Why the US’ FDA is taking time to approve Covid shots for kids

Washington, Sep 13 : While parents are eagerly waiting to inoculate their kids with Covid-19 vaccines to protect them from infections, the US Food and Drug Administration has warned against using the currently available shots for children under 12.

In a recent statement, the regulatory body said it is working round the clock to support the process for making Covid-19 vaccines available for children.

It said that it "cannot offer a specific date or timeline" for the vaccine but assured that they "hope to have paediatric Covid-19 vaccines available in the coming months".

"Parents may be wondering if they can ask their health care providers to go ahead and vaccinate their kids using one of the currently available vaccines outside of the FDA-authorised or approved uses," said Janet Woodcock, MD, Acting Commissioner of Food and Drugs - FDA, and Peter Marks, Director - Center for Biologics Evaluation and Research, in the statement.

"Parents need to remember that the vaccine doses that are currently being studied in younger children are not necessarily the same vaccine doses that were authorised for individuals 12 years and older or approved for individuals 16 years of age and older -there are different dosing regimens being investigated.

The FDA said that they are awaiting completion of clinical trials and results before considering vaccinating young kids.

It wants to ensure that the vaccines are able to prevent Covid-19 in young children and don't cause unexpected safety issues separate from those that have already been observed in adolescents and adults.

The available vaccines, none of which have been cleared for children under 12, may not be a safe or effective dose for young children, the agency noted.

Paediatric clinical trials, which will help determine the right vaccine dose for children under 12, are still underway.

Health officials have previously expressed concern that full approval of the Pfizer-BioNTech vaccine for people 16 and up might prompt parents to seek, or doctors to give, the shots off-label to young children, specifically warning against the move.

"Children are not small adults -- and issues that may be addressed in paediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults," said Woodcock and Marks.



Source: IANS