US warns of 'twindemic' prior to holiday season with COVID-19 pill, booster vaccines in clearance

PILL AND BOOSTERS

On Monday, drugmaker Merck asked the US Food and Drug Administration (FDA) to authorize its pill against COVID-19 in what would add an entirely new and easy-to-use weapon to the world's arsenal against the pandemic. If cleared by the agency, a decision that could come in a matter of weeks, it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an intravenous therapy (IV) or injection.

"An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on US hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations," reported national broadcaster NBC.

Merck and its partner Ridgeback Biotherapeutics said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. Merck expects to be able to produce enough pills for 10 million people by the end of this year. The pill is meant to be taken at home as four capsules twice a day for five days, for a total of 40 pills.

Meanwhile, the US federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the FDA meet on Thursday and Friday to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines. So far, regulators have authorized booster shots only for certain adults who received the Pfizer-BioNTech vaccine.

"The (US President Joe) Biden administration is eager to shore up the protection provided by all three (officially authorized) vaccines. And federal officials have become increasingly worried in particular about the more than 15 million Americans who received the Johnson & Johnson vaccine, which is less effective than the others," reported The New York Times on Monday.

On Thursday, the FDA advisory panel of vaccine experts will discuss safety and efficacy data regarding booster shots for Moderna recipients. On Friday, the group will discuss Johnson & Johnson boosters. The agency typically issues decisions within a few days of advisory committee meetings. The expert committee will also hear a presentation on Friday from scientists on the effectiveness of mixing different brands of vaccines.