(Reuters) – Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a major global trial against multiple variants, giving health officials another weapon to deal with the coronavirus.
In the study of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 ranged from 72% in the United States to 66% in Latin America and only 57% in South Africa, from where a worrying variant has spread.
A high bar has been set by two authorized vaccines from Pfizer / BioNTech and Moderna, which were approximately 95% effective in preventing symptomatic disease in pivotal studies when given in two doses.
However, those studies were conducted mainly in the United States and before new variants emerged.
American infectious disease specialist Anthony Fauci said the differences in effectiveness around the world underline the need to vaccinate as many people as possible as soon as possible to prevent new variants from emerging.
“It’s really a wake-up call for us to be nimble and able to adapt as this virus will certainly continue to evolve,” Fauci said.
The main goal of J & J was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping serious diseases and preventing hospitalization in all regions and against multiple variants 28 days after immunization.
That “will potentially protect hundreds of millions of people from the serious and fatal consequences of COVID-19,” said Paul Stoffels, J & J’s Chief Scientific Officer, of the results, which were based on 468 symptomatic cases.
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J&J plans to seek emergency use approval from the U.S. Food and Drug Administration next week. It has said it plans to deliver 1 billion doses by 2021 and will manufacture the vaccine in the United States, Europe, South Africa and India.
Public health officials are counting 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’s vaccine and an option for another 200 million .
J&J said the vaccine would be ready immediately upon emergency approval, but Stoffels declined to say how many doses.
“Right now, every protection and complementary vaccine is great. The key is not just overall efficacy, but specifically efficacy against serious illness, hospitalization and death, ”said Walid Gellad, 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 for doses, regardless of whether the vaccine is considered highly effective or not. Moderately effective will work fine for now. “
None of the vaccine recipients in the J&J study died of COVID-19, compared with 5 in the placebo group, according to the National Institutes of Health. Three deaths in the vaccine group in total, but none were identified as being from the virus. That’s comparable to 16 deaths in total in the placebo arm, it added.
Unlike the Pfizer and Moderna vaccines, J & Js do not require a second injection weeks after the first or need to be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are a are problem.
SOUTH AFRICAN VARIANT
Several studies have appeared this month showing that a South African variant has mutated in areas of the virus that are the main targets of vaccines, decreasing their effectiveness.
“What we’re learning is that there are different effectiveness in different parts of the world,” Stoffels told Reuters.
In a sub-study of 6,000 volunteers in South Africa, Stoffels said, the J&J vaccine was 89% effective at preventing serious illness. In the South African portion of the trial, 95% of the cases 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 Glenda Gray, lead investigator of the South African vaccine trial.
Gray, who is the CEO of the South African Medical Research Council, said this is by far the best vaccine for South Africa to combat the mutant strain and prevent a large number of hospitalizations and deaths.
A mid-trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy and was found to be 60% effective in volunteers who did not have HIV. In a separate late-stage study in Great Britain, it was 89.3% effective.
In the J&J survey, 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.
J & J’s vaccine uses a cold virus to introduce coronavirus proteins into cells in the body and trigger an immune response, while the Pfizer / BioNTech and Moderna vaccines use a new technology that uses messenger RNA (mRNA) is called.