By Nikolaj Skydsgaard
COPENHAGEN (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 MacleanEditing by Alison Williams, Edmund Blair and Frances Kerry)