FDA urged to publish follow-up studies on covid-19 vaccine safety signals

Author:

Demasi Maryanne

Publisher

BMJ

Subject

General Engineering

Reference10 articles.

1. Food and Drug Administration. Initial results of near real-time safety monitoring covid-19 vaccines. 2021. www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/initial-results-near-real-time-safety-monitoring-covid-19-vaccines-persons-aged-65-years-and-older.

2. Wong HL, Zhou CK, Tworkoski E, et al. Assessment of acute myocardial infarction, pulmonary embolism, disseminated intravascular coagulation and immune thrombocytopenia following covid-19 vaccination. FDA, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology. 2021. https://bestinitiative.org/wp-content/uploads/2021/09/C-19-Vaccine-Safety-AMI-PE-DIC-ITP-Protocol-2021.pdf

3. Food and Drug Administration. Safety assessment of 3rd dose/booster of covid-19 mRNA vaccines (master protocol). 2022. https://bestinitiative.org/wp-content/uploads/2022/09/C19-Post-Booster-Dose-AESI-Risk-Protocol-2022.pdf.

4. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

5. Analysis of Thromboembolic and Thrombocytopenic Events After the AZD1222, BNT162b2, and MRNA-1273 COVID-19 Vaccines in 3 Nordic Countries

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