UK Conditionally Approves Its First Protein-Based COVID-19 Vaccine, From Novavax

A vial of the Phase 3 Novavax COVID-19 vaccine. Alastair Grant/AP Photo

The United Kingdom has conditionally approved its first protein-based COVID-19 vaccine, made by Novavax.

The vaccine, called Nuvaxovid (generic name NVX-CoV2373), is the fifth COVID-19 vaccine authorized by the Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.’s independent medicines regulator.

Other COVID-19 vaccines authorized for use in the U.K. include those from Pfizer/BioNTech, Moderna,  Johnson & Johnson, and Oxford/AstraZeneca.

Nuvaxovid is authorized in the U.K. for people aged 18 and over for a first and second dose.

“It is great to see our world renowned medicines regulator approve another COVID-19 vaccine,” U.K. Health and Social Care Secretary Sajid Javid said in a statement.

“I want the UK to be the best place in the world to conduct clinical trials. It’s a testament to the country’s first-rate research and development capabilities for vaccines—with tens of thousands of people taking part in clinical trials here in the U.K., contributing to the invaluable research that shows our vaccines are safe and effective,” Javid said.

“The next step will be for the independent Joint Committee on Immunisation and Vaccination to consider its use as part of the U.K. COVID-19 vaccination program,” he said.

The meeting will result in a recommendation from the committee as to how or when the vaccine will be deployed. The U.K. previously said it secured at least 60 million doses of the vaccine.

The protein-based vaccine was engineered from the genetic sequence of the first strain of SARS-CoV-2.

Munir Pirmohamed, chair of the Commission on Human Medicines, a committee of the MHRA, said the commission and its COVID-19 expert working group “has carefully considered the available evidence on safety, quality, and effectiveness” and advised that the benefit-risk balance of the vaccine is positive.

“Nuvaxovid is distinct from other COVID-19 vaccines currently in use in the U.K. 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,” he said. “In reaching its decision, the MHRA considered the results of two large clinical trials involving nearly 50,000 participants.”

Both trials were conducted before the emergence of the Omicron variant in November 2021. One trial, the PREVENT-19 trial, involved 30,000 participants in the United States and Mexico, and another trial involved almost 15,000 participants in the United Kingdom. Both trials were published in the New England Journal of Medicine.

“NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies,” the Maryland-based biotechnology company previously said in a statement.

“NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.”

MHRA Chief Executive June Raine said that the agency is continuing to monitor the use of all COVID-19 vaccines in the U.K., including conducting independent batch testing on all the U.K.-approved COVID-19 vaccines for quality control.

Novavax’s COVID-19 vaccine was recently granted conditional authorization by the European Commission and became the 9th COVID-19 vaccine granted emergency use listing by the World Health Organization.