Nuked The food and Drug Administration authorized the emergency use of blood plasma from covid-19 survivors as a treatment for sick patients. The announcement came after President Donald Trump publicly pressured the agency to speed the development of drugs and vaccines.
The agency said plasma should not be the new standard of care for covid-19. However, it may shorten or reduce the severity of the illness in hospitalized patients.
Preliminary research suggests the plasma contains antibodies against the coronavirus. The treatment has only been tested in small groups of covid-19 patients, and not in the large, placebo-controlled clinical trials.
The FDA noted that the evidence supporting the decision to authorize covid-19 convalescent plasma did not come from gold-standard randomized clinical trials.
The FDA had plans to issue an emergency authorization for plasma at the start of August. Health officials raised concerns there was not strong enough data supporting the treatment.
President Donald Trump said without evidence that the delay was politically motivated. He accused the FDA of stalling the development of covid-19 drugs and vaccines on Twitter.
The FDA has been pressured to rush the approval of covid-19 products. Authorizing a new product without publishing the evidence and risks further damage to public trust in the agency.
Emergency authorization is not full FDA approval. It indicates that the benefits of the therapy outweigh the risks. remdesivir is authorized to treat covid-19.
Convalescent plasma is an old-school approach to treating infectious disease. It’s been used to treat diphtheria, pandemic flu, and chickenpox.
Elliott bennett-guerrero is studying the use of convalescent plasma in covid-19 patients at Stony Brook medicine.’we transfer those protective factors to people who are sick and have n’t been able to mount an immune response’.
Thousands of covid-19 patients in the US have already been treated with plasma through clinical trials and emergency access programs. The new authorization would knock down some logistical barriers and make it easier for patients to access the treatment.
Clinical trials on plasma as a treatment for covid-19 are still ongoing. Scientists are also studying if infusions of the plasma could protect healthy people from getting sick.
The US Department of health and Human Services is encouraging people to donate plasma through a series of PSAs. The FDA has a website directing people to donation sites.
