Vaccine missteps bring us back to Earth
The mRNA vaccines screwed us up.
The Covid shots developed by Pfizer-BioNTech and Moderna came so quickly through clinical trials and produced such astonishing results that you could be forgiven for feeling society return to normal with every new press release and regulatory filing.
If those vaccines using largely unproven technologies, hatched from the labs of what were obscure biotechnologies earlier this year, could fight the coronavirus so efficiently, then simply wait until other pharmaceutical giants pile up with more techniques. tried and true, it was easy to think.
While there are many reasons to remain optimistic on the vaccine front, the high-profile testing errors of recent weeks from AstraZeneca Plc and now the Sanofi-GlaxoSmithKline partnership Offer a reminder that vaccine and drug development is often a complicated process.
Astra’s candidate ushered in the uncertainty with a manufacturing error that led to two different results emerging from two dosing regimens, obscuring the question of what is the best amount to use alongside the overall efficacy of the vaccine. It is not yet clear how well the injection works in older people, and uncoordinated efforts to shed light on the details of the trial only cast a cloud over what could still prove to be a highly effective shot – and very affordable and portable.
Meanwhile, Sanofi and GSK joined in the noise on Friday, when they delayed plans for a large-scale advanced study of their own candidate because it hadn’t created enough immune responses in people 50 and older. The reason, they suggested, is not that the vaccine doesn’t work; is that the people who participated in the trial received a lower concentration of viral proteins, the part of the vaccine that triggers an immune response, than was supposed.
The result is that the product will not be available to the masses until the later half of next year, perhaps six months behind its previous expected schedule.
While those setbacks stand in stark contrast to the fluidity of the Pfizer / BioNTech and Moderna candidates, industry veterans say these headaches are basically the norm.
“These kinds of mistakes happen,” said Markus Manns, a Germany-based portfolio manager for Union Investment, which invests in AstraZeneca and Sanofi. “It’s very unfortunate and it shouldn’t have happened, but it’s not unusual.” –Tim Loh
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