Moderna has started testing its Coronavirus vaccine on infants and children between the ages of 6 months and 12 years in a study. The testing has been started by the pharmaceutical company as it seeks to expand approval for its vaccine on children.
The company informed that the first participants have been dosed in the Phase 2/3 study, called the KidCOVE study, on pediatric Coronavirus vaccinations. The participants have been dosed with mRNA-1273, the vaccine candidate of Moderna against COVID-19.
Moderna has become the first of the companies with vaccines authorized in the United States to launch testing among infants. The clinical trial, called the KidCOVE study by Moderna, will enroll approx. 6,750 children in Canada and the United States between the ages of 6 months and 11 years.
We just announced that the first participants have been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, our vaccine candidate against COVID-19, in children ages 6 months to less than 12 years. Read more: https://t.co/FpQ2NCcRxR pic.twitter.com/oWZ0UET8e1
— Moderna (@moderna_tx) March 16, 2021
In December 2020, the US Food and Drug Administration had authorized the emergency use of Moderna’s vaccine for adults along with Pfizer/BioNTech’s Coronavirus vaccine for people aged 16 or older.
KidCOVE Study |
| The clinical trial by Moderna has been divided into two parts. First part of the trial • In the first part, different dosages of the COVID-19 vaccine are being tested on the children. • Children between the ages of 6 months and 1 year will receive the two doses of the vaccine at the gap of 28 days at either a 25 or 50 or 100 microgram level. • Children who are between the ages of 2 and 11 years will receive two doses of the vaccines at the gap of 28 days at either a 50 or 100 microgram level. • The findings of part 1 will be used in determining which dose will be used in part two of the trial. Second part of the trial: For the second part of the KidCOVE Study, the trial will further expand to include children who have been given a saline placebo, which does nothing. The children will be then followed for 12 months after they receive the second injection. |
Moderna begins study on healthy children:
Moderna has been doing the tests to see if the company’s vaccine protects children from getting sick if they come in contact with the Coronavirus.
The Chief Executive Officer of Moderna stated that the company is pleased to begin phase 2/3 study of mRNA-1273 in healthy children in Canada and the US and thanked the National Institute of Allergy and Infectious Diseases- NIAID and Biomedical Advanced Research and Development Authority- BARDA for their collaboration.
The CEO of Moderna further added that it is humbling to know that 53 million doses have been administered to people in the US.
The company has been encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults of 18 years and above and that the pediatric study will help Moderna in assessing the immunogenicity and potential safety of the company’s vaccine candidate in this significant younger age population.
Other pharmaceutical companies studying vaccine on children:
Moderna is not the only company that has been testing the Coronavirus vaccine on children and Pfizer/BioNTech COVID-19 vaccine is also being studied in children.
Simultaneously, Johnson & Johnson has announced its plan of studying the vaccine in adolescents between the age of 12 to 18.
Impact of Coronavirus on children:
Few children under the age of 18 have died due to the virus, the number is less than 300.
However, according to the data from Centres for Disease Control and the American Academy of Pediatrics, the group has accounted for more than 10% of the positive tests for the infection.
Studies attempting to find out how readily the virus can be spread from children to adults have shown some conflicting results.
In addition, some of the infected children have also developed a related disease known as the Multisystem Inflammatory Syndrome which required hospitalization. However, most of the patients have recovered.
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