Britain on Thursday (Feb 3) approved Novavax's two-dose COVID-19 vaccine for use in adults, bringing a fifth coronavirus shot to the country amid the rapid spread of the Omicron variant that has led to a spike in cases.
The vaccine, Nuvaxovid, was approved for use in Britons aged 18 years and older as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement.
The British approval comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a European approval in December which was also delayed.
The first shots, which will be made by Serum Institute of India, will not be shipped until March, Silvia Taylor, head of corporate affairs at Novavax, said in a briefing.
She did not give details on volumes.
British authorities and Novavax had in 2020 agreed to a supply of 60 million doses of the shot, while also agreeing to collaborate on late-stage trials for the vaccine in the country.
The US company started shipping doses to the European Union in January, with 27 million expected to arrive in the first quarter and 42 million in the second, Taylor said.
Novavax's Nasdaq-listed shares were 0.7 per cent lower at 1608 GMT.
Its vaccine in June was found to be more than 90 per cent effective in a US trial against a variety of variants, including Delta, while early data from December also suggested it would work against the Omicron variant.
"It is great to see our ... medicines regulator approve another COVID-19 vaccine ... The next step will be for the independent Joint Committee on Immunisation and Vaccination to consider its use as part of the UK COVID-19 vaccination programme," Health Secretary Sajid Javid said in a statement.
Novavax's protein-based vaccine uses a different technology from currently approved vaccines and gives Britain another option. Protein-based vaccines have been used for many years to prevent illnesses, including Hepatitis B.
"We suspect that those who haven't been vaccinated yet may be now more inclined to be vaccinated (with a traditional vaccine such as Novavax's)," said Paul Heath, leader of the UK trial and professor of paediatric infectious diseases at the University of London.
"There will ultimately be a role for this (vaccine) as a booster," he said. The shot has not been approved as a booster.
"We are continuing our vital safety work in monitoring the use of all COVID-19 vaccines, to ensure that their benefits in protecting people against COVID-19 disease continue to outweigh any risks," MHRA Chief Executive June Raine said.
Vaccines from AstraZeneca-Oxford, Pfizer-BioNTech, Moderna and Johnson & Johnson have already been approved for use in Britain.
The country currently has the seventh-highest tally of COVID-19 cases, according to Reuters, and government data showed it reported 88,171 new cases on Thursday.