Posted on 08/16/2021 8:54:27 PM PDT by SeekAndFind
Novavax has enlisted a pair of industry heavyweights on the quest to push its recombinant COVID-19 vaccine hopeful across the finish line.
The biotech’s new senior vice president of quality assurance, Nasir Egal, Ph.D., hails from Sanofi, while Jim Kelly, Novavax’s new chief financial officer and treasurer, joins from Supernus Pharmaceuticals. Novavax will channel the execs’ quality and commercial know-how toward its experimental COVID-19 vaccine NVX-CoV2373, which it plans to file for an emergency use authorization (EUA) in the U.S. in the fourth quarter.
The news comes after Novavax reported series of vaccine manufacturing and supply issues this year, which forced it to delay its FDA filing timeline from May to July, and then into the final three months of the year.
Egal spent nearly 10 years at Sanofi, working up to the role of head of global quality external affairs. Before Sanofi, he worked in global and regional quality and compliance at pharma heavyweights Novartis and Merck & Co. He’s also served at the U.S. Food and Drug Administration as a research scientist, Novavax said.
For his part, Kelly served as CFO Supernus and had a ten-year run as Vanda Pharmaceuticals’ CFO and treasurer before that. His resume also includes financial roles at Biogen and MedImmune.
Novavax will count on Kelly’s financial and strategic expertise as it “quickly matures into a global commercial company,” Novavax CEO Stanley Erck said in a statement. The biotech, which formed in 1987, has never brought a vaccine to market.
Throughout 2020, Novavax’s shot ranked among the big five expected to comprise the United States' vaccine response in 2021 alongside shots from Pfizer, Moderna, Johnson & Johnson and AstraZeneca. Pfizer and Moderna were the first to win U.S. emergency nods with their mRNA vaccines, followed by Johnson & Johnson with its single-dose prophylactic. AstraZeneca’s shot has not been authorized stateside.
But Novavax’s shot hasn’t had the easiest path to a filing. While the vaccine recently posted 90.4% efficacy in a pivotal phase 3, putting it in a similar league to Pfizer and Moderna’s vaccines, Novavax has stumbled on manufacturing.
The biotech had originally hoped to apply for an EUA in the second quarter, but in May, Novavax said it would push back filings in the U.K., U.S. and European Union into the third quarter. At the time, the company flagged production issues related to an assay needed to prove cross-site manufacturing consistency data to regulators. The company has also had trouble sourcing raw materials like bioreactor bags, depth filters and growth media, though a company spokesperson told Fierce Pharma in late July that those problems have “generally been resolved.”
In an August regulatory filing, Novavax disclosed another delay, stating that the U.S. wanted it to work with the FDA on issues related to analytic methods before advancing additional U.S. manufacturing. “We’re talking weeks here, we’re not talking months,” Novavax CEO Stanley Erck said on an analyst call at the time.
Meanwhile, Novavax recently finalized a deal to sell the European Commission 200 million doses of its vaccine. Under the deal, Novavax is on deck to supply 100 million doses, plus an option for 100 million more, through 2023. It says it aims to complete its rolling submission to the European Medicines Agency in the third quarter.
Elsewhere, Novavax has pledged 100 million doses to the U.S. and 1.1 billion doses to low- and middle-income countries.
I’m hoping for this one, especially for my teen who is still unvaccinated. It seems like a more traditional vaccine, like the MMR and other vaccines she’s had.
Latest development for Novavax:
* It has submitted an emergency use authorization (EUA) application for India, the world’s second-most populous country after China.
* It has also submitted a EUA with Indonesia and the Philippines. Together with India, it forms more than 20% of the global population.
* It has also submitted an emergency use listing application with the World Health Organization. That effectively opens the door for sales to several developing nations, representing roughly 70% of the global population.
* The company’s Booster Development Program has reported stellar results, and it should be ready to ship its Covid-19 vaccine this month.
* Novavax has more than 100 million doses in its inventory that is ready for distribution. On top of that, it collected $1.1 billion in advance payments and is now sitting on a $2.1 billion cash pile.
Its competitive position will depend a lot on its manufacturing ability.
Emergency authorization
We all know what that means
Gun to my head, I have to take one, let it be not one of the mRNA vaccines.
Same here. If it has to be taken i want it to be Novavax.
Agreed. If I have to take one it will be this, but it will be a last resort. I’d rather not take any of them.
the more I read about coronaviruses and ADE, the less I see why any of the various vaccines out there are not candidates for ADE issues down the road.
two links with a lot of info on the general coronavirus/ADE topic - the first is more geared toward (literate) laymen.
https://covidwatching.org/a-must-read-covid19-vaccine-a-ticking-time-bomb/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943455/
agreed. if ADE becomes an issue later it is going to be really bad - but at least this avoids the whole other list of issues with the mrna injections.
if the fda sees fit to approve it, that is.
Don’t confuse emergency authorization with approval.
It could be deadly.
ADE risk seems a given.
then ‘everything else specific to this particular product’ risk which of course will be skated around in trial design in order to avoid having to publicly list it, unless there is a fix in to keep novavax off the market here.
ADE-risk alone is a deal-stopper for me as long as I can manage to avoid it.
also, normally NDA or vax approval is a multi-year process with all kinds of testing to try to nail down issues like ADE in vaccines before you start poking humans with them.
Full approval for these products next month is meaningless. they have avoided compiling data on obvious areas of concern based on the (japanese-released) animal models from pfizer, which only could have happened with active direction FROM the FDA. they are years short of critical data. we are not even past a phase I imo.
ping
ADE hasn’t been seen with SARS-CoV-2 at all.
All the research on SARS-CoV-1 (SARS2003) and MERS-CoV (MERS2012) suggests the N (nucleocapsid) protein is the most likely source for any ADE issues. Vaccination will not produce antibodies to the N protein; only the S protein.
If anybody develops ADE, it’ll be the people who got infected. Thankfully, there has been zero evidence of ANYONE with ADE with COVID-19. Everyone who has been reinfected has shown reduced disease severity, and disease severity is drastically reduced for the vaccinated population over the unvaccinated population. Hence, why nearly everyone hospitalized or dying from COVID-19 is unvaccinated despite 81% of seniors (who are most at risk for severe illness) being fully vaccinated.
So by your tag line, you think we should all just sit down, be quiet and take the jab? Just asking.
No, I think everyone should evaluate the information coming from authoritative sources (i.e. not conspiracy kook websites telling you that 5G towers and dream demons are causing COVID), talk with their doctor, and make the best decision for their own individual medical situation. Someone with a history of anaphylaxis should NOT take the mRNA vaccines as they’re at higher risk of severe reaction to one component within those. Girls and women of reproductive ages should be cautious of the J&J vaccines for clotting risks. And any pro-life person should think about the fact that the J&J and AstraZeneca vaccines made use of fetal stem cells during the R&D, development, and testing. The mRNA vaccines from Pfizer and Moderna did not.
And of course, the Chinese vaccines (all of them) are just as worthless as any red-blooded American should expect. So definitely don’t bother with those. If you want something that works, buy American.
What I do think is that people shouldn’t spread wild myths about vaccines causing autism or having mind control microchips in them or causing magnets to stick or that they’re sterilizing agents or any other complete and utter nonsense. Spreading lies like that spreads fear and robs people of their right to make a rational decision of what’s best for them based on facts; not fear.
historically, how long does ADE take to show up with previous coronavirus vaccine testing?
my undestanding is that there is no fixed time-frame as mutations over time can impact the neutraling antibody efficacy from any targeted vaccine.
https://doctors4covidethics.org/wp-content/uploads/2021/07/Pfizer-pharmacokinetics-and-toxicity.pdf
have you looked over this? what are your thoughts on the animal models in the japanese filing by pfizer?
none of the obvious questions this raised were addressed in the perfunctory trails held prior to EUA
Yep... It's Novavax or the one that's made by used tobacco plants (?) to produce the protein needed to do whatever the heck it is they need... ??
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