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AMSTERDAM, March 18 (Reuters) - The EU's drug watchdog said on
Thursday it is still convinced the benefits of AstraZeneca's
COVID-19 vaccine outweigh the risks following an
investigation into reports of blood disorders that prompted more
than a dozen nations to suspend its use.
Following are reactions after the European Medicines Agency
(EMA) gave an update on its views on the Oxford-AstraZeneca
vaccine.
MORGANE BOMSEL, VACCINES EXPERT & RESEARCHER, FRANCE'S
NATIONAL CENTRE FOR SCIENTIFIC RESEARCH (CNRS)
On the information available, it is a good general stance
taken by EMA, Bomsel said. "A restart in vaccinations with this
vaccine will be a positive signal for the public."
ENRICO BUCCI, BIOLOGIST AND EXPERT IN SCIENTIFIC DATA
ANALYSIS AT TEMPLE UNIVERSITY IN PHILADELPHIA, U.S.
"The communication disaster of the past few days is
unrepairable, so EMA could not today make any possible
communication to repair what the governments have done.
"On the other hand, EMA has always said that vaccination
should not be interrupted. It is the governments that have made
political and emotional decisions. The important thing is that
the EMA today reiterated what it has always said, and which is
also what all scientists except a few German scientists have
always said: that there is not the slightest significant
percentage of cases of thrombosis, and that the vaccine is safe.
"EMA also said other interesting things, such as the
possibility that these rare events may be due to previous
infections and not to the vaccine."
JESSE GOODMAN, PROFESSOR OF MEDICINE AND INFECTIOUS DISEASES
AT GEORGETOWN UNIVERSITY AND A FORMER CHIEF SCIENTIST DIRECTOR
OF THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH AT THE U.S.
FOOD AND DRUG ADMINISTRATION
"When people have cerebral venous clots, among the most
common underlying conditions are oral contraceptives and
pregnancy."
Goodman also said there are several hereditary and acquired
defects in the system that regulates blood clotting.
"It could be when you look at cerebral venous thrombosis
that patients often have some unusual predilection to
thrombosis, like they were pregnant or had oral contraceptives
or some of these were coagulation disorders. My guess is if this
ends up being a rare event associated with vaccine, it could be
through one of those kind of mechanisms. It could be that it
occurs in individuals who perhaps have a predisposition along
one of those lines, but I think this is totally speculative at
this point.
"I think EMA's position, which is to allow informed
immunization while this continues to be investigated is a
reasonable assessment of risk and benefit based on the current
situation.
"I think transparency and honesty with the public is always
the best approach, even though it's often difficult to explain
to people."
PROF. ANDREW POLLARD, CHIEF INVESTIGATOR ON THE OXFORD
VACCINE TRIAL
"I welcome the news that both the MHRA and EMA have
reiterated that the vaccine’s benefits continue to outweigh any
potential risks, and the vaccine should continue to be
administered.
"Thousands of cases of COVID-19 are occurring across Europe
every day, the rate of covid is rising in many countries on the
continent and vaccination remains a central component of our
fight against the pandemic virus.
"It is important that public health bodies monitor the roll
out of the vaccine, and safety has to be paramount with any new
medicine. Importantly, real-world data shows the clear impact of
the vaccine on public health - with far fewer cases and
hospitalisations from coronavirus in those who have been
vaccinated."
DR DOUG BROWN, CHIEF EXECUTIVE OF THE BRITISH SOCIETY FOR
IMMUNOLOGY
“When developing a new vaccine, the two most important
factors are safety and effectiveness. All vaccines have to go
through rigorous clinical trials before they are approved for
use and they are then monitored during subsequent rollout by the
appropriate safety authorities, which in the UK is the Medicines
Healthcare products Regulatory Agency (MHRA). The approved
COVID-19 vaccines in the UK have all been through this thorough
process.
“Over the last few days, a number of countries decided to
pause the rollout of the AstraZeneca-Oxford COVID-19 vaccine to
double check that having the vaccine is not linked to any cases
of blood clots. These reports can sound worrying but we need to
put the risk into perspective. As we all know, people fall ill
for a multitude of reasons. As has happened in this case, it is
right the medicines regulators review the evidence to work out
what the cause is behind the rare reports of blood clots and
whether it is linked to having been given the vaccine or not.
"We must remember that COVID-19 is a disease that can have
serious consequences in its own right, including the development
of coagulation problems. In the case of the AstraZeneca-Oxford
vaccine, the European Medicines Agency have concluded the
vaccine is safe and effective and recommend the continuation of
the vaccine rollout, a viewpoint backed up by the UK regulator,
the MHRA."
STEPHAN LEWANDOWSKY, AN EXPERT IN COGNITIVE PSYCHOLOGY AT
THE UNIVERSITY OF BRISTOL, UK
Risk management is "a very difficult issue, and different
member states and countries may well come to different decisions
on it".
"Exercising precaution is one possible way in which policy
makers manage risk, and it is more prevalent in European
countries than the U.S. or U.K., where the emphasis is more on
weighing of risks and benefits.
"Given that the European public is generally risk averse,
the suspension and careful examination of the cases by the EMA
may therefore help maintain public trust in the vaccination
process, even though it may also mean that more people will get
sick from COVID-19 than if the vaccinations had continued."
PROF. GINO MARTINI, CHIEF SCIENTIST, ROYAL PHARMACEUTICAL
SOCIETY, UK
“I hope that any concerns about potential links between the
Oxford-AstraZeneca COVID-19 vaccine can now be discarded given
the positive verdicts delivered by the EMA, the WHO and the MHRA
(UK's Medicines and Healthcare products Regulatory Agency), who
have all now said it is safe, effective and can continue to be
used. The vaccine is playing a crucial role in protecting
vulnerable groups from hospitalisation and death and helping to
decrease infection rates across the UK.
“As trusted health professionals, pharmacists are playing a
key role in administering COVID-19 vaccinations and have
contributed enormously to the success of the programme so far.
We have full confidence in these vaccines and can confidently
state that pharmacists can continue administering them to
patients. It is so important that we get all those at risk from
the virus vaccinated as soon as possible.”
ANTONELLA VIOLA, PROFESSOR OF IMMUNOLOGY AT ITALY'S
UNIVERSITY OF PADUA
"EMA reiterates that the benefits outweigh the risks ...
very few cases of thrombosis and in line with what would be
expected anyway from the non-vaccinated population. However,
they do not exclude the possibility of a link between the
vaccine and these rare episodes ... and therefore
pharmacovigilance will continue.
"So what we have to do is this: we must reassure everyone,
these events are extremely rare and the vaccine continues to
show a very high level of safety."
JACQUES BATTISTONI, HEAD OF FRENCH DOCTORS' UNION MG
"We are delighted with the EMA's announcement which paves the
way for a restart of vaccination with the AstraZeneca vaccine in
France. General practitioners will be able to do so as soon as
Friday if the French government authorizes us to do so."
(Reporting by Kate Kelland, Julie Steenhuysen, Emilio Parodi
and Matthias Blamont)
