USA: Pfizer can request license for anti-COVID vaccine for children under five

U.S. regulators have urged pharmaceutical company Pfizer to request emergency authorization for its two-dose COVID-19 vaccine for children between six months and five years of age, while it awaits the results of the three-injection treatment, The Associated Press reported. a source familiar with the matter.

The company is expected to deliver its application on Tuesday.

Preliminary data from Pfizer indicate that the vaccine for children – which has a tenth of the potency of the one applied to adults – is safe and provokes an immune response. But last year Pfizer announced that the two-dose treatment is less effective in children between the ages of two and five, and regulators encouraged the company to add another dose to the study, thinking it would increase the effectiveness of the vaccine.

Now the Food and Drug Administration (FDA) is encouraging the company to apply based on the two-dose data, for possible approval this month, and then come back for another authorization once it has data on all three doses, which will likely be in March. said the source.

That two-phase authorization could allow the vaccination of young children more than a month earlier than planned, as long as it is approved by the FDA and the Centers for Disease Control and Prevention (CDC).

The source spoke on condition of anonymity as he was not authorized to discuss the matter.

This process would be good news for parents of young children, the last remaining group to have approved COVID-19 vaccines in the United States.

Children who do get sick with COVID-19 usually have mild symptoms, but severe cases among that social group have been increasing as the omicron variant spreads further. Most of the severe cases and deaths occur among the elderly, particularly those who are not vaccinated.

Accelerating the process for pediatric vaccines has been a priority for the administration of the president Joe Biden, which considers them necessary to keep schools and child care centers open, and therefore to allow parents to return to their jobs.