Vaccine Makers Plan Public Stance to Counter Pressure on FDA

[demmiblue]

Source: Bloomberg

Drugmakers are planning a public pledge to not send any Covid-19 vaccine to the FDA for review without extensive safety and efficacy data, according to people familiar with the effort.

The joint stance is seen as a bulwark against political pressure being applied on the Food and Drug Administration to get a vaccine out as soon as possible. It is likely to be announced in a multi-company statement as soon as next week. The plans, which could still change, were described by people involved in the effort on condition of anonymity.

The companies involved in the discussions include Pfizer Inc., Moderna Inc., Johnson & Johnson, GlaxoSmithKline Plc, Sanofi and possibly others. All are developing vaccines for Covid-19.

The drug industry has long relied on the FDA as a gold-standard seal of approval for its drugs and vaccines, assuring patients that the products are safe and effective. But in the middle of the pandemic, the agency has made several controversial decisions to allow emergency use of therapies without rock-solid evidence they work.

Read more: https://www.bloomberg.com/news/articles/2020-09-04/vaccine-makers-plan-public-stance-to-counter-pressure-on-fda

[MontanaMama]

1. Sounds like they don't want to be sued

for launching a bad vaccine.

[brewens]

6. It is also a remote possibility that they want to do the right thing. I know that might be

the weed talking, but you can't rule it out completely.

[MontanaMama]

7. It's the weed talking!

Big Pharma is really only responsible to their shareholders. Just like insurance corporations. I wish it weren’t so...

[brewens]

10. They do a lot of business overseas too. If their vaccine turned out to be bad, who knows what the

real cost to them might be.

[Massacure]

15. Shareholders generally take a dim view on maiming and/or killing their customers

Dead customers are bad for business, they don't usually make future purchases

[lagomorph777]

17. except for Herman Cain

[Chemisse]

18. Aren't they protected from lawsuits for vaccines? I think they want out of the race to the bottom.

It's a no-win situation for them to be competing to be the first to rush out with an untested vaccine that could very well flop.

And destroy their reputation.

Not to mention many people who would otherwise be anxious to be vaccinated might avoid getting Trump's November Miracle Vaccine and wait for the safe one to come along.

[radius777]

23. Only if properly tested and includes warnings of side effects/risks.

https://www.csmonitor.com/USA/Justice/2011/0222/Parents-can-t-sue-drug-firms-when-vaccines-cause-harm-Supreme-Court-says
The law says in part that no vaccine manufacturer shall be held liable for a vaccine-related injury or death “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”
...
The majority justices read the law to sweep broadly, preempting any and all design defect claims provided that the manufacturing process did not create a defect and that warnings and directions were adequate.
...

The gov't is the one who compensates victims through a fund:

https://www.theatlantic.com/health/archive/2019/05/vaccine-safety-program/589354/
As America enters the worst measles outbreak since the disease was declared eradicated two decades ago, it is worth examining this rarely talked about element of vaccination requirements. The Vaccine Injury Compensation Program has long percolated at the heart of misinformation and misunderstanding. It also raises questions about where large sums of tax money are flowing.

For most drugs—actually, every type of drug other than vaccines—the manufacturer can be legally liable for harm that results from a product it sells. Vaccines are produced by privately held pharmaceutical companies, but they have a unique arrangement with the U.S. government: When a person reports harm that could feasibly be related to a vaccine, a government program—not a pharmaceutical company—pays compensation.

If there is political pressure on the FDA and drug manufacturers are somehow in cahoots - they could all go down . I highly doubt the SCOTUS (Roberts does not like Trump) would protect Trump and his corrupt CDC/FDA and any companies who conspired with them.

I would also think drug companies would be worried about the mere appearance of being political. If they are seen as helping elect one party or the other - they could lose half of the country as potential customers.

[Thekaspervote]

2. Good! Can't even imagine the law suits regarding a rushed and then failed vaccine!!

[cos dem]

3. Good. I know there's a lot of skepticism around drug companies.

I think they realize it's not in their best interest to rush anything. A bad vaccine that blows up in their face will make them all look bad.

[yaesu]

4. they know they are going to scare a lot off people away from the program, including myself

if they speed things up to make trump look good. They already have millions of anti vaxxers to deal with.

[Dem2theMax]

5. Bingo!

I was thinking about this last night. Democrats know better than to rush to take a 'Trump vaccine.' Republicans are the anti-vaxxers.
Either way, Trump loses. Haha!

[SheltieLover]

8. Putin will step up & offer his stash to dimwit

Good for the drug companies, though!

[Pobeka]

9. We've reached a new low. Drug companies telling the US government to be more responsible.

[BlueWavePsych]

11. Drumpf's vaccine

[pnwmom]

12. Why should this statement increase our confidence? What is "substantial evidence"

of safety and efficacy? Russia also thought they had substantial evidence when they decided to rush their vaccine out, before the completion of Phase 3 trials.

[MontanaMama]

13. I'm with you.

It doesn’t increase my confidence. Pharma corporations are about the bottom line....always have been.

[beachbumbob]

14. believe when I see it. Take trump 12 hours of whining

[lagomorph777]

16. Utterly amazing. The henhouse guarding the fox.

[olddad65]

19. Death by vaccine is so much more sophisticated than ovens

[qwlauren35]

20. Late October, according to the Article

I still think it could be a game changer.

[Politicalgolfer]

21. Simple...

They can go through the proper steps to create an effective, safe vaccine and make a gazillion dollars or push a possible disaster for Don and have their entire corporation collapse & become anathema to the public......and Donnie would be the first to feed them to the wolves! The big fish are now eating each other

[Hotler]

22. The multi-company statement may be just a disclaimer to get ahead of

any shit storm that will be coming should the vaccine be crap.

[JustABozoOnThisBus]

24. Sounds like they're colluding to form a regulatory body ...

... since the "official" regulatory body (FDA) won't regulate anything.

Sounds like they're doing something right, in a "deep state"ish sort of way.