Pfizer’s COVID-19 vaccine for children under 5 faces delay

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U.S. regulators on Friday put the brakes on their push to speed Pfizer’s COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.

The Food and Drug Administration had urged Pfizer and its partner BioNTech to apply for authorization of extra-low doses of its vaccine for the youngest children before studies were even finished—citing the toll the omicron variant has taken on children.

Next week, FDA advisers were supposed to publicly debate if youngsters should starting getting two shots before it’s clear if they’d actually need a third.

But Friday, the FDA reversed course and said it had become clear it needed to wait for data on how well that third shot works for this age group. Pfizer said in a statement that it expected the data by early April.

FDA’s vaccine chief Dr. Peter Marks said he hoped parents would understand that the decision to delay was part of the agency’s careful review and high scientific standards.

“We take our responsibility for reviewing these vaccines very seriously because we’re parents as well,” Marks told reporters during a teleconference.

Pfizer’s early data showed two of the extra-low doses were safe for those under 5 and strong enough to give good protection to babies as young as 6 months. But once tots reached the preschool age—the 2- to 4-year-olds—two shots didn’t rev up enough immunity.

And a study of a third dose isn’t finished yet—meaning the FDA was considering whether to authorize two shots for now with potentially a third cleared later, something highly unusual.

Friday, the FDA didn’t say exactly what new data Pfizer was providing except that it involved the critical issue of a third dose.

“We believe additional information regarding evaluation of a third dose should be considered as part of our decision-making,” the agency said in a statement.

The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination.

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8 thoughts on “Pfizer’s COVID-19 vaccine for children under 5 faces delay

  1. Woah, the FDA says, “sorry we’ve taken you this far to allow some child abuse with a failing shot, but bro, we’ve had enough. 5 years and under is too far we guess …”

    1. So rich accusing people of being child abusers while consorting with those now telling parents that all vaccines are not required … your people. No more polio shots, no more MMR, none of them.

      Actual medical professional, indeed, turning your back on centuries of medical progress.

    2. Joe – the scam is over.

      Moderna executives dump $2B in stock. The CMO owns no shares anymore. Pfizer plunges in value.

      Sorry man, even NPR is tracking and calling out the insider trading.

      You’ve lost the narrative.

      And keep projecting assumptions on those who ask for data for experimental drugs.

      “Your people”. You just assume I’m an anti-vaxxxer because I am one of millions who can think for myself, collect data, and make an informed decision.

      Well sorry, haven’t turned my back in the scientific method, transparency and ethics.

      You sound like a toddler throwing a tantrum at this point.

    3. I have no need to make assumptions. You make my point for me with your own words and have done so quite conclusively in the past.

      You’ve seen the data, plenty. Your agenda, your preconceptions, don’t let your process it. Explain to me why I’m seeing your kind talking about why all the required childhood vaccinations shouldn’t be required because no one dies from those diseases anyway. That is the next step is your lost narrative – making measles and polio great again.

      So, yes, you’re one of the anti-vaxers. You protest too much.

  2. The GOP’s anti-vaccine mandate push is seeping into other vaccines — and schools

    “In Georgia, a GOP state senator proposed a bill that would ban the state from requiring “proof of any vaccination of any person as a condition of providing any service or access to any facility.” The bill was endorsed by 17 state senators, about half of the Republican contingent”

    “Efforts by Republicans in Wisconsin also have shown some real momentum. State Senate Health Committee Chairman Patrick Testin (R) held a hearing this month that included Senate Bill 336. The bill would, among other things, prohibit schools and universities from excluding students because of their vaccination status. And, again, it’s not just about coronavirus vaccines.”

    1. What’s the big deal? Well, for one, apparently measles makes your more vulnerable to all other illnesses for around three years.

      “Enter “immune amnesia”, a mysterious phenomenon that’s been with us for millennia, though it was only discovered in 2012. Essentially, when you’re infected with measles, your immune system abruptly forgets every pathogen it’s ever encountered before – every cold, every bout of flu, every exposure to bacteria or viruses in the environment, every vaccination. The loss is near-total and permanent. Once the measles infection is over, current evidence suggests that your body has to re-learn what’s good and what’s bad almost from scratch. “

  3. Did Moderna CEO Suddenly Dump $400M in Stock?

    What’s True
    Bancel’s rarely used personal Twitter account was deleted in February 2022.

    What’s False
    However, Bancel did not “dump” $400 million worth of Moderna stock all at once in February 2022. Bancel had sold less than $10 million worth of shares by mid-month, about $390 million less than claimed. Furthermore, these sales were done at predetermined times and had nothing to do with current events.