PFIZER IS “CAUTIOUSLY optimistic” about getting vaccine authorisation in the US by the third week in November.
Dr Paul Duffy, Vice President of Pfizer Global Supply told reporters in Government Buildings today that the company is making good progress in the development of Covid-19 vaccine.
With a trial of 44,000 participants advancing well, if it proves successful, the company will be seeking emergency use authorisation in the US this month, he said.
Dr Duffy said Pfizer is already in discussions with the European Medicines Agency (EMA) and the European Commission to provide the vaccine to EU governments.
“We’ve also commenced the complex process of manufacturing the vaccine in anticipation of approval,” said Dr Duffy.
While he said it is still in the development phase of the vaccine, “we are cautiously optimistic, based upon the results that we’ve seen in the clinical trials, all going well, we will have results coming through in November with a potential timing for filing to the FDA at the end of November”.
“I would expect to see availability of the vaccine during 2021,” said Dr Duffy.
Any circulation of the vaccine in 2020 “will be very, very minimal”.
His comments come as Pfizer announces approximately €300 million capital investment in its Irish operations which will support the further development of existing manufacturing sites in Grange Castle, Newbridge and Ringaskiddy.
The investment will provide additional manufacturing and laboratory capacity creating approximately 300 roles, with additional anticipated construction roles in Ringaskiddy, in Cork.
The investment and additional roles will be completed over the next two to three years.
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