According to an article by Science, the approval of remdesivir by the US Food and Drug Administration (FDA) has shown irregularities in the approval process.
Remdesivir is particularly well-remembered for being approved by the FDA for emergency use, and again for the results of the Solidarity trial, which was organised by the WHO across the world. The Solidarity trial had shown no benefit for mortality benefit for remdesivir – or any other measures. There were high hopes for remdesivir initially: early on, an NIH trial found that it shortened the disease – but a similar Chinese study found no evidence of that. A later study sponsored by remdesivir’s manufacturer, Gilead, found that it reduced recovery time for a 5 day course – but not for a 10 day course. Gilead was aware of the Soldiarity results early on, and then when they became public because they were conducted across multiple countries with different standards of care.
Meanwhile, the FDA went ahead with its approval process. The Solidarity researchers described the results to the FDA on Oct. 10, and in a preprint paper five days later, but the FDA still gave approval, apparently ignoring the Solidarity results in favour of those of the NIH and other studies. Furthermore, the FDA had not convened a key advisory group – yet it had for all of the COVID vaccine approvals.
Meanwhile, the European Commission signed a procurement for 500 000 doses of remdesivir worth $1.2billion. A European Commission spokesperson confirmed that it only received word of the failure of remdesivir in the Solidarity trial the following day.
