"We are pleased to confirm that Pfizer’s manufacturing facility in Ringaskiddy will support the global manufacturing and supply of our investigational Covid-19 oral antiviral candidate, should it be approved," Pfizer Ireland said in a statement on November 5.
"Pfizer has begun investing – prior to regulatory authorization and solely at our own risk and expense – in the manufacture of our potential Covid-19 oral antiviral candidate to help bring this potential treatment to patients as soon as possible.
"Pfizer’s site in Ringaskiddy has an established and successful history of contributing to our manufacturing efforts."
The statement adds: "Tackling the Covid-19 pandemic will likely require both vaccination and targeted treatments for those who contract the virus. Pfizer continues to dedicate its best-in-class global resources at all levels to work towards the development of responses to the Covid-19 pandemic, including the development of potential antiviral treatments."
Pfizer's COVID game-changer
Pfizer said in a statement on Friday, November 5, that PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.
The treatment is specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness which can lead to hospitalization and death.
In the overall study population through day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo.
At the recommendation of an independent Data Monitoring Committee and in consultation with the US Food and Drug Administration (FDA), Pfizer says it will cease further enrollment into its study due to the overwhelming efficacy demonstrated in these results and plans to submit the data as part of its ongoing rolling submission to the US FDA for Emergency Use Authorization (EUA) as soon as possible.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said: “Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic.
"These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.
“Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”
We’re proud to announce that our #COVID19 oral #antiviral candidate demonstrated significantly reduced risk of hospitalization or death in high-risk adults in new data.
If approved, it could help to lessen the impact of COVID-19 on patients & society: https://t.co/Ek33qj56HV pic.twitter.com/NKTzaOZBeJ— Pfizer Inc. (@pfizer) November 5, 2021
The New York Times reports that Pfizer said it expects to be able to produce enough pills for more than 180,000 people by the end of this year and for more than 21 million people in the first half of next year.
Pfizer's promising trial results come about a week after Britain became the first nation in the world to approve another COVID treatment pill, Lagevrio (molnupiravir) from Merck & Co Inc.
Britain's MHRA’s Conditional Marketing Authorisation for Lagevrio is valid in Great Britain only; an emergency use authorization has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. Both authorizations were made on the basis of the same rigorous evaluation.
Pfizer's results suggest that it is more effective than the Merck & Co Inc treatment, Reuters notes.