Infectious Disease

The FDA panel endorses a one-time J&J vaccine

February 26, 2021

3 min read

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Kuppalli reports to be a consultant for GlaxoSmithKline. Marrazzo does not report any relevant financial information.

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An FDA advisory panel unanimously voted on Friday to recommend approval of a one-time COVID-19 emergency vaccine in the US, which could potentially change the landscape of the country’s response.

Developed by Johnson & Johnson subsidiary Janssen, the shot will become the third COVID-19 vaccine available in the US if the FDA follows the recommendation of the Advisory Committee on Vaccines and Related Biological Products (VRBPAC) and receives an emergency approval (EEA ) granted. what is generally expected.

Johnson and Johnson COVID vaccine

A panel of experts recommended that the FDA grant emergency clearance for Johnson & Johnson’s COVID-19 vaccine.
Photo credit: Adobe Stock

“Another important milestone in containing the COVID-19 pandemic” Krutika Kuppalli, MD, Healio said, an assistant professor of medicine in the Department of Infectious Diseases at the Medical University of South Carolina and an emerging director of biosecurity at the Johns Hopkins Center for Health Security.

An EEA requires that the known and potential benefits of a product outweigh the known and potential risks. In December, the VRBPAC recommended approving emergency vaccines manufactured by Pfizer-BioNTech and Moderna, soon followed in both cases by the FDA, which issued an EUA.

Krutika Kuppalli

Jeanne M. Marrazzo

Both vaccines are given in two shots 21 or 28 days apart. The Johnson & Johnson vaccine was heralded as a potentially transformative vaccine for the US and a worldwide response, not only because it is administered in one shot, but also because it can be kept for months at normal refrigeration temperatures rather than extremely cold storage .

VRBPAC members voted 22-0, recommending the FDA to issue an EUA for the Johnson & Johnson vaccine for adults 18 years and older. The vote came at the end of a one-day discussion and review of relevant clinical trial data, which included presentations from Janssen, external comments from doctors and public officials, and questions from the panel. The meeting took place days after the FDA announced in an information document that Johnson & Johnson “provided adequate information to ensure the quality and consistency of the vaccine for product approval under an EEA”.

Rochelle P. Walensky

Johnson & Johnson previously announced positive data from the Phase 3 ENSEMBLE study showing the vaccine was 85% effective and 66% overall effective to moderate to severe or critical at least 28 days after vaccination Prevent diseases. It was reported that effectiveness was 72% in the US arm of the study, 66% in Latin America, and 57% in South Africa, with 95% of the COVID-19 cases that occurred during the study from the B.1.351 variant derived from SARS-CoV-2.

However, it was found that, according to the data in all regions, the vaccine was 100% effective in preventing hospitalization from COVID-19 in all regions for at least 28 days after vaccination.

Both the editorial board member of Kuppalli and Infectious Disease News Jeanne M. Marrazzo, MD, MPH, The director of the Department of Infectious Diseases at the University of Alabama at the Birmingham School of Medicine called the vaccine a potential “game changer”.

“First, this vaccine has very forgiving storage and transportation requirements, which makes it easier to distribute, especially in areas with less infrastructure. Second, a single dose is a huge benefit – one push and you’re done! “Marrazzo told Healio.

According to the CDC, more than 91.6 million doses of Pfizer-BioNTech and Moderna vaccines have been dispensed in the US since mid-December – enough to vaccinate more than 45 million people. A Johnson & Johnson executive said this week that the company is on track to ship 100 million doses of its vaccine to the U.S. by the end of June, including 20 million doses by the end of March, which would significantly increase vaccine availability .

The single-dose schedule and less demanding storage requirements “will make the logistics of getting vaccines up and running exponentially easier than before,” Kuppalli agreed.

“It will make it easier for us to get into communities to reach disenfranchised patient populations and those in hard-to-reach communities so we can vaccinate vulnerable people at higher rates,” she said. “Eventually it will allow us to have more vaccines available so we can work to vaccinate people around the world and hopefully end this pandemic.”

More than 28 million cases of COVID-19 have been reported in the United States alone, including nearly 510,000 deaths, according to Johns Hopkins University. Weeks of good news of declining case numbers ended on Friday as CDC Director Rochelle P. Walensky, MD, MPH, A White House press conference warned that the daily number of cases may have decreased, with increases reported over the past three days.

Marrazzo noted that protecting the Johnson & Johnson vaccine from serious illness could help hospitals take a break.

“Even if the reduction in mild to moderate illness in the community is less impressive – and it will still be 55% to 60%, which is great in itself – those benefits could take time to our systems, and especially our healthcare workers give to recover from last year, ”she said.

Johan Van Hoof, MD, Janssen’s global director for vaccines said during the meeting on Friday that the company was working on a second-generation vaccine to address emerging SARS-CoV-2 variants that could enter Phase 1 testing before summer. Moderna announced this week that it has sent a variant-specific booster vaccine to the NIH for Phase 1 testing.

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