Thread by @celinegounder

1/ I really appreciated @EricTopol's guest essay in the @nytimes: nytimes.com/2021/07/01/opi…

I agree with much of this, but a few thoughts...

2/ There are really two questions here:

- How long will it take the FDA to grant full approval and why does it take that long?

- Will a full approval lead to greater confidence in the COVID vaccines and uptake among those not yet vaccinated?

3/ Regarding the first question:

I agree with @EricTopol:

I don't understand why the FDA approved aducanumab for treatment of Alzheimer's. There's limited data on its efficacy and there are real risks.

3 FDA advisory board members resigned in protest of this approval.

4/ Meanwhile, there's TONS of data on the safety & efficacy of the Pfizer & Moderna COVID vaccines.

In addition to >70K vaccine clinical trial participants,

>180M doses of Pfizer & ~135M doses of Moderna have been administered in the U.S.

covid.cdc.gov/covid-data-tra…

4/ Around the world, we're talking over a billion doses of Pfizer & Moderna vaccine administered:
ourworldindata.org/covid-vaccinat…
nytimes.com/interactive/20…

This is an UNPRECEDENTED amount of data on the safety & efficacy of any vaccine.

5/ Even with the rise of the Delta variant (more infectious/transmissible, immune-evading), the Pfizer & Moderna vaccines remain safe and effective.

Yes, we're seeing breakthrough infections, but these are generally mild and not leading to hospitalization/death.

6/ Regarding the second question:

Will a full FDA approval lead to greater confidence in the COVID vaccines & uptake among those not yet vaccinated?

I'm not so sure. Perhaps among a subset... especially among parents and younger people... but I don't think this is a panacea.

7/ When people say they want to see a full FDA approval, I think some are genuine in saying that and will get vaccinated.

But I fear that the vast majority of those who haven’t gotten vaccinated will NOT be swayed by a full FDA approval.

8/ A couple months ago, I participated in a focus group with Republican pollster @FrankLuntz & @deBeaumontFndtn @BrianCCastrucci. Our group consisted of women of reproductive age to see what concerns this specific group might have.

9/ We started with an open-ended conversation. Many said they needed more information. I asked them if they had any questions about COVID & COVID vaccines, specifically the impact on menstruation, fertility, pregnancy, or breastfeeding. They had no questions.

10/ In fact, they had NO questions about ANYTHING COVID-related. (@FrankLuntz was a bit frustrated with the group.)

So when people say they need more information about COVID vaccines, I don’t think they’re talking about scientific data.

11/ They’re talking about social & political information.

And that’s really about trust.

Not only do you need to not look down on them, but also, do you have their best interests at heart?
What are you doing to advance their interests?
Are you one of them?

12/ Will people who say they need more data be convinced by a full FDA approval?

Some yes.

But I suspect that most say they still need more data:
1 year, 5 years, 10 years, etc of follow-up data

13/ Impossible expectations are a well-known tool of science denialists.
More on that here:
crankyuncle.com/23-ways-to-mis…
and here:
justhumanproductions.org/podcasts/epide…

14/ We know from our experience with all other vaccines to date

including the *almost 250-year-old smallpox vaccine*

that side-effects from vaccination occur within 2 months of vaccination.

15/ This is why Pfizer, Moderna, & J&J waited until they had at least 2 months of follow-up data before applying for emergency use authorization.

Pfizer & Moderna are now submitting 6 months of follow-up data in their applications for full approval.

16/ There's ample data on the safety & efficacy of the Pfizer & Moderna vaccines to warrant their full approval by the FDA ASAP.

However, it's really important that FDA approval NOT appear to be politicized or influenced by outsiders.

17/ Trump voters have already questioned why the FDA didn’t grant EUA until after the election.

That's because of #14 in this thread.

https://twitter.com/celinegounder/status/1412816202158772227?s=20

It wasn't a political decision.
The science had to play itself out, and there was no time machine to speed that up.

18/ If you look at who still hasn’t been vaccinated,

i.e. the people who we haven’t been able to reach with educational outreach, trusted messengers, incentives, etc,

it’s largely white Republican voters.

washingtonpost.com/politics/2021/…

19/ We cannot risk creating the perception of political or outside interference, especially among vaccine holdouts.

We all wish the FDA had issued full approval of the COVID vaccines by now,

but the FDA surely appreciates the urgency?

20/ The last phase of a vaccination campaign is the hardest and takes the longest in no small part because so much of this is about building trust, and that takes time.

It’s not enough to show people data.

21/ Some thought that if we said you don't need to wear a mask if you're vaccinated, that would be an incentive for people to get vaccinated.

Maybe it was for a few, but not for most who hadn't yet been vaccinated.

That's just not how people think.

22/ We've got to prove ourselves trustworthy, and that doesn't happen overnight. justhumanproductions.org/podcasts/s1e68…
We've made some inroads with communities of color, but we still have much work to do.
Meanwhile, we've barely scratched the surface of that work with white Republican voters.

23/ I think what full FDA approval will do is to empower more employers to require vaccination of their employees.

This will NOT come in the form of government mandates.

24/ The private sector may see that it’s in their business interest to require vaccination:
- fewer lost days of work
- less lost productivity
- reducing liability (e.g. health care industry)
- helping customers feel more comfortable (e.g. travel industry, restaurants, bars)

25/ But how the private sector behaves & whether it feels a full FDA approval gives it cover to require vaccination will really depend on the local social and political culture of its employees and customers.