convalescent plasma

NIH abandons convalescent plasma trial in mild COVID

Another trial of convalescent plasma in people with COVID-19 has missed the mark, this time in mild to moderate disease, further dashing hopes that the therapy could have an impact on the infection.  Convalescent plasma taken from recovered COVID-19 patients is laden with antibodies against SARS-CoV-2, and the hope was this could be used to …

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Convalescent plasma misses the mark in phase 2 trial

Hopes that antibody-laden plasma taken from recovered COVID-19 patients could lessen the severity of the disease in others have taken a knock. The 464-subject PLACID trial – carried out in India – found that the use of so-called convalescent plasma was unable to prevent progression to severe disease or reduce mortality in people hospitalised with …

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Industry group says FDA botched COVID-19 convalescent plasma guidance

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could …

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FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

COVID plasma treatment gets emergency license from FDA after Trump criticism

The FDA has allowed a blood plasma treatment for COVID-19 to be administered under an Emergency Use license – but some have decried the move as a “political stunt” as president Trump accuses the agency of impeding progress on coronavirus therapies. The convalescent plasma treatment involves giving COVID patients antibody-rich blood plasma from people who …

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Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns

The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.