COVID-19: US announces emergency authorisation of plasma therapy
US President Donald Trump on Sunday (August 24) announced the emergency authorisation of convalescent plasma for COVID-19 patients, at a time when the pandemic has infected over 5.68 million people and claimed 1,76,000 lives in the country.
“Pleased to make a truly historic announcement, in our battle against China virus, that will save countless lives. FDA (Food & Drug Administration) has issued an emergency use authorisation for a treatment known as convalescent plasma,” Trump said while announcing the treatment.
#WATCH Washington, DC: US President says, “Pleased to make a truly historic announcement, in our battle against China virus, that will save countless lives. FDA (Food & Drug Administration) has issued an emergency use authorisation for a treatment known as convalescent plasma.” pic.twitter.com/LMKfI1SQSJ
— ANI (@ANI) August 23, 2020
The announcement comes days after White House officials suggested there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s re-election chances.
“This product may be effective in treating COVID-19 and…the known and potential benefits of the product outweigh the known and potential risks of the product,” the FDA said in a statement.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling with the disease. But the evidence has been inconclusive as to how it works or how best to administer it.
Many scientists and physicians believe that convalescent plasma might provide some benefit but it is far from a breakthrough. It is rich in antibodies that could be helpful in fighting the coronavirus, but the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
Related news: COVID could be over faster than Spanish flu: WHO
The White House had grown agitated with the pace of the plasma approval, but the accusations of a slowdown, which were presented without evidence, were just the latest assault from Trump’s team on the so-called deep state bureaucracy.
The White House has sunk vast resources into an expedited process to develop a vaccine and Trump aides have been banking on it being an October surprise that could help the president make up ground in the polls.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from COVID-19 survivors helps other infected patients recover. But it wasn’t considered proof.
More than 64,000 patients in the US have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines. It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.
There’s no solid evidence yet that it fights the coronavirus and, if so, how best to use it.
The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.
But it wasn’t a formal study. The patients were treated in different ways in hospitals around the country as part of an FDA programme designed to speed access to the experimental therapy.
With a COVID-19 vaccine yet to hit the market, several countries including India have warmed up to plasma therapy in the treatment procedure for coronavirus patients.
(With inputs from agencies)
