Ireland is set to play a key role in delivering Pfizer’s new Covid-19 tablet.
The US drug giant has stopped a trial of its experimental antiviral pill to tackle the virus early after the drug was shown to cut by 89 per cent the chances of hospitalisation or death for adults at risk of developing severe disease.
As the Irish Times reports, it said on Friday that it plans to submit interim trial results for the pill, which is given in combination with an older antiviral called ritonavir, to the US Food and Drug Administration as part of the emergency use application it opened in October.
That filing is expected to be submitted before Thanksgiving, November 25th, Pfizer chief executive Albert Bourla said.
Pfizer’s plant in Ringaskiddy, Co Cork, will be used to manufacture the drug which will then go to other plants in Europe for finishing as a tablet, assuming it wins regulatory approval.
The plant has already begun manufacture of the drug so that supplies are available if and when approval is granted. Pfizer employs around 650 people at the Cork plant out of a total Irish workforce of 4,000. It is currently recruiting at the site.
Antiviral treatments
With the virus still circulating widely and current therapeutic options requiring access to a healthcare facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed, Cantor Fitzgerald analyst, Louise Chen, said.
“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 in Ringaskiddy to help bring this potential treatment to patients as soon as possible,” a spokeswoman for the company said.
The combination treatment, which will have the brand name Paxlovid, consists of three pills given twice daily.
The planned analysis of 1,219 patients in Pfizer’s study looked at hospitalisations or deaths among people diagnosed with mild to moderate Covid-19 with at least one risk factor for developing severe disease, such as obesity or older age.
It found that 0.8 per cent of those given Pfizer’s drug within three days of symptom onset were hospitalised and none had died by 28 days after treatment.
That compared with a hospitalization rate of 7 per cent for placebo patients. There were also seven deaths in the placebo group.
