Pfizer announced that it could apply in late November authorization for emergency use of its COVID-19 vaccine in the United States if the treatment is shown to be effective in a large end-phase trial.
Safety reviews will dictate timelines, as the Food and Drug Administration (FDA) requires that at least half of the study participants be monitored During two months looking for side effects.
That condition should reache in the third week of Novembersaid Pfizer CEO Albert Bourla in an open letter posted Friday on the company’s website.
“Let me be clear, assuming the data is positive, Pfizer will apply for emergency use authorization in the US shortly after the security condition is met,” Bourla wrote.
Initial results on whether the vaccine is effective could be known later this month, depending on how quickly the trial subjects – some of whom received a placebo vaccine – become infected with the pathogen.
While Bourla’s letter rules out any possibility that a vaccine could be approved for emergency use before the day of the presidential elections of next November 3 – a goal that President Donald Trump wanted to achieve at all costs – the Pfizer chief executive’s schedule could give the president a partial victory.
How is this? If Pfizer succeeded in announcing at the end of October that the data shows that its vaccine protects people from the SARS-CoV-2 virus, would allow Trump to claim that the pressure that his administration exerted for an effective vaccine was successful, regardless of whether the FDA has reviewed it.
The US company and its German partner, BioNTech SE, could become the first to demonstrate the efficacy of a vaccine against the pandemic.
They and rival vaccine developers are under scrutiny, as every detail of their clinical trials attracts almost unprecedented public interest. Eli Lilly, Johnson & Johnson y AstraZeneca have suffered delays in their studies of possible vaccines or treatments due to safety concerns.
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The letter confirms the timeline presented this week by BioNTech CEO Ugur Sahin. The partners have not had to suspend their final phase study due to security concerns, the executive added.
A group of leading scientists previously urged Pfizer to wait until at least the end of November to request an emergency authorization.
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