A short-lived coronavirus vaccine, developed by Johnson & Johnson, provides strong protection against serious disease and death from covid-19, and can reduce the spread of the virus by vaccinated people, according to a new analysis posted Wednesday by the Food and Drug Administration. A new analysis posted Wednesday by the Drug Administration states. .
The vaccine had an overall effectiveness rate of percent૨ percent in the United States and 64% percent in South Africa, where a highly contagious form emerged in the fall and is now driving in most cases. Effectiveness in South Africa is seven percentage points higher than previous data released by the company.
The vaccine has also been shown to be 86 percent effective against severe forms of Covid-19 in the United States and 82 percent against severe disease in South Africa. This means that the vaccinated person has a lower risk of hospitalization or death from Covid-19.
Analysts have confirmed that the third effective coronavirus vaccine developed under one year is likely to benefit Americans soon, as demand for inoculation largely excludes supply. The FDA will be able to authorize the vaccine as early as Saturday, subject to a vote After its vaccine advisory panel discussed the newly published documents on Friday.
“With the J&J vaccine, we will be able to accelerate the vaccine rollout for our country and the world,” said Dan Baroch, a virologist at Beth Israel Decons Medical Center in Boston. Year.
The Johnson & Johnson vaccine can be stored at normal refrigeration temperatures for at least three months, making its delivery significantly easier than the official vaccines made by Moderna and Pfizer-Bioentech, which require two doses and must be stored at cold temperatures.
But first access to a new vaccine can be severely limited before. Johnson & Johnson’s Drug Development Arm, Johnson Pharmaceuticals’ U.S. Vice President of Medical Affairs, Dr. Ric. Richard Nettles told lawmakers on Tuesday that if the FDA approves the vaccine, about four million doses would be ready for shipment, a million that the federal government had promised to give by the end of February.
He said a total of 20 million doses would be ready by the end of March, 17 million fewer doses than the firm had envisaged in the federal agreement. But he insisted that Johnson and Johnson would deliver on their promise of 100 million doses by the end of June.
Asked about the shortage on Wednesday, White House Coordinator for Epidemic Response Jeffrey D. Zients said the Biden administration was informed that Johnson and Johnson were behind in production when they took office in January and needed federal assistance for equipment and raw materials.
“It was disappointing when we arrived, but I think the progress is real,” he said. Despite the delay, he said, “clearly the prospect of a third approved vaccine is very encouraging” as the lack of supply is the biggest obstacle to the country’s vaccination efforts.
Mr. Zients said that if a new vaccine is authorized, about two million of the initial four million or so will be added to shipments to the United States from Moderna and Pfizer in the coming weeks. 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-Bioentech vaccines, both about 95 percent.
But in South Africa, Johnson and Johnson’s vaccine is the clear winner so far. The effectiveness of Novavax’s shot was 49 percent in South Africa. And a small trial of the AstraZeneca-Ox Xford vaccine in South Africa found that it did not protect at all. Due to the negative results, the South African government had to abandon its plan to give one million doses of the AstraZeneca vaccine to health care workers. Last week, the government began vaccinating Johnson and Johnson instead, and has yet to administer it. More than 32,000.
Newly published documents, including the first technical analysis of the company’s clinical trials of 45,000 individuals by the FDA, presented evidence that the vaccine was safe, without any reports of significant mild side effects and severe allergic reactions such as anaphylaxis. .
Vaccine protection was consistent among black, Hispanic and white volunteers, and also at different ages. The trial showed a low efficacy for more than 0 people, .38..3 percent, who had risk factors such as heart disease or diabetes. But the figure comes with a large number of statistical uncertainties, the FDA noted.
Although many vaccines can protect people from Covid-19 disease, it is unclear whether the shots prevent people from becoming infected and transmitting the virus to others, sparking a debate about how quickly society can return to normal once inoculations begin. .
Modern trials have found some indications that vaccinated people are less likely to become infected without symptoms. And AstraZeneca found that her vaccine reduced asymptomatic infections by about half.
Johnson and Johnson detected asymptomatic infections by testing for coronavirus antibodies 71 days after volunteers received the vaccine or placebo. The new analysis estimates that the vaccine’s effectiveness against asymptomatic infections is 74 percent. But that calculation was based on a relatively small number of volunteers, and the FDA noted that “there is uncertainty about the interpretation of this data and no conclusive conclusions can be drawn at this time.”
“I think it’s going to add to the growing evidence that the vaccine actually prevents infection and disease,” said Dr. Baroch said.
