Oct 22 (Reuters) - Pfizer Inc and Johnson & Johnson
are seeking input from a U.S. Food and Drug
Administration advisory committee on retaining and attracting
volunteers for COVID-19 vaccine trials after a vaccine becomes
available, if they know they might receive a placebo.
Both U.S. companies are among a handful with pivotal,
late-stage COVID-19 vaccine trials underway.
The comments in letters ahead of the meeting of expert
advisers on Thursday underscore dilemmas facing leading
coronavirus vaccine developers and those whose large trials are
just beginning or being planned.
Drugmakers are racing to find vaccines to protect against
the coronavirus that has caused more than 1 million deaths
globally. Many have begun trials involving tens of thousands of
people who receive either an experimental vaccine or a placebo
without knowing which.
J&J, in its comments, said a discussion is needed on the
potential challenges of maintaining trial enrollment in ongoing
large studies, especially after initial vaccines become
It is likely several vaccines will be needed to inoculate
billions of people around the world.
The company said that once the first vaccines are licensed
or authorized, it may lead volunteers to seek available vaccines
instead of participating in ongoing trials. Volunteers already
enrolled in trials might withdraw, it warned.
Pfizer, which is developing its vaccine with Germany's
BioNTech SE, could provide early data from their
late-stage vaccine trial later this month. Moderna Inc
is likely to have early data on its candidate in November.
The FDA will then consider whether to issue a quick
emergency use authorization (EUA), given the desperate need for
a vaccine, or seek additional data before making a decision.
J&J is a step behind after its U.S. trial was paused earlier
this month due to an illness in a study participant.
AstraZeneca's U.S. vaccine trial is also paused due to
an illness in its UK trial, but is expected to resume as soon as
this week, Reuters reported, citing four sources.
In its guidance on EUAs for vaccines, the FDA said earlier
in October that a drugmaker should continue to collect data in
any ongoing trials for as long as feasible, even after getting
an authorization, and work toward submission of a formal
approval application as soon as possible.
Pfizer said it may have an ethical duty to inform at least
some study volunteers that they have been given a placebo. It
has proposed allowing them to move over to the vaccine arm of
the study should its vaccine receive an EUA. (https://bit.ly/3dQqSxP)
J&J said it was evaluating a number of measures aimed at
retaining trial volunteers.
"It would be helpful if FDA could share insights at the
upcoming (meeting) on potential options they believe can be
acceptable," J&J said. (https://bit.ly/37vCKEl)
(Reporting by Ankur Banerjee in Bengaluru, Julie Steenhuysen in
Chicago and Michael Erman in New York; editing by Caroline Humer
and Bill Berkrot)