Johnson & Johnson’s one-shot coronavirus vaccine appeared safe and effective in trials, US Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for emergency authorization in the US.
An advisory panel of independent experts will meet on Friday to decide whether to recommend the vaccine be authorized. While the FDA is not bound to follow the advice of its experts, the agency did so when authorizing the Pfizer and Moderna vaccines late last year.
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The vaccine was effective in reducing the risk of Covid-19 and preventing PCR test-confirmed Covid-19 at least 14 days after vaccination, the FDA said in its briefing documents.
In a trial of more than 44,000 participants, federal regulators said the vaccine was 72% effective in the US, 66% effective in Latin America and 57% effective in South Africa, where the B1351 variant is widespread.
The vaccine was 85% effective at preventing severe cases of Covid-19. The vaccine’s efficacy rate held across Asian, Black, white and Latino trial participants.
J&J’s vaccine study raised alarms about how evolutionary changes in the coronavirus, called variants, could affect the efficacy of vaccines. Scientists are still studying how long the vaccine protects people against Covid-19.
Further, the FDA said “uncertainty” remains about the degree to which J&J’s vaccine prevents asymptomatic transmission of the coronavirus, though it presented promising data.
The expected approval and US distribution of the latest vaccine will be part of a surge in production, distribution and administration of vaccines to the US public this spring, public health authorities have said. The news comes just days after the US death toll passed 500,000, by far the highest in the world.
A J&J executive told congressional lawmakers the company expects to delivery 100m doses of the vaccine by June, including 20m by March. That still puts J&J behind schedule with the federal government. The vaccine maker had expected to deliver 12m doses of the vaccine by the end of February. Instead, it will deliver closer to 4m.
Nevertheless, the potential authorization of the J&J vaccine, and the possible authorization of AstraZeneca’s vaccine in April, would put the US on track to have more than enough doses to vaccinate the entire eligible adult population, about 267 million people.
Like the vaccine introduced by Moderna, children under 18 are not eligible to receive the vaccine, even though they are believed to be efficient spreaders of Covid-19.
J&J’s vaccine uses different technology than the two currently authorized vaccines to prompt immunity in the body. The body is introduced to the genetic code for the spike proteins covering the outside of the coronavirus through a technology called “viral vector”, which uses a second, weakened virus to deliver the genetic payload, and help the immune system recognize the coronavirus.
One advantage of the J&J vaccine is significantly less stringent storage requirements. The vaccine only needs to be stored at common refrigerator temperatures, unlike Pfizer and Moderna’s vaccines, which both require sub-zero freezers.
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