FINAL UPDATE: FDA & CDC officially approve Moderna & Pfizer #COVID19 vaccine for infants/toddlers!

COVID-19 Vaccine

UPDATE 6/17/22: OK, now it's official:

The Food and Drug Administration on Friday approved Pfizer and Moderna COVID-19 vaccines for emergency use in children under the age of 5, a monumental step for parents who have spent the past two years buffeted by day care and school closures while taking strict precautions for the health of their kids.

Shots could be in toddlers’ arms before the end of June, pending approval from the Centers for Disease Control and Prevention.

UPDATE 6/18/22: Advisers to the Centers for Disease Control and Prevention on Saturday unanimously recommended the nation’s first coronavirus vaccines for children under 5, one of the last steps before the Moderna and Pfizer-BioNTech vaccines can be given to as many as 19 million children across the United States.

CDC Director Rochelle Walensky is expected to endorse the recommendation later Saturday, allowing some clinicians, pharmacies and other providers to begin giving the shots as early as Monday. Doses began shipping Friday following the authorization by the Food and Drug Administration, which found both vaccines to be safe and effective.

UPDATE 6/18/22: BOOM, THERE IT IS: CDC approves Covid vaccines for youngest kids

The wait is finally over.

On Saturday, the Centers for Disease Control and Prevention Director Dr. Rochelle Walensky signed off on Covid vaccines for the youngest Americans. Her endorsement means shots can begin immediately, finally ending the two-and-a-half year wait on the part of parents of children under 5.

There's no longer any reasonable excuse for at least 90% or more of the U.S. population to be fully vaccinated by the end of 2022 (or by the end of October or so, really, but I'm trying to be as conservative as possible). That won't happen, of course, but a guy can dream...

Original story below:

I first saw the news via Twitter...

FDA committee votes to approve Moderna's vaccine for children 6 months to 6 years of age!

— Jeremy Faust MD MS (ER physician) (@jeremyfaust) June 15, 2022

...which was quickly confirmed via multiple sources, including the Washington Post:

FDA advisers recommend greenlighting Moderna covid shot for young kids

BREAKING: Independent advisers to the Food and Drug Administration on Wednesday unanimously recommended the use of the Moderna coronavirus vaccine for babies and young children, and were expected to do the same momentarily for the Pfizer-BioNTech shots.

Expert advisers to the Food and Drug Administration are meeting Wednesday to review scientific evidence on coronavirus vaccines for the nation’s young children, the last group in the United States not yet eligible for shots.

Opening the meeting, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, conceded that young children don’t get sick with covid-19 as frequently as adults. But he said 442 children younger than 5 had died of covid through the end of May, a toll higher than for many other pathogens, including influenza, for which there are vaccines. Marks said it was important not to become numb to deaths in children.

I assume the Pfizer-BioNTech version will be formally recommended within the hour as well (it's already authorized for 5yrs+); the FDA itself then has to formally authorize it. After that it's on to the CDC for final authorization.

The recommended dose regimen for the Moderna version is the same for young children as older people (the first 2 doses given 4 weeks apart), so I assume the Pfizer version will also be the same (the first 2 doses given 3 weeks apart). If so, and assuming the CDC gives its formal stamp of approval soon as well (say, by the end of June), the first batch of ~20 million U.S. young children getting their second dose should start showing up in the vaccination data starting around the end of July/early August.

UPDATE: Sure enough, the FDA panel also recommended the Pfizer/BioNTech version of the vaccine as well, although the Pfizer version actually includes a third shot as well (8 weeks after the second one):

The FDA’s independent vaccine advisers voted unanimously Wednesday to recommend the agency authorize two Covid-19 vaccines for babies, toddlers and preschool-age children, putting the country’s youngest age group one step closer to immunizations nearly two-and-a-half years into the pandemic.

The panel — comprised of pediatricians, infectious disease experts and vaccine researchers — found that the benefits of vaccinating children under 5 against Covid outweigh potential risks.

The FDA is expected to quickly authorize for emergency use the Pfizer-BioNTech vaccine for kids under 5 and the Moderna vaccines for kids under 6. Both options could be used in children as young as 6 months old.

The CDC’s panel of expert advisers will consider whether to recommend the shots’ administration during meetings on Friday and Saturday. Once CDC Director Rochelle Walensky signs off on a recommendation, children are expected to begin receiving shots by Tuesday. Children under 6 who receive the Moderna vaccine will get two 25-microgram doses, four weeks apart. The Pfizer vaccine is two 3-microgram doses three weeks apart, followed by a third dose eight weeks later.

Peter Marks, FDA’s top vaccine regulator, started off the daylong meeting pointing to the burden of Covid hospitalizations for young children during the Omicron wave, rates that have equaled or exceeded those for other common childhood vaccine-preventable diseases like the flu. More than half of children under 5 who have been hospitalized for Covid did not have underlying health conditions, and 202 in the 6-month to 4-year-old age group have died of the disease as of May 11.

OK, I stand corrected: If they're both formally approved by both the FDA the CDC by Tuesday, June 21st, that means the first batch of young kids could be receiving their 2nd Moderna shot as soon as July 19th, and their 3rd Pfizer shot as soon as September 6th.