Credit ACIP/CDC
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Over the past few days more than a dozen European countries have temporarily suspended the distribution of the AstraZeneca vaccine (see CIDRAP report Amid probes, more nations suspend AstraZeneca COVID vaccine) following a small number of reports of thromboembolic events in recipients.
Although the evidence of causality is weak at best, the European Medicines Agency (EMA) is conducting an investigation, and yesterday announced they will report on its initial findings tomorrow.
Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continues
News 16/03/2021
EMA’s safety committee (PRAC) made further progress today, Tuesday 16 March, in its detailed evaluation of cases of blood clots, some with unusual features such as low numbers of platelets, in recipients of COVID-19 Vaccine AstraZeneca. As previously stated, while its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.
The evaluation is looking at the available data related to all thromboembolic events reported after vaccination. National agencies are providing additional support to gather missing and incomplete information as quickly as possible, particularly where it relates to these unusual cases. Rapid and thorough analysis of the available data and clinical circumstances surrounding specific cases is continuing, to determine whether the vaccine might have contributed or if events are likely to have been due to other causes.
PRAC will conclude on the information available at its meeting on Thursday 18 March, and issue any necessary recommendations for further action.
Today, the World Health Organization has weighed in, releasing the following statement earlier this morning.
WHO statement on AstraZeneca COVID-19 vaccine safety signals
17 March 2021
Statement
Reading time: Less than a minute (216 words)
Some countries in the European Union have temporarily suspended use of the AstraZeneca COVID-19 vaccine as a precautionary measure based on reports of rare blood coagulation disorders in persons who had received the vaccine. Other countries in the EU – having considered the same information - have decided to continue using the vaccine in their immunization programmes.
Vaccination against COVID-19 will not reduce illness or deaths from other causes. Thromboembolic events are known to occur frequently. Venous thromboembolism is the third most common cardiovascular disease globally.
In extensive vaccination campaigns, it is routine for countries to signal potential adverse events following immunization. This does not necessarily mean that the events are linked to vaccination itself, but it is good practice to investigate them. It also shows that the surveillance system works and that effective controls are in place.
WHO is in regular contact with the European Medicines Agency and regulators around the world for the latest information on COVID-19 vaccine safety. The WHO Global Advisory Committee on Vaccine Safety is carefully assessing the latest available safety data for the AstraZeneca vaccine. Once that review is completed, WHO will immediately communicate the findings to the public.
At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue.
All medicines, including vaccines, carry some risks. Even over-the-counter remedies, like NSAIDs or acetaminophen, can sometimes produce adverse - even fatal - reactions (see BMJ Research: NSAIDs & The Risk Of Heart Failure)..
While it is important to investigate and determine whether the AstraZeneca vaccine - or any other vaccine or medicine - is causing an uptick in serious side effects, those findings will have to be weighed against the risks of not taking it.
We make those same risk-reward calculations every day with antibiotics, pain medications, chemotherapy, vaccines, and everything else we ingest (food, alcohol, tobacco, etc.).
Everything in life is a trade off. The important thing is to have a decent idea of the risks. Hopefully this investigation will produce data that will help assuage those concerns.
