Safety of COVID-19 vaccines

URGENT UPDATE: AstraZeneca Vaccine 

On 8 April 2021, The Australian Technical Advisory Group on Immunisation (ATAGI) released a statement noting rare but serious health concerns in people following receipt of the COVID-19 Vaccine AstraZeneca (external site). The WA Department of Health have accordingly advised the following:

  • If you are an employee under 50 years of age and receiving your first vaccination of AstraZeneca, you should cancel your appointment.
  • VaccinateWA will send an email to employees under 50 years of age, advising them not to attend their AstraZeneca appointment.
  • Advice will be issued by the Department of Health in the coming weeks about how eligible staff can receive an alternative COVID-19 Vaccine.
  • The ATAGI states if you have already received the first dose of the COVID-19 Vaccine AstraZeneca without any serious adverse effects and you are under 50 years of age, you can be given the second dose.
  • AstraZeneca Clinics will remain open for people who are aged 50 years and over.

For the latest news, visit the Australian Government Department of Health website (external site)

In clinical trials of tens of thousands of patients, the vaccines have been shown to be safe. Worldwide, more than 400 million people have received a COVID-19 vaccine, including tens of millions who have received one of the two vaccines registered for use in Australia, Comirnaty and COVID-19 Vaccine AstraZeneca. Most side effects are mild and transient. Reactions at the injection site and systemic symptoms, like headaches, fever, muscle aches and fatigue, are very common within the first 48 hours. Serious adverse events attributable to vaccination are very rare. The potential for rare or unanticipated side effects to emerge over time is low, but is being closely monitored, as for any vaccine.

COVID-19 vaccine safety surveillance information for healthcare providers (PDF 269KB).

Regulation by the Therapeutic Goods Administration (TGA)

The TGA is responsible for assessing COVID-19 vaccines before they are used in Australia. For information on this process, you can visit the TGA website (external site).

The TGA is also responsible for regulating and monitoring the use of COVID-19 vaccines in Australia. Monitoring involves detecting and responding to any emerging safety concerns related to COVID-19 vaccines, particularly any adverse events following immunisation (AEFI), which includes adverse events of special interest (AESI) where there is a temporal association with vaccination (a reaction reported up to six weeks after vaccination).

The TGA works closely with state and territory health departments and expert bodies such as the National Centre for Immunisation Research and Surveillance (NCIRS) and AusVaxSafety to monitor and respond to safety concerns.

Likely side effects from COVID-19 vaccines

Minor side effects are common following COVID-19 vaccines, but they are usually mild and temporary. Clinical trials of COVID-19 vaccines have documented self-limiting side effects typical of many vaccines, such as pain at the injection site, fatigue, fever or muscle aches.

Management of side effects

Most side effects start within 24 hours of vaccination and will resolve in 1–2 days on their own. To reduce discomfort, paracetamol or ibuprofen can be taken. Some of the expected vaccine side effects may be similar to the symptoms of COVID-19; however, a key differentiating factor is that respiratory symptoms (e.g. cough, runny nose etc) are not caused by the vaccine. People with typical vaccine side effects (injection site pain, mild fever, lethargy) within the first 48 hours after vaccination with a complete absence of any respiratory symptoms may not need to get a COVID-19 test or isolate. People with respiratory symptoms should be tested for COVID-19.

Reporting adverse events following immunisation (AEFI)

An AEFI is an unwanted or unexpected event occurring after the administration of a vaccine. An AEFI may occur several hours or days after vaccination. An AEFI may be due to a person’s response to the vaccine, coincidence (that is, it would have occurred regardless of vaccination) or incorrect handling or administration of a vaccine.

Healthcare providers who become aware of an AEFI have a statutory responsibility to notify the Western Australian Department of Health within 72 hours of diagnosis.

You should report:

  • any significant event following immunisation
  • any vaccine reaction which requires assessment by a doctor or nurse
  • any reaction which has affected a family’s confidence in future immunisation.

Common expected reactions following immunisation, such as mild fever, redness or swelling at the injection site, do not need to be reported.

Health care providers can report possible AEFI using the online portal at AEFI-CAN WAVSS (external site).

WA Vaccine Safety Surveillance (WAVSS) staff can be contacted at wavss@health.wa.gov.au and 08 6456 0208 (Monday to Friday, 9am-5pm).

Members of the public may choose to report a suspected AEFI online, or by phone or email.

Please use the AEFI-CAN reporting guide (PDF 1.3MB) to assist with reporting the AEFI online.

Vaccine safety surveillance in WA

Monitoring of vaccine safety occurs through a combination of passive and active surveillance systems.

Passive vaccine safety surveillance is the spontaneous reporting of AEFIs by individuals, including the patient, GPs, specialist doctors, immunisation providers or the vaccine manufacturer.

Active vaccine safety surveillance entails contacting vaccine recipients within the week after vaccination via SMS with a brief survey to collect data on any symptoms they may have experienced following the immunisation. WA participates in a national active adverse events surveillance system called AusVaxSafety.

Clinical guidance and specialist immunisation clinics in WA

Clinicians can access advice regarding investigation and management of suspected AEFIs from the WA Vaccine Safety Surveillance (WAVSS) system. WAVSS assistance can be arranged by calling 08 6456 0208 (Monday to Friday 9am-5pm) or emailing wavss@health.wa.gov.au.

After hours support should be reserved for advice on the immediate investigation and management of serious AEFI. Clinicians may contact the adult immunologist through the Royal Perth Hospital switchboard on 08 9224 2244 for urgent after-hours clinical support.

Should further immunisation specialist consultation or assessment be required, individuals can be referred to appropriate services in consultation with WAVSS staff.

WA COVID-19 vaccine safety advisory committee

Western Australia Vaccine Safety Advisory Committee (WAVSAC) provides independent expert advice to the Department of Health on the surveillance of AEFI and responding to potential safety signals. Members of WAVSAC include clinical immunologists, adult and paediatric subspecialists, and invited experts in fields relevant to vaccine safety surveillance.

Recommendations, contraindications and considerations for COVID-19 vaccination

See the Australian Technical Advisory Group (ATAGI) clinical guidance on COVID-19 vaccine for recommendations, considerations and contraindications COVID-19 vaccination – ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021 (extertnal site).

Allergic precautions to COVID-19 vaccination

See the Australasian Society of Clinical Immunology and Allergy (ASCIA) advice for suitability for vaccination – Guide: Allergy and COVID-19 vaccination (external link).

Last reviewed: 09-04-2021