Britain on Thursday approved Novavax's two-dose COVID-19 vaccine for use in adults, bringing a fifth coronavirus shot to the country amidst 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 authorization of the vaccine following months of struggles with development and manufacturing problems, and follows a European approval in December which was also delayed.
Novavax's Nasdaq-listed shares reversed course and turned positive to trade 1% higher at $90.33 in premarket trading by 1403 GMT.
British authorities and Novavax did not give a timeline for the first deliveries of the vaccine. They 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.
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Novavax's vaccine in June was found to be more than 90% effective in a US trial against a variety of variants, including Delta, while early data from December also suggests 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 in a statement said it will work closely with British authorities and the Vaccine Task Force to expedite deliveries.
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 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 the country.
The United Kingdom currently has the seventh-highest tally of overall COVID-19 cases, according to Reuters, and government data showed it reported 112,458 new cases of COVID-19 on Tuesday https://www.reuters.com/world/uk/britain-reports-112458-new-covid-19-cases-219-deaths-2022-02-01.
Reuters
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