WASHINGTON (BLOOMBERG) - Pfizer has asked United States regulators to clear its Covid-19 vaccine for emergency use in children under age five, a step towards giving the young children pandemic protection.

The drugmaker and BioNTech finalised their application to the Food and Drug Administration (FDA) for emergency-use authorisation for their vaccine in children six months to four years old, the companies said in a statement on Wednesday (June 1). The vaccine partners began the submission process in February.

Pfizer and BioNTech announced in late May that a three-shot regimen was highly effective and prompted a strong immune response in children under five, based on early results from a highly anticipated trial that is likely to pave the way for infants and toddlers to get immunised.

The preliminary analysis found that the regimen was 80.3 per cent effective in preventing Covid-19 infections among the young children, with 10 infections occurring among all participants.

Final results will be determined once 21 children enrolled in the study have been infected, according to the companies.

In February, Pfizer and BioNTech launched a rolling review of data from the trial of 1,678 children under the age of five.

The three-dose vaccine regimen was well tolerated, with a safety profile similar to that of the placebo, and most side effects were mild or moderate.

The full submission includes data on the product’s safety, efficacy and ability to prompt an immune response.

Children under five were given a series of three doses, each 3mcg, or one-tenth the amount given to adults.

With the submission now complete, attention will turn to a forthcoming FDA advisory committee meeting on June 15.

The panel of experts will convene to discuss the risks and benefits of the Pfizer-BioNTech and Moderna vaccines in the youngest children, and provide a recommendation to US regulators as to whether or not these should be cleared for emergency use.