The CDC and the US Food and Drug Administration recommended a break in the use of the J&J coronavirus vaccine last week, after six cases reported in the US of a rare and severe type of blood clot.
They are investigating if there are more cases and if other types of blood clots could be associated with the vaccine. The break was also meant to give experts time to inform doctors about how to look for and treat these clots.
The CDC’s Advisory Committee on Immunization Practices met on April 14, but members said they needed more information about the J&J vaccine and blood clots.
Dr. William Schaffner, a non-voting member of ACIP and a professor of infectious diseases at Vanderbilt University School of Medicine, told CNN that the committee was late in making a decision because there are likely to be more reports of blood clots related to vaccine, and members need to understand the demographics of those cases.
Schaffner said Friday’s meeting could play a few different ways.
ACIP may recommend the use of the vaccine CV without modification or the committee may recommend that the US stop using the J&J vaccine.
Schaffner said ACIP is more likely to recommend using the vaccine with a warning about possible side effects – and potentially advice for people at highest risk to avoid this vaccine altogether.
ACIP President Dr. Jose Romero told CNN that the committee also has the option of recommending that the break be interrupted until more information is gathered – although he believes enough data has been generated at this time for ACIP to make a decision.
Romero said he has not yet considered the data to be considered on Friday, but does not believe the committee will decide to recommend a complete cessation of vaccine use in the United States.
“CDC scientists can make an estimate of the benefit-risk analysis and this will certainly inform us in our decision,” Romero said. “Anyone using the vaccine – as with any vaccine in this country – should be informed of any risks associated with it.”
He noted that a potential booster dose for the Covid-19 vaccine may be considered.
“If there is a high-risk population that is indicated that they should not receive the vaccine, then I would imagine that the CDC would make recommendations on what alternative vaccine would be in that group,” Romero said.
What measures could ACIP take?
A case of a blood clot in a 25-year-old man was reported during the vaccine clinical trial. Although the six cases that led to the break last week were all among women between the ages of 18 and 48, Schaffner said it may not be an accurate representation of the risk.
Nearly 8 million people in the United States have now received the J&J vaccine. Doctors could now realize that the cases of these rare blood clots they saw recently were related to the vaccine, and new cases could occur among people who have received the vaccine in recent weeks.
“Some ACIP members are concerned that this additional reporting could show cases of men or the elderly, who are not currently represented in the reporting of the six cases and therefore did not believe that the full picture of risk, “Schaffner said.
CDC Director Dr. Rochelle Walensky said Monday that the agency is now analyzing a handful of adverse events reported after using the J&J vaccine.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Sunday that the vaccine is expected to return to the market with restrictions or warnings after Friday’s meeting.
J&J Scientific Director Dr. Paul Stoffels said Tuesday that the company believes the benefits of the vaccine outweigh the risks.
“The safety and well-being of people using our product is our number one priority and we strongly support awareness of the signs and symptoms of this extremely rare event to ensure proper diagnosis, proper treatment and accelerated reporting by healthcare professionals,” said Stoffels.
Romero, who also serves as Arkansas’ health secretary, said there could be additional recommendations for states and physicians on how to manage J&J doses that have already been distributed. He said he believes states will accept the committee’s recommendations.
“My advice to the governor as we move forward will be, ‘Let’s see what the CDC says,'” Romero said. “More than likely – I mean more than 98% – I will say that I agree with the recommendations issued by the committee and these are the ones we should follow in our state.”
While there is some concern that the J&J vaccine break will fuel the vaccine’s hesitation, an Axios-Ipsos poll released Tuesday showed that 88% of Americans believe the CDC and FDA are acting responsibly when they recommend the break.
“I really believe and really hope that the American public will analyze this break and analyze what we did during this break as an indication of how safe the vaccination system and vaccine pipeline in this country is,” Romero said.
Will this affect the supply of vaccine in the US?
President Joe Biden and other officials said that regardless of the decision on the Covid-19 vaccine, it would not hinder the US vaccination effort.
The FDA on Monday requested that the manufacture of the J&J vaccine be stopped at a Baltimore Emergent BioSolutions facility, while conducting an investigation into the contamination that affected at least one batch of J&J vaccine.
“We want to convey to the American public that we have two vaccines available – Pfizer and Moderna – and people should continue to roll up their sleeves to get vaccinated,” CDC Director Dr. Rochelle Walensky said last week.
Walensky said that while the CDC is conducting a risk-benefit analysis of the J&J vaccine, the agency has contacted more than 10,000 providers to let them know what to look out for if other people experience similar side effects. .
Those who have received the J&J vaccine in the past three weeks have a very low risk of developing a rare blood clot that will decrease over time, says the CDC. The agency advises those with certain symptoms, including sudden, severe headaches, swelling of the legs and difficulty breathing, to seek medical treatment immediately.
CNN’s Naomi Thomas, Ryan Prior, Jen Christensen, Virginia Langmaid, Ashley Ahn and Jacqueline Howard contributed to this report.