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Regulatory Focus™ > News Articles > 2021 > 2 > Updated: FDA issues EUA for J&J's one-shot COVID vaccine

Updated: FDA issues EUA for J&J's one-shot COVID vaccine

Posted 26 February 2021 | By Kari Oakes 

Updated: FDA issues EUA for J&J's one-shot COVID vaccine

The US Food and Drug Administration (FDA) has issued an emergency use authorization for the COVID-19 vaccine developed by Janssen, a division of Johnson & Johnson.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD in a statement announcing the emergency use authorization (EUA). “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” she said.

As with the other two EUAs issued for COVID-19 vaccines, FDA is requiring Janssen and vaccination providers to adhere to requirements to report serious adverse events, multisystem inflammatory syndrome cases and COVID-19-related hospitalizations and deaths into the Vaccine Adverse Event Reporting System (VAERS). 

The EUA comes the day after Friday's unanimous vote from an FDA advisory committee to recommend authorization of Janssen's single-dose adenivorus type 26 (AD26) vaccine.
 
The 22-0 vote endorsing a favorable benefit-risk profile for the vaccine represents the third positive decision on a COVID-19 vaccine – but the first unanimous one – from FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

In a statement that came soon after Friday's VRBPAC vote, FDA declared its intention to act quickly, writing, "Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution."
 
Despite some technical glitches related to its virtual format, the VRBPAC meeting went relatively smoothly, with little rehashing of the technicalities of the EUA process. Acting chair Arnold Monto, MD, remarked following the vote that he has seen VRBPAC members develop “increased confidence with the process, having been measured by the changing votes that we have had in the subsequent reviews.” Added Monto, of the University of Michigan, “We are very comfortable with the procedure as well as the vaccines that we are approving.”
 
In discussion after the vote, The University of Pittsburgh Cancer Institute’s Patrick Moore, MD, MPH, reflected on how the influx of reassuring data after the December EUAs for vaccines from Pfizer and BioNTech, and Moderna, had allowed his own viewpoint to shift: “This process – the EUA process -- does seem to have worked, despite my own personal concerns about it say, 6 months ago.” (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus 06 October 2020)
 
In Phase 3 double-blinded clinical trials of the AD26 vaccine that involved almost 42,000 adults randomized 1:1 to receive one dose of the vaccine or a saline placebo, the vaccine showed 66% efficacy against moderate, severe and critical COVID-19. Participants in the US who received the vaccine saw 72% efficacy; efficacy was 85% against severe and critical COVID-19 when the full global dataset was considered. Vaccination provided 100% protection against hospitalization with COVID-19.
 
The trial included 7,450 participants over the age of 60 years; individuals with comorbidities were included in each age group. Mean participant age was 51 years; 17% were Black of African American, 3.5% were Asian, and about 8.5% identified as American Indian, Alaskan Native, or Pacific Islander.
 
In presenting the clinical trial data, Janssen representatives made a point that FDA did not dispute: the single-dose vaccine’s apparent reduced efficacy against COVID-19 compared with the performance of the Pfizer-BioNTech and Moderna vaccines was in large part an artifact of the “where” and “when” of the Janssen clinical trials.
 
When trials were run for the vaccine sponsors who were early out of the gate, few SARS-CoV-2 variants of concern were circulating. By contrast, the Janssen studies were conducted later, in regions such as Brazil, South Africa, and the US, which all saw high COVID-19 incidence during the trial period. The P.2 lineage was responsible for 69% of Brazilian cases at that time; in South Africa, fully 95% of cases were caused by the B.1.351 lineage during the trial.
 
In terms of the pre-specified endpoint of vaccine efficacy against severe and critical disease, though, the Janssen vaccine performed about as well in all three regions. Efficacy against severe and critical COVID-19 was 86% in the US, 88% in Brazil, and 82% in South Africa.
 
The vaccine, based on a well-established adenovirus platform, was associated with fewer systemic side effects and adverse events than either the Pfizer-BioNTech or Moderna vaccines. The day before the 26 February VRBPAC meeting, the sponsor received its first report of anaphylaxis following vaccine administration; an investigation is ongoing. Janssen is also trialing a two-dose vaccination regimen.
 
Though the voting question asked VRBPAC members examine “the totality of the scientific evidence” to weigh in on the benefits and risks of the vaccine’s use in those 18 years and older, members acknowledged that the pressing realities of the global pandemic weighed on them as they considered the question. Through the course of the day, many mentioned the usefulness of a single-dose vaccine that can be stored for a full 2 years at normal freezer temperatures and refrigerated for 3 months.
 
Said Chicago Medical School’s Archana Chatterjee, MD, PhD, “I think we have to keep in mind that we are still in the midst of a deadly pandemic.” In light of severe and ongoing vaccine shortages, “Authorization of this vaccine will help meet the needs of the moment,” she said.
 
“This was a relatively easy call,” said Harvard’s Eric Rubin, MD, PhD, editor-in-chief of the New England Journal of Medicine. He noted that efficacy figures for the Janssen vaccine are “way over the bar” set by FDA in its COVID vaccine EUA guidance. “It’s nice to have a single-dose vaccine.”

Editor's note: This article was updated on 27 February to include information about FDA's issuance of the EUA for the Janssen COVID-19 vaccine.
 
Janssen EUA letter
 

 

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