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WASHINGTON: The United States authorized Johnson & Johnson’s COVID-19 vaccine for emergency use on Saturday (February 27), giving the nation a third chance to combat the outbreak that has killed more than 500,000 Americans.
The single-shot vaccine is very effective in preventing severe COVID-19, even against newer variants, the Food and Drug Administration (FDA) said before approving it.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic,” said the acting director of the US regulator, Janet Woodcock.
The FDA announced emergency use authorization for adults 18 years and older following unanimous endorsement Friday by the agency’s panel of outside experts.
In large clinical trials, the efficacy of the vaccine against serious diseases was 85.9% in the United States, 81.7% in South Africa, and 87.6% in Brazil.
Overall, among 39,321 participants across all regions, the efficacy against severe COVID-19 was 85.4 percent, but fell to 66.1 percent when moderate forms of the disease are included.
Crucially, analyzes of various demographic groups did not reveal marked differences by age, race, or people with underlying diseases.
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US President Joe Biden praised the “exciting” announcement, but warned that the nation could not lower its guard.
“This is exciting news for all Americans and an encouraging advance in our efforts to end the crisis,” Biden said in a statement after the J&J vaccine was given the green light.
“But we cannot lower our guard now or assume that victory is inevitable.”
HOW IS IT DIFFERENT FROM PFIZER AND MODERN VACCINES?
The Pfizer-BioNTech and Moderna vaccines use new messenger RNA technology to create an immune response and both require two injections. The J&J vaccine involves a more conventional approach, which uses a common cold virus to introduce coronavirus proteins into cells to trigger an immune response.
The vaccine remains stable for at least three months at normal refrigerator temperatures, while the Moderna vaccine must be shipped frozen and the Pfizer-BioNTech option must be shipped and stored at even colder sub-arctic temperatures.
These factors make it easier to vaccinate larger numbers of people, even in areas with poor transportation and storage infrastructure.
The Pfizer-BioNTech and Moderna vaccines were 94 to 95 percent effective in trials conducted in the United States where the variants were not circulating.
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Both mRNA vaccines showed higher efficacy rates in their trials than the J&J vaccine, but experts cautioned against making too much of a distinction between the vaccines because the trials had different endpoints and J&J were performed while highly new variants were circulating. transmittable virus.
Novavax, which is testing its vaccine in South Africa, said it was 60 percent effective in preventing mild, moderate and severe COVID-19 in patients who did not have HIV. He said that about 90 percent of the cases in the study involved the new South African variant. The South African mid-stage trial included 4,400 patients.
The vaccine developed by AstraZeneca with the University of Oxford provided only minimal protection against mild to moderate COVID-19 of the South African variant in a relatively small trial. There was no data yet on its effectiveness in preventing serious disease in people infected with the variant because the study mainly involved young adults who were not considered to be at high risk for serious disease.
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SUPPLY OFFERS
J&J expects to produce at least 1 billion doses of its vaccine in 2021 and has signed supply agreements for most of that.
The United States has agreed to pay more than $ 1 billion for 100 million doses and can buy an additional 200 million doses.
Other agreements include 22 million doses for Mexico, 9 million for Colombia, 30 million for the United Kingdom, 4 million for South Korea and 400 million for the European Union. It plans to supply 500 million to poorer countries, working with the COVAX alliance.
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