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US FDA gives emergency use authorisation to COVID-19 vaccine from Johnson & Johnson

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.

Published: 28th February 2021 08:47 AM  |   Last Updated: 01st March 2021 08:07 AM   |  A+A-

A file photo taken on November 17, 2020 shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Johnson & Johnson. (Photo | AFP)

A file photo taken on November 17, 2020 shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Johnson & Johnson. (Photo | AFP)

By PTI

WASHINGTON: 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 on Saturday, days after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.

"Today, 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.

He said at the same time, this fight is far from over.

"Though we celebrate today's news, I urge all Americans, keep washing your hands, stay socially distanced, and keep wearing masks. As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse.

"My administration will not make the mistake of taking this threat lightly, or just assuming the best: that's why we need the American Rescue Plan to keep this fight going in the months ahead," Biden said.

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.

"We must continue to remain vigilant, act fast and aggressively, and look out for one another, that is how we are going to reach that light together," Biden said.

Congressman Frank Pallone, who is the chairman of the House Energy and Commerce Committee, said notably, this new vaccine is easier to store and transport than other COVID-19 vaccines and only requires one shot to protect patients.

"This will greatly improve our ability to protect millions of people against COVID-19 in communities across the country and is a giant step towards crushing the virus," he said.

The authorisation of Johnson and Johnson's COVID-19 vaccine brings the country another step closer to the light at the end of the tunnel, Pallone said.

Congressman Michael C Burgess, who is also a senior doctor, said that this is truly a remarkable achievement to see.

"To have three safe and effective vaccines not even a year from learning the virus sequencing is an outstanding accomplishment.

This is a true testament to the dedication of American scientists and a shining example of American resourcefulness," he said.

Earlier this week, an FDA panel released that Johnson and Johnson's single-dose vaccine is effective for the coronavirus and its other severe forms, Burgess said.

"This third vaccine is a signal that we are nearing the end of this pandemic, but we cannot stop taking the proper precautions.

Please continue to wash your hands thoroughly, wear a mask if you are unable to properly social distance, and stay home if you are sick.

At the start of this pandemic, America declared that we are in this together and together we will reach the end," he said.



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