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- Pfizer and BioNTech are expected to officially seek emergency approval of their COVID-19 vaccine for children aged 5 to 11 in the coming weeks.
- The Pfizer-BioNTech vaccine is fully approved for people 16 years of age and older and is available in emergencies for adolescents 12 to 15 years old.
- Pfizer and BioNTech said last week that no serious side effects were found when testing the vaccine in children aged 5 to 11.
Today, Pfizer and BioNTech announced that they have submitted the first data to the Food and Drug Administration (FDA) from their COVID-19 vaccine trial in children aged 5 to 11.
The companies plan to formally apply for an Emergency Use Authorization (EUA) of the vaccine for use in this age group in the coming weeks, they said in a statement. declaration.
The Pfizer-BioNTech vaccine is fully approved for people 16 years of age and older and is available as part of an EUA for adolescents 12 to 15 years of age.
Last week, companies published results of a phase 2 and 3 trial showing that the vaccine was safe and that it generated a “robust” immune response in children aged 5 to 11 years.
This study included 2,268 children from the United States and several other countries. They received two doses of the vaccine about 21 days apart.
The dose used in the trial – 10 micrograms – is one-third of that used for people 12 years of age and older.
Researchers measured the children’s immune response by looking at the level of neutralizing antibodies in their blood.
“These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years old, who were immunized with doses of 30 micrograms, ”the companies said in a declaration.
They plan to submit the data from the full Phase 3 trial to a peer-reviewed scientific publication.
Once the FDA has the complete data from the Phase 2 and 3 trials, FDA scientists will carefully review them.
After that, the FDA Vaccine Advisory Committee is should meet and make a recommendation on whether or not to authorize the vaccine for children aged 5 to 11.
Pfizer and BioNTech said last week that no serious side effects were found when testing the vaccine for this age group.
However, the FDA and its advisory committee will look for any potential concerns that the companies may not have identified.
One of them is heart inflammation –
Most cases have occurred in young men after the second dose.
Dr Christina Johns, Pediatrician and Senior Medical Advisor for PM Pediatrics, said it is important to put the risk of heart inflammation in perspective.
“So far the risk of myocarditis due to COVID-19 infection in the elderly [adolescent] the age group appears to be larger than with the vaccine, ”she said.
In addition, most cases of heart inflammation after vaccination have been mild, with people recovering quickly from treatment.
“Those [older] the kids did well, ”she said,“ so I predict that if we see this side effect in the younger age group, it would take a similar course. “
If the FDA issues an EUA of the vaccine for this age group, the Centers for Disease Control and Prevention’s vaccine committee will meet to discuss whether to recommend its use.
If these exams go well, young children could start to receive doses around Halloween.
Pfizer vaccine trial results in children 6 months to 4 years of age are not expected until Later this year as soon as possible.
The results of Moderna’s pediatric trial are also expected around the same time.
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Sources 2/ https://www.healthline.com/health-news/pfizer-biontech-submit-data-on-pediatric-vaccines-to-fda-what-to-know The mention sources can contact us to remove/changing this article |
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