Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency

Funding

No funding was received for the preparation of this letter.

Conflicts of Interest/Competing Interests

Anders Sundström reported participating in research funded by governmental agencies, universities, Astellas Pharma, Janssen Biotech, AstraZeneca, Pfizer, Roche, (then) Abbott Laboratories, (then) Schering-Plough, UCB Nordic, and Sobi, with all funds paid to Karolinska Institutet, outside the submitted work. Rickard Ljung reported receiving grants from Sanofi Aventis paid to his institution outside the submitted work; and receiving personal fees from Pfizer outside the submitted work. Karl Mikael Kälkner, Marja-Leena Nurminen, Maria Larsson, and Veronica Arthurson have no conflicts of interest that are directly relevant to the content of this letter.

Ethics Approval

The study was approved by the Swedish Ethical Review Authority (2020-06859 and 2021-02186).

Consent to Participate

The need for informed consent is regulated in the Swedish Act on ethical review in human research. An informed consent is waived by the Swedish Ethical Review Authority as this is a register-based study.

Consent for Publication

Not applicable.

Availability of Data and Material

Aggregated data of adverse drug reaction reports can be found at https://www.lakemedelsverket.se/sv/coronavirus/coronavaccin/rapporterade-misstankta-biverkningar-coronavaccin (in Swedish).

Code Availability

Not applicable.

Author Contributions

Drafting of the manuscript: KMK and RL. Analyses of number of spontaneous reports: ML. Critical revision of the manuscript for important intellectual content: all authors. All authors read and approved the final version.

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