UK Gives the Final OK for Novavax Covid Shot

04.02.2022 - February kicked off with a major publicity coup for US vaccine maker Novavax, based in the state of Maryland. Its Covid-19 vaccine was granted conditional marketing authorization in the UK, Germany’s vaccine advisory panel recommended its use and the company officially filed with the FDA for emergency use authorization.

The UK’s independent medicines regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), has awarded conditional marketing authorization (CMA) to Novavax for its Nuvaxovid-branded Covid-19 vaccine. In reaching its decision, the regulator said it considered the results of two large clinical trials involving nearly 50,000 participants.

The shot is the fifth to be authorized by the country, which also has granted the same status to Pfizer-BioNTech’s Comirnaty, Moderna’s Spikevax (both mRNA-based) and the viral vector vaccines of AstraZeneca (Vaxzevria) and Johnson & Johnson’s Janssen subsidiary.

MHRA’s approval covers the use of the vaccine in people aged 18 and older for a first and second dose. As with all vaccines registered in the UK, those with an allergy to one of the components will not receive the vaccine.

In a subsequent step, the country’s independent Joint Committee on Immunisation and Vaccination will be tasked with approving the jab for use within the UK Covid-19 vaccination program. The MHRA’s go-ahead does not cover residents of Northern Ireland, who fall under the European Medicines Agency’s (EMA) conditional marketing authorization granted in December 2021.

German Advisory Panel Recommends Nuavoxid

While the EMA’s nod governs use in all 27member states, it is up to individual governments to authorize and organize vaccination campaigns. On Feb. 3, Germany's immunization advisory panel, STIKO, recommended Nuvaxovid to be administered as part of a two-dose regime for people over 18. It also advised recipients of this shot to get an mRNA vaccine as a booster. The first Novavax doses are due to arrive in mid-March, with altogether 34 million to be deployed this year.

Officials in both Britain and the EU hope that the arrival of Nuavoxid will encourage people who fear that the mRNA technology is too new to get vaccinated. Recombinant protein-type vaccines are already in use against hepatitis B and the human papillomavirus behind cervical cancer, they note.

Novavax Officially Files for EUA in US

At the beginning of February, Novavax, based in Gaithersburg, formally filed with the US Food and Drug Administration (FDA) for an Emergency Application (EUA) for Nuavoxid. The biotech submitted the necessary paperwork just ahead of its self-set end-of-2021 deadline.

Author: Dede Williams, Freelance Journalist