The agency stressed that this didn’t amount to full approval, and that there were distinct limits. There wasn’t evidence the antibodies helped already-hospitalized patients, and it might even lead to “worse clinical outcomes” for those who need high-flow oxygen or ventilators. Officials were still studying the effectiveness and safety of the treatment, the FDA said — the initial authorization came after the regulator determined that the known and likely benefits outweighed the risks.
It’s hard to completely escape the politicization of the approval when President Trump was one of the earliest recipients of the antibodies and credited them with helping his recovery. As the FDA noted, though, there aren’t any other “adequate, approved and available” options for softening COVID-19’s blow. The lab-created antibodies could help save lives until there are widely available vaccines to limit the disease’s reach.
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