FDA Set to Approve Pfizer for 12 and Up

The least vulnerable Americans will soon be vaccinated.

While billions of vulnerable adults worldwide are unvaccinated, the United States will soon start protecting pre-teens. WaPo (“FDA appears poised to authorize Pfizer-BioNTech vaccine for adolescents by next week“):

The Food and Drug Administration is expected by next week to grant expanded emergency use authorization to allow children as young as 12 to receive the coronavirus vaccine developed by Pfizer and German firm BioNTech, according to three federal officials familiar with the situation.

The agency is still working on the authorization, said the officials, who spoke on the condition of anonymity to speak freely. Shortly after the FDA decision, a Centers for Disease Control and Prevention advisory committee is expected to meet to recommend how the vaccine should be used.

[…]

Families and pediatricians have been eager for a vaccine to become available for children, particularly in advance of the next school year.

Stephanie Caccomo, a spokeswoman for the FDA, declined to comment on the timeline.

“The FDA’s review of Pfizer’s request to amend its emergency use authorization (EUA) in order to expand the age range for its COVID-19 vaccine to include individuals 12-15 years of age is ongoing. We can assure the public that we are working to review this request as quickly and transparently as possible,” Caccomo said.

[…]

Pfizer announced at the end of March that it had submitted data from a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom had received the same two-shot regimen that has been shown effective and safe in adults.

The shot triggered stronger immune responses in the teens than those found in young adults. There were 18 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the two-shot regimen offered similar protection to younger recipients as it does to adults.

Children are far less likely to suffer severe illness from covid-19, the infection caused by the virus. About 300 children have died in the United States, out of more than 576,000 total deaths.

Follow-on trials testing the Pfizer-BioNTech vaccine in younger children are ongoing.

The biotech company Moderna is conducing a similar trial of its vaccine in teens, with results expected in the summer. Moderna is also testing its vaccine in younger children. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.

This is good news, indeed, for the wealthy nations who can obtain the vaccine. Certainly, my 12-year-old will be getting her shots, as have my 17-, 20-, and 21-year-old stepchildren. That will leave only my soon-to-be 10-year-old unvaccinated. Given that they’re back in school four days a week and expect to be full-time in the fall, that’s great news for us.

But, again, I’m not sure this is the wisest way to handle a global pandemic. Unless we can stop the spread in places like India, where essentially no one has been vaccinated yet, the virus will continue to mutate.

FILED UNDER: COVID-19, Health
James Joyner
About James Joyner
James Joyner is Professor and Department Head of Security Studies at Marine Corps University's Command and Staff College and a nonresident senior fellow at the Scowcroft Center for Strategy and Security at the Atlantic Council. He's a former Army officer and Desert Storm vet. Views expressed here are his own. Follow James on Twitter @DrJJoyner.

Comments

  1. Jen says:

    I’m going to take minor issue with your subhead:

    “The least vulnerable Americans will soon be vaccinated.”

    A reminder that not all children are “least vulnerable.” Within my own circle of friends/family/neighbors I know:
    1) A child under 16 with cerebral palsy
    2) A tween who was a micro-preemie and has lung problems
    3) A child under 16 who has Type-1 diabetes
    4) A childhood cancer survivor
    5) A child who has a congenital heart defect
    6) And, several children with asthma

    Yes, in general, children are less vulnerable. However, it’s also true that there are many, many parents of medically vulnerable children who are extremely happy that they can now get their children vaccinated, and it’s important for others to do so too–to protect those children further of course, through something resembling herd immunity, but also to prevent this virus from continuing to circulate among children with the potential that variants could make it something far more dangerous for kids.

    9
  2. James Joyner says:

    @Jen: Fair enough. But the overwhelming number of kids who will get vaccinated under this new approval will be those who could wait a year or two with next to no risk.

    2
  3. OzarkHillbilly says:

    @James Joyner: those who could wait a year or two with next to no risk.

    The protection is not just to the children tho, it is to those people around them, some of whom may be unable to be vaccinated. That is what herd immunity is about. As long as there is a large segment of the population where the virus can circulate unimpeded, herd immunity is a unicorn. Something talked of but never actually seen.

    I’m not an epidemiologist and you may well be right that this is the wrong move to make at this time, but I can see the rationale for it (in conjunction with tackling India’s and Brazil’s crises)

    8
  4. Kathy says:

    There’s another matter. Perhaps younger children have been spared the worst contagion because schools were closed for so long.

    I know in the US the school situation varies with the square of the number of school districts or something. In Mexico, schools have not reopened since they closed last year. This may account for the low cases and low deaths among children.

    6
  5. Kathy says:

    But, again, I’m not sure this is the wisest way to handle a global pandemic.

    Very little of what has been done is the way to handle a global pandemic.

    A very large part of the problem was having the King of the Covidiots in the White House. I can’t imagine Clinton not coordinating with other countries on a global response. Meantime, Pessimus trump didn’t give enough of a damn to do something useful in his own country, what chance did the rest of the world have?

    No other global leader emerged. China pretty much dealt with their outbreak, and retreated behind the Great Wall to develop vaccines. Russia had its own mess, and vaccine, to worry about.

    Of the next tier of powers, the biggest is the UK, and they had a slightly less incompetent but just as nativist trump focused on other matters. France, Italy, and Germany were barely up to the task of managing things internally.

    If it were to do any good, I’d set up an agency of Pandemic Management at the UN and place Jacinda Ardern in charge. But the fact is the UN is of limited usefulness, and the WHO also stumbled badly, especially by not recommending masks right away.

    7
  6. just nutha says:

    As to the global part of the issue, the United States is only one country. We can only do what we can do, and in this case, I’m okay with an “America First” approach (and, no, I’m not a nice person). If anyone is making the argument that we haven’t done what we can (however ineptly), I’m not hearing it. Not being said/hardness of listening? Either way…

  7. Michael Cain says:

    @Kathy:

    I can’t imagine Clinton not coordinating with other countries on a global response.

    China didn’t cooperate with anyone. Japan slammed their doors shut. The EU countries couldn’t manage to coordinate with one another. Would Mexico have cooperated with the US? Would Canada? I don’t believe that Clinton would have been a global moderating effect.

    1
  8. Jen says:

    The other aspect of this to consider is that generally speaking, parents can’t just wander off and leave their kids at home, and pretty soon they are going to want to start traveling again. Even if it’s just to fly to grandma’s, people are potentially going to be loading their unvaccinated and potentially infectious (and also, potentially asymptomatic) offspring onto planes, trains, and automobiles and heading wherever–mostly within the US, but I’m sure that the EU would like those tourist dollars to come back, and they aren’t going to risk additional outbreaks by accepting unvaccinated kids as travelers.

    It’s good that we’re at this point. The more vaccinated, the better–including economically.

    4
  9. Kathy says:

    @Michael Cain:

    You know, an offhand comment in an essay by Asimov once got me thinking all the laws of physics ought to be amended to add “In an expanding universe.”

    All you say is true, after three years of Trump, and several of his imitators. Under different leadership (or any leadership) in the US, things might have gone differently come the COVID pandemic.

    We cannot tell, of course. Would Clinton have gone ahead with the TPP? We can be sure she, like Biden now, would not have alienated allies and foes alike. She certainly wouldn’t have gone prancing off to Singapore and Vietnam and the DMZ for photo ops with Trump’s boy crush, nor kissed Putin’s ass at a summit.

  10. Gustopher says:

    But, again, I’m not sure this is the wisest way to handle a global pandemic. Unless we can stop the spread in places like India, where essentially no one has been vaccinated yet, the virus will continue to mutate.

    Let’s assume that vaccinating kids does next to nothing except prevent a tiny number of kids from getting sick. Not true, but skipping past that…

    The fight against covid globally is going to take years, and if the Republicans are in charge again, past experience shows they will do nothing — and the party is even more Trumpy now.

    So, in order for us to help the world, we need to maintain control of the government — including congress. And that means helping less vulnerable Americans before more vulnerable people abroad, so we are in a position to help others later.

    2
  11. Teve says:

    When my age group was eligible here in Florida I signed up the first morning. I got stuck 3 days later. I was motivated by a CT scan of lungs that were destroyed by Covid. Holy shit the awfulness of that black and white picture is etched into my brain.

    2
  12. Kathy says:

    @Teve:

    There was a vaccine for H1N1 back in 2009. I don’t recall mass vaccination, except for vulnerable populations. I am sure I didn’t get one. But that pathogen was neither as contagious nor as lethal. As I recall, preventive measures lasted only a couple of months.

    about the Russian Sputnik V vaccine, it seems the Russian scientists did something clever. It’s a virus vector vaccine, same as AstraZeneca, but with a twist:

    They’re both virus vector vaccines, but whereas AstraZeneca uses a single simian adenovirus to deliver instructions for your cells to make spike proteins, Sputnik V uses two different human adenoviruses.

    AstraZeneca’s results were a bit disappointing (and there was much controversy over dosing). One hypothesis is that the immune system produces antibodies for the adenovirus used as well as the spike proteins, therefore the second dose is not as much of a booster as hoped.

    This same hypothesis states that by using a different virus for the second dose, the Russian vaccine sidesteps this immune system issue and does boost the spike protein response, much as the mRNA vaccines do. Therefor this vaccine has higher effectiveness.

    I guess we’ll see. The vaccine will be administered in Mexico and several other countries as well as Russia. I’ve read some EU members want it, too. Since people get vaccination cards or certificates showing what they got, and since most doses will be accounted for at least as whether they were administered, we may be able to judge.

    If it works as claimed, then we’ve learned something important about virus vector vaccines: use different viruses.

    Of course, if you use virus X for the first dose and virus Y for the second, you’d need a virus Z for a booster. And what happens if COVID requires an annual vaccine like the flu? More viruses? Or does the immune repose to the virus vector also recede over time, allowing you to reuse viruses X and Y the next year?

    Overall, while this is an advance, it seems mRNA is a better choice. there’s no issue about immunity to the micro-lipid carriers of the mRNA bits.

  13. Jen says:

    @Teve: And THAT is the other thing. Kids get covid and recover, but that doesn’t mean they don’t have lingering long-term effects. A high school friend of mine, her daughter, and husband all got sick from covid early on–right after everything shut down. The doctors kept saying that they must have had colds or the flu, because of how sick their daughter (age 11) was–they then settled on pneumonia because “kids weren’t getting that sick with covid.”

    Once antibody tests were available, they all got tested and yep, all three had covid antibodies. They also took x-rays of the daughter’s lungs, and there was significant damage. It’s been over a year, and she’s still working on getting back to 100%.

    I keep saying that the weirdest thing about this disease is how totally arbitrary it seems to be. An 85 year old in a nursing home that we know–mild case, fully recovered. 60 year old acquaintance of my husband’s, fit, ate well, ran 5 miles a day, died.

    That episode of This American Life that featured Frank Luntz’s focus group? Chris Christie was part of the panel trying to encourage Republicans to get vaccinated. He said of the group that got sick from the debate prep episode: he (Christie) was the sickest, then Trump, then Hope Hicks. Two older overweight guys very sick: expected. Hope Hicks, young, very athletic? That’s a surprise.

    We know that chicken pox virus remains in the body, dormant until it decides to reemerge as shingles. We HAVE NO IDEA what the extended effects of this virus will be. It will likely behave like other coronaviruses, but we don’t know that.

    Getting as many Americans vaccinated as quickly as possible is more important than wasting time trying to encourage reluctant adults to do so. At this point, they’re on their own as far as I’m concerned.

    2
  14. Gustopher says:

    @Jen:

    Getting as many Americans vaccinated as quickly as possible is more important than wasting time trying to encourage reluctant adults to do so. At this point, they’re on their own as far as I’m concerned.

    Almost agreed — we should definitely pursue the low hanging fruit (kids with willing parents), but we can’t give up on the morons because sadly they aren’t on their own.

    (Unless we fence the morons into a single area, and never let them out so they can infect us.)

    Plus the whole “try not to let my neighbor die” thing.

    But we can do two things at once. And once vaccinating the rest of the world is easier than vaccinating the homegrown morons, start vaccinating the rest of the world while still trying to vaccinate the morons.

    1
  15. Jen says:

    @Gustopher: You are of course correct, I’m just super-frustrated with some family members and a few friends who are refusing to be vaccinated. No amount of information will sway them, and I’m resigned to just not seeing them in close quarters until this all passes.

    1
  16. Kathy says:

    @Jen:

    We know that chicken pox virus remains in the body, dormant until it decides to reemerge as shingles. We HAVE NO IDEA what the extended effects of this virus will be. It will likely behave like other coronaviruses, but we don’t know that.

    That’s an interesting point. I hope someone is taking blood and other tissue samples from recovered patients, and looking for dormant SARS-CoV-2. We know it eventually clears from the throat, but we also know it can cause infection at any tissue where there are ACE-2 receptors. One symptom reported early on was diarrhea and other types of related maladies.

    There’s post-polio syndrome, too, which may occur decades after recovery from polio (an ever more rare event in much of the world thanks to vaccines).

    2
  17. Teve says:

    @Jen: some weird genetic condition? We just don’t know yet.

    1
  18. Just nutha ignint cracker says:

    @Gustopher: You’re a better person than I am. I’m willing to draw the line at “try not to cause my neighbor to die.”

  19. Lounsbury says:

    @OzarkHillbilly: Correct, second order transmission issue – and while one can view narrowly from ‘equity’ with global vaccination, the cold political reality is that developed country populations and economies will be more ready to help out developing if a level of stable re-opening is achieved.

    Scared voters are not generous voters, human nature is human nature, so work via it, not against it…