FDA rushes emergency authorisation for COVID-19 plasma cure

• Donald Trump has announced the Food and Drug Administration (FDA) has fast-tracked emergency use of convalescent plasma in COVID-19 patients
• The emergency use authorisation is based on preliminary data from trials which have seen more than 70,000 people treated with the plasma
• The treatment has not undergone the usual clinical process required for FDA approval, causing some doubt the decision may have been rushed after the FDA came under attack from the President
• On Saturday night Mr Trump tweeted there was a bureaucratic conspiracy against him and his reelection campaign among officials at the FDA
• Mr Trump appeared at a press conference on Sunday afternoon with FDA Commissioner Stephen Hahn to announce the authorisation
• Mr Trump also continues to insist a vaccine will soon be available, though top medical experts estimate approval won’t come until after the November election
• So far the pandemic has infected almost 5.7 million Americans and claimed over 176,000 lives in the US alone

U.S. President Donald Trump has announced the Food and Drug Administration (FDA) has fast-tracked emergency use of convalescent plasma in COVID-19 patients.

The emergency use authorisation is based on preliminary data from trials which have seen 70,000 people treated with the plasma, with around one in three people showing signs the treatment helped in their recovery, according to FDA Commissioner Stephen Hahn.

The treatment has not undergone the usual clinical trials required for FDA approval, causing some doubt the decision may have been rushed after the FDA came under attack from the President.

Deep state, deep concerns

On Saturday night Mr Trump tweeted there was a bureaucratic conspiracy against him and his reelection campaign among officials at the FDA.

“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,” Mr Trump tweeted.

The president also tagged Mr Hahn in the tweet, who joined Mr Trump at the press conference announcing the emergency authorisation the next afternoon.

There are concerns the President’s pressure on the FDA has forced officials to rush the approval.

Earlier this year, the FDA approved the emergency use of hydroxychloroquine — a malaria drug the President pushed as a potential cure for COVID-19 — before rescinding the authorisation when studies showed it to be ineffective, and sometimes dangerous.

The announcement had been expected to come even earlier, but Dr Anthony Fauci and other top medical authorities intervened to delay the authorisation, citing weak data from the early-stage study.

House Speaker Nancy Pelosi has labelled Mr Trump’s tweet as “dangerous” and accused him of politicising the FDA.

“Even for him, it went beyond the pale in terms of how he would jeopardise the health and wellbeing of the American people,” Ms Pelosi said.

What is convalescent plasma?

The plasma is taken from people who’ve recovered from COVID-19 and given to infected patients. The antibodies in the plasma are believed to help the patient’s immune response against the virus.

The expanded access program, run by the Mayo Clinic and the FDA, administered the plasma to more than 70,000 patients.

The parameters of the study fall well short of FDA approval guidelines though.

The White House has touted the treatment as a “major therapeutic breakthrough.”

“This is what I’ve been looking to do for a long time. This is a great thing,” Mr Trump said during the press conference.

The President also remains insistent a vaccine will be rolled out in coming months — possibly even before the election — despite top medical experts saying any approval likely won’t come before December at the earliest.

Any effort to rush emergency use authorisation of a potential vaccine could be seen as a political tool ahead of the election.

The approval would greatly help the administration which has come under fire for its coronavirus response.

So far the pandemic has infected almost 5.7 million Americans and claimed over 176,000 lives.