February 27th, 2021 – Just a day after the FDA advisory panel’s unanimous recommendation, the US Food and Drug Administration (USFDA) has issued an emergency use authorization (EUA) for Johnson & Johnson’s single-shot COVID-19 Vaccine. “The totality of the available data provides clear evidence that Ad26.COV2.S may be effective in preventing COVID-19 and has met the criteria for EUA”, the agency said in a statement.
“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, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D.
Third Vaccine in the US
Two days ago, Bahrain became the first country to authorize J&J’s vaccine. Today’s US approval is the second for the candidate, and it marks the entry of the third vaccine in the US after the green signals given to Pfizer/BioNTech and Moderna’s candidates last December. Unlike those vaccines, which were developed using a novel mRNA technology, J&J’s Ad26.COV2.S is an adenovirus vector vaccine that encodes a full-length, stabilized variant of the SARS-CoV-2 spike protein.
The availability of Ad26.COV2.S is expected to ease the growing demand for COVID-19 vaccines in several states. Besides, the added benefits of storage at regular refrigerator temperatures and single-dose vaccination will further accelerate vaccination programs.
“This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis,” US President Joe Biden said in an official statement. “We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track.”
J&J will start shipping 4 million doses starting Monday with a goal of providing 20 million doses by the end of March. It has also expressed confidence in delivering 100 million doses during the first half of 2021.
J&J’s vaccine was evaluated in a Phase 3 ENSEMBL trial conducted across three continents, at a time when new and rapidly spreading cases were reported in South Africa and Brazil due to emerging coronavirus variants. The vaccine was found to be 85% effective in preventing severe disease and 66% effective (72% in the US) in preventing moderate to severe COVID-19.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States, and throughout the world.”
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