The U.S. Food and Drug Administration will authorize COVID-19 pills from Pfizer and Merck as soon as Wednesday, according to Bloomberg.
The outlet reports:
Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for Covid. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S.
“It’s the biggest thing to happen in the pandemic after vaccines,” Eric Topol, director of the Scripps Research Translational Institute, told Bloomberg.
In a clinical study involving 2,246 high-risk patients, Pfizer’s pill was 89% effective at reducing hospitalization when administered within three days of symptoms first appearing. Side effects were insignificant. The U.S. has ordered 10 million courses of the treatment, but there are concerns that demand will outstrip supply.
In The Guardian, Topol wrote:
We must find a way to rapidly scale pill pack production for wide accessibility and use throughout the world, whether that involves enacting the Defense Production Act in the United States or other bold measures. It is not appropriate at this juncture to rely on a single company to mass produce a small molecule which companies throughout the world are fully capable of making with the highest manufacturing standards.
This anti-Covid pill has all the features of a breakthrough intervention at the time when we absolutely need it. It’s a sign of light in a very long tunnel. But its extraordinary promise will not get realized unless we pull out all the stops to quickly get it made and distributed at mass scale.
The Merck pill is less effective. It reduced the risk of hospitalization and death among high-risk Covid patients by 30%. There are also outstanding questions about side effects in pregnant women – Merck did not include any in their clinical trials.
“The concern” according to Yale Medicine “might be that this drug would interfere with RNA replication needed for fetus development and cause birth defects. This will be important to tease out as this drug moves from clinical trials to the market.”
But both the Pfizer and Merck pills are promising because they can be distributed at a pharmacy. “Other COVID-19 treatments, such as remdesivir or monoclonal antibodies against the SARS-CoV-2 virus causing COVID-19, are given intravenously. This is a pill your physician could write a prescription for, that you could pick up in a drugstore,” explains Dr. Albert Shaw, a Yale Medicine infectious diseases specialist.
