J&J seeks Covid-19 vaccine clearance, US nears 3rd shot

WASHINGTON: Johnson & Johnson has asked US drug regulators to clear its experimental Covid-19 vaccine for emergency use, setting off a review process that could lead to millions more doses becoming available within weeks to step up a stumbling immunisation drive.

The drugmaker said in a statement on Thursday it had filed an application for an emergencyuse authorisation with the US Food and Drug Administration (FDA). If cleared, the shot would give the US a third vaccine to try to halt a pandemic that has killed more than 450,000 Americans.

FDA officials will now examine J&J’S trial data, and the agency scheduled a February 26 meeting at which a panel of outside advisers will consider the request and make a recommendation about whether to grant it. While its decision isn’t binding, it is unusual for the FDA to reject the experts’ advice.

Vaccines from Moderna and partners Pfizer and Biontech have been given a similar clearance. Both were found to be over 90% effective in clinical studies, and are given in two doses spaced several weeks apart.

J&J’S vaccine was found to be 72% effective in the US in preventing moderate to severe Covid-19 after a single shot, and 66% effective overall in a global trial.

Also, WHO Europe director Hans Kluge appealed on Friday for EU nations and Big Pharma to unite in the struggle to accelerate coronavirus inoculations.