Rare neurological disease: EMA publishes new data on side effect of Astrazeneca vaccine

Created: 01/21/2022 10:26 am

By: Martina Lippl

Astrazeneca's vaccine is safe and effective.

© Sakchai Lalit/AP/dpa

After reports of side effects in Germany, the vaccine from Astrazeneca became a slow seller.

The European Medicines Agency (EMA) publishes new data. 

Amsterdam – There was no other corona vaccine that discussed the side effects as much as Astrazeneca.

Now there is news about serious side effects.

The European Medicines Agency (EMA) is now recommending that the product information for the Astrazeneca vaccine called Vaxzevria be adjusted.

Especially with regard to the second dose.

Severe side effects after the first Astrazeneca vaccination - thrombosis with thrombocytopenia syndrome

The vaccine from the Swedish-British pharmaceutical company was approved by the European Medicines Agency EMA on January 29, 2021.

After reports of severe side effects, several countries, including Germany, stopped using the Astrazeneca vaccine for the time being.

These were very rare blood clots, in medical terminology thrombosis with thrombocytopenia syndrome - TTS for short.

These blood clots often appear in unusual places, such as the brain.

Those affected also have a reduced number of blood platelets. 

Astrazeneca side effects: EMA points to current data after second dose of vaccine

After a second dose of Astrazeneca, fewer cases of rare blood clotting with low platelet counts were observed, the EMA says. A review of the data showed that. Most suspected TTS events worldwide were reported after the first dose. After the second Astrazeneca dose, fewer were observed. In the opinion of the EMA safety committee PRAC, a note should therefore be included in the package insert.

To illustrate this, the EMA presents cumulative figures: A total of 1,809 thromboses with thrombocytopenic syndrome have been reported worldwide.

Of these, 1,643 after the first dose and 166 after the second dose.

The EMA also writes: "According to the current product information, administration of a second dose of Vaxzevria is contraindicated in subjects who have experienced TTS following vaccination with this vaccine."

Astrazeneca vaccine safe despite side effects

Millions of people have now been vaccinated.

Serious side effects are extremely rare.

On the other hand, slight side effects are always to be expected.

According to experts, vaccinations - including those with Astrazeneca - have prevented hospital admissions and deaths.

Like all medicines, the data from Vaxzevria are continuously monitored and carefully evaluated again and again, emphasizes the EMA.

Transverse myelitis - new side effect also with Astrazeneca

At the same time, the EMA published new warnings on side effects for two vaccines in this newsletter. In this case, Vaxzevria is also affected by Astrazeneca. Cases of transverse myelitis (TM) were reported to the agency following the Astrazeneca vaccinations. Transverse myelitis is a rare neurological disorder characterized by inflammation of one or both sides of the spinal cord. "It can cause weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain, or loss of sensation of pain), or problems with bladder or bowel function.

In Germany, the mRNA vaccines from Biontech/Pfizer and Moderna are currently predominantly used.

Above all, a booster should protect against Omikron.

Nevertheless, Novavax's protein vaccine is expected by the end of February.