FDA’s Review of Johnson & Johnson Vaccine Finds It Safe and Effective for Emergency Authorization

The FDA has published a briefing document ahead of Friday’s advisory panel meeting showing that agency staff have found the promising, single-shot Johnson & Johnson COVID-19 vaccine safe and effective enough for Emergency Use Authorization (EUA).

The 62-page briefing document, which outlines the agency’s review of trial data for the vaccine, shows that the agency is in favor of granting an EUA for J&J’s shot, a position that makes authorization likely for what could be the U.S.’s third COVID-19 vaccine.

Specifically, FDA staff found that the vaccine is 66.1 percent effective overall against moderate- to-severe infection at least four weeks after inoculation, which meets the agency’s 50 percent threshold for a COVID-19 vaccine EUA. In the U.S., it demonstrated 72 percent effectiveness at least four weeks after vaccination, but showed lower effectiveness (64 percent) in South Africa, where a concerning new viral strain has emerged. In Latin America, the vaccine demonstrated 61 percent effectiveness.

The agency’s vaccine advisory panel, which is comprised of independent experts, will meet Friday to discuss and vote on an EUA for the vaccine. The committee is expected to give it the green light, but the agency is not required to follow a recommendation in favor of an EUA. Should the committee vote in favor of the shot, the agency is expected to authorize it within days.

The FDA has determined that J&J’s vaccine also appeared highly effective in protecting against severe disease requiring medical intervention, noting that there were seven deaths in the placebo group and none in the vaccine group. In the U.S., it demonstrated 85.9 percent effectiveness against the most severe COVID-19 cases, while demonstrating 81.7 percent and 87.6 percent effectiveness against the most severe cases in South Africa and Brazil, respectively.

The South African efficacy data came from a recently submitted addendum document filed by J&J that the vaccine advisory committee will also look over. The company said the additional data are significant because it implies that its vaccine works against the South African strain that has rapidly spread throughout the country and reached others, including the U.S. The data also show that the vaccine is 64 percent effective against less severe COVID-19 in South Africa.

Approximately 94.5 percent of coronavirus cases that occurred in the South African trial were due to the viral variant, J&J said. The data also suggested that the vaccine’s efficacy in Brazil was not impacted by another variant that has originated there and become prevalent, according to the drugmaker.

The vaccine showed similar efficacy across age groups, but the agency did find that it was only 42.3 percent effective overall in patients over age 60 with comorbidities. There were not enough data to speculate on its effectiveness in patients over the age of 75.

The FDA said it considers the vaccine to be safe, as the data showed a “favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.” It also approved of the chemistry, manufacturing and controls (CMC) data J&J submitted in its authorization request, saying the company “provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA.”

The data are too limited to gauge its effectiveness against viral transmission at the moment, the FDA said, but it believes the vaccine’s “demonstrated high efficacy against symptomatic COVID-19 may translate to overall prevention of transmission in populations with high enough vaccine uptake.”

At a White House briefing Wednesday, Jeffrey Zients, the administration’s COVID-19 response coordinator, spent time discussing Biden’s plans for J&J vaccine distribution should it be authorized.

“If authorized, we are ready to roll out this vaccine without delay … We anticipate allocating 3 [million] to 4 million doses of J&J’s vaccine next week,” Zients said. The figures are in line with what a J&J official told a House subcommittee hearing on Tuesday (DID, Feb. 24).

Zients also reiterated J&J’s assessment to the government that the company would be able to deliver 20 million doses by the end of March.

“We are working with the company to accelerate the pace and timeframe by which they deliver the full 100 million doses, which is required by contract by the end of June,” Zients added, indicating the White House was looking to finish deliveries sooner than the negotiated deadline.

Read the FDA advisory panel briefing here: www.fdanews.com/02-24-21-Vaccine.pdf. — James Miessler