Pfizer and its German partner BioNTech have said that preliminary clinical data showed their three-dose Covid-19 vaccine regimen was 80 percent effective for children aged between 6 months to 5-years-old at 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, Xinhua news agency quoted the companies as saying on Monday.
The safety data for the Pfizer vaccine is based on 1,678 children under age 5 who received the third shot at least two months after the second dose when Omicron was the main variant in circulation.
Kids under age 5 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 authorization,” said Pfizer Chairman and CEO Albert Bourla.
Pfizer said it is preparing relevant documents and expect to complete the submission process to the US Food and Drug Administration this week.