With new approval guidelines, the FDA has dampened Trump's hopes for a rapid corona vaccine.
Washington - The
US Food and Drug Administration (FDA)
has canceled Donald Trump's plans for rapid approval of a
corona vaccine *
in the
US
.
On Tuesday, the agency announced new criteria for accelerated approval of a
corona vaccine
.
Accordingly, manufacturers have to observe a follow-up period in the third and final test phase, which makes it de facto impossible
to bring a vaccine onto the market
before the
presidential election
on November 3rd.
The rule is necessary to collect sufficient data "to assess the
risk-benefit profile of
a vaccine".
Coronavirus vaccine: Trump reacts angrily to new criteria
The two companies Moderna and Pfizer, whose clinical studies are the most advanced so far, did
not begin
the third
test phase
until the end of July.
Since the second
dose of vaccine
is administered 28 days after the first dose, the follow-up period required by the FDA for the very first subjects would end at the end of October.
However, the companies would then probably not have sufficient data
to apply for
approval
in the fast-track
procedure
.
President Donald Trump *
had
repeatedly promised
approval of
a
vaccine
before the election.
On Twitter, he reacted angrily to the new
FDA guidelines
.
This would "make it more difficult to get vaccinations before election day".
This is "another political attack" on him as president.
According to the
US media
, the White House had tried to influence the new
FDA guidelines
.
Accordingly, the White House considered the follow-up time unnecessary and wanted to remove it from the guidelines.
Trump
is
under strong pressure
because of the strong spread of the
corona virus
in the
United States
.
In the polls, he is behind his challenger
Joe Biden
.
The
opposition Democrats
have long been fearing that
Trump is
putting massive pressure on researchers and health authorities to get a
vaccine
approved
as soon as possible and before the election
.
* Merkur.de is part of the nationwide Ippen-Digital editors network.
List of rubric lists: © Patrick Semansky / AP / dpa