Denmark stops use of Johnson & Johnson Covid-19 vaccine

Country cites blood clot risk for move, after dropping AstraZeneca shot last month

The move will delay Denmark’s vaccination calendar by up to four weeks, the country’s health authority has said. File photograph: Mark Kauzlarich/ Bloomberg

The move will delay Denmark’s vaccination calendar by up to four weeks, the country’s health authority has said. File photograph: Mark Kauzlarich/ Bloomberg

 

Denmark on Monday became the first country to exclude Johnson & Johnson’s Covid-19 vaccines from its vaccination programme over a potential link to a rare but serious form of blood clot.

The move comes after the Nordic country last month stopped using AstraZeneca’s vaccine altogether, citing similar concerns.

The country’s health authority said in a statement it had found that “the benefits of using the Covid-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect in those who receive the vaccine”.

Excluding the Johnson & Johnson vaccine, which accounts for about a third of Denmark’s total contracted supplies of Covid-19 vaccines, would delay the country’s vaccination calendar by up to four weeks, it said.

Denmark, which has so far fully vaccinated 11.5 per cent of its population, has gradually been reopening society since early March as infection rates have slowed, including indoor service at restaurants and cafes and allowing football fans into stadiums.

“Taking the present situation in Denmark into account, what we are currently losing in our effort to prevent severe illness from Covid-19 cannot outweigh the risk of causing possible side effects in the form of severe blood clots in those we vaccinate,” the health authority said.

It added that the vaccination rollout is progressing satisfactorily with other available vaccines.

Lawmakers at a meeting on Monday agreed to allow voluntary use of the vaccines from both Johnson & Johnson and AstraZeneca, lawmaker Liselott Blixt of the Danish People’s Party said.

Concerns

The rollout of Johnson & Johnson’s vaccine has also been delayed elsewhere in Europe over similar clotting concerns.

Europe’s drug regulator, the European Medicines Agency, said on April 20th, it had found a possible link between Johnson & Johnson’s vaccine and rare blood clotting issues in adults who received doses in the United States.

But it backed the vaccine’s overall benefits against any risks. Since then, several European countries have resumed administering the vaccine.

EMA said its safety committee had concluded that a warning about unusual blood clots with low platelets must be added to the vaccine’s labels, just as was required of AstraZeneca. Johnson & Johnson said in a news release that it would comply with that measure.

Vaccine approval

Meanwhile, the regulator said on Monday it has begun evaluating a request by Pfizer and BioNTech to extend approval of their coronavirus vaccine to include children ranging in age from 12 to 15.

The EMA’s human medicines committee will carry out an accelerated assessment of data submitted by Pfizer and BioNTech and is expected to reach a decision in June, unless it requires extra information, the agency said.

In a statement Friday, the two pharmaceutical companies said their request is based on an advanced study in more than 2,000 adolescents that showed their vaccine to be safe and effective.

The children will continue to be monitored for longer-term protection and safety for another two years.

The companies’ vaccine is currently approved for use in people aged 16 years and older.

Extending that approval to the younger age group could offer younger and less at-risk populations in Europe access to the vaccine for the first time.

Most Covid-19 vaccines approved by authorities around the world are for adults, who are at higher risk, but health officials believe vaccinating children of all ages will be critical to stopping the pandemic.

Some research has shown that older children may play a role in spreading the virus. – PA/Reuters