(Adds AstraZeneca comment)
By Kate Kelland and Julie Steenhuysen
LONDON/CHICAGO, March 25 (Reuters) - Scientists who have
watched with dismay a series of disputes over AstraZeneca's
COVID-19 vaccine say strong efficacy data from a large
U.S. trial should lay concerns to rest, but worry the skirmishes
may leave a lasting mark on public trust.
Spats with governments across Europe about production,
supplies, possible side effects and the vaccine's merits have
dogged the Anglo-Swedish drugmaker for months. And a highly
unusual public rebuke from U.S. scientists monitoring the
government-funded trial this week added to its woes.
While the disputes have raised questions about AstraZeneca's
messaging and communications, what is crucial, scientists say,
is that the product at the heart of all this appears sound.
On Thursday, the company said the vaccine was 76% effective
in an updated analysis of its U.S. trial after providing a
slightly higher efficacy figure that was criticized for not
being based on the most up-to-date data.
"One has to distinguish between the strong, positive, data
from the U.S. trial on the one hand, and the amazing ability of
AstraZeneca's press-release messaging to continually rescue
defeat from the jaws of victory," said Danny Altmann, a
professor of immunology at Imperial College London.
Among researchers working to develop vaccines, treatments
and other weapons against COVID-19, the frustration is evident.
Altmann told Reuters he is "impatient to get politics out of
vaccinology and get us safe."
A U.S. trial investigator involved in evaluating
AstraZeneca's shot, who was not authorized to speak publicly,
called the avoidable controversy "upsetting, because a lot of
people worked really hard and the vaccine is really important.
I do think it's a good and effective vaccine."
AstraZeneca defended its handling of U.S. trial data this
week, saying in a statement it was "in the public interest" for
the company to disclose the interim results that shed more light
on the vaccine's ability to protect older adults and its safety.
COMMUNICATION BREAKDOWN
AstraZeneca's COVID-19 shot has faced questions since late
last year, when the drugmaker and Oxford University published
data from its first large-scale trial with two different
efficacy readings as a result of a dosing error.
Uncertainty over how the dosing error came about raised
questions about the robustness of the data, and differing
accounts from AstraZeneca and Oxford added to concerns
Trust in the vaccine - and its developers - took a further
hit this month, when more than a dozen countries temporarily
suspended its use after reports of a rare blood clotting
disorder in a very small number of people shortly after they
were inoculated.
Ian Jones, a professor of virology at Britain's Reading
University, said it is "generally accepted that the early trial
data, while positive, did suffer from a communication issue."
The focus now, he agreed, should be results from the latest
trial and from real-world use "which shows an excellent safety
profile and the prevention of severe disease."
AstraZeneca's coronavirus vaccine has so far been most
widely used in Britain, where its rollout January, along with
the Pfizer/BioNTEch shot, is helping reduce
severe COVID-19 cases and deaths.
U.S. scientists were taken aback on Tuesday by a midnight
news release issued from the National Institutes of Health (NIH)
raising doubts about the company's announcement a day earlier
that the vaccine was 79% effective at preventing COVID-19 in the
U.S trial.
That was prompted by a letter from an independent data and
safety monitoring board to the NIH saying the company had
excluded more current data, which top U.S. infectious disease
expert Dr. Anthony Fauci called "a really unfortunate unforced
error."
That assessment seemed to be backed up by the updated
results released by AstraZeneca on Thursday that were only
marginally different.
"To have them write to the trial sponsor, which is the NIH,
to say that they see a problem - no one I know has ever heard of
this," said John Moore, a professor of microbiology and
immunology at Weill Cornell Medical College in New York. "It's
damaged the company's reputation in Washington, D.C. circles.
It's tarnished."
Asked whether the NIH was satisfied with AstraZeneca's
latest news release, a spokesperson said via email, "NIH looks
forward to the review by the U.S. Food and Drug Administration."
FDA staff scientists routinely make public their own review
of a drug's raw data after it is submitted to the agency for
approval.
Some U.S. scientists plan to wait for the FDA analysis,
rather than judge the vaccine's merits based another press
release, "just to avoid any further roller coaster rides," said
Dr. Nahid Bhadelia, an infectious disease expert at Boston
Medical Center.
(Reporting by Kate Kelland in London and Julie Steenhuysen in
Chicago; Editing by Bill Berkrot)
Astrazeneca (AZN)
