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A Step Forward: Moderna Covid19 Vaccine Trials begin in infants and children less than 12 yrs of age

Dr.Reepa Agrawal
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A Step Forward: Moderna Covid19 Vaccine Trials begin in infants and children less than 12 yrs of age

22 Mar, 2021

As the global vaccination campaign against COVID-19 is in full swing in adult population, the clinical trials for younger ones have begun earlier this week. Moderna has announced vaccinating healthy infants and children between 6 months – 11 years in U.S and Canada as a part of Phase 2/3 study of mRNA -1273 vaccine (KidCove study).

This study will be conducted by Moderna in collaboration with National Institute of Allergy and Infectious Diseases ( NIAID) and Biomedical Advanced Research and Development Authority (BARDA). It will be enrolling 6,750 participants for this particular study which will be conducted in 2 parts to evaluate safety and effectiveness of the vaccine.

Its important to note that in de-escalation Part 1of the study, different dosage of vaccine will be administered according to age. Between 6 months – 2 years either a dose of 25 micrograms, 50 micrograms or 100 micrograms will be given and in 2 -12 years of age 50 micrograms or 100 micrograms will be used. After this an interim analysis will be done to determine the dose . Then post this analysis in part 2 that particular dose will be compared with placebo in participants. A total of 2 doses 28 days apart will be given intramuscularly. Now, unlike adult trials where presence or absence of severe covid infections was a crucial parameter , scientists are of the opinion that in this younger age group as incidence of severe Covid is less as compared to adults, the measurement of neutralising antibodies will be crucial.

Having said that we still don’t know the exact protective neutralising antibodies level which prevents disease or infection hence continued evaluation of data from adult population as well is required.

The clinical trials in teens are ongoing. Pfizer had enrolled 2,200 participants between 12-15 years by January 2021, started the same in October 2020. Moderna had enrolled 3,000 teens ( 12 -18 years) in its TeenCove study by February 2021. Johnson and Johnson may also start trials in pediatric population.

Pediatricians and Infectious Diseases experts are awaiting data of the above trials and some experts believe that by end of 2021 the above 12 years may start getting jabs against COVID-19 once the safety and effectiveness is determined.

This pandemic has taken a big toll on all of us including the kids and these jabs are a ray of hope .

Reference :

Clinicaltrials. gov

A Step Forward: Moderna Covid19 Vaccine Trials begin in infants and children less than 12 yrs of age

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A Step Forward: Moderna Covid19 Vaccine Trials begin in infants and children less than 12 yrs of age

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