FDA expected to OK Pfizer vaccine for teens within week

The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.

The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.

The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.

The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.

The New York Times first reported on the expected timing for the authorization.

Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.

The 12-15 age group had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.

But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.

More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.

While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.

The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.

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15 thoughts on “FDA expected to OK Pfizer vaccine for teens within week

  1. There is ZERO reason for a child to receive an EUA inoculation.

    And anyone pushing it has medical ethics issues.

    Statically experimenting on children for a virus with a complete lack of transparency of data is disgusting.

    1. You don’t have a child who had COVID and is excited to get vaccinated so she can resume being a teenager, do you? Should have seen her sob when she realized she’d accidentally exposed her elderly grandparents to COVID.

      This vaccine has better science behind it than most of the anti-vax pap that you’ve read. And I’m amazed that the same people who think we ought to open everything up and get back to living are fighting the very thing – the vaccine – that will allow us to do so.

      Like I’ve said elsewhere, let’s close the ICU’s to everyone who refuses the COVID vaccine and let’s see how this all shakes out.

  2. Please send a factual rebuttal with data rather than emotional fear mongering conjecture.

    I have 3 children and work in healthcare.

    Using the same metaphor, please close ICUs and hospitals to all those who are obese, smoke, drink, do drugs and/or don’t regularly work out and especially to those who drive cars, go outside in a lightning storm…etc.

    Also, please name all immunizations which have been used immediately on kids via EUA and contain mRNA.

    Thanks…I’ll wait.

    1. No no, you work in healthcare. You got educated on this, time for you to educate ME. You share YOUR data. I want to know in detail what pushes someone with a medical education to being a vaccine denier. It must be fantastic, I want to know everything.

      Also, I’m not great with numbers but I’m pretty sure the number of COVID fatalities and longhaulers is a fair bit higher than the number of deaths due to COVID vaccines.

      But if you’re looking for a way to save money on healthcare, your suggestions are good ones.

    2. Which healthcare provider do you work for? I would like to make sure I never see you if I’m ever back in Indiana and need medical attention. Also, I hope your children’s schools require the vaccine by fall. That’s the only way to get the ignorant portion of society vaccinated. Make living regular life extremely inconvenient/impossible if you do not get the vaccine.

      The rest of us should be free to congregate and do what we want. After all, we are the only ones who actually suffered over the last year. Most of you anti-vax people haven’t worn masks or socially distanced since last Summer.

  3. To quickly handle West Coast Wes and his sheep 🐑 marching orders off a Pacific Coast bridge, and concerns from Joe B:

    – I am not anti-vax or a vaccine denier.
    – the current inoculations are EUA and not thoroughly vetted by clinical data
    – children should not be subjected to experimental political products when not at risk
    – the amount of COVID deaths have been overstated
    – hospitals are incentivized by significantly increased reimbursement (~$13k) if they attribute “suspected COVID” to their patient charts
    – the individual facility inpatient treatment by entity does not match data reported by sites such as the IBJ
    – the CDC data are estimates in arrears and do not eliminate for threshold changes and false positives

    Must I go on?

    If West Coast Wes has it all figured out, the most open States would be wastelands of lives lost.

    Thankfully, most in the healthcare who actually treat patients day in and out rely on their localized data to make decisions, know risk profiles, and stay away from media and their agendas.

    1. You confused me at the EUA not being thoroughly vetted. That’s why it’s an EUA and not a full approval. It’s akin to complaining that a Corvette is too loud and has too much wheelspin.

      You then called the vaccine a political product and I realized I was in for the usual anti-vax talking points, backed up with no links or quotes from other sources. And you’re going to lecture me on medical ethics?

      There’s more to education than believing everything Carlson, Hannity, or Facebook shove in your brain to keep you angry and coming back for more.

  4. Unfortunately Joe, I don’t have Facebook, nor do I watch Hannity, etc.

    I do have the ability to think for myself and be critical of the lack of transparency in data.

    Your metaphor regarding a Corvette has no relation to the process for pharma and/or the medical device approval process of the FDA.

    Fauci and the CDC are winging it. Thankfully there are studies like the MIT paper just released critical of social distancing.

    https://www.pnas.org/content/118/17/e2018995118

    There is no data to show anyone under the age of 50 are at mortality risk to this virus.

    If the EUA vaccines, two being mRNA, one being vector based, and a fourth not approved in the USA were so buttoned up there wouldn’t need to be media pressure to demand people be inoculated.

    Further, forcing society into vaccine passports violates Federal law regarding EUA pharmacological products not to mention HIPAA laws.

    Forcing a society in to arbitrary compliance regarding personal health decisions will not yield anything but debates and resistance just like this discussion of do as Wes and Joe say or else.

    What is the famous saying: “my body, my choice”?

    1. There is judicial precedent to force people to get vaccinated in the United States. Look up Jacobson v. Massachusetts.

      What’s also tiresome is big government telling private businesses that they cannot mandate masks or vaccinations if they choose to do so. Apparently the free market can decide except when it can’t.

      Yes, they’re winging it based on their decades of experience. That’s what we’ve asked them to do. The alternative is apparently to pretend COVID isn’t a thing (playing out great in India and Brazil right now) or continued lockdowns.

      I mean, let’s discuss your MIT study.

      “The co-author of a Massachusetts Institute of Technology study dealing with the indoor transmission of the coronavirus this week debunked efforts to portray his findings as evidence that social distancing and the wearing of masks have no value.

      In an email exchange with cleveland.com and The Plain Dealer, MIT Applied Mathematics Professor John Bush, emphatically denied that the study dismisses the importance of maintaining social distances and wearing masks, as some have “oddly and obtusely” inferred.

      “Both inferences are wildly off base, dangerous and directly countered by our study,” he wrote.”

      https://www.msn.com/en-us/health/medical/debunking-claims-that-mit-study-suggests-6-foot-rule-masks-have-no-value-in-mitigating-covid-19-transmission/ar-BB1g9GXK

      Your summarized response of “I’m smarter than all these people, no one under 50 dies from COVID, all the numbers are rigged, and so are the media” is tiresome, inaccurate, and I hope you hold no more medical responsibility than emptying bedpans.

    1. I find the idea that you have a medical education yet think you know more than experts in the field of infectious disease both fascinating and troubling.

      As to your mask paper from April 2020…

      “ In the paper, the National Academies’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats said that, because no studies have been done on the effectiveness of cloth masks in preventing transmission of coronavirus to others, it is impossible to assess their benefits, if any.”

      “We haven’t done a study and have no data” is different than “the data shows no benefit”. The data is admittedly mixed as studies have shown both benefit and no benefit to masks.

      But you know that, right?

  5. Correct. Which again shows all data is in the eye of the beholder.

    A 36 yr old surgeon our community knows died shortly after his first injection due to MIIS. No comorbidities, healthy and recently married. This reaction isn’t the first time from this EUA inoculation, as it has claimed other lives. He received it from a sense of duty, but does the data support given his risk profile experimenting for the “better good” as a HCP? Statistically no. Society pressure/optics yes?

    Data does matter. Science has been politicized and it’s disgusting the media is having a blast being a tabloid.

    As one of my engineering professors taught our class, “you can make data prove most statistical theories you’d like, but is the premise accurate?”

    1. It also shows either don’t read fully or don’t research the stuff you quote. I shouldn’t be able to debunk your sources via Google in 45 seconds … combined. if you’re coming up with this stuff on your own, you need to do a better job of it.

      Similarly, you’re going to have to come with better data than “I know a guy” to support the position that taking an EUA vaccine is riskier than getting COVID. Especially since there are outcomes other than living or dying that never seem to factor into those COVID death numbers. Are people dying from the vaccine? Yep. Are they dying in larger percentages than dying from COVID? Show me the data.

      You also earlier said “There is no data to show anyone under the age of 50 are at mortality risk to this virus” which, I’m sure, is reassuring to those under the age of 50 who died of … something else? I guess their positive COVID tests were … fake news?

      I would also point out that your attitude towards the virus (It’s no big deal, open it all up) tracks towards the attitudes of leadership in Brazil and India which don’t appear to be doing so well at the moment.

      Which, fine, if that’s your approach, let’s open it all up. But if you’ve chosen not to take the vaccine, if you figure your risk on beating the virus is better than taking that vaccine, don’t go to the ER expecting help. Your body, your choice, your consequences, right?

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