US FDA endorses Novavax’s protein-based Covid shot

New York, June 8 (IANS) The US Food and Drug administration’s (FDA) advisory committee has recommended that regulators authorise Novavax’s protein-based Covid shot.

The FDA’s Vaccines and Related Biological Products Advisory Committee met on Tuesday to consider whether the Novavax vaccine should be authorised. The committee’s 22 voting members nearly unanimously endorsed Novavax’s shot, with 21 votes in favour of authorisation and one abstention.

“We speak to make available another option for those who might not otherwise take a vaccine,” Dr Peter Marks, the FDA’s top vaccine official said, in comments to the committee before its vote.

“We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do,” The New York Times quoted Marks as saying.

The FDA had earlier shown concerns regarding the vaccine’s risk of myocarditis and pericarditis.

But clinical trials of the vaccine NVX-CoV2373 has shown the jab to be 90 per cent effective against Covid. However, Novavax is not alone. Covid vaccines developed by Pfizer and Moderna have also shown risk of heart inflammation, while Johnson and Johnson’s shots have been linked with blood clots.

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. It contains purified protein antigen and can neither replicate, nor can it cause Covid-19.

After the FDA approves, the Centers for Disease Control and Prevention must also approve the shots before they could become available. If approved by both agencies, it will become the fourth Covid vaccine after Pfizer, Moderna, and Johnson and Johnson.

“The advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based Covid-19 vaccine developed using an innovative approach to traditional vaccine technology,” said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a statement.

Meanwhile, Novavax plans to also seek FDA authorisation for shots in adolescents and children. The vaccine is already authorised for adolescents in India and Thailand.

The company also plans to seek authorisation for its vaccine as a Covid booster. The company has run trials showing that a booster produces a large increase in antibodies. Last week, the company also began a trial in Australia to test a booster tailored specifically for the Omicron variant, which has become dominant worldwide, the NYT report said.