The conclusion from the EMA's investigation on Friday was expected, it is the same message that came earlier: Astra Zeneca's vaccine against covid-19 has more benefits than risks.
The risk of suffering from rare serious side effects from blood clots in combination with low platelet counts is one in 100,000 vaccinated.
- It is a very rare side effect and in Sweden we have decided that we stay for 65 years and up, then the risk will be much less, says Ali Mirazimi, vaccine researcher and expert at the Public Health Agency on hemorrhagic fevers.
"No action at present"
The Medical Products Agency sees no reason to make any changes to the package leaflet to the vaccine or in any other way to make regulatory measures, says Ulla Wändel Liminga, scientific leader for drug safety at the Medical Products Agency.
The package leaflet for Astra Zeneca's vaccine states today that the unusual side effect in question occurs in less than one in 10,000 cases.
- This is the lowest frequency in our regulatory system.
Now the EMA says that it is even one in 100,000. So that figure does not need to be changed, it is already as low as possible.
"The risk of dying is much higher"
Although the risk presented by the EMA is very rare, it could potentially lead to one in a million vaccinated people, 10 people could suffer from this very severe side effect.
But the EMA has carefully weighed against the risk of the elderly dying of covid-19, says Ulla Wändel Liminga.
- It has been possible to make an estimate of how many people avoid intensive care and death with the help of the vaccine.
Then they have compared it to the estimate of the very rare side effects and come to the conclusion that the benefit still exceeds the risks, she says.
"Do not think it affects the vaccination"
Ali Mirazimi, who also has a position at the Swedish Public Health Agency as an expert on hemorrhagic fevers, has no role of his own in the vaccination program against covid-19.
But he does not believe that today's message from the EMA will affect vaccination in Sweden.
- The Swedish Public Health Agency and the Medical Products Agency had come to this conclusion earlier, that the risk is about one in 100,000 cases, so I do not think it will affect the decision on vaccines.Keywords: