TGA reveals seven new blood clot cases from AstraZeneca vaccine

In addition to the blood clot cases, there have been six reports of Guillain-Barre Syndrome following the AstraZeneca vaccine.

The TGA has observed seven new blood clot cases following the AstraZeneca vaccine. Picture: AFP

The Therapeutic Goods Administration has revealed there have been seven additional cases of blood clots with low platelet counts following the AstraZeneca vaccine.

The new cases of thrombosis with thrombocytopenia syndrome were revealed in the TGA’s COVID-19 vaccine weekly safety report. Three cases are confirmed TTS and four are deemed probable.

In addition, there have been six reports of Guillain-Barre Syndrome following the AstraZeneca vaccine, the first time this kind of adverse event has been reported, but a link with the vaccine has not been established. Guillain-Barre Syndrome is a rare immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking. It usually resolves within months but in some cases can take a year or two years to resolve.

“In adults, this condition occurs in the population at a background rate of 2 – 3 cases per 100,000 per year,” the TGA said. “A link between GBS and the AstraZeneca COVID-19 vaccine has not been confirmed either in Australia or internationally so it is unclear whether this is simply a chance association.

“However, GBS is considered an adverse event of special interest and is being closely monitored by medicine regulators. The European Medicines Agency safety committee is assessing reports of GBS with the AstraZeneca vaccine as part of the review of all safety data that is regularly submitted by the sponsor. The TGA will continue to monitor and investigate Australian reports, assess worldwide safety data submitted by the sponsor and share information with international counterparts.”

The seven new blood clot cases take the total number of TTS cases following the AstraZeneca vaccine in Australia to 18. The incidence is now one in every 100,000 doses.

The new confirmed cases include a 75-year-old man from Victoria, a 75-year-old man from Western Australia, and a 59-year-old Queensland man who was diagnosed in Victoria.

“Of these, only the Victorian man remains in hospital, but is responding to treatment and is in a stable condition. The other two patients are not currently in hospital and are thought to be well,” the safety report said.

The four other cases that are probable TTS include three men from Victoria aged 65, 70 and 81 years, and a 70-year-old man from NSW.

“All but one of the newly reported cases was vaccinated after the 8 April 2021 recommendation by ATAGI that Comirnaty (Pfizer) is preferred over the AstraZeneca vaccine in adults aged under 50 years,” the TGA said.

All of the other 11 cases that were revealed in earlier safety reports are recovering and stable, except one of the cases which resulted in a fatality in a 48-year-old woman from the NSW central coast.

The TGA noted that Australia has not seen the same rates of fatal blood clots that have been observed in other countries following the AstraZeneca vaccine.

“The reporting rates of TTS in Australia are consistent with what is being seen internationally. However, we believe that a higher proportion of less severe cases may be being reported in Australia,” the regulator said. “This may be due to high levels of awareness in the community and among the medical profession around TTS along with less strain on the healthcare system around COVID infections with much lower infection rates than internationally.”