FDA approves Covid-19 antibody therapy given to Trump

WASHINGTON: US drug regulators gave emergency approval to a Covid-19 antibody therapy and G-20 nations pushed for global access to vaccines as the pandemic led to further closures in parts of the world.

With cases surpassing 12 million in the US, the highest in the world, many Americans were still heading to airports to travel for next week's Thanksgiving holiday despite health officials' warnings to stay home.

Some US states were imposing new restrictions, including California, where a 10pm to 5am curfew was taking effect.

The antibody therapy approval in the US offers some hope for those infected, though a relatively small number of doses will be available in the coming weeks. The therapy was used to treat President Donald Trump when he was infected.

The green light for drugmaker Regeneron came after Regen-Cov2, a combination of two lab-made antibodies, was shown to reduce Covid-19-related hospitalisations or emergency room visits in patients with underlying conditions.

"Authorising these monoclonal antibody therapies may help outpatients avoid hospitalisation and alleviate the burden on our health care system," said US Food and Drug Administration (FDA) commissioner Stephen Hahn.

Regeneron's antibody treatment is the second synthetic antibody treatment to receive an emergency use approval from the FDA after a similar therapy developed by Eli Lilly was granted the status on Nov 9.

The company expects to have doses ready for 80,000 patients by the end of this month and about 300,000 patients in total by the end of January next year.

These will be available to US patients at no out-of-pocket cost under the terms of a US government programme.

But with cases surging across the US and globally, that means access will not be widespread.

The US has added more than 360,000 new cases in the past two days alone.

Biotech firm Moderna, which said its vaccine is about 95 per cent effective, said it will charge governments between US$25 (S$34) and US$37 a dose, chief executive Stephane Bancel told German weekly Welt am Sonntag. "Our vaccine therefore costs about the same as a flu shot, which is between US$10 and US$50," he was quoted as saying. - AFP