A 52-year-old woman from New South Wales in Australia is dead after presenting with a "severe form" of blood clotting in the brain "likely linked to the AstraZeneca vaccine".
The Therapeutic Goods Administration, which monitors and reports on all suspected side effects from the Covid-19 vaccine in Australia, issued a report yesterday outlining the circumstances of the woman's death.
"Since last week's report, a further four reports of blood clots and low blood platelets have been assessed as confirmed TTS (Thrombosis with thrombocytopenia syndrome) likely to be linked to the AstraZeneca vaccine," the report reads.
"One of these cases was in a 52-year-old woman from NSW who sadly died. This case presented as a severe form of this syndrome, with a blood clot in the brain, known as a cerebral venous sinus thrombosis.
"We extend our sincere condolences to her family. There were also new cases confirmed in a 77-year-old man from NSW and a 70-year-old man from South Australia. The fourth case was in an 87-year-old South Australian woman, which was previously reported as probable but not confirmed at that stage."
The TGA says it reviews all deaths reported after a vaccination is administered and compares them with expected natural death rates.
"To date, the observed number of deaths reported after vaccination is actually less than the expected number of deaths," the TGA said.
"Each year in Australia, there are about 160,000 deaths, equating to 13,300 a month or 3050 each week. In the most recent reporting year, two-thirds of these deaths were in people aged 75 years and over."
The regulator last week said "apart from a single Australian case in which death was linked to TTS, Covid-19 vaccines have not been found to cause death".
There have now been two.
Speaking to reporters yesterday afternoon, chief medical officer Paul Kelly said the new blood clotting case was "extremely unfortunate" but stressed it was "extremely rare".
"I will point out that it is only the second death with now over 3.6 million doses of this vaccine being given across Australia, I will point out that this remains an extremely rare event to get these serious clots, but when they happen, as we have seen in this case, it can have tragic circumstances.
"My heart goes out to the family, and all the friends and colleagues of this particular person."
But Kelly said AstraZeneca was still the recommended vaccine for those aged over 50, and Pfizer for under 50s.
"There is definitely a much lower risk of this event, this clotting events, the older one gets. There is a definite cut point there at about the age of 50," he said.
"[The woman's death] is clearly concerning… but I would say this - we have made those decisions based on the risk and benefit equation. At the moment, the AstraZeneca is a really important element of the vaccine rollout. But nothing is compulsory.
"Individuals who have concerns about any medical procedure but including and in particular the private vaccine at this time should talk to their GP about those concerns."
In its report, the TGA cited another "four new cases classified as probable in the past week" that included three cases in NSW and one in Victoria.
A 50-year-old woman and two men aged 83 and 91 years presented with issues in NSW and a 74-year-old woman presented with issues in Victoria.
"This takes the total Australian reports of cases assessed as TTS following the AstraZeneca vaccine to 48, with 35 confirmed cases and 13 probable cases," the TGA reports reads.
Of those, 31 have been discharged from hospital and are recovering, with some receiving ongoing outpatient medical care, and 15 remain in hospital, including one who remains critically ill in intensive care. Two people have died in hospital.
A New South Wales woman, 48, died after receiving the AstraZeneca vaccine in April. The medicines regulator said her death from rare blood clots was "likely" linked to the vaccine.
NSW Premier Gladys Berejiklian offered her sympathies to the 48-year-old woman's family.
"We just extend our heartfelt condolences to the family and loved ones during this difficult time," she said.
The Australian Technical Advisory Group on Immunisation (ATAGI) issued a report last week. It noted that there had been "31 confirmed cases reported and a further 10 are considered probable in around 2.2 million doses of COVID-19 Vaccine AstraZeneca given up to 19 May 2021".
ATAGI estimates the risk of TTS in Australia at around 3.1 per 100,000 for people over 50 years and 1.8 per 100,000 for people under 50 years.