FDA Says One-Dose Johnson & Johnson COVID-19 Vaccine Is Safe, Effective
MADRID, SPAIN – NOVEMBER 19: A sign for Johnson & Johnson is seen outside the Johnson & Johnson headquarters on November 19, 2020 in Madrid, Spain. The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the first phase 3 clinical trial on November 18, 2020 for the COVID-19 vaccine from the company Janssen, belonging to the American multinational Johnson & Johnson. Trials of this vaccine had to be stopped due to "unexplained illness" in one participant. The tests were resumed eleven days later, after verifying that the event was not related to the administration of the drug. (Photo by David Benito/Getty Images)
David Benito/Getty Images

The Food and Drug Administration (FDA) on Wednesday released its analysis of Johnson & Johnson’s one-shot dose COVID-19 vaccine, supporting its authorization for emergency use.

The vaccine would be the third to become available in the United States, after the Pfizer-BioNTech vaccine and the Moderna vaccine were approved. A panel of advisers to the FDA will reportedly meet on Friday in order to evaluate the vaccine and make their recommendation on whether it should be given the green light.

The FDA’s analysis found that the Johnson & Johnson vaccine has “a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA [Emergency Use Authorization].” This language is similar to the assessments for the Moderna and Pfizer-BioNTech vaccines, according to NPR.

Immunization requires only one shot, which is different from the current vaccines from Pfizer and Moderna that are being distributed in the United States, which are composed of two shots. It also doesn’t need unique refrigeration for its transportation and storage.

Its efficacy in preventing COVID-19, however, is lower than the other two vaccines. The FDA review reportedly pointed to an international study that was conducted with about 40,000 people — half receiving the placebo, half the vaccine. The study showed the Johnson & Johnson vaccine was 66% effective in preventing moderate to severe COVID-19. This particular study was done in the U.S., Latin America, and South Africa.

The Pfizer and Moderna vaccines report an efficacy rate of 95% and 94%, respectively.

NPR reports that though the new variants of the coronavirus in South Africa and Brazil, “where the Johnson & Johnson vaccine was tested, mutated in ways that help them evade the immune response prompted by vaccines developed against the original form of the virus,” the vaccine’s effect is still promising.

Dr. Ashish Jha, the dean of the Brown University School of Health, spoke to NPR’s “All Things Considered” on Monday.

NPR reported:

“What you care about is hospitalizations and deaths,” he said. In the large clinical trial that is the centerpiece of the company’s application to the FDA, nobody who received the vaccine required hospitalization or died once the vaccine took full effect (28 days after immunization). “Johnson & Johnson appears to be just as good as Moderna and Pfizer at preventing those,” Jha said. 

The most common adverse reactions among more than 6,000 study participants who were queried about their experience were injection site pain (49%), headache (39%), fatigue (38%) and muscle pain (33%). These side effects were mostly mild or moderate.

The authorization of a third vaccine could help more Americans get vaccinated, expanding the supply of effective doses. NPR noted it won’t immediately make a big difference, however.

A Johnson & Johnson executive spoke at a congressional hearing Tuesday, saying that 4 million doses of vaccine would be available in the U.S. when the FDA grants an emergency use authorization. A total of 20 million doses would be ready by the end of March, he said, and the company could deliver a total of 100 million doses by the end of June.

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