Transparency tightrope: Why regulators are being taken to court over COVID vaccine

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Transparency tightrope: Why regulators are being taken to court over COVID vaccine - The US and South African medicines regulators have faced legal challenges regarding information used to review and approve Pfizer’s Covid-19 vaccine

to the FDA, their vaccine had been rolled out in 56 countries and the company had received about 42 000 notifications of reactions, which included 158 893 side-effects .10-page table

In Tuesday’s webinar, Semete said that people should think of vaccines like any drug in their medicine cabinet. Any packet of pills comes with a pamphlet that lists all the possible side-effects caused by that drug — some of which are more rare than others. Sahpra said it had not seen exactly the same documents as the ones in the FDA’s document dump, because Pfizer sent the local regulator newer information — the company applied to have the vaccine approved in South Africa after it had requested authorisation in the US, so more updated information had been available.

These include access to a global database where multiple parties and regulatory bodies submit their data in order to help identify symptoms in people who have been immunised.

 

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