Novavax delays U.S. trial of COVID-19 vaccine to November

FILE PHOTO: A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic

(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

Source Article