(Reuters) – Johnson & Johnson said Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a comprehensive global study against several variants that will give health officials another weapon to fight coronavirus .
In the study of nearly 44,000 volunteers, the level of moderate and severe protection against COVID-19 ranged from 72% in the United States to 66% in Latin America and only 57% in South Africa, where a worrying variant spread. .
A high level was established by two licensed vaccines from Pfizer / BioNTech and Moderna, which were approximately 95% effective in preventing symptomatic disease in the essential studies when administered in two doses.
However, these studies were conducted primarily in the United States and before the advent of new variants.
Top US infectious disease specialist Anthony Fauci said variations in efficacy around the world have highlighted the need to vaccinate as many people as possible as soon as possible to prevent new ones.
“It’s really a wake-up call for us to be agile and able to adapt, because this virus will continue for certain to evolve,” Fauci said.
The main goal of J&J was to prevent moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization in all geographies and against several variants 28 days after immunization.
This “will potentially protect hundreds of millions of people from the serious and fatal results of COVID-19,” said Paul Stoffels, J & J’s chief scientific officer, of the results, which were based on 468 symptomatic cases.
SEEKING APPROVAL
J&J intends to apply for emergency use authorization from the US Food and Drug Administration next week. He said he plans to deliver 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.
Public health officials are relying on the J&J vaccine to increase much-needed supply and simplify immunization in the United States, which has a deal to buy 100 million doses of J&J vaccine and an option for another 200 millions.
J&J said the vaccine would be ready immediately after emergency approval, but Stoffels declined to say how many doses.
“At present, any additional protection and vaccine are great. The key is not only overall effectiveness, but specifically effectiveness against severe illness, hospitalization and death, ”said Walid Gellad, an associate professor of health policy at the University of Pittsburgh.
Michael Breen, Director of Infectious Diseases and Ophthalmology at research firm GlobalData, said: “Most countries are still desperate to get their hands on doses, whether or not the vaccine is considered extremely effective. Moderately effective will work well for the time being. ”
None of the patients who received the vaccine in the J&J study died from COVID-19, compared with 5 in the placebo group, the National Institutes of Health said. Three deaths in the vaccine group in general, but none were determined to be caused by the virus. This compares to 16 deaths overall in the placebo arm, he added.
Unlike Pfizer and Moderna vaccines, J&Js do not require a second shot weeks after the first or must be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are an issue.
SOUTH AFRICA VARIANT
Several studies have emerged this month showing that a variant in South Africa has moved to areas of the virus that are key targets for vaccines, reducing their effectiveness.
“What we are learning is that there is a different effectiveness in different parts of the world,” Stoffels told Reuters.
In a sub-study of 6,000 South African volunteers, Stoffels said, the J&J vaccine was 89 percent effective in preventing severe disease. In the South African part of the process, 95% of the cases were infections with the South African variant.
“I am overwhelmed that this vaccine has protected against severe disease even in South Africa,” said Glenda Gray, lead investigator of the South African vaccine study.
Gray, who is the executive director of the South African Medical Research Council, said it is by far the best vaccine for South Africa to fight the mutant strain and can prevent a large number of hospitalizations and deaths.
An interim study of a Novovax coronavirus vaccine in South Africa also showed lower efficacy, proving to be 60% effective among volunteers who did not have HIV. In a separate, late-stage study in the UK, it was 89.3% effective.
In the J&J process, which was conducted in eight countries, 44% of 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.
The J&J vaccine uses a common cold virus to introduce coronavirus proteins into the body’s cells and trigger an immune response, while Pfizer / BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).