European Regulator Starts Assessing Novavax’s Covid Vaccine—Stock Jumps 8%; Green Light Could Come "Within Weeks"

Forbes ^ | 11/17/2021 | Robert Hart

[SeekAndFind]

Europe’s medicines regulator said Wednesday it could greenlight Novavax’s Covid-19 vaccine “within weeks” if data provided is able to demonstrate the shot’s efficacy and safety, a major boon for the Maryland-based biotech, which has been plagued with manufacturing difficulties and until November had not managed to bring a vaccine to market in its 34-year history.

KEY BACKGROUND

While Novavax may be late to arrive, the shot has a number of advantages over existing vaccines and has the potential to dramatically boost vaccination rates worldwide. It appears to have an impressive efficacy on par with mRNA vaccines from the likes of Moderna and Pfizer and, unlike those vaccines, can be stored and shipped at normal refrigeration temperatures. The shot uses a protein that contains part of the coronavirus to stimulate an immune response, an older design—shots now available in the U.S. rely on newer mRNA or viral-vector technologies—that some vaccine-hesitant individuals might be more comfortable with. Despite bringing no vaccine to market in its 34-year history, the U.S. government invested $1.6 billion in the company as part of Operation Warp Speed, more than any other vaccine maker at the time. Despite some successes in having regulators clear the shot pressure is rising as Novavax faces growing delays and manufacturing issues, many of which have been promised to low- and middle-income countries.

WHAT TO WATCH FOR

Novavax says it anticipates filing with the Food and Drug Administration (FDA) by the end of the year and is prioritizing clearance in less affluent countries left behind in the rollout of other vaccines. If endorsed by the FDA, it will represent a major milestone for the company and an important seal of approval for the vaccine from a widely respected regulator.

[SeekAndFind]

The company has already filed for emergency authorization in India, the World Health Organization, Canada, the U.K. and Australia.

[ClearCase_guy]

I remember when it took more than “weeks” to get a new medicine approved.

[rolling_stone]

yeah but now they grease the skids or palms and voila...

[Harmless Teddy Bear]

And I am not taking this one either.

[ClearCase_guy]

Maybe it’s too bad that some of the Regulators aren’t grown up Thalidomide babies — no palms to grease.

[SeekAndFind]

SOME Q&A about the Novavax Covid vaccine:

SOURCE:

https://www.mercurynews.com/2021/11/15/novavax-coronavirus-vaccine-when-can-i-get-it-and-how-does-it-work/

Q: When can I get a Novavax coronavirus vaccine?

A: The vaccine, called NVX-CoV2373, is not currently available in the United States. The company expects to submit data to the Food and Drug Administration by the end of the year. Once authorization is requested, a rigorous review process will take place before the shot is cleared for use in the general public.

Q: What makes this coronavirus vaccine different from the ones we already have?

A: The Novavax vaccine is protein-based and uses the same platform as shots for shingles and hepatitis. The proteins deliver immune stimulation directly into a person’s cells as opposed to a fragment of genetic code. It is not an mRNA as is the case with Moderna and Pfizer, or an adenovirus vector, such as the Johnson & Johnson vax.

Q: How does it work?

A: The Novavax coronavirus vaccine is engineered from the genetic sequence of coronavirus with nanoparticle technology. The technology binds with human receptors targeted by virus which is critical for effective protection. When the vaccine is injected, it stimulates the immune system to produce antibodies.

Q: Is it safe and effective?

A: Clinical trials for the Novavax shot have shown an overall 90% efficacy against coronavirus and 100% protection against moderate and severe disease. Most common side effects include injection site pain and tenderness, fatigue, headache and muscle pain. No single adverse reaction was reported by more than 1% of trial participants.

Q: Can foreign travelers show proof of the Novavax vaccine to enter the United States?

A: Yes. Novavax clinical trial participants from sites outside the U.S. are considered fully vaccinated if they received the same product that was administered in the U.S. clinical trials. It is one of the vaccines already approved by the Centers for Disease Control and Prevention for air travel in the U.S., giving the 30,000 in the trial for the jab a passport to move around, whereas other shots haven’t made the cut.

Q: Could children get this vaccine?

A: The vaccine is not yet authorized for use in the United States, but Novavax initiated a pediatric expansion of a phase 3 clinical trial in May 2021 for children ages 12-17. The company intends to pursue authorization in that age group and younger age groups.

Q: How is it administered?

A: Two doses are given three weeks apart.

[rolling_stone]

excellent point!