Why Do Babies Get Vaccinated After 6 Months

Kids nether v may soon exist able to get the Pfizer vaccine if regulators decide the shots are safe and effective for this age group. Robyn Brook/AFP via Getty Images hide caption

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Robyn Beck/AFP via Getty Images

Kids nether 5 may soon be able to become the Pfizer vaccine if regulators decide the shots are rubber and effective for this age group.

Robyn Beck/AFP via Getty Images

Babies as young as 6 months sometime could be able to get a COVID-19 vaccine in the U.S. inside a few weeks if regulators hold the vaccines are safe and effective for this age group.

On Tuesday, Pfizer and its partner BioNTech took the get-go big step that could lead to COVID-19 shots actually becoming available to kids when they submitted their clinical trial data to the Food and Drug Assistants for its review. At that place are several regulatory steps to come, merely things could move quickly from here. For context, the process with 5- to 11-year-olds terminal autumn took just over four weeks.

Here'south what has to happen before little ones under 5 years old tin can start getting vaccinated against COVID-19.

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It remains to be seen whether parents will be eager to cover the shots if they're authorized. According to a poll published Tuesday past the Kaiser Family Foundation, more than than ii-thirds of parents of children in this age group say they'll wait and see nearly vaccination or are "definitely" not planning to vaccinate their kids. Almost one-third of parents say they'll vaccinate their babies and young children right away.

Currently, Pfizer is the furthest forth in the process toward potency, but Moderna is also testing its vaccine with this age grouping — the company plans to submit data to the FDA on 2- to 5-year-olds in March. Johnson & Johnson is expected to conduct vaccine trials for immature kids in the future as well.

Here are more than details on what each step of the regulatory process entails and how information technology is going for the Pfizer vaccine.

Step one: Drugmakers carry clinical trials and submit data to the FDA

Pfizer and BioNTech have done a three-phase clinical trial in children 6 months through 4 years old. The companies announced in December that efficacy of the two-dose series for children older than age 2 but nether five was disappointing, and many public health experts and parents causeless this meant many more than months of waiting.

But in an unusual motility, the companies decided to pursue applying for dominance equally they keep to study the vaccine because of the "urgent public health need," Pfizer-BioNTech said in a news release.

On Feb. 1, the companies began to submit information on the safety and efficacy of two doses of the vaccine in this age group — describing them as "office of a 3-dose primary series" — in an application for emergency employ authorization to the Food and Drug Administration. Data on the third dose, given at to the lowest degree viii weeks after the second, is still beingness nerveless and analyzed.

The pediatric clinical trial for this vaccine includes a total of approximately viii,300 children from half dozen months to 12 years old. In the youngest historic period groups, the vaccine is given every bit a series of three shots — the second is 21 days after the first, and the third is eight weeks subsequently that.

Kids' dosage is smaller than for adults: The dose for littles is 3 micrograms, a much smaller dose than the thirty microgram dose given to adults and teenagers. For children ages five-xi, the dose is 10 micrograms.

Pfizer has yet to publicly release detailed safe and efficacy data for children in this youngest age group.

Step 2: Independent scientists review the data

On February 15, a panel of exterior scientists will consider Pfizer's prophylactic and efficacy data forth with an analysis from FDA scientists on the risks and benefits of the vaccine in unlike pandemic scenarios.

After presentations and discussion, the group of advisers will vote on whether the benefits of the Pfizer vaccine outweigh the risks for use in this age group.

Footstep 3: FDA officials weigh in

Next, the FDA — the agency itself — will consider the directorate' vote on Pfizer's smallest-dose shot for the youngest kids.

Then FDA officials will make up one's mind whether to extend the emergency use authorization for Pfizer's COVID-19 vaccine to this youngest age grouping.

Step four: More independent scientists fence and vote

But wait, there'south more than. Yet another federal wellness agency and its advisers have to weigh in before the shots can become available — this time, it's the Centers for Disease Control and Prevention.

Y'all can think of information technology like this: When it comes to vaccines, the FDA is in charge of the what and the CDC is in accuse of the who.

The CDC's vaccine advisory group volition meet soon later the FDA has completed its evaluation. Afterwards more than presentations and more discussion, the group of CDC advisers will vote to recommend the vaccine for all children in the half dozen month to 5 year age group, or information technology could too recommend limiting it to a subset of that age group (for case, children with underlying conditions or those who oasis't had a prior coronavirus infection).

Step v: CDC director makes final recommendation

The vote from the CDC's advisers isn't an official recommendation — that comes from the CDC'due south director, Dr. Rochelle Walensky.

She needs to greenlight the directorate' recommendation. She tin can change the recommendation from what the committee voted on — every bit she did with boosters — only she usually follows its lead.

Only later on the CDC manager bug an official recommendation can shots go distributed to pediatricians and pharmacies around the country.

Step six: Doses go distributed to providers and pharmacies

Subsequently an initial crisis when vaccines for five- to 11-year-former kids were first approved, shots shortly became widely available. Since many pediatricians' offices have had months of practice administering Pfizer's COVID-19 vaccines to older kids, information technology's probable that the rollout for little kids and babies volition get smoothly.

Experts suggest looking out for guidance from your child'southward pediatrician and schoolhouse about where shots will exist available and when. Parents should also be able to find pharmacies with these depression-dose pediatric COVID-19 shots in stock at vaccines.gov, a CDC website that helps people who desire COVID-19 vaccines figure out where to become.

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Source: https://www.npr.org/sections/health-shots/2022/02/02/1077376625/covid-vaccine-kids-under-5

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