A health care worker gives a dose of the Pfizer-BioNTech COVID-19 vaccine to a child in a pediatrician office in Bingham Farms, Michigan. Federal agencies are considering starting giving the vaccine to children ages 5-11.
Emily Elconin / Bloomberg via Getty Images
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Emily Elconin / Bloomberg via Getty Images
A health care worker gives a dose of the Pfizer-BioNTech COVID-19 vaccine to a child in a pediatrician office in Bingham Farms, Michigan. Federal agencies are considering starting giving the vaccine to children ages 5-11.
Emily Elconin / Bloomberg via Getty Images
As early as next week, children aged 5 and over in the USA can be vaccinated against COVID-19.
While some parents not sure how they feel Others eagerly await a chance to protect their children from COVID-19.
But federal agencies cannot be rushed. Here’s what still needs to happen before the Pfizer BioNTech shots can get into the arms of the kids.
Currently Pfizer is furthest advanced in the process, but Moderna has shared some promising results from its vaccine study with this age group, and Johnson & Johnson is expected to begin vaccine trials for young children in the future. Here you can find more details on what the regulatory process involves and how it works for the Pfizer vaccine.
Step 1: drug manufacturers complete the clinical study
Pfizer and BioNTech have a three-phase clinical study in children aged 5 to 11. The companies submitted all data from this study and an application for emergency approval to the Food and Drug Administration on October 7th.
The main study involved 2,250 children and found that the lower-dose version of the vaccine was 90.7% effective in preventing symptomatic COVID-19. It was given as a series of two syringes 21 days apart and the dose was 10 micrograms, one third of the dose given to adults and adolescents.
No serious side effects, such as heart inflammation, have been reported, although with only a few thousand children in research, such a rare problem would not necessarily be recognized.
Step 2: Independent scientists review the data
This week, October 26th, a panel of outside scientists considered Pfizer safety and efficacy data, along with a Analysis by FDA scientists about the risks and benefits of the vaccine in various pandemic scenarios.
After a lively discussion, the group overwhelmingly voted Yes, that the benefits of the Pfizer vaccine outweigh the risks of its use in this age group.
Step 3: FDA officials weigh in
Now the FDA – the agency itself – has to consider the consultants’ vote on Pfizer’s small dose for children and decide on an extension of the deadline Emergency use authorization for Pfizer’s COVID-19 vaccine for this age group.
Step 4: More independent scientists debate and vote
But wait, there’s more. Yet another federal health agency and their advisors have to weigh up before the shots become available – this time it’s the Centers for Disease Control and Prevention.
Think of it like this: The FDA is responsible for vaccines What, and the CDC is responsible for that who.
The advisory group of the CDC is scheduled meeting on November 2nd. Dr. Amanda Cohn recently served as the executive secretary of the CDC’s Vaccine Advisory Group and is a voting member of the FDA’s Vaccine Advisory Group, so she is in a unique position to explain the difference between the two:
The FDA decides whether a vaccine (or other product) is safe and effective, they stated at the FDA advisory meeting this week. The CDC group then examines and votes on “who would benefit from the vaccine and who should be vaccinated”. Her considerations include factors such as equity, feasibility, and the “potential impact of referrals on a population,” she said.
If they vote, CDC advisors could recommend the vaccine for all children ages 5-11, or they could “make more focused or nuanced recommendations,” Cohn said. For example, they might recommend it for a specific subgroup, like children with underlying medical conditions or those who have not had a previous coronavirus infection.
Step 5: CDC director makes final recommendation
Even then, a vote by the CDC advisors is not an official recommendation – it comes from the CDC director, Dr. Rochelle Walensky. She can simply give the advisor’s recommendation the green light or – as with the boosters – change it. There is no prescribed timetable for when her recommendation is to fall, but it is widely expected that she will rule next week.
Only after the CDC director issues an official recommendation will the shots be distributed to pediatricians and pharmacies across the country.
Step 6: The recordings are distributed to providers and pharmacies
Experts have assured the public that the launch of this new lower-dose vaccine will not be a replication of the clutter of the original COVID-19 vaccine launch last winter.
“We will be ready as soon as the FDA and CDC make decisions so that parents can have their children vaccinated quickly, easily and conveniently,” said Jeffrey Zients, the White House COVID-19 Response Coordinator, at a Press conference Wednesday.
The vaccination managers planning to roll out in each state feel much better prepared this time around, says Claire Hannan, executive director of the Association of Vaccination Managers.
“We have enough vaccines and I think we are very well prepared,” she says.
However, she warns parents shouldn’t expect to have their child vaccinated once the regulatory hurdles are cleared. There will be challenges getting the vaccine to the right suppliers to meet demand.
Experts recommend seeking advice from your child’s pediatrician and school. Parents can also find pharmacies stocked with pediatric COVID-19 syringes vaccines.gov, a CDC website launched in February to help people who want COVID-19 vaccines figure out where to go.
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Reference: www.npr.org