Infectious Disease

Pfizer Absolutely Enters Pediatric COVID-19 Vaccine Research with Extra Than 2K Youngsters

January 28, 2021

3 min read

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Chandra-Puri and Ghazvini do not report any relevant financial information.

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Pfizer has fully registered its COVID-19 pediatric vaccine study with 2,259 participants, ages 12-15, according to a company spokesperson.

Currently, children are only offered one of the two COVID-19 vaccines available – the shot made by Pfizer and BioNTech has been approved by the FDA for use in people aged 16 and over. The Moderna vaccine is only approved for people aged 18 and over.

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Anita Chandra-Puri

“The AAP has strongly encouraged vaccine manufacturers to include adolescents, and then younger children, in vaccine studies so that we can better understand the safety and efficacy profile of COVID-19 vaccines and then, ideally, safely vaccinate millions of children before the next school year begins, “said AAP spokesman and pediatrician for Northwestern Medicine Anita Chandra-Puri, MD, FAAPsaid Healio.

As of January 21, nearly 2.68 million children had tested positive for COVID-19, according to the AAP, with more than 165,000 pediatric cases reported the previous week.

Although COVID-19 cases have been reported far less frequently in pediatric populations, the data suggest that trends in new cases are close 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 12 to 17 year olds as it is in 5 to 11 year olds.

After initially hiring children ages 12-15, Pfizer plans to enroll children ages 5-11 later this year.

“Getting under 12 will require a new study and possibly a modified formulation or dosage schedule. We will be better able to complete these plans if we have data from the 12 to 15 year old cohort. ” Keanna Ghazvini, a Pfizer spokesman, said Healio.

In response to the shortage of COVID-19 vaccines, President Joseph R. Biden Jr. announced this week that the government has bought an additional 200 million doses of Pfizer-BioNTech and Moderna to be dispensed sometime in the summer to vaccinate the entire country by fall.

It is unclear whether a COVID-19 vaccine will be approved for people under the age of 16 by then.

“As with all vaccines that are initially studied in adult populations, we take a cautious, step-by-step approach as we move on to younger age groups,” said Ghazvini.

When asked how studying COVID-19 vaccines in children could help keep schools open, Chandra-Puri said, “If children can be vaccinated it will add an extra layer of protection against COVID-19 and a greater sense of security Giving them what they can Return to their educational homes – which we all know are critical to their academic development and mental and physical wellbeing. “

References:

AAP. Children and COVID-19: Country Level Data Report. https://services.aap.org/de/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 leverage for these pediatric trials is an immune correlate of protection that we can get from these large phase 3 adult trials. That said, if we can identify the magic number you need to be protected from COVID-19, subsequent studies and a wide 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 your immune system needs to get in terms of antibodies that your immune system needs to be protected. Then we can do these pediatric studies, studies on pregnant women, and special population studies much faster.

Because of this, I would assume that we will see data from this study over the next several weeks, recognizing that everyone must receive both doses. Everyone has to run their rehearsals; and then the samples need to be compared to these thresholds that we pulled from these phase 3 studies.

C. Buddy Creech, MD, MPH

Member of the editorial board, infectious diseases in children

Director of the Vanderbilt Vaccine Research Program

Associate Professor of Pediatrics at Vanderbilt University School of Medicine

Disclosure: Creech reports that he is a lead phase 3 researcher for the Johnson & Johnson and Moderna COVID-19 vaccine studies, the funding of which was paid by the NIH, which sponsored the studies.

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