FDA willing to approve Covid-19 vaccine without waiting for end of trials

The FDA is buckling to Trump's pressure, willing to release vaccine for emergency use without waiting for trails to complete. Who else is doing this? That's right, Russia and China.

Some history.

- Trump pressures FDA on hydroxychloroguine. FDA authorizes emergency use, then reverses after data came in.
- Trump pressures FDA on plasma. FDA authorizes emergency use, with the FDA head over-hyping the data (he apology later for 'mis-stating').
- Trump pressures FDA on vaccine release. FDA now willing to do so as an emergency use prior to clinical trails completing.

The FDA told congress a few months ago that making a vaccine available BEFOER trials end lack public confidence and willingness to be vaccinated - not only can it be dangerous to individuals, even if it's safe, it ends up being counter-productive and ineffective due to mistrust and unwillingness to be vaccinated.

Maybe someone that know this can chime in - has there ever been an emergency authorization of a vaccine? It seems completely inappropriate to issue emergency use for vaccination vs for treatment. For treatment, it make some sense - sick people without a good option can try an emergency yet un-proven use of a drug or method. For vaccine, you are talking about injecting not proven material into healthy people.

Financial Time:

The head of the US Food and Drug Administration has said he is willing to bypass the normal approval process to authorise a Covid-19 vaccine as soon as possible

 

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3 days ago, the FDA stopped Phase3 trial from STARTING. They wanted to start manuf and distributing the vaccine. Even if they want to start manuf early (fine and probably prudent given the pandemic), why would you STOP a clinical trial from getting data? If the data comes back bad, you stop. If the data comes back good, you continue. But no data? Just blindly go and assume it's good?


COVID vaccine trial in county paused due to 'political pressure,' doctor says

After much fanfare about its launch, the vaccine trial for COVID-19 in Palm Beach County is on pause because of "political pressure," its principal investigator says.

Researchers said at a news conference Aug. 17 that they had received the vaccine and were ready to administer it to the first 10 test subjects.

But the chief investigator for the vaccine trial confirmed to The Palm Beach Post on Thursday that the trial is on pause because of a question by the U.S. Food and Drug Administration on whether a European trial is good enough to start manufacturing and distributing the vaccine.

The news of the trial's pause comes as Vice President Mike Pence told the nation at the Republican National Convention on Wednesday night that a vaccine would be available by the end of the year.

Dr. Larry Bush, the vaccine trial's primary principal investigator, said the FDA is looking at whether the trial can be bypassed altogether and the vaccine approved using “emergency utilization access." The European trial found the vaccine to be effective.

Emergency utilization access is used by the FDA for compassionate use with patients with a life-threatening condition.

The problem, Bush said, is that the FDA usually approves a vaccine using results only from U.S. trials — not those conducted in other countries.

The renowned infectious disease specialist describes himself as apolitical, but he said "there is a group of people" in the high levels of the federal government pushing to short-circuit U.S. vaccine trials on COVID-19.

"What is holding all this up is the political pressure," he said. "I think having a pandemic in an election year is a problem. Either way, people use that as a point that they are right and the other side is wrong."

He said that if President Donald Trump's FDA does approve emergency access utilization for the vaccine, then the true effectiveness of it may never be known and a bad precedent will be set for vaccine trials going forward.

Getting trial subjects for a vaccine that has already been approved will prove especially difficult, he said.

Bush noted, however, that emergency utilization access can be a good thing.

He agreed with the FDA's recent approval of the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the ill, even though a study found it ineffective.

The reason it was ineffective, he said, was patients with COVID-19 weren't getting it soon enough because of bureaucratic red tape. The FDA's decision streamlined the process for physicians so patients can receive blood plasma faster.

Researchers in Palm Beach County had hoped to be able to enroll hundreds of test subjects by October with results rolling in by the next month.

"We can go any day at 24-hour green light notice," said Bush, adding that he hopes the FDA's question will create only a "slight pause" in the trial.

The vaccine was developed by AstraZeneca and scientists at England’s Oxford University. One among many vaccines currently in Phase 3 trials, the AstraZeneca vaccine appears to be especially hopeful because it not only creates antibodies to block the virus, but it also creates T cells that could destroy it.

 

Are you joking or serious? If serious, what in my post lead you to believe that I’m antivax?

I’m not an antivax and if the FDA does this, one of the potential danger is it grows the antivax movement.

The FDA said a few months ago that if they approve a vaccine that hasn’t completed clinical trial, the public would lose trust in it.

 

Trials were already fast tracked. 9 of them are already in phase 3. Target for a safe and effective vaccine is still 2021... way faster than of typical vaccine development. NO one criticized the urgent push for that.

This is potential approval of vaccine prior to completion of trial under fda emergency use. AFAIK, emergency use was intended for treatment of someone sick, not for vaccinating someone healthy.

 

Not for those that are sick. Front line workers would likely be first.