US secures supply of AstraZeneca, Oxford coronavirus vaccine, pledging more than $1B.
The U.S. government will invest up to $1.2 billion in British drugmaker AstraZeneca to develop, produce and widely distribute, as early as this fall, a coronavirus vaccine created by researchers at the University of Oxford in England. AstraZeneca recently licensed the vaccine, now called AZD1222, from the institution.
The agreement secures for the U.S. "at least" 300 million doses, to be delivered beginning in October. But the first supplies of the vaccine will go to the U.K., which recently reached a deal with AstraZeneca to obtain 100 million doses, starting in September.
AstraZeneca has said it can supply a total of one billion doses of the vaccine, which is currently being tested in a clinical study of 1,000 healthy volunteers in the U.K. Through the Biomedical Advanced Research and Development Authority, or BARDA, the U.S. will help support a 30,000-patient Phase 3 study of the vaccine this summer.
The BARDA grant comes less than a week after the Trump administration unveiled "Operation Warp Speed," an exceedingly ambitious project to make a vaccine for the new coronavirus widely available by the end of the year.
Upon announcing the goal on May 15, the administration said it was focusing on 14 vaccine candidates, selected by government experts as the most promising from a list of roughly 100 candidates. The University of Oxford's vaccine appears to be one of them, and could be in position to meet the aggressive U.S. timeline. Data from the Phase 1 trial are expected "shortly," and will provide a preliminary gauge of whether the vaccine could work as researchers expect.
There's no guarantee results will be positive, however, nor that the vaccine will make it through subsequent testing. BARDA's grant is a major bet on technology that, while widely researched, isn't as proven as more established vaccine approaches.
BARDA's investment in AstraZeneca and Oxford's candidate is greater than any of the three previous grants it's awarded for coronavirus vaccines. The federal agency has pledged as much as $483 million to Moderna, which recently disclosed preliminary human results, and granted a similar $456 million to Johnson & Johnson earlier this year. A smaller $30 million award was also given to France-based Sanofi.
All three companies are moving at unprecedented speeds, part of a massive worldwide push to do in months what would normally take many years, if not a decade to achieve. Moderna, for instance, aims to start late-stage testing of a vaccine in July. Johnson & Johnson plans to begin human tests in the fall and have its first doses available for emergency use by early 2021. Such speed likely means many key questions about coronavirus vaccines will remain unanswered when they first become available.
The vaccine now in the hands of AstraZeneca is advancing at a similarly fast pace.
The candidate relies on a genetically modified and weakened adenovirus, the type that causes colds, to deliver genetic instructions into the body's cells. Those instructions tell cells to produce a key protein on the coronavirus' surface, thereby familiarizing and training the immune system to respond to an actual infection.
Oxford researchers began their work earlier than most groups, and had already started a human trial in England before they struck a deal with AstraZeneca in April. Results from that study, which enrolled more than 1,000 healthy volunteers aged 18 to 55, are expected soon. Initial data will give researchers a sense of whether AZD1222 is generally safe, and whether it can spur the body to produce antibodies against the virus.
Determining whether the vaccine can actually prevent disease will require larger and longer studies, such as the 30,000-person test now in planning.
BARDA's cash will help accelerate that work, as will funding already provided by the U.K. government. Like many other companies, AstraZeneca is scaling up manufacturing efforts "at risk," meaning it could end up with millions of vials of useless product if the vaccine doesn't work. Government funding, however, means AstraZeneca does not expect its outlays to "significantly impact" the company's financial plans for the year.
AstraZeneca said it is in discussions with the WHO, as well as groups like the Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance, to allocate and distribute its vaccine around the world. Negotiations with the Serum Institute of India, a major vaccine producer in that country, are also underway, AstraZeneca said.
"We will do everything in our power to make this vaccine quickly and widely available," said CEO Pascal Soriot, in a statement.
Separately, AstraZeneca is also developing a variety of other drugs for COVID-19. It's one of several companies, for example, making engineered antibodies against the coronavirus— drugs that, if successful, could offer short-term protection from the virus or treat those who have been exposed or infected. The first human tests could start in "three to five months," the company said. AstraZeneca is also repurposing existing medicines like Calquence and Farxiga for treating COVID-19 symptoms.
Author: Ben Fidler
Published:May 21, 2020 https://www.biopharmadive.com/news/astrazeneca-oxford-barda-coronavirus-vaccine/578400/