2021-10-05 19:48:29 Johnson & Johnson Seeks F.D.A. Approval for Covid Booster
Johnson & Johnson Seeks F.D.A. Approval for Covid Booster
Johnson & Johnson asked federal regulators on Tuesday morning to approve a booster shot for adults, becoming the third coronavirus vaccine manufacturer to do so.
The company claims that a second dose of its vaccine given about two months after the first significantly improves protection against moderate to severe disease, increasing it to 94 percent. Other coronavirus vaccines have been administered in two doses, but Johnson & Johnson’s is administered in a single dose.
The Food and Drug Administration approved boosters for many Pfizer-BioNTech vaccine recipients last month, and Moderna is seeking approval for boosters of its inoculation. Regulators could make decisions on both Moderna’s and Johnson & Johnson’s applications as soon as this month.
Senior federal health officials have been privately convinced for some time that recipients of Johnson & Johnson’s vaccine require a booster shot.
According to a recent CDC study, Johnson & Johnson’s single-dose vaccine was 71 percent effective against hospitalization from Covid-19, compared to 88 percent for Pfizer-and BioNTech’s 93 percent for Moderna’s two-dose vaccines. Other research discovered that recipients of the Johnson & Johnson vaccine were more likely to develop breakthrough infections or symptomatic Covid-19 than recipients of the other two vaccines.
Johnson & Johnson’s own research found that its vaccine was 81% effective against hospitalization and 79% effective against infection. According to the company, its study also discovered that the protection provided by its vaccine does not wane over time, as does the protection provided by Pfizer-vaccine. BioNTech’s
Nearly 15 million Americans have received the Johnson & Johnson vaccine, compared to 102 million who have received the Pfizer-BioNTech vaccine and nearly 69 million who have received the Moderna vaccine.
Some scientists are unsure whether it is better to give a booster shot of Johnson & Johnson after two months or six months. According to Johnson & Johnson’s FDA submission, when a booster shot was administered six months after the initial injection, antibody levels increased ninefold within a week and 12-fold within a month.
According to some National Institutes of Health research, Moderna’s vaccine may work even better as a booster for Johnson & Johnson’s shot.
“We look forward to discussing boosters with the FDA and other health authorities to support their decisions,” said Dr. Mathai Mammen, a key research and development leader at Johnson & Johnson. “At the same time, we continue to believe that a single-dose Covid-19 vaccine that provides strong and long-lasting protection is an essential component of vaccinating the global population.”