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(Adds quote from J&J)
By Nikolaj Skydsgaard
COPENHAGEN, June 25 (Reuters) - Health authorities in
Denmark said on Friday that COVID-19 vaccines from AstraZeneca
and Johnson & Johnson would remain excluded from
the country's vaccine roll-out following a review of new safety
data.
"The balance between possible benefit and possible harmful
effects is still not favourable, even when we include
assumptions in our analyses that benefit the vaccine," the
Danish Health Authority said in a statement.
Denmark was the first country to suspend and altogether
ditch Johnson & Johnson's and AstraZeneca's vaccines in April
and May over safety concerns due to their potential link to a
very rare but serious form of blood clot.
Health authorities said then the benefits of the vaccines
did not outweigh the risks, especially since most of the elderly
population had already been inoculated and the epidemic was
largely under control.
The European Union's drug regulator has found a possible
link between the vaccines and an extremely rare form of blood
clotting, but says the benefits of the vaccines outweigh any
risks of side effects.
In late May, the Danish government asked health authorities
to reconsider the exclusion of those vaccines since new data on
their effects and side-effects had been reported.
Based on a review of fresh data from United States and the
European Union, the health agency said on Friday there was now a
certain link between both vaccines and so-called vaccine-induced
immune thrombotic thrombocytopenia (VITT).
It could not conclude whether the risk of suffering from
VITT-syndrome was lower, the same or higher after inoculation
with Johnson & Johnson's shot compared with AstraZeneca's
vaccine.
"On April 20th the EMA (European Medicines Agency) confirmed
a positive benefit-risk profile for use of the Janssen COVID-19
vaccine. The decision was informed by data and science," a
spokesperson for J&J's Janssen unit said in an emailed comment
to Reuters.
"We respect the independent decision made by the Danish
Health Authorities and will continue to collaborate closely with
them to provide all the information they require to continue
their investigations," she added.
The ditched vaccines have however been made available for
Danes on a voluntary basis following a doctor's consultation.
2.4% of people vaccinated have been fully vaccinated with J&J's
shot, while just 0.1% have received two doses of AstraZeneca's
vaccine.
Just over half of Denmark's population has received their
first shot, the vast majority of them with Pfizer-BioNTech's
, vaccine.
(Reporting by Nikolaj Skydsgaard and Jacob Gronholt-Pedersen;
Editing by William Maclean
Editing by Alison Williams, Edmund Blair and Frances Kerry)
