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J&J's COVID vaccine headed for VRBPAC on 26 February

Posted 05 February 2021 | By Kari Oakes 

J&J's COVID vaccine headed for VRBPAC on 26 February

A third vaccine against COVID-19 is headed for review by the US Food and Drug Administration (FDA). On Thursday, the Janssen group of Johnson & Johnson submitted an application for emergency use authorization of its single-dose recombinant human adenovirus vaccine; FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to review the application on 26 February.
 
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” said acting FDA commissioner Janet Woodcock, MD in a press release announcing the VRBPAC meeting. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”
 
FDA explained that the timing of VRBPAC’s independent review of the Johnson & Johnson vaccine allows for FDA staff to conduct an independent analysis of the data submitted in support of the emergency use authorization (EUA) request. FDA is not obligated to follow the advice of its advisory committees, though it usually does.
 
As with the prior VRBPAC meetings reviewing the two vaccines currently holding EUAs, FDA is planning live streams of the meeting via Facebook, YouTube and Twitter, in addition to the webcast it ordinarily uses for remote viewing of advisory committee meetings.  (RELATED: FDA authorizes Pfizer-BioNTech vaccine for emergency use, Regulatory Focus 11 December 2020; FDA issues EUA for Moderna COVID vaccine, Regulatory Focus 18 December 2020)

The application is backed by interim Phase 3 clinical trial data released by Johnson & Johnson on 29 January. The unpublished results, said the National Institutes of Health (NIH) in a press release, showed 72% efficacy in preventing moderate and severe COVID-19 in the United States. For Latin American countries participating in the trial, the figure was 66%, while efficacy against moderate to severe disease was 57% in South Africa, where a SARS-CoV-2 variant is becoming increasingly prevalent.
 
The efficacy figures reported by Johnson & Johnson fall below the approximate 95% efficacy seen in clinical trials of the messenger RNA (mRNA) vaccine produced by Pfizer and BioNTech as well as the mRNA vaccine jointly developed by Moderna and the NIH. Still, the figures reported last week by Johnson & Johnson best the 50% efficacy FDA set as its lowest threshold for considering granting an EUA for COVID-19 vaccine. (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus 06 October 2020)
 
At the time of interim analysis, a total of 468 symptomatic cases of COVID-19 were seen among the global total of 44,325 adult participants in the trial. However, none of the participants who received vaccine died of COVID-19, while 5 deaths in the placebo arm were attributed to COVID-19.
 
According to the NIH, 55% of the development work for the Johnson & Johnson COVID-19 vaccine was funded by the US Government through NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA).
 
“As part of Janssen’s collaboration with the federal COVID-19 response effort, representatives from NIAID, BARDA and Janssen are included in the oversight group that receives recommendations from the trial’s independent data and safety monitoring board (DSMB),” wrote NIH. “The same DSMB also oversees the other federally supported Phase 3 clinical trials evaluating COVID-19 vaccine candidates.”
 
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Tags: coronavirus, FDA, US

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