More European countries suspend vaccine rollout, perplexing experts
Click Here to Manage Email Alerts
Several more European countries have halted the rollout of AstraZeneca’s COVID-19 vaccine following reports of blood clots in people who have received it.
However, regulators and the manufacturer said there is no evidence that the vaccine causes these types of adverse events.
To date, Denmark, Germany, France, Ireland, Norway, Italy, Spain and Sweden have stopped vaccinations over safety concerns, according to reporting from multiple news outlets.
Countries began suspending use of the vaccine after two patients, one in Austria and one in Denmark, died after being administered the vaccine. Another patient in Austria experienced a pulmonary embolism after being given the vaccine and is currently recovering.
“I do not think the decision being made by these European countries is justified,” Amesh A. Adalja, MD, senior scholar at Johns Hopkins Center for Health Security and an Infectious Disease News Editorial Board Member, told Healio. “Just because something occurs after a vaccine does not mean that it is caused by the vaccine.”
According to the European Medicines Agency (EMA), there is currently “no indication” that the vaccine causes blood clots.
“The number of thromboembolic events in vaccinated people is no higher than the number seen in the general population,” the EMA wrote in the statement.
AstraZeneca said it evaluated safety data from more than 17 million people who were inoculated in the European Union and the United Kingdom with its vaccine and found “no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country.”
Adalja noted that the decision to halt vaccinations in Europe will have serious downstream consequences.
“This is particularly problematic because Europe is facing increases in cases and entering shut down in some countries with a very flawed vaccine rollout program,” Adalja said. “I also worry that they will undermine confidence in what is a very good vaccine when it comes time to reinitiate the programs.”
Based on a survey of 19 countries, researchers reported in Nature Medicine that “current levels of willingness to accept a COVID-19 vaccine are insufficient to meet the requirements for community immunity.”
References:
AstraZeneca. Update on the safety of COVID-19 Vaccine AstraZeneca. https://www.astrazeneca.com/media-centre/press-releases/2021/update-on-the-safety-of-covid-19-vaccine-astrazeneca.html. Accessed March 16, 2021.
EMA. COVID-19 vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine’s benefits currently still outweigh risks – Update. https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits. Accessed March 16, 2021.
Jordans F. Associated Press. Major European nations suspend use of AstraZeneca vaccine. https://apnews.com/article/germany-suspends-astrazeneca-vaccine-blood-clotting-0ab2c4fe13370c96c873e896387eb92f. Accessed March 16, 2021.
Lazarus JV, et al. Nat Med. 2020;doi: 10.1038/s41591-020-1124-9.
Perspective
Back to Top
The administration of the University of Oxford/AstraZeneca vaccine was suspended in some countries in Europe over a concern of an adverse effect of clotting. Of 17 million doses administered, there are reports of 15 deep venous thromboses and 22 pulmonary emboli, which is a very low number of clotting events compared with those recorded in the general population without vaccination. In fact, the AstraZeneca vaccine rollout in the United Kingdom is going extremely well, with a recent report showing that the vaccine is associated with a 94% reduction in COVID-19 hospitalizations after just one dose. WHO and the EMA state that the data do not suggest the vaccine caused the clots and that the benefits of vaccination right now in the midst of a pandemic are vast. This suspension of AstraZeneca vaccine administration in Italy, France, Germany, and Spain has occurred despite increasing cases and imposition or consideration of new lockdowns. The data are not at all convincing that the vaccine is causing a clotting disorder, and most experts completely disagree with this decision by these European countries. Given the profound efficacy of the vaccines, and the fact that there is no causation implied by the data, I hope European countries will reinstate the rollout of the AstraZeneca vaccine in order to achieve the benefits of mass vaccination. Vaccine rollout in the midst of a pandemic must be brisk to achieve the goal of reducing hospitalizations and cases via population-level immunity.
References:
Horowitz J. The New York Times. Italy imposes lockdown measures as cases spike across Europe. https://www.nytimes.com/2021/03/15/world/italy-covid-lockdown.html. Accessed March 17, 2021.
Rosa-Aquino P. Intelligencer. Did Europe Go Too Far in Pausing the AstraZeneca Vaccine? https://nymag.com/intelligencer/2021/03/did-europe-go-too-far-in-pausing-the-astrazeneca-vaccine.html. Accessed March 17, 2021.
Vasileiou E, et al. Lancet. 2021;doi:10.2139/ssrn.3789264.
White RH. Circulation. 2003;doi:10.1161/01.CIR.0000078468.11849.66.
Collapse
Healio Interview
Read more about
Click Here to Manage Email Alerts