Novavax seeks FDA emergency approval for its coronavirus vaccine

The request is based on data that includes the results of two large clinical studies that showed a total effect of around 90% and a “reassuring safety profile”, according to the company.

“We believe our vaccine offers a differentiated alternative built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help combat the COVID-19 pandemic,” said Stanley Erck, Novavax’s president and CEO. , said in the announcement Monday.
Novavax announced in June that their vaccine candidate was found to have a total efficacy of 90.4% in a Phase 3 study conducted across the United States and Mexico; the trial took place before the Omicron variant dominated in the United States.
The vaccine can be stored at normal cooling temperatures, between 2 and 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), and has a shelf life of about nine months, according to the company. Erck told CNN in November that if the FDA gives the green light to the EUA, the first 100 million doses of the protein-based vaccine will be ready to be sent.

Novavax’s vaccine – administered as two doses three weeks apart – is made using small, laboratory-built parts of the coronavirus to stimulate immunity, a more traditional approach to vaccine development that some people may be more familiar with or comfortable with, compared to mRNA. the vaccines made by Moderna and Pfizer / BioNTech.

“In the United States, I think the primary market in 2022 will be to deliver a vaccine, our usual two-dose regimen, to many people who have been hesitant to get other vaccines,” Erck said in November. “And to give a booster.”

Novavax’s coronavirus vaccine relies on recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response and high levels of neutralizing antibodies.

When the genetic sequence of the coronavirus was first published, Novavax researchers identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells – specifically cells from the autumn armyworm – with that virus, which caused them to produce the nail protein from the coronavirus.

These virus-like nanoparticles were harvested to make Novavax’s vaccine.

The FDA has authorized vaccines made by Pfizer, Moderna and Johnson & Johnson for emergency use in the United States. The Pfizer vaccine is now approved for use in people 16 years and older, and the Moderna vaccine is approved for adults 18 years and older.

In 2020, Novavax, based in Maryland, received a $ 1.6 billion contract from the US government to develop the vaccine.
In November, Indonesia became the first country to grant emergency use approval of Novavax’s vaccine. Since then, the South Korean Ministry of Food and Drug Safety has approved the vaccine, the Australian Therapeutic Goods Administration has given approval for preliminary registration, and the Drug Controller General of India has given emergency use approval. The European Union and the Philippines have also approved it.

Novavax has applied for authorization in several other countries, including the United Kingdom, Canada and New Zealand.

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