Tuesday, March 30, 2021

A string of vaccine bungles on the Continent threatens health and the global economy

See Europe’s Gang That Couldn’t Shot Straight. WSJ editorial. Excerpt:

"Take the latest fumble first. Various European regulators and politicians spent this week claiming the Oxford/ AstraZeneca vaccine—the only one currently widely available in the EU—might be unsafe, only to rethink and now beg people to start accepting it.

This time the concern was that the jab caused blood clotting or problems with blood platelets in some patients. Some people who received the vaccine developed blood clots, but the European Medicines Agency (EMA) found the vaccine was not associated with an increase in the overall risk.

Among the 11 million or so vaccinated in the U.K., serious clots were less common than would be expected in the general population. People can develop clots for many reasons including other health conditions and medications. Covid-19 can also cause clots, so any risk-benefit calculation favors vaccination.

This is of a piece with a distinctly European safety-ism that has dogged the vaccine program since the start. Introduction of the AstraZeneca jab was held up even after the EMA approved it because bureaucrats in Germany claimed there was no evidence it works in patients older than 65.

Fewer elderly patients were included in the sample during the vaccine’s trial phase, but that’s as far as the truth to this claim went. It was quickly rebutted—real-world evidence available even then from the U.K. showed high efficacy in the older cohort—but not before French President Emmanuel Macron picked up the theme.

Such careless talk deterred vulnerable elderly Europeans from accepting the vaccine last month. It also skewed priority lists. Younger teachers and university professors in Italy received jabs ahead of the ill and elderly under a scheme developed when officials claimed the shot wouldn’t work for the old.

One problem is that no one seems to be fully in charge of monitoring safety and efficacy. Nominally that’s the EMA’s job, and the agency handled it with typical eurocratic aplomb. The EMA’s approval process is more bureaucratic, requiring input from all EU member states. Imagine if the FDA consulted all 50 states.

But national governments also are allowed to make their own safety rulings on an “emergency” basis. The U.K. used this option to approve the Pfizer and AstraZeneca shots quickly despite still being an EU member late last year.

Other governments used this discretion to slow-roll vaccines. EU capitals refused to follow the U.K. in granting emergency-use authorization, apparently for fear of hurting European solidarity. But some governments have been happy to impose unilateral blocks on the vaccine, as with the AstraZeneca clot kerfuffle. European regulators live by the maxim “better safe than sorry,” but in this case they’re getting the sorry with no added safe.

At least now, millions of doses are available for Europeans who do want them. This wasn’t always the case, after procurement bungles delayed deliveries and nearly sparked several trade wars. Brussels officials last year jumped at the chance to push common vaccine procurement to bolster the EU’s credibility with European voters. Buying on behalf of 500 million Europeans also was supposed to give the bloc more leverage with pharmaceutical companies.

It’s been chaos. The EU bureaucracy has little experience with procurement on this scale, and it also struggled to strike bloc-wide deals for ventilators and protective equipment. Brussels officials signed vaccine contracts months after the U.S. and U.K. did last year—and only after some European governments threatened to organize their own procurement.

Washington and London understood that crucial to mass procurement was throwing large amounts of R&D money at many companies in hopes some would work. Brussels focused on haggling down the cost per dose. Europeans pay a few dollars less per dose but ended near the back of the shipment line.

The EU response—a combination of threatened export curbs, noisy commercial disputes with pharma companies, and sour-grapes caviling about imaginary efficacy concerns—has mainly undermined Europe’s credibility on trade issues. It also risks stoking vaccine nationalism and trade restrictions elsewhere."

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