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Johnson & Johnson Single-Shot COVID-19 Vaccine Unanimously Recommended for Emergency Use Authorization by FDA Advisory Committee

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the staff of the Ridgewood blog

New Brunswick NJ, Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial.

“We are extremely grateful to the VRBPAC members for their extensive review of the data supporting emergency use of Johnson & Johnson’s single-shot COVID-19 vaccine candidate,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.”

The next step in the process is for the FDA to decide whether to grant an EUA for Janssen’s COVID-19 vaccine candidate. The recommendation of the FDA Advisory Committee is non-binding, and the final decision on authorization is made by the FDA. Under an EUA, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency. If authorized by the FDA, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will then provide a recommendation on the use and roll-out of the Janssen COVID-19 vaccine candidate.

“We are grateful to everyone who has contributed to the wealth of data we presented today, including study participants, site investigators and teams, collaborators and everyone who has worked so hard to bring us to this moment. We are confident our COVID-19 vaccine candidate will have a significant impact in protecting people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

Johnson & Johnson is committed to making its COVID-19 vaccine candidate available on a not-for-profit basis for emergency pandemic use. The Company is prepared to supply its vaccine immediately upon EUA and expects to deliver enough single-dose vaccine candidate by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-dose vaccines to the U.S. during the first half of 2021.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

According to analysis by Johns Hopkins Center for Health Security , the briefing document from the FDA indicates that the vaccine demonstrated acceptable safety and efficacy profiles in the Phase 3 clinical trials. Overall, the vaccine demonstrated 66.1% efficacy in preventing moderate-to-severe COVID-19 disease, with 66 cases in the vaccine group compared to 193 in the control group, and it was 85.4% efficacious in preventing severe and critical disease. Notably, there were no deaths among vaccinated participants (compared to 7 in the control group), and there were no hospitalizations identified in the vaccine group after 28 days post-vaccination. In addition to assessing efficacy in preventing COVID-19 disease, the data also provide insight on the vaccine’s ability to prevent infection. Among a small portion of the participants—2,650 out of approximately 40,000 total—the vaccine reduced the risk of infection by 65.5%, demonstrating an effect in limiting transmission. The FDA’s analysis indicates that the efficacy could potentially be lower among older adults (e.g., ages 60 or 75 years and older), although additional data are needed.
With respect to emerging variants, the vaccine demonstrated 81.7% efficacy in preventing severe or critical COVID-19 disease and 64.0% efficacy in preventing moderate disease in the South Africa portion of the trial—where the B.1.351 variant represented 94.5% of the sequenced cases. The vaccine’s efficacy was not markedly lower in Brazil, where the P.2 variant is prominent. No cases were identified for the B.1.1.7 or P.1 variants.
As we have covered previously, the J&J-Janssen vaccine requires a single dose, rather than 2 doses spread over a period of weeks (or months in some countries). Additionally, the vaccine only requires refrigeration temperatures for medium-term storage and transportation. These characteristics could reduce operational and logistical challenges for large-scale vaccination operations, which could have a substantial impact on the speed at which vaccination programs can proceed. Notably, however, the current supply is limited, and it could be another month or longer before high-volume distribution can begin.

One thought on “Johnson & Johnson Single-Shot COVID-19 Vaccine Unanimously Recommended for Emergency Use Authorization by FDA Advisory Committee

  1. Let’s hope the J&J vaccine wasn’t developed by their baby powder department!

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