Bolstering COVID-10 Protection

"If authorized by the FDA [U.S. Food and Drug Administration] we may soon have pills that treat the virus in those who become infected."

"The therapy would be another tool in our took box to protect people from the worst outcomes of COVID."

U.S. President Joe Biden

 

"It makes the landscape a lot more promising because what these antivirals represent is more evidence of the ability to tame the virus."

"It gives us a big toolbox, makes it a more treatable infection. It brings it down from the level of being a five-alarm fire."

"I think that when you have oral antivirals that can decrease complications and decrease hospitalizations, that makes Covid-19 a much more manageable respiratory infection, and that's always been the goal."

Dr. Amesh Adalja, senior scholar, Johns Hopkins Center for Health Security

 

"Effective, early, oral medicines will be fundamental to ending Covid-19."

"[Health agency Unitaid] welcome[s] additional small molecule antivirals -- supported by evidence -- and with meaningful commitments to access in all countries, including low and middle income countries." 

Herve Verhoosel, spokesperson, World Health Organization affiliate Unitaid

Pfizer's experimental antiviral pill for COVID-19 has great potential to drive down mass hospitalizations and reduce death, says infectious diseases specialist Dr. Zain Chagla. 'There is a lot of optimism,' he said. (Bebeto Matthews/The Associated Press)

 

In the interim, on the strength of Pfizer's trial results suggesting that its oral drug with the brand name Paxlovid was proven in trials to slash the risk of severe COVID-19 by 89 percent, the American government has pre-ordered millions of doses of the Pfizer drug. Giving a strong indication that the FDA will be giving its approval for the drug's use in the United States. Once that happens, other countries will appraise the results of the study -- cut short because of the volume of its positive results -- guaranteeing it will be in wide use as a COVID prevention therapy.

It is no small thing to produce an anti-viral medication whose results have demonstrated the chances of hospitalization or death for adults at risk of developing severe disease, would be cut by 89 percent. Merck's pill molnupiravir, introduced a month earlier, was shown to cut risk of dying or hospitalization for COVID-19 patients at high risk of serious illness by 50 percent.

The pill is meant to be taken alongside an older anti-viral called ritonavir. Therapeutic treatment consists of three pills taken twice daily. The treatment price tag would approximate that of Merck's product whose U.S. contract price is approximately $700 each five-day course. Experts point out that despite the potential seen by these anti-viral pills, COVID-19 infection prevention will remain based on the broad use of vaccines.

Inoculation is recognized as a superior overall protection against the pandemic that has killed over five million people worldwide, as far as infection disease experts are concerned, to the present time. Over seven billion vaccine doses have thus far been administered globally, and even at that only about half the world's population has been covered. Over 400,000 new cases are reported daily across the globe.  And 50 countries are seeing rising infection rates.

 

58 percent of Americans are now fully vaccinated. It is Pfizer's intention to submit interim trial results for its anti-viral pill before the U.S. November 25 Thanksgiving holiday, to the Food and Drug Administration. 180,000 treatment courses are expected to be available by the end of 2021, with another 40,000 million courses by next year's end -- with 21 million in the first half of 2022 available. Pfizer has revealed it has been in discussions with 90 countries to date.

In Pfizer's study 1,219 patients wee analyzed  through examination of hospitalizations or deaths among people who had been diagnosed with mild to moderate COVID-19 with at least one risk factor for the development of severe disease (such as obesity or age). Within three days of symptom onset, the pill lowered chances of hospitalization or death for adults at risk of developing severe COVID-19 by 89 percent in comparison with patients receiving a placebo.

For patients treated within five days of symptoms, rates were similar; one percent of the treatment group was hospitalized, compared to 5.7 percent for the placebo group, including ten deaths. Those numbers work out to 85 percent effectiveness in the prevention of hospitalization or death. No side effects were detailed by Pfizer, adding that adverse events occurred in roughly20 percent of both treatment and placebo patients; likely in the form of nausea and diarrhea.

"I see them as a one-two punch. Vaccines are prevention. These antivirals are early treatment. Both have utility," 

"Neither one is a substitute for the other."

Dr. William Schaffner, professor of medicine, Division of Infectious Diseases, Vanderbilt University School of Medicine

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