Pfizer hopeful of seeking FDA approval for Covid vaccine in late November 1 month ago

Pfizer hopeful of seeking FDA approval for Covid vaccine in late November

Promising news.

Pfizer has said it could file for US authorisation of a Covid-19 vaccine it has been developing with German partner BioNTech as early as late November.

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This raises the chances that the vaccine could be available in the US before the end of the year.

In a statement posted on the company website, chief executive Dr. Albert Bourla said it would have preliminary numbers by the end of October on whether the vaccine is effective but it would take until at least the third week of November to collect the safety and manufacturing data.

The company is currently running a 40,000 person clinical trial on the vaccine.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorisation Use in the US soon after the safety milestone is achieved in the third week of November,” Bourla said.

"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."

Bourla said the vaccine must come through three phases before it can be released to the public.

It must first demonstrate it is effective in a majority of patients and also must be proven to be safe.

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Then the company must be able to demonstrate the vaccine can be consistency manufactured at the highest quality standards.

However, the news means it's unlikely to be ready in time for the US election, something US President Donald Trump has said on a number of occasions.

Two vaccine trials were put on hold in the US in recent weeks. This week, Johnson & Johnson's Covid-19 vaccine trial was paused after an unexplained illness in a volunteer.

It is not known if the unidentified illness is related to the vaccine, but clinical protocols require a pause of the trial while the matter is investigated.