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.
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