F.D.A. Analyses Find Johnson & Johnson Vaccine Works Well

The vaccine also showed 86 percent efficacy against severe forms of Covid-19 in the United States, and 82 percent against severe disease in South Africa. That means that a vaccinated person has a far lower risk of being hospitalized or dying from Covid-19.

“With a J&J vaccine, we’ll be able to accelerate the vaccine rollout for our country and for the world,” said Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who led much of the early research on the vaccine last year.

Johnson & Johnson’s vaccine can be stored at normal refrigeration temperatures for at least three months, making its distribution considerably easier than the authorized vaccines made by Moderna and Pfizer-BioNTech, which require two doses and must be stored at frigid temperatures.

An adenovirus helps prime the immune system to fight the coronavirus.

But access to the new vaccine could be severely limited at first. Dr. Richard Nettles, the vice president of U.S. medical affairs at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, told lawmakers on Tuesday that nearly four million doses would be ready for shipment if the F.D.A. authorizes the vaccine, far below the 12 million it had originally pledged to give the federal government by the end of February.

He said that a total of 20 million doses will be ready by the end of March, 17 million fewer doses than the firm’s federal contract envisioned. But he insisted that Johnson & Johnson will fulfill its promise of 100 million doses by the end of June.

Asked about the shortfall on Wednesday, Jeffrey D. Zients, the White House coordinator of the pandemic response, said the Biden administration learned that Johnson & Johnson was behind on manufacturing and needed federal help for equipment and raw materials when it took office in January.

“It was disappointing when we arrived” he said, but “I think the progress is real.” Despite the delays, he said, “obviously the prospect of a potential third approved vaccine is very encouraging” because lack of supply remains the biggest obstacle to the nation’s vaccination effort.

Mr. Zients said if the new vaccine is authorized, roughly two million of the initial four million or so doses would be added to the shipments from Moderna and Pfizer to the United States next week. The remainder would go to federal vaccination programs at pharmacies and community health centers, he said.

Johnson & Johnson’s vaccine has a lower efficacy rate than the vaccines from Moderna and Pfizer-BioNTech, which are both around 95 percent.

The newly released documents, which include the F.D.A.’s first technical analysis of the company’s 45,000-person clinical trial, presented evidence that the vaccine was safe, with noticeably milder side effects than the Pfizer and Moderna vaccines and without any reports of severe allergic reactions like anaphylaxis.

The vaccine’s protection was consistent across Black, Hispanic and white volunteers, and also across different ages. The trial indicated a lower efficacy, of 42.3 percent, for people over 60 who had risk factors like heart disease or diabetes. But this figure came with a large amount of statistical uncertainty, the F.D.A. noted.

Moderna’s trial found some hints that vaccinated people were less likely to develop an infection without symptoms. And AstraZeneca found that its vaccine reduced asymptomatic infections by about half.

Johnson & Johnson looked for asymptomatic infections by checking for coronavirus antibodies 71 days after volunteers got a vaccine or a placebo. The new analyses estimate that the vaccine has an efficacy rate of 74 percent against asymptomatic infections. But that calculation was based on a relatively small number of volunteers, and the F.D.A. noted that “There is uncertainty about the interpretation of these data and definitive conclusions cannot be drawn at this time.”

“I think it’s going to add to the growing evidence that the vaccines really do prevent infection as well as prevent disease,” Dr. Barouch said.

Category: Science

Source: New York Times