Coronavirus vaccine: Pfizer to seek emergency approval for Covid-19 jab next month
The company’s president says they will not apply for emergency authorisation before the third week in November
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Your support makes all the difference.Pfizer said on Friday it would likely submit its Covid-19 vaccine to the Food and Drug Administration (FDA) for emergency authorisation in November - but after the election.
The announcement marks the first time a United States vaccine trial has given a timeline for when it might be available to roll out to the public.
In a statement, Pfizer Chairman and CEO Albert Bourla said the company would submit its application the third week in November with its German partner BioNTech . Submitting this application would hinge on positive results from its late-stage human trials, which are currently taking place.
This means there would be no chance the vaccine would receive emergency authorisation before the election on 3 November – what President Donald Trump has pushed for in recent months.
Questions about the safety of the vaccine have circulated given the sped up timeline multiple companies are operating on in order to roll out the treatment swiftly.
Mr Bourla addressed the concerns in the statement, detailing the process the vaccine would go through before it would receive emergency authorisation.
"Let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November," Mr Bourla wrote.
“All the data contained in our US application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”
Involving an independent commission of experts to review the data could be in an effort to quell any concerns that politics would playing a part in if the vaccine would receive the authorisation or not.
In order for Pfizer to receive emergency authorisation, it must prove to the FDA that its vaccine provides three sets of data points: efficiency, safety, and an ability to be manufactured on a large scale at a high standard.
The company said it would have each of these data points by the third week of November.
"To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines," Mr Bourla said.
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