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Expert committee on immunoprophylaxis recommends reserving AstraZeneca COVID-19 vaccine primarily for people over 60 years of age in coming weeks

COVID-19 vaktsineerimine

Yesterday, on 18 March, the national expert committee on immunoprophylaxis formulated new recommendations for the use of the AstraZeneca COVID-19 vaccine in Estonia. The expert committee recommends reserving the AstraZeneca COVID-19 vaccine primarily for the immunisation of people aged 60 and over in the coming weeks.

‘At a meeting held last night, the committee considered at length both the preliminary results of the investigation conducted by the European Medicines Agency and the COVID-19 situation in Estonia. Our experts based the recommendation both on the data published by the European Medicines Agency and on the fact that the current priority in Estonia is to protect people over the age of 60, who are at increased risk of developing severe illness from COVID-19 and needing hospital care,’ stated Maris Jesse, the head of the national expert committee on immunoprophylaxis. ‘Since last night, discussions have been taking place in all European countries, many of which will be taking an official position regarding the matter in the next few days. We are, of course, also monitoring the discussions and decisions in other countries.’

The full recommendations of the national expert committee on immunoprophylaxis are published below.

Resolutions of the expert committee on immunoprophylaxis on 18 March 2021 regarding the use of the AstraZeneca vaccine

Background

In March, a co-occurrence of low platelet counts (thrombocytopenia) and severe thrombosis in some younger people 7–14 days after administration of the AstraZeneca vaccine was reported in several countries. At a hearing held on 11 March, the European Medicines Agency (EMA) did not change its risk assessment regarding the AstraZeneca vaccine and launched a further investigation of the highly rare and unusual cases of combined thrombocytopenia and thrombosis. Based on the EMA’s assessment and available data, on 11 March, Estonia’s expert committee on immunoprophylaxis recommended, as a precautionary measure, to avoid the use of the AstraZeneca vaccine in people at high risk of thrombosis until the publication of the EMA’s investigation results. On 12 March, instructions for assessing the risk of thrombosis were issued to vaccination providers.

On 18 March, the EMA’s Pharmacovigilance Risk Assessment Committee held a discussion of the available data and the results of the investigation. The Committee reached the following conclusions:

  • The benefits of the vaccine continue to outweigh the risks.
  • The use of the AstraZeneca vaccine is not associated with an increased risk of thromboembolism. The number of thromboembolic events reported is significantly lower than expected in the general population of the same age as the vaccinated persons.
  • Adverse reactions to the AstraZeneca vaccine cannot be linked to quality or manufacturing problems.
  • The AstraZeneca vaccine may be associated with a very rare and unusual form of thrombosis, which can be accompanied by low levels of blood platelets and which has been reported in people under 60 years of age. The EMA is aware of seven cases of widespread intravascular thrombosis and 18 cases of cerebral venous thrombosis. Whether there was a causal link with the vaccine in these cases is uncertain, but was deemed possible and will therefore be further investigated. No such cases of thrombosis have been reported in people over 60 years of age.
  • These cases of thrombosis are, however, highly rare, considering the total number of people who have been given the AstraZeneca vaccine. As of 16 March, more than 20 million people have been administered the AstraZeneca vaccine in the United Kingdom and the European Economic Area. 
  • As the events of thrombocytopenia and thrombosis reported to the EMA were extremely rare, the EMA chose not to impose any restrictions on the use of the vaccine in people belonging to younger age groups.

The EMA will continue to investigate the thrombotic events and aims to establish whether the people who suffered from the low platelet counts and thrombosis presented with any additional risk factors for thrombosis, as well as how these rare thrombotic events could be prevented.

Having regard to:

- the available data on the AstraZeneca vaccine, including the conclusions of the EMA’s Pharmacovigilance Risk Assessment Committee and the fact that the EMA continues to consider the benefit–risk balance of the vaccine to be positive; 

- the fact that, pursuant to the objectives of Estonia’s COVID-19 vaccination plan, vaccination priority should be given to the elderly and to risk groups, a significant proportion of whom have yet to be given the opportunity to get vaccinated due to limited vaccine supply; 

- the fact that hospital care for illness from COVID-19 is primarily needed by people over the age of 60;

- the fact that, based on available data, the AstraZeneca vaccine is effective in older people and protects well against severe illness;

- the epidemiological situation in Estonia;

- the fact that the EMA will continue to investigate the mechanism behind the reported unusual thrombotic events in younger people (under 60 years of age) and to evaluate the potential link with the vaccine;

- the fact that COVID-19 significantly increases the risk of thrombosis in people;

the expert committee on immunoprophylaxis is hereby issuing the following recommendations:  

1. The AstraZeneca COVID-19 vaccine should be reserved primarily for the immunisation of people aged 60 and over in the coming weeks. 

2. As the risk of thromboembolism in vaccinated persons was not confirmed by the EMA, the previously issued recommendation to avoid administering the vaccine to people with risk factors for thrombosis as a precautionary measure may be disregarded. Therefore, the AstraZeneca vaccine may be used to vaccinate people aged 60 and over presenting with risk factors for venous thrombosis.

3. The European Medicines Agency has not restricted the use of the medicine in any age group, as the cases of thrombocytopenia and thrombosis have been highly rare. Therefore, people immunised with the AstraZeneca COVID-19 vaccine do not need to worry about their health. 

The committee recommends that persons vaccinated with the AstraZeneca coronavirus vaccine thereafter monitor their health over 14 days and, upon developing any of the following symptoms, seek medical attention immediately:

- shortness of breath,

- chest pain or abdominal pain,

- swelling or coldness in a limb,

- severe or worsening headache or blurred vision,

- persistent bleeding,

- small bruises, reddish or purplish spots, or blood blisters on the skin.

4. These recommendations should be reviewed upon receipt of additional information from the EMA on the causes of and mechanism behind the reported thrombotic events in patients under 60 years of age.

The objectives of COVID-19 vaccination are to protect at-risk groups of the population, who have a higher risk of becoming infected or developing severe illness from COVID-19; to prevent and reduce COVID-19-related illnesses and deaths; to reduce the burden on the health care system and the economy; and to ensure the normal functioning of society.

The national expert committee on immunoprophylaxis is a committee advising the Ministry of Social Affairs on the national immunisation plan and other vaccination-related matters. The committee is composed of representatives of immunologists, allergists, infectious disease specialists, family physicians, paediatricians, nurses, the Health Board, the Health Insurance Fund, and the Ministry of Social Affairs.

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