extrapolation for example of data from younger, healthier populations to older populations that are being more adversely impacted by COIVD-19, New York University bioethicist Alison Bateman-House said during a panel discussion as part of the Biotechnology Innovation Organization’s digital convention earlier this month.
COMPANIES WANT GOVERNMENTS TO DETERMINE WHO GETS FIRST ACCESS POST-MARKET
While companies are taking responsibility for the diversity of clinical trials, few want to be in charge of who will get first dibs on a product once its clears regulatory authorities, punting those decisions to governmental bodies or non-governmental organizations.
“I do think there’s a role for the government here, private-public partnerships to figure out for each country’s population, who are the people who are at greatest risk and who need it the most,” Zaks said. “And I don’t think that is necessarily a role that companies are optimally suited to define. I think its where our elected and trusted officials and other stakeholders in the government are going to have an opinion and that opinion matters because they actually represent the public here.”
Other companies have made similar comments.
“We also have to recognize that public health authorities not us as a company will really play the leading role in guiding which populations,” get a vaccine said Johnson & Johnson’s Chief Medical Officer Joanne Waldstreicher said on the BIO panel. Public health authorities will make decisions and it is the industry’s role to provide them with the science and data to inform that decision making, she said.
On the BIO panel, Inovio Pharmaceuticals Inc. CEO Joseph Kim said that government and non-governmental organizations like the Gate Foundations or the Coalition for Epidemic Preparedness Innovations (CEPI) roles in funding the vaccines is a reason why they should make distribution decisions.
“I feel that these large funders are going to have major implications and decision making impact on how these vaccines get allocated and distributed,” he said.
MODERNA SAYS IT SPENT LITTLE GOVERNMENT MONEY, WANTS PRICING AUTONOMY
One area where Moderna wanted less interference from the government is on pricing, despite the company receiving nearly half a billion dollars from the US government.
“I think the price is something that a commercial entity would expect to own,” Zaks said, saying it’s too early to talk about price points in particular because more needs to be known about the potential benefits of a vaccine to really understand the value proposition.
“It’s pretty clear that the value of these vaccines is going to be among the highest value of any medical intervention,” he added.
Zaks said that while the US Biomedical Advanced Research and Development Authority awarded the company up to $483 million for its vaccine development, that should be thought of “more as a loan,” saying the company has only submitted a few million dollars of expenses to the US government thus far.
He said its largely the company’s shareholder capital that has been put to risk so far, while acknowledging that the US National Institutes of Health conducted the vaccine’s Phase I study. In fact, a key reason Moderna was able to move so fast on this work, he acknowledged, was because the company was already talking to NIH about working together on a demonstration project where they would arbitrarily pick a virus and test how fast they could prove the utility of Moderna’s vaccine technology when COVID-19 came along.
Zaks said what Moderna owes the government from their collaboration is transparent access to the vaccine’s entire data set. This should help the government improve development and licensure for other COVID-19 vaccines, he said.
“They will be able to look at the assays as we run them and be able to maybe have an easier path to licensure for follow-up vaccines that come late,” Zaks said. “In other words, by allowing them to actually run the assays and define the assays that determine how is an immune response categorized, how strong is it and the exact nuances of that, it increases their confidence and their ability to actually mark out performance against other vaccines that they’re working with and down the road, potentially other vaccines that will up come. And so we’re allowing them to take advantage of us being first in a way that will make our competitors in the future benefit.”
Moderna’s focus on value-based pricing distinguishes it from other leading companies involves in COVID-19 programs like AstraZeneca PLC, which has committed to providing its vaccine on a not-for-profit basis for the duration of the pandemic period, and Gilead Sciences Inc., which has called is coronavirus pricing considerations “different” than those for other products. (Also see “Gilead’s Second Chance To Re-Set The Drug Price Debate” – Pink Sheet, 6 May, 2020.)
This article was first published on June 22, 2020, in the Pink Sheet.
Image: iStock/Aliaksandr Bukatsich
