Vaccines that have been authorised for use:
There are several COVID-19 vaccines at developing process. Updates about authorisations and assessments are available on the website of the European Medical Agency.
The safety of the vaccines
Like any other medications, COVID-19 vaccines are developed by strict criteria. No concessions were made in the quality, efficacy and safety of the COVID-19 vaccines when they applied for expedited marketing authorizations. Like all other medicines, COVID-19 vaccines are tested at first in lab conditions and test-animals, and then followed by volunteers in clinical researches. All vaccines are assessed by the standards of the EU, that apply to all medications. Because the need for the COVID-19 vaccine was urgent, the development and assessment were made in a fastened paced compared to the traditional time-frame.
The European Medicines Agency (EMA) protects and promotes human and animal health by evaluating and monitoring medicines within the European Union. They also advise issuing the marketing authorization. Currently, the Agency evaluates corona vaccines within a fastened procedure. Pandemic hasn’t changed the conditions or criteria (safety, quality, effectiveness) to get the selling licence.
All scientists and professionals who are included in the evaluation, need to guarantee, that vaccines are up to the current quality, safety, and effectiveness requirements.
To fasten the vaccine production, entrepreneurs use multiple approaches:
- To employ more people to analyse the results of the researches and map out the next steps.
- Combining the different stages of clinical researches, and if possible, and safety is guaranteed, do these researches simultaneously.
Evaluating and monitoring medicines will continue even after issuing the marketing authorization, as well as continue the analyses after the vaccine is in use.
Side effects of COVID-19 vaccines
Although people respond differently to vaccines, most of them don’t experience any remarkable side effects after getting vaccinated against COVID-19. Foremost, even when side effects appear, they tend to pass within a few days.
If you have any questions about the vaccination, and you don’t find the answers from our website, please ask your family physician or phone family doctor’s helpline 1220.
The data about the side effects is collected by the Estonian State Agency of Medicines. Reports are published weekly on their website www.ravimiamet.ee
What are the most common side effects of the COVID-19 vaccines?
Most people don’t experience any side effects after the COVID-19 vaccination. People who’ve had side effects, have reported mostly about soreness of the injection area, flu-like symptoms (dizziness, headache, small fever, nausea) and tiredness. Generally, all these symptoms have passed within a few days. In case they do last longer, or your condition gets worse, contact your family doctor.
All known side effects are described on a vaccination information letter.
What to do, if you suspect that your health conditions are related to the vaccination?
All the complications after the vaccinations should be reported to your family doctor. To improve the safety profile, medical health care workers must report all systematic and serious side effects, if they think it’s likely that there’s a link with the vaccination. If the doctor sends the report, a patient doesn’t need to do that.
A patient may report the side effects to the State Agency of Medicines ( teata kõrvaltoimest) even if the doctor doesn’t think the serious side effects are related to the vaccination. This feature is currently available only in Estonian.
What happens with the reports sent to the State Agency of Medicines?
The State Agency of Medicines collects all the data and makes an initial assessment, if these symptoms might be related to that particular medicine or these health problems might be caused by some other reasons. If the cases include severe reactions, the contact details of the doctor is also asked to have the medical confirmation to the situation.
The database of the side effects can’t be used to assess the safety of any medicine or vaccine, because that database includes all reports that are sent about medicines and vaccines, and after including them in the database, the assessment of the data begins.
Data gathered in Estonia will be forwarded to the European Medical Agency. The safety of the vaccine is assessed in their risk-assessment committee and human medicines’ committee, where Estonian experts are included as well. To assess the safety, a lot of data is processed, and all safety data is reviewed monthly.
How do they get the information about new side effects of the vaccines?
Currently, a lot of people are vaccinated against coronavirus in a very short period of time. So it’s very likely, that some illnesses appear at the same time with the vaccination, but they are not actually caused by the vaccination.
To assess the safety, it’s important to include the frequency of certain illnesses in the population. If data management shows that some diseases are more frequent in people who are vaccinated, or in a certain age group of the vaccinated, it’s a very clear alarm. If this alarm is confirmed, it’ll be assessed separately, and if a clear cause is found, it’ll be added as a side effect.
This has been the process of the mRNA vaccines (Pfizer/Corminatry and Moderna/Spikevax), and myocarditis was added as a side effect of these vaccines. Adenovirus vector vaccines (Janssen, AstraZeneca/Vaxzevria) side effects include thrombosis with thrombocytopenia. All currently known side-effects of the vaccines are included in the vaccine information letter. Information about the risks are collected and exchanged all over the world: according to that, each vaccine has its own risk groups (people whose health conditions make them suitable for some other vaccine).
How many side-effects of COVID-19 vaccines have been reported in Estonia?
From the 27th of December 2020 until the morning of the 25th of April 2022, 1 980 917 doses of COVID-19 vaccine have been injected. Within this time frame, the State Agency of medicines has received, 7018 reports of possible side effects of COVID-19 vaccines, so it’s 0.35% of the whole vaccinations. There have been 363 reports about at least one adverse side effect, and 43 mortal cases, from which 5 of them the relationship between the vaccination and the death has been confirmed.
A detailed weekly report (in Estonian) is available here:
Safety assessment so far proves that the benefits of the vaccination outweighs the possible risks of a vaccination. Adverse reactions are very rare and they are often preventable, quickly diagnosed and well treatable if patients inform their doctor about their health issues on time.
The risks and warnings, what to look for, can be found from the information letter of the vaccine. If you have more questions, ask from your family doctor or the state helpline 1220
Vaccine damage payment
The Estonian Government has created an insurance system to cover possible vaccine damages. This system is prepared in order to offer the sense of security for people making the decision to get vaccinated, and support those who’ve had severe health complications after the vaccination.
The vaccine damage payment included in the vaccine insurance law will come into force on the 1st of May 2022.
According to the scheme, the one-off payment covers situations, where after the vaccination has caused serious health complications that have lasted at least for four months, or vaccination has caused a miscarriage, organ failure, or the complications are related to the lost or partial working capability, or the death. The base rates of the compensation are fixed, and both — material and non-material damage depending on the severity of the damage will be compensated. The maximum amount per case would be 100 000 euros.
With the current state of plans, all the cases will be handled by the Estonian Health Insurance Fund.
At the first stage, COVID-19 vaccines will be included since the beginning of the vaccination in Estonia, all other vaccines are included from 2023.
During the first stage, all COVID-19 vaccination cases will be covered that happened during 2021, or 2022. From 2023, other vaccines are included.
- If there are complications after the vaccination, you should seek a medical help. Depending on the reaction, contact your family physician, or turn to the AE.
- The doctor will document your general state of health, all symptoms, and prescribe treatment based on the results of medical test.
- If the complications are severe, and last longer than for four months, or a person dies, an application for the vaccination insurance can be filled via the Estonian Health Insurance Fund.
- The application will be sent within the 30 days to the State Agency of Medicines, to get an assessment, whether the health complications were related to the vaccination.
- The State Agency of Medicines have 90 days to assess if these complications or the death of a patient was related to the previous vaccination.
- Based on the assessment, and the possible damage caused by the vaccine, the Health Insurance Fund will decide within 30 days the amount of the Vaccination Damage Payment.
- If the decision includes the Payment, the bank transfer will be done within 30 days by the Health Insurance Fund.
- In case of a disagreement, a person who applied, have a right to object to the decision. The solution will be decided within 90 days.
More information available in Estonian here.