(Reuters) – COVID-19 vaccine makers ought to make their approved shots available for trials to help speed the development of more vaccines, the Coalition for Epidemic Preparedness Innovations (CEPI) said on Tuesday.
CEPI was launched in 2017 to fund epidemic vaccine development and is funded by countries across the globe as well as by the Bill & Melinda Gates Foundation.
Major vaccine studies have so far examined COVID-19 infection rates comparing the prospective vaccine with a placebo.
Such trials may no longer be considered ethical in countries where an effective vaccine is widely available.
Instead, new vaccines would need to be tested in comparison to an established shot, involving two groups of trial volunteers, CEPI said.
A rate of protection or blood analysis measuring so-called immunogenicity that is comparable to or better than the established product would lead to approval, it said.
CEPI said incumbent shots are often not made available, hindering the development of a wider variety of vaccines.
“Lack of access to comparator vaccines is already stalling the development of promising vaccine candidates, and the potential impact on COVID-19 vaccine development and supply is huge,” Melanie Saville, director of vaccine research and development at CEPI, said in a statement posted on the organisation’s website.
A version of the statement was also published as a letter to the editors of scientific journal Nature.
Established vaccine manufacturers have committed production capacity to serve immunisation campaigns in various nations but those supply contracts do not foresee any use in clinical trials, according to CEPI.
“Thus far, vaccine manufacturers have been reluctant to change this arrangement, threatening to bring vital COVID-19 vaccine R&D to a standstill,” CEPI’s Saville said.
“Companies that have a big market advantage or are selling lots of doses are not very motivated to participate in a trial in which another vaccine might be seen to be comparable or potentially even more immunogenic,” Nicole Lurie, CEPI’s U.S. director and strategic adviser to the CEO, told Reuters.
She added countries also need to re-negotiate their procurement contracts with manufacturers to free them to transfer doses for use in trials.
Volumes in the tens of thousands of doses would already make a huge difference for trials, which is small compared to the hundreds of millions being delivered, she added.
Top Western suppliers are the BioNTech-Pfizer partnership and AstraZeneca working with Oxford University, with each having distributed more than a billion doses.
AstraZeneca’s Vaxzevria-branded shot, however, has been obtained by challengers.
Planned or ongoing vaccine trials that use Vaxzevria as a comparator include Italy’s ReiThera Srl, Valneva of France, Taiwan’s Medigen Vaccine Biologics and South Korea’s SK Bioscience.
A Valneva spokesperson said the trial was recruited quickly and she was not aware of difficulties in procuring the Astra doses.
(Reporting by Ludwig Burger; additional reporting by Richard Lough; editing by Jason Neely)
