There is potentially good news on the COVID-19 front: Pfizer’s anti-COVID pill, Paxlovid, may be up to 89% effective in reducing hospitalizations and deaths in high-risk unvaccinated people with the disease, according to a new analysis from the company. And the company said the pill appeared to work against the omicron variant in lab studies.
Last month, Pfizer released interim data suggesting that his oral drug regimen was about 89% effective in achieving this goal compared to a placebo. This number was based on a study of approximately 1,200 unvaccinated people. Today’s final analysis included an additional 1,000 people, and no one in the trial who received the anti-COVID pills died. Twelve people in the placebo group died during the same period.
The company also released the first data from a second clinical trial involving 673 adults who tested positive for COVID-19 and who were unvaccinated and at standard risk for serious illness or vaccinated with at least one risk factor for serious illness. . Just over half (338) received the Pfizer anti-COVID pill and the rest received a placebo. The first results showed that the pill reduced hospitalizations by about 70% compared to the placebo, and no deaths were reported.
« This highlights the potential of the treatment candidate to save the lives of patients around the world, » said Albert Bourla, Chairman and CEO of Pfizer, in a declaration.
The company also said the drug appears to be effective against the omicron variant in lab tests, and they expect it to remain effective. There is a good reason. The main concern with the variants so far has been with the spike proteins on the virus. This is because the antibodies generated by both vaccination and natural infection rely, at least in part, on defenses built against advanced COVID-19 proteins. When these spike proteins change as new variants emerge, it can be more difficult for our bodies to recognize and put in place an early defense against the virus. The numerous mutations of the omicron variant on the spike protein are what have raised serious concerns among experts, as SELF previously explained.
But Pfizer’s drug is believed to work by inhibiting the virus’s ability to break down into small pieces and replicate by attenuating an enzyme called protease, not by fighting spike proteins. The treatment consists of 30 tablets over five days, some of which are Paxlovid and others an antiviral called ritonavir, which helps Paxlovid to work longer in the body.
The company said it sent its final data to the United States Food and Drug Administration (FDA), where it will need to be approved before it becomes publicly available. Pfizer chief scientist Mikael Dolsten said he expects it to be cleared for high-risk patients soon and may not need an advisory board meeting from the FDA. “We are in very advanced regulatory dialogues with Europe and the UK, and we have dialogues with most of the major regulatory agencies in the world,” Dolsten said. in an interview.
The effectiveness of the drug Pfizer appears to be a significant improvement over the anti-COVID pill from Merck and Ridgeback Biotherapeutics. The Merck pill, which does not affect the protease but instead introduces mutation errors via an enzyme called polymerase, initially showed a 50% reduction in hospitalizations and deaths in high-risk unvaccinated people with COVID -19 light or moderate. After a final examination, its effectiveness fell to 30%, and experts feared that intentional mutations in the drug Merck could even affect other enzymes in the body. But the FDA voted to recommend the drug at the end of November, although it is still not cleared for use by patients.
We’ve seen how quickly aspects of this pandemic, including the data, have changed over time, so even promising results like Pfizer’s aren’t necessarily set in stone. (And, of course, it’s not the same as an official third-party independent analysis.) But this news certainly offers a potential bright spot as the COVID-19 era continues.