Did the Croatian government warn health care workers against the side effects of the COVID-19 vaccines but hide them from the citizens? No, that's not true: The Croatian Agency for Medicinal Products and Medical Devices (HALMED) has published news about vaccines against COVID disease and other topics from a meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on its website.
The claim appeared at the end of 2023 in a video (archived here) on TikTok by @katy.ojdanovski on December 31, 2023. The caption (translated from Croatian to English by Lead Stories staff) said:
They have sent the side effects warnings to hospital employees, and who cares about the people!
The same claim appeared at the end of 2023 and the start of 2024 in this video (archived here), this video (archived here), this video (archived here), this video (archived here) and this video (archived here).
All of these videos contain an internal letter (archived here) addressed to hospital employees in Osijek on October 18, 2021, written by Domagoj Drenjančević (archived here), assistant director for quality at the Clinical Hospital Osijek. In the videos, however, the date the letter was sent is covered by a marker so that it cannot be seen. Croatian health workers were officially informed about new side effects of vaccines via HALMED so that they could inform citizens about them.
This information is a standard procedure for all medicinal products and vaccines authorized in European Union (EU) member states, not only during the COVID pandemic but generally in the context of communication between medicinal product manufacturers, the European Medicines Agency and health professionals in the EU member states. This is part of pharmacovigilance (archived here), which is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or other problems associated with medicinal products.
On October 1, 2021, HALMED published (archived here) that the Pharmacovigilance Risk Assessment Committee (PRAC) (archived here) of the European Medicines Agency (EMA) (archived here) had concluded that there was a possible link between Johnson & Johnson's Janssen COVID-19 vaccine (archived here) and rare cases of venous thromboembolism (VTE).
PRAC therefore recommended that venous thromboembolism be included as a very rare side effect of Janssen's COVID-19 vaccine in the product information, along with a warning to raise awareness among health care professionals and people receiving this vaccine, especially those who might be at increased risk of VTE.
At the same meeting, PRAC evaluated the cases of immune thrombocytopenia (ITP) that had occurred following the use of the Vaxzevria vaccine (archived here), formerly COVID vaccine AstraZeneca, and the COVID vaccine Janssen.
PRAC evaluated all available data and recommended that the product information for both vaccines be updated to include ITP as an adverse reaction of unknown frequency. In addition, a warning was included in the medicinal product documentation to indicate that there had been very rare cases of platelet deficiency, usually within the first four weeks after administration of the Janssen or Vaxzevria COVID vaccine.
As part of the awareness efforts, PRAC had ordered the mailing of direct health care professional communication (DHPC) letters (archived here) containing the following safety information for the Janssen and Vaxzevria COVID-19 vaccines:
- COVID-19 vaccine Janssen: risk of immune thrombocytopenia and venous thromboembolism
- Vaxzevria: risk of thrombocytopenia, including immune thrombocytopenia
The letters to health care professionals for these vaccines were forwarded to the EMA's Committee for Medicinal Products for Human Use (CHMP) (archived here). Following the CHMP decision, the letters were sent to health care professionals using the approved communication plan and published on the EMA and HALMED websites.
Drenjančević's letter to the health staff of the Osijek Clinical Center, which circulated on social media in October 2021 and late 2023 as alleged evidence that citizens were being deprived of information about the side effects of vaccines, actually shows the opposite -- that he had done his job and informed employees about the new PRAC data on vaccines as part of the communication plan.
On October 13, 2021, Janssen Cilag International NV sent a letter to health care professionals via HALMED about the risk of ITP and venous thromboembolism VTE with the use of COVID vaccine Janssen. On the same day, AstraZeneca AB sent a letter to health care professionals about the risk of thrombocytopenia (including immune thrombocytopenia) with or without bleeding when using Vaxzevria.
Drenjančević, who forwarded these letters from HALMED to the department heads of the Osijek Clinical Hospital, has already refuted the misinterpretation of the letter and emphasized that it was merely an additional and usual safety measure. He reconfirmed to Lead Stories his statement published on the web portal (archived here) on October 22, 2021.
