In two months, 1.2 thousand. adverse reactions to vaccines, two vaccinated deaths are not associated with the vaccine

Gytis Andrulionis, head of IWT, and Rugilė Pilvinienė, senior advisor to IWT’s Pharmacovigilance and Poison Information Division, spoke at the press conference Thursday morning about suspected adverse reactions.

As G. Andrulionis said, the data is collected from two months of vaccination, starting in 2020. December 27 to 2021 February 28, when people in the country are vaccinated against COVID-19.

They resulted in 1201 reports of suspected adverse reactions to vaccines. Since the start of vaccination, 729 notifications have been received for Pfizer-BioNTech, 61 for Moderna and 401 for AstraZeneca. The 10 rapporteurs did not indicate what the vaccine was.

The number of reports of suspected adverse reactions received represents 0.5% of the doses of vaccine used.

Two deaths have also been reported in people vaccinated against the coronavirus, but these deaths are not related to the vaccine. According to G. Andrulionis, people died from age-related health disorders.

868 messages are classified as mild to moderate and 22 as severe. Women reported more suspected adverse reactions than men aged 817 and 73, respectively. The age range for notifiers is 19 to 87 years old.

The number of reports received from health professionals is 86, from patients – 799; Five notifications were received from the Eudravigilance database.

In February, it received 890 notifications of adverse reactions.

During February, the second month of the coronavirus vaccination, the IUD received 890 initial reports of suspected adverse reactions to COVID-19 vaccines in Lithuania.

In February, there were 432 reports of suspected adverse reactions after vaccination with Comirnaty, 48 with the COVID-19 Vaccine Moderna vaccine, and 401 with the COVID-19 AstraZeneca vaccine.

Nine reports of suspected adverse reactions did not include the name of the vaccine.

The second vaccinated dead was 86 years old

As mentioned, sudden deaths of two elderly patients were also reported during the second month of vaccination. Both cases were assessed as unrelated to the vaccine.

The first death was announced by IWT on February 26. A newly vaccinated 77-year-old man with severe comorbidities was reported to have died on February 25 in Pasvalys district. You can read more about it here.

A report of the second death of a person who had been vaccinated with COVID-19 was received on Monday, but the person passed away over the weekend.

“It was the sudden death of a patient who had been vaccinated 3 days ago. A man from the Klaipėda region, Priekulė, ”reported R. Pilvinienė, adding that it was a sudden death related to heart disease. The person was 86 years old and suffered from chronic heart and respiratory disease.

“He really was not a healthy, hardworking person,” said R. Pilvinienė.

Different amounts of vaccines have been vaccinated.

As the IWT noted, the three vaccines did not have the same amounts. In the first month of vaccination, people were vaccinated with two vaccines that were available on the Lithuanian market at that time. The third vaccine started in early February.

“The least used of the 3 available vaccines is the Moderna vaccine, although it is not the most recently registered, but its quantities are the lowest. The AstraZeneca vaccine was recently introduced. Comirnaty (manufacturer of Pfizer-BioNTech, aut. last.) and “Moderna” are the same in terms of the vaccine structure, and “AstraZeneca” is completely different when using an adenovirus, ”said R. Pilvinienė.

According to her, the AstraZeneca and Moderna vaccines are much easier to transport because they do not require the strict conditions required for the transport of Comirnaty. This explains why the AstraZeneca vaccine is being used more in the regions.

As explained by the specialist, none of the vaccines contains the SARS-Cov-2 virus, which can cause coronavirus. All cases of COVID-19 that can occur after the second dose of the vaccine are due to insufficient immunity, to the ineffectiveness of the vaccine.

The side effects of the three vaccines are very similar

Based on data from clinical trials, the adverse reactions of the 3 vaccines are very similar. Pain and fatigue at the injection site, as well as headaches, are the most common. Muscle pain, nausea, and fever also occur.

These reactions are reported to be more common after the first dose after Comirnaty, and AstraZeneca is reported to be milder and less common after the second dose than after the first dose.

According to R. Pilvinienė, AstraZeneca vaccines are administered to people in Lithuania only with the first dose, after which side effects occur more than after the first. For this reason, there are now relatively many reports of side effects from this vaccine.

“We noticed that after the first dose [„AstraZeneca“] the reactions scared people, we got calls, we warned about the second dose. Still, after the second dose, there should be fewer and milder such reactions, ”said R. Pilvinienė.

The Summary of Product Characteristics and Package Leaflet for registered COVID-19 vaccines included recommendations and precautions for healthcare professionals and patients to follow in order to use the vaccines safely and effectively. As with all medicines, data on vaccine use is constantly monitored. Any reports of suspected unresponsive reaction to COVID-19 vaccines received by IWT will be carefully evaluated and all necessary steps will be taken to protect patients.

There were no antiphylactic reactions.

No anaphylactic reaction to COVID-19 has been reported in the past month.

“There have been 9 reports of peripheral facial paralysis, 6 of which have been associated with Comirnaty, 2 with Moderna and 1 with AstraZeneca. Facial paralysis is temporary and disappears without any treatment in a few days,” said the specialist.

Comirnaty is mainly given to the elderly.

There is also a trend by age group: the age group with the highest number of vaccinations and the highest number of notifications.

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“Now we no longer see that trend and it shows a slightly different vaccinated population. In the first month, most of those vaccinated were doctors, who are very sober about their adverse reactions, they know how to report and react appropriately,” said R. Pilvinienė .

Comirnaty is mainly given to the elderly. Younger people were also vaccinated with the same vaccine, although there were far fewer, but they reported a number of side effects. This is believed to be due to young people’s computer literacy and activity. However, the reactogenicity of the vaccine may be lower in the elderly.

“We have received the most reports from young people of working age, even where the vaccination scale was small,” said R. Pilvinienė.

Due to adverse reactions to Comirnaty, the majority of reports were classified as general disorders and application site conditions. The second class in terms of frequency of complaints were skeletal, muscular and connective tissue disorders. Third is a class of nervous disorders, fourth, disorders of the gastrointestinal tract.

“Fever and accompanying phenomena were the most common: headache, chills, general weakness, muscle pain,” said the IWT specialist. The same events occurred with Moderna and AstraZeneca. However, these phenomena resolved in 1-3 days without any consequences.