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January 28, 2021
3 min read
Source / Disclosures
Interviews with Healio.
Disclosures: Chandra-Puri and Ghazvini do not communicate any relevant financial information.
Pfizer has fully enrolled its pediatric COVID-19 vaccine trial with 2,259 participants aged 12 to 15, a company spokesperson said.
Currently, only one of the two available COVID-19 vaccines is offered to children – the vaccine manufactured by Pfizer and BioNTech has been cleared by the FDA for use in people 16 years of age or older. The Moderna vaccine is only authorized for people 18 years of age or older.
Anita Chandra-Puri
“The AAP strongly encouraged vaccine manufacturers to include adolescents and then younger children in vaccine trials so that we can better understand the safety and efficacy profile of COVID-19 vaccines and then be able to providing the vaccine safely to millions of children, ideally. before the start of the next school year, ”AAP spokesperson and pediatrician for Northwestern Medicine Anita Chandra-Puri, MD, FAAP, Healio said.
As of Jan.21, nearly 2.68 million children have tested positive for COVID-19, with more than 165,000 pediatric cases reported the previous week, according to the AAP.
Although cases of COVID-19 have been reported much less frequently in pediatric populations, the data suggests the trends in new cases are almost identical to those in adults – rising and falling at the same time. Other research has shown that COVID-19 appears to be twice as common in people aged 12 to 17 compared to those aged 5 to 11.
Following its initial recruitment of children aged 12 to 15, Pfizer plans to enroll children aged 5 to 11 later this year.
“Going below 12 years will require a new study and potentially a modified formulation or dosing schedule. We will be able to further finalize these plans when we have data on the 12 to 15 year old cohort ”. Keanna ghazvini, a spokesperson for Pfizer, told Healio.
In response to COVID-19 vaccine shortages, the President Joseph R. Biden Jr. announced this week that the government has purchased an additional 200 million doses from Pfizer-BioNTech and Moderna, which will be delivered at some point during the summer to hopefully vaccinate the entire country by autumn.
It is not known if a COVID-19 vaccine will be approved for people under the age of 16 by then.
“As we do with all vaccines, which are initially studied in adult populations, we take a cautious and gradual approach as we move down to the younger age groups,” Ghazvini said.
Asked how the study of COVID-19 vaccines in children could help keep schools open, Chandra-Puri said that “when children can be vaccinated there will be an extra layer of protection against COVID- 19 and a stronger sense of security that they can return to their school homes – what we all know is essential for their academic development and their mental and physical well-being.
The references:
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 January 28, 2021.
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C. Buddy Creech, MD, MPH
C. Buddy Creech
What we’re really trying to take advantage of from these pediatric studies is an immune correlate of protection that we can derive from these large phase 3 trials in adults. This means that if we can identify the magic number you need to be protected from COVID-19, then further studies and a variety of populations should go much faster.
Instead of waiting for someone to get COVID-19 and proving that the vaccine works that way, we have a really good number that your immune system needs to hit in terms of the antibodies your immune system needs to hit to protect. you. Then we can do these pediatric studies, studies of pregnant women, and special population studies much faster.
Because of this, I anticipate that we will see the data from this study over the next few weeks, recognizing that everyone should receive their two doses; everyone must have their samples analyzed; then the samples should be compared to those cutoffs that we got from those phase 3 studies.
C. Buddy Creech, MD, MPH
Member of the Editorial Board, Infectious Diseases in Children
Director, Vanderbilt Vaccine Research Program
Associate Professor of Pediatrics, Vanderbilt University School of Medicine
Disclosures: Creech claims to be a Phase 3 principal investigator for the Johnson & Johnson and Moderna COVID-19 vaccine studies, whose funds were paid by the NIH, which sponsored the trials.
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