By Jared S. Hopkins and Matt Grossman
Pfizer Inc. said a global late-stage trial evaluating its
Covid-19 vaccine is almost fully enrolled with participants, the
company said, as its chief executive called for patience as
researchers advance in collecting trial results.
The drugmaker hasn't yet conducted the first review of whether
its experimental vaccine works safely.
Pfizer's Phase 3 trial seeking 44,000 volunteers needs fewer
than 2,000 people to be fully enrolled, the company said Tuesday
while announcing third-quarter earnings. The New York-based company
also said that nearly 36,000 people in the trial received their
second injection of either the two-dose vaccine or a placebo.
Pfizer's Covid-19 vaccine, which it is developing in partnership
with Germany's BioNTech SE, is among the most advanced shots from
pharmaceutical companies working to help stem the global
"We have reached the last mile," Pfizer Chief Executive Albert
Bourla said on a conference with analysts discussing earnings.
"Let's all have the patience required for something so important
for public health and the global economy."
Mr. Bourla reiterated the time line he laid out earlier this
month for the vaccine's potential rollout. He said Pfizer could
file for an emergency authorization to put the vaccine into initial
public use in late November, assuming positive trial results --
suggesting shots could be made available in the U.S. before the end
of the year.
He also sought to provide assurances that vaccine development
won't be politicized. Mr. Bourla called the upcoming U.S.
presidential election "an artificial milestone" and asked for
patience as trial data is collected, analyzed and potentially filed
to regulators. "This is going to be not a Republican vaccine or a
Democratic vaccine. It would be a vaccine for the citizens of the
world," he told investors.
He added, "I know how much stress levels are growing. I know how
much a vaccine is needed for the world."
An outside panel of experts hasn't performed the first review of
whether the vaccine works safely, known as an interim analysis,
which was planned once 32 study participants become infected with
symptomatic Covid-19, Pfizer said Tuesday. The review is performed
by an outside group of experts known as the data safety monitoring
committee. "We don't have the 32 events right now," Mr. Bourla
In an interview, Mr. Bourla said it is "extremely unlikely" any
efficacy data about the vaccine would be made public before Nov. 3,
partly because once the company gets the data it would take about a
week to thoroughly analyze it.
In Pfizer's study, half the participants get a two-dose regimen
of the vaccine three weeks apart, with the rest getting placebo
shots. A week after subjects receive their second shot, researchers
begin checking whether the vaccinated group develops symptoms more
or less frequently than those who weren't vaccinated. The Food and
Drug Administration is requiring two months of observational safety
data of vaccinated study participants.
President Trump has said a Covid-19 vaccine could be available
before election day. Pfizer's development time line, as well as
those of the other top Covid-19 vaccine developers, make a
pre-election greenlight highly unlikely.
Pfizer has already spent nearly $2 billion on its Covid vaccine
program. AstraZeneca PLC, Moderna Inc. and Johnson & Johnson
also have vaccines in advanced development.
Mr. Bourla said that Pfizer, which is ramping up manufacturing
capabilities, will be able to meet its commitment to provide 100
million doses in the U.S. by March, and to deliver about 40 million
by the end of this year.
He also said the company plans to provide the Covid-19 vaccine
to developing and low-income countries, such as some in Africa, on
a "not for profit" basis. The company's price in the U.S. has
tracked to about $20 a dose, although the government purchased the
initial doses and plans to provide them to people free of
Sales for the vaccine are estimated at $3.5 billion next year
before steadying at $1.4 billion annually, according to analysts at
SVB Leerink LLC. Revenue from the vaccine would be included in 2021
guidance announced during fourth-quarter earnings, Chief Financial
Officer Frank D'Amelio said in an interview.
Pfizer recorded third-quarter sales of $12.13 billion, compared
with $12.68 billion in the same three-month period last year.
Analysts surveyed by FactSet had forecast $12.31 billion of
The company's biopharma revenue grew by 3% to $10.22 billion as
sales expanded for drugs such as blood thinner Eliquis,
rare-disease drug Vyndaqel and arthritis treatment Xeljanz. Revenue
from the company's Upjohn segment, which focuses on off-patent and
generic drugs, declined by 18% to $1.92 billion.
Pfizer plans to spin off Upjohn in a combination with U.K.-based
Mylan NV that will be called Viatris. In September, Pfizer and
Mylan won approval from the European Commission for the deal, which
is expected to close in the fourth quarter.
Pfizer said the pandemic dragged down its third-quarter revenue
by approximately $500 million, or 4%, as it disrupted demand for
some products in China and scrambled U.S. health-care visits that
aren't related to the viral disease. Reduced doctor visits have
thrown off prescribing patterns for some products, according to the
Pfizer's profit in the third quarter was 39 cents a share,
compared with $1.36 a share in last year's third quarter. On an
adjusted basis, its profit was 72 cents a share. Analysts had
anticipated an adjusted profit of 70 cents a share.
The company said it expects to report full-year revenue between
$48.8 billion and $49.5 billion, and an adjusted profit of $2.88 to
$2.93 a share. The guidance doesn't assume revenue contributions
from its Covid-19 vaccine.
Write to Jared S. Hopkins at firstname.lastname@example.org and Matt
Grossman at email@example.com
(END) Dow Jones Newswires
October 27, 2020 15:59 ET (19:59 GMT)
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