News & Politics

FDA, Big Pharma Pledge Not to Release COVID Vaccine Before It's Ready Because Orange Man Bad or Something

AP Photo/Hans Pennink

There is some concern — most of it political nonsense — that Donald Trump will “strong-arm” the FDA, the CDC, the pharma companies, and presumably family doctors into approving a vaccine before it’s ready.

The thinking is that Trump wants an “October surprise” for the voters and will force the release of a vaccine — ready or not — before Election Day.

The final stage of human trials for the three major vaccine candidates isn’t scheduled to end until December of this year or January 2021, so the best Trump could hope for would be optimism from manufacturers before Election Day—unless Trump starts throwing his weight around and bullying bureaucrats, corporate executives, and medical professionals into approving a vaccine prematurely.

If it was one lone pencil-neck bureaucrat sitting in a windowless office, going over the results of the trials and making the decision on whether to release the vaccine, then Trump might have a chance.

But Big Pharma giving in to pressure when a wrong decision could cost them billions in liability suits? Or the FDA and CDC chiefs not being concerned about getting hauled before Congress to explain why they approved a dangerous, ineffective vaccine?

The vaccine approval process has been streamlined considerably in this “Operation Warp Speed” coronavirus emergency, but there are too many entities involved for a president to lean on to get approval before a vaccine is truly ready.

Just to be on the safe side, the companies manufacturing the vaccine are going to pledge not to release it unless it follows “rigorous efficacy and safety standards, according to representatives of three of the companies.”

New York Times:

The statement, which has not yet been finalized, is meant to reassure the public that the companies will not seek a premature approval of vaccines under political pressure from the Trump administration. President Trump has pushed for a vaccine to be available by October — just before the presidential election — and a growing number of scientists, regulators and public health experts have expressed concern over what they see as a pattern of political arm-twisting by the Trump administration in its efforts to combat the virus.

The companies’ joint statement was planned for early next week, but it may be released before then after its existence was made public on Friday by The Wall Street Journal. The manufacturers that are said to have signed the letter include Pfizer, Moderna, Johnson & Johnson, GlaxoSmithKline and Sanofi.

Not to be outdone in the CYA department, bureaucrats at the FDA are going to release their own pledge.

The pharmaceutical companies are not the only ones pushing back. Senior regulators at the Food and Drug Administration have been discussing making their own joint public statement about the need to rely on proven science, according to two senior administration officials, a move that would breach their usual reticence as civil servants.

Trump could jawbone the principle involved between now and Election Day but shaming these people into releasing a vaccine before it’s ready won’t do any good. In fact, it might slow the process down. Political interference in the bureaucracy usually does that.

But the “growing number of scientists, regulators, and public health experts” who are supposedly warning that Orange Man Bad will start working the phones and threatening to mention their names on Twitter, are the ones who are politicizing the vaccine approval process, not Trump.