The pharma giant says the pill cuts the risk of severe Covid by 89%.
Pfizer has confirmed that its manufacturing facility in Ringaskiddy in Cork will support the global manufacturing and supply of its new Covid-19 pill, should it be approved.
It comes as the pharma giant said on Friday (5 November) that its investigational antiviral candidate, which will have the brand name Paxlovid, was shown in trials to cut the risk of hospitalisation or death in non-hospitalised adults at risk of developing severe Covid-19 by 89%.
Due to the “overwhelming efficacy” shown in the results and following the recommendation of independent experts, Pfizer is ceasing further enrollment in the study.
It plans to submit its data to the US Food and Drug Administration (FDA) for emergency use authorisation as soon as possible.
“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 said in a statement.
“Pfizer has begun investing – prior to regulatory authorisation 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.
“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 study looked at hospitalisations or deaths among people diagnosed with mild to moderate Covid-19 and who had at least one risk factor for developing severe disease.
Pfizer’s study found that 0.8% of these in the trial who were given Paxlovid within three days of the onset of symptoms were hospitalised while none died within 28 days after treatment.
In comparison, 7% of patients who received a placebo were hospitalised and seven subsequently died.
Similar reductions in Covid-19-related hosptialisation or death were observed in patients treated within five days of the onset of symptoms.
Out of patients who received Paxlovid, 1% were hospitalised with no deaths within 28 days, compared to 6.7% for the placebo group, which included ten deaths.
According to Pfizer, if the drug is approved, it could be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalisations and deaths, as well as reduce the probability of infection following exposure, among adults.
Paxlovid works by blocking the activity of the SARS-CoV-2-3CL protease, an enzyme the coronavirus needs in order to multiply, and is given in combination with an older antiviral called ritonavir.
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