AstraZeneca on Thursday cemented its lead in bringing a preventative COVID-19 shot for the non-infected to market for people who do not respond well to vaccines, saying its antibody drug cocktail offered 83% protection over six months.
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 unhospitalized COVID-19 patients.
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 prioritized 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 defenses. 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 Frankfurt; Editing by Shounak Dasgupta and Mark Potter