The country director of Pfizer UK has said that the company’s oral antiviral treatment for COVID-19—which last week was shown to cut the rates of hospitalisation and death by nearly 90 per cent in high-risk adults—has said that the pill could be made available by early 2022, subject to regulatory approval.
“We expect to be filing in the near future—in the coming weeks—and then, subject to their approval, we may see this medicine being available very early in 2022,” Ben Osborn told Sky News.
The UK has already ordered 250,000 courses of the treatment, and 450,000 courses of Merck’s molnupiravir.
The treatment, which Pfizer called PAXLOVID, is a “specifically designed SARS-CoV-2-3CL protease inhibitor,” designed to be prescribed “at the first sign of infection or at first awareness of an exposure”. It includes two drugs, PF-09321332 and ritonavir, which are co-administered. While PF-09321332 inhibits viral replication at the proteolysis stage of the virus (which occurs before viral RNA replication), the ritonavir slows its metabolism so that it remains active in the body for longer periods of time at higher concentrations to help combat the virus.
Pfizer began its EPIC-HR study on the treatment in July. Preliminary analysis of the data was taken from 1,219 adults, all of whom had a lab-confirmed COVID-10 diagnosis within a five-day period with mild to moderate symptoms as well as one characteristic or underlying medical conditions associated with an increased risk of developing severe illness from COVID-19. The study was halted after the data was shown to be statistically and clinically meaningful.
Pfizer is expected to apply for emergency use authorisation in the US for its treatment soon. It joins Merck, which has also sought EUA for its COVID-19 treatment, molnupiravir, which was last week authorised for use within the UK.
In an earnings call with investors last week, Pfizer CEO Albert Bourla and the company’s chief scientific officer Mikael Dolsten discussed the company’s preparations for a COVID-endemic world, where viral outbreaks occur regularly, requiring routine immunisations to tackle. Bourla said the company was ramping up manufacturing of its orally administered pill for COVID-19.
