US FDA approves J&J single-dose COVID-19 vaccine

Washington, Feb 28 (PTI):
The US Food and Drug Administration has authorised a single-dose Johnson and Johnson anti-coronavirus vaccine for emergency use, giving the nation its third jab against the deadly disease.
President Joe Biden described the approval as an encouraging development in efforts to end the COVID-19 crisis and said this is exciting news for all US citizens.
The Johnson and Johnson vaccine, which works with one dose instead of two, got approval, days after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.
“After a rigorous, open, and objective scientific review process, the Food and Drug Administration (FDA) issued an emergency use authorisation for a third safe and effective vaccine to help us defeat the COVID-19 pandemic – the Janssen COVID-19 (Johnson and Johnson) vaccine,” Biden said.
The EUA allows the Janssen COVID-19 vaccine to be distributed in the US for use in individuals of 18 years of age or older. Unlike the other two approved vaccines, the Johnson and Johnson vaccine is administered as a single dose. The Pfizer and Moderna vaccines requires two shots within two weeks. “The authorisation of this (Johnson and Johnson) 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 US,” Acting FDA Commissioner Janet Woodcock said.
The FDA said the totality of available data provides clear evidence that the Janssen COVID-19 vaccine may be effective in preventing the infection. Data also shows that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people of 18 years of age and older, it said.
“We know that more people that get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track,” President Biden said, adding that the country is moving in the right direction. There is light at the end of the tunnel, but people cannot let their guard down now or assume that victory is inevitable, the president said.

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