Words by GOLD newsdesk
Pfizer’s COVID-19 antiviral Paxlovid (PF-07321332 and ritonavir) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) following a rigorous review of its safety, quality and effectiveness.
The regulator, which also received expert advice from the UK government’s independent scientific advisory body, the Commission on Human Medicines, found Paxlovid to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at high risk of developing severe disease.
It is most effective when taken within five days of the start of symptoms and is authorised for use in people aged 18 and above who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness such as obesity, older age, diabetes mellitus, or heart disease. It can be taken by mouth rather than administered intravenously, meaning it can be administered outside a hospital setting.
“We have given our regulatory approval for Paxlovid, a COVID-19 treatment found to cut COVID-19 related hospitalisations and deaths by 89% when taken within three days of the start of symptoms,” said Dr June Raine, MHRA Chief Executive. “I hope the announcement today gives reassurance to those particularly vulnerable to COVID-19, for whom this treatment has been approved. For these individuals, this treatment could be life-saving.”
In a clinical trial in high-risk adults with symptomatic COVID-19 infection, a five-day treatment course of Paxlovid reduced the risk of COVID-19 related hospitalisation and death within 28 days by 89% when compared to a placebo group when treatment was started within three days of the onset of COVID-19 symptoms. The number of hospitalisations and deaths were 0.8% (three out of 389) in the Paxlovid group compared with 7% (27 out of 385) in the placebo group. Similar favourable results were seen in patients when treatment was started within five days of the start of symptoms.