FDA’s At-Home Testing Screw-Up Is Undermining Promising New COVID Treatments

If the severe omicron virus variant turns out to be more infectious and potentially more deadly than the current circulating variants, then the COVID-19 antiviral medications developed by Merck (Pfizer) will most likely reduce the risk of death and hospitalization. Why? Why? Because they both interfere with parts of the virus’ genome necessary to reproduce and, unlike most vaccines, are very rare for mutation.

Pfizer’s pill (Paxlovid), is a mixture of an HIV protease inhibitor and a protease inhibitor. It targets a particular enzyme the coronavirus requires to reproduce and grow. Merck’s pill, Molnupiravir, was developed in collaboration with Ridgeback Biotherapeutics. It is an analog of ribonucleosides. When the virus incorporates it during its replication it causes it to die.

Initial indications from clinical trials indicated that the medicines worked so well that control subjects were not allowed to be enrolled in placebo-controlled studies. Merck announced in October that 50 percent of COVID-19 patients were hospitalized or died as a result of its drug. Merck has now revealed that their molnupiravir pill can reduce the risk of COVID-19-related death or hospitalizations by approximately 30 percent.

Pfizer revealed that Paxlovid reduced the risk of death and hospitalization by 89% when compared with placebo among non-hospitalized COVID-19 high-risk patients. Alberta Boula, CEO of Pfizer, stated yesterday that he is confident that the treatment won’t be affected by the omicron variation.

The United Kingdom approved Molnupiravir on November 4th as an effective treatment for COVID-19. The U.S. Food and Drug Administration continues to delay approval of medications so efficient that two independent Data Monitoring Committees determined that giving placebos for study participants was unethical.

Talking of dawdling: The FDA has for years obstructed the release and development of an essential component to effective antiviral medications, namely at-home COVID-19 screening. To prevent hospitalization or death, both pills should be consumed within three to five days after exposure. This means people must be able test themselves easily and inexpensively.

Up until mid-October, the FDA had approved only two over-the-counter at-home COVID-19 diagnostic tests, one of which has now had to be recalled. Agency regulators finally authorized nine additional tests in the past month. Preliminary evidence shows that self-tests currently in use can detect Omicron variant infections.

A February 2021 poll by researchers at the Harvard T.H. Chan SchoolPublic Health Reports if COVID-19 Self-Tests Cost 11 each A majority of Americans will test their self regularly at home, which is 79 percent. This number dropped to 33% if it was $25 each test. A majority of those polled said positive results would encourage them to take preventative measures to keep their loved ones, friends, family and coworkers safe. The poll found that 94% would remain home and 93% would seek out family members. 90 percent of respondents would use a mask to protect their close contacts and household members.

It is not easy to find COVID-19 self test kits that are widely available. Those that are readily available are more expensive than $20. However, a faster FDA approval for COVID-19 self tests would have encouraged competition among brands and made them easier to access.

Interestingly, New Hampshire public health officials began offering to send free (tax-paid) at-home COVID-19 tests to any of the state’s residents on Monday. Within 24 hours, more than 100,000 homes had asked for them. This was despite the state’s “Live Free or Die!” supplies. While I was covering the U.N. Climate Change Conference, 28 COVID-19 self tests were given to me by Scottish public health officials.

The Biden Administration declared in October that $1 billion would be spent on the purchase and distribution of at-home COVID-19 test kits. These tests will be free to all community health centers, food pantries and public health clinics. In December, the goal is for production to reach 200 million. This is approximately 0.6 test per American each month. It’s too little testing to be able to identify a large number of individuals who would benefit from COVID-19 when it comes to approval by FDA.

Let’s not be afraid of the omicron variation. But, increasing the availability to inexpensive COVID-19 self testing daily would allow those who become infected to make voluntary efforts to avoid passing the virus onto their loved ones, friends and fellow Americans.