UK government orders 730,000 doses of COVID-19 antivirals for this winter

Sajid Javid confirmed that 480,000 doses of molnupiravir and 250,000 doses of PF-07321332/ritonavir have been ordered, even though neither manufacturer has published full clinical trial results.
Health Secretary Sajid Javid

Health secretary Sajid Javid has announced what he called “landmark deals” to secure hundreds of thousands of doses of two antiviral treatments, which have not yet been approved by the medicines regulator.

At a press conference at Downing Street on 20 October 2021, Javid said that he was aiming to deploy these treatments “as quickly as possible” to protect the most vulnerable during the winter months.

The two antivirals ordered by the government are molnupiravir, developed by Merck Sharp and Dohme (MSD) in collaboration with Ridgeback Biotherapeutics (480,000 doses ordered), and PF-07321332/ritonavir, developed by Pfizer (250,000 doses ordered).

Neither manufacturer has published the full results from clinical trials of the drugs as yet, but MSD press released interim trial results in early October 2021.

The results were taken from a planned interim analysis of a global, phase III, randomised controlled trial and showed that 7.3% of patients who received molnupiravir were either hospitalised or had died by day 29 compared with 14.1% of placebo-treated patients.

However, these data have not yet been peer-reviewed and it is not clear yet if molnupiravir or PF-07321332/ritonavir will be approved for use in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

The Pharmaceutical Journal revealed in September 2021 that NHS England had begun working with the government’s Antivirals Taskforce to scope out the deployment of oral antivirals to treat COVID-19 in the community.

The taskforce was established by the Department of Health and Social Care in April 2021 with the aim of identifying at least two effective oral antiviral treatments in 2021 that can be taken at home by individuals who have a positive COVID-19 test, or who have been exposed to someone with the virus.

Eddie Gray, chair of the Antivirals Taskforce, said that the government’s announcement was a “very important development”.

“Should they be approved by the medicines regulator, we could see [antiviral] treatments rolled out to patients this winter, providing them with vital protection.”

Jonathan Van-Tam, deputy chief medical officer for England, added that antivirals will be “particularly vital” in protecting those who may not get the same antibody response to the vaccines as the majority of the population.

“We will now work quickly to ensure the right cohorts of people receive these treatments as soon as possible, should they be approved by the MHRA.”

Siu Ping Lam, director of licensing at the MHRA, said: “As confirmed by MSD, the MHRA is reviewing the antiviral drug, molnupiravir, for the treatment of COVID-19. The review is being done in the shortest time possible under the rolling review process while maintaining our high standards of safety, quality and effectiveness.”  

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Citation
The Pharmaceutical Journal, PJ, October 2021, Vol 307, No 7954;307(7954)::DOI:10.1211/PJ.2021.1.111459

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