Emergency COVID-19 vaccine approval to require 2 months of follow-up data, FDA says

The Food and Drug Administration told makers of experimental COVID-19 vaccines that, in order to request emergency approval, they need to provide at least two months of follow-up data after trial participants received their final injection.

The new requirement –­­ listed within the agency’s newly published guidelines for Emergency Use Authorization (EAU) –­­ creates an unlikely timeline for drugmakers to receive approval by Nov. 3.

FDA SET TO ANNOUNCE GREATER RESTRICTIONS FOR COVID-19 VACCINE: REPORT

As part of its updated requirements, the FDA noted that vaccine makers should follow participants for a minimum of two months after receiving their final dosage in an effort to rule out any major side effects before submitting candidates for EAU approval.

This data will help to “provide adequate information to assess a vaccine’s benefit-risk profile including adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe

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New FDA COVID-19 vaccine guidance requires two months of follow-up data for approval

Oct. 6 (UPI) — New guidelines issued by the U,S. Food and Drug Administration on Tuesday require manufacturers of potential new COVID-19 vaccines to provide two months’ worth of “follow-up” data on safety and possible adverse events.

The mandate would appear to dash President Trump’s hopes of having a new vaccine approved by the Nov. 3 election.

The two-month period was decided upon because agency research suggests that most adverse events or severe side effects with vaccines emerge within two to three months after administration, an FDA administrator said.

“Ideally, we’d like to have longer-term safety follow-up, but we are in the middle of a pandemic and people are dying,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Marks was among several top public health officials who spoke during a virtual symposium Tuesday entitled “Preserv[ing] the Scientific Integrity of COVID-19 Vaccine Development and Allocation,”

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