|
 The study of nearly 30,000 volunteers in the United States and
Mexico puts Novavax on track to file for emergency authorization in
the United States and elsewhere in the third quarter of 2021, the
company said.
Novavax's protein-based COVID-19 vaccine candidate was more than 93%
effective against the predominant variants of COVID-19 that have
been of concern among scientists and public health officials,
Novavax said.
Protein-based vaccines are a conventional approach that use purified
pieces of the virus to spur an immune response and vaccines again
whooping cough and shingles employ this approach.
During the trial, the B.1.1.7 variant first discovered in the United
Kingdom became the most common variant in the United States, it
said.
Novavax also detected variants of COVID-19 first found in Brazil,
South Africa and India among its trial participants, Novavax's head
of research and development, Dr. Gregory Glenn, told Reuters.
The vaccine was 91% effective among volunteers at high risk of
severe infection and 100% effective in preventing moderate and
severe cases of COVID-19. It was roughly 70% effective against
COVID-19 variants that Novavax was unable to identify, Glenn said.
"Practically speaking, it's very important that the vaccine can
protect against a virus that is wildly swinging around" in terms of
new variants, Glenn said.
[to top of second column] |
 Novavax said the vaccine was
generally well tolerated among participants.
Side effects included headache, fatigue and
muscle pain and were generally mild. A small
number of participants experienced side effects
described as severe.
Novavax remains on track to produce 100 million
doses per month by the end of the third quarter
of 2021 and 150 million doses per month in the
fourth quarter of 2021, the company said.
The Maryland-based company has repeatedly pushed
back production forecasts and has struggled to
access raw materials and equipment needed to
make its vaccine. However, in a
May investor call, Chief Executive Stanley Erck said major
manufacturing hurdles have been cleared and that all of its
facilities can now produce COVID-19 vaccine at commercial scale.
Erck said that Novavax has begun its regulatory filing in India in
partnership with the Serum Institute of India, which is contracted
to make Novavax shots.
Erck said his understanding is that SII is no longer constrained by
raw materials shortages.
SII had said in March that U.S. restrictions on exports of supplies
used for vaccines were limiting its ability to scale up production.
(Reporting by Carl O'Donnell; Editing by Lisa Shumaker)
[© 2021 Thomson Reuters. All rights
reserved.] Copyright 2021 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content |
