FDA finds J&J coronavirus vaccine effective

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Johnson & Johnson’s coronavirus vaccine is safe and effective, U.S. regulators said, a key milestone on the path toward giving Americans access to the first such shot to work in a single dose.

The vaccine was 72% effective in the U.S.-based trial arm of its global study of more than 43,000 participants, Food and Drug Administration staff wrote in a document that summarized the company’s results and confirmed findings J&J released earlier this month.

Vaccines from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE were authorized by the FDA in December, just before the first major coronavirus variants were seen in the U.S. Since then, mutant versions have become a major concern, and J&J’s vaccine has been found to be less effective in South Africa and Latin America, where two quickly spreading versions were identified. Another variant that first arose in the U.K., called B.1.1.7, has been seen at even higher levels in the U.S.

The FDA’s analysis found the shot to have a favorable safety profile. There were no Covid-related deaths in the vaccinated group, the staff wrote, nor any other safety concerns that would preclude an emergency-use authorization. The agency lacked data to determine whether the J&J vaccine prevented asymptomatic cases, the report said.

Agency officials prepared the document ahead of a meeting Friday where external advisers will make a nonbinding recommendation as to whether the vaccine should be authorized.

If J&J’s shot is quickly authorized after Friday’s advisory panel meeting, as the other two vaccines were, the company will initially be able to provide 4 million doses, according to Richard Nettles, vice president of U.S. medical affairs for J&J’s Janssen Infectious Diseases and Vaccines unit.

Those doses are well short of J&J’s initial promise to the U.S. government to supply 12 million doses by the end of February. Speaking in a Congressional hearing on Tuesday, Nettles said the company continues to ramp up production facilities, aiming to have seven manufacturing sites active by midyear.

In the interim, J&J will likely produce enough of its one-dose vaccine to inoculate more than 20 million Americans by the end of March, Nettles said. The New Brunswick, New Jersey-based company’s contract calls for 100 million doses delivered by the end of June.

Unlike the Moderna and Pfizer-BioNTech vaccines that require two doses given three to four weeks apart and must be frozen, J&J’s single shot can be stored at refrigerator temperatures for as long as three months. J&J’s vaccine is made from a cold virus that doesn’t replicate but helps the body develop an immune response and prepare for a covid-19 infection.

The most frequent side effects included fever, fatigue, headache, muscle pain and injection-site pain, FDA staff wrote. One serious hypersensitivity reaction that began two days after vaccination was likely related to the shot, the FDA said. The reaction was not classified as anaphylaxis, a severe allergic reaction that’s been seen rarely in recipients of other covid shots.

J&J plans to offers its vaccine to clinical trial participants who received the placebo, the FDA said in its prepared documents. Upon authorization, J&J investigators would begin informing participants whether they’ve received the real shot. Those who received a placebo would be offered the opportunity to get it. Participants will be monitored for as long as two years after vaccination.