(Adds expert comment)
By Manas Mishra and Julie Steenhuysen
Oct 27 (Reuters) - Novavax Inc on Tuesday delayed
the start of a late-stage U.S. trial of its experimental
coronavirus vaccine by roughly a month to the end of November,
citing delays in scaling up the manufacturing process.
The U.S.-based drug developer said data from a separate
Phase III trial being conducted in Britain was expected by the
first quarter of 2021 and could be the basis for global
regulatory approvals although it did not elaborate. Shares of
the company rose nearly 3%.
It is not immediately clear whether that could apply in the
United States. Novavax did not respond to a request for
clarification.
"I think the FDA has generally been loathe to approve
vaccines for Americans that haven't been tested in Americans,
historically," Dr. Paul Offit, an infectious disease expert at
the University of Pennsylvania and a member of the U.S. Food and
Drug Administration's vaccine advisory panel, said on in an
interview with the editor of JAMA medical journal on Tuesday.
Data from an early-to-mid stage trial of the vaccine is
expected on Friday, the company said. Earlier data had showed
the vaccine produced high levels of antibodies against the novel
coronavirus.
A handful of companies, including larger rivals Pfizer Inc
and AstraZeneca Plc, are conducting late-stage
trials of their experimental COVID-19 vaccines, though none have
reported pivotal data that would be used to seek emergency
authorization or approval.
The companies, including Novavax, have already made
distribution deals with several countries for the vaccines, once
approved.
Novavax in August said it will supply 60 million doses of
its coronavirus vaccine to the UK from as early as the first
quarter of 2021.
The company is also preparing to deliver 100 million doses
to the United States by January after it was awarded $1.6
billion for its potential vaccine, and has also signed supply
agreements with Canada and Japan.
(Reporting by Manas Mishra in Bengaluru and Julie Steenhuysen
in Chicago; Editing by Arun Koyyur and Bill Berkrot)
Astrazeneca (AZN)
