Thread by @ASlavitt

COVID Update: A setback is a setback. And we’ve had 3 setbacks with vaccine testing this week.

But all of those setbacks remind me of how blessed we have been so far by science and the people who monitor safety.

1/

One setback, announced yesterday, is the change of position from the CDC on Johnson & Johnson’s vaccine. 2/

J&J’s vaccine was flagged and pulled from the market temporarily in the Spring when reports of several blood clotting issues arose.

Many criticized the decision for causing doubt & disruption of vaccines at a critical moment after it was ultimately put back on the market. 3/

Having been in the WH at the time, there were 2 incontrovertible reasons the vaccine was temporarily pulled.

One was the standard treatment for w blood clot turned out to be the wrong clinical response. Flagging the vaccine was the only way to be sure docs treated it right. 4/

There were 2 deaths at the time & the FDA wanted to see if more reporting would come in if people hunted for the problem. Not much was there.

But today the death toll = 9, enough for the recommendation to say people are better off w Pfizer or Moderna. 5/

A setback? Yes. We need more safe & effective vaccines, not fewer.

But this should be massively comforting as well. Vaccines have been used over 8.5 BILLION times. Thee safety profile is extraordinary. And the safety regulators are monitoring closely. 6/

And only 9 deaths, considering the millions of times it has been given, means that in places where mRNA vaccines are not available, makes J&J still a very safe vaccine.

But this call is exactly right. It’s not as safe as the others given a choice. 7/

The bigger concern- and a real one— is how J&J holds up in effectiveness against Omicron. And it appears not very well.

Which is why people w J&J are being encouraged to revaccinate & boost. 8/

The second setback that was announced today was the lack of a response in Pfizer’s testing of the dose given to 2 to 5 year olds (it had a good response on 6 Mo to 2 year olds).

For many parents this is incredibly frustrating & disappointing. Small kids are at risk to Omicron.9/

The latest thinking is that it will be 6 months before a dosing can be approved now for kids under 5. And then it may be 3 doses— also disappointing for parents.

This creates barriers & inequities for the many parents who will find that very difficult. 10/

We’re not used to reading disappointing news about vaccine trials. We’ve had a streak of successful first trials from the original vaccines to teens to kids that it’s easy enough to forget that the vast majority of trials fail. 11/

Getting the dosing right in children is obviously something to test & roll out carefully. Too much vaccine in a 25 pound healthy child is something people who make vaccines are expert at preventing.

So it is smarter to test smaller doses than bigger. 12/

But this means of you err, this is what happens. A safe bit ineffective dose is far better than an unsafe effective one.

Just imagine if we were reading today that a vaccine trial hospitalized toddlers. It would be a long time before parents trusted the vaccine. 13/

Thanks to the safety regulators & people who conduct these trials, we are not in that situation.

There’s no denying how worrying it is to go into 2022 without a vaccine for pre-school age kids in the face of Omicron. As a baseline parents & gparents need to boost. 14/

On that note Pfizer filed to extend boosters down to age 12. 15/

More in the “the news isn’t always good” front is early signs from the UK that the booster may wane over the first few months with Omicron.

This would be another setback. But like the others not one we can’t deal with. 16/

Vaccine makers can adjust the vaccine to target the variant better. Two & three doses seem to do a great job protecting against severe disease. 17/

The reality is the virus is highly adaptable & fit. But I still think science is better.

It’s not always as fast as we want. Doesn’t always get us what we need in time. And every day feels costly. But our ability to prevail isn’t in doubt. 18/

There are many at risk while science adjusts. People who can’t be vaccinated & boosted. Older people & those with chronic conditions or immuno-compromised. Our policies & our resources should protect them. 19/

Our policies, including disability policies & health coverage policies, should also be cognizant of long-term COVID effects.

Where science has temporary shortcomings, our policies should fill the gap. 20/

And so should our behavior. A very opinionated news anchor read me what he considered to be his tough common sense wisdom.

“Nobody’s going to alter their plans over Christmas so Biden better do something else.” 21/

Aside from being classic gaslighting, believe me the president doesn’t expect people to be safe on his account.

But if you’re going to be around kids under 5, older people or sick people, if science won’t protect them, that means we have to. 22/

Our will ought to harden in the face of setbacks. Their presence makes me appreciate or progress I’ve taken for granted.

But no matter how good science gets, we won’t be able to science away indifference. /end