Pfizer confirms Covid-19 pill’s results, potency versus omicron
Pfizer said Tuesday that its
experimental pill to treat COVID-19 appears effective against the omicron
variant.
The company also said full results
of its 2,250-person study confirmed the pill’s promising
early results against the virus: The drug reduced combined hospitalizations and
deaths by about 89% among high-risk adults when taken shortly after initial COVID-19
symptoms.
Separate laboratory testing shows
the drug retains its potency against the omicron variant, the company
announced, as many experts had predicted. Pfizer tested the antiviral drug
against a man-made version of a key protein that omicron uses to reproduce
itself.
The updates come as COVID-19 cases,
deaths and hospitalization are all rising again and the U.S. topped 800,000
pandemic deaths. The latest surge, driven by the delta variant, is accelerating
due to colder weather and more indoor gatherings, even as health officials
brace for the impact of the emerging omicron mutant.
The Food and Drug Administration is
expected to soon rule on whether to authorize Pfizer’s pill and a
competing pill from Merck, which was submitted to regulators several weeks
earlier. If granted, the pills would be the first COVID-19 treatments that
Americans could pick up at a pharmacy and take at home.
President Joe Biden called Pfizer’s drug “another
potentially powerful tool in our fight against the virus,” in a statement
Tuesday.
The U.S. government has agreed to
purchase enough of Pfizer’s drug to treat 10 million people.
But company executives have indicated that initial supplies will be limited,
with only enough to treat tens of thousands of people before the end of the
year. By March Pfizer hopes to ramp up production to provide millions of
courses of treatment.
Pfizer’s data could
help reassure regulators of its drug’s
effectiveness after Merck disclosed smallerthan-expected benefits for its drug
in final testing. Late last month, Merck said that its pill reduced
hospitalizations and deaths by 30% in high-risk adults.
Both companies initially studied
their drugs in unvaccinated adults who face the gravest risks from COVID-19,
due to older age or health problems, such as asthma or obesity.
Pfizer is also studying its pill in
lower-risk adults — including a subset who are
vaccinated but reported mixed data for
that group on Tuesday.
In interim results, Pfizer said its
drug failed to meet its main study goal: sustained relief from COVID-19 for
four days during or after treatment, as reported by patients. But the drug did
achieve a second goal by reducing hospitalizations by about 70% among that
group, which included otherwise healthy unvaccinated adults and vaccinated
adults with one or more health issues. Less than 1% of patients who got the
drug were hospitalized, compared with 2.4% of patients who got a dummy pill.
An independent board of medical
experts reviewed the data and recommended Pfizer continue the study to get the
full results before proceeding further with regulators.
Across both of Pfizer’s studies,
adults taking the company’s drug had a 10-fold decrease in
virus levels compared with those on placebo.
The prospect of new pills to fight
COVID-19 can’t come soon enough for communities in the
Northeast and Midwest, where many hospitals are once again being overloaded by
incoming virus cases.
Both the Merck and Pfizer pills are
expected to perform well against omicron because they don’t target the
coronavirus’ spike protein, which contains most of the new
variant’s mutations.
Centers for Disease Control and
Prevention Director Rochelle Walensky, appearing on NBC’s “Today” on Tuesday,
said the best way for people to protect themselves against COVID-19 is to get
vaccinated and get a booster shot. She said the Pfizer pill, if authorized by
the FDA, “will be another great tool, but we need to
diagnose people early.”