AstraZeneca Joins Forces with Operation Warp Speed to Defeat COVID-19
Editor’s note: This information was provided by AstraZeneca and was edited for consistency and clarity by U.S. Medicine staff. The article was not verified or reported by U.S. Medicine, however.
WASHINGTON — Defeating COVID-19 has required an unparalleled cooperation between government and private industry across the globe. In the U.S., that teamwork has captured the nation’s full attention throughout the pandemic as these joint efforts have produced vaccines and novel therapeutics in record time.
Among the most closely watched partnerships have been those between Operation Warp Speed, a joint program of the U.S. Department of Health and Human Services and the DoD committed to delivering 300 million doses of vaccine as quickly as possible, and the vaccine manufacturers the U.S. government selected for funding.
Operation Warp Speed (OWS) chose AstraZeneca in May as one of six preferred vaccine manufacturers. At the same time, OWS announced $1.2 billion in support of development, production, and delivery of the company’s leading vaccine through the U.S. Biomedical Advanced Research and Development Authority (BARDA). The agreement called for a phase 3 clinical trial with at least 30,000 participants as well as a pediatric trial.
The vaccine produced by AstraZeneca was created at the University of Oxford by the Jenner Institute and Oxford Vaccine Group. In late April, AstraZeneca and Oxford reached an agreement under which AstraZeneca would be responsible for global manufacturing and distribution of the recombinant chimpanzee adenovirus vaccine to prevent infection by the SARS-CoV-2 virus, if clinical trials proved it safe and effective.
Today, the AstraZeneca vaccine is recognized as essential to the U.S. government’s plan to vaccinate most Americans by next summer. Early results of trials conducted in the U.K. and Brazil demonstrated vaccine efficacy of 62% and 90%, depending on dosage received. The company is also undertaking a phase 3 trial in the U.S. that is expected to report out results by late January, roughly at the same time that detailed data on the earlier trials will be available. Assuming the outcomes are as positive as the evidence to date indicates, AstraZeneca will likely file for an emergency use authorization from the U.S. Food and Drug Administration (FDA) shortly afterward.
The U.S. trial is proceeding in close coordination with OWS. “It’s a trial that we and the FDA have overseen totally, and ultimately it may have the largest weight in a decision” around authorizing the vaccine, said Moncef Slaoui, chief scientific adviser to OWS.
Following publication of interim results of the vaccine’s pooled phase 3 international trials in The Lancet, the editor-in-chief of the esteemed medical journal said the AstraZeneca vaccine had a “distinct comparative advantage” over other vaccines in its ability to reduce the spread of COVID-19 as well as illness and death. Unlike the already approved vaccines which must be shipped and held at very low temperatures, AstraZeneca’s requires only standard refrigeration. That will make it easier to distribute across the country and around the world, reducing the risk of reintroducing the virus or its variants to the U.S. again.
Beyond the Vaccine
In addition to its vaccine operations, AstraZeneca has also quickly mobilized global research efforts to discover novel coronavirus-neutralizing antibodies to prevent and treat progression of the COVID-19 disease. In October, the U.S. government provided $486 million to develop and supply up to 100,000 doses of the company’s long-acting antibody (LAAB) combination, AZD7442, with the right to acquire an additional one million doses. BARDA and the Defense Advanced Research Projects Agency (DARPA) previously provided $25 million for the discovery and early evaluation of the monoclonal antibodies and their phase 1 trial.
“This agreement with the U.S. government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections. We will be evaluating the LAAB combination in different settings from prophylaxis, to outpatient treatment to hospitalization, with a focus on helping the most vulnerable people,” said AstraZeneca CEO Pascal Soriot.
The injectable treatment contains two monoclonal anti-SARS-CoV-2 antibodies, each of which targets a specific coronavirus-produced antigen. By combining two LAABs, the company hopes to reduce the risk of resistance to treatment developing in the virus. The antibodies have been modified to extend their half-lives and resulting protection.
Two phase 3 trials of AZD7442 are in process. One is enrolling about 5,000 adults to evaluate the LAAB’s ability to prevent COVID-19 for up to 12 months. The other includes approximately 1,100 adults, who will be treated following exposure to SARS-CoV-2 with the goal of assessing AZD7442’s ability to prophylactically prevent and treat infections. The treatment could be a literal lifesaver for individuals with compromised immune systems, who often fail to mount a sufficient response to vaccines.
AZD7442 will also be tested in another 4,000 patients for treatment of COVID-19 in other clinical trials.
Additionally, the company has explored multiple therapies in its expansive arsenal and deep pipeline to treat the infection. While not all of those have proved successful, AstraZeneca continues to evaluate options to give patients an edge in the battle against the coronavirus.
“Since the beginning of the year, AstraZeneca has been committed to doing everything we can to respond to COVID-19, including investigating existing medicines as potential treatments,” said José Baselga, AstraZeneca executive vice president for Oncology Research and Development. “[W]e remain committed to advancing science that helps patients during this unprecedented global pandemic, including clinical trials for the AstraZeneca Oxford coronavirus vaccine and our long-acting antibody combination.”