The FDA advisory committee will meet in 3 weeks to discuss the Janssen investigational vaccine.
Johnson & Johnson has submitted an emergency use authorization (EUA) to the FDA for its single-dose vaccine candidate for coronavirus disease 2019 (COVID-19).1
The EUA submission is based on the company’s phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary endpoints; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19.
Related: Johnson & Johnson Reports Efficacy Rates of COVID-19 Vaccine Candidate
The company has also applied for authorization of the Janssen vaccine with several health agencies outside the US on a rolling basis and plans to submit a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks.
According to Johnson & Johnson, provided authorization is granted, vaccines will be shipped immediately following authorization.
In a White House COVID-19 news briefing that took place on Friday, Andy Slavitt, senior advisor to President Biden’s coronavirus response team, provided updates on when the FDA will be making a decision on the Janssen vaccine.2
“The data are now with the FDA, they are examining, they have scheduled the advisory committee…which will meet in 3 weeks,” Slavitt said.2
Notably, the Janssen vaccine, which is being tested in 3 countries – the US, Brazil, and the Republic of South Africa – demonstrated “rather complete protection against severe disease, including hospitalizations and deaths,” with an efficacy rate of about 88.8% across all 3 sites, Slavitt explained. However, in regard to COVID-19 variants, such as B.1.351 in South Africa, the vaccine candidate was shown to be 57% effective against moderate disease.
In the recent briefing, officials also stressed that if Americans continue to adhere to public health measures, such as mask-wearing, social distancing, and avoiding crowded place, the variants will fail to evolve, mutate, and spread.
“Today’s submission for emergency use authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a statement.1
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” Stoffels said.
1. Johnson & Johnson Announces Submission of Application to the US FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine. News release. Johnson & Johnson; February 4, 2021. Accessed February 8, 2021. https://www.jnj.com/johnson-johnson-announces-submission-of-application-to-the-u-s-fda-for-emergency-use-authorization-of-its-investigational-single-shot-janssen-covid-19-vaccine-candidate
2. White House COVID-19 Response Team Holds News Conference. ABC News. February 5, 2021. Accessed February 5, 2021. https://www.pscptv/w/1qKDejEOLEGV.