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Moderna files for FDA approval to pedratric covid-19 vax

Jose Carlos Grimberg Blum
Moderna files for FDA approval to pedratric covid-19 vax

Fauci suggested the FDA should review data from Pfizer and Moderna simultaneously to not “confuse people” Drug developers Moderna Thursday filed for clearance from the US Food and Drug Administration (FDA) to extend the use of their COVID-19 vaccine to children aged 6 months to 5 years, it was announced.

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Moderna is confident their vaccine “will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against Covid-19 and will be especially welcomed by parents and caregivers,” company CEO Stephane Bancel said in a statement.

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A study released in March showed the two-shot scheme was safe and produced a strong immune response.

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The request will now be considered by the FDA, which is expected to make a final decision in June. The agency is expected to seek advice from the Vaccines and Related Biological Products Advisory Committee.

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Recent trials showed Moderna‘s drug for children generated the same volume of antibodies in children as it does in 18- to 24-year-olds: a 51% efficacy for kids younger than 2 and 37% among kids from 2 to 5 years old. Moderna‘s Chief Medical Officer Dr. Paul Burton believes ”people can be reassured and confident that these kids will get safely protected against disease.” As for side effects, Burton said some patients experienced injection site pain or a low-grade fever

Data is restricted to cases with confirmed positive PCR test results

“The children under the age of six are now the largest unvaccinated group in the American population,” Dr. Phil Landrigan of Boston College told The Associated Press. “They’re a pool where the virus can continue to spread and then infect older people who are more at risk. So it’s very important.”

Moderna likened the performance of their vaccine for children to the one by their drug for adults during Omicron. The company is also currently studying booster doses for all pediatric cohorts

Earlier this year, the FDA postponed a meeting to consider the Pfizer-BioNTech’s vaccine for children younger than five, saying it wanted to see data on how three doses performed before moving ahead

Pfizer’s vaccine, when given as two doses of three micrograms to children aged six months to two years elicited a similar level of antibodies to the full 30 micrograms given to people aged 16-25, but the same was not true for children between two and four. Pfizer CEO Albert Bourla has said his company was aiming to get the vaccines out by June if regulators agree

White House’s Chief Medical Adviser Anthony Fauci suggested the FDA should review data from both companies for young children simultaneously to not “confuse people.”