U.K. Drug Regulator Approves Novavax Covid-19 Shot

(Bloomberg) --

Novavax Inc.'s Covid-19 vaccine, a protein-based shot, won clearance from U.K. regulators, providing another weapon to fight the disease.

The Medicines and Healthcare Products Regulatory Agency said nuvaxovid, as the shot is known, will be the fifth Covid vaccine authorized for use in Britain, in a statement Thursday. It has been approved for people aged 18 and over for a first and second dose.

U.K. Health Secretary Sajid Javid said the next step will be for the Independent Joint Committee on Immunisation and Vaccination, the government's advisory panel on inoculations, to consider its use as part of the country's Covid vaccination program.

Novavax's shares rose 2.9% in premarket trading in the U.S.

Gaithersburg, Maryland-based Novavax's vaccine mimics the coronavirus's spike protein, sparking an immune response that prepares the body for a real infection. It requires two doses three weeks apart and can be stored at refrigerator temperatures, making it easier to transport than some messenger RNA shots.

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.

The MHRA said in reaching its decision it considered the results of two large clinical trials involving nearly 50,000 participants from the U.K., the U.S. and Mexico.

News of the approval comes a few hours after German vaccine authority Stiko also recommended Novavax's shot for immunization of people aged 18 and over. The European Union's drug regulator granted conditional authorization at the end of last year.

On Monday, Novavax; which secured some of the largest funding from the U.S. government in the early stages of the pandemic, submitted a request to the FDA for emergency use authorization of its vaccine. It said that results from its two large clinical trials had demonstrated an overall efficacy of about 90% and a “reassuring safety profile.”

Despite early funding help from the U.S. government, Novavax has lagged in the commercial development of a shot compared to rivals such as Pfizer Inc. and Moderna Inc.

Progress was slowed by manufacturing problems but the company has since secured a number of large advance purchase orders with various countries, including the U.K.