The FDA has given an emergency use approval to Pfizer’s low dose COVID-19 vaccine for children aged 5-11 years.
Pfizer and BioNTech’s joint vaccine has proven highly successful at preventing infections and deaths among people of all ages. Since the approval of their vaccine in children aged 12 and above, vaccine manufacturers have been working to get authorization for a younger age group. Earlier this month, Pfizer released data of its Phase 2/3 trials that assessed a low-dose version in young children. According to the trial, Pfizer’s vaccine was found to be safe for children aged 5-11 years. Now, based on those results, the US Food and Drug Administration (FDA) has granted an emergency use approval to the vaccine.
The Phase 2/3 clinical trial included over 2,000 children between the ages of 5 and 11 years. As part of the trial, the vaccine group received two 10 µg doses of the vaccine, three weeks apart. Although the dose was one-third of the dose used in teens and adults, it managed to evoke a significant immune response, comparable to that in other age groups. Furthermore, researchers reported a 90.7% efficacy and no serious side effects among the vaccine group.
Pfizer Remains First
FDA’s authorization has made Pfizer’s vaccine the first to receive approval for younger children.
Currently, children in this age group account for 16.5% of all COVID-19 cases and 39% of cases in children. Although children don’t always develop a severe infection, some infections can result in hospitalizations and even death. The approval will make the vaccine available to approximately 28 million kids in the country.
The CDC’s advisory panel will now meet next week for a decision. According to Dr. Anthony Fauci, if CDC approves, the vaccine will likely become available within the first few weeks of November.
Source: US Food and Drug Administration