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 The therapy, called AZD7442 or Evusheld, had previously been shown
to confer 77% protection against symptomatic illness after three
months, in an earlier readout of the late-stage PROVENT trial in
August.
The Anglo-Swedish company also said a separate study in patients
with mild-to-moderate COVID-19 showed a higher dose of AZD7442 cut
the risk of symptoms worsening by 88% when given within three days
of first symptoms.
The treatment is given in one go, as two sequential shots in the
arm.
The latest results from the longer-term follow-ups potentially
position AstraZeneca, like rival Pfizer as a future supplier of both
COVID-19 vaccines and treatments, with AstraZeneca having said the
therapy's "real advantage" was as a preventative shot.
Pfizer has presented promising efficacy data on its oral COVID-19
treatment candidate, which can be more easily distributed than
injections, and is also a leading vaccine supplier with partner
BioNTech.
"These new data add to the growing body of evidence supporting
AZD7442's potential ... We are progressing regulatory filings around
the world and look forward to providing an important new option
against SARS-CoV-2 as quickly as possible," AstraZeneca Executive
Vice President Mene Pangalos said in a statement, referring to the
coronavirus that causes COVID-19.
The group last month sought approval for the medicine from U.S. and
European authorities. Monoclonal antibodies from Regeneron, Lilly
and GSK-Vir have been approved by U.S. regulators for treating
unhospitalised COVID-19 patients.
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LONG-TERM
For AstraZeneca's PROVENT trial, close to 5,200
participants without an infection were randomly
split into two groups, with one volunteer
receiving an ineffective placebo without knowing
for every two receiving Evusheld.
Participants were at risk of suffering severe
COVID-19 if infected or were immunocompromised,
meaning they were in cancer care, or receiving
drugs due to an autoimmune disease or an organ
transplant.
The trial volunteers were not vaccinated, even
though high-risk groups have been prioritised in
global vaccination campaigns. Anyone opting to
get vaccinated during the trial was excluded
from the analysis.
AstraZeneca has said the shot is primarily meant
to help immunocompromised and at-risk
individuals but at some point a wider group
could benefit, such as military personnel on
tours of duty or cruise ship passengers.
It added that about 2% of the global population
was considered to inadequately respond to a
COVID-19 vaccine.
Trial volunteers will be followed up for 15
months to provide evidence of longer-lasting
protection.
Evusheld belongs to a drug category that is
based on monoclonal antibodies which are
lab-made proteins that mimic the body's natural
defences. They are based on antibodies that the
human body produces in response to infection or
vaccination.
(Reporting by Pushkala Aripaka in Bengaluru and
Ludwig Burger in FrankfurtEditing by Shounak
Dasgupta and Mark Potter)
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