Federal panel wants to understand risks-benefits before recommending future for J&J vaccine rollout

Federal panel wants to understand risks-benefits before recommending future for J&J vaccine rollout

ATLANTA, Ga. (WMBF) - After reviewing the evidence available at this time, a federal advisory panel said Wednesday they won’t be making a decision yet on who the Johnson & Johnson vaccine should be recommended for.

Members of the Advisory Committee on Immunization Practices (ACIP) met virtually in an extended emergency meeting to review the Janssen manufacturer’s findings, along with the vaccine surveillance and assessments conducted by the Centers for Disease Control and Prevention.

The point of the meeting was to decide if the committee had enough information to give a recommendation on the vaccine, following the federal pause due to reports of blood clotting in six women, who all had received the shot.

It’s a small number in comparison to the 7.5 million Americans who have received the same vaccine.

Doctors said the fact that these six rare blood clots were noticed is evidence that the safety systems in place are working.

These particular cases entailed not just blood clotting (CVST) but also thrombocytopenia, a condition where one’s blood has an abnormally low level of platelets.

The CDC said in its presentation that they have not seen cases like these following the mRNA vaccines (the Pfizer nor Moderna shots).

Doctors also observed that it appeared there were some similarities in these cases to the ones experienced by some recipients of the AstraZeneca vaccine in Europe.

CDC doctors shared that some of the initial features that cropped up in five of these six cases were headaches.

“I do think it’s important, in the setting where we are right now, that health care providers maintain a high index of suspicion for possible CVST, and confirm vaccination history, among other things,” said Dr. Tom Shimabukuro, a member of the CDC COVID-19 Vaccine Task Force.

Shimabukuro’s presentation recommended that doctors be on the lookout for potential symptoms in patients who had recently gotten the Johnson & Johnson shot.

These include severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin, or easy bruising.

Physicians are also urged to not treat patients with the drug heparin if their symptoms resemble these six cases.

Some members said they did not want this to be an indefinite pause on the vaccine’s distribution, but committee members shared why they were conflicted on taking a vote.

“We really need to have a balanced picture of both the benefits and the risks,” said Dr. Grace Lee, an ACIP member.

Lee discussed the need to figure out which groups of people are at the highest risk for this possible complication and adapt recommendations to minimize that exposure.

She also explained they also need to educate patients on the benefits and risks, along with when to quickly seek care.

Healthcare systems need to be able to diagnose and manage these cases in a timely fashion, said Lee.

Members of the public are strongly encouraged to report any symptoms felt after receiving a COVID-19 vaccine.

This should be done through VAERS, the Vaccine Adverse Event Reporting System. Committee members expect that if there are indeed more instances of these blood-clotting cases, they’ll be more likely to be reported going forward, which can, in turn, provide more data.

“What I’m hearing is that there is a strong desire to reconvene as quickly as possible after both some risk-benefit as well as additional risk refinement has been done, which we will commit to - the CDC is doing - as rapidly as possible,” said Dr. Amanda Cohn, the executive secretary for the committee. “At this time, ACIP does not wish to vote, or put any motions on the table to vote, for a change in the current recommendations.”

The ACIP’s previous recommendation for the J&J vaccine remains unaltered while the FDA and CDC continue on that advisory guidance.

Cohn said the idea would be for the committee to reconvene in the next week or so.

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