FDA clears Johnson & Johnson's single-dose COVID-19 shot for emergency use
ORLANDO, Fla. - The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus. This allows single-dose vaccines from Johnson & Johnson to be distributed in the U.S for use in individuals 18 years of age and older.
The approval comes just one day after an FDA panel of U.S. health advisers endorsed the vaccine, and as new supplies are urgently needed to stay ahead of a mutating virus that has killed more than 500,000 Americans.
After daylong discussions, the FDA panelists voted unanimously on Friday that the benefits of the vaccine outweighed the risks for adults.
More than 47 million people in the U.S., or 14% of the population, have received at least one shot of the two-dose vaccines from Pfizer and Moderna, which the FDA authorized in December. But the pace of vaccinations has been strained by limited supplies and delays due to winter storms.
The Johnson & Johnson vaccine is less effective than other COVID vaccines and many have expressed concerns but studies have shown that it is effective in preventing serious infection or death.
University of South Florida epidemiology associate professor Dr. Jason Salemi said don't let reports of it being less effective than Pfizer or Moderna vaccines deter you from getting it.
"Oh, only 66%, I think I’ll just give it a 'D'...no, that’s not what we should be harping on," said Dr. Salemi.
The Pfizer and Moderna vaccines are about 95% effective overall.
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The Johnson & Johnson vaccine is about 66% effective overall. But Dr. Salemi said the Johnson & Johnson shot is 85% effective at preventing severe disease, almost 100% effective at preventing hospitalization, and 100% effective at preventing death.
"All of these vaccines, even though you can play with the numbers...the most important thing is we are preventing people from getting severely ill," said Dr. Salemi.
Florida Gov. Ron DeSantis has been touting the shot for weeks now because you only need one dose. It’s also easier to distribute because there are no specialty freezers needed. On Wednesday, the governor also addressed people’s concerns about it.
"What I would tell people is just understand, because the way it gets portrayed sometimes, I don’t think is fair and I don’t think is accurate."
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Dr. Salemi agreed and said you may still get COVID with this vaccine, but it’ll be a very mild case.
"If it’s more like flu-like symptoms and it doesn’t elevate to the severity that you need to be hospitalized, then again to me that’s a vaccine doing its principal job."
The governor hopes that the additional vaccine will enable Florida to open vaccines soon to another group.
"Once we get to the point of the senior population where we start to see the demand go down, then we obviously are going to lower the age and get people at a minimum 60 and then maybe even 55 off the bat but it really is dependent on making sure we have the supply," said DeSantis.
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J&J’s vaccine can be stored for up to three months at refrigerator temperatures, making it easier to handle than the previous vaccines, which must be frozen. While early J&J supplies will be small, the company has said it can deliver 20 million doses by the end of March and a total of 100 million by the end of June.
Projected deliveries from Pfizer, Moderna and J&J combine for 240 million doses slated for late March, and 700 million jabs by mid-year, the latter of which is more than enough to vaccinate the U.S. population.
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