The U.S. Food and Drug Administration gave full approval Monday to the Pfizer COVID-19 vaccine, a major step that will likely have significant implications for vaccination mandates nationwide. The Moderna and Johnson & Johnson vaccines have not yet received full FDA authorization.
The Pfizer vaccine previously received FDA authorization, which allowed its emergency use but did not give the full approval. Pfizer is the first company to receive full approval in the U.S.
The Biden administration announced Wednesday that federal health experts now recommend vaccinated Americans receive a COVID booster shot.
The boosters will be widely distributed to the public after research indicated that the vaccine’s effectiveness declines over time.
Workers at a Baltimore plant responsible for producing two separate coronavirus vaccines mistakenly mixed up their respective ingredients, ruining approximately 15 million doses of Johnson & Johnson’s vaccine and pausing all production at the plant, the company confirmed Wednesday.
The facility, run by Emergent BioSolutions, had partnered with both Johnson & Johnson and AstraZeneca to produce vaccines. Federal officials said that the mistake was a result of human error, according to The New York Times, which first reported the mix up that reportedly occurred several weeks ago.
A quality control review “identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” Johnson & Johnson said in a statement. “This batch was never advanced to the filling and finishing stages of our manufacturing process.”
Johnson & Johnson’s coronavirus vaccine began distribution across the country Monday, and the company’s CEO said shots could begin within 48 hours.
“We’re shipping 4 million [doses] literally as we speak,” Johnson & Johnson CEO Alex Gorsky told NBC News Monday morning. “Within the next 24 to 48 hours, Americans should start receiving shots in arms.”
Gorsky added that the company was on track to distribute 100 million shots by the end of June and 1 billion by the end of 2021. Johnson & Johnson’s vaccine was recommended by the FDA’s vaccine advisory panel on Friday and officially approved one day later.
The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide.
The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself.
Johnson & Johnson’s one-dose vaccine is effective in preventing severe and fatal coronavirus cases, and may reduce the virus’s transmission among vaccinated people, the FDA said in new analyses Wednesday.
The drug maker announced in January that its vaccine was 72% effective against the virus in the United States and 64% effective in South Africa, where a mutated, more transmissible strain has become dominant. Its vaccine was 86% effective in preventing severe virus cases in the U.S., meaning that a vaccinated individual is at a far smaller risk of being hospitalized or dying from COVID-19.
Johnson & Johnson filed for emergency use authorization from the FDA on Thursday for its coronavirus vaccine.
The drug maker’s application followed its announcement that its vaccine was 72% effective in combating the virus. Although that’s slightly lower than Pfizer and Moderna’s vaccines, Johnson & Johnson’s requires one dose instead of two.