|
 The trial's results suggest that Pfizer's drug surpasses Merck & Co
Inc's pill, molnupiravir, which was shown last month
https://www.reuters.com/
business/healthcare-pharmaceuticals/mercks
-covid-19-pill-cuts-risk-death-
hospitalization-by-50-study-2021-
10-01 to halve the chance of dying or being hospitalized
for COVID-19 patients at high risk of serious illness.
Pfizer's pill, with the brand name Paxlovid, could secure U.S.
regulatory approval by the end of the year. Pfizer said it plans to
submit interim trial results to the Food and Drug Administration
(FDA) before the Nov. 25 U.S. Thanksgiving holiday. The trial was
stopped early due to its high success rate.
President Joe Biden said the U.S. government has secured millions of
doses of Pfizer's drug.
"If authorized by the FDA we may soon have pills that treat the
virus in those who become infected," Biden said. "The therapy would
be another tool in our toolbox to protect people from the worst
outcomes of COVID."
Shares in Pfizer, which also makes one of the mostly widely used
COVID-19 vaccines, rose 11% to close at $48.61. Merck's fell 10% to
close at $81.61. Shares of vaccine makers took a hit, with Moderna
Inc, Pfizer's German partner BioNTech SE and Novavax all down
11-21%.
Pfizer's pill is given in combination with an older antiviral called
ritonavir. The treatment consists of three pills given twice daily.
It has been in development for nearly two years
https://www.reuters.com/business/
healthcare-pharmaceuticals/inside-
race-find-covid-19-treatment-pill-
2021-05-21.
The Pfizer and Merck pills are eagerly anticipated, with only
limited options currently available for treating people sick with
COVID-19. Full trial data is not yet available from either company.
Pfizer is in active discussions with 90 countries over supply
contracts for its pill, Chief Executive Officer Albert Bourla said
in an interview.
"Our goal is that everyone in the world would be able to have it as
quickly as possible," Bourla said. Bourla added that for high-income
countries Pfizer expects to price its treatment close to where Merck
has priced its drug. Merck's U.S. contract price is around $700 for
a five-day course of therapy. For low-income countries, Bourla said
Pfizer is considering several options, with the goal of "no barrier
for them as well to have access."
Merck's pill was approved by British regulators
https://www.reuters.com/
business/healthcarepharmaceuticals/
britain-approves-mercks-oral-covid
-19-pill-2021-11-04 in a world first on Thursday.
Even with the potential offered by the Pfizer and Merck pills,
preventing COVID-19 infections through broad use of vaccines remains
the best way to control a pandemic that has killed more than 5
million people worldwide, including more than 750,000 in the United
States, infectious disease experts said.
"Vaccines are going to be the most effective and reliable tool that
we have in this pandemic," said Dr. Grace Lee, professor of
pediatrics at Stanford University School of Medicine. "These oral
medications are going to augment our ability to really reduce the
risk of severe disease, hospitalization and death, which is huge,
but it won't prevent infection."
[to top of second column] |
 While more than 7 billion
vaccine doses have been administered worldwide,
that has covered only about half the world's
people. In the United States, 58% of all people,
including 70% of adults, are fully vaccinated.
Mizuho analyst Vamil Divan forecast a "very
minor impact" from Pfizer's drug on vaccination
among people who do not want the vaccine or a
booster shot as recommended by U.S. health
regulators.
"I think there's a small percentage of people
that may decide not to get vaccinated now that
there are good treatment options," Divan said.
MANUFACTURING GOALS
Pfizer said it expects to manufacture 180,000
treatment courses by the end of this year and at
least 50 million courses by the end of next
year, including 21 million in the first half of
2022. Bourla said that, based on the
better-than-expected trial results, Pfizer is
considering potentially doubling next year's
manufacturing target.
Antivirals need to be given as early as
possible, before an infection takes hold, to be
most effective.
The planned analysis of 1,219 patients in
Pfizer's study examined hospitalizations or
deaths among people diagnosed with mild to
moderate COVID-19 with at least one risk factor
for developing severe disease, such as obesity
or older age.
Among those given Pfizer's drug within three
days of symptom onset, the pill lowered the
chances of hospitalization or death for adults
at risk of developing severe COVID-19 by 89%
compared to those receiving a placebo. Among
these patients, 0.8% were hospitalized and none
died by 28 days after treatment, compared to a
7% hospitalization rate and seven deaths in the
placebo group.
Rates were similar for patients treated within
five days of symptoms: 1% of the treatment group
was hospitalized, compared to 6.7% for the
placebo group, which included 10 deaths. Pfizer
said that represents 85% effectiveness at
preventing hospitalization or death.
Two other trials - one in people without
underlying risk factors and another in people
who have been exposed to the virus but are not
yet infected - are continuing, with those
results likely be available in the first quarter
of 2022, Bourla said.
Pfizer did not detail side any effects but said
adverse events happened in about 20% of both
treatment and placebo patients. Possible side
effects include nausea and diarrhea.
(Reporting by Deena Beasley; additional
reporting by Ankur Banerjee, Leroy Leo and
Manojna Maddipatla in Bengaluru; Julie
Steenhuysen, Trevor Hunnicut, Michael Erman and
Francesco GuarascioEditing by Will Dunham, Anil
D'Silva, Caroline Humer and Mark Potter)
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