Numbers in the US continue to improve: cases flat or falling in 40/50 states.  Deaths are down to “only” 1400/day, with about 12 times as many deaths in the unvaccinated as in the people who had already gotten their shots.

More in the good news category: seven BILLION vaccines have been given world wide, and there’s been no new side effects detected.

Covid is now the biggest vaccine campaign in the history of the world: currently 31 million shots a day carried on planes, trains, trucks, car trunks, motorcycles, scooters, buses, bicycles, horses, mules, donkeys, burros, one intrepid walker with a cooler on her back after another after another.  My word.  One world.

Pediatric vaccines

The big news this week is the FDA’s committee’s (VRBPAC) approval of an EUA for the Pfizer vaccine for 5-11 year olds.  Next step is the CDC’s  ACIP committee’s Tuesday/Wednesday meeting looking at the question — and then CDC director Dr Rochelle Walensky’s review.

They’ll look at the data about transmission and illness, and they’ll also try to anticipate the “public health consequences” of any guidelines — not just the impact on individual numbers but also on society, on next steps, on the US as a whole.

Although CDC approval isn’t a “slam dunk” — kids are more complex than vulnerable adults — the manufacturer has already begun the process of shipping “pediatric vials.”  They are a different dose  —one-third the adult dose — so they have their own specially color-coded orange-topped vials.

Since it is new dosing, they can’t just use the old vials on the shelf (which have, incidentally, a purple top).  So it’s going to be a whole new roll-out.

Remember how when the first vaccines first came out, some of us hit “refresh” on the scheduling website 30,000 times in one day and ended up with carpal tunnel syndrome?  Remember how we set our alarms for 12:01 am so we could jump on the first batch of CVS appointments and then were so triumphant with victory or enraged with frustration that we couldn’t go back to sleep until 4 in the morning?

Hopefully it won’t be that crazy. For one thing, there’s “only” 28 million kids 5-11 and plenty of vaccine to go around.  On the other hand, the thought of getting that shot into kids’ arms definitely is bringing out the Mama Bear in a lot of parents.

This time it’s going to be a much more de-centralized vaccine program.  It will take place more in doctors’ offices and children’s hospitals and some pharmacies.  Some towns and school districts will have vaccine clinics, too — and on week-ends, reminiscent of the polio vaccines I received way back when.

So it might be crazy at the start, with pent-up demand exceeding roll-out for a bit.  But sooner or later anybody who wants to get their kids vaccinated will be able to.  With or without the carpal tunnel syndrome.

Safety/effectiveness

The FDA’s committee looked long and hard at how the vaccine worked against Covid in the 3000 trial kids. 

Answer: fantastically. This vaccine again showed itself to be a miracle — 90% effective at preventing infections and no new side effects. In all the headlines and chit-chat, it’s easy to forget their fantastic power. These vaccines are a TREASURE.

The Committee also looked at the “epidemiology” of kid Covid — the numbers.  They looked at how many kids get regular Covid, how many get hospitalized or god forbid die, how many get MIS-C, and how many get long Covid.

It turns out, as we know, that tons of kids 5-11 are getting Covid, especially in communities with high transmission, low vaccination, little masking, etc.  Most do fine, but a fraction end up hospitalized and a third of them end up in the ICU.  And the chances of these bad things happening are THREE TIMES higher in children of color.

They also looked at how many kids developed heart issues like “myocarditis” or “pericarditis” (inflammation of heart muscle or lining).

It turns out there actually wasn’t any heart impact in the vaccine trials in these littler kids — very encouraging, since we know serious heart effects can happen with Covid and with MIS-C and are seen in long Covid.

Some people say, “Oh the numbers of kids in the trials were too small to detect heart issues” and that may well be true.  It is certainly possible we will end up seeing a few cases of myocarditis in kids post-vaccine, but the data so far is reassuring that it’s a) not going to be very many and b) we can spot it right away. 

So: so far it looks like heart issues from the shot are much rarer than heart issues from a Covid infection in kids this age.

Other side effects are the “minor” and temporary ones we’ve gotten used to (but love talking about as well, since we are all once again charter members of the Vaccine Misery Litany Club, Boost Edition): headaches, fatigue, fever, shot site tenderness, sometimes swollen lymph nodes.

A few people have wondered aloud to me if the kid vaccines were rushed.  This is a puzzling fear to me. There was years and years and DECADES of work on these kinds of vaccines. These are some of the most extensively studied and researched compounds in the history of the world.

A few people have also wondered aloud to me their worries that there could be long-term side effects we don’t know about.  This is also puzzling to me as it goes against science and the history of vaccines:

  • The vaccine components start vanishing from the blood within minutes and hours and are gone within days.
  • mRNA has nothing to do with DNA.  No communication, no connection, no impact, no worries.
  • In the history of the world of vaccination, we have very rarely seen a long-term side effect occur after a couple weeks.
  • We have a follow-up surveillance program that has shown it can spot a one-in-a-100,000 event. 
  • These vaccines have been given to SEVEN BILLION people for over 15 months and we haven’t seen any hint of any long-term problems. 

So no, it’s not “rushed” rushed, and yes, the chances of a horrible long-term side effect is pretty remote. And the idea of reducing cases and probably transmission and suffering and worry — and maybe getting away from masks and school disruptions for all of us— seems worth the small risks to me.

The CDC Director Dr Walensky and I both worked at MGH at the same time but never really overlapped. 

However, one time I sent her an email which I signed with my first initial as simply “r.” In her email back to me, she signed off as “the other r.”  I found this hugely thrilling — I admired her very much — and I saved the email (maybe I’ll sell it on Ebay some day). 

So let’s see if “the other r” agrees with me and approves the shot for all kids.  We’ll probably know by Thursday.