This is the third COVID-19 vaccine to be granted emergency use authorization, and is the first single-dose vaccine.
The FDA granted an emergency use authorization (EUA) to Janssen Biotech’s COVID-19 vaccine, now brining the third vaccine – but the first single-dose vaccine – to the United States public.
The EUA, which makes medical products available during public health emergencies, was granted after a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021. At the meeting, VRBPAC members – independent experts in the scientific and public health field, as well as a consumer and industry rep – offered comments on whether the vaccine should be granted an EUA.
The committee then unanimously voted in favor of the FDA granting the vaccine an EUA.
“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, MD, in a statement. “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.”
Johnson & Johnson, parent company of Janssen, submitted the EUA application to the FDA based on findings from topline data from the phase 3 ENSEMBLE trial, which involved 43,783 individuals and a total accrual of 468 symptomatic COVID-19 cases. Findings showed that the vaccine is 72% effective in the US and 66% effective overall at preventing moderate- to severe-COVID-19 infection 28 days after injection.
Additionally, according to study findings, the vaccine was 85% effective overall in preventing severe disease and had complete protection against COVID-19—related hospitalization and death by day 28.
“We are extremely grateful to the VRBPAC members for their extensive review of the data supporting emergency use of Johnson & Johnson’s single-shot COVID-19 vaccine candidate,” said Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, in a statement. “We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.”
The vaccine may also be easier to administer, as it is a single-shot (as opposed to the Moderna and Pfizer/BioNTech vaccines, which are given in 2 doses). Johnson & Johnson said that it plans to vaccinate more than 20 million Americans by the end of March, and 100 million within the first half of 2021.
The company also said that the vaccine is easy to store and deliver – even to remote areas of the country – as it can be stable for up to 2 years when kept a -4 degrees F (-20 degrees C).
“We are grateful to everyone who has contributed to the wealth of data we presented today, including study participants, site investigators and teams, collaborators and everyone who has worked so hard to bring us to this moment. We are confident our COVID-19 vaccine candidate will have a significant impact in protecting people around the world,” said Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development, Johnson & Johnson.