Bulgaria’s vaccination chief: No severe side-effects among more than 235 000 who had AstraZeneca jab

There had been no severe side-effects among the more than 235 000 people in Bulgaria who had received the AstraZeneca vaccination against Covid-19, national vaccination headquarters chief Professor Krassimir Gigov told Bulgarian National Radio on April 9.

Gigov said that the number of cases of side effects in EU countries after the use of the AstraZeneca vaccine were very small.

If a person had not experienced severe side-effects after the first dose, there should be no problem with the second, he said.

There was no scientific justification for using a vaccine for the second dose that was different from the first, Gigov said.

“If there is scientific evidence, we will give patients the opportunity to make choices in this regard.”

The April 9 report by Bulgaria’s national information system said that so far, 552 516 doses of vaccines against Covid-19 had been administered.

Gigov said that supplies for second doses were being kept for everyone who had received a first dose.

There had been isolated cases of people getting Covid-19 after receiving two doses, but the cases had been very mild.

“If they had not been tested, they would not have known that have a coronavirus infection,” he said.

The first doses of the Johnson & Johnson (Janssen) vaccine are expected in Bulgaria on April 16, Gigov said.

The European Medicines Agency (EMA) said on April 9 that its Pharmacovigilance Risk Assessment Committee (PRAC) had started a review of a safety signal to assess reports of thromboembolic events (formation of blood clots, resulting in the obstruction of a vessel) in people who received Covid-19 Vaccine Janssen.

Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with Covid-19 Vaccine Janssen, the EMA said.

One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the United States. One of them was fatal.

The Janssen vaccine is currently only used in the US, under an emergency use authorisation.

The Janssen vaccine was authorised in the EU on March 11 2021.

The vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.

The EMA said that these reports point to a “safety signal”, but it is currently not clear whether there is a causal association between vaccination with Covid-19 Vaccine Janssen and these conditions.

PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information, the EMA said.

The EMA said that it would further communicate once the evaluation has concluded.

Earlier, the EMA said that PRAC has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria, the new name of the Vaccine AstraZeneca.

The EMA said that the benefits of the vaccine outweighed the risks.

PRAC also has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria.

The agency said that five cases of this very rare disorder, characterised by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure, were reported in the EudraVigilance database.

“At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome. These reports point to a ‘safety signal’ – information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation.”

PRAC will evaluate all the available data to decide if a causal relationship is confirmed or not, the EMA said.

“In cases where a causal relationship is confirmed or considered likely, regulatory action is necessary in order to minimise the risk. This usually takes the form of an update of the summary of product characteristics and the package leaflet,” the EMA said.

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