Agency Reporter

Pfizer Inc has scaled the next hurdle in the race to get its COVID-19 vaccine approved for emergency use after the U.S. Food and Drug Administration (FDA) released documents that raised no new issues about its safety or efficacy.

Pfizer and German partner BioNTech SE said last month that their coronavirus vaccine’s two-dose regimen was 95% effective against COVID-19 and had no major safety issues. It asked the FDA for emergency use authorisation.

The vaccine’s efficacy and safety data met its expectations for emergency use authorisation, FDA staff said in documents released ahead of tomorrow’s meeting of outside experts to the FDA, who will discuss whether to recommend the Pfizer shot for people aged 16 and older.

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Jefferies analyst Michael Yee said in a research note that the documents were “very simple and straightforward, which we think will lead to approval imminently.”

The agency typically follows the recommendations of its advisory panels but is not required to do so. It is not clear how many days or weeks the FDA will take to make a decision, but states are prepping for vaccine deliveries in mid-December.

The documents were released on the day Britons began getting the Pfizer/BioNTech vaccine, the world’s first recipients outside of clinical trials.

“There are no surprises here. The efficacy and safety are consistent with what we heard and what we hoped for. It does look like the vaccine is safe, at least in the short term,” said Dr. Daniel Culver, chair of Pulmonary Medicine at Cleveland Clinic, in an interview. He said the data showing it was as effective in older people as in younger people was reassuring.

Pfizer shares rose nearly 2% and BioNTech’s U.S. shares were up 2.5% in early trading.