To ask the Secretary of State for Health and Social Care, what plans his Department has to make available in winter 2021-22 novel options for covid-19 prophylaxis, such as antivirals or monoclonal antibodies, to people who are immunocompromised or immunosuppressed, and have not had an adequate immune response following three doses of a covid-19 vaccine.
15 November 2021
Ronapreve is the first neutralising monoclonal antibody to receive marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat and prevent COVID-19. The interim clinical policy was updated on 4 November to expand treatment access to a wider group of hospitalised patients, which may include immunocompromised patients.
This is the only neutralising antibody product currently that has evidence of efficacy in hospitalised patients. The clinical policy prioritises the most vulnerable patients for whom this treatment will have the largest benefit. Other antibody products are expected to undergo regulatory review, which, if approved, could be available to other patient groups.
On 20 October 2021 we announced that the Government had secured two COVID-19 oral antiviral treatments for UK patients. Molnupiravir (Lagevrio), one of the antivirals procured, has now received MHRA authorisation. The use of the second antiviral, PF-07321332 (Paxlovid), will depend on approval from the MHRA.
The Government intends to deploy antivirals initially through a national study that will prioritise those who are at most risk to COVID-19, including those who are immunocompromised, and help identify those who will benefit most from treatment. The Department will provide more information on the national study, including detail on eligibility, in due course.
The RAPID C-19 collaboration enables active multi-agency oversight of national and international trial evidence as it emerges for COVID therapies, for both treatment and prophylactic indications. To date, the evidence has most strongly supported treatment indications, but the evidence around prophylactic use will continue to be actively reviewed.