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.

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

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More from @ASlavitt

16 Dec
COVID Update: Three groups of Americans will face Omicron in 3 very different ways.

Those who can
Those who can’t
And the biggest group— those who can but haven’t

17% of Americans have gotten boosted, a dangerously low number with a virus which doesn’t respect prior infection or those with 1 or 2 doses. 2/
23% of Americans either aren’t eligible for boosters (17%) or eligible for the vaccine (6%).

That’s 75 million Americans who are basically counting on the rest of us to stay safe through no choice of their own. 3/
Read 12 tweets
16 Dec
COVID Update: Omicron will peak in the US in the third wave in January according to a consensus of 10 scientists we interviewed. 1/
So far Omicron is doubling every 2-4 days, extraordinarily fast. People with prior infections or have been vaccinated but not boosted are right in the path of the spread.

This makes the spread 2-3x as fast as Delta. 2/
Even with a limited understanding of the severity of Omicron, it feels like this implies some concerning news and some better news (it’s all relative at this point😕). 3/
Read 21 tweets
13 Dec
COVID Update: Vaccine boosters appear to double the effectiveness of vaccines against Omicron.

But with only 14% of the country boosted, we should brace for a tough winter. 1/
Studies in the UK and SA are coming back with a consistent finding.

Prior Delta immunity is not preventing Omicron. Re infection rates are at least triple Delta.
2 Pfizer vaccines (presume same for Moderna) have a 30-40% efficacy against Omicron. 2/
Some good news. In both cases (prior immunity & 2 vaccines), studies are showing T cell response (our line of defense that prevents more severe illness in the lungs) continues to work against Omicron. 3/
Read 20 tweets
12 Dec
COVID Update: At a time when most scientists are concluding an additional mRNA vaccines is needed, a Republican senator wants to go the other direction.

His idea? Prior infection should count as immunity. 1/
Roger Marshall from Kansas thinks the country should officially recognize prior COVID infection as the equivalent of being vaccinated when considering a vaccine requirement.

He’s not alone but he’s wrong in so many ways. 2/
Roger also recently said this:

“The people that have thus far not gotten the vaccine are not going to do it until this White House acknowledges natural immunity.”

He’s calling for a sort of protest? Wut? 3/
Read 21 tweets
9 Dec
COVID Update: 2 weeks ago we said we would know a lot more about Omicron in 2 weeks.

I’ve rounded up the best scientific opinions to share a consensus. 1/
The bottom line-up front: We should expect a significant wave of COVID this weekend: likely a Delta + Omicron wave. 2/
The consensus view of Omicron is that it is NOT innately more contagious, but that it IS spreading much faster. 3/
Read 25 tweets
4 Dec
Here’s the explanation. Omicron will only spread as fast as there are people to infect.

So the Rt or spread will be lower if Omicron can’t outcompete Delta or if it finds large amounts of unvaccinated people, even with prior Delta infections (as it has in S Africa). 10/
It’s possible that this is what’s happening. Omicron could be spreading no faster than Delta but because prior infection slows Delta down but not Omicron, that creates a higher Rt. 11/
This means Omicron, at least in parts of the US with low vaccination rates, will likely be dominant over the next few months even if it is no fastero than Delta.

Again, we all pay for the bad choices any of us make. 12/
Read 11 tweets

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