其 他 安 全 警 示
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| Australia: ICMRA statement on the safety of COVID-19 vaccines (English only) |
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Therapeutic Goods Administration (TGA) announces the International Coalition of Medicines Regulatory Authorities (ICMRA) statement on the safety of COVID-19 vaccines. This statement provides the general public with important information regarding the safety of COVID-19 vaccines, which have now been in use for more than two years. It also addresses some of the most common types of misinformation about COVID-19 vaccine safety.
COVID-19 vaccines significantly reduce the risk of severe disease, hospitalisation and death from infection with SARS-CoV-2. SARS-CoV-2 keeps changing and revaccination may be needed to maintain protection against new variants and continue saving millions of lives worldwide.
Evidence from the more than 13 billions of vaccine doses given worldwide shows that COVID-19 vaccines have a very good safety profile in all age groups. The benefits of the approved vaccines far outweigh the possible risks. The vast majority of side effects are mild and temporary. However, safety monitoring (pharmacovigilance) systems have identified some very rare (occurring in less than 1 in 10,000 people) but serious side effects. Medicines regulators around the world have put in place measures to reduce the risk of harm from these side effects. As for all medicines, reports of medical events after COVID-19 vaccination (suspected side effects) are collected and continuously evaluated by the authorities. These evaluations show that in most cases the medical events were not caused by the vaccine.
False and misleading information about the safety of COVID-19 vaccines on social media often exaggerates the frequency and severity of side effects. Misinformation also wrongly attributes unrelated medical events to the vaccines. Vaccine misinformation leading individuals to decline vaccination has very likely led to many more deaths than adverse effects of the vaccines. There is no evidence that COVID-19 vaccines have contributed to excess mortality during the pandemic. Excess mortality largely coincides with peaks of SARS-CoV-2 infections, particularly during the first waves when vaccines were not available. In fact, there is strong evidence that COVID-19 vaccines save lives and prevent the serious harm associated with SARS-CoV-2 infection.
Emerging evidence also suggests that long COVID is less likely to develop in people who have been vaccinated.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/media-releases/icmra-statement-safety-covid-19-vaccines
In Hong Kong, there are 9 registered pharmaceutical products which are COVID-19 vaccines, namely:
- Coronavac COVID-19 Vaccine (Vero Cell) Inactivated 0.5ml/dose 0.5ml Pre-filled Syringe (HK-67662), Coronavac COVID-19 Vaccine (Vero Cell) Inactivated 0.5ml/dose 0.5ml Vial (HK-67663) and Coronavac COVID-19 Vaccine (Vero Cell) Inactivated 0.5ml/dose 1ml Vial (HK-67664) which are registered by Sinovac Biotech (Hong Kong) Ltd;
- Comirnaty Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) 30 micrograms/dose (HK-67665) and Comirnaty Original/Omicron BA.4-5 Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) (15/15 micrograms)/dose (HK-67666) which are registered by Fosun Industrial Co Limited;
- Convidecia COVID-19 Vaccine (Ad5-nCoV-S) Recombinant 0.5ml/dose 0.5ml Vial (HK-67825) and Convidecia COVID-19 Vaccine (Ad5-nCoV-S) Recombinant 0.5ml/dose 1.5ml Vial (HK-67826) which are registered by Cansino Biologics (Hong Kong) Limited; and
- Spikevax Bivalent Original/Omicron BA.4-5 Dispersion For Injection COVID-19 mRNA Vaccine (Nucleoside Modified) (50 micrograms/50 micrograms)/ml (HK-67830) and Spikevax Bivalent Original/Omicron BA.4-5 Dispersion For Injection In Pre-filled Syringe COVID-19 mRNA Vaccine (Nucleoside Modified) (25 micrograms/25 micrograms) (HK-67831) which are registered by DKSH Hong Kong Limited.
All products are prescription-only medicines. Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 6 Jul 2023. The Department of Health will remain vigilant on safety update of the products issued by other overseas drug regulatory authorities.
Ends/Tuesday, Jul 11, 2023
Issued at HKT 15:00
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