Friday, October 22, 2021

FDA Advisors Assess Authorization of Moderna and J&J Covid Boosters

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Scientific advisers to the U.S. Food and Drug Administration have begun discussing whether to authorize the Moderna and Johnson & Johnson boosters of Covid vaccines, in what is expected to be another heated debate on whether to need additional injections and by whom.

The outcome of the two-day meeting, which began Thursday, could help clear up the confusion over the US reinforcement program, which has been much more limited than the Biden administration had initially envisioned.

Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, told panel members that they would have to balance the efficacy of the booster vaccines with any safety concerns.

“There appears to be a decrease in protection against Covid-19 in general. [infections]”He said, adding:” We must take into account the fact that mild and moderate Covid-19 may be associated with adverse outcomes. “

And he tried to address members’ concerns about the small sample sizes in the studies on the effectiveness of booster doses, saying, “All of these studies tend in the same direction here.”

Last month, advisers from the FDA and the Centers for Disease Control and Prevention clashed over the advisability of recommending booster shots for Pfizer’s vaccine. In an unusual move, Rochelle Walensky, the director of the CDC, overruled the agency’s advisory panel and expanded authorization for additional injections from Pfizer to people at high risk of exposure to Covid-19 in the workplace.

Complex eligibility criteria and the lack of additional vaccines for those who initially received the Moderna and J&J vaccines complicated the Biden administration’s plan to roll out booster vaccines last month.

The advisers will also discuss the results of a preliminary study from a US trial of mixing Covid-19 vaccines as part of a booster program, a practice that some experts believe could stimulate a person’s immune response and alleviate logistical challenges when implementing reinforcements.

Moderna has asked the FDA to recommend authorizing a half dose of its mRNA vaccine for people who received their second prick at least six months ago, arguing that this would restore declining antibody levels and protect against Covid-19 infections. .

People over 65 years of age; those with health conditions that make them vulnerable to Covid-19; and people in jobs or institutions with high exposure to the virus should receive a booster, the company said in its application.

Both Moderna and J & J’s applications are consistent with the CDC’s decision to authorize Pfizer’s booster strikes to those most at risk from Covid-19.

Most health experts predict that the FDA’s vaccine advisory committee will back both companies’ applications, though some question whether there is enough evidence to show that additional injections are needed to prevent serious disease or whether the boosters fully restore protection. .

“I believe both Moderna and J&J thrusters should receive emergency clearance, but the data the two companies presented is well below the evidence needed to demonstrate restoration of full efficiency with additional firing,” said Eric Topol, director of the California-based Scripps Translational Research Institute.

Amesh Adalja, a senior fellow at the Johns Hopkins Center for Health Security, said scientific advisers are likely to have another robust discussion about the data due to concerns that the policy has tainted the decision-making process about authorizing boosters.

The administration’s beefed-up strategy has sparked internal disputes within the FDA. Two senior scientists, who left the regulator, published an article last month arguing against the boosters, saying the doses could save more lives if used in unvaccinated populations.

“Obviously, the president announced this idea about the drivers long before any of these committees. [and] long before the data was sent, ”Adalja said. “Many of us [experts] They are left with the impression that when the director of the CDC added that fourth recommendation of the [CDC advisory panel] that was trying to make the president’s promise stick instead of looking at the data. “

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