FDA reviewer backs J&J COVID jab for emergency OK

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. 

In a briefing document published ahead of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the FDA says the Ad26.COV2.S vaccine – developed by J&J’s Janssen Biotech unit – is “consistent” with recommendations in its EUA guidance for COVID-19 vaccines.

According to the document, clinical trials filed to support the EUA show that Ad26.COV2.S (JNJ-78436735) was 66.9% effective at preventing COVID-19 14 days after dosing, and 66.1% effective 28 days later, with “no specific safety concerns identified that would preclude issuance of an EUA.”

The safety of the vaccine was consistent across patients of different age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.

The FDA also says that the clinical data show that Ad26.COV2.S is 85% effective at preventing severe COVID-19 at 28 days, and retained good activity against some emerging strains including the South African and Brazilian variants which are more transmissible.

Although it has been shown to be less effective against these, the FDA analysis puts its efficacy at preventing moderate or severe COVID-19 at 64% for the South African variant, which is higher than the 57% reported by the company in a recent analysis.

It also notes interesting if preliminary data on asymptomatic infections at 29 days, pointing to a 66% efficacy, although that should be “interpreted with caution”, according to the agency, and the early signs are that it is protective in people aged over 60.

If the EUA is granted, Ad26.COV2.S will be the third shot cleared for use in the US after the Pfizer/BioNTech and Moderna mRNA-based vaccines.

While its top-line efficacy is lower than the 90%-plus for the first two vaccines, expectations are high for J&J’s candidate because it only requires one dose rather than two, so limited supplies will be stretched further.

Moreover, it only needs regular refrigeration temperatures to remain stable, so will be easier to distribute than the mRNA jabs that need to be stored at very low temperatures.

Last year, the US ordered 100 million doses of the Janssen vaccine, with an option for a further 200 million doses, and the company has agreed to supply them at cost as the federal government contributed $1 billion towards its development.

J&J says it has 4 million doses of the vaccine ready to ship if and when the EUA comes through, and should have 20 million ready by the end of March.

At last count, 65 million doses of the Pfizer/BioNTech and Moderna vaccines doses have been administered in the US, with the daily average now running at more than 1.2 million. Almost 14% of the population has now received one dose, and 6% have had two.

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