Protect Their Future Urges FDA to Speedy Review of Moderna Data for Young Children
March 23, 2022 – Today, Moderna announced that its COVID-19 vaccine for children 6 months - 6 years was found to be safe and effective, setting the stage for a submission to the FDA for Emergency Use Authorization. Two years into the pandemic, the FDA owes a speedy review to families and the 18 million children under five who still have no vaccine access, especially as a new COVID-19 surge is disrupting the health and safety of communities in Asia and Europe and threatens to do the same in the US within the next few weeks.
“We saw the devastating impact Omicron had on children under 5 who are still vulnerable without any access to vaccines,” said pediatrician and co-founder of Protect Their Future, Katherine Matthias. “A significant portion of pediatric deaths occurred during that surge, and we cannot permit any more of these preventable losses. No more parents should have to bury their children, especially when there is a safe and effective vaccine available. The FDA has a moral obligation to do everything possible to urgently review Moderna’s data, and if favorable, grant an Emergency Use Authorization. Our children’s lives and health depend on it.”
Over 400 kids under five have died from COVID-19 during this pandemic, many during the last few months. Approximately 40,000 children have been hospitalized for COVID-19, according to the American Academy of Pediatrics’s data collected from 25 states and New York City. A growing number of children suffer from long-COVID and MIS-C, and we’ve seen that Omicron hits babies and young children harder than previous variants, causing croup and bronchiolitis.
Since June 2021, the FDA has delayed approval for Moderna’s submission for ages 12-18 in order to investigate risks of myocarditis. While the risk of myocarditis is extremely low in all ages, doctors agree that myocarditis is primarily seen in post-pubescent individuals, and that children under five do not fit this profile. Over 40,000 children under five have already safely received mRNA vaccines off-label in Germany with no serious side effects.
We have seen our health leaders cut bureaucratic red tape to ensure safe COVID-19 vaccines for the adult population. We now have abundant information that mRNA vaccines are safe and effective at preventing severe disease. Our children cannot wait any longer–the FDA must make the review of Moderna’s data a top priority so that young children can receive the same access to COVID-19 vaccines as the rest of the population.
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Protect Their Future is a grassroots group of physicians, parents, and activists advocating on behalf of young children and patients to have access to COVID-19 vaccines as the pandemic rages on. The organization is calling on health leaders to PUT KIDS FIRST and allow parents and doctors the option to protect children with a safe and effective vaccine.
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