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The Ministry of Health (SAM) has already faced the dilemma of introducing a lower age limit for vaccination with AstraZeneca.
The European Medicines Agency (EMA) has reported that the benefits of this vaccine are greater for the elderly, and each country must decide whether to vaccinate people between 18 and 39 years based on the epidemiological situation.
IWT has provided this information to SAM and is awaiting its decision. It is true that after a while Aistė Šuksta, Advisor to the Minister of Health Arūnas Dulkis, will be at the portal. lrytas.lt stated that SAM is not considering changes to the vaccination recommendations from the manufacturer of the AstraZeneca vaccine.
One person has recovered and another is still under treatment at the hospital.
Rugilė Pilvinienė, senior advisor to IWT’s Pharmacovigilance and Poisoning Information Division, reported on Monday that two cases of thrombocytopenia along with sagittal sinus (very large cerebral vein) thrombosis had been recorded in Lithuania.
In both cases, the reaction occurred in young people aged 27 and 30.
According to the specialist, it is already known that in one case a person recovered without serious consequences, another person continues to be treated in the hospital.
“These are those rare serious side effects,” added the IWT specialist, confirming that both reactions occurred after the AstraZeneca vaccine.
R. Pilvinienė also said that a report had been received on the case of mesenteric thrombosis. However, the information provided is “deficient”, so it is difficult to say if it is a vaccine case.
G.Andrulionis: serious cases of thrombocytopenia registered in Lithuania may create a precondition for reconsideration of vaccination strategy
For his part, Gytis Andrulionis, director of IWT, noted that the overall assessment of EVA remains the same: the benefits of the vaccine outweigh its risks.
He said that although the EVA had enacted a regulatory change to the AstraZeneca vaccine in early April, which identified thrombocytopenia and thrombosis as one of the possible adverse reactions in the product information and summary of product characteristics, the reports to the respect they were worrisome.
For this reason, the European Commission has asked the EEA to carry out a more comprehensive assessment by issuing a scientific opinion on the benefit-risk balance of Vaxzevria.
“It just came to our knowledge then. We appreciate them too. Both SAM and all the experts were informed. A hearing took place. As far as I know, today and in the near future, that assessment will also take place at a higher level.” explained the IWT director.
G. Anddrulionis stated that “there are no prohibitions to use the vaccine for certain age categories or in terms of gender”, but the serious cases of thrombocytopenia registered in Lithuania can create a pre-condition to review the vaccination strategy.
“The overall assessment, as in the past, remains that the overall benefits of the vaccine outweigh all risks, but it was suggested that use of the vaccine in younger categories should be evaluated at moderate to high exposures.
We believe that the CHMP assessment, the updated Summary of Product Characteristics and the serious cases of thrombocytopenia registered in Lithuania may lead to a review of the vaccination strategy.
We have discussed this in a working group created by the Ministry. The decisions of the ministry itself must be awaited. For our part, there are no contraindications or prohibitions to use the vaccine for certain age or gender categories.
However, given the epidemiological situation and the availability of other vaccines, there is certainly the possibility that countries will reconsider the use of this particular vaccine for individual age groups, ”he noted.
SAM recommendations are not being considered for changes
A.Dulkis advisor to the portal A.Šuksta lrytas.lt He later stated that SAM is not considering changing the vaccination recommendations of the AstraZeneca vaccine manufacturer. It’s true, he added, that vaccine-related information is constantly monitored and everyone can choose the vaccine for themselves.
“With regard to vaccines, a very liberal vaccination process is currently applied in Lithuania, when a person can choose any of the four vaccines currently available in Lithuania. Therefore, everyone has the opportunity to choose the vaccine that they think is most suitable. for them, ”he said.
Recalling that the youngest still cannot choose the vaccine and only the AstraZeneca vaccine is offered through various promotions, the minister’s counselor assured that the youngest would have more freedom to choose at the beginning of the summer.
“Currently, vaccination in stages has already started in Lithuania. Every week a different age group opens. In the first week of June, we will already have the so-called mass vaccination, when anyone will be able to choose any vaccine,” assured A. Šuksta.
