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Vaccine missteps bring us back to Earth

Coronavirus Daily
Bloomberg

Vaccine missteps bring us back to Earth

The mRNA vaccines spoiled us.

The Covid shots developed by Pfizer-BioNTech and Moderna came so quickly through clinical trials, and produced such eye-popping results, that you could be forgiven for feeling society returning back to the old normal with each new press release and regulatory filing.

If those vaccines using largely untested technologies, hatched from the labs of what were obscure biotechs earlier this year, could tackle the coronavirus so efficiently, then just wait till other pharma giants pile on with more tried-and-true techniques, it was easy to think.

While there's plenty of reason to stay optimistic on the vaccine front, high-profile trial missteps of recent weeks from AstraZeneca Plc and now the Sanofi-GlaxoSmithKline partnership offer a reminder that developing vaccines and medicines is usually a messy process.

Astra's candidate ushered in the uncertainty with a manufacturing mistake that led to two different results emerging from two dosing regimens, obscuring the question of what's the best quantity to use along with the vaccine's overall efficacy. It's still unclear how well the shot works in older people, and the uncoordinated efforts to shine light on the trial details only cast more of a cloud over what still might prove to be a highly effective -- and highly affordable and portable -- shot.

Astra's vaccine candidate ushered in the uncertainty with a manufacturing mistake.

Photographer: Justin Tallis/Getty Images

Meanwhile, Sanofi and GSK added to the noise Friday, when they delayed plans for a large-scale advanced study of their own candidate because it hadn't created enough of an immune response in people age 50 and over. The reason, they suggested, isn't that the vaccine doesn't work; it's that people taking part in the trial received a lower concentration of viral proteins -- the part of the vaccine that sparks an immune response -- than they were supposed to.

The upshot is that the product won't be available to the masses until the back half of next year, perhaps six months behind their previous hoped-for schedule.

While those setbacks stand in stark contrast to the smooth sailing 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, who invests in AstraZeneca and Sanofi. "It's very unfortunate and it should not have happened, but it's not unusual." --Tim Loh

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