Pfizer’s New Antiviral Drug Could Transform The Pandemic, But Challenges Still Lie Ahead

(Posted on Thursday, December 23, 2021)

The approval of Pfizer’s Paxlovid antiviral pill for Covid by the FDA is a transformative development at this critical stage of the pandemic. Paxlovid has been authorized for use in adults and pediatric patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe illness. The pill could reduce the burden on our overwhelmed hospitals during this current surge of Omicron-driven cases that has already exceeded the peak of the recent Delta wave.

Final clinical trial data, conducted during the Delta surge showed that the drug reduced the risk of hospitalization or death by 88 percent when given to high-risk unvaccinated adults within five days of the start of their symptoms. Pfizer’s laboratory studies indicate that its pills are likely to work against the Omicron variant, but this has not yet been confirmed.

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets.

Presently, the pill has been authorized for Covid patients age 12 and over who are vulnerable to becoming severely ill because they are older or have medical conditions such as obesity or diabetes. However, once manufacturing increases and supplies are more plentiful there is potential for the pill to be used prophylactically for those potentially exposed in high-risk, congregate settings such as nursing homes, prisons, and military ships.

However, there are several challenges that will prevent us from utilizing the full power of this tool. The first is insufficient supplies of the drug. In the coming week, the US is contracted to receive enough pills to cover 65,000 Americans. With a current daily average of 242,794 cases nationwide that wouldn’t even cover half of the people testing positive for the virus daily. Pfizer needs to be working with other manufacturers to significantly increase production.

The US is purchasing the drug at a cost of $530 per patient, a cost significantly out of reach for poorer countries. Based on comparable drugs manufactured in India, I estimate that the true cost should be more like $25 – $30 per patient. By pricing these countries out of the market, we risk making the same mistakes we have with global vaccine inequity. As we have learned from bitter experience, in our highly globalized world, no population is safe until we all are.

The second major issue is our woefully inadequate testing infrastructure. Currently, Americans are facing long wait times to access a Covid test and even longer wait times to receive the results. Rapid tests are nearly impossible to find during the holiday period. Paxlovid is only effective if taken within the first few days of symptoms, without an efficient testing infrastructure that cannot be achieved. We need to be dramatically increasing testing sites across the country.

I have long been an advocate of free, mass rapid testing to control the spread of Covid-19 since March 2020. Yet well over a year since the first at-home rapid antigen test was approved, despite desperate pleas from many epidemiologists and public health experts, the US is yet to embrace the power of mass rapid testing, focusing instead on vaccines. The Biden administration recently announced they would ship as many as 500 million at-home test kits to Americans in January, but the amount is still insufficient.

Widespread accessibility to rapid tests in the US is presently hampered by a cumbersome F.D.A. process intended for high-tech medical devices. To be approved, the rapid tests must demonstrate that they are nearly as sensitive as the gold standard PCR. tests. But rapid tests are the “public health gold standard”, they deliver the most important public health metric by detecting when someone is infectious and is likely to transmit the virus. Therefore they should be regulated as a Public Health Good. President Biden could accomplish this with a simple Executive Order, increasing competition among manufacturers and flooding the market with inexpensive, high-quality rapid tests.

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Originally published on Forbes on December 23, 2o21