The CDC and the U.S. Food and Drug Administration last week recommended a pause in J&J coronavirus vaccine use after six reported U.S. cases of a rare and serious type of blood clot.
They are investigating whether there are more cases and whether other types of blood clots may be associated with the vaccine. The break was also intended to give experts time to educate 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 the cases of blood clots.
Dr. William Schaffner, a non-voting ACIP member and professor of infectious diseases at Vanderbilt University School of Medicine, told CNN the committee has delayed making a decision as there are likely to be more reports of blood clots related to the vaccine , and members need to understand the demographics of those cases.
Schaffner said Friday’s meeting could go in several ways.
ACIP could recommend resuming use of the vaccine without changes, or the committee could recommend that the US discontinue use of the J&J vaccine altogether.
Schaffner said it is more likely that ACIP will recommend resuming use of the vaccine with a warning about possible adverse effects – and possibly advice to the most at-risk populations to stay away from this vaccine altogether.
ACIP Chairman Dr. Jose Romero told CNN the committee also has the option of recommending the break until more information is gathered – although he believes enough data has been generated on this point for ACIP to make a decision.
Romero said he has yet to investigate the data to be considered on Friday, but does not believe the committee will decide to stop using the vaccine in the US completely.
“CDC scientists can estimate what the benefit-risk analysis would be, and that will certainly inform us in our decision,” said Romero. “Whoever uses the vaccine – as with any vaccine in this country – must be informed of the risks associated with it.”
He noted that a possible booster dose of the Covid-19 vaccine should eventually be considered.
“If there is a high-risk population that indicates that they should not receive the vaccine, then I imagine the CDC will make recommendations on what the alternative vaccine would be in that group,” Romero said.
What action can ACIP take?
One case of blood clots in a 25-year-old male was reported during the clinical trial with the vaccine. While the six cases leading to the hiatus last week were all in women between the ages of 18 and 48, Schaffner said this may not accurately reflect risk.
Nearly 8 million people in the US have now received the J&J vaccine. Doctors could now realize that cases of these rare blood clots they’ve seen recently were related to the vaccine, and new cases could arise in people who have received the vaccine in recent weeks.
“Some ACIP members are concerned that this additional reporting may show cases of men or the elderly, who are currently not represented in the reporting of the six cases, and therefore they did not think the full picture of the risk has been developed.” Schaffner.
CDC Director Dr. Rochelle Walensky said Monday that the agency is now reviewing a handful of reported side effects after using the J&J vaccine.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on Sunday that he expects the vaccine to return to the market after Friday’s meeting with restrictions or warnings.
Dr. Paul Stoffels, J & J’s Chief Scientific Officer, said Tuesday that the company believes the benefits of the vaccine outweigh the risks.
“The safety and well-being of the people using our product is our number one priority and we advocate raising awareness of the signs and symptoms of this extremely rare event to ensure proper diagnosis, appropriate treatment and expedited report by health professionals,” Stoffels said.
Romero, who also serves as Arkansas’s secretary of health, said there may be additional recommendations for states and physicians on how to handle J&J doses that have already been dispensed. He said he believes states will accept the committee’s recommendations.
“My advice to the governor as we go along will be, ‘Let’s see what the CDC says,’” said Romero. “More than likely – I mean over 98% – I’m going to say I agree with the committee’s recommendations, and those are the recommendations we need to follow in our state.”
While there is some concern that the J&J vaccine break will fuel vaccine hesitancy, an Axios-Ipsos poll published Tuesday showed that 88% of Americans think the CDC and FDA were acting responsibly when they recommended the break .
“I really think, and I really hope the American public will look at this break and look at what we’ve been doing during this break as an indication of how safe the vaccine system and pipeline is in this country,” said Romero.
Will this affect the vaccine supply in the US?
President Joe Biden and other officials have said that whatever decision is made about the Covid-19 vaccine, it will not hinder vaccination efforts in the US.
The FDA on Monday requested that production of the J&J vaccine be paused at a Baltimore Emergent BioSolutions facility while it investigates contamination that has affected at least one batch of the J&J vaccine.
“We want to make it clear to the American public that we have two vaccines that are readily available – the Pfizer and Moderna – and people need to keep rolling up their sleeves to get vaccinated,” said CDC director Dr. Rochelle Walensky last week.
Walensky said that while the CDC is conducting a benefit-risk analysis of the J&J vaccine, the agency has contacted more than 10,000 providers to tell them what to look for in case other people experience similar side effects.
Those who received the J&J vaccine within the past three weeks have a very low risk of developing the rare blood clot that will decline over time, the CDC says. The agency recommends that those who experience certain symptoms, including sudden, severe headache, leg swelling, and shortness of breath, seek immediate medical attention.
CNN’s Naomi Thomas, Ryan Prior, Jen Christensen, Virginia Langmaid, Ashley Ahn and Jacqueline Howard contributed to this report.