April 13, 2021 coronavirus news | CNN

April 13 coronavirus news

A nurse fills a syringe with a dose of the Johnson & Johnson COVID-19 vaccine at Wayside Christian Mission on March 15, 2021 in Louisville, Kentucky.
Would-be recipient of Johnson & Johnson vaccine reacts to pause
02:19 - Source: CNN

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FDA: Decision to authorize Pfizer vaccine for 12- to 15-year-olds could be made "in a couple of weeks"

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.

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.

College campuses are feeling the fallout from J&J interruption

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.

Johnson & Johnson pausing vaccinations in all clinical trials

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.

Don't dismiss men who have symptoms of an adverse event after J&J vaccine, FDA says

Prepared doses of the Johnson & Johnson COVID-19 vaccine sit in a box on March 6 in Thornton, Colorado.

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. 

Moderna says its Covid-19 vaccine is more than 90% effective for at least six months

A nurse prepares the Moderna Covid-19 vaccine at the West Wales General Hospital on April 7 in Carmarthen, Wales.

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 recently announced that its Covid-19 vaccine appears to provide protection for at least six months after the second dose.

Pfizer will deliver Covid-19 vaccines to the US ahead of schedule

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.

Protection from mRNA Covid-19 vaccines likely lasts at least nine months, FDA official says

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.

Variants account for about 78% of recent Covid-19 cases in New York City, data shows

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. 

Covid-19 cases among US children increased slightly last week

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. 

Arkansas governor will pause use of J&J vaccine to better understand reactions

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.

Canada reports first case of rare blood clot with AstraZeneca's Covid-19 vaccine

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.

CDC vaccine advisers will meet about Johnson & Johnson's vaccine tomorrow

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.

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.

Turkey announces partial lockdown as daily Covid-19 cases hit record high

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. 

Biden reacts to J&J vaccine pause and says there is enough vaccine for every American

President Joe Biden speaks before a meeting in the Oval Office of the White House on April 13 in Washington, DC.

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.

South Africa suspends rollout of Johnson & Johnson Covid-19 vaccine

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.

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.

Pregnant and postpartum women who wish to get vaccinated encouraged to receive Pfizer or Moderna vaccines

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.

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.

Nearly 23% of US population is fully vaccinated against Covid-19, CDC data shows

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.  

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. 

Lockdown measures in the Netherlands to remain in place for another 2 weeks

Dutch outgoing Prime Minister Mark Rutte speaks during a press conference on Covid-19 measures in the Netherlands, in The Hague, on April 13.

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.

No US governors pushed back on pausing J&J vaccinations during weekly Covid-19 call, official says

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.

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. 

J&J European Union vaccine rollout "paused by the company," health commissioner says

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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