Pharmaceutical company Moderna announced plans to expand its coronavirus vaccine testing trials to include children aged five to 11 years old, officials confirmed on Monday.
The expansion of the trial aims to increase the possibility of detecting potentially rare side effects among infected individuals, Moderna said. However, the company declined to reveal how many children it planned to include in the trials.
COVID-19 Vaccine Trials for Children
Last month, the Food and Drug Administration (FDA) included a warning label on Pfizer and Moderna's COVID-19 vaccines, noting the potential risk of heart inflammation, which was reported in younger individuals as a rare side effect.
In a statement, Moderna said it was currently discussing the expansion of the trial and expected that in late 2021 or early 2022, they would be able to have authorization. The company noted that the FDA would be responsible for choosing the route of authorization.
Earlier this Monday, reports noted that the FDA requested both Moderna and Pfizer to include 3,000 children aged five to 11 years in their vaccine trials. Pfizer did not provide any updates regarding the previously stated timelines or information regarding its vaccine trials, CNBC reported.
However, Pfizer said that it expects results from its Phase 2.3 trials to come out in September for children aged five to 11 years. Officials said that they expect the results for younger children shortly after.
Many parents across the United States are eagerly waiting for the eligibility of their young children to get vaccinated. The incident comes as schools begin preparing to open for in-person learning in the fall. Pfizer's vaccine is currently authorized to be given to children as young as 12 but no treatment is available for those younger.
Last week, United States President Joe Biden said that children younger than 12 years old could soon become eligible for COVID-19 vaccination. He predicted that the go signal for the process could come in the next few months.
Cases of Rare Side Effects
The nation's top infectious disease expert, Dr. Anthony Fauci, who is also the director of the National Institute of Allergy and Infectious Diseases, said earlier this month that the FDA has the final say in the matter. The medical professional said he did not expect the process to be available until later on in the winter season, CNN reported.
Members of a CDC advisory committee noted that the benefits of having vaccinations available for children under 12 years old far outweighed the risks, which include heart problems.
Moderna's trial started recruiting participants in March and initially planned to enroll 6,795 children younger than 12 years old. Officials will split the children into three age brackets. Ray Jordan, a company spokesman, said they were discussing the details with the FDA.
The Centers for Disease Control and Prevention published data that showed the Moderna and Pfizer vaccines have been linked to myocarditis and pericarditis, where more than 1,200 Americans reported the issue, where about 500 of the victims were younger than 30. Authorities said that the symptoms typically occurred within two weeks and were more frequent in young men and boys, the New York Times reported.
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