What is molnupiravir and how does it fight covid-19?
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(CNN) -
During the global scramble for COVID-19 vaccines, many Asia-Pacific countries lagged behind.
This time, they are not making the same mistake.
Countries in the region are rushing to order the latest weapon against covid-19: an antiviral pill whose use is not yet authorized.
Molnupiravir - produced by the US pharmaceutical company Merck - is being heralded as a potential game changer in the pandemic, especially for those who cannot get vaccinated.
Merck is seeking emergency use authorization from the US Food and Drug Administration (FDA) for the drug, and if granted, the capsule will become the first oral antiviral treatment against COVID-19.
Merck seeks authorization of pill against covid-19 0:40
According to the analysis company Airfinity, at least eight countries or territories in the Asia-Pacific region have signed agreements or are in talks to acquire the drug, including New Zealand, Australia and South Korea, which relatively took time to start their programs vaccination.
Covid-19 pill shows promise, but there are concerns
Experts say that while the pill looks promising, they are concerned that some people are using it as an alternative to vaccines, which still offer the best protection.
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And they warn that the race to stock up on the pill in Asia could repeat the hoarding of vaccines that occurred last year, when richer countries were accused of hoarding doses while lower-income countries ran out of them.
"(Molnupiravir) really has the potential, the potential, to change the game a little bit," said Rachel Cohen, executive director for North America of the nonprofit Drugs for Neglected Diseases Initiative.
"We have to make sure that history does not repeat itself, that we do not fall into the same patterns or repeat the same mistakes that we saw with the covid-19 vaccines."
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What is molnupiravir?
Molnupiravir is considered a positive step because it offers a way to treat COVID-19 without requiring patients to be in the hospital.
The pill works like this: once COVID-19 is diagnosed, the patient can start treatment with molnupiravir.
It consists of four 200-milligram capsules that are taken twice a day, this over five days for a total of 40 pills.
Unlike vaccines, which elicit an immune response, molnupiravir disrupts virus replication, says Sanjaya Senanayake, an infectious disease physician and associate professor of medicine at the Australian National University School of Medicine.
"In a sense, it makes the virus produce unhealthy babies," he said.
Merck headquarters in Kenilworth, NJ, on January 25, 2021. (Photo: Christopher Occhicone / Bloomberg)
Change in game
Preliminary phase 3 results from a trial of more than 700 unvaccinated patients published earlier this month showed that the pill could reduce the risk of hospitalization or death by about 50%, compared to patients taking a placebo.
All participants were given either the pill or the placebo within five days of the onset of symptoms, and none of those who took the pill died within 29 days, compared with the eight who received the placebo. .
The full data from the molnupiravir trial has not yet been released, and the data has not yet been peer-reviewed or published.
Wendy Holman, executive director of Ridgeback Biotherapeutics, which is collaborating on the development, said in a statement that the results were encouraging, and that she hoped the drug could have a "profound impact on controlling the pandemic."
"Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically necessary," he said.
Experts agree that the drug is promising.
Instead of patients waiting to see if they become seriously ill, the virus could be treated immediately after diagnosis, said Cohen of the Drugs for Neglected Diseases Initiative.
And unlike other COVID-19 treatments, molnupiravir can be taken at home, freeing up hospital resources for more seriously ill patients.
"Getting a pill is much easier," Senanayake said.
"This is a game changer."
What does this pill mean for covid-19 vaccines?
Vaccines are still the best protection, experts say;
After all, they can reduce a person's risk of contracting COVID-19.
But even in Asia-Pacific, where vaccination rates in many countries have improved after a slow start, millions of people remain unvaccinated because they are not eligible or cannot access vaccines.
And that's where the pill comes in.
"There are a lot of people who can't get vaccinated," says Nial Wheate, associate professor at the University of Sydney School of Pharmacy.
"This drug will be a first-line solution for those people who end up getting sick."
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The pill is not a substitute for vaccines
But Wheate and other experts worry that the pill could make it difficult to convince some people to get vaccinated, compounding questions about vaccines seen in several countries, including Australia.
Research shows that people prefer to take the drugs rather than have them injected, Wheate said.
"If you had told me a year and a half ago that people would reject a vaccine for a disease that is killing the planet, I would have thought you were crazy," he said.
"There is always scope for people to think that this drug will be a much better solution than getting vaccinated."
But experts say the pill is not a substitute for vaccines.
Senanayake says the approach is similar to how we treat the flu: There is a flu shot, but there are also antiviral drugs to treat those who get sick.
Cohen says the pill doesn't make it less urgent to expand equitable access to vaccines.
"Vaccine equity is kind of the defining challenge of our time. But you never fight an infectious disease with just one set of tools," he said.
"We really need the entire arsenal of health technologies."
Unvaccinated adults face 11 times greater risk of dying from COVID-19 than vaccinated ones, according to CDC
Why are Asia-Pacific countries buying the pill?
According to Airfinity data, 10 countries or territories are negotiating or have signed deals for the pill, and eight of them are in Asia-Pacific.
Some of these countries may be trying to avoid the mistakes of the past, when slow ordering caused delays in vaccine implementation.
"I think we want to make sure that we stay ahead of these new developments," Senanayake said.
"There are some middle-income countries that I think are trying not to fall into the same trap that they fell into when high-income countries hoarded all vaccines," Cohen added.
It is not clear how much each of these countries will pay for the pills.
The United States has agreed to pay $ 1.2 billion for 1.7 million treatments if the pill is approved, meaning the government will pay about $ 700 per treatment.
An analysis by researchers Melissa Barber and Dzintars Gotham revealed that a molnupiravir treatment costs about $ 18 to produce, based on a raw material cost estimate.
Gotham, which investigates access to drugs, said it was common for pharmaceutical companies to impose a large surcharge on drugs, but said it was surprised to see such a high price, as US funding contributed to the development of the pill.
A woman receives a dose of the Pfizer vaccine on October 5, 2021 in Gua Musang district, Kelantan, Malaysia.
Merck did not confirm whether those estimates were accurate, although the company said in a statement to CNN that the calculations do not take into account research and development.
"We have not yet set a price for molnupiravir because its use has not been approved," the company said.
"We have an advance purchase agreement with the US government and that price is specific to a substantial volume of molnupiravir and does not represent a list price for the United States or any other country."
In a June statement, Merck said it planned to use a tiered pricing approach for different countries, and that it had also reached licensing agreements with generic manufacturers to accelerate the availability of the pill in 104 low- and middle-income countries.
Inequity
Lower-income countries may be at a disadvantage when it comes to using the pill.
Once the drug is approved for use, countries will have to decide whether to give it to anyone showing symptoms, or to require a positive test before they can obtain it.
But that requires access to evidence.
And in some countries that could be a problem, according to Cohen.
Preliminary results for the pill are for people who received it within five days of symptoms, and in some countries getting a test so quickly could be a problem.
The non-profit organization Doctors Without Borders called the drug "potentially saving care" for people who live in areas where many are not vaccinated and vulnerable to the disease.
However, first there is the question of how they can access it.
Although the drug would be simple to produce, according to Leena Menghaney, who is responsible for the group's access campaign in South Asia, Merck controls the patent and can decide which countries to supply the drug to and at what price.
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Again, the risk that the rich receive more
Menghaney reiterated his request for a patent exemption to waive intellectual property rights so that countries around the world can produce versions of the drug, which could save many more lives.
Early in the pandemic, activists lobbied for an exemption for covid-19 vaccines, but the request was blocked by a small number of governments, including the UK.
Cohen said that healthcare tools and technologies should be treated as a public good, and that the situation raised questions about how we can ensure those benefits are shared equitably.
"We are concerned that this could lead to a kind of therapeutic nationalism," he said.
"What concerns us most, however, is that equitable access to antivirals can be especially difficult in low- and middle-income countries."
Senanayake said that, once again, there is a risk that the richest countries will receive more than their fair share.
"With covid, you have to be selfless to be selfish," he said.
"Otherwise, if you protect your little cocoon, your little country, and if it replicates in other countries, a new variant may emerge that escapes the vaccine."
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