(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 that will give health officials another weapon to fight the coronavirus.
In the trial of almost 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 standard was established by two vaccines authorized by Pfizer / BioNTech and Moderna, which were about 95% effective in preventing symptomatic diseases in essential trials when administered in two doses.
These tests, however, were carried out mainly in the United States and before the emergence of new variants.
Leading infectious disease specialist in the United States, Anthony Fauci, said that variations in efficacy around the world underline the need to vaccinate as many people as soon as possible to prevent the emergence of new variants.
“It is really a warning sign for us to be agile and adjust as this virus is sure to continue to evolve,” said Fauci.
The main objective of J&J was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping serious illness and preventing hospitalization in all geographies and against multiple 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, scientific director of J&J, about the results, which were based on 468 symptomatic cases.
LOOKING FOR APPROVAL
J&J plans to seek authorization for emergency use from the Food and Drug Administration next week. She said she 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 counting on the J&J vaccine to increase much-needed supplies and simplify immunization in the United States, which has an agreement to buy 100 million doses of the 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 vaccine is great. The key is not just overall effectiveness, but specifically effectiveness 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 the research firm GlobalData said: “Most countries are still desperate to get their hands on doses, regardless of whether the vaccine is considered highly effective or not. Moderately effective for now. “
None of the vaccine recipients in the J&J trial died of COVID-19, compared with 5 in the placebo group, said the National Institutes of Health. Three deaths in the vaccine group overall, but none have been determined to be from the virus. This compares with 16 deaths overall in the placebo arm, he added.
Unlike Pfizer and Moderna vaccines, J&J do not require a second injection weeks after the first or need to be kept frozen, making them a strong candidate for use in parts of the world where transportation and cold storage are an issue.
SOUTH AFRICAN VARIANT
Several studies have emerged this month showing that a South African variant has mutated in areas of the virus that are the main targets of vaccines, reducing its effectiveness.
“What we are learning is that there is a different effectiveness in different parts of the world,” Stoffels told Reuters.
In a substudy of 6,000 volunteers in South Africa, said Stoffels, the J&J vaccine was 89% effective in preventing serious illnesses. In the part of the study in South Africa, 95% of cases were infections with the South African variant.
“I am impressed with the fact that this vaccine protected against serious illnesses, even in South Africa,” said Glenda Gray, the lead joint investigator for the South African vaccine trial.
Gray, who is the executive head of the South African Medical Research Council, said this 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 intermediate-stage trial of a Novovax coronavirus vaccine in South Africa also showed less efficacy, proving to be 60% effective among volunteers who did not have HIV. In a separate final-stage study in Britain, it was 89.3% effective.
In the J&J trial, 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 the Pfizer / BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).