April 23 coronavirus news

Vaccine advisers to the US Centers for Disease Control and Prevention voted Friday to recommend resuming use of the Johnson & Johnson coronavirus vaccine.

Members of the CDC’s Advisory Committee for Immunization Practices agreed the benefits of the vaccine outweigh the risks from rare blood clots linked with the vaccine.

The language of the vote said: “The Janssen Covid-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s emergency use authorization.”

More context: The US Food and Drug Administration will update the label for the vaccine, indicating that women under the age of 50 should be aware of the risk of blood clots from the vaccine.

Earlier, Johnson & Johnson officials said they had agreed to updated language for the label.

CDC Director Dr. Rochelle Walensky will sign off and then the US Food and Drug Administration will prepare an amended emergency use authorization for the vaccine, Dr. Amanda Cohn, ACIP’s executive secretary, said at the meeting earlier.

“We are awaiting and anticipate that the FDA will be putting out a new, a newly approved EUA language,” Cohn said. “And additionally, we will be taking the input from today, along with this language that FDA will publish and both FDA and CDC will have communication materials and education materials including infographics, patient fact sheets."

Canada’s Prime Minister Justin Trudeau received his first shot of the AstraZeneca vaccine Friday as the country’s Covid-19 case count rises to record levels.

Trudeau went to a local pharmacy with his wife, Sophie Gregoire Trudeau, where they both received the vaccine, Trudeau saying he was "very excited" and gave a thumbs up when it was done. 

Trudeau was also told after the vaccination that his second dose was not yet scheduled, and he would receive an email notice to schedule a follow-up shot. Canada’s vaccine rollout has suffered from supply issues and most second doses are being delayed by up to four months. 

Some context: About an hour after Trudeau received his vaccine, Canada’s expert advisory panel updated its guidance on AstraZeneca, saying it should be offered to all Canadians 30 or older. It had previously recommended it be administered only to those 55 or older although some provinces have already administered doses to those 40 and older. 

The panel also indicated that mRNA vaccines, either Pfizer or Moderna, should be "preferentially offered" and that a complete series of the AstraZeneca vaccine should be used if an individual does not wish to wait for an mRNA vaccine. 

Currently in most Canadian provinces, people aged 55 and younger have not yet been prioritized for an mRNA vaccine unless they are essential workers or they qualify in other categories like caregivers. 

The news on vaccines came as Canada released new modeling on the impact of new infections in the weeks to come. 

Daily case counts, hospitalizations and ICU admissions continue to increase as well as evidence that there is a troubling increase in mortality, now up more than 17% in the last week alone, according to Canada’s public health agency. 

Officials also said Friday that extensive restrictions and lockdowns across the country seem that have stalled the growth of the pandemic, although new daily case counts have perhaps plateaued at very high levels. 

National Football League commissioner Roger Goodell has modified the league's Covid-19 protocols due to the reduced risk of infection for vaccinated players.

Goodell outlined the amended protocols in a memo sent to all NFL teams on Friday. A source provided a copy of the memo to CNN. 

The NFL said that fully vaccinated team personnel will only be tested for Covid-19 once a week instead of daily tests. Last season, every personnel member was tested for the virus daily.

The memo also says that all fully vaccinated players and staff members will not need to quarantine if they come in close contact with an infected person.

Earlier this month: League spokesperson Brian McCarthy told CNN that the NFL will strongly encourage players to take the vaccine, but it will not be required.

The NFL Draft is scheduled to start on April 29 and conclude on May 1, in Cleveland, Ohio.

Vaccine advisers to the US Centers for Disease Control and Prevention are considering four choices for changing the agency’s recommendation on Johnson & Johnson’s coronavirus vaccine, including label changes or a complete end to its use.

The CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting and is expected to vote later Friday on recommendations.

At issue: The vaccine has been linked to 15 cases of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome, or TTS, all among women. Three have died.

It’s a tricky question because all but two cases have been in women under the age of 50, and no cases have been reported among men since the vaccine has been in general use, although the CDC says it’s unlikely the risk is zero among men. 

CDC staff laid out several possible scenarios, all of which show that while resuming vaccination would result in more cases of blood clots, adding the J&J shot to the mix of available vaccines would save lives and keep people out of the hospital.

The committee’s four possible choices are:

Earlier, Johnson & Johnson officials said they had agreed with the FDA on new wording to add to the label saying the risk of blood clots is plausible and warning of the risks.

Resuming use of Johnson & Johnson’s coronavirus vaccine would save hundreds of lives and result in at most a few dozen cases of rare blood clots, a US Centers for Disease Control and Prevention analysis shows.

CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting to discuss potential changes to guidance for who should get the vaccine.

CDC and the US Food and Drug Administration have paused use of the vaccine while they investigate the risk of a rare blood clotting syndrome called thrombosis with thrombocytopenia syndrome, or TTS. The CDC has reports of 15 cases, all in women, and 13 of them in women under the age of 50. Three have died.

The CDC’s Dr. Sara Oliver presented the results of several models laying out what might happen if the vaccine is used again, including with restrictions on use in certain groups. The CDC took into consideration deaths from coronavirus and the likelihood that people would get vaccinated more quickly if the Johnson & Johnson vaccine was in the mix.

If the vaccine were restricted to people over the age of 50, three TTS cases could be expected, but between 40 and 250 Covid-19 deaths would be prevented, and as many as 1,000 people would not need treatment in the ICU. 

For every million doses of vaccine given to women ages 18 to 49, 13 TTS cases can be expected, Oliver said. But 12 deaths from Covid-19 would be prevented and 127 ICU admissions would be prevented among those women if they had access to the Johnson & Johnson vaccine.

 The CDC did not consider a gender-based restriction, Oliver said, because it would be too hard to explain – even though the risk of blood clots appears to be very low among men.

“There are also benefits beyond efficacy. This vaccine is able to be shipped and stored at refrigerator temperatures, and as a single dose series, which may make it easier to reach some disproportionately affected groups,” Oliver said.

“We note that the benefits of vaccination apply to the whole population over a six month period and result from both direct and indirect effects,” she added.

The United States added more than 3.3 million Covid-19 vaccine shots to its cumulative tally Friday, according to data from the US Centers for Disease Control and Prevention. 

This is the largest single-day increase reported this week, but still leaves the United States short of the daily average peak reached in early April. 

The seven-day average of new Covid-19 shots reported administered continued to fall, and now sits at 2,862,758. This is the second consecutive day this average has been under 3 million. The United States has not seen a seven-day average for vaccination below 3 million for two days in a row since April 2.

The average pace of new shots reported administered has been greater than 3 million shots per day for most of April, reaching a peak of nearly 3.4 million shots per day on April 13.  

By the numbers: More than 200 million Covid-19 vaccine shots have been reported administered since President Biden took office, reaching a threshold the administration had set for Biden’s 100th day in office about a week early.

About 41% of the US population – over 137 million people – have received at least one dose of Covid-19 vaccine, and about 28% of the population – more than 90 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. 

Members of the Advisory Committee on Immunization Practices have started discussions about what updated recommendation they may have for the Johnson & Johnson vaccine.

A vote is expected following the deliberations.

Johnson & Johnson has agreed to revised language on the label of its Janssen coronavirus vaccine that warns of the danger of blood clots, a company official told US Centers for Disease Control and Prevention vaccine advisers on Friday.

CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting to discuss potential changes to guidance for who should get the vaccine.

CDC and the US Food and Drug Administration have paused use of the vaccine while they investigate the risk of a rare blood clotting syndrome.

Johnson & Johnson Chief Medical Officer Dr. Joanne Waldstreicher said the company had worked out revised label language with the FDA.

“To that end, here is the language from our label that we have agreed upon with the FDA regarding thrombosis with thrombocytopenia.”

The revised language refers to blood clots in the brain combined with a blood clotting abnormality called thrombocytopenia. “Reports of adverse events following use of the Janssen Covid-19 vaccine … suggest an increased risk of thrombosis,” it reads, and says the relationship between the vaccine and the clots is “plausible.”

“In addition to the description of the event, health care professionals are alerted in the fact sheet to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the COVID vaccine from Janssen,” Waldstreicher said.

“It also states that symptoms began approximately one to two weeks following vaccination, and that most people were females, aged 18 through 49, and that some cases have been fatal. Health care professionals are also directed to the published American Society of Hematology considerations, relevant to the diagnosis and treatment. In addition, the patient's fact sheet contains a clear warning and instruction. J&J strongly supports this enhanced labeling.”

ACIP will vote later Friday on whether to change recommendations.

A Johnson & Johnson official argued Friday the company’s coronavirus vaccine is valuable to both the US and the world, saying it protects against variants and is easy to distribute.

The benefit of a one-shot vaccine is “critical,” Dr. Mathai Mammen, global head of Janssen Research and Development, told a meeting of US Centers for Disease Control and Prevention vaccine advisers. 

Plus, it’s easily stored at regular refrigerator temperatures for three months – as opposed to the Moderna and Pfizer vaccines, which must be stored frozen.

Some context: ACIP is meeting to discuss whether to change guidance for J&J’s Janssen vaccine.

The CDC and the US Food and Drug Administration recommended pausing its use after six reported cases of women who developed a rare blood clotting syndrome called thrombosis with thrombocytopenia syndrome, or TTS, after receiving Johnson & Johnson’s Janssen vaccine in the United States. Now the CDC says it has learned of 15 cases, including three deaths.

That total does not include one man who experienced clots after taking the vaccine as part of the clinical trial in the fall. That case was not included in the CDC’s analysis of cases seen after the vaccine was authorized and distributed to the public. 

Mammen said clinical trials have shown the Janssen vaccine offers protection quickly – within a week of the single dose. Plus, he said, it protects against concerning variants, including the B.1.351 variant that is now dominant in South Africa. The company’s data showed the vaccine had 82% efficacy in South Africa.