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Sept 7 (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)
