Pfizer executives said in a third-quarter investor presentation Tuesday that they had still noticed the first knowledge of interim power. The Data Monitoring Committee, an independent panel of experts that monitors clinical studies and knowledge collection, “has conducted interim efficacy analyses to date, “according to Pfizer.
The slight delay of a previous knowledge forecast until the end of October means that the effects are unlikely to be known until Election Day, despite President Donald Trump’s months-long claim that a vaccine would be “in a few weeks. “
The knowledge monitoring committee has review thresholds that are activated when several volunteers in the trial become ill with COVID-19. The first interim investigation is expected to take a position when 32 other people expand COVID-19, according to Pfizer’s in-depth clinical trial protocol.
Bourla said, however, that the company is still on track to obtain an application for approval in November, if the vaccine is effective and, more importantly, safe.
Pfizer CEO Albert Bourla said in the past that the company “could know whether or not our vaccine is effective until the end of October. “
Once there are 32 volunteers inflamed with COVID-19, Pfizer will look at how many have won the vaccine and how many have won a placebo. If more than 76. 9% of the organization belongs to the placebo organization, Pfizer will make the vaccine effective.
Once an independent review committee publishes data on the trials, the company will want a week to review it internally, Bourla said.
Pfizer plans to publish provisional knowledge if it is negative (less than 11. 8%) (better than 76. 9%). If knowledge is somewhere in between, Pfizer will expect more conclusive results, Bourla said.
“On the occasion of a conclusive, positive or negative reading, we will tell the public as soon as we have finished the mandatory administrative work, that we will be finished within a week of the moment we know,” he told investors, adding that the corporate “has reached the last kilometer here and we are waiting for those things to begin soon. Let’s fix it so we’re patient. “
He said he was “cautiously optimistic” that the vaccine would work based on previous studies.
Pfizer said it hoped to have knowledge of efficacy and protection in November and would, if so, seek an emergency use authorization.
Pfizer’s candidate vaccine also evolved with German biotechnology company BioNTech. There are 150 clinical trial sites worldwide.
More than 42,000 participants were enrolled and nearly 36,000 earned a moment dose of the vaccine. The increase in the number of participants allowed trials to arrive with more populations, adding young people between the ages of 12 and 18 and others with existing pre-conditions.
When asked about production and sourcing, Bourla said Pfizer’s contract with the US government was not the only one in the world to do so. But it’s not the first time To produce one hundred million doses until March. Forty million doses may be available in the United States until the end of the year if the Food and Drug Administration authorizes the vaccine, meaning 20 million more people can be vaccinated, probably other high-risk people, such as fitness providers and the elderly.
Bourla also promised transparency of the data, reminding investors that the company took government cash to “stay out of politics. “Pfizer, along with other pharmaceutical companies that develop vaccines, are committed to maintaining the integrity of the clinical process.
“It may not be a Democratic or Republican vaccine; it will be a vaccine for the world,” he said.
Teri Whitcraft and Sony Salzman of ABC News contributed to the report.
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