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‘Possible link’ between AstraZeneca vaccine and rare blood clots, EMA concludes

The European Medicines Agency has come to the conclusion that the unusual blood clots suffered by numerous people around Europe should be considered as rare side effects of AstraZeneca's Covid-19 vaccine, but that overall the benefits of the jab outweigh the risk.

'Possible link' between AstraZeneca vaccine and rare blood clots, EMA concludes
Photo by Tiziana FABI / AFP

A statement published online read: “The EMA’s safety committee has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of the COVID-19 AstraZeneca vaccine.”

The EMA added however that the benefits of the vaccine outweigh the risks.

While millions of doses of the vaccine developed with Oxford University have been administered, small numbers of people have developed deadly blood clots, which prompted countries including the European Union’s three largest nations – Germany, France and Italy – to temporarily suspend injections pending the EMA investigation.

In March the EMA said the vaccine was “safe and effective” in protecting people against Covid-19 but that it couldn’t rule out a link to blood clots, and that more investigations were needed.

On Wednesday the EMA said the AstraZeneca vaccine should continue to be used for all age groups but that people should be told of the possible rare side effects. The announcement came as the UK’s own drugs regulator said the AZ vaccine should now only be given to over 30s.

The EMA said it was “reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination.”

One plausible explanation for the combination of blood clots and low blood platelets is an immune response, the EMA said but that it had not identified any clear risk factors for causing the clots including age or gender.

So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination. 

The EMA advised that people who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets.

Symptoms include shortness of breath, chest pain, swelling in legs, abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin at the sight of the injection.

The EMA committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal

The agency concluded: “COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.”

Germany, France and Italy have all restarted AstraZeneca vaccines, but in the case of France and Germany with extra guidelines on the age of patients it should be used for. France is currently not administering the AstraZeneca vaccine to under 55s or over 75s.

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COVID-19 RULES

Germany should prepare for Covid wave in autumn, ministers warn

German health ministers say that tougher Covid restrictions should come back into force if a serious wave emerges in autumn.

Germany should prepare for Covid wave in autumn, ministers warn

Following a video meeting on Monday, the health ministers of Germany’s 16 states said tougher restrictions should be imposed again if they are needed. 

“The corona pandemic is not over yet – we must not be deceived by the current declining incidences,” said Saxony-Anhalt’s health minister Petra Grimm-Benne, of the Social Democrats, who currently chairs the Conference of Health Ministers (GMK).

According to the GMK, new virus variants are expected to appear in autumn and winter. Over the weekend, federal Health Minister Karl Lauterbach (SPD) also warned that the more dangerous Delta variant could return to Germany. “That is why the federal Ministry of Health should draw up a master plan to combat the corona pandemic as soon as possible and coordinate it with the states,” Grimm-Benne said.

Preparations should also include an amendment of the Infection Protection Act, ministers urged. They want to see the states given powers to react to the infection situation in autumn and winter. They called on the government to initiate the legislative process in a timely manner, and get the states actively involved.

The current Infection Protection Act expires on September 23rd this year. Germany has loosened much of its Covid restrictions in the last months, however, face masks are still compulsory on public transport as well as on planes. 

READ ALSO: Do people in Germany still have to wear Covid masks on planes?

The health ministers said that from autumn onwards, it should be possible for states to make masks compulsory indoors if the regional infection situation calls for it. Previously, wearing a Covid mask was obligatory in Germany when shopping and in restaurants and bars when not sitting at a table. 

Furthermore, the so-called 3G rule for accessing some venues and facilities – where people have to present proof of vaccination, recovery, or a negative test – should be implemented again if needed, as well as other infection protection rules, the ministers said. 

Bavaria’s health minister Klaus Holetschek, of the CSU, welcomed the ministers’ unanimous call for a revision of the Infection Protection Act. “The states must be able to take all necessary infection protection measures quickly, effectively, and with legal certainty,” he said.

North Rhine-Westphalia’s health minister Karl-Josef Laumann (CDU) warned that no one should “lull themselves into a false sense of security”.

“We must now prepare for the colder season and use the time to be able to answer important questions about the immunity of the population or the mechanisms of infection chains,” he said.

On Tuesday, Germany reported 86,253 Covid infections within the latest 24 hour period, as well as 215 Covid-related deaths. The 7-day incidence stood at 437.6 infections per 100,000 people. However, experts believe there could be twice as many infections because lots of cases go unreported. 

READ ALSO: Five things to know about the Covid pandemic in Germany right now

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