The US FDA has issued new standards for viral vaccines that are at least 50 per cent more effective than placebos for health emergencies

On Wednesday, it was reported that the US Food and Drug Administration (FDA) had issued new standards for health event virus vaccines, requiring that any candidate vaccine to be approved must prove to be at least 50 per cent more effective than a placebo and show insufficient immune response data.
The new standard could further dim hopes that a vaccine for health events will be available in the US by 2020.

“It is hard to see how those studies can recruit thousands of patients before the end of the year, vaccinate them, look at their safety for six months or more and then get approval,” said SVB Leerink analyst Geoffrey Porges. “A fully approved vaccine requires extensive safety data and full clinical efficacy.”

Earlier On Wednesday, an experimental vaccine developed by Pfizer (PFE.US) and BioNtech(BNTX.us) produced antibodies in patients and showed no serious side effects.

“Pfizer and BioNtech, Inovio Pharmaceuticals(ino.us) and Moderna(mrna-US) candidates all require longer-term results to establish safety, particularly for DNA vaccines such as Inovio, which may be required to meet more stringent standards given widespread concerns about the risks of gene integration,” Porges said.

Leave a Comment

Your email address will not be published.