FDA snubs Moderna over necessity of COVID-19 booster dose in Pfizer fiasco repeat

• FDA says two doses of vaccine enough to provide protection against hospitalization and death due to coronavirus

• Last month, FDA refrained from taking stance on Pfizer’s Covid booster shots as well

Food and Drug Administration scientists on Tuesday denied taking a stance on supporting COVID-19 booster shots of Moderna.

According to data, the FDA scientists said, two doses of vaccine are enough to provide protection against hospitalization and death due to coronavirus.

“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,” they wrote in a 45-page document published on the agency’s website. 

“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.”

Also Read: Merck seeks FDA approval for antiviral Covid-19 pill

Last month, FDA refrained from taking stance on Pfizer’s Covid booster shots as well.

The report by FDA scientists will be used in the committee’s meeting on Thursday to review Moderna’s request for booster doses.

High-risk settings

FDA had approved Covid booster shots by Pfizer last month which will be used for the elderly, adults with underlying medical conditions, and those who work or live in high-risk settings like health and grocery workers.

Moderna applied for authorization of its booster dose to FDA on September 1 claiming the dose was safe and produced a stronger immune response than the one produced by the second dose in its phase three clinical trial.

Also Read: Pfizer asks FDA for authorization of its COVID-19 vaccine for kids ages 5 to 11

Moderna is requesting FDA to allow its boosters for the same groups as allowed for Pfizer. Moderna said that the side effects of boosters are comparable to those of the second dose.

The Biden administration expects that these additional doses will provide long-term protection against hospitalization and death due to the spread of the delta variant.

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