The US Food and Drug Administration on Saturday authorized Johnson & Johnson's single-dose COVID-19 vaccine for emergency use, making it the third vaccine on the US market. The approval comes a day after the FDA Vaccines and Related Biological Products Advisory Committee unanimously voted to approve the vaccine.
"The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," Acting FDA Commissioner Janet Woodcock said in a release on the agency's website.
In early February, a week after announcing that its single-dose vaccine was 66% effective overall in preventing COVID-19 in a global clinical trial, Johnson & Johnson submitted an application requesting the FDA grant the emergency use authorization.
The FDA granted emergency use authorizations for the Pfizer and Moderna coronavirus vaccines in December, with vaccinations beginning just days later. Those vaccines are said to be 95% and 94% effective, respectively. Unlike the Pfizer and Moderna vaccines, Johnson & Johnson's, also known as the Janssen COVID-19 Vaccine, requires only a single shot.
The Johnson & Johnson vaccine has also shown 85% efficacy against severe forms of COVID-19 and 100% efficacy against hospitalization and death, The New York Times reported Saturday. "Don't get caught up, necessarily, on the number game, because it's a really good vaccine, and what we need is as many good vaccines as possible," Anthony Fauci, a top infectious disease expert and the chief medical advisor to President Joe Biden, told the publication. "Accept the fact that now you have three highly effective vaccines. Period."
Earlier this month, Biden announced that the US is buying enough doses of Pfizer and Moderna COVID-19 vaccines to cover 300 million people in the country by the end of July -- though this doesn't mean everyone will be vaccinated by then.
"We've now purchased enough vaccine supply to vaccinate all Americans," Biden said. Actually administering the vaccines to all Americans could take longer because vaccinations are managed at a state and local level.
Johnson & Johnson has said it will provide the US with 100 million doses by the end of June, the Times reported, adding that the vaccine could start reaching Americans by early next week.
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