The Pfizer vaccine for children under the age of 5 can arrive quickly. Here’s the timeline: Shots

Children under 5 years of age can soon be vaccinated with Pfizer, if regulators decide the shots are safe and effective for this age group.

Robyn Beck / AFP via Getty Images

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Robyn Beck / AFP via Getty Images

Children under 5 years of age can soon be vaccinated with Pfizer, if regulators decide the shots are safe and effective for this age group.

Robyn Beck / AFP via Getty Images

6-month-old infants can be immunized against COVID-19 in the United States within weeks, If regulatory agencies agree, the vaccine is safe and effective for this age group.

On Tuesday, Pfizer and BioNTech took the first big step that could make COVID-19 vaccinations actually available to children when they submitted their clinical trial data to the Food and Drug Administration. Medicines for review by this agency. There are some regulatory steps to be taken, but things can progress quickly from here. For context, the process with children aged 5 to 11 last fall took place just over four weeks.

Here’s what has to happen before kids under 5 can start getting vaccinated against COVID-19.

It remains to be seen whether parents are eager to receive the shots if they are allowed. Based on a poll released on Tuesday According to the Kaiser Family Foundation, more than two-thirds of parents with children in this age group say they will wait and see about vaccinations or are “definitely” not planning to have their children vaccinated. Nearly a third of parents say they will vaccinate their babies and young children right away.

Currently, Pfizer is furthest is in the licensing process, but Moderna is also testing its vaccine for this age group – the company plans to send data to the FDA about Children 2 to 5 years old in March. Johnson & Johnson is also expected to conduct trials of the vaccine for young children in the future.

Below are details on each step of the claims management process and how it works for Pfizer vaccines.

Step 1: Drugmakers conducts clinical trials and submits data to FDA

Pfizer and BioNTech made a three-phase clinical trial in children 6 months to 4 years old. The companies announced in December that the effectiveness of the two-dose series of drugs in children over 2 years old but under 5 years old so disappointingand many public health experts and parents say this means waiting months.

But in an unusual move, the companies have decided to pursue obtaining permission as they continue working on a vaccine because of an “urgent public health need,” Pfizer-BioNTech said. in a news bulletin.

On February 1, companies began submitting data on the safety and effectiveness of two doses of the vaccine in this age group – describing them as “part of a three-dose series” – in their applications. Emergency use authorization for Food and Drug Administration. Data on the third dose, given at least eight weeks after the second dose, are still being collected and analyzed.

The clinical trials for children of this vaccine includes a total of approximately 8,300 children aged 6 months to 12 years. In the youngest age groups, the vaccine is given as a series of three doses – the second dose is 21 days after the first dose, and the third dose is eight weeks later.

Dosage for children is smaller than adults: the dose for young children is 3 micrograms, a much smaller dose than the 30 microgram dose for adults and adolescents. For children aged 5-11 years, the dosage is 10 micrograms.

Pfizer has not yet released detailed safety and efficacy data for children in this youngest age group.

Step 2: Independent scientists review data

On February 15, a team of outside scientists will review Pfizer safety and effectiveness data, along with analysis from FDA scientists, of the vaccine’s risks and benefits in different pandemic situations.

After presentation and discussion, advisory group will vote on whether the benefits of the Pfizer vaccine outweigh the risks of its use in this age group.

Step 3: FDA officials consider

Next, the FDA — the agency itself — will review the advisors’ vote on the smallest dose of Pfizer’s drug for the youngest children.

FDA officials will then decide whether or not to renew emergency use authorization for Pfizer’s COVID-19 vaccine for this youngest age group.

Step 4: Many independent scientists debate and vote

But please wait a moment. Yet another federal health agency and its advisers must weigh before the shots can be made available – this time, it’s the Centers for Disease Control and Prevention.

You can think of it like this: When it comes to vaccines, what the FDA is responsible for, and who the CDC is responsible for.

CDC’s vaccine advisory group will meet as soon as FDA completes the review. After more presentations and discussion, the CDC advisory group will vote to recommend the vaccine for all children in the 6 months to 5 year age group, or it may also recommend limiting the vaccine to a subset of the population. that age group (for example, children with underlying conditions or people who have never had coronavirus).

Step 5: Director of CDC makes final recommendations

The vote from the CDC advisors is not an official recommendation – but comes from the director of the CDC, Dr. Rochelle Walensky.

She needs to reveal the recommendations of her advisors. She can change the proposal from what the committee voted on – like she did with boosters – but she usually follows their lead.

Only after the CDC director makes an official recommendation can the shots be distributed to pediatricians and pharmacies nationwide.

Step 6: Dosage is distributed to providers and pharmacies

After the early stages when vaccines for children aged 5 to 11 were first approved, the shots quickly became widely available. Since many pediatricians’ offices have had months of practice giving Pfizer’s COVID-19 vaccine to older children, it’s likely that rollout to young children and infants will go smoothly.

Experts recommend seeking guidance from your pediatrician and your child’s school about where and when shots are available. Parents can also find pharmacies that have these low-dose pediatric COVID-19 shots available at vaccines.gova CDC website that helps people who want a COVID-19 vaccine find out where to go.