Nuvaxovid, developed by Novavax, has been approved by the MHRA for use in adults aged 18 and over for a first and second dose. The vaccine contains purified SARS-CoV-2 spike protein - produced using recombinant DNA technology - combined with a saponin-based adjuvant.
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In August 2020, the government announced an agreement to buy 60 million doses of the jab. It was originally thought these would be made at a plant in Stockton-on-Tees, but Novavax has now said initial doses will be shipped from the Serum Institute in India.
Nuvaxovid was shown to be 89.7% effective in preventing symptomatic COVID-19 in a randomised, placebo-controlled UK trial in 14,039 people, conducted before the emergence of the Delta and Omicron variants. In December, Novavax said two doses were also effective in generating an immune response against the Omicron variant.
The jab's efficacy was also demonstrated in another ongoing pivotal trial in approximately 30,000 people in the US and Mexico. In both trials the vaccine had an acceptable safety profile.
With its MHRA approval Nuvaxovid joins the widely used COVID vaccines Comirnaty (Pfizer), Vaxzevria (AstraZeneca) and Spikevax (Moderna), and a single-dose vaccine developed by Janssen which has yet to be made available. As a protein-based vaccine, Nuvaxovid is simpler to produce than some other vaccines and can be stored in a refrigerator at 2–8° for up to 9 months.
Professor Sir Munir Pirmohamed, Chair of the independent Commission on Human Medicines, said: 'The independent Commission on Human Medicines and its COVID-19 Expert Working Group has carefully considered the available evidence on safety, quality and effectiveness. We are pleased to say that we have advised that the benefit risk balance of Nuvaxovid is positive.
'Nuvaxovid is distinct from other COVID-19 vaccines currently in use in the UK as it uses recombinant protein-based technology which has been used for many years in the development of vaccines to prevent other illnesses, for example hepatitis B. In reaching its decision, the MHRA considered the results of 2 large clinical trials involving nearly 50,000 participants.'
Nuvaxovid will be added to MIMS as and when it becomes available in the UK.