The FDA is split on whether or not J&J vaccine recipients require a booster shot.
According to the Associated Press, the Food and Drug Administration (FDA) is split on whether or not recipients of the one-dose Johnson & Johnson COVID-19 vaccination should get a booster shot.
According to scientists who undertook an online assessment of the shot, there were gaps in J&J’s data and no information on the booster’s efficiency against the highly contagious Delta type.
The questionable assessment comes ahead of deliberations slated for Thursday and Friday by an FDA advisory panel, which will decide whether or not the Moderna and J&J vaccinations require a booster dosage. If a J&J booster is recommended, the agency must decide whether the vaccine should be given two months or six months after the original vaccination.
If the FDA approves the booster injections, further distribution guidelines will need to be established when they reach the next stage of the government’s vaccine approval procedure. According to the Associated Press, the Centers for Disease Control and Prevention (CDC) will have to pick who in the United States should receive them.
See the list below for more Associated Press reporting.
All vaccines used in the United States, according to health officials, continue to give substantial protection against serious sickness or death from COVID-19. However, the government has already approved supplemental doses of the Pfizer vaccine for certain patients starting six months after their last injection, despite concerns that protection against milder infections may be decreasing.
Moderna also sought the FDA to clear its booster dose at six months, aiming for consistency. J&J, on the other hand, made the decision more difficult by providing a second shot in two to six months.
A study of the two-month booster plan implies “there may be a benefit,” according to FDA reviewers, despite the fact that just a tiny percentage of participants were given another shot at six months instead.
Overall, the FDA reviewers determined that the J&J vaccine “still provides protection against severe COVID-19 illness and death.” However, statistics on its efficacy “consistently less” than the protection provided by Pfizer and Moderna shots.
J&J, for its part, submitted data to the FDA from a real-world trial demonstrating that its vaccine is still roughly 80% effective in preventing hospitalizations. This is a condensed version of the information.