FDA has not 'green light' for Moderna's COVID-19 booster vaccine

FDA experts have not given a final opinion on Moderna's license application for the booster vaccine developed by the company.

Moderna pharmaceutical company's COVID-19 vaccine. Photo: AFP
Moderna pharmaceutical company's COVID-19 vaccine. Photo: AFP

Food and Drug Administration officials have not yet assessed Moderna's request for a license to use a booster shot of the COVID-19 vaccine, a move that may stem from the lack of availability. enough data.

The FDA official review process is part of the usual process before the agency makes a decision on whether to open the way for approval for a product to market. Usually, after reviewing an application for a license, the FDA makes an assessment of whether it is a "green light" for approval or disapproval. But FDA officials themselves did not reach a conclusion on Pfizer's proposal for the booster shot, but then approved it anyway.

In a statement issued on October 12, the FDA simply reiterated Moderna's recommendation and analyzed its scientific data. FDA experts said the booster dose of Moderna "appears" to be safe and effective, but the benefit of the shot depends on how much protection from the previously injected vaccine is reduced. The FDA also said data shows that two doses of Moderna's vaccine still provide good protection against severe illness and death.

According to FDA officials, the third dose of Moderna enhances antibody response, one of the key points of the study. But this booster shot a little short of the criteria for increasing the amount of antibodies to a large extent and at a rate high enough for the purpose of the study.

Previously, on October 12, Moderna released data on its booster vaccine dose. Moderna believes that the FDA should authorize the use of a booster dose of its vaccine for older adults and people at high risk of infection who have received two full doses.

According to Moderna, the booster dose of its vaccine supports public health by restoring the immune response, while reducing the number of infections in adults who have completed immunization.

Google Tech News

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