When will the pill against covid-19 be approved for use?
Pharmaceuticals developed by Pfizer and Merck could offer an effective response to infections in high-risk patients but they are still awaiting FDA approval.
Earlier this week pharmaceutical giant Pfizer announced that its antiviral covid-19 pill had shown 89% efficacy in preventing hospitalisations and deaths in high-risk patients in recent clinical trials.
For the past year vaccinations have been the only real source of pharmaceutical intervention against the pandemic but there are hopes that antiviral pills could offer a vital alternative. The pill, which will be known as Paxlovid , is designed for use in patients already infected with covid-19 and it will hopefully prevent cases becoming serious.
The Pfizer pills are to be taken every 12 hours for five days from the onset of symptoms, and a similar drug called Molnupiravir has been developed by pharmaceutical companies Merck and Ridgeback.
When will a covid-19 pill be approved in the United States?
Pfizer CEO Albert Bourla confirmed last week that the manufacturer is close to submitting full data on the developmental pill to the Food and Drug Administration (FDA) in the coming days. The initial application was submitted in November due to the “very high sense of urgency” and Boura expects the FDA to issue a ruling this month.
“We will have the full set in a few days,” Bourla told CNBC last week. “And we will submit them. I feel comfortable the data that we will submit will mimic at large what we saw in the first part of the study. When we ‘unblind’ the data I don’t expect we will have a difference.”
The United States has already committed to the purchase of 10 million courses of Pfizer’s Paxlovid pill. If the FDA grants authorisation, Bourla said the pill could be available to patients before the end of the year:
“We have already shipped product into the U.S., so product will be available this month if it’s approved,” he said.
Does the covid-19 pill work against Omicron?
The United States, as is the case in many countries around the world, is in the midst of a new wave of cases sparked by the more transmissible Omicron variant of covid-19. Although studies into the potency of the variant are still in early stages, it does seem that Omicron is better able to evade vaccines than previous iterations of the coronavirus.
However the pill should not be affected by the unique molecular structure of Omicron and experts expect Paxlovid to remain its effectiveness against the variant. The antiviral pill works by inhibiting one of the enzymes used by the virus to replicate, preventing it from multiplying in the body.
Speaking on NBC recently Rochelle Walensky, director of the Centers for Disease Control and Prevention, said that the pill is “another great tool” in the fight against covid-19 but reiterated the importance of early diagnosis and widespread vaccination to prevent infections.