Good news! Pfizer data today indicate they have a safe and effective COVID-19 vaccine for kids ages 5 to 11. Kids vexed by Halloween? 🧵
🔵  Antibody titers as high as adults
🔵  "Favorable safety profile" with 10 microgram dose used
🔵  Filing with FDA.

pfizer.com/news/press-rel…
🔵  Antibody titers were as high as adults

The fact that the peak antibody titers are equal between the kids 5 to 11 years old and young adults indicates the COVID vaccine will be protective in the kids.
🔵  "Favorable safety profile" with the 10 microgram dose used

Pfizer used a dose of 10 in the kids instead if the 30 used in adults. That was a reasonable decision, and they see fewer side effects with the lower kid dose (fevers, chills, etc). Other doses were tested early on.
It will be good to see the full data set, but Pfizers reports have been accurate before, and dropping the dose from 30 to 10 is likely to result in fewer side effects than seen in the 12-15 year olds with the 30 dose.
The vaccine study enrolled 2,268 kids.
"The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said pediatric studies should be large enough to rule out any higher risk to young children."
That’s from this article
apnews.com/article/busine…
🔵  Filed with the FDA
It looks like they are filing this with the FDA ASAP, with the hope of having FDA EUA authorization before the end of October.
The antibody data are clear evidence the vaccine will work in the kids,
The FDA will have to make a judgement call on the safety data relative to “rule out any higher risk”, but one can expect the FDA to make a judgement relatively quickly.
I am going to repost this to fix the annoying autocorrect typo of vaxxed 🙄

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More from @profshanecrotty

20 Sep
Good news! Pfizer data today indicate they have a safe and effective COVID-19 vaccine for kids ages 5 to 11. Kids vaxxed by Halloween? 🧵
🔵  Antibody titers as high as adults
🔵  "Favorable safety profile" with 10 microgram dose used
🔵  Filing with FDA

pfizer.com/news/press-rel…
🔵  Antibody titers were as high as adults

The fact that the peak antibody titers are equal between the kids 5 to 11 years old and young adults indicates the COVID vaccine will be protective in the kids.
🔵  "Favorable safety profile" with the 10 microgram dose used

Pfizer used a dose of 10 in the kids instead if the 30 used in adults. That was a reasonable decision, and they see fewer side effects with the lower kid dose (fevers, chills, etc). Other doses were tested early on.
Read 10 tweets
14 Sep
Our newest study is out in Science!
It cover 5 COVID-19 RNA vaccine topics. Using samples from the "low dose" 25mcg Moderna RNA COVID-19 vaccine clinical trial 🧵👇🏼
science.org/doi/10.1126/sc…
By the LJI team! @Dani6020 @SetteLab @jmateust @ljiresearch
The five finding summarized here:
🔵  T cell memory to an RNA vaccine at 7 months
🔵  Vaccine dose sparing (25mcg v 100mcg)
🔵  Vaccine v. natural immunity
🔵  T cell memory with age
🔵  Pre-existing crossreactive memory T cells: Do they do anything?
🔵  T cell memory to an RNA vaccine:

Impressive T cell memory at 7 months (6 months after 2nd dose). CD4s & CD8s. Tfh & cytokine+.

Overall, looks like two doses of an RNA vaccine generates impressive T cell memory that is likely to last for many years.
Even 25mcg Moderna dose
Read 12 tweets
31 Aug
Just a friendly reminder that this study also addressed natural immunity compared to vaccine immunity. Vaccine immunity did somewhat better than natural immunity, including against Delta. Image
In that large, carefully done, prospective, longitudinal study in the UK of over 300,000 people with regular testing, both vaccine immunity and natural immunity showed significant protection against COVID-19, with vaccine immunity doing somewhat better than natural immunity. ImageImage
As a prospective study, with a randomization component, the conclusions have higher confidence compared to some other studies. including against Delta.
Read 4 tweets
21 Aug
Boosters+global equity:
Practically speaking, the US should continue to retain enough doses to vaccinate all unvaccinated Americans. But resistance to vaccination remains high, so there is probably little to no real cost in allowing Americans who want boosters to get a 3rd dose
The USA has to keep trying hard to vaccinate the unvaccinated. But many of those reserved doses will likely expire otherwise, sadly.

Discussed some in the chat with @CarlosdelRio7 @Bob_Wachter at the end
Any vaccine dose given to an unvaccinated American is FAR more valuable than a 3rd dose given to a vaccinated American. For preventing deaths, hospitalizations, cases, and transmissions.
washingtonpost.com/outlook/corona…
Read 7 tweets
20 Aug
I have no problem with boosters allowed at 8 months for people who want them.

Is there American data indicating waning immunity against Delta? No. Nothing substantial.

Is there uncertainty about protective efficacy against Delta COVID-19 at 6 months? Yes 🧵
The COVID vaccines are incredible--they have exceeded all expectations. But, Delta is tougher to stop. It is so transmissible. The original coronavirus wasn't that hard for the immune system to stop, and 2-doses of vaccine worked amazing.
2-dose gives overall good immune memory. New Moderna science paper on antibodies at 6 months. Our T cell data. Multiple memory B cell data. The COVID vaccines have worked incredibly well! Six month clinical trial efficacies of 91% and 93%.
Read 12 tweets
20 Aug
The science of COVID-19 booster vaccines 🧵

Will the boosters works?
Yes.
They work really well. Great clinical trial results.
Antibody levels go back to peak or 4x more, and the booster teaches your immune system to recognize Delta even better.

Many vaccines are 3-doses
You will also probably have more durable immune memory after the COVID vaccine booster (including antibodies, CD4 T cells, CD8 T cells, and memory B cells). Not guaranteed, but likely.
That's because your immune system is basically a cost:benefit analysis machine.
Immune memory / protective immunity has a real caloric cost over time. If your immune system sees something once, it doesn't tend to commit much energy into making memory and sustaining all of those antibodies. But if your immune system sees an infection 3 times (or a vaccine)…
Read 10 tweets

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