AstraZeneca is a safe vaccine

Fact checking

Dunja Djuranovic, UNICEF Young Reporter
Fact checking blog AstraZeneca is a safe vaccine visual
UNICEF Montenegro
14 April 2021

At the time of vaccination against COVID-19, various pieces of unverified information about the safety of vaccines and their impact on the health of vaccinated people have been published in the media and on social networks. Following the announcement that vaccines from the European Union would arrive in Montenegro in late March, there were many comments on social networks stating that the "AstraZeneca vaccine is not safe because it causes thrombosis and death in vaccinated people". Such comments were supported by earlier decisions by some European countries to suspend vaccination using this vaccine until additional testing was carried out.

 The World Health Organization then explained that the cases of thrombosis were not necessarily related to the vaccine, and that it was the third most common cardiovascular disease. Therefore, they supported the continuation of immunization, albeit noting that it definitely had to be examined whether those diseases were related to the vaccine itself.

AstraZeneca reported that over 17 million people had received the vaccine in the EU and the United Kingdom, among whom there were slightly under 40 cases of thrombosis.

"We keep the effects of these vaccines under review all the time and we know that the Oxford-AstraZeneca vaccine is saving lives in the UK right now so if you get the call, get the jab,” UK Health Minister Matt Hancock said, the BBC reports.

The US trial of the Oxford-AstraZeneca vaccine confirms that the vaccine is safe and very effective. The BBC writes that more than 32,000 volunteers took part in the trial, mostly from the US, but also from Chile and Peru.

"The vaccine was 79% effective at stopping symptomatic Covid disease and 100% effective at preventing people from falling seriously ill. And there were no safety issues regarding blood clots.

Both the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency voiced their opinion, claiming that the benefits of the AstraZeneca vaccine still far outweigh the risks.

"After rigorous scientific scrutiny, regulatory agencies have concluded that there is no evidence that blood clots in the veins are occurring more than would be expected in the absence of vaccination. Trials are still ongoing, and no cause-and-effect relationship with the vaccine has been established so far. Thromboembolic events are known to occur frequently. Venous thromboembolism is the third most common cardiovascular disease on a global level," explained Marija Bozovic, an epidemiologist from the Public Health Institute of Montenegro (PHI), for the Montenegrin media.

She added that in the extensive vaccination campaigns, countries had indicated potential adverse events after immunization on a routine basis. "That does not necessarily mean that the events are related to the vaccination itself, yet it is good practice to investigate them," said Bozovic.

UNICEF's young reporters also asked Senad Begic, an epidemiologist at the PHI, about these cases. He explained that a combination of thrombosis (clot formation) and thrombocytopenia (a decrease in the number of thrombocytes – platelets, the elements responsible for stopping bleeding after damage to a blood vessel), followed by bleeding in some cases, was observed and registered, extremely rarely, after vaccination with the AstraZeneca vaccine against COVID-19.

"The cases included some registered severe cases of venous thrombosis in 'unusual places', such as: the central nervous system – cerebral venous sinus thrombosis, the abdomen, as well as arterial thrombosis followed by thrombocytopenia. Most of those cases occurred in the first seven to 14 days after vaccination, mostly in women under the age of 55," Begic said.

He explained that, based on those events, the standing EMA authority for drug safety had carried out a full investigation and stated that a thorough analysis had established the following:

  • The benefits and advantages of using the AstraZeneca vaccine against COVID-19 far outweigh the potential risks and possible association with very rare cases of low-platelet blood clots.
  • The combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed extremely rarely after vaccination with the AstraZeneca vaccine against COVID-19. Nevertheless, healthcare professionals are advised to be vigilant and to monitor and look for signs and symptoms of thromboembolism and/or thrombocytopenia.
  • Vaccinated people in the EU are advised to seek medical assistance if they develop symptoms such as: shortness of breath, chest pain, swelling of the legs, and permanent abdominal pain after vaccination. In addition, all people with persistent headaches and blurred vision after vaccination, or people who develop bruises on the skin a few days after, not at the injection site, need to request a medical examination.
  • Over 11 million doses of the vaccine itself have been given in the United Kingdom, which is a number of vaccinated people that exceeds any study.

The UK’s supervisory and regulatory body concluded that there was no evidence to suggest that blood clots in the veins occurred with a higher frequency than would be expected in the absence of vaccination in the general population. Thus, when comparing the frequency of those events in the populations vaccinated with the AstraZeneca vaccine and unvaccinated ones, no differences were found.

In an effort to contribute to preventing the dissemination of coronavirus misinformation and to promoting credible sources of information, UNICEF’s young reporters have decided to check the accuracy of information published on social media and in the media that has attracted public attention. In verifying the accuracy of information, they have followed the example of the Public Disclosure Platform “Raskrinkavanje“ and partly used its publicly available methodology.