Prizer Inc, which has been behind the distribution and partly the development of the earliest COVID-19 vaccine invented by German-based company BioNTech, has now filed an application with the Food and Drug Administration for the approval of its anti-coronavirus pill.
Pfizer submitted the application on Tuesday, asking the FDA to authorize for emergency use the pill called Paxlovid, which is said to cut the rates of COVID-19 hospitalizations and deaths by 90% - based on its latest clinical trial data.
The pill has been touted as having a big potential to impact the negative trajectory of the pandemic in countries or cities with low vaccination rates or just insufficient access to COVID-19 vaccines.
Previously, Albert Bourla, Pfizer’s CEO, had announced that the county was going to submit the relevant data to the FDA already before Thanksgiving.
The Paxlovid pill falls in a class of medications called protease inhibitors, and it works by inhibiting an enzyme that is used by the coronavirus to copy itself inside human cells.
In its announcement, Pfizer said that protease inhibitors have been effective in the treatment of other viruses, including HIV and hepatitis C, either on their own, or in combination with other antiviral medications.
According to the preliminary results that the company released earlier this month of its study involving a total of 775 adults with mild-to-moderate COVID-19, the risk of hospitalization or death was reduced by 89% a month after the trial started.
All participants in the experiment were unvaccinated and at high risk for hospitalization because of underlying conditions such as obesity and diabetes.
They were treated in three to five days since reporting the first symptoms, for a period of five days.
The new Pfizer drug was administered together with an antiviral HIV medication.
Only 0.8% of the patients had to be hospitalized and no one died.
At the same time, the comparison group, saw the hospitalization of 7% of the placebo patients and a total of seven deaths.
In its statement, Pfizer said side effect rates were about 20% but it didn’t provide details as to the nature of the side effects.
Swift application for FDA approval
Apparently, the company considered the results from the trial to be “so impressive” that it stopped it ahead of schedule in order to seek emergency usage approval from the FDA.
Pfizer’s Paxlovid is the second pill said to be effective at treating the coronavirus, after last month Merck & Co announced its own antiviral reduces serious illness and death rates by half.
For the time being, it remains unknown how quickly the FDA might approve Pfizer’s pill.
The company has also submitted it for approval to the regulators in Australia, South Korea, and New Zealand, and plans similar applications in a number of other countries.