FDA Panel Convenes To Discuss Requirement Of Moderna Vaccine Booster Shots

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The U.S Food and Drug Administration panel is holding an important meeting on Thursday to discuss and vote on whether permission should be given for the use of booster shots of Moderna's Covid Vaccine for certain adults.

The meeting is the first one of a two-day Vaccine and Related Biological Products Advisory Committee, which will also discuss and vote on booster shots of the Johnson & Johnson vaccines. There will be discussions on the topics of mix-and-match vaccines as well. On Thursday, the FDA panel will discuss the Moderna vaccine and on Friday, they will debate on the topic of J&J booster shots.

On its part, Moderna is asking for approval of a 50-microgram booster dose, which is half the 100-microgram doses, used in the main first two doses. Moderna recommends that the booster dose be administered six months after the second dose, and only for people of certain age groups like people age 65 and older; people ages 18 to 64 who risk getting severe Covid-19; and people between 18-64 years, who can be exposed to severe Covid-19 symptoms due to their job profile or other settings.

Moderna's demand for the booster shot is similar to the one for Pfizer's mRNA vaccine. The third dose of the Moderna vaccine and Pfizer vaccine have already been approved for certain category of people with lesser immunity.

Last month, the FDA approved the emergency use of a booster dose of the Pfizer-BioNTech's COVID-19 vaccine for people over 65 years of age, healthcare workers, and others at high risk of severe COVID-19. The company had claimed that although its vaccine was effective in preventing Covid-19 in early months, the vaccine lost its efficacy over a period.

Meanwhile, a recent study by the Centers for Disease Control and Prevention has found that the Moderna vaccine holds out better than Pfizer.

In documents made public on Tuesday, there is no mention about the fact that Moderna's vaccine needs a booster to prevent severe COVID or hospitalization. Instead, the documents highlighted the need for preventing infection and mild to moderate disease.

The vaccine maker said that the mean antibody level of participants in its study was 1.8 times higher after the booster than it was after the second shot. In other information, the company said that the booster raised neutralizing antibodies at least four times in 87.9 percent people compared to after the second dose, thus missing the FDA requirement of 88.4 percent by a small percentage.

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