The one-shot coronavirus vaccine produced by Johnson & Johnson offers strong protection against serious illness and death from Covid-19 and may reduce the spread of the virus among vaccinated people, according to new analyzes published online by the Food and Drug Administration on Wednesday. market .
The vaccine had an overall effectiveness rate of 72% in the United States and 64% in South Africa, where a highly contagious variant appeared in the fall and is now causing most cases. The effectiveness in South Africa was seven percentage points higher than the previous data released by the company.
The vaccine also showed 86 percent effectiveness 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 the demand for inoculations far exceeds the supply. The FDA may authorize the vaccine as early as Saturday, depending on the vote of your vaccine advisory panel on Friday, after discussing the newly released documents.
“With a J&J vaccine, we will be able to accelerate the vaccine’s release to our country and the world,” said Dan Barouch, virologist at Beth Israel Deaconess Medical Center in Boston who led much of the first research on the vaccine. year.
The Johnson & Johnson vaccine can be stored at normal refrigerated temperatures for at least three months, making its distribution considerably easier than the authorized vaccines of Moderna and Pfizer-BioNTech, which require two doses and must be stored in cold temperatures.
But access to the new vaccine may be severely limited at first. Dr. Richard Nettles, the vice president of US medical affairs for Janssen Pharmaceuticals, Johnson & Johnson’s drug development arm, told lawmakers on Tuesday that nearly four million doses would be ready for shipment if the FDA authorized it the vaccine, well below the 12 million that it had originally promised to donate to the federal government by the end of February.
He said a total of 20 million doses will be ready by the end of March, 17 million less than the company’s federal contract predicted. But he insisted that Johnson & Johnson will keep its promise of 100 million doses by the end of June.
Asked about the deficit on Wednesday, Jeffrey D. Zients, the White House coordinator for the response to the pandemic, said the Biden government knew that Johnson & Johnson was lagging behind in manufacturing and needed federal aid for equipment and raw materials. when she 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 possible third approved vaccine is very encouraging” because the lack of supplies remains the biggest obstacle to the country’s vaccination effort.
Zients said that if the new vaccine is authorized, about two million of the four million initial doses would be added to shipments of Moderna and Pfizer to the United States next week. The rest will go to federal vaccination programs at pharmacies and community health centers, he said.
The Johnson & Johnson vaccine has a lower efficacy rate than the Moderna and Pfizer-BioNTech vaccines, which are both around 95 percent.
But in South Africa, the Johnson & Johnson vaccine is, so far, the winner. The Novavax injection was 49% effective in South Africa. And a small trial in South Africa with the AstraZeneca-Oxford vaccine found that it did not offer much protection. The negative results prompted the South African government to abandon its plan to give health professionals one million doses of AstraZeneca vaccines. Last week, the government started giving Johnson & Johnson vaccines, and has so far administered more than 32,000.
The recently released documents, which include the FDA’s first technical analysis of the company’s 45,000-person clinical trial, provided evidence that the vaccine was safe, with side effects noticeably milder than the Pfizer and Moderna vaccines and with no reports of reactions severe allergies such as anaphylaxis.
Vaccine protection was consistent among black, Hispanic and white volunteers, and also at different ages. The trial indicated a lower effectiveness, 42.3%, for people over 60 who had risk factors such as heart disease or diabetes. But that number came with a great deal of statistical uncertainty, noted the FDA.
Although several vaccines can protect people from becoming sick with Covid-19, it is not clear whether vaccines can also prevent people from becoming infected and spread the virus to others, leading to a debate about how quickly society can return to normal after the start of inoculations.
The Moderna trial found some evidence that vaccinated people were less likely to develop an infection without symptoms. And AstraZeneca found that its vaccine cut asymptomatic infections in half.
Johnson & Johnson searched for asymptomatic infections by checking for the presence of antibodies to the coronavirus 71 days after the volunteers received the vaccine or placebo. The new analyzes estimate that the vaccine has a 74 percent effectiveness 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 definitive conclusions cannot be drawn at this time”.
“I think it will increase the growing evidence that vaccines do prevent infections as well as prevent diseases,” said Dr. Barouch.