Pfizer Inc. and BioNTech SE sought permission from the American health officials to use their revised COVID-19 booster in children between the ages of 5 and 11. As the redesigned shots for children aged 12 and above start rolling out across the country, the companies made the request on September 26, 2022. To increase protection from the coronavirus in the event of a spike in cases in fall or winter, health authorities are urging people to get vaccinated.
The US FDA is expected to decide on the request from the companies before the end of 2022. Before making a recommendation, the Centers for Disease Control and Prevention would call a conference of their outside advisers, including pediatricians, public health professionals, and other vaccine specialists.
In the week ending September 23, 2022, Moderna sought approval from the FDA for the use of its revised booster shot in kids between the ages of 6 and 17. The company expects to make a request for the booster's usage in kids between the ages 6 months and 5 years later in 2022.
The novel "bivalent" vaccination targets two sub-strains of Omicron strain and the virus's ancestor strain. Following research that revealed that the original COVID-19 vaccines were not as effective against Omicron as they were against the earlier strains of the coronavirus, vaccine producers retooled their products at the direction of regulators early in 2022.
Pfizer and BioNTech claimed to have started clinical trials of the vaccine on children but did not divulge any results. The companies said that additional data, including manufacturing data, animal testing, trial data from a shot directed at the original Omicron variant that has not been approved for use, and other information, was the basis for the request.
Although their rate of immunization lagged what doctors and health experts had planned, children aged 5 to 11 have been eligible for COVID-19 doses for about a year. The American Academy of Pediatrics estimates that more than 10 million children in this category, or around 38%, received at least one dose.
Regulators approved boosters for these kids in May. The CDC estimates that 15% of 5-11-year-old kids who received all their recommended vaccinations also received a booster. According to opinion polls, not all parents support vaccinating their kids. Pediatricians and health professionals recommended parents to vaccinate their children against COVID-19 to protect them and others.
According to studies and health professionals, children have a lower overall risk of contracting COVID-19 than adults, and many kids who have had the infection have little or no symptoms. However, during the Omicron wave, hospitalization rates for kids increased, particularly for those who were not vaccinated. In September 2022, 4.4 million redesigned boosters for those at least 12 years old become accessible.
Without evidence from human trials demonstrating the efficacy of the vaccines, the US health regulators approved the vaccines using other sources of information such as the effectiveness of earlier booster rounds. Pfizer and BioNTech stated that they plan to submit a request to regulators in Europe in the coming days for the approval of the injections.
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