The first oral and at-home treatment, Pfizer Inc's antiviral COVID-19 pill was authorised on Wednesday by the United States. The pill was authorized for use by people aged 12 and older at risk of severe illness.
According to Pfizer's clinical trial, its antiviral regimen, Paxlovid, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. Recent studies have also suggested that the drug retains its effectiveness against Omicron.
"Paxlovid's approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection," said Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security.
180,000 treatment courses are ready to ship this year reported Pfizer. The company raised its 2022 production projections to 120 million courses of treatment from 80 million and said it was ready to start immediate delivery in the United States. The treatment's two-drug regimen includes the new medicine and a second older antiviral called ritonavir. Ritonavir is known to have interactions with some other prescription medicines. Pfizer has however said that it should be manageable. They also suggested to lower the dose of their other medications while being treated for COVID-19.
The emergency authorization for the treatment was issued by the Food and Drug Administration's to combat a surge in COVID-19 cases driven by the Omicron variant. The drug is available by prescription only. It is to be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset, the FDA said. The pills are meant to be taken every 12 hours for five days.
William Schaffner, a leading infectious disease expert from the Vanderbilt University School of Medicine said that the pills can fill a treatment gap opened by the Omicron variant. The most widely used monoclonal antibody treatments for COVID-19 have proven to be less effective at fighting the variant and there is limited supply of the one remaining treatment that works, he said.
Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection (in this case, SARS-CoV-2) and are given to you directly in an infusion. They are typically administered intravenously in hospitals, are not widely available and cost more than twice the Pfizer pill.
Pfizer has agreed to allow generic manufacturers to supply versions of the treatment to 95 low- and middle-income countries through a licensing agreement with international public health group Medicines Patent Pool (MPP).
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) had advised on Monday that Pfizer’s Paxlovid™ (PF-07321332 and ritonavir) may be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.