Thread by @KashPrime

How is it that 18m after the first mRNA vaccine was developed we still don’t have an approved vaccine for kids?
This will be one of the greatest preventable public health failures in history, and it is happening in real time right before our eyes
What can we do? Some ideas:

The stakes are massive; cases in children in the US are rising exponentially. Given how infectious Delta is, and the lack of mitigations in most schools, we can expect many, perhaps most, children to be infected in the next few months. aap.org/en/pages/2019-…

And it must be emphasized, as seen above, children can get seriously ill from this virus; 1/100 will need hospital admission, 1/10000 will die. 24 died in the US last week out of 200k new infections
1/50 will get Long Covid:
covid.joinzoe.com/post/long-covi…

In June the FDA’s Vaccines and Related Biological Products committee (VRBPAC) met and asked vaccine makers to expand trial sizes. A lot of concern was raised about the risk of myocarditis. Full meeting is here. It's 7h but very interesting to watch:

Key was the role of Dr Cory Meissner, who argued that case counts were low, and that this wasn’t a serious disease in children. What’s more curious is Meissner’s role in anti-mask advocacy, including this editorial in WSJ. Some quotes from the meeting:
wsj.com/articles/masks…

Meissner is a prominent signatory to the Great Barrington Declaration (GBD), which many right-leaning and libertarian physicians support, but has been roundly criticized by most others
usnews.com/news/healthies….

It’s fair to say that these views are not supported by the majority of the medical community, and viewpoints held by supporters of the GBD, against mask-wearing, lockdowns, airborne spread, protecting children, etc. have been proven wrong repeatedly throughout the pandemic

I bring up ideology in what should be a medical discussion because it pops up in the UK as well.
The JCVI in the UK has not even recommended for 12-15 year olds, and has enormous errors in analysis:

https://twitter.com/dgurdasani1/status/1433868576075784200?s=20

When you look deeper at the data presented at the FDA, and in the ACIP meeting the following week
-Risk is primarily in adolescents
-80% of cases were after 2nd dose
-Myocarditis occurred within 1-6 days of any dose
ACIP meeting recording is here:

Indeed, in Israel the cost benefit analysis was seen in a more positive light and vaccinations for younger patients was approved. Children 5-11 with serious conditions are being vaccinated now: timesofisrael.com/no-major-side-…

Sadly the FDA asked for 6 more months of data, and to double the trial size for kids. Most committee members knew this would likely find little, This will put vaccine approvals far into the winter, rather than September as expected.raps.org/news-and-artic…

It is unfortunate that deliberations in Canada, Europe aren't as transparent, and it seems a lot is deferred to the FDA by every medical authority.
Going by meeting minutes, the EMA doesn’t seem to have discussed pediatric vaccines at all:
ema.europa.eu/en/committees/…

Obviously regulators have a heavy burden; they have to approve something that could go to millions of children. Rare side will manifest. But these trials are too small to pick up the rarest of conditions anyway, and almost all children are likely to contract Covid this year.

Regulators and drug makers face no liability for virus-related complications, for the kids who will end up in ICU with Covid, or those who will endure #LongCovid for years, so the urgency is less. Also, two key officials stepped down recently:

https://twitter.com/ZacharyBrennan/status/1432702730389311504?s=20

A modest proposal given the crisis we're facing:
Step 1: Release what data currently exists. Data is continuously being submitted by Pfizer and Moderna to the FDA, Health Canada, EMA and others. Time to open it up so we can all see if these vaccines are safe or not:

Step 2: Step-wise vaccinate younger and younger children. Already some children age 11 have been vaccinated in Ontario with few ill effects. Study carefully, look for myocarditis. Do cardiac MRIs to look for Late Gadolinium Enhancement. Halt if there's a safety signal.

Step 3: Skip second doses for now, where 80% of myocarditis cases happen. These can be given once more fulsome data is available.

We could save millions of children from the short and long-term effects of Covid, save the school year, and prevent side effects. There is a massive cost to inaction and inertia; we simply cannot defer and hope for the best at this point.. it is far too late for that now

I and many of my colleagues hesitate to pile on the tough job these regulatory bodies have; but we are facing a very real threat to an entire generation of children and must act and decide quickly.

Good example of a politician overruling an advisory body's wrong opinion on vaccines for children. All politicians will need to do the same to ensure children are protected. Too bad ours in Canada are paralyzed by the current federal election.

https://twitter.com/2primates/status/1434469329534398468?s=20

Time for us to follow the lead of Israel and Slovakia:

https://twitter.com/itosettimd_mba/status/1435680976986902529