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It has been announced that a new medicine, Evusheld (tixagevimab/cilgavimab), has today been authorised for COVID-19 prevention by the Medicines and Healthcare products Regulatory Agency (MHRA).
Prof Hugh Montgomery, UCL Professor of Intensive Care Medicine, UCL, said:
“Sensible behaviours combined with vaccination offer excellent protection from severe illness for most of the UK population. But, for some, our new freedoms impose a prison sentence: they do not mount adequate antibody responses to vaccines, meaning that they are more vulnerable to SARS-CoV-2 infection and also to more serious consequences of it. For them, one option is to receive the antibody – here, simply through an intramuscular injection. Side effects seem mild and few, and protection long-lasting (the antibodies have been engineered to last for months, compared to native antibodies which may have a half-life of only 26 days or so). So this is good news for all those patients, if the antibodies can be made available in the UK now that it has been approved for use.”
Prof Penny Ward, Independent Pharmaceutical Physician, and Visiting Professor in Pharmaceutical Medicine at King’s College London, said:
“Evusheld is a combination of two monoclonal antibodies – tixagevimab and cilgavimab – which is given as two intramuscular (IM) injections and thus can be given in a GP surgery/in the community rather than, as for other monoclonal antibodies, needing to be given by IV infusion. Evusheld has been investigated in three clinical trials, a study called PROVENT in which it was given to adults for ‘pre exposure’ prevention in which adults that had not had and were not in contact with a COVID case were given the medicine and then followed up for 6 -12 months to understand how successful the treatment was in preventing infection and COVID illness compared to a control group that received a placebo; a study called STORM-CHASER in which it was given to adults within 8 days of their being in close contact with an individual with COVID (post exposure prophylaxis) and lastly a study called TACKLE in which it was given within 7 days of first onset of symptoms to people with COVID. Today’s MHRA approval follows emergency use approval of this medicine for the pre-exposure prevention of COVID in adults who are unlikely to have responded adequately to vaccination. This group includes adults being treated for cancer, who have had a transplant and are taking immune suppressing drugs to prevent rejection of the transplant, and people taking immune suppressing treatments for other diseases such as rheumatoid arthritis, systemic lupus erythematosus and multiple sclerosis. Individuals like this may not have been able to mount an effective vaccine response and remain at risk of infection and more severe illness if they become infected. Data presented in the FDAs summary basis of approval for the emergency use authorisation (Emergency Use Authorization (EUA) for EVUSHELD (tixagevimab co-packaged with cilgavimab) (fda.gov)) showed that Evusheld reduces the number of people developing COVID by at least 77% and also reduced all-cause mortality during the period of follow up.
“This treatment could therefore be a good way to protect patients who are not able to respond normally to vaccination and allow this group to be able to return to a more normal life than they are currently able to enjoy. Many of these folks are continuing to shield while COVID is still circulating in the community and this agent could help them feel more confident to return to a more normal life.
“The MHRA comment that there is no current clinical data on Omicron but the MHRA has advised, as has the FDA, a higher dose of the product (600 rather than 300mg) may prevent illness caused by the omicron variant, based on the concentrations needed to neutralise this variant in vitro.
“Regrettably, none of the ongoing clinical trial data have yet been published but based on the information in the FDA summary approval report, the product looks likely to be reasonably well tolerated with injection site reactions being the most likely adverse effect. A slightly higher risk of cardiac events was seen in the Evusheld recipients than in the placebo group. The frequency of these events is very low and might have been due to chance but doctors will need to consider this prior to treating patients with severe existing heart disease (see Emergency Use Authorization (EUA) for EVUSHELD (tixagevimab co-packaged with cilgavimab) (fda.gov)).
“So in summary a good day for the immune-compromised who can at last access a product which may offer them the protection the rest of us have been enjoying post vaccination. Let us hope the NHS has ordered enough to offer this to all that can benefit.”
Prof Paul Moss, Chief Investigator of the UK-Coronavirus Immunology Consortium and Chronic Lymphocytic Leukaemia-Vaccine Response (CLL-VR) Study, said:
“It is excellent to hear that the MHRA has given approval for Evusheld for patients with poor immune responses. The clinical data for pre-exposure prophylaxis is strong and this will be a boost for the health and morale of patients. We know that many people with primary or secondary immune deficiency do not make adequate antibody responses after vaccination and this represents a major step forward.”
Prof Alex Richter, Director of the Clinical Immunology Service at University Hospitals Birmingham and member of British Society for Immunology COVID-19 Taskforce, said:
“I am delighted that the Evusheld COVID monoclonal antibody has been approved by the MHRA. We hope this translates quickly into clinical use within the NHS. The safety and effectiveness of Evusheld has been assessed through several clinical trials and it is already in use as an approved therapy in several other countries. There are many patients with immunodeficiency who have not responded to vaccination and so remain vulnerable to COVID; using monoclonal antibodies as a preventative treatment will give a lot of hope to these patients as the country opens up from COVID and infection rates are still so high.”
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Prof Hugh Montgomery: “I am International Coordinator of the TACKLE trial, and am paid by AZ in that capacity.”
Prof Alex Richter: “No conflicts to declare.”
None others received.