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Pfizer says no COVID-19 vaccine data yet, could be week or more before it reports

Stock MarketsOct 27, 2020 12:40PM ET
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2/2 © Reuters. FILE PHOTO: A man walks past a sign outside Pfizer Headquarters in the Manhattan borough of New York City 2/2

By Michael Erman and Manas Mishra

(Reuters) - Drugmaker Pfizer Inc (N:PFE) said on Tuesday it does not yet have data from the late-stage trial of the COVID-19 vaccine it is developing with Germany's BioNTech SE (F:22UAy), and provided a timeline that makes its release unlikely ahead of the Nov. 3 U.S. presidential election.Pfizer said there had not yet been enough infections in the 44,000-volunteer trial to trigger an analysis of whether or not the vaccine works. An independent panel will conduct the first analysis when it reaches 32 infections.

Chief Executive Albert Bourla said after it has enough data for the analysis, it typically takes 5 to 7 days before the company can publicly release the data, meaning it is likely to happen after the election.

U.S. President Donald Trump had said a vaccine could be available before the Nov. 3 election, but in recent weeks his administration has emphasized that one will be ready this year.

Bourla has previously said the company could release data on whether or not the vaccine works as early as this month.

"For us, the election is an artificial milestone," Bourla said on a conference call for the company's earnings. "This is going to be not a Republican vaccine or a Democrat vaccine. It will be a vaccine for the citizens of the world."

Pfizer shares were flat at $37.92.

Pfizer hopes to be the first U.S. drugmaker to unveil successful data from a late-stage COVID-19 vaccine trial, ahead of rival Moderna Inc (O:MRNA). Pfizer and BioNTech launched their phase 3 study in late July.

The data monitoring board is scheduled to make its first assessment of the vaccine's performance after 32 participants in the trial become infected with the novel coronavirus.

Healthcare investor Brad Loncar said it was difficult to draw a positive or negative conclusion from the fact that the trial has not yet had its first interim analysis.

"I think this means that the overall infection rate is a lot lower than Pfizer initially estimated," Loncar said.

Dr. David Boulware, professor of medicine at University of Minnesota, said the study's participants may be more adherent to social distancing guidelines than the general population.

"Who the vaccine trials really need are the people who don't wear masks, who are going out to bars, who go to crowded events, who are singing in church choirs - those are the high risk people," he said.

Boulware said that a data monitoring board could still review the data relatively quickly - perhaps in less than a day - once the trial hits its first interim point.

As the pandemic crimps demand for certain Pfizer therapies and damages global economies, investors are keenly focused on seeing the late-stage study data of the vaccine candidate being developed with BioNTech.

The company also said that if the trial is successful, it still expects to file for emergency authorization of the vaccine candidate from U.S. regulators shortly after it has enough safety data in late November. It expects to have manufacturing data ready to submit to those regulators before then.

Pfizer reported quarterly earnings that beat estimates by one cent, helped by lower-than-expected costs. Sales fell 4.3% to $12.13 billion in the third quarter due to a sharp drop in revenue from its off-patent pain drug Lyrica, as well as a $500-million hit from the COVID-19 pandemic. Excluding items, Pfizer earned 72 cents per share, beating analysts estimates of 71 cents per share, according to IBES data from Refinitiv.

Pfizer says no COVID-19 vaccine data yet, could be week or more before it reports
 

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Comments (3)
Kelly Mayer
Kelly Mayer Oct 27, 2020 3:16PM ET
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44k volunteers and not even 32 infections yet? What does that tell us about the infection rate? Yeah, it's low. The numbers you see are over inflated. And how about scientists being baffled about the 98% current drop in influenza infections? You can forget about a twin pandemic.
Ronan Gallagher
Ronan Gallagher Oct 27, 2020 3:16PM ET
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they aren't baffled. Social distancing, mask wearing and hand washing stop all viruses spreading from person to person. A smaller influenza season was always guaranteed because of this
Aa Bb
MysteryInvestor Oct 27, 2020 3:16PM ET
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Doctors often participate in vaccine trial, so they are good at not getting infected.... Damn. They should have paid Sturgis bikers to get vaccine. ☺️
Trader UJ
Trader UJ Oct 27, 2020 1:20PM ET
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will the virus or the vaccine results magically disappear first?
Plopseven Schwartz
Plopseven Schwartz Oct 27, 2020 12:43PM ET
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“Better let the president pump our stock until the election before we tell the truth.”
 
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