AstraZeneca announced that its Phase III clinical trial of its COVID-19 vaccine candidate, AZD1222, is expanding into the U.S. It will be dubbed D8110C00001 and is funded by the Biomedical Advanced Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID-supported COVID-19 Prevention Network (CoVPN) is also participating.
In July, the company, which is developing the vaccine with the University of Oxford, published resultsfrom a Phase I/II clinical trial at five locations in the UK, with 1077 healthy volunteers demonstrating a positive effect.
“We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups and are proud to be collaborating with BARDA and NIAID to accelerate the development of this vaccine,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D for AstraZeneca. “Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
The U.S. expansion will recruit up to 30,000 adults over the age of 18 years from a broad range of racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions. This will also include patients with HIV, who are at increased risk from COVID-19 infections.
Also, centers outside the U.S. are included in the trial based on transmission rates predicted, and sites in Peru and Chile are expected to begin recruiting soon.
The participants will be randomized to receive two doses of the vaccine or a placebo four weeks apart. About twice as many are expected to receive the vaccine than the control.
A week ago, there were rumors, according to the Financial Times, that President Trump wanted to give AstraZeneca and the University of Oxford’s vaccine emergency use authorization (EUA) ahead of the U.S. presidential election on November 3. AstraZeneca indicated to the Financial Times they had not discussed an EUA with the U.S. government and a spokesperson for Health and Human Services (HHS) denied it.
Perhaps in response to this persistent rumor as well as a general politicization of the pandemic and therapies, yesterday AstraZeneca issued a statement regarding its “commitment to the highest safety standards and to broad and equitable access around the world for its COVID-19 vaccine AZD1222.”
AstraZeneca indicated it was implementing a clinical development program that will enroll more than 50,000 volunteers, including 30,000 in the U.S., and others in Latin America, Asia, Europe, Russia and Africa.
“In recent weeks we have seen an increasing number of questions around the safety and availability of vaccines to fight this terrible COVID-19 pandemic and I want to reiterate my commitment that we are putting science and the interest of society at the heart of our work,” said Pascal Soriot, AstraZeneca’s chief executive officer. “We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVID-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around the world.”
As part of its program, AstraZeneca has entered into recent supply deals with Russia, South Korea, Japan, China, Latin America and Brazil to build global supply of the vaccine toward three billion doses. In June, AstraZeneca announced plans to manufacture two billion doses, with 400 million allotted for the U.S. and UK and one billion for low- and middle-income countries.
Published: Sep 01, 2020 By Mark Terry