States, according to data published Tuesday by the US Centers for Disease Control and Prevention.
The CDC reported that 192,282,781 total doses have been administered – about 78% of the 245,364,805 doses delivered.
That’s about 2.6 million more doses reported administered since yesterday, for a record-high seven-day average of nearly 3.4 million doses per day. The seven-day average has been topped 3 million doses for about a week.
Nearly 37% of the US population – about 122 million people – have received at least one dose of vaccine, and nearly 23% – more than 75 million people – are fully vaccinated, CDC data shows.
Note: Data published by the CDC may be delayed, and doses may not have been given on the day reported.
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Lockdown measures in the Netherlands to remain in place for another 2 weeks
From CNN’s Arnaud Siad and Mick Krever
Dutch outgoing Prime Minister Mark Rutte speaks during a press conference on Covid-19 measures in the Netherlands, in The Hague, on April 13.
Bart Maat/ANP/AFP/Getty Images
Most lockdown measures currently in place to tackle the Covid-19 pandemic in the Netherlands must remain in place until at least April 28, Prime Minister Mark Rutte said on Tuesday.
“The first step in the opening plan will be taken on April 28 at the earliest. Until then, the current coronavirus measures will continue to apply,” the government said in a statement.
The opening plan will consist of authorizing terraces and shops to open under certain conditions, the lifting of curfews and authorizing two guests per household instead of one.
It also says that the government will make an announcement on April 20 whether the opening plan can proceed on April 28.
Under current restrictions, the country is under an evening curfew and there is a ban on public gatherings of more than two people.
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No US governors pushed back on pausing J&J vaccinations during weekly Covid-19 call, official says
From CNN's Kaitlan Collins
A dose of the Johnson & Johnson coronavirus vaccine is seen on a table at the Northwell Health pop-up coronavirus vaccination site at the Albanian Islamic Cultural Center in Staten Island on April 8 in New York City.
Michael M. Santiago/Getty Images
No governors pushed back on putting a pause on Johnson & Johnson vaccinations during the White House’s weekly call with governors on the pandemic, an official familiar with the call said.
The call followed an earlier decision by the US Centers for Disease Control and Prevention and US Food and Drug Administration recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
The new announcement from the FDA and CDC means all federal health channels — mass vaccination sites, community health centers and the like — that were previously administering the Johnson & Johnson vaccine will immediately stop for the time being, according to a federal health official.
The agencies are recommending that states do the same, but it will be up to the individual states to make that decision because they are given a separate allocation of doses.
The pause happened because this type of blood clot is not listed on the list of potential adverse side effects that were part of the emergency use authorization for J&J.
While officials are stressing it is rare, they want health care providers to have time to understand what potential side effects are and how to best treat them.
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J&J European Union vaccine rollout "paused by the company," health commissioner says
From CNN’s Pierre Bairin in Paris
The rollout of the Johnson & Johnson coronavirus vaccine in Europe “has been paused by the company,” Stella Kyriakides, the European Union’s health commissioner, tweeted Tuesday, shortly after US health authorities recommended halting distribution of the vaccine in the United States.
Johnson & Johnson made a similar announcement earlier in the day. Kyriakides said the European Medicines Agency was monitoring developments with the vaccine and was in contact with the US Food and Drug Administration.
The vaccine has not yet been administered in the EU, health spokesperson Stefan De Keersmaecker said separately.
“It should be noted that as regards this vaccine, there is no data yet from the EU, as deliveries only began yesterday, and the vaccine has not yet been administered in the EU. The EMA therefore will have to rely on other regulators, from countries where the vaccine has been administered, such as the FDA, before deciding on next steps,” the statement continued.
See the EU health commissioner’s tweet:
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Don't "over-interpret" Johnson & Johnson vaccine news, former FDA commissioner says
From CNN’s Virginia Langmaid
Reports of clotting cases potentially connected to Johnson & Johnson’s Covid-19 vaccine should not be overblown, former Food and Drug Administration Commissioner Dr. Scott Gottlieb told CNBC on Tuesday.
“I want to be cautious not to over-interpret the report because it is an early report and we don’t have details about these six cases,” he said.
Gottlieb said his concerns now are getting mRNA vaccines – those made by Pfizer and Moderna – into areas where the Johnson & Johnson vaccine was being used, such as low-income and low-accessibility areas.
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Fauci says J&J vaccine may "come back," but doesn't want to speculate
From CNN's Jacqueline Howard
A Premise Health healthcare worker loads a syringe with the Covid-19 Johnson & Johnson Janssen vaccine on March 26, in Buffalo, West Virginia.
Stephen Zenner/Getty Images
The Johnson & Johnson coronavirus vaccine may return to being used in the United States following the recommendation to pause production, but more investigation is needed, and it would be premature to comment, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House press briefing on Tuesday.
“That’s the reason why the pause was done — so that they can take a good look at it, very carefully look at every factor,” Fauci said.
Some more context: The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the US pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.
Several states and cities — including Washington, DC, New York City and New Jersey — announced they would pause administration of the Johnson & Johnson vaccine. CVS and Walgreens also announced they would immediately pause use of the vaccine.
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Fauci: If you took the J&J vaccine more than a month ago, "you're OK"
From CNN's Maureen Chowdhury
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, speaks during a briefing in the press briefing room of the White House on April 13.
Pool
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said that people who took the Johnson & Johnson Covid-19 vaccine “a month or two ago” should not be concerned about the recommendation to pause production.
“You’re OK,” Fauci reassured during a White House press briefing.
Fauci explained that the recommendation to pause production of the vaccine, which resulted because of blood clot concerns, is “out of an abundance of caution.”
“People say, ‘what does a pause mean?’ It really allows the FDA and the CDC to further investigate these cases to try and understand some of the mechanisms of what it is, some more detail in the history of the individuals involved, it might shed some light, looking forward, what will happen and what we will do. That’s the first thing. The other thing is to make physicians out there aware of this… “So, the pause not only allows us to take a look at the cases and learn more but it is also a signal out there to help the physicians,”” Fauci said.
“This is a really rare event. If you look at what we know so far, there have been six out of the 6.85 million doses, which is less than 1 in a million. So remember, this is something that we always — really out of an abundance of caution… to see if we can get further information,” Fauci said.
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Decision to recommend pausing J&J vaccine came from FDA and CDC, not the White House, Fauci says
From CNN's Jason Hoffman
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a press briefing at the White House on April 13 in Washington, DC.
Patrick Semansky/AP
The decision to recommend pausing the use of the Johnson & Johnson Covid-19 vaccine was done out of “an abundance of caution” and made by the US Food and Drug Administration and Centers for Disease Control and Prevention, Dr. Anthony Fauci said Tuesday.
White House Covid response coordinator Jeff Zients said the White House was made aware of the decision from those agencies Monday night, but said the White House had “no other involvement” in the decision.
“This decision was made by the CDC and the FDA and that’s one of the things that’s I think such a good thing about our system here, is that we’re ruled by science, not by any other consideration. So the decision was really thoroughly made by the CDC and the FDA,” Fauci said during a briefing at the White House on Tuesday.
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J&J vaccine pause allows further investigation of blood clots, Fauci says
From CNN's Jacqueline Howard
The US Food and Drug Administration and US Centers for Disease Control and Prevention’s recommendation to pause the use of Johnson & Johnson’s coronavirus vaccine provides time to investigate the extremely rare cases of blood clots following vaccination, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House briefing on Tuesday.
“Our FDA is internationally known for their capability of making sure that we have the safest products out there and that’s what I meant when I said, ‘an abundance of caution.’ We want to make sure that safety is an important issue here,” Fauci said.
“We want to get this worked out as quickly as we can possibly can,” he added.
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J&J vaccine pause won't have "significant impact" on US vaccination efforts, White House coordinator says
From CNN's Adrienne Vogt
White House Coronavirus Response Coordinator Jeff Zients speaks during a briefing in the press briefing room of the White House on April 13.
Pool
White House Coronavirus Response Coordinator Jeff Zients said the the US Centers for Disease Control and Prevention and the US Food and Drug Administration’s recommendation to pause Johnson & Johnson Covid-19 vaccines won’t have a big impact right now on the country’s vaccination program.
“The J&J vaccine makes up less than 5% of the more than 190 million recorded shots in arms in the United States to date,” Zients said to reporters in the White House press briefing room.
“The President took action earlier this year, before the J&J vaccine was even authorized, to secure enough Pfizer and Moderna doses for 300 million Americans by the end of July,” Zients said.
This week, 28 million doses of Pfizer and Moderna vaccines will be made available, he said.
“We have more than enough supply of Pfizer and Moderna vaccines to continue the current pace of about 3 million shots per day,” Zients said.
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WHO is "watching closely" reports of clotting connected to Johnson & Johnson vaccine
From CNN’s Virginia Langmaid
A syringe is filled with a dose of the Johnson & Johnson Janssen Covid-19 vaccine at a vaccination site inside Reuther Hall at Forty Acres on March 13 in Delano, California.
Patrick T. Fallon/AFP/Getty Images
The World Health Organization will wait for further information on adverse events potentially related to Johnson & Johnson’s Covid-19 vaccine, the organization said Tuesday.
“We’re watching closely, waiting for EMA and FDA reviews, and monitoring the global database of adverse event reports to see if there have been cases anywhere else,” WHO said in an email to CNN, referring to the European Medicines Agency and US Food and Drug Administration. “It will take a little time to review the data.”
According to WHO, the organization’s Global Advisory Committee on Vaccine Safety will communicate any findings on these reports following a review of data. WHO encouraged national regulators to work together to compile information on adverse events, but said that events are still incredibly rare.
According to Gavi, the organization which handles manufacturing agreements for WHO’s vaccination efforts, the COVAX program has agreed to access 500 million doses of Johnson & Johnson’s vaccine for the purpose of global distribution.
Last week, WHO updated its recommendations on AstraZeneca’s vaccine to indicate there is a “plausible” link between AstraZeneca’s vaccine and clotting events.
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Delaware opens up vaccine eligibility to people 16 and older
Delaware opened up vaccination eligibility to people 16 and older on Tuesday, the governor said in a release.
“This news means that any eligible Delawarean who wants a COVID-19 vaccine should be able to get one — whether it’s at their doctor’s office, a local pharmacy, or a community vaccination event,” Gov. John Carney said in the statement.
The numbers: At least 568,003 vaccines doses have been administered in the state, according to the release.
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US health officials recommended pausing the J&J vaccine today. Here's what we know so far.
Doses of the Johnson & Johnson COVID-19 vaccine are prepared at a clinic targeting immigrant community members on March 25 in Los Angeles.
Mario Tama/Getty Images
The US Centers for Disease Control and Prevention and the US Food and Drug Administration this morning recommended that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine following reports of several cases of a “rare and severe” type of blood clot.
If you’re just reading in now, here’s what you need to know about the vaccine, the rare clots and what happens next:
Six cases after about 7 million doses: The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States. Of the six cases — all of whom were in women between the ages of 18 and 48 — one person died and another is in critical condition.
When the clots happened: With the six cases, symptoms occurred six to 13 days after vaccination, officials said today. The vaccine was authorized for emergency use on Feb. 27 and shots started going into arms a few days after, in early March.
How vaccine sites are reacting: Several states and cities — including Washington, DC, New York City and New Jersey — announced they would pause administration of the Johnson & Johnson vaccine. CVS and Walgreens also announced they would immediately pause use of the vaccine.
What happens next? It’s not clear how long the pause could last, but Dr. Janet Woodcock, the acting commissioner of the FDA, said she expects the pause to be “a matter of days.” The CDC will hold an emergency meeting of the Advisory Committee on Immunization Practices tomorrow to review the blood clot cases.
What if I’ve already gotten the Johnson & Johnson vaccine? For people who have received the Johnson & Johnson shot, those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, according to a statement from the FDA and CDC. And remember: These adverse events “appear to be extremely rare,” the statement said.
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FDA official says similarities between J&J and AstraZeneca vaccines are "plainly obvious"
From CNN's Jacqueline Howard
A dose of the Johnson & Johnson coronavirus vaccine is prepared on April 7 in New York City.
Michael M. Santiago/Getty Images
There appears to be similarities between the rare blood clotting events possibly associated with Johnson & Johnson’s coronavirus vaccine and the AstraZeneca coronavirus vaccine, Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday.
“It’s plainly obvious to us already that what we’re seeing with the Janssen vaccines looks very similar to what was being seen with the AstraZeneca vaccine,” Marks said. Janssen is the vaccine arm of Johnson & Johnson.
The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as “very rare side effects” of the AstraZeneca vaccine. The AstraZeneca vaccine isn’t in use in the United States but has been authorized in other countries.
The mechanism behind the blood clotting events among those who have received the Johnson & Johnson vaccine remains unknown – but may be similar to the mechanism behind possible events connected to the AstraZeneca vaccine, Marks said.
“We don’t have a definitive cause, but the probable cause that we believe may be involved here – that we can speculate – is a similar mechanism that may be going on with the other adenoviral vector vaccine,” Marks said. “That is that this is an immune response that occurs very, very rarely after some people receive the vaccine and that immune response leads to activation of the platelets and these extremely rare blood clots.”
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No clear link between potential J&J vaccine clotting events and birth control, FDA official says
From CNN's Jacqueline Howard
The rare blood clotting events among six people who have received the Johnson & Johnson coronavirus vaccine do not appear to be connected to birth control, but the events are still being investigated, Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday.
“At this time, it’s not clear that there’s any association with the oral contraceptive pill birth control in the individuals who had these blood clots,” Marks said.
Overall, Marks added that it’s too early to tell exactly how many blood clotting events may have occurred or may emerge in connection to the vaccine.
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Rio de Janeiro had more deaths than births for sixth month in row, government data shows
From CNN's Rodrigo Pedrosa and Mitchell McCluske
A general view of Caju cemetery is seen on March 24 in Rio de Janeiro, Brazil.
Buda Mendes/Getty Images
Rio de Janeiro, the second most populous city in Brazil, registered more deaths than births for the sixth month in a row ending in March, according to the Brazil’s civil registry.
There were 16% more deaths than births in Rio de Janeiro since October, with a total of 36,437 deaths and 32,060 births in those six months, according to the civil registry.
The city has been facing a surge in Covid-19 cases and deaths in the past months. When the pandemic reached its peak in the region last year, in May and June, Rio de Janeiro registered 52% more deaths than births.
Since the beginning of the pandemic, in March 2020, Rio de Janeiro had more births than deaths in only five out of thirteen months, according to the civil registry.
Rio de Janeiro currently has 237,974 confirmed cases of Covid-19 and 21,752 deaths, according to figures from the municipal health secretariat.
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US blood clot events after vaccination tied to 1 fatality
From CNN's Jacqueline Howar
One person who experienced a rare type of blood clot after receiving the Johnson & Johnson coronavirus vaccine has died and another is in critical condition, Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday.
The US Centers for Disease Control and Prevention and the FDA are recommending that the United States pause the use of Johnson & Johnson’s coronavirus vaccine following six reported US cases of a rare and severe type of blood clot.
All six cases occurred among women between the ages of 18 and 48, the CDC and FDA said, and symptoms occurred 6 to 13 days after vaccination.
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Acting FDA commissioner expects J&J Covid-19 vaccine pause to last "a matter of days"
From CNN Health’s Ashley Ahn)
Doses of the Johnson & Johnson Covid-19 vaccine are prepared at a clinic in Los Angeles, California, on March 25.
Frederic J. Brown/AFP/Getty Images
Dr. Janet Woodcock, acting commissioner of the US Food and Drug Administration, said she expects the pause of the Johnson & Johnson’s Covid-19 vaccine to be “a matter of days.”
The US Centers for Disease Control and Prevention and the FDA recommended the US pause the use of the Johnson & Johnson vaccine after six cases of a “rare and severe” blood clot were reported among the more than 6.8 million doses of the vaccine administered in the US.
The CDC will hold an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) tomorrow from 1:30 p.m. to 4 p.m. ET to review the blood clot cases. The FDA will also review the ACIP’s analysis as it investigates the cases.
Dr. Anne Schuchat, principal deputy director of the CDC, said Tuesday that the intent is to “provide an update regularly.”
“We are committed to an expeditious review of the available information, and to an aggressive outreach to clinicians so that they know how to diagnose, treat and report,” Schuchat said. “One of the things that the ACIP’s deliberation will do is review the data on the cases, and the context of risks, benefits and possible subsets of the population that may be in a different category.”
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Doctors and patients can decide whether to receive J&J vaccine, FDA official says
From CNN's Adrienne Vogt
A nurse prepares a Johnson & Johnson Covid-19 vaccine dose on March 25, in Los Angeles, California.
Frederic J. Brown/AFP/Getty Images
Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation & Research, said the recommendation to pause the Johnson & Johnson Covid-19 vaccine over blood clot concerns is “not a mandate.”
“A provider and patient can make the determination whether or not to receive the vaccine,” Marks said.
Dr. Anne Schuchat, principal deputy director of the US Centers for Disease Control and Prevention, said that 121 million people have been vaccinated with at least one dose of one of the three vaccines.
“With our intensive safety monitoring, we have not detected this type of syndrome with the low platelets among the other vaccines,” she said. “So we’re taking this pause and precautions around the J&J product in the context of a large, robust, and highly safe and effective vaccination effort.”
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Clotting events may be activated by immune response after vaccination, FDA leaders say
From CNN’s Virginia Langmaid
Clotting events that may be linked to Johnson & Johnson’s Covid-19 vaccine could be a result of an immune response, Dr. Peter Marks, director of the United States Food and Drug Administration’s Center for Biologics Evaluation and Research said on Tuesday.
Acting FDA Director Janet Woodcock called this the “leading” theory on the clotting response right now.
“The person being vaccinated makes an immune response potentially that actually involves their own platelets or other parts of the coagulation system and can cause this problem,” Woodcock said. “That’s the sort of leading theory or hypothesis about what’s going on here.”
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CDC vaccine advisers will meet about Johnson & Johnson Covid-19 vaccine at 1:30 p.m. ET Wednesday
From CNN's Ashley Ahn
The US Centers for Disease Control and Prevention will hold an emergency meeting of its Advisory Committee on Immunization Practices, or ACIP, from 1:30 to 4 p.m. ET Wednesday to review “rare and severe” blood clot cases among people who received the Johnson & Johnson Covid-19 vaccine.
The meeting will be virtual, with no in-person attendance.
The CDC and the US Food and Drug Administration have recommended that the United States pause the use of the Johnson & Johnson vaccine until the review is complete.
The FDA will also review the ACIP’s analysis as it investigates the cases, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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FDA official explains quick decision on pausing J&J vaccine
From CNN's Jacqueline Howard
The US Food and Drug Administration and US Centers for Disease Control and Prevention quickly made the recommendation to pause the use of the Johnson & Johnson coronavirus vaccine – even without giving states a heads up – because of concern that rare blood clot incidents might be treated inappropriately.
The rare type of blood clots observed in association with the vaccine require unique treatment, officials said. The six reported cases were among more than 6.8 million doses of the vaccine administered in the US.
“The issue here with these types of blood clots is that if one administers the standard treatment that we as doctors have learned to give for blood clots, one can cause tremendous harm,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday.
Marks added that health care providers had to be made aware of the pause immediately in case they see patients with possible blood clot symptoms.
“This was taken rapidly in order to honor our commitment to the American public to ensure that any safety signal was fully addressed in a transparent matter,” Marks said.
Acting FDA Commissioner Dr. Janet Woodcock also said during the briefing that the decision to recommend a pause was made quickly to alert the health care community.
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NYC pausing J&J vaccine administration at city-run sites immediately, mayor says
From CNN's Kristina Sgueglia
New York City Mayor Bill de Blasio speaks during a briefing on Tuesday, April 13.
NYC Media
New York City Mayor Bill de Blasio, who received the Johnson & Johnson shot himself along with the city’s top health official, said all city-run sites will stop administering the vaccine in light of federal recommendations.
“The federal government has called for a cautious approach here. We are acting on that immediately,” de Blasio said Tuesday. “Here in the city we are immediately pausing all Johnson & Johnson vaccinations.”
“We have a lot of work to do to figure out how to make other adjustments and obviously we’ll be watching very very carefully for the results of the federal investigation here.”
New York City so far has administered 234,000 doses of Johnson & Johnson vaccine and “thank god no reports at all of any blood clots, but we take this very seriously.”
“Look it’s a challenge, and certainly something that makes me sad given how much progress we’ve been making lately, but it’s also an example of an early warning system working,” De Blasio said.
“I received the shot, our health commissioner Dave Chokshi received the shot, we believe in the effectiveness of this vaccine, but obviously we take seriously any warning and it needs to be fully investigated,” he added.
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CDC official says these are the symptoms to look out for if you’ve had the J&J vaccine
From CNN's Adrienne Vogt
A healthcare worker loads a syringe with the Johnson & Johnson Covid-19 vaccine on March 26, in Buffalo, West Virginia.
Stephen Zenner/Getty Images
If you’ve already received the Johnson & Johnson Covid-19 vaccine, here’s what you can do to “be on alert,” according to the US Centers for Disease Control and Prevention’s Principal Deputy Director Dr. Anne Schuchat.
“While these events are very rare, we’re recommending a pause in the use of the J&J Covid-19 vaccine in order to prepare the health care system to recognize and treat patients appropriately and to report severe events they may be seeing in people who received the J&J vaccine,” she said.
Schuchat recommends that people be on the lookout for any serious symptoms, such as severe headache, abdominal pain, leg pain or shortness of breath.
“These symptoms are different from the mild flu-like symptoms — fever and so forth — that many people experience in the couple days after receipt of the vaccine. Importantly, there are three vaccines available. And we are not seeing these clotting events with low platelet counts with the other two vaccines. People who have vaccine appointments with the other vaccines [should] continue with their appointment,” Schuchat said.
While Johnson & Johnson vaccine appointments will be rescheduled, it may be a “bit bumpy,” she cautioned.
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Your risk is "very low" if you got the Johnson & Johnson vaccine more than a month ago, CDC official says
From CNN Health's Jacqueline Howard
The risk for people who have received the Johnson & Johnson coronavirus vaccine more than a month ago is “very low,” Dr. Anne Schuchat, principal deputy director of the US Centers for Disease Control and Prevention, said during a virtual briefing on Tuesday.
“For people who recently got the vaccine within the last couple of weeks, they should be aware to look for symptoms. If you received the vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your health care provider,” she added.
Shuchat added that the CDC is working on “aggressive” outreach to clinicians so they are aware of the possible risks and how to identify symptoms.
The CDC and US Food and Drug Administration recommended on Tuesday to pause the use of the Johnson & Johnson vaccine due to the risk of blood clots. There have been six reported cases among the more than 6.8 million doses of the vaccine administered in the US.
“The pause provides us time for deliberations,” Schuchat said.
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CVS and Walgreens pause administration of Johnson & Johnson Covid-19 vaccine
From CNN's Ashley Ahn and Samira Said
CVS and Walgreens are pausing use of Johnson & Johnson’s Covid-19 vaccine after the US Centers for Disease Control and Prevention and the US Food and Drug Administration recommended pausing use of the vaccine.
Six cases of a “rare and severe” type of blood clot were reported among more than 6.8 million doses of the vaccine administered in the United States.
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“We are immediately implementing a pause in the use of the Johnson and Johnson’s COVID-19 vaccine per the recommendation from federal health agencies,” CVS spokesperson Ethan Slavin tells CNN.
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Johnson & Johnson release a statement addressing Covid-19 vaccine concerns
Frederic J. Brown/AFP/Getty Images
Johnson & Johnson released a statement addressing concerns over their vaccine after the FDA and CDC paused use of the vaccine in the US “out of an abundance of caution.”
The company said they “are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals,” and are reviewing these cases with US and European health authorities.
J&J stressed that there have so far been six cases out of more than 6.8 million doses administered.
If you have already received the vaccine, “and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination” you should contact your health care provider, the company said.
Read the full statement here:
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NOW: CDC and FDA officials give an update following Johnson & Johnson vaccine pause
A healthcare worker loads a syringe with the Johnson & Johnson Covid-19 vaccine on March 26, in Buffalo, West Virginia.
Stephen Zenner/Getty Images
The US Food and Drug Administration and the US Centers for Disease Control is holding a media call right now after the agencies recommended this morning that the US pause Johnson & Johnson vaccine use over blood clot concerns.
The six reported cases were among more than 6.8 million doses of the vaccine administered in the US.
All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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Moderna says its Covid-19 vaccine is not associated with blood clots
From CNN's Jacqueline Howard
Vaccine maker Moderna said in a Twitter post on Tuesday that its Covid-19 shot does not appear to have an association with blood clots.
The statement comes just a few hours after the US Centers for Disease Control and Prevention and the US Food and Drug Administration recommended that the use of the single-dose Johnson & Johnson Covid-19 vaccine be paused in the United States due to rare events involving blood clots.
“A comprehensive assessment of the totality of the available safety data for mRNA-1273 after over 64.5 million doses administered globally does not suggest an association with cerebral venous sinus thrombosis (CVST) or thrombotic events,” Moderna tweeted, referring to its vaccine, named mRNA-1273.
Moderna’s safety analyses was performed used data through March 22, 2021, according to the tweet.
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FDA explains how it's reviewing Pfizer's request to expand vaccine to children ages 12 to 15
From CNN's Jacqueline Howard and Michael Nedelman
The US Food and Drug Administration confirmed to CNN on Tuesday that its Vaccines and Related Biological Products Advisory Committee is not expected to meet as part of Pfizer/BioNTech’s request on Friday to expand the age range for its Covid-19 vaccine to includes children ages 12 to 15.
When companies apply for emergency use authorization, or EUA, of their vaccines, the advisory committee typically reviews data and makes a recommendation to the FDA. Previously, it has taken an average of three weeks from submission to authorization for Covid-19 vaccines.
But for this Pfizer/BioNTech request, which would be an amendment to an existing EUA, the committee is not expected to be involved. This could mean a quicker turnaround than the initial authorization, but the FDA did not give a timeline for the decision.
“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” FDA spokesperson Abigail Capobianco told CNN in an email.
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White House says J&J pause won't have a "significant impact on our vaccination plan"
From CNN's Kaitlan Collins
The recommended pause in the use of the Johnson & Johnson vaccine will not impact the Biden administration’s vaccination plan, White House Covid-19 Response Coordinator Jeff Zients said Tuesday.
“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” Zients said.
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Scotland will allow travel to England and Wales starting April 26
From Amy Cassidy
Scotland will allow its citizens to travel to and from England and Wales starting April 26, First Minister Nicola Sturgeon announced on Tuesday, as “encouraging” recent data allows for an acceleration of easing lockdown measures.
Northern Ireland is due to review its restrictions later this week, “so we will review our approach to travel there before 26 April and we hope that that can be freed up to,” she said, adding: “It may still be necessary in future to have temporary travel restrictions to and from places with high rates of Covid, either within Scotland or other parts of the UK.”
Friday will see the “Stay Local” rule lifted, meaning Scots will be able to leave their local area “for the purposes of outdoor socialising, recreation, and informal exercise.” Six adults from up to six households will also be able to meet outdoors, up from four adults from two households as is currently the rule.
April 26 will see wider travel permitted, as well as the reopening of all shops and pubs, restaurants and cafes – indoors as well as outdoors.
“It is worth noting that the restricted indoor opening of hospitality on 26 April will be three weeks ahead of any indoor opening of hospitality in England,” Sturgeon said.
Cases in Scotland are at the lowest level since September, she said, and have declined by more than 85% since early January. The nation has seen higher infection rates than in other parts of the UK in recent weeks, however cases are now “falling consistently” with a 40% reduction in the last two weeks alone, she added.
Most of the country has been in lockdown since Dec. 26. Out of a population of 5.4 million, 2,682,706 people have been vaccinated against Covid-19 with a first dose and 605,126 people with a second dose as of Tuesday, the First Minister said.
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Expert urges people to get vaccinated: "The risk-benefit ratio is way in favor of benefit"
From CNN’s Virginia Langmaid
Even with news of potential issues from Covid-19 vaccines, vaccination in general is still worth the risk, Emory University executive associate dean of medicine Dr. Carlos del Rio told CNN on Tuesday.
Earlier this morning, the US Centers for Disease Control and Prevention and the Food and Drug Administration recommend US pause Johnson & Johnson vaccine use over blood clot concerns “out of an abundance of caution.” The six reported cases were among more than 6.8 million doses of the vaccine administered in the US.
Del Rio said it is still important to continue vaccinations and for federal agencies to understand any potential side effects.
“I would recommend people get vaccinated. I would not say ‘do not get vaccinated just because of this very rare side effect,’” he said. “I would say that it’s the right thing to do for the CDC and the FDA to hold the vaccinations with the J&J vaccine, until we understand further what’s going on.”
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A look at Johnson & Johnson's Covid-19 vaccine, by the numbers
From CNN Health’s Deidre McPhillips
Doses of the Johnson & Johnson Covid-19 vaccine are prepared at a clinic in Los Angeles, California, on March 25.
Mario Tama/Getty Images
US Centers for Disease Control and Prevention and Food and Drug Administration today recommend US pause Johnson & Johnson vaccine use over blood clot concerns “out of an abundance of caution.” The six reported cases were among more than 6.8 million doses of the vaccine administered in the US.
Since we’re talking a lot about the Johnson & Johnson vaccine today, here’s a look at it by the numbers:
Since the Johnson & Johnson Covid-19 vaccine was authorized for emergency use in the United States at the end of February, it has accounted for about 1 in every 17 shots administered in the United States.
Of the nearly 121 million people who have received at least one dose of Covid-19, less than 6% — fewer than 7 million — have received Johnson & Johnson’s single-dose shot.
Federal allocations of the Johnson & Johnson vaccine have varied widely week-to-week, with close to 5 million doses available for states to order from one week and fewer than 500,000 doses available another. Allocations of the Pfizer/BioNTech and Moderna vaccines, however, have remained largely consistent.
Data from the US Centers for Disease Control and Prevention shows that states and other jurisdictions have received more than 16 million doses of the Johnson & Johnson vaccine, suggesting that they’re sitting on more than 9 million unused doses. And even 16 million doses delivered to states and jurisdictions is a fraction of the 100 million doses the company has committed to provide to the US by the end of May.
According to Andy Slavitt, the White House’s senior adviser for Covid-19 response, the US is “not dependent” on additional Johnson & Johnson vaccine to reach its vaccination goals.
“If you do the math, there is plenty of supply to continue to vaccinate Americans at 3 million per day, and then some. That’s not to mention the fact that there are many doses that have already been distributed into states,” Slavitt said at a virtual White House briefing on Monday.
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New York following pauses Johnson & Johnson vaccine statewide
From CNN's Brynn Gingras
A dose of the Johnson & Johnson coronavirus vaccine is prepared at a pop-up vaccination site on April 8, in New York City.
Michael M. Santiago/Getty Images
New York state is following the recommendation of the CDC and FDA and pausing the use of the Johnson & Johnson vaccine statewide, New York’s top health official said Tuesday.
All prescheduled appointments scheduled for the Johnson & Johnson vaccine will be honored with the Pfizer vaccine, Health Commissioner Howard Zucker said Tuesday in a statement.
He reiterated, echoing the federal agencies, that any adverse events related to the Johnson & Johnson vaccine appear to be extremely rare.
He encouraged people who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks to contact their medical providers.
“I am in constant contact with the federal government and we will update New Yorkers as more information becomes available,” Zucker said in a statement
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Tokyo 2020 Paralympics accredited guests reduced
From CNN's Aleks Klosok
The International Paralympic Committee (IPC) is reducing the number of people it will accredit as guests for the rearranged Tokyo 2020 Paralympic Games, the governing body announced on Tuesday.
The Tokyo 2020 Paralympics are scheduled to run from Aug. 24 until Sept. 5.
The reduction in guests pertains to IPC Honorary Board members (with the exception of international dignitaries) and participants from the 14 Recognized International Sport Federations including Presidents or Secretaries General.
There will also be a “significant reduction” in the number of IPC honored guests, distinguished guests and IPC guests, while National Paralympic Committee (NPC) Guest Passes providing access to the Paralympic Village have also been cancelled.
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White House is taking Johnson & Johnson vaccine news "extremely seriously," Biden adviser says
From CNN's Betsy Klein
White House economic adviser Jared Bernstein offered some of the Biden administration’s first on-camera reaction to news that the Johnson & Johnson vaccine would be paused following concerns regarding severe blood clot cases, saying the administration is taking it “extremely seriously” and largely declining to forecast what it means for reopening the economy.
As for the economic impact of the pause, with markets down on the news, he declined to forecast those implications, but acknowledged, “There is a clear connection — in fact we’ve said this from the beginning, Andrew, and so has Chair Powell — between controlling the virus, distributing the vaccine, and a robust and lasting economic recovery.”
Later adding that “recovery is very much a function of people feeling and being willing to reengage with commerce,” Bernstein otherwise declined to directly say how this could change reopening predictions.
“What I can’t answer now is your question which is what is the impact about what we’re hearing about on this timeline trajectory. Because I just don’t have that information and it wouldn’t be at all useful for me to speculate,” he said.
But asked whether it changes the timing on infrastructure, he said it would not.
“It is just as important as it was a few hours ago that we make the requisite investments in broadband, in grid, in water, in modernizing our schools, our hospitals, and our ports and our airports and our rail,” he said, adding that infrastructure “will continue to be a top priority for our economic team and our president.”
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Washington, DC, cancels all Johnson & Johnson Covid-19 vaccine appointments for 5 days
From CNN's Kristen Holmes
Following the CDC and FDA’s recommendation to pause the Johnson & Johnson vaccine use over blood clot concerns, the District of Columbia health department is canceling appointments for those scheduled to receive it from today until Saturday.
The department will send out invitations to reschedule the appointments for a later date.
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New York Javits Center suspends use of Johnson & Johnson vaccine
From CNN's Brynn Gingras
Administration of the Johnson & Johnson vaccine has been immediately suspended at the Javits Center state facilitated vaccinated site, according to its SVP and Chief Communication Officer Tony Sclafani.
This comes after the US Centers for Disease Control and Prevention and the US Food and Drug Administration recommend that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported US cases of a “rare and severe” type of blood clot.
Anyone who had an appointment to receive the J&J vaccine will be offered Pfizer, Sclafani said. It’s unclear how man appointments were scheduled for J&J that will now be altered.
Following production issues, Johnson & Johnson doses were already expected to be significantly lower across the state of New York this week, as well as across other states.
New York was expected to receive just 34,900 J&J shots – a drop of 88% week-over-week, Gov. Andrew Cuomo said Friday.
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Experts worry Michigan could be a warning sign for what could becoming in other parts of the US soon
Just how bad are things in the state? Covid-19 cases per million people are four times higher what they were in mid-February. The percent of positive tests are also four times higher than the numbers then.
In one part of the state, emergency room physician Dr. Rob Davidson told CNN that hospitalizations have gone up “four fold in just the last two weeks.”
“Because we are seeing so many cases a day, our public health system is overwhelmed,” she said. “We are not able to get information on many cases nor are we able to identify their close contacts.”
A doctor's advice for those who have gotten the Johnson & Johnson vaccine: "You're likely going to be okay"
From CNN's Naomi Thomas
A registered nurse administers a Johnson & Johnson Covid-19 vaccine in Lakewood, California, on March 31.
Irfan Khan/Los Angeles Times/Getty Images
Dr. Carlos del Rio, executive associate dean at Emory University School of Medicine, said on CNN’s “New Day” Wednesday that people who have gotten the Johnson & Johnson Covid-19 vaccine will likely be OK, but they should be attuned to their body for possible symptoms.
On Wednesday, the US Centers for Disease Control and US Food and Drug Administration recommended that the US pause use of Johnson & Johnson’s Covid-19 vaccine over six reported cases or “a rare and severe type of blood clot.”
“So, I think what people need to be is, don’t freak out, I’ll be going on with my life, but I would be very attuned to my body,” he continued.
He continued: “If I develop shortness of breath, if I develop leg pain, if I develop a headache and I’m within two to three weeks of having had Johnson & Johnson’s vaccine, I would immediately notify my health care provider.”
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German government agrees on law change that would give it more powers to battle Covid-19
From Inke Kappeler in Berlin
The German federal cabinet has agreed to amend the country’s Infection Protection Act that enables the federal government to impose nationwide curfews and lockdowns during the coronavirus pandemic.
The so-called “federal emergency brake” automatically overrules measures in Germany’s 16 states if the seven-day-incidence of new coronavirus infections surpasses 100 per 100,000 residents in an administrative district for three consecutive days, Chancellor Angela Merkel told a press conference on Tuesday in Berlin.
“We may now overburden our health care system” and we must help health care workers to overcome the pandemic, Merkel said.
“Our fight against the pandemic must be more stringent. We must stop the third wave,“ Merkel urged. “I am aware that these are hard limitations,” she added.
At present, only one state, Schleswig-Holstein on the northern coast, records an incidence-rate under 100, all other states report higher levels, Saxony and Thuringia are even above 200, as monitored by Germany’s Robert Koch Institute.
The proposed law change must now go before Germany’s parliament for approval. For a nationwide lockdown to be implemented, Parliament must have consented to the Act and the incidence-rate threshold must be surpassed.
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"Don’t freak out" over Johnson & Johnson vaccine pause, infectious diseases professor says
From CNN's Adrienne Vogt
Dr. Carlos del Rio said it’s the “right move” for the Centers for Disease Control and Prevention and the US Food & Drug Administration to recommend that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported cases of a “rare and severe” type of blood clot.
“It’s rare. But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more and really trying to understand what’s going on. I think vaccine safety has always been a priority. And I think this is exactly the right move until we understand what’s going on and what’s the way forward,” del Rio, the executive associate dean of Emory School of Medicine & Grady Health System, said on CNN’s “New Day.”
More than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States. All six cases of the blood clot occurred among women ages of 18 and 48.
“I would still recommend people get vaccinated. I would not say do not get vaccinated just because this very rare side effect,” he added.
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India will fast-track emergency use authorization for Covid-19 vaccines approved in other countries
From CNN's Aditi Sangal
India will fast-track emergency use authorization for Covid-19 vaccines that have been granted approval in the US, Europe, UK and Japan or have have been listed for emergency use by the World Health Organization, the Indian Minister for Health and Family Welfare Dr. Harsh Vardhan announced Tuesday.
The goal of this move is to “augment our basket of Covid-19 vaccines,” he said in a tweet, adding that the decision was made based on the recommendations of India’s expert group on vaccine administration NEGVAC.
This comes as India, a country of nearly 1.4 billion people, is witnessing a record surge in Covid-19 cases despite rolling out one of the fastest vaccination drives in the world.
India’s total caseload stands at more than 13.6 million — second only to the US — including more than 171,000 fatalities. Vaccinations topped 100 million, with India being the fastest country globally to reach that milestone, reaching the figure in just 85 days, the health ministry said.
In announcing the latest vaccine plans, Dr. Harsh Vardhan also said that government plans to assess the first 100 beneficiaries of such foreign vaccines for seven days for safety outcomes before it is further rolled out within the country. However, it’ll be mandatory to conduct post-approval parallel bridging clinical trial as per prescribed provisions.
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Federal health channels will stop using J&J vaccine immediately, White House says
From CNN's Kaitlan Collins
A Johnson & Johnson Covid-19 vaccine is prepared at a vaccination clinic in Lakewood, CA, on March 31.
Irfan Khan/Los Angeles Times/Getty Images
The new announcement from the FDA and CDC means all federal health channels – mass vaccination sites, community health centers and the like – that were previously administering the Johnson & Johnson vaccine will immediately stop for the time being, according to a federal health official.
The agencies are recommending that states do the same, but it will be up to the individual states to make that decision because they are given a separate allocation of doses.
The pause happened because this type of blood clot is not listed on the list of potential adverse side effects that were part of the emergency use authorization for J&J. While officials are stressing it is rare, they want health care providers to have time to understand what potential side effects are and how to best treat them.
The CDC and FDA came to a decision late last night, a federal health official said. The two agencies will do a press call at 10 a.m. this morning to answer more questions about the development.
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CDC and FDA recommend US pause Johnson & Johnson vaccine use over blood clot concerns
From CNN’s Elizabeth Cohen
The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over “six reported US cases of a rare and severe type of blood clot.”
A federal official previously told CNN that US health agencies were taking concerns about blood clots and the Johnson & Johnson vaccine “seriously.”
An expert outside the government who is familiar with the situation agreed that health officials are taking the matter seriously.
There have been “four serious cases of unusual blood clots” reported after people received the Johnson & Johnson vaccine, according to European health authorities. Like their US counterparts, the European authorities are investigating these cases and that “it is currently not clear” whether there’s a causal association between the vaccine and the clots.
The concern in the United States isn’t just about the Johnson & Johnson shot per se.
At a time when US health officials are encouraging Americans to get vaccinated as soon as they can, there’s a worry that news coverage about clots being studied in relation to Johnson & Johnson’s vaccine might make some Americans more hesitant to get any Covid-19 vaccine.
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"Don't declare victory prematurely," Fauci warns
From CNN's Christina Maxouris
Dr. Anthony Fauci testifies during a Senate Health, Education, Labor and Pensions Committee hearing in Washington, DC, on March 18.
But that’s not all the US needs to be doing right now. Dr. Anthony Fauci, the US’ top infectious disease expert, told CNN Monday night that the country shouldn’t “declare victory prematurely.”
But with a combination of the fast vaccinations and a doubling down on safety measures, the US could soon see a “turnaround,” Fauci continued, and cases could start to come down again.
India approves use of Russia's Sputnik V Covid--19 vaccine
From CNN's Manveena Suri in Delhi
India’s drug regulator has approved the Russian-made coronavirus vaccine Sputnik V as the country grapples with a second wave.
Sputnik V is the third coronavirus vaccine to get emergency use approval after Covishield, developed by Oxford-AstraZeneca and manufactured by the Serum Institute of India, and the Indian firm Bharat Biotech’s Covaxin.
Sputnik V, which has been approved for use in 60 countries across the world, is manufactured in India by the company, Dr. Reddy’s Laboratories.
In September, the pharmaceutical firm partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and distribute the vaccine in India, according to a press release issued by Dr. Reddy’s Laboratories.
The bigger picture: India reported 161,736 new cases of coronavirus on Tuesday, a slight dip following six consecutive days of record single-day rises, according to a CNN tally of figures from the Ministry of Health.
The country has recorded a total of 13,689,453 cases, which includes 171,058 deaths and 1,264,698 active cases.
A total of 108,533,085 vaccine doses have been administered and so far, to health and frontline workers and people aged 45 and above.
Several states have announced tighter restrictions to curb the spread of coronavirus. On Monday, the northern state of Haryana announced a nightly curfew to come into immediate effect from 9:00 p.m. till 5:00 a.m. until further notice.
The capital territory of Delhi, which reported 11,491 cases on Monday, is preparing for a surge in cases.
The state government has declared 14 private hospitals in the capital be made into “full COVID-19” hospitals and asked them not to admit patients other than those infected with coronavirus. Nineteen private hospitals have been directed to reserve at least 80% of their ICU beds for Covid patients while a further 82 private hospitals have been asked to reserve 60% of their ICU beds for coronavirus patients, according to an order tweeted by Delhi Health Minister Satyendar Jain.
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Thailand bans "water splashing" at New Year festival as Covid-19 cases rise
From CNN's Kocha Olarn in Bangkok
Thailand’s government bans “water splashing” at its Songkran New Year water festival after the country reported record numbers of new coronavirus infections for three consecutive days.
On Tuesday, Thailand reported 965 new Covid-19 cases, bringing its total number of cases to 34,575 including 97 deaths from the virus.
Often referred to as the world’s biggest water fight, Songkran is a three-day festival during which revelers splash water – a symbol of cleansing and purification – on each other. This year’s main days of celebration start Tuesday and run through to Thursday though some Thai cities have been known to stretch out the fun a few extra days.
The government will allow religious activities and “mild watering” with coronavirus measures in place.
According to Thailand’s Ministry of Interior’s website, there are 41 provinces where mandatory quarantine is required but enforced at various degrees of restrictions and conditions.
Dr Opas Karnkawinpong said during Tuesday’s government press briefing that the prime minister has urged companies to resume working from home after the holiday is over.
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Germany reports more than 10,000 single-day Covid-19 cases
From CNN's Samantha Beech
Medical staff prepares samples from students at a new built COVID-19 test center for the beginning of the new semester at the university in Dortmund, Germany, on April 12.
Martin Meissner/AP
Germany reported an increase of 10,810 Covid-19 cases on Tuesday, according to data from the Robert Koch Institute, the country’s national agency for disease control and prevention.
The reported death toll in Germany rose by 294 to 78,746.
The country has now reported 3,022,323 Covid-19 cases, with Chancellor Angela Merkel emphasizing the urgent need for people in Germany to be vaccinated to break the third wave.
One to watch today: Merkel is expected to meet with Cabinet members on Tuesday to discuss ways to slow down the third wave.
Germany has seen a consistent rise in cases. On Saturday, the director of the German intensive care association tweeted that the country’s ICUs had reached “peak” capacity. Christian Karagiannidis warned that even with a hard lockdown, numbers will continue rising for the next 10 to 14 days and added that healthcare workers are “breaking down.”
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UK variant more transmissible but not as severe, new studies suggest
From CNN Health's Jacqueline Howard
Two new studies suggest that the B.1.1.7 coronavirus variant, which was first identified in the United Kingdom, is more transmissible, but the variant does not appear to affect disease severity.
The new findings clash with separate research that previously suggested the variant may be tied to a higher risk of dying from Covid-19.
One of the new studies, published on Monday in The Lancet Infectious Diseases, found no evidence in a sample of hospitalized patients that the B.1.1.7 variant is associated with severe Covid-19. However, the variant was associated with increased viral load, which supports the growing evidence that it is more easily transmissible.
The other study, also published on Monday in The Lancet Public Health, found no statistically significant association between the B.1.1.7 variant and the types or duration of Covid-19 symptoms people said that they experienced.
The Lancet Infectious Diseases study included data on 496 people who were admitted to hospitals in London and tested positive for coronavirus infection.
Nose and throat swab samples were collected from the patients between November 9 and December 20. Among those samples, 341 underwent genome sequencing. The sequence data showed that 198 of the patients, or 58%, had infections caused by the B.1.1.7 variant while the others were cased by other strains of the coronavirus.
The researchers found no difference in the outcome of severe disease or death between the variant and other lineages.
But the researchers identified increased viral load among the B.1.1.7 patients.
The Lancet Public Health study included data on 36,920 people who reported testing positive for Covid-19 and logged their symptoms into the COVID Symptom Study app between September 28 and December 27.
The app – designed by designed by researchers at King’s College London, Guys and St Thomas’ Hospitals and the tech company Zoe Global Limited – helps track the spread of Covid-19 and the range of symptoms experienced.
The study’s authors, based in the United Kingdom and the United States, analyzed the data reported in the app along with Covid-19 surveillance data for the UK.
The analysis showed that the prevalence of the B.1.1.7 variant in certain regions and over time was not associated with changes in Covid-19 symptoms reported in the app or the duration of symptoms.
The researchers found that the rate of coronavirus reinfections was low – with 0.7% of app users who reported a positive Covid-19 test, testing positive again after 90 days – and there was no evidence of increased reinfection rates associated with the B.1.1.7 variant.
UK hits Covid vaccination target, PM praises the "precious" protection vaccines offer
From CNN’s Arnaud Siad and Sarah Dean
Prime Minister Boris Johnson leaves number 10, Downing Street in London, on April 12.
Leon Neal/Getty Images
The United Kingdom has reached its Covid-19 vaccination target of offering doses to all adults over 50, the clinically vulnerable, and social care workers, the British government said in a statement on Monday.
The statement said the target had been reached ahead of schedule, with the government having pledged to offer a first dose to priority cohorts by April 15.
The UK has now administered nearly 40 million doses, and fully vaccinated 7.4 million people, according to data from Johns Hopkins University.
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Recording reveals Bolsonaro asked senator to investigate governors and mayors for handling of the pandemic
From CNN's Rodrigo Pedroso in Sao Paulo
President of Brazil Jair Bolsonaro speaks at the Planalto Palace, Brasilia, Brazil, on March 31.
Mateus Bononi/Getty Images
Brazilian President Jair Bolsonaro asked a senator to expand a parliamentary inquiry into the federal government’s handling of the Covid-19 pandemic, to include mayors and governors, according to a recording of the conversation.
Sen. Jorge Kajuru published a recording of his conversation with Bolsonaro on social media, which Bolsonaro condemned on Monday. Bolsonaro said he did not know he was being recorded, and called for the full conversation to be released, which Kajuru then did.
The phone call: In the recording, Bolsonaro said that if the inquiry is not expanded, then only the federal government and its allies will be investigated.
In the full recording, Bolsonaro also cursed opposition leader Sen. Randolfe Rodrigues, calling him “a punk” and saying if the commission didn’t change the scope, he would have to “kick his ass.”
The investigation: Last week, Supreme Court judge Luis Roberto Barroso ordered a parliamentary inquiry to be opened by the Brazilian Senate on the federal government’s actions on handling the pandemic.
The inquiry would examine the possibility Bolsonaro and other federal, state and local leaders made omissions that led to hospital systems collapsing at the beginning of the year. Several Covid-19 patients reportedly died in the city of Manaus due a lack of oxygen.
Barroso’s order is expected to be voted on by the Court on Wednesday.
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US official: Health authorities are taking reports of blood clots and J&J vaccine "seriously"
From CNN's Elizabeth Cohen
An Army medic removes vials of Johnson & Johnson Covid-19 vaccine from a box at a vaccination site in Orlando, Florida, on April 10.
Paul Hennessy/SOPA Images/Sipa USA
US health agencies are working to assess whether the Johnson & Johnson Covid-19 vaccine is associated with a very small increased risk of rare blood clots, a federal official told CNN.
An expert outside the government who is familiar with the situation agreed that health officials are taking the matter seriously.
“The CDC is very concerned and they’re very working hard on this and monitoring this closely,” said the expert, who spoke on the condition of anonymity due to the sensitive nature of the issue.
Cases so far: There have been “four serious cases of unusual blood clots” reported after people received the Johnson & Johnson vaccine, according to European health authorities.
Some of the types of blood clots observed are relatively common, such as deep vein thrombosis, so it wasn’t surprising that among roughly 20,000 participants who received the vaccine, some would experience those clots.
What made FDA scientists take note, however, is that in the trial, about the same number of people received a placebo – a shot of saline that does nothing – as received the vaccine. However, when comparing the two groups, more study participants developed clots after receiving the vaccine than the placebo.
The link is “not clear: Like their US counterparts, the European authorities say they’re still investigating these cases and that “it is currently not clear” whether there’s a causal association between the vaccine and the clots.