Britain’s regulator approved Pfizer Inc.’s Covid-19 antiviral pill as Prime Minister Boris Johnson’s government races to build an armory of weapons against the resurgent pandemic.
The Pfizer drug, Paxlovid, was authorized for use in people over 18 with mild to moderate Covid and at least one risk factor for developing severe illness, the U.K.’s Medicines and Healthcare Products Regulatory Agency said Friday.
Paxlovid joins a growing array of tools to fight the pandemic, including vaccines and antiviral treatments. The U.K. has been out in front on approvals and has accelerated its booster campaign as the omicron variant advances.
Britain has ordered 2.75 million courses of the Pfizer drug, which gained emergency use authorization in the U.S. last week. The U.K. has also ordered Merck & Co.’s antiviral pill, molnupiravir, developed with partner Ridgeback Biotherapeutics LP, which was approved by the British regulator in November.
It’s too early to tell whether omicron has any impact on Paxlovid’s effectiveness, but the regulator said it’s working with Pfizer to determine this.
Pfizer shares rose 0.5% in premarket trading.
In a clinical trial in high-risk adults with symptomatic Covid, a five-day course of Paxlovid reduced the risk of hospitalization and death within 28 days by 89%, compared with a placebo group, when treatment was started within three days of the onset of symptoms.
Such drugs have been described as potential game-changers in the fight against Covid because of their ease of use and the effectiveness they’ve shown in trials.
“We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously,” MHRA Chief Executive June Raine said in a statement. “This means it can be administered outside a hospital setting before Covid-19 has progressed to a severe stage.”
