While waiting for data on a three-dose course, US regulators are urging Pfizer to apply for emergency approval for a two-dose regimen of its Covid-19 vaccine for children aged 6 months to 5 years old, aiming to clear the way for the shots as soon as late February, according to a source familiar with the situation.
The corporation was planning to submit its application as early as Tuesday.
The vaccination, which is given to younger children at one-tenth the strength of the adult dose, has been found to be safe and to produce an immunological response in early Pfizer data. However, Pfizer announced last year that the two-dose shot was less effective at preventing Covid-19 in children ages 2 to 5, and regulators encouraged the company to add a third dose to the study, assuming that a third dose would boost the vaccine’s effectiveness, similar to how booster doses boost adult vaccine effectiveness.
According to a source familiar with the situation, the FDA is pressuring the business to submit its application based on the two-dose data for probable approval in February, and then return for further permission once it receives results from the third dose study, which is expected in March.
If the FDA and the Centers for Disease Control and Prevention approve the shots, young children could be vaccinated more than a month earlier than previously estimated. To discuss sensitive regulatory matters, the source spoke on the condition of anonymity. Given the development of the highly transmissible omicron strain of Covid-19, the person indicated that the two-dose vaccine’s lower efficiency was not surprising.
Allowing young children to receive a two-dose vaccine sooner might speed up the time it took for them to receive the projected better protection from a third dose. That would be good news for families of children, who are the last age group to have Covid-19 shots approved. Young children are significantly less likely than adults to have major complications or die from Covid-19, although the number of cases among this age group has increased as the omicron variant’s instances have grown across the country. The majority of infections and deaths occur in older adults, particularly those who have not been immunised.
The Biden administration has been working to expedite the approval of paediatric vaccines against Covid-19 for more than a year, believing that they are vital to reopening and maintaining schools and day care centres, as well as allowing parents with childcare duties to return to work. Vaccines for children aged 5 to 12 were approved by US regulators in November, though vaccination uptake has been slower than expected. Pfizer’s primary series is spread out across 3 weeks. The third dose for young children is being researched for at least two months after the second dose.