Home Coronavirus FDA Scientists Raise Questions About Moderna, J&J Boosters Ahead Of Approval Meeting

FDA Scientists Raise Questions About Moderna, J&J Boosters Ahead Of Approval Meeting

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Food and Drug Administration (FDA) scientists did not give a resounding endorsement to booster shots of Moderna and Johnson & Johnson’s COVID-19 vaccines just days before an agency panel is set to review applications from both companies.

The agency released a trove of documents this week ahead of meetings Thursday and Friday of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on whether to approve the Moderna and J&J boosters. In those documents, scientists at the FDA did not take a firm stance on whether the boosters should be approved or if they provide substantial utility to individuals who are already fully vaccinated.

The FDA says it is wrestling with whether recipients of the single-dose Johnson & Johnson COVID-19 vaccine need a booster shot. FDA scientists didn’t reach a firm conclusion, citing shortcomings with J&J’s data. A final decision is expected next week. https://t.co/yIYuEybbDz

— The Associated Press (@AP) October 13, 2021

In their report, designed to prepare VRBPAC ahead of its meeting, scientists wrote that the data is mixed on just how much the efficacy of the Moderna vaccine declines over time, and argued that the two-dose regimen still provides plenty of protection against hospitalization and death: “Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not.”

“However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” the report continued. (RELATED: The Pentagon’s Vaccine Mandate Is Driving Yet Another Wedge Between Troops And Leadership)

Moderna applied for approval of its booster dose on Sep. 1, presenting data that a third dose at half the amount of the initial two produced stronger immune response in its clinical trial of around 170 adults. The company is petitioning the FDA to approve the booster for individuals above age 65, adults at high risk of serious COVID-19 cases, and adult workers at increased risk of exposure to the virus due to their jobs.

That’s the same group of people eligible to receive Pfizer’s booster shot, which was approved by the FDA and recommended by the Centers for Disease Control and Prevention (CDC) last month.

Regarding the J&J booster, FDA scientists reported inadequacies with the company’s data, particularly that there was limited information on the utility of boosters against the Delta variant. Johnson & Johnson proposed a booster timeline where individuals received a second shot as early as two months after their single dose vaccination, far earlier than the six-month delay after dose two proposed by both Moderna and Pfizer. (RELATED: Fauci Flips On Boosters, Now Says It’s Not A ‘Mistake’ For FDA To Limit Recommendations)

These same FDA scientists did not take a strong stance in either direction on Pfizer’s booster application, either, but VRBPAC proceeded to recommend it be approved, which the FDA then did. Moderna and Johnson & Johnson’s will go through the same procedure, and will potentially be approved by the top leadership of the FDA within days after VRBPAC’s meetings this week. Then, the ball will be in the CDC’s court, which will have its Advisory Committee on Immunization Practices determine who to recommend the vaccines for. CDC director Rochelle Walensky will then make the final call on that agency’s stance.

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