President Donald Trump has announced the emergency authorisation of convalescent plasma for people with COVID-19, in a move he described as “a breakthrough”.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those struggling to cope with the disease. The evidence is inconclusive about whether it works, when to administer it and what dose is needed.
“COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months,” said Food and Drug Administration Chief Scientist Denise Hinton in a letter describing the emergency authorisation.
The announcement from the FDA of the “emergency use authorisation” comes on the eve of the Republican National Convention, where Donald Trump will be nominated to lead his party for four more years. A day before the FDA’s announcement, Trump tagged Food and Drug Administration Commissioner Stephen Hahn in a tweet and said, “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. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
In the authorisation letter, Food and Drug Administration officials emphasised the use of convalescent plasma is still under investigation.
“COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months,” it said.
An emergency use authorisation is not the same as full FDA approval and it is likely the vaccine being trialled by University of Oxford and AstraZeneca is likely to follow a similar path.
— The White House (@WhiteHouse) August 23, 2020
The number of recorded COVID-19 deaths in the US has fallen with 402 recorded on Sunday (it had 974 recorded COVID-19 deaths 24 hours earlier), lower than India (846), Mexico (644) and Brazil (495). A total of 95% of closed cases recorded in the US have recovered, according to Worldometers.
Trump displayed discipline in his evening news conference, sticking to his talking points, deferring to the head of the FDA, Stephen Hahn, and only taking three questions from reporters.
Mayo Clinic researchers earlier this month stated reported people who’ve recovered from COVID-19 have antibodies — proteins the body uses to fight off infections — to the disease in their blood. The blood from people who’ve recovered is called convalescent plasma. Plasma is the liquid portion of the blood.
Researchers hope that convalescent plasma – blood from people who’ve recovered from COVID-19 contains proteins the body uses to fight off infections – can be given to people with severe COVID-19 to boost their ability to fight the virus. It also might help keep people who are moderately ill from becoming more ill and experiencing COVID-19 complications.
More than 70,000 patients in the US have been given convalescent plasma, which is a century-old approach to fend off influenza and measles before the advent of vaccines. It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.
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 program designed to speed access to the experimental therapy. That “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.
Administration officials, in a call with reporters on Sunday, discussed a benefit for patients who were within three days of admission to a hospital and were not on a respirator, and were given convalescent plasma containing higher concentrations of antibodies. They were then compared to similar patients who were given plasma with lower concentrations of antibodies. The findings suggest deaths were 35% lower in the group administered higher concentrations of antibodies.
Aiming to stop a possible shortage of on convalescent plasma after the announcement, government officials have been working to obtain plasma and to team with corporate partners and nonprofit organisations to generate interest among previously infected patients to donate.
Hahn, who called the development “promising,” said Trump did not speak to him about the timing of the announcement, which comes just before a pivotal week for the president’s reelection chances. Hahn said “this has been in the works for several weeks” and came after a data validation for which the Food and Drug Administration had been waiting.