World Health Organization cautious on Covid-19 plasma as U.S. issues emergency authorization

World Health Organization cautious on Covid-19 plasma as U.S. issues emergency authorization

The US on Sunday issued emergency approval for plasma taken from recovered coronavirus patients, so that more people can get access to the experimental treatment.

"COVID-19 convalescent plasma is safe and shows promising efficacy", Stephen Hahn, MD, commissioner of the FDA, said during a press briefing with President Donald Trump. Last month the administration launched an $8 million ad campaign to encourage those who have recovered from COVID-19 to donate plasma. And these antibodies are found in a person's blood. By collecting and using plasma from people (donating plasma is similar to donating blood) who have recovered from the virus, these antibodies in plasma can be given to seriously ill patients giving their immune system an extra boost to fight off the infection.

Dr Soumya Swaminathan, chief scientist of the World Health Organization, said a few smaller trials have reported their findings but "the results, in some cases, point to some benefit, but have not been conclusive". So the concept behind the treatment is to assist ill individuals install an antibody response to the virus by moving plasma intravenously from those who now have antibodies.

The FDA's emergency authorization of the convalescent plasma use for COVID-19 treatment has boosted the prospect of blood plasma COVID-19 treatment development that is actively undergoing among Korean biotechnology and drug companies.

For the treatment to be used, a blood donor who has recovered from COVID-19 receives a needle in both arms while their blood is removed and put into a sterile machine that separates out the plasma portion.

Those who received plasma after four or more days had an 11.9 percent death rate.

This means nearly anyone who has tested positive for the virus can receive the plasma while they're sick, not just the patients who are the sickest.

These are known as "monoclonal antibodies" and they are being developed by biotech firms including Regeneron and Lilly. And they based their emergency authorization on the historical evidence of convalescent plasma that has worked in other outbreaks of respiratory viruses.

Political commentators have questioned the timing of the FDA's latest move as Trump lags in polls before the November election.

The data indicates that the plasma can reduce mortality in patients by 35%, particularly if patients are treated within three days of being diagnosed.

"At the moment, it's still very low-quality evidence", Swaminathan told a news conference.

"It does undermine the credibility of the entire United States government and the administration but specifically these institutions", said Dr Matthew Heinz, a physician in Arizona who served in former president Barack Obama's health department. It has entered a phase 2 clinical trial upon approval skipping phase 1 on the widely recognized safety profile of a plasma med on Thursday.

"One thing to emphasize is this information is coming in faster than it has in any other pandemic", he told AFP.

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