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The US government has licensed Johnson & Johnson’s single-dose Covid-19 vaccine, allowing millions more Americans to get vaccinated in the coming weeks and setting the vaccine for additional approvals around the world.
The J&J vaccine is the third licensed in the United States, after Pfizer / BioNTech and Moderna, which require two doses.
The US Food and Drug Administration announced the emergency use authorization of the J&J vaccine for adults 18 years of age and older following unanimous endorsement on Friday by the agency’s panel of outside experts.
Shipments to vaccination sites are expected to begin today or tomorrow.
President Joe Biden praised the move, but warned Americans not to celebrate too soon. “Things are likely to get worse again as new variants spread,” he said in a statement, urging people to continue washing their hands, wearing masks and maintaining social distancing.
“There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable,” he said.
The J&J vaccine is also under review by the European Union, where deliveries are expected to begin in April.
In J & J’s global trial of 44,000 people, the vaccine was found to be 66% effective in preventing moderate to severe Covid-19 four weeks after inoculation.
It was 100% effective in preventing hospitalization and death from the virus.
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Both the Pfizer and Moderna vaccines, which are based on new messenger RNA technology, showed higher efficacy rates in pivotal trials using two doses versus J & J’s single injection vaccine.
However, direct comparison is difficult because the trials had different objectives and J&J were conducted while new, more contagious variants of the virus circulated.
“We believe that people should take the vaccine that they have access to,” said Acting FDA Commissioner Dr. Janet Woodcock in a post-authorization call, noting that the three vaccines had not been properly studied. comparative.
“We believe that each of these vaccines will be effective, prevent hospitalizations, deaths, and should be used,” he said.
Very few serious side effects were reported in the trial, which also provided preliminary evidence that the vaccine reduced asymptomatic infections.
More studies are expected. The FDA yesterday dismissed the idea that the evidence proved the vaccine prevented human-to-human transmission, adding that there was no data to determine how long the vaccine’s protection lasted.
The J&J vaccine is expected to be widely used around the world because it can be shipped and stored at normal refrigerator temperatures, making it easier to distribute than for the Pfizer / BioNTech SE and Moderna vaccines, which must be shipped frozen.
The US government, which has purchased 100 million doses of the J&J vaccine, plans to distribute between 3 and 4 million next week. That would be in addition to about 16 million doses of the Pfizer / BioNTech and Moderna vaccines that the government already planned to ship nationwide.
“We are ready to implement it,” wrote White House senior adviser Andy Slavitt on Twitter after authorization.
Johnson & Johnson said it had started shipping vaccines to the government.
J&J plans to provide a total of 20 million doses by the end of March, which together with the more than 220 million total doses expected from Pfizer and Moderna would be enough to fully vaccinate 130 million Americans.
So far, the United States has distributed more than 90 million doses of Covid-19 vaccines, some of which have been used for second injections. About 14% of Americans have received at least one dose, according to the US.
government data.
Covid-19 has claimed more than half a million lives in the United States, and states are calling for more doses to stop cases, hospitalizations, and deaths.
Public health officials have warned of an increase in the prevalence of more contagious variants of the virus, adding to the urgency to vaccinate millions more as soon as possible.
In the meantime, they said, the use of face masks and other measures to slow the spread of the virus should remain in place, as recent declines in Covid-19 cases appear to be stabilizing.
In South Africa, regulators were awaiting the FDA’s decision as its government seeks to roll out more J&J vaccines against a variant of the virus called B.1.351 that may evade some vaccine protection.
The J&J vaccine is being launched there ahead of official authorization for some 500,000 healthcare workers in an attempt to stop infections of the variant, which has spread across the country and spread globally, including to the U.S.
The vaccine is one of the few that has been tested in clinical trials against the variant and had a 64% efficacy rate in preventing moderate to severe disease in South Africa.
J&J said on Friday that the company was developing a second-generation vaccine that would target the concerning South African variant, and that it will be ready to begin Phase I testing this summer.
The J&J vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into the cells of the body and trigger an immune response. J&J is testing a two-dose version of its vaccine, and results are expected this summer.
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