Again, reports of the very rare side effect of thrombosis and low platelet counts after vaccination are in the news. Now we are talking about the Janssen vaccine and not about AstraZeneca, which is already being pricked in the Netherlands. Are the notifications similar?
Less than a week ago, the demissionary minister De Jonge people under 60 years of age decided not to vaccinate with AstraZeneca anymore because of the very rare side effect of thrombosis and low platelet counts. Today, manufacturer Johnson & Johnson decided to temporarily suspend deliveries of the Janssen vaccine to Europe, following reports of the same clinical picture.
In AstraZeneca, the package leaflet has been updated following examination, which now mentions the clinical picture as a very rare side effect. At Janssen, there is now only reports. A possible connection is being investigated.
This research is carried out by the CDC, the American counterpart of the RIVM, the American drug guard dog FDA and the European Medicines Agency (EMA). There are six cases of thrombosis, which occurred in women in the US between 18 and 48 years of age. One of them died, another is in the hospital.
A link between these reports and the Janssen vaccine has not been established (yet). Almost 7 million Americans have now been vaccinated with the Janssen vaccine, with one shot sufficient for immunity against the coronavirus.
AstraZeneca and the reports are likely to have a link, the EEA said last week. On April 4, 222 reports of the rare clinical picture after vaccination with AstraZeneca were reported worldwide. Reports were mainly seen in women under 60 years of age. In Europe and the United Kingdom, a total of 34 million vaccinations have been carried out with the vaccine.
According to the EEA, the risk of the very rare adverse reaction with AstraZeneca is about 1 in 100,000. After almost 7 million injections, six reports are known at Janssen, which is less than 1 notification per million vaccinations.
The EEA says about AstraZeneca that the benefits outweigh the risks. Therefore, according to the EEA, AstraZeneca can be used simply. It is up to countries themselves to make any risk assessments about not giving AstraZeneca to certain target groups. This is now happening in the Netherlands: 60 minners are no longer given AstraZeneca, because the reports are mostly found in people under 60 and the risk of corona mortality increases in people over 60.
According to the College for the Evaluation of Medicines, the Dutch branch of the EEA, it is still too early to draw conclusions about the Janssen vaccine and the reports. “At the moment, the benefits of the Janssen Coronav vaccine outweigh the potential risks.”
Earlier, experts already warned about a “hyperfocus” on the possible side effects of vaccines. According to them, it is important to look at the magnitude of the risk of the possible side effects. “Risks can never be ruled out 100 percent. You have to look at the benefits and disadvantages of a vaccine and weigh them against each other. In this case, the risk is very small,” said Professor of Immunology Marjolein van Egmond then.
There are fewer people for Astrazeneca vaccinations, notes an Amsterdam general practitioner in a community centre where she vaccinates people from the Bijlmer:
Another similarity between AstraZeneca and Janssen is the type of vaccine: both vaccines are a vector vaccine. All vaccines bring a small piece of coronavirus genetic code into our cells. Pfizer/Biontech and Moderna do this via a fat ball, Janssen and AstraZeneca use a harmless cold virus as a means of transport. The piece of genetic code causes our cells to produce a piece of virus protein. That protein should trigger an immune response that protects us from the coronavirus.
It is still unknown what causes the clinical picture, and therefore it cannot be said whether this is related to the type of vaccine.
Reports of this clinical picture have also been received at Pfizer and Moderna. At Moderna, its about 5 reports on 4 million shots. At Pfizer, it is 35 reports out of 54 million shots. Also in these vaccines no link has yet been established between the reports and the vaccine.