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WASHINGTON (REUTERS) – Johnson & Johnson said on Friday (January 29) that its single-dose vaccine was 72% effective in preventing Covid-19 in the United States, but that a lower rate of 66% was seen at world level in the big trial. made on three continents and against multiple variants.
In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe Covid-19 was 66 percent in Latin America and only 57 percent in South Africa, where a particularly worrisome variant of the new coronavirus circulates.
Those results compare with the high level set by two licensed vaccines from Pfizer-BioNTech and Moderna, which were about 95 percent effective in preventing symptomatic disease in pivotal trials when given in two doses. However, those trials were conducted primarily in the US and before the wide spread of new variants that are now in the spotlight.
Leading US infectious disease specialist Anthony Fauci said variations in efficacy around the world underscore the need to vaccinate as many people as quickly as possible to prevent new variants from emerging.
“It’s really a wake-up call for us to be nimble and adapt, as this virus will continue to evolve safely,” said Dr. Fauci.
The main objective of the J&J study was the prevention of moderate to severe Covid-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization in all geographies and against multiple variants 28 days after vaccination .
That level of prevention “will potentially protect hundreds of millions of people from the severe and fatal outcomes of Covid-19,” Dr. Paul Stoffels, J & J’s chief scientific officer, said in a statement.
The company plans to apply for emergency use authorization from the US Food and Drug Administration next week. J&J has said it plans to administer 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.
Public health officials have been counting on the J&J vaccine to increase the much-needed supply and simplify the US immunization campaign.
The United States has an agreement to purchase 100 million doses of J & J’s vaccine for one billion dollars (1.3 billion Singaporean dollars) and the option to purchase an additional 200 million doses.
The company said in a statement that the vaccine would be ready immediately after emergency approval, but Dr. Stoffels declined to specify how many doses.
“Right now, any additional protection and vaccine is excellent,” said Dr. Walid Gellad, associate professor of health policy at the University of Pittsburgh.
“The ‘South Africa’ strain is still rare in the US and obviously we would like to see greater efficacy, but the key is not just overall efficacy, but specifically efficacy against serious illness, hospitalization, and death,” added the Dr. Gellad.
None of the vaccine recipients in the J&J trial died of Covid-19, compared with five deaths in the placebo group, according to the National Institutes of Health. The NIH said there were three deaths in the vaccine group overall, but none were determined to be from the virus. That compares with 16 deaths overall in the placebo group.
Unlike the Pfizer-BioNTech and Moderna vaccines, J&J does not require a second injection weeks after the first nor does it need to be kept frozen, making it a strong candidate for use in parts of the world with weak transportation infrastructure and facilities. insufficient cold storage.
South Africa
Several studies have emerged this month showing that a South African variant of the coronavirus has mutated in areas of the virus that are key targets of vaccines, reducing their effectiveness.
“What we are learning is that there is different efficacy in different parts of the world,” Dr. Stoffels said in a telephone interview. However, it is important to note that in a substudy of 6,000 volunteers in South Africa, Dr. Stoffels said, the J&J vaccine was 89 percent effective in preventing serious disease.
Ninety-five percent of the cases in the South African part of the trial were infections with the South African variant.
“I am overwhelmed by the fact that this vaccine protected against serious diseases even in South Africa,” said Professor Glenda Gray, joint principal investigator of the vaccine trial in South Africa.
Professor Gray, who is the executive director of the South African Medical Research Council, said that this is by far the best vaccine for South Africa to combat the mutant strain and can prevent a large number of hospitalizations and deaths.
A mid-stage trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy in the country. It turned out to be 60 percent effective among volunteers who were not HIV-positive. In a separate late-stage trial in the UK, the vaccine was 89.3% effective.
In the J&J trial, which was conducted in eight countries, 44% of the participants were from the United States, 41% from Central and South America, and 15% from South Africa.
Just over a third of the volunteers were over 60 years old.
There were no serious adverse events among those who received the injection, the company said. The full results will be published in a peer-reviewed journal.
The J&J vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.
The Pfizer-BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA) that requires it to be stored in a freezer.
Vaccination targets
The news of another safe and effective vaccine comes as the US has passed 430,000 deaths from Covid-19 and with hospitals in many states still struggling to keep up with patients despite the recent decline in new infections.
Concerns about further surges in the US have also increased due to the presence of a more contagious variant of coronavirus first discovered in the UK and news of the arrival of the South African variant in South Carolina on Thursday. .
The US vaccination program got off to a slow start in December and has accelerated to about a million injections per day nationwide.
US President Joe Biden has promised that at least 100 million injections will be administered in his first 100 days in office, but concerns about supply disruptions have added uncertainty to that goal.
Results from the US trial of the AstraZeneca vaccine and the University of Oxford are expected in early February, opening up the possibility of a fourth vaccine option. It has already been approved in the UK, Europe and many countries based on the results of a separate trial.
Novavax is also discussing with the FDA whether its data is sufficient to request an emergency use authorization.
J&J is studying the effects of its vaccine given in two doses two months apart, but the results of that trial won’t be available until this summer, Dr. Stoffels said.
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