Adverse events ‘within normal expectations’


Jane Malysiak receives Australia's first COVID-19 vaccine. Image courtesy Scott Morrison via Twitter.
Jane Malysiak receives Australia's first COVID-19 vaccine. Image courtesy Scott Morrison via Twitter.

The TGA is set to start publishing weekly reports on the safety of COVID-19 vaccines, with all 79 adverse events reported so far nothing out of the ordinary

In a statement on Monday, the Therapeutic Goods Administration said that Australia’s safety monitoring system for COVID-19 vaccines is operating, and that it expects weekly reports will be published from this Wednesday (3 March).

Now that Australia has begun vaccinating against the novel coronavirus, the TGA is collecting and evaluating reports of suspected side effects.

As of Sunday, February 28, almost 30,000 Australians, including some pharmacists and other health workers placed in the hotel vaccination program, had already been vaccinated against the disease, announced Health Minister Greg Hunt.

“Like other medicines and vaccines, COVID-19 vaccines can cause side effects,” the TGA said, noting that if these occur, they are usually mild and temporary, lasting one or two days.

“To the end of 28 February 2021, the TGA had received 79 reports of suspected adverse events related to the COVID-19 vaccine,” it said.

“The reports received so far are within normal expectations for any vaccine. Early reports have most frequently included cases of feeling faint, headache, dizziness or nausea.

“Two cases of administration error in a Brisbane aged care facility have also been reported to the TGA and to date have not been associated with any adverse outcome.”

In that instance, an untrained GP gave an incorrect dose to two aged care residents. The GP has since been stood down, as has the CEO of Healthcare Australia, the company responsible for the vaccine rollout in Queensland residential aged care communities.

The TGA notes that the National Centre for Immunisation Research and Surveillance is funded by the Australian government to run the AusVaxSafety active surveillance program.

“AusVaxSafety sends some people who receive COVID-19 vaccines (or their carers) follow-up SMS messages with a survey about potential side effects,” it said.

“AusVaxSafety has received over 5000 responses from people across the country who received the vaccine in the first three days of the rollout.

“Early data shows that approximately one third of people who responded reported at least one expected side effect, most commonly soreness at the injection site, headache and fatigue.”

The TGA says it plans to publish weekly updates on the number of COVID-19 vaccine adverse event reports received beginning this Wednesday, 3 March 2021.

Subsequent weekly reports will also include commentary relating to its safety monitoring and assessment of this data.

“We will also publish safety alerts and media releases in response to any significant new safety issues,” it said.

“The TGA collects adverse event reports directly from health professionals and consumers, as well as through state and territory health departments, other Australian vaccine safety organisations and vaccine sponsors.

“We review adverse event reports to look for any patterns that indicate a possible safety issue that should be investigated.

“We thoroughly investigate these issues to determine what action is required, if any, to maintain public safety.”

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