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* New vaccine trials need established shots for control
group-CEPI
* Warns against development "standstill" amid lack of
vaccines
* Companies, countries need to spare 10s of thousands of
doses
(Adds company comments)
By Ludwig Burger
Sept 7 (Reuters) - COVID-19 vaccine makers ought to make
their approved shots available for trials or risk hobbling the
development of more vaccines, the Coalition for Epidemic
Preparedness Innovations (CEPI) said on Tuesday.
Major vaccine studies have so far examined COVID-19
infection rates comparing the prospective vaccine with a
placebo. But 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, said CEPI, which was launched in 2017 to
fund epidemic vaccine development and is funded by countries as
well as by the Bill & Melinda Gates Foundation.
"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 https://cepi.net/news_cepi/comparator-vaccines-are-needed-if-vital-covid-19-rd-is-to-progress,
a version of which was published as a letter https://www.nature.com/articles/d41586-021-02398-6
to the editors of scientific journal Nature.
Established vaccines have been sold under supply contracts
that do not foresee 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.
An exception appears to be AstraZeneca, whose shot developed
along with Oxford University has been obtained as a comparator
for planned or ongoing trials, including by Italy's ReiThera
Srl, Valneva of France, Taiwan's Medigen Vaccine
Biologics and South Korea's SK
Bioscience.
When asked to comment on the CEPI remarks, AstraZeneca said
it "continues to collaborate with the industry and share
resources to tackle the pandemic".
A Valneva spokesperson said the trial was recruited quickly
and she was not aware of difficulties in procuring the
AstraZeneca doses. The other main Western COVID-19 vaccine
makers - Pfizer and partner BioNTech, Moderna
and Johnson & Johnson - did not immediately
respond to requests for comment.
CEPI's U.S. director, Nicole Lurie, told Reuters that
companies selling approved vaccines are not motivated to assist
trials that could lead to the development of a competing
product. Countries should renegotiate contracts with
manufacturers to let them use doses in trials, she said.
Volumes in the tens of thousands of doses would make a huge
difference for trials, small compared to the hundreds of
millions being delivered, she added.
(Reporting by Ludwig Burger
Additional reporting by Richard Lough
Editing by Jason Neely and Peter Graff)
