April 14 coronavirus news

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 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 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. 

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.

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 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.  

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.

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 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.