(CN) — Advancing the process toward allowing Johnson & Johnson’s Covid-19 vaccine to be used in the United States, FDA scientists reported Wednesday that the one-shot candidate is effective at preventing moderate to severe illness.
The vaccine is safe to use, the FDA said, and overall, it is about 66% effective.
Studies of J&J’s vaccine candidate suggest it was highly effective in preventing the most serious Covid-19 symptoms, which were conducted in 44,000 trial participants. There were no hospitalizations or deaths starting 28 days after the shot was administered.
With several coronavirus variants circulating in the U.S. and internationally, it is unclear exactly how well the vaccine performs against each variant. Strains from the United Kingdom, South African and Brazil have each been detected in the U.S.
In previous data from J&J, the company said its vaccine performed better in the U.S., at 72%, compared with 66% in Latin America and 57% in South Africa.
After conducting those clinical trials, J&J submitted its vaccine data to the FDA on Feb. 4, saying the company would be ready to ship its vaccine immediately following the agency’s green light.
“Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” the company said in a statement about its submission. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”
If approved, a few million doses would be ready to ship within the first week. J&J has said that 20 million doses would be available by the end of March, and 100 million doses by summer.
The FDA could make its decision soon. The agency’s independent advisers are expected to debate on Friday whether the evidence is strong enough to recommend the vaccine, and following that, it could be just a few days before regulators make the call.
The candidate would be the third approved for emergency use in the U.S., along with the two-dose Pfizer and Moderna candidates. Both of the vaccines in circulation today have efficacy of around 95%.
Though the J&J vaccine falls short of that, it can be stored at refrigeration temperatures, eliminating some of the cold-chain storage issues plaguing the first two U.S. vaccines. And the single dose it requires could ease supply issues slowing distribution.
Factors including transportability, logistics and efficacy will have to be balanced in regulators’ decision over whether to designate a third Covid-19 vaccine in the U.S.
Also stored at refrigeration levels is the Oxford-AstraZeneca vaccine, which is used widely in the U.K., Europe and Israel. Its creators have lauded its potential to be a global vaccine, thanks to its easier storage and potentially lower price tag, however the Oxford candidate does require a second dose.
J&J has submitted its vaccine for emergency use listing by the World Health Organization. Also in front of the WHO is an application for a one-shot vaccine made by China’s CanSinoBIO, which the country says it is exporting to 27 countries, and providing free doses to 53 countries. Mexico approved the candidate on Feb. 10.
The Moderna and Pfizer vaccines also made news Wednesday regarding their efficacy.
Moderna announced that it will begin testing a booster shot that it says will target the South African variant of Covid-19.
The drugmaker said it has shipped doses of the booster to the National Institutes of Health for study in clinical trials.
“We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic,” said Stéphane Bancel, chief executive officer of Moderna, in a statement.
And a study published Wednesday in the New England Journal of Medicine showed the Pfizer vaccine reduced symptomatic cases of Covid-19 after the second dose by 94%.
The study, performed in Israel, compared about 600,000 people who had received the vaccine to nearly 600,000 who had not. Israel has vaccinated almost half of its nine million residents.
In the United States, more than two months into the vaccination effort, nearly 20 million people are fully vaccinated. About 44.5 million American have gotten at least one shot.
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