EMA Opts for Warning Label on AstraZeneca Shot

08.04.2021 - The more things change, the more they stay the same, at least in pandemic times, in Europe. After its second look at an unusual string of rare blood clotting incidents, mostly in younger women receiving AstraZeneca's Covid-19 vaccine, the European Medicines Agency (EMA), the EU’s drugs regulator, said on Apr. 7 it believes there is probably a “strong association” but stressed once again that the benefits of vaccination outweigh any risks.

The Amsterdam-based agency said largely the same thing two weeks ago, though this time it was firm that blood clots “should be listed as a rare side effect” on the vaccine’s packaging. It again saw no need for restrictions in any age group. Several EU countries are currently offering the shot only to adults over 60 years of age. In some countries, this is a switch from an earlier rollout to younger people. In several Scandinavian countries, administration of AstraZeneca’s vaccine remained halted as of early this week.  

EMA has been investigating an estimated 46 reports of blood clots including cerebral venous sinus thrombosis (CVST) and splanchnic vein thrombosis, according to the latest reports. An estimated 9.2 million people have received the AstraZeneca vaccine in the European Economic Area, including the 27 EU member states as well as Iceland, Liechtenstein and Norway.

UK now taking a closer look at thrombosis cases

For the first time since the discussion over thrombosis arose, the UK has now decided that some action is needed. For the present, it plans to stop offering the jab to anyone under 30 years old. Both the EU and the UK are now dosing younger people with Pfizer /BioNTech and Moderna rather than AstraZeneca. The Johnson & Johnson vaccine has been approved but not yet been rolled out in Europe.

Separately from the EMA, UK drugs regulator MHRA has catalogued 79 cases of blood clots and 19 deaths among people vaccinated with the AstraZeneca’s product. Nearly two-thirds of the cases of the rare clots have been observed in women. Ages of those who died were in a wide range between 18 and 79, with three under 30 years old.

UK clinical trials with AstraZeneca in children are also being paused. While saying there were no safety concerns in the pediatric study, Professor Andrew Pollard from the University of Oxford, which developed the vaccine, told broadcaster BBC that the trial’s scientists are waiting for further information.

Pfizer/BionTech shot effective in adolescents

Pfizer/BioNTech meanwhile have reported good results from trials of their vaccine with young people. The companies said it was 100% effective against the virus in a placebo-controlled study of 2,260 adolescents aged 12 to 15. The vaccine was "well-tolerated" by this age group, the they said, with participants experiencing a similar range of usually mild side effects to those seen in older teens and young adults.

Author: Dede Williams, Freelance Journalist