The race over funding and access to a Covid-19 vaccine is heating up as the U.S. government pledged to commit up to $1.2 billion to AstraZeneca (AZN) for its efforts and obtain at least 300 million doses of any vaccine by October. And as part of the deal with the Biomedical Advanced Research and Development Authority, the drug maker will begin late-stage clinical trials this summer with roughly 30,000 people in the U.S.
In a statement, Health and Human Services Secretary Alex Azar called the contract a “major milestone” in Operation Warp Speed, a newly launched Trump administration program to accelerate Covid-19 medical products to the American public. The arrangement with AstraZeneca is labeled a public-private partnership and BARDA will provide technology transfers and scaled-up manufacturing.
The agreement comes just four days after the U.K. government pledged $79 million to the drug maker, which is developing a vaccine with Oxford University, and indicated the deal will provide access to 30 million doses in September. On Thursday, AstraZeneca maintained it has arranged enough production capacity to make 400 million doses by the fall.
The moves underscore the frantic efforts to develop a Covid-19 vaccine as quickly as possible as the novel coronavirus has so far infected nearly 4.8 million people and claimed more than 318,000 lives across the globe, according to the World Health Organization. In the U.S., the number of infections has exceeded 1.47 million people and caused more than 89,200 deaths.
An effective vaccine is considered critical to ending the pandemic and dozens of research teams around the world are investigating several different approaches to inoculation, including scientists at some of the world’s biggest drug makers. Besides AstraZeneca, Pfizer (PFE) is working with BioNTech on a vaccine, and Sanofi (SNY) and GlaxoSmithKline (GSK) are partnering on an effort.
At the same time, the various arrangements between governments and companies are causing anxiety over what might be called pandemic chauvinism. The U.S., for instance, is hoping that its investments will place at or near the head of the line for any vaccine. This was evident two months ago, when the Trump administration tried to lure CureVac, a German company, to do research in the U.S.
The issue erupted last week when Sanofi chief executive officer Paul Hudson said the U.S. would have first crack at any vaccine, since BARDA provided a $30 million grant for the effort. The U.S. does not have a claim on a vaccine, but the funds would help speed production at Sanofi plants in the country. Hudson walked back his statement after French officials expressed outrage. Sanofi is headquartered in Paris.
Despite those concerns, there is no assurance just how soon a useful vaccine will emerge. Last month, AstraZeneca began testing its vaccine in a Phase I/II trial involving over 1,000 volunteers between 18 and 55 years old across five sites in England. Data from the study is expected this month and the company hopes to move to late-stage trials by the middle of this year.
Meanwhile, there is emerging controversy over the Oxford vaccine after a paper posted on a pre-print server, a forum for scientific papers, suggested results of trials in monkeys indicated the vaccine may only offer “partial protection,” according to a blog post written by William Haseltine, a former professor at Harvard Medical School and Harvard School of Public Health.
Other experts also debated the findings. But scientists at Oxford’s Jenner Institute, which is conducted the research, called his conclusions “incorrect and misleading.”
[UPDATE: Later, an AstraZeneca spokeswoman wrote us this: “It’s important to note that these debates would typically take place in scientific and academic journals. We are confident in the early data. The results from the NIH clearly show the vaccine is immunogenic and protection from the virus in the lower respiratory tract was high in the inoculated animals.
“We need to be cautious not to over interpret these studies — used to assess safety to support advancement to human clinical trials where immune response can be fully evaluated. The NIH study used a very high viral challenge that would not reflect natural exposure to the virus and for single dose of the vaccine at half of the expected human dose.”]