By Julie Steenhuysen
CHICAGO (Reuters) – An influential epidemic preparedness and response foundation supporting nine potential coronavirus vaccines has identified manufacturers with the capacity to produce four billion doses a year, the group’s top manufacturing expert told Reuters.
The Coalition for Innovation in Epidemic Preparation (CEPI) plans to have two or three manufacturing plants for each vaccine, said James Robinson, a biopharmacy executive who led CEPI’s vast manufacturing drive, in an interview.
“Right now, we know we can take the two billion doses we have as our minimum target” by the end of 2021, he said.
The group is planning eight to 10 regional distribution sites “so that we don’t have to do everything centrally and try to ship it worldwide,” he said.
Even without existing approved vaccines, CEPI is already aligning manufacturing and supply chains in a quest to ensure that coronavirus vaccines are distributed equally across the world.
The Oslo, Norway-based group is backed by 14 governments, the Bill and Melinda Gates Foundation and the Wellcome Trust of Great Britain.
CEPI has deployed up to $ 829 million so far in pursuit of a COVID-19 vaccine through partnerships with nine developers, hoping that at least some will succeed.
They are Inovio Pharmaceuticals Inc
Robinson said CEPI has taken the first steps to secure manufacturing capacity with more than 200 companies producing sterile or biopharmaceutical vaccines.
“Most people don’t think four billion is possible. I do,” he said.
Robinson, a manufacturing consultant who has worked at some of the world’s largest vaccine companies, including Sanofi
Effective vaccines are considered critical to stopping a pandemic that has infected more than 9.3 million people and killed nearly 480,000 worldwide with little sign of releasing.
CEPI ensures that work to produce a vaccine to prevent COVID-19 does not neglect other critical vaccines. That has been a particular concern in the least developed countries, Robinson said.
‘EVERYTHING HAS TO BE BUILT FROM SCRATCH’
Manufacturing capacity has been easier to locate for vaccine candidates using traditional technology. But three of the candidates CEPI endorses involve more complex technology based on mRNA or DNA.
Since there has never been a licensed vaccine using those approaches, there is no network of manufacturers contracted to support high-volume production, Robinson said.
“The capacity is simply not there and everything has to be built from scratch,” he said.
Access to medical glass is another known bottleneck. To overcome this, CEPI has purchased enough glass vials for two billion doses and is considering buying more.
“We don’t want the vials to be the reason we don’t have enough vaccine,” he said.
CEPI maintains the packaging products you choose uniformly, so you can fill the vials and finish the packaging of any of the vaccines, rather than tailoring them to individual products.
They have done the same with rubber stoppers that seal the vials and aluminum caps to cover them.
“Some companies are choosing not to use our network … and they are also buying their own vials,” said Robinson. That will allow for greater capacity for smaller biotechnologies and university labs that do not have sophisticated supply chains.
Another massive challenge facing CEPI is the need to work with dozens, if not many, of regulators worldwide.
“Each regulatory agency could ask for something different, so our work is a little more complex,” said Robinson.
A CEPI regulatory working group has been looking for ways to try to standardize the requirements as much as possible, Robinson said. “But then, each of the countries that receive the vaccine also needs to license it.”
(Report by Julie Steenhuysen; Edited by Bill Berkrot)
