NOVAVAX CORONAVIRUS VACCINE ENTERS LATE-STAGE TRIALS IN THE UK

 Evening Standard 25 September 2020 - by David Child

© Provided by Evening Standard

US biotechnology firm Novavax has announced it is starting its Phase 3 trial of an experimental Covid-19 vaccine in the UK.

Up to 10,000 volunteers aged between 18 and 84 will be enrolled for the study, which is set to take place over the next four to six weeks and marks the final step of the regulatory approvals process.

Half of the volunteers will receive two shots of NVX-CoV2373 with Matrix-M, Novavax's adjuvant, which is meant to strengthen the vaccine. The other participants will be given a placebo.

Up to 400 volunteers will also get a seasonal flu vaccine to measure the potential effectiveness of administering a Covid shot alongside a flu shot.

At least a quarter of those enrolled in the study will be aged over 65, and priority will be given to groups most affected by Covid-19, including racial and ethnic minorities.

Data from the trial will support regulatory submissions for license in the UK, EU and other countries, the company said.

The Novavax candidate is the second vaccine to enter Phase 3 clinical trials in the UK alongside another potential vaccine being developed by Oxford University and British biopharmaceutical firm AstraZeneca.

The move to take the company's candidate to trial comes after the UK Government announced in August that support and infrastructure would be given to Novavax during its Phase 3 study.

This includes plans to manufacture the vaccine in the UK and the promise of 60 million doses if the vaccine proves safe and effective.

Novavax said it could produce up to 2 billion annualised doses, once all capacity is brought online by mid-2021.

Gregory M Glenn, president of research and development at Novavax, said the team was "optimistic" that the trial would "provide a near-term view" of the candidate's efficacy.

The vaccine candidate produced high levels of antibodies against coronavirus in a small, early-stage clinical trial earlier this year.

"We are grateful for the support of the UK government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research," Mr Glenn said.

The UK now has access to six different Covid-19 vaccine candidates in development, across four different types, representing more than 340 million doses.

Priority groups such as frontline health workers, those with serious diseases, the elderly and ethnic minorities are first in line to receive a jab, should a vaccine be approved.

The UK recorded its highest number of daily cases of Covid-19 on Thursday at 6,634, reflecting a second wave of infections sweeping through the country but also a much higher level of testing than during the first wave.