(Staffarticle from the ABC NEWS AUSTRALIA on May 20, 2021.)
It is the first case recorded in the state, with
150,000 South Australians so far receiving the AstraZeneca jab. Authorities are
also investigating a second case of blood clotting in an 87-year-old woman who
received the AstraZeneca vaccine last month.
South Australia's Chief Public Health Officer, Nicola Spurrier, said the man was in a "very serious condition" after receiving his first dose on May 4. He was admitted to hospital with severe abdominal pain on Tuesday.
SA Health received confirmation from the Australian Technical Advisory Group on Immunisation (ATAGI) that his clotting was linked with the AstraZeneca vaccine last night. "My thoughts and the thoughts from others in SA Health are with him and his family at the moment," Professor Spurrier said. She said the case was "obviously of great concern but not unexpected". She is in a stable condition, Professor Spurrier said.
One fatality linked to AstraZeneca vaccine
The two cases
bring the total Australian reports of cases of thrombosis with thrombocytopenia
syndrome (TTS), including suspected cases, following the AstraZeneca vaccine to
24. The Therapeutic Goods Administration (TGA) said 21 other linked cases were
out of hospital, while another two were in hospital.
There has been one fatality, a 48-year-old woman
from New South Wales. About 2.1 million AstraZeneca jabs have been administered
in Australia. Immunisation Coalition chairman Rod Pearce said there appeared to
be about 11 blood clot cases per 1 million people vaccinated, which was about
the same number that could be anticipated going on overseas trends.
"It's
important we keep rolling out our vaccine program because in the long run it's
going to be our fight against the disease, which is more important than
managing the side effects," Dr Pearce said.
Professor
Spurrier said people who have had a vaccine should watch for a severe
persistent headache or severe abdominal pain between four and 28 days after
receiving a dose. Her husband, physiotherapist David Spurrier, received the
AstraZeneca vaccine last Thursday.
She said he was
"not getting too stressed about it" but "keeping a bit of an eye
on" possible blood clot symptoms. "Just being aware if there was
anything like that that he would need to go and get a health check," she
said. Professor Spurrier also announced a new case of COVID-19 reported in
hotel quarantine, bringing South Australia's total to 747. Four new cases were reported on Tuesday.
Seven deaths in UK among AstraZeneca vaccine recipients
The UK medical
regulator said Saturday that out of 30 people who suffered blood clots after
receiving the Oxford-AstraZeneca vaccine, seven have died. "Out of the 30
reports up to and including 24 March, sadly 7 have died," the Medicines
and Healthcare Products Regulatory Agency (MHRA) said in a statement sent to
AFP.
Announcing the
thirty blood clot cases on Friday, MHRA said "the benefits of the vaccines
against Covid-19 continue to outweigh any risks", urging the public to
keep taking the vaccine. Up to 24 March, 22 reports of cerebral venous sinus
thrombosis (CVST) and eight of other thrombosis events with low platelets were
logged.
"The risk
of having this specific type of blood clot is very small," the agency
noted. "The number and nature of suspected adverse reactions reported so
far are not unusual in comparison to other types of routinely used
vaccines," the MHRA online statement on April 2 said. However there were
no such reports for the Pfizer/BioNTech vaccine.
The Netherlands on Friday became the latest in a
line of European countries to halt vaccinations with the AstraZeneca jab for
people under the age of 60 amid fears of links to rare blood clots. The move
came after five new cases in the Netherlands affecting women between 25 and 65 years
of age, one of whom died. Germany had taken a similar decision earlier this
week.
The European
Medicines Agency (EMA), which has also previously declared the AstraZeneca
vaccine safe, as has the World Health Organization, is expected to announce
updated advice on the issue on April 7.
The EMA said again on Wednesday it believes the vaccine is safe and that experts have found no specific risk factors such as age, gender or medical history. Britain, where the vaccine was developed with Oxford University, has been one of the countries worst-hit by coronavirus with nearly 127,000 dead.
On the evening
of March 24, AstraZeneca announced its Covid-19 vaccine is 76 percent effective
at preventing symptomatic disease, based on its Phase III trial of over 32,000
participants mostly in the United States. The results concluded a whirlwind of
news stories about the AstraZeneca vaccine in March.
At this point, the vaccine has been approved for use
in the United Kingdom and several European Union countries since December. It
has not yet been approved in the U.S. because the Food and Drug Administration
(FDA) asked the company to provide results from a large-scale trial, Umair
Irfan reports for Vox.
Experts have
expected the data to show that the vaccine is safe and effective, but worry how
AstraZeneca’s recent hurdles might impact its reputation around the world. “I
think the way that the ship will be righted is by having the FDA’s scrutiny,”
says biostatistician Stephen Evans of the London School of Hygiene &
Tropical Medicine to Smriti Mallapaty and Ewen Callaway at Nature. Evans
expects the vaccine will be approved when the FDA is able to review the raw
data.
On March 18, the
European Medicines Agency (EMA) completed its review of the AstraZeneca
vaccine, which is made in partnership with Oxford University, and concluded
that it is safe and effective, BBC News reports. The E.U.’s medical regulation
agency had revisited the vaccine’s safety because, out of about 17 million
people who had gotten the shot by early March, 37 people developed unusual
blood clots.
More than 20
countries suspended use of the vaccine while the EMA reviewed the cases, Kai
Kupferschmidt and Gretchen Vogel report for Science magazine. Most countries
resumed vaccine use after the EMA concluded that it is safe, but last week
Friday, Norway extended its suspension of the vaccine until April 15, Gwladys
Fouche and Terje Solsvik report for Reuters. Norwegian officials hope more data
about the cause of the blood clots will become available soon.
On March 22,
AstraZeneca released its initial results of the Phase III trial, which showed
slightly higher effectiveness at preventing Covid-19 than the latest results.
The results were long-awaited. The FDA asked the company to conduct a larger
trial in order to get clearer data than they gathered in their first rounds of
testing.
In the first
trials in the U.K., some participants unexpectedly received half-doses of the
first shot in the vaccine, and the early trials did not include enough people
older than 65, reports the Washington Post.
By the morning
of March 23, officials at the National Institute of Allergy and Infectious
Diseases released a letter from its data and safety monitoring board that's
been examining the AstraZeneca trial, Andrew Joseph reports for STAT News. The
letter stated that AstraZeneca had used outdated data to reach its efficacy
number. The move was unprecedented; usually, monitoring boards keep their
correspondence with companies private.
“We just felt we
could not remain silent. Because if we did remain silent, we could be
understandably accused of covering something up. And we definitely didn’t want
to be in that position,” says Anthony Fauci, director of the NIAID, to STAT
News. “In my mind, it’s an unforced error by the company.”
AstraZeneca explained the initial results included data gathered until February 17, per Nature. Within 48 hours, AstraZeneca released its revised results with updated data. According to the statement, the vaccine has 76 percent efficacy at reducing symptomatic Covid-19 overall, and 85 percent efficacy in people 65 years old and older. A specific review of the 32,000 participants in the U.S. trial found no cases of the unusual blood clots that caused hesitation in Europe, per STAT News.
“The benefits of
these results will mainly be for the rest of the world, where confidence in the
AstraZeneca vaccine has been eroded,” said Evans to the New York Times. AstraZeneca
plans to submit the data for emergency use authorization in the coming weeks
and then the FDA additional time to review the data and make its decision.
The AstraZeneca vaccine may not have a large role in
vaccinating people in the United States because the three companies already
approved to supply vaccines in the country agreed to provide enough doses for
anyone who wants one this year. But AstraZeneca is participating in the COVAX
program to provide doses to low- and middle-income countries for no profit, and
FDA approval is a global gold-standard for safety of medications.
“At the end of
the day, the FDA looks at the data, not the press releases,” says the FDA’s
former chief scientist Jesse Goodman to Vox. “Looking at that data and doing
their own analysis is what’s going to determine whether this vaccine gets an
[emergency use authorization], whether the benefits outweigh the risk.”
