Barbara Binzak Blumenfeld, shareholder in the firm's Life Sciences Industry Group, was quoted in The Philadelphia Inquirer article, “Pfizer’s COVID-19 vaccine has been fully approved by the FDA. What does that mean for the pandemic?”
What’s more, the legal basis for off-label usage in this case is somewhat murky, said Barbara Binzak Blumenfeld, an attorney in the FDA and biotech group in the Washington office of Buchanan Ingersoll & Rooney.
That’s because the Pfizer-BioNTech vaccine is approved for one age group, 16 and up, but remains under the emergency-use designation for another, children aged 12 to 15. Off-label usage is permitted only for drugs with full approval, not for those that are authorized for emergency use, yet the Pfizer-BioNTech vaccine fits both of those descriptions.
“The way FDA worded the final label, I think it leaves it unclear as to whether that leeway for doctors to prescribe off-label exists,” she said.