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Many parents are now waiting for the time when their young children can sign up for a Covid-19 vaccine – but there are several steps that must be taken first.
1. Pfizer must seek authorization for this age group from the FDA
Pfizer and BioNTech have yet to apply to the U.S. Food and Drug Administration for emergency authorization to use their Covid-19 vaccine to include children aged 5 to 11.
“The company must submit a request to change its EUA to include the additional population,” an FDA spokesperson told CNN in an email Monday.
The Pfizer and BioNtech Phase 2/3 trial included 2,268 children aged 5 to 11 and involved a two-dose regimen of the vaccine administered 21 days apart. The trial used a 10 microgram dose of vaccine, lower than the 30 microgram dose currently used in people 12 years of age and older.
Pfizer said Monday that its application to the FDA would be submitted shortly.
Former FDA commissioner and Pfizer board member Dr. Scott Gottlieb told CNBC’s Squawk Box Monday morning that Pfizer could submit to the FDA “very quickly.”
“The data came in a little earlier than expected, and depending on how long the FDA takes to review the application, whether it’s a four-week review or a six-week review, you might have a vaccine available for children as early as probably by the end of October, maybe that slips a bit around November, “Gottlieb said.
2. FDA to change vaccine EUA to include young people
Therefore, the EUA should be extended to include the youngest.
“However, the agency’s ability to promptly review these submissions will depend in part on the quality and timeliness of submissions by the manufacturers,” said Woodcock and Marks. “Like every vaccine decision we have made during this pandemic, our assessment of data on COVID-19 vaccine use in children will not cut any shortcuts.”
Members of the FDA’s Vaccines and Related Biologics Advisory Committee will likely meet to discuss the data from Pfizer and BioNTech and whether they recommend changing the EUA to include children aged 5 to 11.
“Once we see a timeline for this actual meeting, it will give us a good idea of when we could potentially see approval,” Dr. Evan Anderson, physician at Children’s Healthcare in Atlanta and professor of pediatrics and medicine at Emory University, said on a call with reporters Monday.
“This meeting of advisers will then have to take place,” he said. “The FDA would then have to agree or disagree with its external group of advisers about a possible approval.”
3. CDC to weigh in on vaccine for 5-11 year olds
After the FDA makes its decision to authorize the vaccine for young children ages 5 to 11, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss new clinical recommendations for the vaccine.
“It usually happened within a few days of FDA approval, and I think it would probably happen again here – and once that is in place, the vaccines can be used,” Anderson said.
In the meantime, Pfizer said in an emailed statement to CNN on Monday that it continues to focus on providing the vaccine to those who are currently eligible to receive the vaccine.
“Pfizer and BioNTech continue to supply the vaccine, under their existing supply agreement with the US government, which runs until April 2022. When introducing booster doses in the US under EUA, and approval and / or EUA in new age cohorts, The supply agreements that Pfizer and BioNTech have in place with governments around the world and international health organizations will not be affected, “the statement said.” Businesses will continue to deliver on their commitment to deliver two billion doses to low- and middle-income countries in 2021 and 2022, or one billion each year. “
4. Once the CDC and FDA are signed, a deployment for young children could begin
The vaccine Pfizer tested in children is the same one used in adults, but at a lower dose – 10 micrograms instead of 30 micrograms.
Although many adults were vaccinated very early on in nursing homes or mass vaccination sites, the rollout looked different by the time people aged 12 to 15 were vaccinated. For them, the focus was on pharmacies and doctors’ offices – and that’s probably the case with even younger children.
When the vaccine was cleared for children ages 12 to 15 in May, state health officials said it went “better than expected,” with appointments made quickly. However, shots in adolescents have not kept pace and cases in children have increased in recent weeks.
“I think there is certainly a lot of hope that we will see some absorption in our 5-11 year olds if and when a vaccine becomes available, but I think, similar to what we are seeing in adolescents and adults, there will be some hesitation which will be a major issue as to the potential impact of such a vaccine approval, ”Anderson said.
It also shouldn’t be the last group to go through the clearance process.
The results are yet to come for even younger children. Pfizer said Monday it expected test data for children as young as 6 months “as early as the fourth trimester of this year.”
Both Moderna and Johnson & Johnson vaccines are approved for people 18 years of age and older, but are also under study in younger people.
CNN’s Naomi Thomas contributed to this report.
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