This is the fourth of five updates on the pandemic.  Monday will be the last in this miniseries. (I've posted about 30 articles on the virus and the pandemic.)

Every day, we hear that America is dumping beaucoup bucks on BiochemE or BigPharma firms to rush development of COVID-19 vaccines.  The hope is dangling this money in front of the developers will induce them to develop solutions faster.

That is not how research works.  But, one can always hope.  The one fact is there is a unanimity among researchers to find a solution to this pandemic-  they have reacted to this war on COVID-19.

Viral vaccines were the very first pharmaceuticals that employed cellular organisms.  (Think polio vaccines back in the 1950s. Or smallpox before that.)  The problem is that viral vaccines take long periods to develop, to effect clinical trials- and then to produce the cells for mass delivery.   That’s why some of the vaccines being touted against COVID-19 use hybrid approaches- virus vectors, virus-like particles, and the like.  These formulations- IF THEY WORK- radically reduce the development, manufacturing, and scale-up timelines.

But, one must recognize that our testing involves injecting these vaccines into the bodies of healthy folks- not to ones already infected with SARS-CoV-2.  Wait- not just healthy folks- but young children, the elderly, the medically compromised patients.

And, GMP rules will prevail.  These FDA protocols covering Good Manufacturing Protocols for drug manufacture address the starting material(s) quality, the entire manufacturing processes, as well as the final product testing.

In the case of SARS-CoV-2, one will have to verify the viral seed integrity, to ensure it matches the known genome sequence for the virus- and to ensure that when isolated from the animal (or human), only the virus was collected.  Any adjuvants also must stand up to scrutiny.

The manufacturing process must be inherently reproducible among all the batches to be made.  (If recombinant DNA is employed, its integrity must also be verified.)  It must be produced under sterile conditions (since the vaccine is an injectable), with any potential endotoxins and bioburdens fully eliminated from the final product.

(Not to mention that the FDA has never approved an RNA-based vaccine, which may be the best COVID-19 choice available.  And, a recombinant vaccine poses other risks.)

The real question is whether our fanatical hope for a rapid vaccine development will lead to shortcuts in approval and verification.  (I worry even more about this now that the CDC- the Centers for Disease Control- caved in to the demands of TheDonald, watering down the protocols they had developed for safe school openings.)

Plus, such shortcuts will make it even more likely that the anti-vaxxers (who lack a shred of evidence that vaccines cause whatever their pet ailment of the day) will be able to convince more sentient beings to avoid getting inoculated against SARS-CoV-2.

And, while I’m at it- WTF is it with Russia and China attempting to hack into our scientists’ accounts to steal our data about vaccines?  Is it so they can claim they developed these ideas first?  I’m virtually certain every one of these biotech entities have been documenting their research so they can prove primacy of date- should there be a patent fight.

Or, is it that they hope to scoop our firms, offering the hijacked vaccine to developing countries in return for their agreeing to the geopolitical demands of China or Russia?  (You know this is going to be an issue.  After all, TheDonald is playing vaccine nationalism- those that own the vaccine get to choose where it’s first employed [a.k.a. “America First”] and the rest of the world be damned.)

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