The FDA had mixed feelings about Johnson & Johnson’s booster shot.
According to a highly anticipated FDA analysis released on Wednesday, Johnson & Johnson’s COVID-19 booster shot may have potential benefits. The FDA, on the other hand, did not offer any recommendations on whether or not those who had the J&J vaccine should also receive a booster from the business.
They also did not submit the datasets in time for FDA to undertake an independent assessment to verify the company’s research, according to the report.
“Although not independently confirmed by FDA from datasets,” the FDA wrote in a 54-page report, “summaries of the data suggest there may be a benefit in a second dose delivered roughly 2 months after the primary dose.”
While recipients of the J&J vaccination may benefit from a second dose of the initial vaccine, people may be better protected if the booster shot comes from Pfizer or Moderna, according to another National Institute of Health analysis.
J&J conducted two trials.
The first was a major study that looked at the efficacy of two doses given two months apart. The other was a smaller research with two doses separated by six months.
Both were submitted to the FDA for approval for emergency use.
On Friday, the Vaccines and Related Biological Products Advisory Committee (VRPAC) will examine the timing of doses, current need, and overall safety of the booster alongside this report and the one from the National Institutes of Health (NIH) to determine approval for emergency use permission.
New research from the National Institutes of Health shows that Moderna and Pfizer boosters gave Johnson & Johnson recipients a far stronger boost than another dose of J&J. medrxiv.org/content/10.110… On Moderna/J&J boosters, @kavitapmd: “Documents are being loaded in real time by the FDA.” They prepared a statement for Johnson and Johnson that simply stated, “While the data supplied is credible, they were unable to draw inferences from it…” (1/3) “…& other aspects of data analysis were not verifiable,” says #AMRstaff. @kavitapmd. Moderna attempted to closely coincide with what Pfizer’s emergency permission looked like, despite a large shadow of doubt on J&J’s estimate of getting a booster available. “So many of us believed…” (2/3) #AMRstaff “… was something of an easier decision,” Andrea Mitchell (@mitchellreports) tweeted on October 13, 2021. But it’s half the dose (for Moderna) that we’ve been getting in 1 & 2, and it comes with controversy because Moderna hasn’t had as big of a decline in immunity over time as Pfizer.” (3/3) Andrea Mitchell (@mitchellreports) on the 13th of October 2021. The Washington Newsday Brief News is a daily newspaper published in Washington, D.C.