For the European Medicines Agency (
Ema
), all
four
anti Covid-19 vaccines approved in Europe
are valid
: there is therefore no back-front on
AstraZeneca
by the European regulatory body, he told ANSA the coordinator of the EMA vaccines task force, Marco Cavaleri. The data on the risk-benefit ratio are also positive for the other viral vector vaccine, that of
Janssen (Johnson & Johnson)
and for the two vaccines based on messenger RNA (mRna) technology, namely those of
Moderna
and
Pfizer / BioNTech
. And '
being
, then, the
clinical study
of the vaccine company
Curevac
, based in Germany, which could come to the examination of the EMA
towards the end of the summer
: for Europe it could become the fifth anti Covid vaccine and the third in mRna.
"All the vaccines approved by the EMA, including that of AstraZeneca, maintain a
positive risk-benefit ratio
especially in the
elderly and vulnerable
, so they should continue to be used", noted Cavaleri. Ema's position on the AstraZeneca vaccine "has not changed", but of course the
cases of thrombosis
that have so far occurred mainly in young women are under
attention
of the regulatory body. "Cases of thrombosis with thrombosis have emerged, which have been examined by our pharmacovigilance committee" and "in addition, the EMA has conducted
new analyzes
to contextualize the risk of thrombosis in different age groups, by sex and in different epidemiological contexts. ", which made it possible to define how to use the vaccine in the context of vaccination campaigns."
The results are expected in July
.
For young people so far vaccinated with AstraZeneca and awaiting the
second dose
"so far
there is no evidence
that thrombosis cases are associated with the second dose: in the coming weeks we will analyze the available data and take stock of the evidence. To date - observed Cavaleri - the
preliminary data bodes well
".
What can be said about this vaccine is that" it was
approved at the beginning of the year in the population aged 18 and over
in the light of a report and positive risk-benefit, especially for the elderly. "the latter were not included in the initials trials in sufficient numbers, but now there are elements to confirm that" among the population over 60 years the benefits outweigh the risks. "
They continue to collect data on
Janssen's
vaccine as well
following the cases of thrombosis detected in young women in the United States: "it is important to
continue monitoring
, but the position of the EMA confirms that the cost-benefit ratio of this vaccine is positive from 18 years of age".
All four vaccines approved in Europe
continue to be studied
also
to understand if and how much are effective against variants
of the virus SarsCoV2. The
first data are expected "by the summer"
Cavaleri said, and the decision to administer a third dose of the vaccine will also depend on him. It is an issue "on which we are already working with the manufacturers" because "the duration of vaccine protection is not known to date, but preliminary data suggest that it may last over time, for example for a year or more. '.
However this time - he observed - could change the face of the circulation of variants. " Any decision on when and how to give a
third dose
of the vaccine, he added, "will have to be
made on the basis of the data
"on possible cases of infection or disease in people already vaccinated. If the circulation of the variants of the virus should make it necessary to modify the vaccine, it is expected that it will be possible" to obtain authorization from the EMA in a short time ".