The US Food and Drug Administration (FDA) has given emergency authorisation to use plasma to treat Covid patients.
The technique uses antibody-rich blood plasma from people who’ve recovered from the disease and has already been applied to 70,000 people in the US – in trials or for the gravely ill.
The FDA says initial trials indicate it is safe, although more are needed to prove effectiveness.Several experts have questioned the robustness of studies into its use.
The announcement came each day after President Donald Trump accused the FDA of impeding the rollout of vaccines and therapeutics for political reasons, and on the eve of the Republican National Convention, where he will launch his campaign to win a second term within the White House.
“This is what i have been looking forward to doing for an extended time,” the president told reporters on Sunday.
“I’m pleased to form a very historic announcement in our battle against the China virus which will save countless lives.”
Mr Trump described the procedure as a strong therapy, as he appealed to Americans to return forward to donate plasma if that they had recovered from Covid-19.
More than 176,000 people have died from coronavirus since the beginning of the outbreak within the us , consistent with a tally by Johns Hopkins University. Nearly 5.7 million cases have also been confirmed nationwide. The country has had more confirmed cases and deaths than anywhere else within the world.
Does plasma treatment work?
The FDA had already approved the utilization of plasma transfusions on coronavirus patients under certain conditions.
It has now given the treatment “emergency use authorisation”, instead of full approval, saying that early research suggests plasma can decrease mortality and improve patient health if it’s administered within the primary three days of admittance to hospital. However, more trials are needed to prove its effectiveness.
The agency said it had concluded it had been safe after reviewing the results of 20,000 patients who had received the treatment thus far .
The FDA said people under the age of 80 who weren’t on a respirator and received plasma containing high levels of antibodies had a 35% better survival rate a month after the treatment than those that had received plasma with a coffee level of antibodies.
“It appeared that the merchandise is safe and that we ‘re comfortable thereupon and we still see no concerning safety signals,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
In his own comments, Mr Trump didn’t use such nuanced language, saying instead that the plasma treatment had been “proven to scale back mortality by 35%”.
Several experts, including Dr Anthony Fauci, a member of the White House’s coronavirus task force, have expressed reservations about the robustness of studies thus far .
Balance of risks
Many countries are using plasma as a coronavirus therapy, but it isn’t yet clear how effective the treatment is.
The decision by the US FDA to grant emergency use may be a balance of risks. It says, supported the evidence thus far , convalescent plasma may lessen the severity or shorten the length of Covid-19 illness.
Certainly, sick coronavirus patients whose own immune systems are struggling to repel the pandemic virus might get protection from a transfusion of antibody-rich plasma from someone who has successfully recovered from Covid-19.
Convalescent plasma has been wont to successfully treat other diseases, including Ebola.It is generally well-tolerated, but unwanted effects can occur, including harmful allergies .
A recent UK analysis said it remained “very uncertain” whether plasma was beneficial for people admitted to hospital with Covid-19.Trials are ongoing to know precisely which patients might benefit and by what proportion .
Experts want “gold standard” evidence to tell treatment decisions and gathering that data will take time.
In a statement, the Infectious Diseases Society of America said that while there have been “some positive signals that convalescent plasma are often helpful in treating individuals with Covid-19…. we lack the randomised controlled trial data we’d like to raised understand its utility in Covid-19 treatment”.
Jonathan Reiner, a professor of drugs at Washington University, called it “a political stunt”.”Convalescent plasma may have some efficacy, but we’d like to possess definitive data,” he wrote on Twitter.
World Health Organization (WHO) officials said on Monday that using convalescent plasma was “still an experimental treatment”.
They added that the risks and side effects related to it, starting from mild to severe, must be considered.
Source: bbc news