FDA Panel Endorses Johnson & Johnson's COVID-19 Vaccine for EUA

A panel of advisors to the FDA voted 22 to 0 to recommend the Janssen vaccine, named Ad26.COV2.S, for emergency approval, according to the FDA Advisory Committee Meeting held on Friday. The decision moves Ad26.COV2.S one step closer to receiving emergency use authorization (EUA) by the FDA. If approved, it will be the first single-dose vaccine for COVID-19 and the third vaccine to be authorized in the US for the virus.¹

Although both Pfizer and Moderna utilized messenger RNA (mRNA) technology, the Johnson & Johnson vaccine is an adenovirus-based vaccine that employs a portion of genetic material from a weakened pathogen in order to induce an immune response. The company leveraged its AdVac vaccine platform that has also been previously deployed to investigate Zika, RSV, and HIV investigational vaccine candidates.

Janssen’s request for EUA for its vaccine is based on its phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary end points; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. Johnson & Johnson submitted its EUA request on February 4.²

On Wednesday, the FDA released results of its analysis of the data, confirming the safety and efficacy of the vaccine. According to the data, vaccine efficacy against moderate to severe/critical COVID-19 was 66.9% (95% CI 59.0, 73.4) when considering cases occurring at least 14 days after the single-dose vaccination and 66.1% (55.0, 74.8) when considering cases occurring at least 28 days after vaccination. The vaccine was also demonstrated to be 76.6% and 85.4% effective against severe/critical cases after 14 days and 28 days, respectively.²

A post hoc analysis showed no COVID-19 hospitalizations in the vaccine group after 28 days compared with 16 cases in the placebo group.²

The briefing document provided a breakdown of efficacy rates in regions where the new SARS-CoV-2 variants emerged, looking at efficacy across 3 countries: United States, South Africa, Brazil. In a subgroup analysis, there was lower efficacy against moderate to severe/critical COVID-19 observed in South Africa compared with the United States. However, efficacy against severe/critical COVID-19 was comparably high across all 3 countries.²

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.

Johnson & Johnson recently stated that upon authorization, vaccines will be shipped out to health care facilities and pharmacies immediately.

Kaitlyn Rivard, PharmD, BCPS, BCIDP, AAHIVP infectious diseases residency director at the Cleveland Clinic, recently discussed the significance of the Johnson & Johnson COVID-19 vaccine for at-risk populations in an interview with Drug Topics®.

Related: Pharmacist Leads COVID-19 Vaccination Clinic

“Certainly, a single dose vaccine will be incredibly helpful from a logistic standpoint, especially for patients who have trouble coming in for 2 doses,” Rivard said.

“I think it'll also depend on the federal government and where they allocate that product. I could see them focusing that product in areas where cold storage is a bigger concern, such as rural areas and underserved areas. I think there's still a lot more to learn about where Johnson & Johnson is going to fit in from a logistics standpoint,” she said.

For pharmacists, the Johnson & Johnson vaccine also means pivoting in terms of strategy in order to make room for additional products.

“I would encourage anyone who is currently working through the mRNA vaccines to begin planning for the next round of vaccines that are coming as well,” Rivard said. “We’re going to need as many products on hand as possible to get the population vaccinated to have the impact we’re aiming for.”

Lisa Holle, PharmD, BCOP, FHOPA, FISOPP, associate clinical professor at the University of Connecticut School of Pharmacy, agreed that the Janssen vaccine will make COVID-19 vaccination much more accessible for many Americans.

"The significance of the EUA for Johnson & Johnson COVID-19 vaccine is huge," Holle wrote in an email to Drug Topics. "With more vaccines available on the market, more of the US population can be vaccinated more quickly. This in turn should help us more quickly return to normal life."

"Furthermore, with only requiring 1 dose not 2 doses, this may help more folks be able to get the vaccine as well. Two-dose vaccines may be difficult for some, especially in areas where vaccine clinic availability is only during typical M-F 9-5 type hours and they may work during those times," Holle wrote.

The FDA is not required to follow the committee’s advice, but it is expected to do so.

References

1. US Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee – 2/26/2021.

2. FDA. FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Vaccine and Related Biological Products Advisory Committee Meeting, February 26, 2021. Accessed February 24, 2021. https://www.fda.gov/media/146217/download