Former FDA commissioner says he wouldn’t take Russian vaccine for Covid-19

CNN Health ^ | 08/11/2020 | Naomi Thomas

[SeekAndFind]

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on Tuesday that he would not take the Russian vaccine outside of a clinical trial.

“I wouldn’t take it, certainly not outside of a clinical trial right now,” Gottlieb said on CNBC. “It appears that it’s only been tested in several hundred patients, at most. There’s some reports that it’s been in as few as 100 patients.” Gottlieb explained that it was an adenoviral vector vaccine, which is “not a trivial vaccine in terms of the technical complexity that goes into manufacturing.”

China is also developing an adenoviral vaccine, which is in clinical trials in Canada, but early data from that vaccine isn’t very encouraging, he said.

There are more things that can go wrong from a safety standpoint with this type of vaccine, Gottlieb said, including that people could have a reaction to the viral vector itself.

“It’s not clear how efficacious the Russian vaccine is going to be and whether or not people have some prior immunity to the adenovirus that they’re using to deliver the coronavirus gene sequence,” he said.

Gottlieb said that at this point he was worried about both the safety and the efficacy of the Russian vaccine. Something that has only been tested in several hundred patients, which is effectively a phase one clinical trial, is not something you would want to take outside of a clinical trial where you are closely monitored, he said.

“In a lot of these situations, you might only get one shot at taking a vaccine within a season, so if you put a vaccine on the market that’s not efficacious, it’s going to be hard to revaccinate the population, so you want to make sure it works,” he said.

[SeekAndFind]

For news about the Russian Covid-19 vaccine, refer to this:

Russia becomes 1st country to approve COVID-19 vaccine

[AnotherUnixGeek]

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on Tuesday that he would not take the Russian vaccine outside of a clinical trial.

That's nice, but while the FDA brings its regulatory BS to delay release of a vaccine by months, it'd be nice if the rest of us were allowed to make decisions for ourselves.

[neverevergiveup]

I agree with him. Adenovirus, non-replicative or not, tends to go to the liver when injected. That means your liver will be making and secreting Covid proteins - in conjunction with having another foreign protein (remnant adenovirus capsid) in the same cells. This could lead to a significant inflammatory response in the liver - as just one potential complication. Plus, lots of people have antibodies against adenovirus - which will attenuate their response to the vaccine, AND could also contribute to an inflammatory response.

[2aProtectsTheRest]

President Trump is streamlining the FDA’s approval process. It’s not holding anything up now. They’re still required to do phase 1, 2, and 3 clinical trials to test whether the various vaccine candidates are safe for use and whether they work (very important to know), but there’s no FDA bureaucrat snoring at his desk while the paperwork languishes in his inbox this time.

[cmj328]

Volunteer him for the trial!

[kickstart]

I don’t understand. According to the media, this is a deadly virus. Should we not cut corners to keep the death toll from rising?

[butlerweave]

Doesn’t like Vodka ?

[Roman_War_Criminal]

MY BODY...MY CHOICE...

[chuckee]

So the folks who brought you Chernobyl have developed with minimal safety testing a vaccine ahead of schedule. What could possibly go wrong? That’s okay, you can skip ahead of me. No need to thank me. I think I’ll go last on this particular line.

[chopperk]

The good doctor may be the same clown who would not take HCQ and Zinc Sulfate.

[Mr. Rabbit]

The Russian vaccine is probably “safe” in that I’d bet it’s just a placebo to mollify the Covidiot Hysteria. After they distribute it, there will be lots of cases of “Is cold, blyat! Beer flu is lie or is Gulag for you, blyat!”