The pharmaceutical company Merck is in the process of getting authorization from the Food and Drug Administration (FDA) for the first oral treatment of COVID-19. However, who can access the pill and if it will be distributed at USF is still unknown.
In a partnership between pharmaceutical companies Merck and Ridgeback Biotherapeutics, molnupiravir, the first COVID-19 treatment that can be taken orally in the form of a pill, was introduced Oct. 1 in a news release. Merck requested emergency use authorization for the drug Oct. 11, which could make it available to the public in the coming weeks.
The drug is taken over a period of five days, with four pills taken twice a day. In the past, similar treatments could only be taken intravenously or by injection. It will assist natural functions in the body in order to subdue the virus, according to Jill Roberts, associate professor at the USF College of Public Health. By allowing the virus to mutate without fully infecting the body, the immune system will be able to target the virus.
“[The pill] is going to stop replication,” she said. “It’s not going to completely eliminate the disease. Your immune system needs to do that.”
During the authorization process, the drug will be scrutinized by the FDA, including the results from clinical trials. Merck is already producing the pill in anticipation of FDA approval and expects to manufacture 10 million courses of treatment by the end of 2021, the news release said.
The government has purchased the drugs before authorization to streamline the process, according to Roberts.
“They can move it to the locations at which they want to distribute it, but not a single pill can go out until that FDA approval code comes through,” said Roberts.
Who can get the pill has yet to be determined, but Merck requested the authorization to prioritize access for adults with mild to moderate symptoms of COVID-19 and risk of hospitalization or death.
Professor of epidemiology at the College of Public Health Edwin Michael said there has been no discussion or indication that USF is planning to distribute it.
“As far as USF is concerned, I’ve not heard anything yet on whether they’re going to allow prescribing these pills,” he said. “But they might, down the line, if there’s a lot of resistance to [not distributing the pills].”
lt is unlikely the pill will be offered at USF in the near future, according to Roberts and Michael. Roberts said if a COVID-19 case was serious enough to require molnupiravir, the student would no longer be required to self-isolate.
Instead, she said community members are more likely to receive physician recommendations at USF after reporting a positive case, and will be able to obtain the treatment elsewhere through pharmacies and hospitals.
“It is unclear yet how it will be distributed. It’s very unlikely that it’s going to be easy to get. More than likely it’s going to require a positive COVID test, and a prescription from a physician,” said Roberts. “I would say more than likely it’s going to require a visit to another physician.”
If the USF community has access to the treatment, Roberts said it’s possible symptoms could be ignored until it is too late for the drug to be as effective as seen in the clinical trials.
“Once you get too far along that pathway, it’s just too late,” said Roberts. “You’re going to get to the point where it’s just too late, and now you’re going down a different road.”
The pill is inexpensive compared to other COVID-19 treatments, as reported by CBS News. Monoclonal antibodies, used for treating symptoms after developing COVID-19, costs $2,000 a treatment, while each five-day Merck treatment costs $700.
Access to the pill may lead to a plateau in vaccine rates, according to Roberts and Michael, as the pill could be seen as a reason to avoid the vaccine.
Roberts said if an individual receives the Merck treatment, it would not be considered the equivalent of becoming vaccinated. The pill will reduce the intensity and duration of symptoms, but the vaccine is proven to reduce transmission more effectively than contracting COVID-19, according to both Roberts and Michael.
“We have seen in a couple of studies that the antibody from getting COVID is not equivalent to the antibody from getting the vaccine,” said Roberts. “The vaccine is actually outperforming the actual infection with COVID in terms of antibodies.
“Even if a student followed exactly that course: they got COVID, they got the pill, they got better — we would still recommend they get vaccinated.”
Michael said the pill is a means to ease the symptoms after contracting COVID-19, but vaccines offer prevention and the most promise for managing cases.
“It’s vaccinations that’s going to take us out of this, it’s going to stop the pandemic,” said Michael. “It’s not going to be these drugs.”