The CDC and the U.S. Food and Drug Administration last week recommended a halt to the use of the J&J coronavirus vaccine after six reported U.S. cases of a rare and serious blood clot.
They are investigating whether there are more cases and whether other types of blood clots are related to the vaccine. The break was also meant to give experts time to inform doctors on how to look for and treat these blood 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 blood clot cases.
Dr William Schaffner, a non-voting ACIP member and professor of infectious diseases at Vanderbilt University School of Medicine, told CNN that the committee was delaying a decision because there are likely to be more reports of blood clots related to the vaccine. to understand the demographics of the cases.
Schaffner said Friday’s meeting could play out in different ways.
ACIP may recommend that the use of the vaccine be resumed without modification, or the Committee may recommend that the United States discontinue 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 populations at greatest risk of removing this vaccine altogether.
The ACIP chairman, dr. Jose Romero, told CNN that the committee also has the option to recommend that the interruption continue until more information is gathered – although he believes that at this stage enough data has been generated to make a decision.
Romero said he has yet to investigate the details that will be considered on Friday, but does not believe the committee will decide to stop using the vaccine in the US altogether.
“CDC scientists can make an estimate of what the benefit-risk analysis would be, and it will definitely inform us in our decision,” Romero said. “Whoever uses the vaccine – as with any vaccine in this country – should be informed of the risks involved.”
He noted that a possible dose of Covid-19 vaccine enhancer should finally be considered.
“If there is a high-risk population that indicates they should not receive the vaccine, I would think the CDC would make recommendations on what the alternative vaccine would be in the group,” Romero said.
What steps can ACIP take?
One blood clot case in a 25-year-old man was reported during the clinical trial of the vaccine. Although the six cases that led to the outbreak 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 US have now received the J&J vaccine. Doctors may now realize that cases of these rare blood clots they have recently seen are related to the vaccine, and that new cases may occur among people who have received the vaccine in the past week.
“Some of the ACIP members are concerned that this additional reporting may show cases of men or older people, which are not currently represented in the reporting of the six cases, and therefore do not think that the overall picture of risk has developed. , Schaffner said.
CDC Director, Dr. Rochelle Walensky, said Monday that the agency is now investigating a handful of reported adverse events 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 with restrictions or warnings after Friday.
J&J, chief scientific officer, dr. Paul Stoffels, said on Tuesday that the company believes that the benefits of the vaccine outweigh the risks.
“The safety and well-being of people who use our product is our top priority and we support the awareness of the signs and symptoms of this extremely rare event in order to ensure the correct diagnosis, appropriate treatment and accelerated reporting by healthcare professionals.” said.
Romero, who also serves as Arkansas’ secretary of health, said there could be additional recommendations for states and physicians on how to administer J&J doses that have already been distributed. He said he believes states will accept the committee’s recommendations.
“My advice to the governor would be, ‘Let’s see what the CDC says,'” Romero said. “More than likely – I mean more than 98% – I’m going to say I agree with the committee’s recommendations, and these are the ones we should follow in our state.”
Although there are concerns that the J&J vaccine break will fuel the vaccine’s reluctance, an Axios Ipsos poll published on Tuesday showed that 88% of Americans think the CDC and FDA act responsibly. they recommend the break.
“I really think, and I really hope, that the American public will look at this break and see what we did during this break as an indication of how safe the vaccine system and the vaccine pipeline are in this country,” Romero said.
Will it have an impact on the vaccine supply in the US?
President Joe Biden and other officials said whatever decision is made about the Covid-19 vaccine, it will not hamper the vaccination effort in the US.
The FDA on Monday requested that production of the J&J vaccine be stopped at a Baltimore Emergent BioSolutions facility while investigating contamination affecting at least one group of J & J’s vaccines.
“We want to inform the American public that we have two vaccines available – the Pfizer and Moderna – and people need to keep up their sleeves to be vaccinated,” said Dr. Rochelle Walensky, director of the CDC, said last week.
Walensky said that although the CDC is conducting a risk benefit analysis of the J&J vaccine, the agency has reached out to more than 10,000 providers to inform them of what to watch out for, if other people experience similar adverse events.
Those who have received the J&J vaccine within the past three weeks have a very low risk of developing the rare blood clot that will decrease over time, the CDC says. The agency recommends that those experiencing certain symptoms, including sudden, severe headaches, swelling in the leg and shortness of breath, should seek immediate medical attention.
CNN’s Naomi Thomas, Ryan Prior, Jen Christensen, Virginia Langmaid, Ashley Ahn and Jacqueline Howard contributed to this report.