US FDA endorses Pfizer's COVID-19 vaccine for children aged 5 to 11

United States Food and Drug Administration’s (FDA) advisory panel on Tuesday, 26 October voted in support of Pfizer’s COVID-19 vaccine for kids aged 5 to 11. As per The Associated Press, the FDA advisory panel voted unanimously with one abstention, endorsing the kid-size doses of Pfizer shots. The panel also agreed that the vaccine’s benefits in preventing COVID-19 in the said age group outpower the potential risks associated with inoculation. Notably, these risks include questions linked to heart problems which have been very rare among teens and young adults even though much higher vaccine doses were used for them. 

Even though children are far less likely than older people to contract coronavirus infection, the FDA panellists decided that it was essential to provide the parents with the choice to protect their kids, particularly the ones who are either at high risk of illness such as those living in environments without any precautions.   

The committee reviewed Pfizer's clinical data showing its COVID-19 vaccine "showing a favourable safety profile and high vaccine efficacy of 90.7% in children 5 to <12 years of age during a period when Delta was the prevalent strain," said the US drugmaker in a statement. Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer also said, "We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our COVID-19 vaccine in children 5 to under 12 years of age."

Jansen said, "About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner."

"We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population,” she added.

However, FDA is not bound by the panel’s recommendation and will be making its own decision within a few days. If the FDA agrees with the panellists, then the Centers for Disease Control and Prevention (CDC) will have to decide if the shots should be recommended or which youngsters should receive them. Presently, the full-strength Pfizer-BioNTech shots are recommended for everyone at the age of 12 and above. But, both parents and paediatricians are reportedly seeking protection for younger children.  

'Robust neutralising antibody response' is generated by COVID-19 vaccine: Moderna 

FDA’s advisory panel endorsing Pfizer shots for children aged 5-11 came after Moderna on Monday stated that a “robust neutralising antibody response” is generated by its COVID-19 vaccine in children between the ages 6 and 11. Following the phase 2-3 trials, the company said that it would soon submit the data to global regulators.

Moderna Chief Executive Officer Stephane Bancel said in a statement, “We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints...We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”

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