(Reuters) – Johnson & Johnson said Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a major global trial against multiple variants that will give health officials another weapon to fight the coronavirus.
In the trial of about 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, where ‘has spread a worrying variant.
Two authorized vaccines from Pfizer / BioNTech and Moderna have set a high bar, which have been around 95% effective in preventing symptomatic disease in fundamental trials when administered in two doses.
These trials, however, were conducted primarily in the United States and before new variants appeared.
U.S. infectious disease specialist Anthony Fauci said variations in efficacy around the world underscored the need to vaccinate as many people as possible to prevent new variants from appearing.
“It’s really a wake-up call for us to be agile and able to adjust, as this virus will continue 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 the serious disease and preventing hospitalization in all geographies and against multiple variants 28 days after vaccination.
This “will potentially protect hundreds of millions of people from the severe and fatal results of COVID-19,” said Paul Stoffels, chief scientist at J&J, on the results, which were based on 468 symptomatic cases.
SEEKING APPROVAL
J&J plans to apply for emergency use authorization to the U.S. Food and Drug Administration next week. He has said he 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 are counting on the J&J vaccine to increase much-needed supply and simplify vaccination in the United States, which has an agreement to buy 100 million doses of J&J vaccine and an option for an additional 200 million.
J&J said the vaccine would be ready immediately after emergency approval, but Stoffels declined to say how many doses.
“At the moment, any additional protection and vaccination is fantastic. The key is not just overall effectiveness, but specifically effectiveness against serious 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 the doses, regardless of whether the vaccine is considered effective or not. Moderately effective will go very well for now. “
None of the vaccine recipients in the J&J trial died due to COVID-19, compared with 5 from the placebo group, according to the National Institutes of Health. Three deaths in the vaccine group overall, but it was not determined that any of the virus came from. This compares with 16 deaths overall in the placebo group, he added.
Unlike the Pfizer and Moderna vaccines, J&Js do not require a second shot weeks after the first nor do they have to stay frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are a problem.
VARIANT OF THE SOUTH AFRICAN
This month, several studies have emerged that show that a South African variant has mutated into areas of the virus that are key targets for vaccines, reducing their effectiveness.
“What we’re learning is that there’s a 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 in preventing serious illness. In the South African part of the trial, 95% of the cases were infections with the South African variant.
“I am overwhelmed by the fact that this vaccine protects against serious diseases even in South Africa,” said Glenda Gray, lead joint researcher on 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 fight the mutant strain and that it can prevent a large number of hospitalizations and deaths.
A mid-phase trial 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 trial in the final phase in Britain, it was 89.3% effective.
In the J&J trial, which took place 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 body cells and elicit an immune response, while the Pfizer / BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).