Johnson & Johnson’s coronavirus vaccine offers strong protection against serious illness and death caused by COVID-19 and could reduce the spread of the virus by vaccinated people, according to new analyzes published online Wednesday by the Food and Drug Administration (FDA for its acronym in English).
The vaccine had overall efficacy of 72 percent in the United States and 64 percent in South Africa, where a highly contagious variant emerged in the fall and now causes the most cases. Efficacy in South Africa was seven points higher than previous data published by the company.
The vaccine was also 86 percent effective against severe forms of COVID-19 in the United States and 82 percent against serious illnesses in South Africa. This means that a vaccinated person has a much lower risk of being hospitalized or dying from COVID-19.
The analyzes confirmed that Americans are likely to soon benefit from a third effective coronavirus vaccine developed in less than a year, as vaccination demand far outstrips supply. The FDA could approve the vaccine on Saturday, depending on the vote of the vaccine advisory panel on Friday, after discussing the newly released documents.
“With a J&J vaccine, we will be able to accelerate the deployment of the vaccine for our country and for the world,” said Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston who has done much of the early research into it. vaccine. last year.
The Johnson & Johnson vaccine can be stored at normal refrigeration temperatures for at least three months, which greatly facilitates distribution compared to approved vaccines manufactured by Moderna and Pfizer-BioNTech, which require two doses and must be stored at freezing temperatures.
But access to the new vaccine can be very limited at first. Richard Nettles, vice president of U.S. medical affairs for Janssen Pharmaceuticals, Johnson & Johnson’s drug development division, told lawmakers on Tuesday that about four million doses would be ready for shipment after the FDA approved the vaccine, well below 12 million which it had originally promised to deliver to the federal government in late February.
White House officials had an even lower estimate on Tuesday, telling the governors in a weekly call that about two million doses would be available next week, according to a government official.
Nettles said on Tuesday that a total of 20 million doses would be ready by the end of March. The company has a contract to deliver 100 million doses by the end of June.
The Johnson and Johnson vaccine has lower efficacy than Moderna and Pfizer-BioNTech vaccines, which are about 95 percent.
But in South Africa, the Johnson & Johnson vaccine is the clear winner so far. The Novavax vaccine was 49 percent effective in South Africa. And a small trial in South Africa with the AstraZeneca-Oxford vaccine found it didn’t offer much protection. The negative results prompted the South African government to abandon its plan to administer one million doses of AstraZeneca vaccines to health professionals. Last week, the government began administering Johnson & Johnson vaccines instead, and so far the government has been spreading this more than 32,000
The recently released documents, including the FDA’s first technical analysis of the company’s 45,000-person clinical trial, provided evidence that the vaccine was safe, with significantly milder side effects than the Pfizer and Moderna vaccines, and without any reports of serious allergic reactions such as anaphylaxis. .
Vaccine protection was consistent in Black, Hispanic and White volunteers, and also at different ages. The study found a lower efficacy, 42.3 percent, for people over the age of 60 with risk factors such as heart disease or diabetes. However, this figure comes with a lot of statistical uncertainty, the FDA noted.
While several vaccines can protect people from COVID-19 disease, it is unclear whether vaccines can also prevent people from becoming infected and transmitting the virus to others, leading to a debate about how quickly society can return to normal after the start of the vaccination. campaigns.
Moderna’s study found some evidence that vaccinated people were less likely to develop an infection without symptoms. And AstraZeneca found its vaccine halved asymptomatic infections.
Johnson & Johnson looked for asymptomatic infections by testing for antibodies to coronavirus 71 days after the volunteers were vaccinated or received a placebo. The new analyzes estimate that the vaccine has a 74 percent efficacy rate against asymptomatic infections. But that calculation was based on a relatively small number of volunteers, and the FDA noted that “there is uncertainty about the interpretation of these data and no definitive conclusions can be drawn at this time.”
“I think it will add to the growing evidence that vaccines actually prevent both infection and disease,” said Barouch.
Carl Zimmer is the author of the column MatterHe has published thirteen books, including She has her mother’s smile: the powers, perversions, and potential of heredity @carlzimmer • Facebook
Noah Weiland is a reporter for the Times agency in Washington, where he writes about health services. He grew up in East Lansing, Michigan, and graduated from the University of Chicago. @noahweiland
Sharon LaFraniere is an investigative journalist. He was part of the 2018 Pulitzer-winning team for its investigation of Donald Trump’s connections to Russia. @RTLnews