Fewer than one percent of coronavirus vaccine doses result in side-effects

A vial of the Moderna vaccine.
A vial of the Moderna vaccine. Source: Mufid Majnun / Pixabay

Cases of adverse side effects and other negative outcomes have been registered in 0.37 percent of coronavirus vaccine doses, the State Agency of Medicines (Raviamet) says.

The agency says of 1,375,659 doses administered in Estonia since supplies started arriving at the end of last year, 5,140 have led to its being notified of side effects.

A link between the vaccines and four deaths, which all came with elderly individuals with an average age of over 85, cannot be ruled out, the agency adds.

The agency publishes a summary of the adverse reaction notifications on its website, with the bulk of these being non-serious cases, BNS reports.

Over 70 percent of notifications have been made by patients, the remainder by doctors.

Mitigating factors include the large numbers of people who have been vaccinated against the virus in a comparatively short space of time.

Over 300 notifications, made mainly by doctors, concerned vaccinated patients going on to contract symptomatic coronavirus, while nearly 200 related to delayed reactions, which may in fact be unrelated to the vaccine itself.

Thirty-nine cases of blood clots have been reported, with three of these relating to venous thromboembolism, associated with the Janssen vaccine.

Twenty-four fatalities were referred to the agency in relation to the vaccination,

As noted, in four cases, the agency says a link between vaccine and fatality cannot be categorically ruled-out.

Otherwise, he benefits of all four COVID-19 vaccine products which have been available in Estonia since the end of 2020 outweigh the potential harms, the agency says, with even serious adverse reaction being preventable, rapidly diagnosable and treatable if precautions are taken and doctor is promptly consulted.

The agency says its adverse reactions database should not be used as a gauge of the safety of any vaccine or medicine, as it is only a notifications list and not the final word.

The information collected in Estonia is transmitted to the Adverse Reactions Database of the European Medicines Agency (EMA), while the safety of vaccines is assessed by the EMA's Risk Assessment Committee and the Committee for Medicinal Products for Human Use.

Experts from the State Agency of Medicines sit on this latter body.

Estonia has made use of four international suppliers' vaccine products, procured at EU-level, so far: Pfizer/BioNTech, Moderna, Janssen and AstraZeneca, while the latter's product is no longer in use in Estonia.

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Editor: Andrew Whyte

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