April 14, 2021, Covid-19 vaccine and world news | CNN

April 14 coronavirus news

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Johnson & Johnson Covid-19 vaccine under review after 6 cases of blood clots
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MLB player tests positive for Covid-19 after refusing vaccine

Minnesota Twins' Andrelton Simmons  seen during a baseball game against the Seattle Mariners, Saturday, April 10, in Minneapolis.

Major League Baseball’s Minnesota Twins shortstop Andrelton Simmons has tested positive for Covid-19 after refusing to be vaccinated against the virus.

In late March, Simmons said in a tweet, he would not be getting or advocating for the vaccine due to “personal reasons and past experience.” 

Simmons is currently experiencing “very mild symptoms” and is resting comfortably at home, according to the Twins’ president of baseball operations Derek Falvey.

Simmons was notified of the positive test after Tuesday’s game against the Boston Red Sox and was placed on the Covid-19 protocol list before Wednesday’s doubleheader against the Red Sox.

Falvey added, “We’re not out of the woods by any means on that front. Now is the time to be as vigilant as possible.”

NIH director on J&J Covid-19 vaccine pause: "We need to figure this out"

The pause on the Johnson & Johnson Covid-19 vaccine will allow researchers to investigate a potential link to severe blood clotting events, particularly whether certain populations are more susceptible, National Institutes of Health Director Dr. Francis Collins said Wednesday.

The US Centers for Disease Control and Prevention and FDA 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.

Collins said that individuals who experience this kind of event have extremely low platelet counts, “because they’ve essentially been consumed.”

Collins noted that the concerns are similar to those raised with the AstraZeneca Covid-19 vaccine, which also uses an adenovirus vector platform.

“Some possibility here that it’s something about the vector that in a very rare individual sets off this cascade,” he said. “We need to figure this out.”

More context: The cases of severe blood clots after vaccination with the J&J vaccine in the US were all among women. Collins noted that the pause will allow researchers to investigate whether particular populations are more susceptible and should perhaps not take the vaccine.

He assured people that the pause will not set back the vaccination effort in the US.

“In fact, the J&J vaccine supply was the smallest of the three and was not going to be particularly critical to get us to the point where everybody would have vaccine access by the end of May, or certainly by June,” Collins said.

About 195 million Covid-19 vaccine doses administered in the US, according to CDC data

Healthcare workers wait for people to arrive for their Covid-19 vaccine at Florida Memorial University Vaccination Site in Miami Gardens, Florida on April 14.

Nearly 195 million doses of Covid-19 vaccine have been administered in the United States, according to data published Wednesday by the US Centers for Disease Control and Prevention. 

The CDC reported that 194,791,836 total doses have been administered, about 78% of the 250,998,265 doses delivered. 

That’s about 2.5 million more doses reported since yesterday, for a 7-day average of about 3.3 million doses per day. 

By the numbers: About 37% of the US population – nearly 124 million people – have received at least one dose of vaccine, and about 23% of the US population – about 76.7 million people – are fully vaccinated, CDC data showed.

Data published by the CDC may be delayed, and doses may not have been given on the day reported.

CDC vaccine advisers end emergency meeting without voting on J&J vaccine

Vaccine advisers to the US Centers for Disease Control and Prevention ended an emergency meeting Wednesday without voting on changing any recommendations for Johnson & Johnson’s coronavirus vaccine.

Members of the committee said they did not have enough information to recommend changes in their recommendations, or even to suggest extending a pause in administering the vaccine.

The CDC and the US Food and Drug Administration recommended Tuesday that the United States pause the use of the Johnson & Johnson vaccine.

The vaccine has been linked, but not definitively, to cases of rare blood clots.

On Wednesday, the Advisory Committee on Immunization Practices heard details of six known cases of a rare type of blood clot called CVST found in combination with a low level of key blood-clotting cells. The condition is tricky to treat and doctors are warned not to use typical blood thinners to treat it.

They also heard about a possible seventh case, and heard details of one case in a volunteer during trials of the vaccine – a case that J&J initially said was not linked to the vaccine.

ACIP staff said they would look for a time that the committee could meet again quickly so the vaccine is not unnecessarily delayed if they decide it’s safe to continue giving it.

“We will find a time to reconvene,” ACIP executive secretary Dr. Amanda Cohn told the meeting. “We will try to identify what that date is by Friday of this week so that people have a little bit more time to get it on the calendars.”

CDC vaccine advisers signal they may not be ready to decide on J&J vaccine and blood clots

Vaccine advisers to the US Centers for Disease Control and Prevention signaled Wednesday they may not be ready to vote on whether to revise their recommendations on who should get Johnson & Johnson’s coronavirus vaccine.

The CDC’s Advisory Committee on Immunization Practices held an emergency meeting to decide on whether to recommend extending a pause on giving the vaccine while investigators check into a possible link with rare blood clots. They may also be asked to vote on whether to recommend limits on who gets vaccinated based on age or sex.

But members said they may not know enough yet to make such recommendations.

“We do need to better understand the risk, which we know is going to be very rare, very low, but we really don’t know exactly how low and how to correctly characterize it,” Bell added. “I think we need to not vote and gather the necessary information so we can make an evidence-based decision.”

More context: The group has a scheduled meeting in three weeks – on May 5, or could schedule another emergency meeting in a week or two.

But Dr. Nirav Shah, director of Maine’s Center for Disease Control and Prevention and representative for the Association of State and Territorial Health Officials (ASTHO), said waiting was equally bad.

“We in a situation where not making a decision is tantamount to making a decision,” said Shah.

Shah said people who could benefit from getting a one-dose vaccine would go unvaccinated as a result of further delay.

CDC vaccine advisers could be asked to recommend extension of J&J vaccine pause

Vaccine advisers to the US Centers for Disease Control and Prevention could be asked to decide whether to recommend extending the pause on giving out Johnson & Johnson coronavirus vaccines.

The CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting Wednesday to discuss cases of rare blood clots that may or may not be linked with J&J’s coronavirus vaccine.

They will be asked whether to modify their recommendations for the vaccine, the CDC’s Dr. Sara Oliver said. They may also be asked to consider a recommendation to extend the pause in administering vaccines.

“This could potentially allow for a more informed, specific recommendations for the Janssen vaccine,” Oliver told the meeting. The committee may recommend giving the vaccine only to certain age groups, since most cases appear to be among people under the age of 50, or perhaps only to men, as most cases of the rare blood clots have been among women.

“We could evaluate the risk by age, an informed possible age based recommendation. It would also allow for further assessment to see if the thrombocytopenic thrombotic risk extends beyond CVST cases,” she added. 

The concerning cases involve a rare type of blood clot, known as cerebral venous sinus thrombosis (CVST), that is found in combination with a condition known as thrombocytopenia – a low level of important blood clotting cells called platelets.

The ACIP will vote later Wednesday on its recommendations.

Go There: CNN answers your questions about J&J's vaccine

CDC vaccine advisers met today to review “rare and severe” blood clot cases among a small number of people who received the Johnson & Johnson vaccine.

Officials say there were six cases among more than 6.8 million Americans who received the vaccine. The FDA and CDC have recommended pausing use of the vaccine while it is being reviewed.

CNN was live earlier today, answering your questions about the vaccine pause. Watch more:

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09:34 - Source: cnn

Headache appears to be initial symptom of blood clotting events, CDC's vaccine safety lead says

Headache appears to be the main symptom among the six women who developed blood clots after receiving a Johnson & Johnson coronavirus vaccine, Dr. Tom Shimabukuro, vaccine safety lead with the US Centers for Disease Control and Prevention’s Covid-19 Response Team, said during a meeting of the CDC’s Advisory Committee on Immunization Practices on Wednesday.

Shimabukuro referred to the six cases and said that “if you look at five of these six cases, really headache is the initial presenting feature and so I do think it’s important in the setting where we are right now that health care providers maintain a high index of suspicion for possible CVST and confirm vaccination history among other things.”

CVST refers to cerebral venous sinus thrombosis, which involves clotting in veins that drain blood from the brain. Shimabukuro noted that four of the six patients were treated with the anticoagulant drug heparin, but heparin is not the recommended treatment for this particular type of rare blood clot, which is accompanied by a low level of a blood clotting cell known as platelets. Heparin is a blood thinner and giving it to people with low platelet counts could cause hemorrhaging.

Among the six patients, Shimabukuro said that one has died, three remain hospitalized – among which two are in intensive care, and two have been discharged home.

Remember: The CDC and FDA recommend the US pause the vaccine after six reported blood clot cases among more than 6.8 million doses of the vaccine administered in the US. The majority of people who took the vaccine are fine. Mild headaches and flu like symptoms are common after taking the vaccine – and mean it’s working. However, if you are concerned or have severe side effects you should contact your health provider.

Blood clot patients often got wrong treatment at first, CDC vaccine advisers hear

Some patients who developed blood clots after receiving a Johnson & Johnson coronavirus vaccine received the wrong treatment at first, a company representative told an emergency meeting of federal vaccine advisers Wednesday.

The Advisory Committee on Immunization Practices, which advises the US Centers for Disease Control and Prevention on vaccine issues, heard details of the six known cases of rare blood clots among about seven million people who got the vaccine in the US, plus a seventh suspected case. 

At least four of the six cases were treated with heparin when they first developed symptoms, Dr. Aran Maree, chief medical officer for pharmaceuticals at J&J’s Janssen vaccine arm, told the meeting. 

He gave details of what’s known about the cases, which include: a 45-year-old woman who died; a 38-year-old woman who has not recovered; an 18-year-old woman who has not recovered; a 48-year-old woman who has not recovered, a 26-year-old woman who has recovered and a 28-year-old woman whose status is unknown. They also include a possible seventh case – a 59-year old woman who has not yet recovered and whose blood clots might not fit the same profile as the others.

Heparin is not the recommended treatment for this particular type of rare blood clot, which is accompanied by a low level of a blood clotting cell known as platelets. Heparin is a blood thinner and giving it to people with low platelet counts could cause hemorrhaging.

Pause on Johnson & Johnson vaccine is important for vaccine confidence, infectious disease expert says

The recommended pause on the use of Johnson & Johnson’s Covid-19 vaccine due to potential blood clots may be helpful in improving long-term trust in vaccine rollout, an infectious disease expert said Wednesday. 

Gounder said that one of the biggest motivators of vaccine hesitancy is a lack of trust in the systems rolling out vaccines, and that this pause shows health care and government systems working as intended. 

“It is absolutely essential that the CDC and FDA behave in a way that is transparent, honest, aboveboard, where they show they’re doing their due diligence, because that is really what is going to predict, in the longer term, whether people feel comfortable getting vaccinated.”

J&J official says an unusual blood clot event was reported in vaccine trial

At least one vaccine trial volunteer also developed unusual blood clots after getting Johnson & Johnson’s coronavirus vaccine, a top official for the company said Wednesday. 

Dr. Aran Maree, chief medical officer for J&J’s vaccine arm Janssen, said blood clots were seen in two patients in Phase 3 vaccine trials – one who got vaccine and one who was given a placebo shot. 

Maree also detailed a seventh possible case to an emergency meeting of the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

There was one case of the concerning type of blood clot, known as cerebral venous sinus thrombosis (CVST), in September, during the Phase 3 trial of the single-dose vaccine, Maree said. It involved a 25-year-old white man who has recovered. Plus, a 59-year-old woman developed a series of blood clots known as deep vein thromboses or DVTs. 

The company is looking for more possible cases, Maree said.

“There is also an ongoing study, a large open label study, in South African health care professionals. This has enrolled currently, 272,438 participants,” Maree said. “We have had no reports of CVST. We have had one case of pulmonary embolism.”

A pulmonary embolism is a blood clot in the lung.

Johnson & Johnson believes vaccine benefits outweigh any blood clot risk

A healthcare worker loads a syringe with the Johnson & Johnson vaccine on March 26 in Buffalo, West Virginia.

Johnson & Johnson is reviewing all reports of adverse events associated with its coronavirus vaccine to see if there are any more cases of rare blood clots that may not have been noticed, a top company official said Wednesday.

Dr. Aran Maree, chief medical officer for pharmaceuticals at J&J’s Janssen vaccine arm, detailed the known cases of blood clots for an emergency meeting of US Centers for Disease Control and Prevention vaccine advisers.

“We strongly support ensuring awareness of the signs and symptoms of this very rare event, as well as recommendations to ensure the correct diagnosis, treatment, and reporting by healthcare professionals,” Maree added.

CDC’s Advisory Committee on Immunization Practices is reviewing the reports of blood clots to determine whether to change guidance on the use of the Janssen vaccine.

Spain to use J&J vaccine as soon as EU regulator gives approval on safety, health minister says

Spain has received its first 146,000 doses of the Johnson & Johnson vaccine against Covid-19 and will use them in shots as soon as the European Medicines Agency (EMA) approves the vaccine’s safety, Health Minister Carolina Darias said Wednesday. 

Spain hopes the EMA’s decision will be favorable for this vaccine, Darias told a media conference. 

This came a day after two top US government health agencies recommended a pause in its use following reports of six cases of “rare and severe” blood clots out of almost seven million shots given. That prompted an urgent review by the EMA. 

Darias also said that Spain will receive “four to five million doses more” than expected of Pfizer-BioNTech’s Covid vaccine in the second quarter this year, after the European Union announced Wednesday announced millions more Pfizer doses for the 27-nation bloc. 

Link between vaccines and blood clots not yet clear, CDC vaccine advisers hear

It’s not yet clear whether blood clots seen after people got the AstraZeneca and Johnson & Johnson vaccines are the same, a US Centers for Disease Control and Prevention expert said Wednesday. 

The CDC’s Advisory Committee on Immunization Practices was holding an emergency meeting Wednesday to discuss whether to update its recommendations for use of the vaccine, made by J&J’s Janssen.

The CDC and US Food and Drug Administration recommended a pause in giving the Janssen vaccine after six cases of rare blood clots were seen in people recently given the vaccine in the US.

Similar blood clots were seen in Europe and the UK after people got AstraZeneca’s vaccine, which is not authorized in the US. Both vaccines use common cold viruses called adenoviruses to carry genetic material from the coronavirus into the body and elicit immunity.

“The extent to which the cases seen after each of these adenoviral vector vaccines represent exactly the same syndrome is not entirely clear at this time,” the CDC’s Dr. Beth Bell told the meeting.

Oxford/AstraZeneca Covid-19 vaccine should continue to be used where available, WHO official says

A person fills a syringe with AstraZeneca's Covishield vaccine in Mumbai, India, on March 17.

Countries should continue using the Oxford/AstraZeneca Covid-19 vaccine, as well as all vaccines authorized by the World Health Organization, even as regulatory agencies are reviewing the latest information about adverse events, Dr. Carissa Etienne, WHO’s regional director for the Americas, said during a virtual media conference on Wednesday. 

Reports of blood clots among individuals “revealed by strong vaccine surveillance systems are now being reviewed by regulatory agencies,” Etienne said. “We expect additional recommendations soon.” 

The four vaccines authorized by WHO – the Pfizer-BioNTech vaccine, the Johnson & Johnson vaccine and the two versions of the Oxford/AstraZeneca vaccine, including one made by the Serum Institute of India – “are already helping to prevent severe disease and deaths in places where they are in use,” said Etienne. 

“These vaccines can save your lives and the lives of your friends and family,” she said. “Covid is actively spreading throughout our regions. Remember, none of us are safe until we are all safe.” 

Turkey hits record daily high in Covid-19 deaths as cases continue to soar

Turkey reported at least 279 Covid-19 deaths in the last 24 hours — the highest fatalities in a day since the start of the pandemic – as the number of daily cases hit an all-time record of 62,797, according to the Turkish health ministry. 

Turkey entered a partial lockdown announced by Turkish president Recep Tayyip Erdogan on Tuesday. The new measures include an extended nighttime curfew, restrictions on intercity travel, limited work hours for government employees and work from home incentives for the private sector. 

Turkey’s intensive care unit capacity is at 68.8%, according to the health ministry. The Turkish Doctors Association (TTB) has warned that there is a strain on hospitals and have called for stricter measures.  

NOW: CDC vaccine advisers start meeting to discuss Johnson & Johnson coronavirus vaccine

The Advisory Committee on Immunization Practices has started its meeting to discuss the safety of the Johnson & Johnson coronavirus vaccine.

The vaccine has been linked to six cases of a rare but dangerous blood clot, out of nearly seven million doses given.

ACIP, an independent panel that advises the US Centers for Disease Control and Prevention about vaccine safety and administration issues, will discuss potential changes to recommendations for use of the vaccine.

The meeting will run from about 1.30 p.m. to 4.30 p.m. ET, with a vote scheduled after 3.30 p.m. ET.

SOON: CDC advisers will meet to discuss safety of Johnson & Johnson Covid-19 vaccine

Vaccine advisers to the US Centers for Disease Control and Prevention will meet Wednesday afternoon to discuss what’s known about the safety of Johnson & Johnson’s coronavirus vaccine after federal regulators recommended a pause.

The vaccine, made by J&J’s Janssen vaccine arm, has been associated with six cases of a rare type of blood clot among about 7 million doses given out in the US.

The US Food and Drug Administration and CDC are looking to see if the vaccine may actually cause the blood clots, and also to brief doctors on how to diagnose and treat them. The blood clot that has been detected cannot be safely treated with blood thinners, as most common blood clots are.

The meeting starts at 1:30 p.m. ET and after a discussion, committee members are expected to vote on potential updates to recommendations for use of the vaccine at 3:30 p.m. ET.

CDC staff and a representative of Janssen will speak during the meeting.

Sweden pauses Johnson & Johnson's Covid-19 vaccine pending investigation

Sweden will pause the distribution of Johnson & Johnson’s Covid-19 vaccine pending a safety investigation by the European Medicines Agency (EMA), the Public Health Agency of Sweden announced in a statement on Wednesday.

According to the statement, Sweden had received 31,000 doses of the vaccine so far, although none had been distributed yet.

In a media release on Wednesday, the European Medicines Agency said it “remains of the view that the benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects.” 

The agency, which is in charge of verifying the safety of vaccines for the European Union, also said they are still assessing the “very rare cases of unusual blood clots with low platelets” with the Johnson & Johnson vaccine and the “EMA is expediting this evaluation and currently expects to issue a recommendation next week.”

On Tuesday, the US Centers for Disease Control and Prevention and the US Food and Drug Administration recommended 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.

Johnson & Johnson vaccine pause means systems in place are working, CDC director says

The recommended pause on Johnson & Johnson’s Covid-19 vaccine in the United States after reports of blood clots means the vaccine safety system is working, according to US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky. 

“I want to share with you my confidence in the system that we have in place. Jointly, CDC and FDA were able to identify these rare events, and act quickly to alert health care providers and the public,” Walensky said in a White House Covid-19 Task Force briefing on Wednesday.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the identification of an issue and the response that followed should reassure people who might be hesitant to get a Covid-19 vaccine.

“It should reinforce in those individual how we take safety so seriously,” Fauci said during the briefing. “So as opposed to looking at this as a negative safety issue, it could be looked at as a positive issue, where they know that when we let a vaccine be available, and give it a go-ahead to be put into the arms of the American people, we do it with a considerable degree of confidence as to its safety.”

CDC director discusses Johnson & Johnson vaccine pause: 

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01:45 - Source: cnn

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US pauses Johnson & Johnson rollout over clotting reports
States scramble to halt Johnson & Johnson vaccinations after CDC and FDA recommend pause
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WHO calls for ‘reality check’ as global Covid-19 cases surge for seventh week
Fauci says we can’t end mitigation measures now even with impressive vaccine rollout