Thread by @DonnaYoungDC

If a #COVID19 vaccine is approved in 2020, 65% of U.S. voters surveyed believe it would be rushed without enough testing and 58% said they would wait to get the shot, while 21% said they would never get it, according to a Sept. 6 CBS News poll.

#vaccines #FDA #pharma #biotech

https://twitter.com/SPGMIHealthcare/status/1303268387762638848

.@GOPHELP @HELPCmteDems today will hear from @NIHDirector Francis Collins & @Surgeon_General Jerome Adams about #COVID19 #vaccines.

help.senate.gov/hearings/vacci…

#pharma #biotech #FDA #NIH

.@SenWarren said this morning she plans to question @NIHDirector Collins & @Surgeon_General Adams on how the Trump administration will ensure the American people can get a safe, effective vaccine for #COVID19 free of politicization and interference by Trump.

#vaccines #FDA #NIH

.@GOPHELP @HELPCmteDems #COVID19 #vaccines hearing now underway with @NIHDirector Collins & @Surgeon_General Adams help.senate.gov/hearings/vacci…

c-span.org/video/?475442-…

.@SenAlexander says he's been reading Jared Diamond's "Guns, Germs & Steel" & then cites from it.

#COVID19 #vaccines #NIH #FDA #pandemic

.@SenAlexander: What's new about epidemics is modern medicine.
True modern miracle is vaccines.

#COVID19 #vaccines #NIH #FDA

.@SenAlexander notes how #polio terrified his generation's parents.

#COVID19 #vaccines #NIH #FDA

.@SenAlexander notes #BARDA [ U.S. taxpayers ] covering the costs of manufacturing #COVID19 #vaccines before they are approved by #FDA.

"If they are not approved, they will be thrown in the dumpster." [again, at U.S. taxpayer cost]

#NIH #FDA

.@SenAlexander: Is the doctor's office safe for kids to get their childhood #vaccines now?
He notes @AmerAcadPeds says pediatricians are working to make their offices as safe as possible.
Don't be afraid.

#COVID19 #vaccines #NIH #FDA

.@SenAlexander: While in midst of #COVID19 #pandemic, wise any legislation that Congress passes this year to make sure onshoring plants are functioning, stockpiles are full, public health properly funded & states have right tools/resources.
The next pandemic could be next year.

.@PattyMurray: Trump has promoted unproven treatments & junk science.
Trump has repeatedly insisted this will all go away. He's telling outright lies at a time when truth is a matter of life & death.

#COVID19 #vaccines #NIH #FDA

.@PattyMurray: Frustrated @SteveFDA & @CDCDirector not invited to testify today.
Hearing from them more urgent in light of political interference.
Watched Trump promote conspiracies about #FDA & #CDC & seen pressure on FDA on #convalescentplasma & CDC #COVID19 testing guidelines.

.@PattyMurray insists need transparency from #FDA & #CDC on their decisions/activities & also on #WarpSpeed contracts.

"We need transparency from top to bottom."

#COVID19 #vaccines #NIH

While not at today's @GOPHELP @HELPCmteDems hearing on #COVID19 #vaccines, .@SenAlexander notes @SteveFDA, @CDCDirector, #NIH Fauci & @HHS_ASH Giroir are scheduled to testify at Sept. 23 hearing on update on the federal response.

.@NIHDirector Collins: You have a #biotech company inside your body.

It may take a week or two for your factory to make a new product but it keeps the blueprint on file for any antibody it's ever made.

#COVID19 #vaccines #NIH #FDA

.@NIHDirector Collins on 6 #COVID19 #vaccines with U.S. contracts:

"We hope & expect that one or more of these will succeed.

#NIH #FDA #CDC

.@Surgeon_General Adams: This will be the most important #flu season in our lifetimes.
Hope all will get your flu vaccines early & publicly

[Publicly??]

#COVID19 #vaccines #NIH #FDA #GetYourFluShot #FightFlu

In an update to #HHS guidance, .@Surgeon_General Adams says state licensed pharmacists will be able to administer #COVID19 #vaccines when they are available.

#FDA #NIH #CDC

.@Surgeon_General Adams: Use your bully pulpit to tweet, text, blog & shout that #vaccines are safe & effective.

Vaccines are the quickest & easiest way for minorities to protect their health.

Vaccines are how we achieve health equity & social justice.

#COVID19 #NIH #FDA

.@NIHDirector: Reason investing in six #COVID19 #vaccines is expect not all to work but would be lovely if they did.

.@NIHDirector: None of the vaccines done old way.

"You're not going to get infected with #COVID19 by any of these [six #vaccines under U.S. contracts], I promise you.

#NIH #FDA #CDC

.@NIHDirector: #COVID19 is probably a better virus for a vaccine to work well than flu, which is a tough one.

We will not know until we get through these trials if as safe & effective as #measles & #polio #vaccines.

.@NIHDirector: I'm a scientist & best way to engender trust is to be as transparent as possible.
There's so many conspiracy theories out there right now — some breathtaking.
Best antidote is to say exactly what we're doing.

#COVID19 #vaccines #NIH #FDA

.@NIHDirector: None of trials will go to FDA review until DSMB looks at the data.
Those are not federal employees. Only when they say …does this get brought forward.
He notes statement from 9 #pharma #biotech CEOs.

#COVID19 #vaccines #NIH #FDA

.@NIHDirector: What a heartbreak that would be if people are afraid to use #COVID19 #vaccines.

#NIH #FDA #CDC

.@Surgeon_General insists been no politicization of #COVID19 #vaccines process
[Except all those remarks from Trump & @MarkMeadows]

@PattyMurray: You making sure Trump understands risk?

Adams: I'm using my bully pulpit to make sure entire country understands. [dodges on Trump]

Just wondering on those questions to .@Surgeon_General Adams on clinical trials: Has he ever actually been involved in conducting any clinical studies of anything, ever?

He also likes to interrupt a lot.

#COVID19 #vaccines #NIH #FDA

.@Surgeon_General Adams: I promise you we will use every federal tool that we have to make sure cost is not an obstacle for people receiving the most highly anticipated vaccine of our lives.

@NIHDirector: I share that 100%.

#COVID19 #vaccines #NIH #FDA

.@SenSanders: What is most important is that vaccine is safe.
Will you join me in telling Trump to get out of science & let scientists do their job?

@NIHDirector: I'm a scientist. I can't say strongly enough decisions about #COVID19 #vaccines is going to be based on science.

.@NIHDirector: Will it be done by a certain date? I can't possibly tell you right now.
I do have cautious optimism that by end of 2020 one #COVID19 #vaccines may emerge as safe/effective.

But particular date in early Nov is well beyond any scientists could tell you/be confident.

.@Surgeon_General Adams: When a vaccine is approved or authorized by FDA, I & my family will be in in line to get it.

#COVID19 #vaccines #NIH #FDA

.@NIHDirector: We're doing something very novel.
He notes #NIH's #ACTIV public-private partnership [before the White House took over with #WarpSpeed]

#COVID19 #vaccines #FDA #CDC #BARDA

.@SenBobCasey: Americans have to see it. They have to see others taking the vaccine.
Will you commit to receiving #COVID19 vaccine in public view.

.@Surgeon_General Adams: Absolutely.

.@NIHDirector: I'm ready to roll up my sleeve as soon as they say it's safe & effective.

.@RandPaul says he's annoyed: We think everything is smallpox & submit.
He's insisting every individual needs to make their own decision.

[He seems to be playing to the antivaxxers here. ]

#COVID19 #vaccines #NIH #FDA

.@NIHDirector: I think it would be premature what would be appropriate [on mandating #COVID19 #vaccines for children for school entrance]
Collins says he's not ready to give an answer to @RandPaul.

#NIH #FDA #CDC

On #COVID19 vaccine trial paused, .@NIHDirector says the company … in best position to let other participants know why there's a hold. A single adverse event. Best approach to quickly stop. Not much time until all in trial get direct communication.

#vaccines #pharma #NIH

.@SenatorCollins: Who is going to make decision on allocation of #COVID19 #vaccines?
.@Surgeon_General Adams notes no final recommendations yet from @theNASEM & #CDC #ACIP but agree health care workers first. Then who is most vulnerable.

#NIH #FDA

.@NIHDirector notes #COVID19 #vaccines storage is a component of #WarpSpeed & working w/ #CDC on it. must remain frozen at minus 70 degrees Celsius. That is a challenge for a lot of situations.
Intense attention on it.

#NIH #FDA

.@SenWarren: People more likely to take #COVID19 #vaccines if trust decision on science.
Unfortunately, Trump has undermined trust. Overruled scientists.
He's spread dangerous misinformation & appointed former #pharma exec to run vaccine efforts.
#NIH #FDA #CDC

.@SenWarren on Trump's politicization of #COVID19 #vaccines & his insistence one will be approved before Nov. #2020Election: "It has gotten so out of hand, that #pharma #biotech promised to adhere to high ethical standards & sound scientific principles."

.@NIHDirector: We're going to have to work really hard to get the facts out there.

#COVID19 #vaccines #NIH #FDA #CDC

.@SenWarren: Is that Trump is doing helpful or not?
.@NIHDirector: I just hope Americans will choose to take information they need from scientists & not from politicians.

#COVID19 #vaccines #NIH #FDA #CDC

.@SenWarren: Congress is lying to itself & to the public if it pretends Trump cares about anything other than his own political survival when it comes to vaccine development.

#COVID19 #vaccines #NIH #FDA #CDC #2020Election

.@Surgeon_General Adams: Public health has long been underfunded

[Reminder: Trump has repeatedly sought to cut #CDC & other public health funding in his annual budget requests, including for FY 2021 in the midst of #COVID19 #pandemic]

#vaccines #NIH #FDA

.@NIHDirector notes monoclonal antibodies might be helpful for people sick with #COVID19 but also may act as a preventative therapy.

#vaccines #NIH #FDA

.@NIHDirector again notes he doesn't have any other details on #COVID19 vaccine trial participant adverse event beyond what @nytimes reported as transverse myelitis, which is sometimes confused with guillain barre on first presentation.

#NIH #vaccines #FDA #CDC

.@NIHDirector: 2-dose #COVID19 #vaccines not ideal. Ideally like to have a single dose that didn't require refrigeration/was easily transported.
May not be lucky enough in big push to have something w/ perfect parameters. But most important we get something that works/saves lives

.@Surgeon_General Adams: People will trust their local provider more than anyone out there.

[How may local providers are listening to Trump?]

#COVID19 #vaccines #NIH #FDA #CDC #masks #MaskUp

.@Surgeon_General Adams: We need people to stop attacking the process.

https://twitter.com/realDonaldTrump/status/1297138862108663808

#COVID19 #vaccines #NIH #FDA #CDC

.@Surgeon_General Adams today: We need people to stop attacking the process.

.@MarkMeadows Aug. 23 on #FDA & #NIH scientists: "If they don’t see the light, they need to feel the heat."

abcnews.go.com/Politics/week-…

#COVID19 #vaccines #CDC

.@SenatorHassan: Should #FDA #VRBPAC adcom meets before any U.S. approval of #COVID19 vaccines?
.@Surgeon_General Adams: I think we need to follow the process. Need to be careful about inserting new barriers.

Hassan: This isn't a new barrier or process. It's the existing process

.@NIHDirector: People have forgotten kids die of #measles.
We have benefited from success of #vaccines & a generation has lost track that these save lives.
It's heartbreaking/frustrating that misinformation is so readily spread by people who have another agenda.

#COVID19

.@NIHDirector: The way in which the Russians rolled this out declaring victor did not win them a lot of confidence in the scientific community.
We must be insistent that if somebody is going to say vaccine is safe/effective, they've lived up to high standard.

#COVID19 #vaccines

.@NIHDirector acknowledges there may be administrative costs for administering #COVID19 #vaccines & says administration is working on that.

Costs for boosters a downstream conversation.

.@NIHDirector: By time seen 150 cases #COVID19, if vaccine is at least 50% effective, you're going to know it.
This is an event-based decision process.
You count those events & you know if it worked or not.
DSMB raises their hand & says OK #FDA it's time to have a look.

.@DougJones asks about crazy #COVID19 #vaccines conspiracy theories.

.@NIHDirector: The craziest one I've heard is this is all designed by @BillGates & it has a chip in it & watch everything you're doing.

"And people believe that stuff."

.@Surgeon_General Adams giving @ladygaga lots of attention today at Senate #COVID19 #vaccines hearing.

Meanwhile,

https://twitter.com/mkraju/status/1303727747899035649

#COVID19 #coronavirus #pandemic

.@SenAlexander asks about multiple shots for #COVID19 #vaccines?
.@NIHDirector notes HPV is a two-shot vaccine & started out as 3 shots.

[Also #shingles is a two-dose vaccine. #Flu is annual. Others require periodic boosters, like tetanus]

#NIH #FDA #CDC

.@SenAlexander: The time to sustain our preparedness is now while our eye is on the ball.

[So, the past two decades of lawmakers saying this & the outcome has been …]

#COVID19 #vaccines #NIH #FDA #CDC

.@SenAlexander: You can have herd immunity where let it rip & let #COVID19 roar through the population killing people until everyone either is killed or recovers or can have it through #vaccines.

#NIH #CDC #FDA

In closing out today's #COVID19 #vaccines hearing, @NIHDirector & @Surgeon_General praise @SenAlexander, who is retiring at end of this term. But Alexander reminds them he's "not gone yet."

Out from the paywall:
US NIH chief urges COVID-19 vaccine makers to earn trust through transparency spglobal.com/marketintellig… #COVID19 #vaccines #NIH #FDA #CDC #pharma