Also blood clot risk with Johnson & Johnson vaccine – VG

That means another disappointing vaccine novelty. But it is too early to say what will happen to the vaccine in Norway.

The first doses of the Johnson & Johnson vaccines arrived in Norway this April, but have not yet been used. Of the more than seven million doses administered in the United States, eight cases of rare and severe blood clots have been detected. All eight were under the age of 60, most were women and one of them died.

Then there is the question of whether this is related to the vaccine (which is also called the Janssen vaccine).

The European Medicines Agency (EMA), which approves vaccines for the EU and Norway, is now presenting its conclusions:

• They find a possible link between the Johnson & Johnson vaccine, rare blood clots and a low platelet count.
• They emphasize that the benefits of using the vaccine still outweigh the risks. And that the risk of getting these side effects is very low.
• They include a blood clot warning in the drug review – and list blood clots as a possible side effect.
• However, they have not been able to identify any particular risk factors. Thus, they can not establish that the risk of getting these rare side effects is greater if you are young, old, woman or man, for example.

– This is very reminiscent of what happened with AstraZeneca, says Steinar Madsen in the Norwegian Medicines Agency about EMA’s conclusions.

He emphasizes that it is very rare side effects.

– They also state that the benefit outweighs the risk. So the vaccine remains approved throughout Europe, including Norway, says Madsen.

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Now it’s up to the government – and FHI

When the EMA came to the same conclusion for the AstraZeneca vaccine, FHI’s recommendation was to scrap that vaccine in Norway. Because they believed that here in Norway, with low infection and the oldest groups vaccinated, the benefit of using the vaccine was not high enough.

The Norwegian Institute of Public Health says they will discuss the EMA’s conclusion with the Norwegian Medicines Agency.

– We will also study several experiences from the USA and South Africa where this vaccine has been used a lot, writes FHI chief physician Preben Aavitsland in an e-mail to VG.

NIPH provides professional advice, but it is the government that decides. Although FHI recommended dropping the AstraZeneca vaccine, the government postponed the decision – and appointed an expert committee in which FHI is not involved.

– We will gather this knowledge and give our assessment to the ministry, writes Aavitsland.

Do not know why it happens

The EMA has not been able to establish the exact mechanism by which these side effects occur.

– What directly triggers these violent reactions is uncertain, says Madsen in the Norwegian Medicines Agency.

– We have a pretty good overview of what happens when the reaction first starts. Then the platelets clump together, form blood clots, and then there may be bleeding later. There are great similarities in the disease picture at AstraZeneca and Johnson & Johnson, says Madsen.

May mean delays in Norway – but not so great

The news that rare thrombosis cases among the Johnson & Johnson vaccine were particularly bad news for those between 18 and 45 years in Norway. Because it could mean a delay in vaccination by a full seven weeks.

But then came the good news from Pfizer: Two million extra doses this summer, enough to vaccinate one million Norwegians. Thus, FHI estimates that the delay only stays for a few weeks if The Johnson & Johnson vaccine is not used in Norway.

In other words: They reckon that everyone has been offered a vaccine during August, even without Johnson & Johnson.

• What’s Happening in the United States? The vaccination with Johnson & Johnson has also been put on hold there. An independent panel of experts for the American infection control agency CDC met to discuss the matter last Wednesday, but did not come to a conclusion. The USA is struggling with a significantly higher infection pressure than Norway.

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