Johnson & Johnson revealed recently that it has begun the process of seeking emergency use authorization of the booster shot for its COVID-19 vaccine for people 18 years of age and older. In order to embark on the process, the pharmaceutical giant submitted data to the U.S. Food and Drug Administration for review.
Included in the submission is data from a late-stage study that determined that a booster shot given 56 days after the original vaccine dose would provide 94% protection against symptomatic COVID-19 cases in the United States. The booster shot was also found to provide 100% protection against severe cases once 14 days had passed since the booster shot was administered.
In addition to the U.S. Food and Drug Administration, Johnson & Johnson is also planning to submit this data to other regulatory authorities such as the World Health Organization and National Immunization Technical Advisory Groups.
Prior to Johnson & Johnson’s filing, the FDA had approved the booster shot of Pfizer Inc and BioNTech for use on people over the age of 65, those who are regularly exposed to the virus, and people at high risk of severe disease. Last month, Moderna Inc also submitted an application for emergency use of its booster shot for the company’s two-dose vaccine.
