UNITED KINGDOM – The UK government will roll out Merck’s COVID-19 antiviral pill, Molnupiravir, later this month, and a drug trial will begin in early December.
The UK after it became the first country to approve the pill in early November. The UK government has obtained 480,000 courses of Merck’s antiviral pill and 250,000 courses of Pfizer’s COVID pill.
Molnupiravir will be marketed as Lagevrio in the United Kingdom and will be used to treat mild to moderate COVID patients who have at least one risk factor for developing serious illness.
These risk factors include advanced age, obesity, type 2 diabetes, and heart disease. Molnupiravir approval, according to Health Secretary Sajid Javid, is a “gamechanger for the most vulnerable and immunocompromised.”
Molnupiravir inhibits virus replication, which helps to keep virus levels in the body low. This reduces the severity and impact of the disease, as well as the time it takes to recover. Clinical trial data suggests that the pill is most effective when administered during the early stages of infection.
Meanwhile, Pfizer has released preliminary findings from a study involving 775 adults, revealing that after one month, patients taking the pill in conjunction with another antiviral had an 89 percent reduction in their combined rate of hospitalization and death.
Given the trial’s encouraging results, the company intends to submit the findings to the US Food and Drug Administration as soon as possible in order to request emergency approval.
Pfizer intends to discontinue enrollment in phase 3 study as a result of the significant efficacy findings, and will submit the data as part of the ongoing application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of Paxlovid for the treatment of COVID-19.
This, according to Pfizer, will help it play a role in at-home COVID-19 treatment to reduce illness, severity, and transmission risk, pending an FDA decision.
Pfizer preparing for endemic covid outbreaks
The company is preparing for a near-future in which covid-19 is endemic, or occurs on a regular basis, throughout much, if not all, of the world.
While the booster dose of the vaccine improves immunity, including against newly emerged virus variants, its effect is expected to fade after about a year.
Pfizer is already planning on continuing routine immunizations. “We are already preparing for revaccination,” said Mikael Dolsten, the company’s chief scientific officer, “when the third boost immunity may start to fade possibly after a year, which we think would…support an annual vaccination, similar to the flu.”
Meanwhile, the US Food and Drug Administration (FDA) has denied an emergency use authorization (EUA) for NRx Pharmaceuticals’ Zyesami (aviptadil) therapy to treat critical Covid-19 patients with respiratory failure.
The agency stated in a letter to the company that its decision is based on insufficient evidence on the known and potential benefits of the treatment as well as its risks in critical Covid-19 patients with respiratory failure.