* Approved for use in 18 year olds and older
* Agreement in place for supply of 60 mln doses
* Novavax shares turn positive in premarket trading
(Adds Novavax statement, shares, detail, background)
By Pushkala Aripaka
Feb 3 (Reuters) - Britain has approved Novavax's
COVID-19 vaccine for use in those 18 years of age and older, the
country's medicines regulator said on Thursday, bringing a fifth
coronavirus shot to its roster amidst the rapid spread of the
Omicron variant.
The vaccine, Nuvaxovid, was approved as a first and second
dose as it met the required safety, quality and effectiveness
standards, the UK's Medicines and Healthcare products Regulatory
Agency (MHRA) said https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra
in a statement.
The British approval for Nuvaxovid comes days after the
drugmaker filed for U.S. authorization https://www.reuters.com/world/us/novavax-files-us-authorization-covid-19-vaccine-2022-01-31
of the vaccine following months of struggles with development
and manufacturing problems, and follows a German backing
earlier in the day.
Novavax's Nasdaq-listed shares reversed course to trade 3.7%
higher at $92.76 in premarket trading by 1146 GMT.
"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.
"Nuvaxovid will be the first protein-based vaccine option
authorized by MHRA as the United Kingdom tackles this next phase
of the pandemic," Novavax Chief Executive Stanley Erck said in a
statement.
Novavax's vaccine last June was found to be more than 90%
effective in a U.S. trial against a variety of variants,
including Delta, while early data from December also suggests it
would work against Omicron.
Britain and Novavax in 2020 agreed https://www.reuters.com/article/us-health-coronavirus-novavax-britain-idUSKCN25A0HG
for the supply of 60 million doses of the shot, while also
agreeing to collaborate on conducting late-stage trials for the
vaccine in the country.
Following the approval by the MHRA, the Joint Committee on
Immunisation and Vaccination will release guidelines for the use
of the vaccine in Britain's COVID-19 vaccination programme.
(Reporting by Pushkala Aripaka in Bengaluru; Additional
reporting by Manas Mishra; Editing by Aditya Soni and David
Evans)