Table 5. Vaccine safety monitoring and management in major countries.
| Countries | Surveillance system | Operating entity | Function | |
|---|---|---|---|---|
| USA59 | Existing safety monitoring systems | CDC | As people get vaccinated, CDC, FDA, and other federal partners will use the Existing Safety Monitoring Systems to conduct ongoing safety monitoring. | |
| General public; members of the military; veterans; tribal nations | FDA | Expanded Safety Monitoring Systems add an extra layer of safety monitoring, giving CDC and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are safe. | ||
| Expanded safety monitoring systems | DOD | |||
| • CDC: V-safe | VA | |||
| • CDC: National Healthcare Safety Network | IHS | |||
| • FDA: Other large insurer/payer databases | ||||
| UK60 | The Yellow Card Scheme | The Medicines and Healthcare products Regulatory Agency | The system collects and monitors information on safety concerns about medicines, medical devices and e-cigarettes. This includes all adverse events as well as concerns related to product quality or counterfeit products. System contains COVID-19 yellow card reporting page. | |
| Germany61 | • Routine pharmacovigilance | Paul-Ehrlich-Institut responsible for monitoring the safety of vaccines and biomedicines. | Routine pharmacovigilance is based on established real-time monitoring of possible side effects. Smartphone app (SafeVac 2.0) will prospectively track the frequency and severity of adverse effects. | |
| • SafeVac 2.0 | ||||
| Australia62,63 | Passive surveillance | TGA | TGA collects reports of suspected side effects from health professionals and consumers and analyses them to detect signals for possible safety issues. | |
| • AEFI (adverse events following immunisation) | Some people who receive COVID-19 vaccines will be sent follow-up SMS messages with a survey to ask if they have experienced any potential side effects. | |||
| • DAEN (Database of Adverse Event Notifications) | ||||
| Active surveillance | ||||
| • AusVaxSafety | ||||
| • PAEDS (Paediatric Active Enhanced Disease Surveillance) | ||||
| Canada64 | CAEFISS | Public Health Agency of Canada | The system is a FPT public health post-market vaccine safety surveillance system. CAEFISS includes both passive (spontaneous reports from FPTs) and active surveillance. | |
| France65 | Pharmacovigilance | l'Agence nationale de sécurité du médicament et des produits de santé | The system monitor how well people are tolerating the new vaccines. And collects unwanted side-effects. | |
| Sweden66 | Suspected adverse reaction reports | MPA | Suspected adverse reaction reports are sent to the MPA by patients, consumers or health and welfare professionals. This can be done via electronic or paper forms or directly from health and welfare care record systems. | |
| Saudi Arabia67 | Sehhaty app | MOH | Saudi Arabia monitors side effects through mobile app, phone calls. | |
| The nearest medical facility | ||||
| 937 Call center | ||||
| Israel35 | Reporting an adverse event during or after COVID-19 vaccination | MOH | People can report any adverse event during or after getting coronavirus (COVID-19) vaccine through online form. | |
CDC = Centers for Disease Control and Prevention, FDA = Food and Drug Administration, DOD = Department of Defense, VA = Department of Veterans Affairs, IHS = Indian Health Service, COVID-19 = coronavirus disease 2019, TGA = Therapeutic Goods Administration, CAEFISS = The Canadian Adverse Events Following Immunization Surveillance System, FPT = federal, provincial and territorial, MPA = Swedish Medical Products Agency, MOH = Ministry of Health.