Pfizer announced that the Covid-19 antiviral pill it has developed for Covid-19 reduced hospital admissions and deaths by almost 90%. The drugmaker is now joining the race to make the first coronavirus medication available in the US.
All Covid treatments in the US currently require an injection or IV. After showing promising initial results, Merck's Covid pill competitor is currently under review by the Food and Drug Administration. The UK was the first country that approved it on Thursday.
After independent experts suggested that Pfizer stop its study due to the strength of its results, Pfizer stated it would request the FDA and international regulators for authorization to market its pill. The FDA may make a decision in weeks or months after Pfizer has applied.
Researches around the world have been trying to find a home-based pill to relieve Covid symptoms and speed up recovery.
Pfizer has released preliminary results from its study on 775 adults. Pfizer found that patients who took the drug in combination with another antiviral experienced an 89% decrease in hospitalisations and deaths after one month, as compared to those who received a placebo pill. Patients who took the drug were admitted to hospital less than 1%, and none of them died. In comparison, 7 % were admitted to hospital while there were seven deaths.
We had hoped for something special, but it is rare to see great drugs with nearly 90% efficacy, and 100% protection against death, stated Dr Mikael Dolsten (Pfizers chief scientific office), in an interview.
Participants in the study were unvaccinated and had mild-to-moderate Covid. They were also considered high-risk for hospitalisation because of health conditions such as diabetes, obesity, heart disease, or diabetes. The treatment began within three to five working days of the initial symptoms and lasted five days.
Pfizer did not provide any details about side effects, but stated that the rates of problems between the groups were approximately 20%.
A group of independent medical experts that monitored the trial recommended it be stopped early. This is standard procedure if interim results prove to have a clear benefit. Although the data are not yet available for review by outsiders, this is the usual process to approve new medical research.
Top US health officials insist that vaccinations will continue to be the best method of protecting against infection. However, with millions of Americans still not vaccinated and many others around the world, it is crucial to find effective and simple ways to prevent future outbreaks.
Merck's pill, molnupiravir, has been scheduled for review by the FDA. In September, the company reported that it had reduced hospitalisations and deaths by half. Experts advise against comparing preliminary results due to differences in studies.
Mercks pill is still in the US regulatory process. Pfizers drug, however, could be more appealing to regulators because it has a safer profile and has fewer red flags. Merck's trial excluded pregnant women from its trials due to the possibility of birth defects. Pfizers drug had no such restrictions. Merck drugs work by interfering in the genetic code of coronavirus, which is a novel way to stop the virus.
Pfizers drug is part a long-standing family of antiviral medications known as protease inhibitors. These drugs have revolutionized the treatment of HIV/hepatitis C.
The Sars virus, which originated in Asia, first identified the drug. Company researchers revived the drug and studied it for Covid-19 last year due to the similarity between the coronaviruses.
The USA has approved remdesivir as an antiviral drug for Covid and three antibodies therapies to help the immune system fight the virus. They must be administered by intravenous injection or in hospitals and clinics. The supply was limited by the recent surge of the delta variant.