J&J asks FDA to clear booster shot
Increased protection 94%
Johnson & Johnson submitted data to the Food and Drug Administration asking for clearance for its booster shot, which was shown to increase protection against symptomatic coronavirus by 94%.
“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, global head of Janssen research and development at Johnson & Johnson.
Recent study results included in the submission for emergency use authorization show protection against symptomatic coronavirus rose 94% when a booster was given 56 days after the first shot, and protection against severe disease was 100%.
When a J&J booster was given six months after the first dose, antibody levels increased ninefold one week after the booster and continued to climb to twelvefold higher four weeks later, according to the company.
One of the main selling points of the J&J vaccine is that it is a single dose, compared to the two-dose regimen of Moderna and Pfizer.
J&J officials were sure to mention that point is not lost. Mammen said, “We continue to recognize that a singleshot COVID-19 vaccine that provides strong and longlasting protection remains a crucial component to vaccinating the global population.”
Antibody and immune responses are strong through eight months after the primary Johnson & Johnson vaccination, the company shared last month.
Johnson & Johnson is the third drugmaker to submit a request for booster shot authorization after Moderna and Pfizer.
Last month, Pfizer’s booster shot was granted emergency use authorization for people 65 and older and those with certain medical conditions or workplace exposure. The decision came after hours of debate and discussion.
The FDA’s Vaccine and Related Biological Products Advisory Committee is scheduled to meet Oct. 14 and 15 to consider the booster requests from Moderna and Johnson & Johnson.
J&J said it also plans to submit booster requests to global health organizations such as the World Health Organization and National Immunization Technical Advisory Group.
Johnson & Johnson stock rose slightly on Tuesday when the news was announced and closed at $159.58 a share.