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Lower standards, deliver faster: How pharmaceutical companies could accelerate vaccine development


Three pharmaceutical companies leading in corona vaccine development have published study protocols. Two US corporations reserve the right to terminate the investigations prematurely and apply for emergency approval.

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Vaccine Search: Balancing Speed ​​and Safety

Photo: Ganna Martysheva / iStockphoto / Getty Images

At the beginning of August, Russia announced the approval of the first corona vaccine.

The professional world quickly agreed: It was a sham package.

The crucial phase III study, in which the safety and efficacy of the drug are comprehensively tested, had not yet taken place.

In the USA, too, it is now becoming increasingly clear that a vaccine could get emergency approval far from the regular standards.

This is indicated by study protocols that the leading companies Moderna, Pfizer and AstraZeneca have released under pressure from the public (here, here and here).

According to the documents, large phase III studies with tens of thousands of participants are currently taking place.

However, the companies have defined termination criteria for the studies.

If this is met, the examinations could be terminated prematurely and the emergency license applied for.

In particular, the US companies Moderna and Pfizer seem to be keeping open to applying for emergency approval before the studies have even been completed.

Your test criteria meet the requirements for such an accelerated procedure drawn up by the American drug safety authority (FDA), but these are far removed from the usual internationally recognized standard for regular approval.

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Source: spiegel

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