J&J’s COVID-19 Vaccine Moves Forward After FDA Panel Vote

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An FDA advisory panel Friday unanimously endorsed the third US COVID-19 vaccine, a 1-shot vaccine produced by Janssen, a subsidiary of Johnson & Johnson (J&J), and an emergency use authorization by the FDA is expected to follow shortly.

This story has been updated.

An FDA advisory panel Friday unanimously endorsed the third US COVID-19 vaccine, a 1-shot vaccine produced by Janssen, a subsidiary of Johnson & Johnson (J&J).

An emergency use authorization by the FDA is expected to follow shortly.

But the vote came as CDC Director Rochelle Walensky, MD, cautioned in a briefing of the White House COVID-19 Response Team that recent declines in deaths are leveling off at a number that is still too high to provide much comfort.

“We at CDC consider this a very concerning shift in the trajectory,” she said, according to a transcript of the press briefing. “The most recent 7-day average of cases—approximately 66,350—is higher than the average I shared with you on Wednesday. In fact, cases have been increasing for the past 3 days compared to the prior week.”

While noting that the number of deaths shifts more than infections and hospitalizations, she said the most recent 7-day average (about 2000 deaths a day) is slightly higher than the 7-day average reported earlier in the week.

Walensky said the CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting over the weekend to review the same data discussed Friday at the FDA panel meeting and she will sign whatever ACIP decides.

Assuming it is approved, it will be the third to enter the market in the United States, which has lost more than 500,000 American lives.

As with the first 2 committee meetings, held in December for the Pfizer/BioNTech and Moderna products, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a day-long meeting broadcast online.

The J&J vaccine, Ad26.COV2.S, is a replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding a stabilized variant of the SARS-CoV-2 S protein, meaning it helps prime the immune system to fight coronavirus. The vaccine platform has also been used for the company's Ebola vaccine.

Phase 3 trial data showed effectiveness against common COVID-19 strains and emerging variants. The vaccine has demonstrated 86% and 82% effectiveness against severe COVID-19 cases in the United States and South Africa, respectively, with overall effectiveness rates of 72% and 64%.

After adding in moderate cases, the total effectiveness dropped to about 66%, and panel discussion Friday noted that the J&J vaccine cannot be compared directly with the other 2 vaccines.

J&J’s vaccine was tested in the United States, Latin America and South Africa at a time when more contagious, mutated variations were spreading. By that time, Pfizer and Moderna were wrapping up their testing.

The panel members also expressed concern that the public could come to consider the latest entry a less-than-optimal vaccine choice, but given the speed at which the virus is mutating, the faster more people are vaccinated, the better, health officials said.

Earlier in the day, at the White House press briefing, Anthony Fauci, MD, head of the National Institute of Allergy and Infectious Diseases, made that point, saying, "viruses will not mutate if you don't give them the opportunity to spread and replicate," and noted that there were no deaths or hospitalizations from COVID-19 in the J&J trials.

The Biden administration plans to send states, pharmacies, and community health centers 3 to 4 million doses as early as next week, while the company aims to deliver 20 million doses by the end of March and 100 million by the end of June.