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Coronavirus: Gates Foundation invests millions in Covid cure Molnupiravir

By Jaysim Hanspal
Posted on Tuesday, 26 October 2021 12:06

A handout photo of an experimental COVID-19 treatment pill, called molnupiravir and being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP
An experimental Covid-19 treatment pill called Molnupiravir. May 17, 2021. Merck & Co Inc/Handout via REUTERS

The Bill and Melinda Gates Foundation announced it was spending up to $120m to secure a “dedicated, low-cost” supply of the drug Molnupiravir for lower-income countries. The next potential Covid-19 breakthrough, still pending authorisation from bodies like the American FDA, is an oral antiviral that has shown a reduction in hospitalisation and death from Covid-19 by 50%.

Molnupiravir, first created by Emory University’s not-for-profit biotechnology company, targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It works by introducing errors into the genetic code of the virus, like sand in a machine. The drug is now in the hands of American pharmaceutical companies Ridgeback Biotherapeutics and Merck & Co.

In the US, the drug will retail at $700 per treatment – 40 capsules over five days. In an advisory meeting on 30 November, it is expected that the drug will be regulated for ‘emergency use authorisation’ in the US and could be rolled out as soon as December.

‘Easier and cheaper’

Despite concerns over the cost of treatment, Trevor Mundel, president of the Foundation’s Global Health Programmes, tells The Africa Report that the new synthesis supported by the Foundation makes it “easier and cheaper” to make the drug. Mundel says they’re “looking at the single digits” for a full treatment.

The push for Molnupiravir has drawn concerns over potential shortfalls in lower-income countries that may induce similar issues to the COVAX programme, which has proven to be slow and ineffective as wealthier countries stockpile supplies of vaccines.

“We are agnostic about where manufacturing would be in Africa, as the[re] would be confidential discussions between them and Merck…”

Mundel admits that this could be a problem. “Yes, countries might stockpile the drug. We need manufacturing, we need the regulatory systems to approve the drug, and we need health professionals within the countries to get familiar with how to use the drug.”

Production

Merck & Co. intends to supply higher-income countries while the Foundation will look for more “generic manufacturers”. According to Reuters, five Indian companies, including Dr Reddy’s Laboratories, are in the trial stages for the drug in Covid-19 patients with mild symptoms.

According to Mundel, Merck is also considering manufacturers in Africa and the Middle East.  “We are agnostic about where manufacturing would be in Africa, as the[re] would be confidential discussions between them and Merck, although we are encouraging Merck to look at manufacturers in Africa.” Once a rollout is expected on the continent, the African Medical Supply Platform (AMSP) will most likely be distributing the drug.

The Gates Foundation has previously used the AMSP to distribute dexamethasone for more severe Covid-19 patients. Dexamethasone, like Molupiravir, needs to be administered at a specific time to be effective. The drug will be offered to ‘individuals of high-risk’ who get Covid-19.

Concerns of side effects

Mundel says there is also the potential for the drug to be more effective than vaccines against potential new variants. “If there is a new variant that the vaccines would not be effective against, then it’s quite possible that the drug would still be effective.”

There are, however, some potential concerns with the drug’s potential for nutrigenetics or birth defects. In 2003, Gilead Pharmasset Inc, an American pharmaceutical company abandoned the potential use of one of the principal drugs in Molupiravir due to worries about the drug’s harmful effects.

In May 2020, Rich Bright, an American immunologist and vaccine researcher working for the Trump administration, filed a whistleblower complaint following concerns that the government was pushing for new Covid-19 treatments due to political incentives.

In his testimony, ​​Bright said he knew that “similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and parts of their skulls.” At the time, Bright said Emory University had not conducted reproductive studies for toxicity for Molupiravir.

“There’s been a lot of toxicology testing, which the FDA will look at. We’ve seen some of the data, but not all of the data,” says Mundel.

“We need to be cautious, we have investments, and we need pharmacovigilance to be able to detect if there are any problems with the new drug. We need to move with one eye [on] safety, whilst also providing for desperate patients who have no other options.”

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