Johnson & Johnson Booster Shot Gets Mixed Review From FDA
A highly expected report from the FDA on Wednesday found that drug maker Johnson & Johnson's COVID-19 booster shot may have potential benefits. The FDA, however, did not make a recommendation about whether those who received the J&J vaccine should also get a booster from the company.
The report also noted that they did not submit the datasets in sufficient time for FDA to conduct an independent review to verify the company's analysis.
"Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the FDA said in a 54-page report.
An additional National Institute of Health report revealed that while recipients of the J&J vaccine could benefit from a second dose of the original vaccine, people may receive better protection if the booster shot came from Pfizer or Moderna.
J&J ran two separate trials. One was a large trial determining the efficacy of two doses two months apart. The other was a smaller study of two doses six months apart.
Both were submitted to the FDA for emergency use authorization.
On Friday, the Vaccines and Related Biological Products Advisory Committee (VRPAC) will use this report and NIH's when discussing the timing between doses, current need, and overall safety associated with the booster to determine approval for emergency use authorization.
New from NIH: Johnson & Johnson recipients got a much better boost from Moderna and Pfizer boosters than another shot of J&J medrxiv.org/content/10.110…
Emily Kopp (@emilyakopp) October 13, 2021
On boosters for Moderna/J&J, @kavitapmd: "The FDA is loading up documents in realtime. They loaded up a statement that said basically said for Johnson and Johnson that the data presented, while it is believable, they could not draw conclusions from it..." (1/3) #AMRstaff
Andrea Mitchell (@mitchellreports) October 13, 2021
.@kavitapmd: "...& some parts of data analysis were not verifiable. Through a big shadow of doubt on J&J's prediction to get a booster ready, Moderna tried to closely align with what Pfizer's emergency authorization looked like. So many of us thought that..." (2/3) #AMRstaff
Andrea Mitchell (@mitchellreports) October 13, 2021
@kavitapmd: "... was somewhat of an easier decision. But it is a half of dose (for Moderna) that we've been receiving in 1 & 2, & it is accompanied with controversy because Moderna has not had as much decreasing immunity over time compared to Pfizer." (3/3)
Andrea Mitchell (@mitchellreports) October 13, 2021
© Copyright IBTimes 2024. All rights reserved.