April 14 coronavirus news

By Jessie Yeung and Kara Fox, CNN

Updated 2:39 AM ET, Thu April 15, 2021
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6:22 p.m. ET, April 14, 2021

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

From CNN’s Maggie Fox

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.

“However extension of the pause could have broad consequences. Individuals may want to receive the Janssen vaccine. In addition, a pause could have global implications, such as pausing clinical trials or limiting the ability of the Janssen vaccine in other countries with more limited vaccine supply,” Oliver said.

The ACIP will vote later Wednesday on its recommendations.

8:34 p.m. ET, April 14, 2021

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:

4:35 p.m. ET, April 14, 2021

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

From CNN's Jacqueline Howard

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.

"The important thing to note here is the initial features are largely kind of nonspecific symptoms, which at initial presentation – or when a patient starts to become symptomatic – may seem kind of mild and not that clinically significant. Things like headaches, lethargy, chills, myalgia," Shimabukuro said. "Later features include severe headache, some focal signs, in one case severe abdominal pain, bruising, swelling in the lower extremities."

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.

4:13 p.m. ET, April 14, 2021

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

From CNN’s Maggie Fox

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.

4:12 p.m. ET, April 14, 2021

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

From CNN's Virginia Langmaid

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. 

“I think it’s really important to understand that the FDA has not pulled the Johnson & Johnson vaccine from the market, that the Emergency Use Authorization still stands,” Dr. Céline Gounder, assistant professor of medicine and infectious diseases at the New York University School of Medicine, told the United States Congress Joint Economic Committee. “This is just a pause, a timeout for the scientists to step back and review the data."

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.”

3:48 p.m. ET, April 14, 2021

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

From CNN's Jacqueline Howard

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.

3:47 p.m. ET, April 14, 2021

Johnson & Johnson believes vaccine benefits outweigh any blood clot risk

From CNN’s Maggie Fox

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

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.

“I'd like to reiterate that based on the current data, Janssen believes the overall benefit-risk profile for our vaccine is positive across the population for which it's authorized,” Maree said.

“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.

3:02 p.m. ET, April 14, 2021

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

From CNN’s Al Goodman

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. 

“The vaccines are safe and are saving lives,” Darias said, after meeting with health officials from Spain’s 17 regional governments, which administer the vaccines. “It’s also our most potent tool for economic recovery,” she added. 
2:26 p.m. ET, April 14, 2021

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

From CNN's Maggie Fox

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.