EMA Statement On AstraZeneca Vaccine

Credit ACIP/CDC   

#15,875

As we discussed yesterday, no vaccine or medicine is 100% safe for 100% of the people who take it, but vaccines have excellent safety profiles, and severe side effects are very rare.  

But because vaccines are preventative - and not a cure - people seem to have less tolerance for risk with vaccines. As with any pharmaceutical, one must balance the risks and the rewards of taking it. 

Over the past week a furor has erupted in Europe over a very small number of thromboembolic events reported among recipients of the AstraZeneca COVID vaccine (see CIDRAP report Amid probes, more nations suspend AstraZeneca COVID vaccine).

Yesterday the World Health Organization weighed in with their Statement on AstraZeneca COVID-19 Vaccine Safety Signals and today - as promised - the European Medicines Agency has issued their initial report.

While the evidence of a link between the vaccine and these blood clots is very weak, the EMA allows that `. . .   the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia', but goes on to say:

The Committee was of the opinion that the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19 outweighs the extremely small likelihood of developing DIC or CVST. However, in the light of its findings, patients should be aware of the remote possibility of such syndromes, and if symptoms suggestive of clotting problems occur patients should seek immediate medical attention and inform healthcare professionals of their recent vaccination. Steps are already being taken to update the product information for the vaccine to include more information on these risks.

It can take months, or even years, to establish a causal link when suspected cases are so rare. Sometimes, that question can never be satisfactorily answered.  

What we do know is, COVID kills between 1 and 2 out of every 100 people, making the risks of not taking the vaccine far greater than the risks of taking it. 

I've posted some excerpts from the EMA statement. Follow the link to read it in its entirety. 

COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets

News 18/03/2021

EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021. The Committee confirmed that:

• the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
• the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
• there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
• however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).

These are rare cases – around 20 million people in the UK and EEA had received the vaccine as of March 16 and EMA had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST. A causal link with the vaccine is not proven, but is possible and deserves further analysis.

The PRAC involved experts in blood disorders in its review, and worked closely with other health authorities including the UK’s MHRA which has experience with administration of this vaccine to around 11 million people. Overall the number of thromboembolic events reported after vaccination, both in studies before licensing and in reports after rollout of vaccination campaigns (469 reports, 191 of them from the EEA), was lower than that expected in the general population. This allows the PRAC to confirm that there is no increase in overall risk of blood clots. However, in younger patients there remain some concerns, related in particular to these rare cases.

The Committee’s experts looked in extreme detail at records of DIC and CVST reported from Member States, 9 of which resulted in death. Most of these occurred in people under 55 and the majority were women. Because these events are rare, and COVID-19 itself often causes blood clotting disorders in patients, it is difficult to estimate a background rate for these events in people who have not had the vaccine. However, based on pre-COVID figures it was calculated that less than 1 reported case of DIC might have been expected by 16 March among people under 50 within 14 days of receiving the vaccine, whereas 5 cases had been reported. Similarly, on average 1.35 cases of CVST might have been expected among this age group whereas by the same cut-off date there had been 12. A similar imbalance was not visible in the older population given the vaccine.

The Committee was of the opinion that the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19 outweighs the extremely small likelihood of developing DIC or CVST. However, in the light of its findings, patients should be aware of the remote possibility of such syndromes, and if symptoms suggestive of clotting problems occur patients should seek immediate medical attention and inform healthcare professionals of their recent vaccination. Steps are already being taken to update the product information for the vaccine to include more information on these risks.

The PRAC will undertake additional review of these risks, including looking at the risks with other types of COVID-19 vaccines (although no signal has been identified from monitoring so far). Close safety monitoring of reports of blood clotting disorders will continue, and further studies are being instituted to provide more laboratory data as well as real-world evidence. EMA will communicate further as appropriate.

Information for patients

COVID-19 Vaccine AstraZeneca is not associated with an increased overall risk of blood clotting disorders.

There have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination. The reported cases were almost all in women under 55.

Because COVID-19 can be so serious and is so widespread, the benefits of the vaccine in preventing it outweigh the risks of side effects.

However, if you get any of the following after receiving the COVID-19 Vaccine AstraZeneca:

• breathlessness,
• pain in the chest or stomach,
• swelling or coldness in an arm or leg,
• severe or worsening headache or blurred vision after vaccination,
• persistent bleeding,
• multiple small bruises, reddish or purplish spots, or blood blisters under the skin,

please seek prompt medical assistance and mention your recent vaccination.

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