FDA issued an Emergency Use Authorization for Janssen COVID-19 vaccine for active vaccination to prevent COVID-19 in individuals 18 years and older.
On October 4, 2021, Janssen submitted a request to amend their EUA to include the use of booster dose for individuals aged 18 years and older; it was proposed an interval between the first vaccination and the booster dose by six months or later based on the strength of the immune responses, though a booster dose can be administered as early as two months.
The J&J Vaccine
Janssen submitted an analysis of data from four clinical trials that evaluated the safety and immunogenicity or efficacy of the vaccine either as a second dose administered in 2-3 months after the first dose or as a booster dose administered six months after the first vaccination.
The datasets were not submitted on time for the FDA to conduct an independent review with the exception of the assessment of immunogenicity of the six-month booster interval. Hence, they were not able to review the Sponsor’s (Janssen) Analysis.
The total number of exposed subjects is 8,049, and out of that number, only 17 were tracked after getting a second shot after the six-month interval.
On September 3, 2021, Stéphane Bancel, the Chief Executive Officer of Moderna, announced that it has submitted for a Conditional Marketing Approval (CMA) with European Medicines Agency (EMA) for evaluation of a booster dose of Moderna COVID-19 vaccine at 50 µg dose level. Moderna will remain committed to staying ahead of the virus.
And on September 15, 2021, Moderna emphasized a new study analysis that the Moderna COVID-19 Vaccine is highly effective against variants of concern in a vaccine effectiveness study conducted in partnership with Kaiser Permanente Southern California (KPSC), 352, 878 recipients of 2 doses of Moderna COVID-19 vaccine compared to 352, 878 unvaccinated individuals found vaccine effectiveness of 87 percent against COVID-19 diagnosis and 96 percent against COVID-19 hospitalization.
In a separate publication by the U.S. Centers for Disease Control and Prevention (CDC), Moderna COVID-19 vaccine efficacy against emergency visits was 92 percent and 95 percent against COVID-19 hospitalization. Across all age groups, the Moderna vaccine recipients show significantly higher vaccine efficacy than other COVID-19 vaccines.
This coming October 15, 2021, the Vaccines and Related Biological Products Advisory Committee meeting will be held to discuss the data presented by Janssen its safety and effectiveness for emergency authorized use as a booster dose after the first vaccination with two months interval. According to USA Today, the committee will consider on October 21 and 22 who should be given the Moderna and J&J boosters.
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