The company plans to submit interim trial results for its pill to the US Food and Drug Administration as part of the emergency use application it opened in October
A trial of Pfizer’s experimental antiviral pill for COVID-19 was stopped 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, the company said.
The results appear to surpass those seen with Merck’s pill, molnupiravir, which was shown last month to halve the likelihood of dying or being hospitalized for COVID-19 patients also at high risk of serious illness.
Full trial data is not yet available from either company.
Pfizer said it plans to submit interim trial results for its 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.
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 diseases, 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 hospitalisation rate of 7 per cent for placebo patients. There were also seven deaths in the placebo group.
Rates were similar for patients treated within five days of symptoms – 1 per cent of the treatment group was hospitalized, compared with 6.7 per cent for the placebo group, which included 10 deaths.
“We saw that we did have high efficacy, even if it was five days after a patient has been treated … people might wait a couple of days before getting a test or something, and this means that we have time to treat people and provide a benefit from a public health perspective,” Annaliesa Anderson, head of the Pfizer programme, told Reuters.
The company did not detail the side effects of the treatment but said adverse events happened in about 20 per cent of both treatment and placebo patients. “These data suggest that our oral antiviral candidate if approved 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 hospitalisations,” Pfizer Albert Bourla, CEO, Pfizer said
Pfizer said it was currently expecting to produce more than 180,000 packs by the end of 2021 and at least 50 million packs by the end of 2022, of which 21 million would be produced in the first half.
Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs to multiply. Merck’s molnupiravir has a different mechanism of action designed to introduce errors into the genetic code of the virus. Merck has already sold millions of courses of the treatment, which was approved this week by UK regulators, to the United States, the UK and others.
Reuters
