Pfizer not yet ready to release COVID-19 vaccine data By

Grant Boone
October 28, 2020

In a presentation by the company on Tuesday, Pfizer noted that the interim efficacy analyses of its vaccine candidate is awaited.

Pfizer said its Phase 3 Covid-19 trial had enrolled more than 40,000 participants, with almost 36,000 having received their second vaccination as of Monday.

The announcement, by Dr. Albert Bourla, came on the same day that Pfizer announced third-quarter earnings, and all but ruled out the possibility of early results before the presidential election next Tuesday.

"Let's be very patient - I know how much the stress levels are growing", Bourla said.

Pfizer executives expressed measured optimism Tuesday over the prospect of providing a coronavirus vaccine in 2020 even as they signaled key data on the vaccine would not be released before the U.S. election.

After weeks of dangling the possibility of coronavirus vaccine results by October, Pfizer's chief executive said Tuesday that would now be almost impossible.

Moderna announced last week that it has reached full enrollment of 30,000 in its late-stage trial for a vaccine. Additionally, President Trump mentioned the company during the final presidential debate.

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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. Pfizer and BioNTech launched their 44,000 volunteer phase 3 study of their vaccine in late July.

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

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. The company could seek approval for emergency use from USA regulators in late November.

The maker of the world's top-selling vaccine, Prevnar 13 for preventing pneumonia and related bacterial diseases, reported net income of $2.2 billion, or 39 cents per share, down from $7.7 billion, or $1.36 per share, in 2019's third quarter.

Pfizer estimated a revenue hit of $500 million connected to Covid-19 due to lower pharma demand in China and fewer wellness visits by U.S. patients. It had adjusted earnings per share of 72 cents for the quarter, against a FactSet consensus of 71 cents.

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