Oral Covid-19 Drug Shows Promise, but Scientists Want More Data

The pharmaceutical company Merck has produced an oral drug that it says could reduce Covid-19 hospitalisations and deaths by 50 percent worldwide.

Company representatives say the drug, called molnupiravir, has shown encouraging results in a clinical trial. Merck has submitted a request to the U.S. Food and Drug Administration to authorise the emergency use of the drug. The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has already granted it conditional approval.

Unlike other approved drugs, which are administered by injection, molnupiravir is the first medicine for treating Covid-19 that can be taken orally.

The drug works by reducing the ability of SARS-CoV-2, the virus that causes Covid 19, to multiply in the body. It does this by increasing the number of mutations in the virus’s genetic material in a way that impairs its ability to multiply.

The new medicine makes early intervention possible for patients with mild to moderate cases of Covid-19. This could keep hospitals from becoming overcrowded, especially in countries where vaccination rates are still low.

Islam Hussein, an Egyptian virologist now based in Boston, told Al-Fanar Media: “Molnupiravir is an excellently effective drug. Clinical trials have proven that it cut the incidence of hospitalisation and death by 50 percent.”

The availability of drugs like molnupiravir, along with vaccines, will play an important role in ending the pandemic, Hussein said. “One of its most important advantages is that it can easily be administered orally.”

Promising Clinical Trial Results

In October, Merck released an interim analysis of outcomes for 775 patients with mild to moderate Covid-19 who were enrolled in a clinical trial of the drug. The data showed that only 7.3 percent of those who received molnupiravir were hospitalised, compared with 14.1 percent of patients who received a placebo. While none of those who took molnupiravir died, eight placebo-treated patients died.

Hussein, whom the portal Nature Middle East has called one of the top five science communicators in the Arab world, cautioned that the picture is still incomplete.

“It is expected that the research paper the company will publish will contain more details and possibly more data on a larger number of people who have undergone the drug trials,” he said.

The early results suggest a high degree of safety, Hussein said, but is difficult to judge all aspects of the drug’s safety without more detail.

“However, we should not lose sight of the British Medicines Regulators’ decision to authorise an emergency use of the drug,” he added. “Mostly, this decision was based on a careful examination of efficacy and safety results.”

Global Access to Molnupiravir

Merck has committed to global access to the drug. It has entered into non-exclusive voluntary licensing agreements with established companies to manufacture it around the world, to accelerate its availability in more than 100 low and middle-income countries.

However, Hussein is worried about whether the medicine will be widely available in poor countries. “The most important obstacle facing its global availability is its high price, which might hit $700 for a single five-day course of treatment,” he said.

“But there is also a good step taken by the producing company, which is to grant a license to some Indian companies to manufacture the drug and sell it for $15 to $20 in low-income countries.”

Several countries have submitted requests to purchase the drug. The United States has requested 3.1 million courses for $2.2 billion. The Japanese government is  trying to purchase 1.6 million courses. A course of treatment consists of 10 doses, with the pill administered twice a day for five days.

In Britain, which is seeing high levels of Covid-19 despite its early vaccination success, the government confirmed that it had ordered 480,000 courses of the drug. The country’s conditional approval of the drug was granted in early November.

“The U.K. is now the first country in the world to approve an antiviral that can be taken at home for Covid-19,” said Sajid Javid, Britain’s health secretary. “This will be a game changer for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.”

Risks and Challenges

Some researchers, however, believe that there are still concerns regarding the medicine’s safety.

“Any medicine has side effects,” said Ahmed Refaat, a lecturer of oncology in the Faculty of Medicine at Egypt’s Assiut University. “The trials on the drug have not ended yet, so we do not know all the details.”

He added: “Merck is a great, trusted company. However, we know nothing so far but the company’s press release. We are waiting for official results soon.”

Refaat believes that if the treatment is successful, “the big problem we will face will be a speedy diagnosis because the new drug has to be taken in the first days of infection.”

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Pharmaceutical companies are currently in a race to license their drugs to treat Covid-19.  In the United States alone Pfizer has produced paxilovid pills, Gilead Sciences is developing a pill version of remdesivir, and Atea Pharmaceuticals also has an antiviral medicine in the works.

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