Top Line

The Food and Drug Administration’s independent advisory committee meets on Thursday to decide whether to recommend a booster shot of Moderna’s COVID-19 vaccine for the general public, a decision that comes after questions over the need for booster shots of this vaccine. comes between.

important facts

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The panel, made up of outside experts who advise on FDA decisions on vaccines, is set to vote later on Thursday whether booster shots are safe and effective for a specific subgroup of Americans.

Following the same panel ruling against Pfizer-BioNtech’s application to give boosters to all Americans, Moderna is trying to reach an audience of businesses that put them at greater risk for the disease.

The company is seeking authorization only for a 50-microgram dose, which is about half the strength of the original mRNA vaccine, given in two shots a few weeks apart.

Voting will follow presentations from Moderna officials, Food and Drug Administration scientists and Israeli health officials, as well as members of the public, who will be given a chance to voice their opinion.

While the FDA is not required to comply with the decision of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), it often does and does make important decisions during the COVID-19 pandemic.

The FDA will be expected to issue its decision on Moderna booster shots within days of this panel’s vote, before an advisory committee to the Centers for Disease Control and Prevention (CDC) will next week discuss who gets the shots and when. needed.

what to see

FDA advisers will meet again Friday, a two-day event to debate Johnson & Johnson’s booster shot. The J&J vaccine requires only one shot, so experts may be considering the need for a second dose, which many have long considered necessary given its low efficacy.

main background

FDA advisors are expected to be more skeptical in recommending boosters for Moderna’s COVID-19 vaccine because a lack of evidence shows a decline in efficacy against severe disease. Recently a CDC Study It found that Pfizer’s vaccine fell from 91% to 77% that was effective in preventing hospitalizations from the virus over a four-month period, with Moderna Vaccine showing no decline during this period. However, Moderna released the results of a larger clinical trial last month, which speculated that its vaccine might have lower immunity. 600,000 additional cases Covid-19, including some severe cases (it did not identify how many). Moderna is basing its case on preventing a surge in breakthrough infections, but FDA employees are already skeptical whether that’s enough to justify an additional dose. Scientists inside the agency said Tuesday that Moderna did not meet all of the agency’s criteria to support the use of a booster dose because the difference in antibody levels before and after the shot was not substantial.

important quotes

“Some real-world effectiveness studies have suggested a decline in the effectiveness of the modern COVID-19 vaccine against symptomatic infections or against the delta variant over time,” FDA scientists wrote in an assessment before the meeting. Others haven’t.” “However, overall, the data indicate that currently US-licensed or authorized COVID-19 vaccines still provide protection against serious COVID-19 illness and death in the United States.”

“US FDA Staff Says Moderna Didn’t Meet All Criteria for COVID-19 Booster” (Reuters)

“Modern vs Pfizer: Both Knockouts, But One Seems To Have The Edge” (the new York Times)