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 Pfizer and German partner BioNTech SE said last month their
coronavirus vaccine's two-dose regimen was 95% effective against
COVID-19 and had no major safety issues and asked the FDA for
emergency use authorization.
The vaccine's efficacy and safety data met its expectations for
emergency use authorization, FDA staff said in documents released
ahead of a Thursday meeting of outside experts to the FDA who will
discuss whether to recommend the Pfizer shot for people aged 16 and
older.
Jefferies analyst Michael Yee said in research note the documents
were "very simple and straightforward, which we think will lead to
approval imminently."
The agency typically follows the recommendations of its advisory
panels but is not required to do so. It is not clear how many days
or weeks the FDA will take to make a decision, but states are
prepping for vaccine deliveries in mid-December.
The documents were released on the day Britons began getting the
Pfizer/BioNTech vaccine, the world's first recipients outside of
clinical trials.
"There are no surprises here. The efficacy and the safety is
consistent with what we heard and what we hoped for. It does look
like the vaccine is safe, at least in the short term," said Dr.
Daniel Culver, chair of Pulmonary Medicine at Cleveland Clinic, in
an interview. He said the data showing it was as effective in older
people as in younger people was reassuring.
Pfizer shares rose nearly 2% and BioNTech's U.S. shares were up 2.5%
in early trading.
Pfizer Chief Executive Albert Bourla said on Tuesday he expects a
"very intense" meeting with a U.S. vaccine advisory panel this week,
but is counting on the panel of outside experts to sign off on his
company's COVID-19 vaccine candidate.
"I think they will vote 'yes' given the strength of the data,"
Bourla said at a conference hosted by a pharmaceutical industry
group.
PROTECTION AFTER ONE SHOT
Data from the trial showed that the vaccine began conferring some
protection to recipients even before they received the second shot,
the FDA said. The effect became most pronounced about 14 days after
people received the first shot.
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The agency's staff noted that more data would be needed to assess the potential
of a single-dose shot. It said that the efficacy after dose 1 and before dose 2
was around 52 percent.
A two-dose vaccination was highly effective in preventing confirmed cases of
COVID-19 at least seven days after the last dose, FDA staff said.
The FDA staff also said that available data, while limited, suggested the people
who had been previously infected with the new coronavirus could benefit from
vaccination. Very few cases of confirmed COVID-19 occurred among participants
with evidence of infection prior to vaccination, though more of those that did
were in the placebo group than the vaccine group, the staff said.
FDA staff also said that the trial, which was designed to look at effectiveness
against COVID-19, did not produce data to answer the question of if it also
stopped infection.
In terms of safety, the FDA staff said there was currently insufficient data to
make conclusions about the safety of the vaccine in people below 16 years of
age, pregnant women and those with compromised immune systems.
There were a total of six deaths in the 44,000 person trial, with two deaths
among those who got the vaccine and the rest in those who received a placebo,
the documents showed. All deaths represent events that occur in the general
population at a similar rate, FDA staff said.
(Reporting by Manas Mishra in Bengaluru, Rebecca Spalding, Caroline Humer and
Michael Erman in New York; Editing by David Clarke and Nick Zieminski)
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