Pfizer and its German partner BioNTech have said that preliminary clinical data showed their three-dose COVID-19 vaccine regimen was 80 percent effective in children aged between six months to five years for preventing illness during the Omicron wave.
The vaccine was found to elicit a strong immune response following a third dose, and was well tolerated by the kids with a majority of the side effects mild to moderate, the companies said on Monday, 23 May.
The safety data for the Pfizer vaccine is based on 1,678 children under age five who received a third shot at least two months after the second dose, when Omicron was the main variant in circulation.
Kids under age five receive 3-microgram shots, one-tenth the dosage level for adults.
"These topline safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorisation," said Pfizer Chairman and CEO Albert Bourla.
Pfizer said it was preparing relevant documents and expected to complete the submission process to the US Food and Drug Administration this week.
(At The Quint, we question everything. Play an active role in shaping our journalism by becoming a member today.)