FDA Pushes Vaccine For Children Under 5 Year Back For More Data

(RTTNews) - The US FDA has said on Friday that it will wait for the data of Pfizer, Inc. (PFE) vaccine's three doses on children below 5 years before authorizing the shot. As per reports, the delay can be as long as eight weeks.

The Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, MD, said that there will be a meeting held with the Vaccine and Related Biological Products Advisory Committee this week to decide on the vaccine's efficacy before the agency comes to a decision.

The drugmaker has already urged the agency to go ahead with the vaccine but Marks said, "in looking through the data we realized now… that at the time it makes sense for us to wait until we have the data of the evaluation of a mid dose before taking action."

"If we feel something doesn't meet (our) standard, we can't go forward. Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard," he added, reassuring the parents and caregivers of the children.

Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases had said that the vaccine for children under 5 years is going to be available by February but the vaccine would be authorized after its result after three doses.

The company, however, believes that the 3-microgram dosage that it has deemed suitable for children between 6 months to 4 years, is not going to have any adverse effects on them. Usually, adults receive a 30-microgram dosage for their vaccines.