* Approved for use in 18 year olds and above
* Agreement in place for supply of 60 mln doses
* Novavax shares turn positive in premarket trading
(Adds details from statements)
By Pushkala Aripaka
Feb 3 (Reuters) - 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 https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra
in a statement.
The British approval 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 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 https://www.reuters.com/article/us-health-coronavirus-novavax-britain-idUSKCN25A0HG
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.
Novavax's vaccine in 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 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.
(Reporting by Pushkala Aripaka in Bengaluru; Additional
reporting by Manas Mishra; Editing by Aditya Soni, David Evans
and Mark Porter)