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Novavax delays US COVID-19 vaccine trial again, now sees start in the coming weeks

It is the second time that Novavax, which already has a late-stage UK trial underway, has rescheduled the Phase 3 trial after first flagging an October start, hampered by issues in scaling up its manufacturing.

November 30, 2020 / 08:09 PM IST

Vaccine maker Novavax Inc said on Monday it has pushed back the start of a US - based, late-stage trial for its experimental COVID-19 vaccine and now expects it to begin in the coming weeks instead of November.

It is the second time that Novavax, which already has a late-stage UK trial underway, has rescheduled the Phase 3 trial after first flagging an October start, hampered by issues in scaling up its manufacturing.

Novavax plans to use vaccine material produced at commercial scale for the trial in the United States and Mexico and has been working closely with the US Food and Drug Administration to greenlight the use of the vaccine made at a North Carolina plant.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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The company also said it has completed enrollment for its 15,000 participant UK trial and expects interim data as soon as the first quarter of 2021.

It has previously said that the UK trial could be the basis for some global regulatory approvals.

More than 25 percent of enrollees in the UK trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

Novavax is also running a fully enrolled Phase 2b trial in South Africa, which has 4,400 volunteers including 245 who are medically stable, HIV positive participants. Efficacy data from that trial could also be available in the first quarter of next year.

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Reuters
first published: Nov 30, 2020 06:15 pm

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