COVID-19 UPDATE: Pfizer’s late-stage trial with 42,000 volunteers
|Covid-19 vaccines. Photo: Euronews|
Covid-19 vaccines may not arrive quite as soon as people hoped. An October surprise didn’t happen, there will be no vaccine by Election Day, and even Thanksgiving might be pushing it.
Front-runner Pfizer Inc.'s oft-repeated suggestion that it might have vaccine data by Halloween was wrong, and Anthony Fauci now suggests an immunization might not be available on even a limited basis until January. Efforts to speed results and availability have been historic, but they have limits. Specifically, quick vaccine hopes have a math problem. To clear a high statistical bar and prove effective enough to get emergency use authorization from the Food and Drug Administration, early candidates would have to be both very protective and quite lucky. That won’t be easy, as said by Bloomberg.
How many volunteers registered for Pfizer’s late-stage coronavirus vaccine trial?
|Pfizer’s late-stage coronavirus vaccine trial. Photo: CNBC|
Pfizer’s late-stage coronavirus vaccine trial has enrolled more than 42,000 volunteers, the company announced Tuesday when it released a mixed third-quarter earnings report.
It said nearly 36,000 of the volunteers have already received the second of its two-dose Covid-19 vaccine. Pfizer has as been working alongside German drugmaker BioNTech on the experimental vaccine. It contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus.
In September, Pfizer expanded the enrollment of its phase three trial to up to 44,000 volunteers from the initial target of up to 30,000. The company said the expansion would allow it to further increase diversity in the trial as well as include adolescents as young as 16 years old and people with preexisting conditions.
How effective the vaccine is in this clincal trial?
Crucial coronavirus vaccine data expected from Pfizer this week now appears unlikely to come before the U.S. election on Nov. 3. according to CNBC.
On a call with investors Tuesday, Pfizer CEO Albert Bourla said that the company doesn’t anticipate making any announcement on its trial until about a week after the data and safety monitoring board conducts its review of the company’s phase three vaccine trial. The board, which will assess whether its trial with German drugmaker BioNTech has been successful, has not conducted an interim efficacy analysis yet, Pfizer said.
“In case of a conclusive readout ... we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know,” Bourla said on the call.
“Let’s all have patience,” he added. “I know how much the stress levels are growing. I know how much the vaccine is needed for the world.”
The phase three trials are a critical last step needed to get the vaccines cleared for distribution. Three other U.S.-backed candidates are in phase three: Moderna, AstraZeneca and Johnson & Johnson. Pfizer expects to apply for an emergency use authorization with the Food and Drug Administration next month.
The board will not conduct its analysis until after there are 32 cases of Covid-19 diagnosed in Pfizer’s phase three trial. The board could recommend ending the trial if the vaccine is found to be at least 77% effective, which means it could reduce the risk of getting Covid by 77%.
With no interims conducted yet, Pfizer’s “infection rates must be much lower than initially estimated given that they were previously ‘confident’ of a conclusive answer in October,” Brad Loncar, biotech investor and chief executive officer at Loncar Investments, said in a tweet Tuesday.
Since early September, Bourla has repeatedly said the company could have late-stage vaccine trial data as early as October. The timeline drew concerns and skepticism from infectious disease experts and scientists who also feared the process could be influenced by politics, not science. President Donald Trump has insisted a Covid-19 vaccine could be ready before Election Day.
In a phone interview with CNBC’s Meg Tirrell later Tuesday, Bourla said his October timeline created some “unintended consequences.”
“But I never regret that I follow the guideline that I go with the speed of science,” he said. “If the speed of science is telling me end of October, so be it. But it is true that created unintended consequences because some people connected it that to the election.”
|What Is Pfizer? |
Pfizer is a publicly-traded global pharmaceutical company headquartered in New York City. Its revenues reached $52.5 billion in 2017.
Pfizer makes Advil, Xanax, Depo-Provera, Neosporin, Lyrica and Dimetapp. It specializes in vaccines and cancer, heart and diabetes treatments. It also makes medicines for disorders of the endocrine (hormones) and nervous systems.
The shareholder-owned company operates in 180 countries. Its research headquarters are in Groton, Connecticut. It employs more than 96,000 people worldwide, according to Drugwatch.
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