Product may help protect people with specific health conditions
BARDA began supporting development of AstraZeneca’s long-acting antibody combination last year with the goal of protecting people whose health conditions prevent them from getting vaccines or are at increased high risk of severe infections due to an inadequate response to vaccines, for example people with suppressed immune systems or who take immune suppressant medications. The high-level results from the phase 3 clinical trial, called PROVENT, were unveiled today.
The clinical trial met its primary endpoint, reducing the risk of symptomatic COVID-19 by 77 percent for at least three months when administered prior to infection, compared to a placebo. The clinical trials showed the product to be safe and well tolerated. The antibody combination provided protection after a single dose administered as two intramuscular injections during the same visit.
The PROVENT clinical trial began in November 2020 and recruited 5,197 volunteer participants in the United States, United Kingdom, Spain, France and Belgium to evaluate the long-acting antibody product in preventing symptomatic SARS-CoV-2 infections. Participants included people with suppressed immune systems and others at high risk of severe infection from SARS-COV-2. The clinical trial participants’ health will be followed over the next 15 months to determine how long the long-acting antibody protection lasts.
The two antibodies that comprise the product were discovered by Vanderbilt University and licensed to AstraZeneca, which engineered the antibodies to become long-lasting antibodies, potentially providing six months or more of protection. AstraZeneca developed the product with support from the Defense Advanced Research Projects Agency (DARPA) and conducted preclinical and early clinical studies of the product candidate as a possible COVID-19 prevention with funding from DARPA and BARDA.
The company undertook late-stage development and led the phase 3 clinical trial as the regulatory sponsor with support from BARDA, including $146.2 million for late-stage development, expert input on the study design, and funding for production of the drug supply used in the placebo-controlled clinical trial.
BARDA and DoD collaborated on an agreement to purchase up to 600,000 doses of the antibody combination for distribution nationwide if FDA grants emergency use authorization (EUA) of AZD7442 for preventing COVID-19. DoD also has a separate agreement for an additional 100,000 doses of the product, pending FDA EUA. If purchased by BARDA for use across the U.S., the long-acting antibody product would be available at no cost to patients.
The company also is working with us and the National Institutes of Health to evaluate the use of the company’s long-acting antibody product as a COVID-19 treatment for hospitalized patients as part of the ACTIV-3 study and for an outpatient treatment as part of the ACTIV-2 clinical trial.
While BARDA scientists continue to encourage use of COVID-19 vaccines for all eligible people in the U.S., they will continue working with industry on easy-to-administer products that can provide potentially life-saving protection for people with certain health conditions and to help reduce the strain on community hospitals.