- Pfizer released additional findings from studies proving Paxlovid reduced the risk of hospitalization or death by 89 percent in a trial.
- Pfizer CEO Albert Bourla described the medication as a “game-changer,” and said Paxlovid might be accessible this month if the FDA grants emergency approval.
- The Biden administration purchased a total of 10 million Paxlovid courses for Americans.
Pfizer’s effective COVID pills
Pfizer released additional findings from studies evaluating its five-day course of COVID antiviral tablets, proving Paxlovid reduced the risk of hospitalization or death by 89 percent in a trial for people at high risk of severe COVID-19 when administered during the first three days of symptoms.
Pfizer also released an interim review of data from another trial, which indicated a 70% reduction in the chance of hospitalization and no fatalities when compared to placebo, in a study that included unvaccinated persons who did not have underlying diseases that put them at high risk of severe COVID-19.
According to preliminary lab data, the company’s antiviral will likely continue to be effective against all varieties of concern, including Omicron.
Pfizer CEO Albert Bourla described the medication as a “game-changer,” and said Paxlovid might be accessible this month if the FDA grants emergency approval.
Even before the Omicron variant was found, government health officials lauded Pfizer’s antiviral medicines as a possible game-changer in the fight against COVID-19.
Paxlovid is a protease inhibitor that acts by interfering with the process by which SARS-CoV-2 replicates in the body. It might be supplied and administered without the logistical challenges that other medicines, such as monoclonal antibodies, face.
The business claims to have submitted its fresh data to the Food and Drug Administration, which, according to Pfizer’s CEO, is awaiting the final results of Paxlovid before deciding whether to issue emergency use authorization for the tablets.
Another oral antiviral tablet, molnupiravir, created by Merck and Ridgeback Biotherapeutics, had initially shown encouraging results in early data from its studies, suggesting that it cut the risk of hospitalization or death in half. However, later results from the company’s final data revealed a small risk reduction of only 30%.
Molnupiravir’s lower-than-expected performance and concerns about its hazards dimmed enthusiasm for the tablet, which gained a narrow endorsement from the FDA’s outside advisors last month but has yet to be approved by regulators. Some consultants encouraged the FDA to approve molnupiravir only until “an alternative treatment with higher effectiveness and fewer safety concerns” becomes available.
Available by the end of the year
Unlike molnupiravir, Pfizer officials have stated that they do not anticipate Paxlovid to go before the FDA’s advisers, stating that its high effectiveness and minimal safety concerns are more akin to the monoclonal antibody medicines approved by the FDA without the participation of the advisory panel.
According to Pfizer, Paxlovid will be available as a package of three pills — two tablets of nirmatrelvir and one tablet of ritonavir — to be taken twice a day for five days, beginning immediately after the first indication of infection.
The Biden administration purchased a total of 10 million Paxlovid courses for Americans. Pfizer’s CEO stated that he expected just a part of Paxlovid’s supply to be available for shipment by the end of this year.