The US FDA has granted full approval for Pfizer-BioNTech’s two-dose Covid-19 vaccine for the age group of 16 and above this week. However, for anxious parents of kids, the grant of approval for the covid-19 vaccines is still some way to go.
For children in the age group of 12 to 15, the Pfizer vaccine can still be administered since the vaccine is authorized for emergency use. But for children below 12 years of age, there is no vaccine approved for use. The grant of authorization or approval still has several steps ahead.
Vaccines For Under 12 – Still A Long Way To Get Vaccinated?
According to Dr. Peter Marks, the Director of the FDA’s Center for Biologics Evaluation and Research, the clinical trials for the vaccine on children are underway and the US-FDA is waiting for vaccine manufacturers to submit results from clinical trials. He wants to ensure that the FDA has a good safety dataset to be certain that the dosage is right for the kids and that the side effects are minimal.
According to him, administering a vaccine to a young population requires additional safety and scrutiny when compared to people ages 12 and above. While it is proven that the Pfizer vaccine is highly safe and effective against the deadly coronavirus even for kids, the vaccine manufacturers and authorities are trying to determine the right dosage levels for children and studying its after-effects.
Dr. Marks added that the “FDA will obviously move swiftly once those data are submitted, but first, the trials have to be finished up, or at least the parts of the trials that can be submitted to us have to be finished up, and then the data needs to be submitted to us.”
Large-scale studies by Pfizer and Moderna are currently underway and that Pfizer is expected to finish trials in September while Moderna tests are expected to be completed in late fall or early winter. Pfizer is in the final stages of clinical trials for kids in the age group of 5 to 11 while for kids below 5 years of age the trials may continue for some more time.
One reason why the clinical trials are taking more time and effort is due to the FDA’s request for four to six months of follow-up safety data for children’s trials compared to only two months of follow-up safety data for the adult population.
Meanwhile, looking at the rapid spread of the delta variant in the country and the fact that a large number of children are being infected by the virus, authorities are urging FDA to speed up the approval process for the vaccine for kids.
According to an update by the American Association of Pediatrics or AAP, last week there were close to 180,000 new cases of coronavirus infections amongst children and adolescents. AAP is hoping that the FDA grants at least the emergency use authorization for the vaccine for kids at the earliest so that the transmission of the virus can be prevented.