Pfizer fully enrolls pediatric COVID-19 vaccine trial with more than 2K kids
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Pfizer has fully enrolled its pediatric COVID-19 vaccine trial with 2,259 participants aged 12 to 15 years, a company spokesperson said.
Currently, only one of the two available COVID-19 vaccines is being offered to any children — the shot manufactured by Pfizer and BioNTech was authorized by the FDA for use in people aged 16 years or older. The Moderna vaccine is only authorized for people aged 18 years or older.
“The AAP has strongly encouraged vaccine manufacturers to include adolescents and then younger children in the vaccine trials so that we can better understand the safety and efficacy profile of the COVID-19 vaccines and then be able to deliver vaccine safely to millions of children, ideally before the next school year begins,” AAP spokesperson and pediatrician for Northwestern Medicine Anita Chandra-Puri, MD, FAAP, told Healio.
As of Jan. 21, nearly 2.68 million children have tested positive for COVID-19, with more than 165,000 pediatric cases being reported in the week prior, according to the AAP.
Although COVID-19 cases have been reported far less frequently in pediatric populations, data have suggested that trends in new cases have nearly paralleled those in adults — rising and falling at the same time. Other research has demonstrated that COVID-19 seems to be twice as common in those aged 12 to 17 years than in those aged 5 to 11.
Following its initial recruitment of children aged 12 to 15 years, Pfizer plans to enroll children aged 5 to 11 years later this year.
“Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule. We’ll be able to finalize those plans more so when we have data from the 12-to-15-year-old cohort,” Keanna Ghazvini, a spokesperson for Pfizer, told Healio.
In response to COVID-19 vaccine shortages, President Joseph R. Biden Jr. announced this week that the government purchased an additional 200 million doses from Pfizer-BioNTech and Moderna, to be delivered at some point during the summer to vaccinate, it is hoped, the entire country by the fall.
It is unclear if a COVID-19 vaccine will be approved for those aged younger than 16 years by then.
“As we do with all vaccines, which are initially studied in adult populations, we are following a careful, stepwise approach as we move down to younger age groups,” Ghazvini said.
Asked how studying COVID-19 vaccines in children could help keep schools open, Chandra-Puri said that “when children are able to be vaccinated, there will be an added layer of protection against COVID-19 and a stronger feeling of safety that they can return to their educational homes — which we all realize is critical for their academic development and mental and physical well-being.”
Reference:
AAP. Children and COVID-19: State-level data report. https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Accessed Jan. 28, 2021.
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What we are really trying to leverage for these pediatric studies is an immune correlate of protection that we can pull from these large phase 3 adult trials. Meaning, if we can identify the magic number that you need in order to be protected from COVID-19, then subsequent studies and a variety of populations should go much more quickly.
Instead of waiting for someone to get COVID-19 and proving that the vaccine works in that way, we have got a really good number that your immune system has to get to in terms of antibodies that your immune system has to get to in order to be protected. Then we can conduct these pediatric studies, pregnant women studies and special population studies much more quickly.
Because of that, I would anticipate that we will see data from this study over the next several weeks, recognizing that everybody's got to get both their doses; everybody's got to have their samples run; and then the samples must be compared with these thresholds that we've pulled from these phase 3 studies.
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