The Food and Drug Administration has authorized a third COVID-19 vaccine for public use.
As expected on Saturday, acting commissioner Dr. Janet Woodcock has granted emergency use authorization for a vaccine developed by Janssen Pharmaceuticals, a Johnson & Johnson company.
About 4 million doses of the new vaccine are expected to be available next week, 20 million in total in March and another 80 million by the end of June. Since the vaccine requires only one dose, it will help protect 100 million people and will take effect faster than two-dose vaccines.
The J&J vaccine joins two others, one from Pfizer-BioNTech and the other from Moderna, which have been administered to almost 50 million Americans since they were authorized in December.
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An FDA advisory committee voted on Friday to support the J&J vaccine, finding that its benefits far outweighed the risks.
Woodock agreed.
“The authorization of this vaccine expands the availability of vaccines, the best method of medical prevention for COVID-19, to help us fight this pandemic, which has already cost more than half a million lives in the United States,” said Woodcock in a demonstration. . “The FDA, through our open and transparent scientific review process, has authorized three COVID-19 vaccines with the urgency required during this pandemic, using the agency’s stringent standards for safety, efficacy and manufacturing quality necessary to support the authorization of emergency use. ”
President Joe Biden in a statement said Saturday’s authorization meant “there is a light at the end of the tunnel”, but again emphasized the importance of mitigation measures such as hand washing and social detachment.
“We know that the more people get vaccinated, the faster we will get over the virus, get back to our friends and loved ones and get our economy back on track,” he said.
He added: “This fight is far from over. Although we celebrate the news today, I ask all Americans: keep washing your hands, stay socially apart and keep wearing masks. As I said several times, things must still get worse again as new variants spread and the current improvement can be reversed. “
Dr. Richard Besser, president and CEO of the Robert Wood Johnson Foundation and former acting director of the Centers for Disease Control and Prevention, applauded the FDA decision, but warned against complacency.
“With three COVID-19 vaccines now available, the number of cases and deaths across the country continuing to drop, and Congress taking steps to approve critically needed additional economic relief, I have never been more excited that we are finally around the corner. this pandemic, “he said in a statement.
Besser also said that increases in vaccine supply “are welcome, but insufficient in themselves to end” racial disparities in the distribution of the vaccine.
“People of color in the United States have suffered a cruel dichotomy: among the highest rates of COVID-19 cases, hospitalizations and deaths, and among the lowest rates of vaccination.”
The Moderna and Pfizer-BioNTech vaccines appear to be more effective than the J&J vaccine, showing greater than 94% efficacy in large trials conducted last year.
Although they cannot be compared directly, because the tests were conducted at different times, the J&J vaccine appeared to be 72% effective among test participants in the United States. It was less effective in South Africa and Latin America, where new strains of the virus are circulating.
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The single-dose J&J vaccine should also be easier to distribute in rural areas and other places without pharmaceutical-grade freezers, because it can be stored longer in a refrigerator.
And it can cause fewer side effects than the other two vaccines, with only about half of the trial participants reporting pain at the injection site compared to nearly 80% for the Pfizer-BioNTech and Moderna vaccines, particularly with the second injection.
The company will offer those who received the placebo an active vaccine and will continue to monitor trial participants for two years.
The government has several security monitoring systems to monitor any health problems related to the shots.
An advisory committee of the Centers for Disease Control and Prevention will meet on Sunday and Monday to discuss how the J&J vaccine should be used. Dr. Rochelle Walensky, head of the CDC, will review the vaccine and it should be ready for distribution early next week.
Contact Karen Weintraub at [email protected]
USA TODAY health and safety coverage is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Health. The Masimo Foundation does not provide editorial contributions.
This article was originally published in USA TODAY: FDA authorizes Johnson & Johnson’s single dose COVID vaccine, the third in the USA