Pfizer requests approval of its vaccine for children under 11 years old 0:44
(CNN) -
Pfizer said Thursday it has asked the U.S. Food and Drug Administration (FDA) to authorize the use of a low-dose version of its covid-19 vaccine to children from 5 to 11 years old.
It would be the first covid-19 vaccine for younger children.
The Pfizer / BioNTech vaccine is approved for individuals 16 years of age and older and is licensed for emergency use for adolescents 12-15 years of age.
What does that mean for children and their parents?
Here are some questions and answers:
When will the vaccine be authorized?
In theory, it could be licensed for children before Halloween (October 31).
Two different federal agencies will consider whether children should receive these new vaccines.
The FDA will review the data submitted by Pfizer and BioNTech and has made it clear that it will do so with care.
The FDA is aware of people's sensitivity to vaccinating children.
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"We know from our vast experience with other pediatric vaccines that children are not young adults, and we will conduct a comprehensive evaluation of the clinical trial data presented to support the safety and efficacy of the vaccine used in a younger pediatric population, which may need a different dosage or formulation than that used in an elderly or adult pediatric population, "says FDA Acting Commissioner Dr. Janet Woodcock.
The FDA has already scheduled a meeting of its independent advisers, the Vaccines and Related Biologicals Advisory Committee or VRBPAC, for October 26 to discuss the data.
VRBPAC, which includes several pediatricians, will listen to what both Pfizer and the FDA have to say about what the studies show and will also listen to the opinions of the public.
The FDA could act quickly after the VRBPAC meeting, even within hours, and then vaccine advisers from the US Centers for Disease Control and Prevention (CDC) will meet.
The Advisory Committee on Immunization Practices is made up of different experts.
CDC Director Dr. Rochelle Walensky will decide if children should receive the vaccine based on this information.
Does that mean children could be protected for Halloween?
As with adults, Pfizer is testing and proposing a two-dose series for children.
That would mean two doses of vaccine administered three weeks apart.
And as with adults, immunity is not immediate, even after the second dose.
People have been considered to be fully vaccinated two weeks after the second dose and the same will be true for children.
Therefore, children are advised to continue to take precautions for five weeks after receiving the first dose of the vaccine, as soon as possible.
That means wearing masks, keeping a physical distance from others, and avoiding crowded indoor spaces when possible.
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As for the reinforcements, it's too early to ask about them.
It took several months to collect real-world data before Pfizer petitioned the FDA to authorize the boosters in adults.
Will children get the same dose as adults?
No. Pfizer has been testing a 1/3 dose in children under 11 years of age.
But there are indications that this smaller dose will protect children just as well as a larger dose protects teens and adults, even if a particular 10- or 11-year-old is old for his age.
Vaccine manufacturers test different doses when conducting clinical trials to try to get the best possible immune response with the lowest possible dose.
This can reduce side effects and stretch the supply.
Trials in children showed a strong response to a 10-microgram dose in clinical trials, says Dr. Robert Frenck, who directs vaccine trials at Cincinnati Children's Hospital and has been testing covid-19 vaccines. in children there.
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"We looked at 10 micrograms, 20 micrograms and 30 micrograms in adults," Frenck told reporters last month.
"We found in people ages 18 to 55 that a 10-microgram dose gives a very good immune response," he added.
"But those 65 and older didn't respond as well to the lower doses, and that's why we chose that 30-microgram dose in the adult age range of 18 and older."
A higher starting dose did not appear to improve immunity, so even older children will not be left behind if they get the lower dose.
"I suppose if we gave a 12-year-old a 10-microgram dose, he would still have an immune response similar to that of a 30-microgram dose, but we don't have the data for that," Frenck said.
For younger children, children under the age of 5, doctors are testing a 3-microgram dose of vaccine.
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What are the side effects?
Frenck says that so far, the Pfizer vaccine seems very safe in younger children.
"What we found is that the side effects in children really mirror exactly what we saw in adults," he said.
For the most part, that means arm pain at the vaccination site.
Some people feel a headache or feel tired.
In the trials, about 10% of the children had a fever or chills after the vaccine, similar to the side effects of other types of vaccines.
They last a day or two at the most, Frenck said.
The CDC recommends a cold compress on the site or a dose of non-aspirin pain reliever if the side effects bother children.
Many parents may be concerned about reports of a rare heart inflammation called myocarditis, which has been seen with the Moderna and Pfizer vaccines.
"On myocarditis, which means inflammation of the heart muscles, we have seen that as a rare side effect it has been associated with what appears to be the second dose of the Moderna or Pfizer vaccine," Frenck told reporters.
"Uncommon means that it is the probability of a few per 100,000 people, so there is still a 99.999% probability that this will not happen. It has been almost all in male adolescents, and it has been mild, it has been treated with Motrin (ibuprofen) and have improved. "
In how many children has this vaccine been tested?
Pfizer has conducted several clinical trials in hospitals across the country and more details will be released when the FDA publishes what Pfizer has submitted, likely in the next few days.
Last month, Pfizer released details of a phase 2/3 trial involving 2,268 children ages 5 to 11.
Unlike trials that involved tens of thousands of adults who gave placebo or dummy doses to some and then looked at how many people were infected, Pfizer used what are called immune bridging studies among children.
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These studies, long accepted as a way to test an approved or licensed vaccine for adults in children, use the immune system response generated by the vaccine as a surrogate for protection.
If children's bodies generate the same level of antibodies as adults after vaccination, it is assumed that children are equally protected.
Pfizer said that the antibody levels seen in the children who received the 10-microgram doses compared well with those of the older people who received the larger doses, demonstrating a "strong immune response in this cohort of children one month later. of the second dose ".
Where will the children get vaccinated?
The same places you get your flu shot: your pediatrician's offices, local pharmacies, and maybe some schools.
"This is the pediatrician's haven," Dr. David Kimberlin, who helps lead the division of pediatric infectious diseases at the University of Alabama at Birmingham, told CNN on Thursday.
"We're trying to enroll pediatricians and that's an important strategy," Claire Hannan, executive director of the Association of Immunization Managers, told CNN's Jacqueline Howard.
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One possible sticking point is the smallest dose of vaccine, which means that younger children cannot receive stock doses for adults and adolescents.
The children's vaccine is expected to ship in 100-dose packages, which is much smaller than the 1,170-dose packages used for adult vaccines.
"The fact that they are moving into smaller packages and smaller shipping quantities is really great news," Hannan said.
That will be easier for medical offices to manage.
The CDC notes that government websites help people find places to get vaccinated.
"Search vaccines.gov, text your zip code to 438829 or call 1-800-232-0233 to find locations near you," advises the CDC.
"I think the real key is getting enough parents interested in vaccinating their children," Kimberlin said.
Dr. Peter Hotez, a pediatrician and vaccine expert at Baylor College of Medicine in Houston, noted that there is a large divide in the US "Only 33% of adolescents ages 12 to 17 have received the covid- 19 here in the south, "Hotez told CNN's Ana Cabrera on Thursday.
"So once again, we have this geographic divide where parents are holding back from vaccinating their teens, and I have to believe that they will probably refrain from vaccinating younger children as well," Hotez said.
"We may be seeing very low consumption of this pediatric vaccine in the south and also in the western mountains, and that will be a problem that will set us back."
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What about other vaccines?
Children can get the covid-19 vaccine along with flu shots and other vaccines.
"It is safe and effective to receive both vaccines at the same time," CDC Director Dr. Rochelle Walensky said Wednesday at the White House COVID-19 briefing.
"You can get all the vaccinations that are necessary," Frenck said.
"The only restriction is if we have live viral vaccines, such as chickenpox and measles, if they don't get them on the same day, we'd like to space them at least a month apart. But for covid vaccines, they can be administered with the flu vaccine, "he added.
"There is no need to space, our immune system can handle all vaccines at the same time."
If possible, different vaccines should be placed in different arms and legs if given on the same day, CDC vaccine officials told doctors during a call Thursday.
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"Co-administration of influenza and covid-19 is encouraged," said Dr. David Shay, a medical officer with the CDC's National Center for Immunization and Respiratory Diseases, in a Clinics Outreach and Communication Activity call. CDC.
"The recommendation for this year is that covid-19 vaccines can be administered regardless of the schedule of other vaccines, and that would include the simultaneous administration of the covid-19 vaccine and other vaccines on the same day," he said, He added that the CDC is currently monitoring the effects of co-administration of the covid-19 vaccine.
CNN's Jacqueline Howard and Virginia Langmaid contributed to this story.
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