Novavax files for vaccine approval…

Has potential to be a very big deal.
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First, some context…

I’ve been reading:

You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation” by Paul A Offit, MD

Dr. Offit, a member of the FDA’s vaccine advisory committee, has been described in The Wall Street Journal as “an outspoken advocate of the science and value of vaccinations,” including the Covid-19 vaccine. WSJ

Offit builds the case that “the first vaccines aren’t always the best, safest, and last”.

For example, Offit recounts the early days of the Salk polio vaccine, which saved lives yet also tragically transmitted the disease to some patients. The Salk vaccines was displaced by the Sabin (sugar cube) vaccine, which was displaced by a refined Salk vaccine, which is the current state-of-medical-art.

Similarly, the first measles vaccine in 1963 caused a high rate of fever and rash and was replaced by a safer, better vaccine in 1968.

And, the first shingles vaccine introduced in 2011 was replaced by a much better one in 2017.

With respect to Covid-19 vaccines, Offit makes 4 major points:

  1. Covid-19 is a novel virus
  2. The (mRNA) vaccines had never before been used against any other virus in history.
  3. The vaccines “had not been subjected to the typical research, development, testing and licensure processes” so longer-term effects weren’t known with any degree of certainty.
  4. Historically, scaling up to mass production of vaccines has had pitfalls, especially “inactivating viruses for mass production”.

Bottom line: Though Offit is pro-vaccine, “his review of the history of vaccination and of its complexities evokes surprising empathy for the vaccine-hesitant.” WSJ

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Let’s connect a dot…

Serendipitously, this Medscape article hit my screen:

image

About the Novavax vaccine:

Novavax produces a recombinant protein subunit vaccine that reconstitutes spike without the need for genetic materials (i.e. DNA or RNA).

The upshot here is that this construct has a significant history of use for diseases like pertussis, hepatitis B, and pneumococcus.

In trials, the vaccine showed similar protection to currently available vaccines, and none of the participants experienced severe clotting, anaphylaxis, or myocarditis.

With international authorizations from the WHO and European Medicines Agency, key partnerships with the Coalition for Epidemic Preparedness Innovations and the Serum Institute of India, the company is well positioned worldwide.

This week Novavax applied for their U.S. emergency use authorization.

Medscape opines that “Novavax’s real value may be in giving the un-jabbed another option.”

Vaccines will continue to be our best means to fight the enemy no matter how many therapeutics are advanced.

But still, millions of Americans refuse to be vaccinated.

Adding a protein subunit construct to the melee finally gives us the much needed, traditional option.  

Many unvaccinated do not see themselves as anti-vaccine, per se.

Novavax may provide a path forward for some who are pro-vaccine, but who drew the line at novel mRNA products.

Or, more broadly, Novavax may be another example of Offit’s observation that “the first vaccines aren’t always the best, safest, and last”.

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For the record, though fully vaccinated and boosted, I’ve been skittish about the possible long-term effects of the current vaccines, especially the J&J viral vector DNA vaccine … and I’ve been very optimistic about Novavax’s more traditional (and road-tested) vaccine modality.

See: Atlantic: “mRNA vaccines are extraordinary, NovaVax is better”

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DISCLAIMER: I’m not a medical professional or scientist — just a curious, self-interested guy.  So, don’t take anything that I say or write as medical advice. Get that from your doctor!

FINANCIAL DISCLOSURE: I own a whopping 100 shares of NVAX stock.

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