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FDA authorizes Pfizer’s Covid-19 vaccine for use in people ages 12 to 15

The US Food and Drug Administration has expanded the emergency use authorization for Pfizer’s Covid-19 vaccine to include people ages 12 to 15.

This is the first Covid-19 vaccine in the United States authorized for use in younger teens and adolescents; the vaccine had previously been authorized for people age 16 and older. Covid-19 vaccines from Moderna and Johnson & Johnson are authorized for use in people age 18 and older.

To support the extended use, the FDA reviewed data submitted by Pfizer. The company said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed the vaccine’s efficacy is 100% and it is well tolerated.

The FDA’s independent Vaccines and Related Biological Products Advisory Committee did not meet to vote on whether to recommend the expansion of the EUA to 12-to-15-year-olds. But the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Wednesday to advise CDC on whether to recommend use of the vaccine in this age group. CDC Director Dr. Rochelle Walensky will then decide whether the agency will recommend the vaccine’s use in the new group.

Vaccinations for 12-to-15-year-olds are not expected to begin until after that recommendation. The Biden administration has said it will quickly mobilize to ready vaccinations for 12-to-15-year-olds through the federal pharmacy program, pediatricians and family doctors.

Expanding authorization to people 12 to 15 opens Covid-19 vaccination to another 5% of the US population, nearly 17 million more people. The expanded authorization means 85% of the US population is eligible to receive a Covid-19 vaccine.

Pfizer said last week it expects to submit for emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 years old in September. Its vaccine safety and efficacy study in children ages 6 months to 11 years old is ongoing.

Coronavirus / National & World / News / Top Stories

CNN Newsource

Comments

17 Comments

      1. Pfizer / BioNTech started the full approval process on Friday. Moderna is expected to follow later this month. My money is on folks pivoting to the good old “FDA are government hacks” and/or “Big Pharma bought the approval” arguments.

  1. Zillions of kids have been getting vaccines for decades and the benefits of being vaccinated far outweigh the risks of getting things like measles, mumps, rubella, diptheria, chickenpox, etc. Oh, and polio. Remember polio? That’s right, no one does. Because it was eradicated to almost nothing with a vaccine.
    The whole anti-vax thing seems like a first world entitlement. And it’s ironic that it’s mostly being propagated by people who are against entitlements. I guess we all have a sense of entitlement for some things no matter how virtuous we think we are.

      1. Remember not to take the mRNA miracle drugs these companies invent in the near future to prevent/cure/treat Cancer, Alzheimer’s, HIV, heart disease, etc. while the rest of us continue to enjoy the benefits of science.

      2. “On April 26, 1954, the Salk polio vaccine field trials, involving 1.8 million children, begin at the Franklin Sherman Elementary School in McLean, Virginia. Children in the United States, Canada and Finland participated in the trials, which used for the first time the now-standard double-blind method, whereby neither the patient nor attending doctor knew if the inoculation was the vaccine or a placebo.

        One year later, on April 12, 1955, researchers announced the vaccine was safe and effective and it quickly became a standard part of childhood immunizations in America.”

  2. I have a cousin who is extremely autistic because of a vaccine that was studied and then approved by the fda hacks so go ahead and put your trust in something that was studied by 1200 and put it in your kids arm. Especially when this so called virus isn’t even killing kids that age. Have fun with what you get out of that.

    1. LOL wow. Yes the CDC and the news are in cahoots to share factual information about how effective medicine is at curing medical issues.

    1. Regardless of whether we may have different opinions about the approach to solving this, the one big thing we can agree on is that THIS SUCKS and we NEED to go back to normal ASAP. To answer your question about masks/vaccine, we are at an intersection where people are getting vaccinated but there is still a lot of the population that either isn’t eligible yet (basically everyone under 16), or doesn’t want it (despite extensive testing and millions of doses administered with practically 0 negative issues), so there is still a significant portion of the population that is susceptible to either get it, or spread it. And although the concern isn’t really with young people getting the virus because their risk of a bad outcome is low, it’s that young people can still spread it to those who are more at risk and could have a more negative outcome. So, yah, until enough people are vaccinated so that continued spreading within the general population (all ages) is less likely, then we will continue to see masks. You don’t want to see masks, then help everyone else by getting the (proven safe) vaccine. And yes, YOU aren’t likely to have a bad outcome from the virus, but you don’t KNOW that for sure, and in the meantime there is an available tool that you can use that could help to protect both yourself and someone else, and also help get society back to normal sometime soon. Because we’re ALL TIRED of this garbage no matter how political you may think this is!

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