People With History of Rare Blood Clotting Disorders Should Defer Vaccine, Says Advisory Group

covid vaccine blood clotting

Update: Thursday, March 25

Almost two weeks after reports started to emerge that people were experiencing isolated cases of bleeding, blood clots and a low count of blood platelets following their COVID vaccination, the expert advisory group on vaccines within Australia has recommended that those who have a history of specific rare blood clotting disorders defer the COVID-19 vaccine.

Australian Technical Advisory Group on Immunisation (ATAGI) — who has advised on the timings of flu vaccines vs COVID vaccines — released the statement earlier today advising of the deferral. This is currently only recommended for people with a confirmed medical history of cerebral venous sinus thrombosis (CVST) and/or heparin induced thrombocytopenia (HIT), but it does apply both to AstraZeneca and Pfizer.

However, ATAGI advised this is “only a precautionary measure” and is until “further information from ongoing investigations in Europe is available”.

ATAGI co-chair Professor Allen Cheng, speaking to the ABC, said he imagined this advice would only apply to “a couple of hundred people”.

Update: Monday, March 22

It’s been a big few days for COVID-19 vaccines, to say the least.

Rains and flooding have lashed NSW — severe enough to be declared a “natural disaster” in some parts — causing further vaccine delays. However, phase 1b of the vaccine rollout has begun.

Phase 1b will see another six million Australians receive the vaccine, including Aboriginal and Torres Strait Islanders aged 55 and over, healthcare workers, younger Australians with underlying health conditions, and people who do not fall into the three prior categories but are 70 or older.

GPs are reporting that they’ve been inundated with calls, but some are reporting not having received the number of doses they expected — preparing for thousands and only having received 50. The number of GPs available to administer the vaccinations is expected to increase over the coming weeks.

Yesterday, the Therapeutic Goods Administration granted approval for the domestic production of the AstraZeneca vaccine, which had previously been experiencing trouble due to reports of blood clotting and allergic reactions. It will be produced at two sites in Melbourne, according to the ABC.

The TGA called it a “critical and very exciting milestone”; the first batches are expected to be released “in the next few days.”

Greg Hunt, Federal Minister for Health, says this approval was a “critical next step”, calling it “the fundamental approval which allows Australia to proceed with our national vaccination strategy based on 50 [million] doses of Australian-made vaccines.”

In addition to this, the Australian Technical Advisory Group on Immunisation has released information for “vaccine providers” as influenza season approaches, and how the vaccination against both these diseases should work.

Their advice is that like all vaccines, there should be a 14-day interval between the COVID vaccine and “any other vaccine”, and that those in earlier phases for the COVID vaccine should receive that first, then the influenza vaccine, and those in later phases should receive the influenza vaccine as soon as it’s available, then the COVID vaccine.

Update: Thursday, March 18

The hits keep coming for the AstraZeneca vaccine. Following the news that several European countries have halted vaccination efforts after reports of blood clots associated with the vaccine — even though the drugmaker has conducted reviews which have shown there’s no evidence of this — five people have experienced an allergic reaction after being vaccinated.

Four of these occurred over the last two days in Queensland, and one occurred in Western Australia.  The Guardian stated that the people “potentially experienced anaphylactic reactions within 30 minutes” of receiving the first dose.

Due to the reports, the TGA announced a comprehensive review of vaccine data, to confirm if these rates were consistent with the expected rate. However, the regulator said the vaccine should continue to be administered, according to national guidelines, and that anaphylaxis is “a very rare side effect that may occur with any vaccine”.

The head of Queensland Health, Dr John Wakefield, stressed the fact that allergic reactions to any vaccine are “not a surprise” but the reason people are hearing about every single case that arises is that “there is so much focus on this”. He said it also occurs in the Pfizer vaccine, and that they do expect to get more.

There have, so far, been 14 reports of anaphylaxis following the Pfizer vaccine.

Update: Tuesday, March 16

Germany, France and Italy have joined the list of EU countries to stop administering the AstraZeneca vaccine — after isolated cases of bleeding, blood clots and low count of blood platelets were reported. Spain has also put a two-week ban on the vaccine.

This follows AstraZeneca’s statement that the review — which covered 17 million people — had shown no evidence of increased risk of blood clots.

The World Health Organisation also stands by the vaccine, appealing to countries not to suspend vaccinations. WHO spokesman, Christian Lindmeier said, “As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus.”

Health experts in Australia remain confident in the current vaccine rollout, calling the pauses “precautionary”.

Former president of the Royal Australian College of General Practitioners, Dr Tony Bartone, speaking on Nine’s Today show, said, “We need to remember there is no proof, no evidence to that effect. They’ve even acknowledged that in their statements.”

Update: Monday, March 15

Following the news out of Norway that three health workers who received the AstraZeneca vaccine were treated for bleeding, blood clots and low count of blood platelets — which saw Norway, Denmark and Iceland halt the rollout — AstraZeneca has said it conducted a review of people vaccinated, which has shown no evidence of an increased risk of blood clots.

The Syndey Morning Herald reported that over the weekend, Ireland also temporarily suspended the AstraZeneca vaccine “out of an abundance of caution”.

The review looked at people throughout the United Kingdom and European Union and covered more than 17 million vaccinated people. In a statement, the drugmaker said: “A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country.”

The company also confirmed that additional testing has been conducted and that they’re continuing to do so — European health authorities are also conducting tests — and none of the re-tests has shown cause for concern.

Update: Friday, March 5

250,000 AstraZeneca vaccine doses, intended for Australia, were blocked by Italy according to news released overnight.

Italy made the objection last Friday and lodged it with the European Commission. The European Commission endorsed the decision, marking the first time they’ve used their powers as to whether or not vaccines manufactured in Europe by Pfizer and AstraZeneca can leave its territory. The Sydney Morning Herald reports that its “a ploy set to trigger a major diplomatic dispute”.

The justification for the ban came from the Italy Ministry of Foreign Affairs, saying Australia is considered “not vulnerable”, and that AstraZeneca was trying to send a “high number” of doses to Australia — compared to the quantity supplied to Italy, and other European countries.

Although 50 million AstraZeneca doses will be manufactured in Melbourne, 3.8 million will have to arrive from overseas. And yes, they’ll primarily be from Europe.

These export controls mean Pfizer and AstraZeneca have to ask countries where the vaccine was manufactured for approval before the jabs can be flown abroad. A country can decide to reject the application but must consult with the European Commission. Experts are calling this “vaccine nationalism”.

Update: Monday, March 1

The first vials of Australia’s second COVID-19 vaccine, AstraZeneca, landed in Sydney Airport yesterday — doubling the country’s coronavirus vaccine supplies. A total of 300,000 doses arrived, carried by an Emirates plane.

GPs will be largely responsibly for administering the AstraZeneca vaccination, and this is the vaccine the majority of the population will be receiving.

Premier Gladys Berejiklian says NSW is prepared to step in to help with the mass vaccine rollout. “We want people to get vaccinated as quickly as possible and my attitude is, if we can bring things forward we will.”

The Premier also said she’s keen for more clarity at a federal level for the AstraZeneca rollout plans, and that she looks forward to getting briefings about the rollout.

She also clarified that NSW Police will be supporting hospital security. This is being done to ensure anti-vaxxers won’t target supplies of the vaccines.

After the AstraZeneca vaccine is cleared by the Therapeutic Goods Administration — done through batch testing, expected to be within the week — the Premier will receive the vaccine.

According to Federal Health Minister Greg Hunt, 200,000 doses will be sent to the states — subject to the aforementioned batch-test approval. This will be for use in phase 1a of the rollout, starting March 8.

50,000 additional doses of the Pfizer vaccine will be distributed by the end of today.

Update: Tuesday, February 23

It’s good news for those who live in NSW. Premier Gladys Berejiklian this morning announced the whole state could be vaccinated against COVID-19 within months — much earlier than the original flagged deadline of October.

Speaking to ABC radio, the Premier said: “We’re hopeful that if some of the supplies that we hadn’t anticipated are coming in sooner than expected, it could be within months that large cohorts of the public are invited to have the vaccine.”

However, in the same breath, the World Health Organisation (WHO) has warned that coronavirus vaccines will be in short supply for the remainder of the year; available vaccine supplies have to be used carefully.

WHO director-general Tedros Adhanom Ghenreyesus said: “More vaccines are being developed, approved and produced. There would be enough for everyone. But for now, and for the rest of this year, vaccines will be a limited resource. We must use them as strategically as we can.”

Update: Monday, February 22

In some good news to start the week, the COVID-19 vaccine rollout started a day early, with 20 people being vaccinated yesterday, Sunday, 21 February.

84-year-old Jane Malysiak, a WWII survivor was Australia’s first recipient of the vaccination. Other recipients included aged care residents, and three experienced Australian Border Force personnel. Prime Minister Scott Morrison also received the vaccination; he does not fall into any of the sub-groups for the Group 1 rollout.

Each state is beginning the full roll-out of Phase 1 today, excluding Tasmania and the Northern Territory. Tasmania will begin its rollout tomorrow.

South Australia received 4,000 doses of the Pfizer vaccine yesterday at Adelaide Airport, and is aiming to vaccinate more than 1,700 people over the coming week. The two vaccination hubs are the Royal Adelaide Hospital and the Flinders Medical Centre. First to be vaccinated will be all frontline workers at the airport, and in the medi-hotel system.

However, the arrival was met with backlash with people rallying against “enforced vaccinations” chanting phrases like “my body, my choice”. The vaccination is not mandatory. SA Health Minister Stephen Wade called it “propaganda” put out by anti-vaxxers. Mentions of the rollout at the Australian Open, held in Melbourne, received booing from fans.

Victoria and NSW have both begun their rollouts this morning.

Update: Friday, February 19

Following the arrival of the Pfizer vaccine earlier this week, and the TGAs approval of the AstraZeneca vaccine, details of the actual vaccine rollout within Australia have been announced.

These include 240 aged care facilities in nearly 200 towns across the country, as well as Western Australia receiving 5,000 doses. Greg Hunt, Federal Health Minister, says in addition to the initial aged care facilities that were carefully selected by health authorities, there would also be 16 “Pfizer vaccination hubs” at hospitals in major cities nationwide. A list can be found on the ABC.

Aged care facilities have been selected on a “risk basis”, as well as “making sure there’s diversity across urban and rural [areas].” As for the hubs, Health Department boss Brendan Murphy said they would be for quarantine workers, the “single most high-risk group at the moment”.

WA Premier, Mark McGowan, echoed the sentiment — saying quarantine and international border workers would be among the first in the state to be eligible for the vaccine.

“Our quarantine hotel workers, including hotel staff, cleaners, police, security and clinical staff working in our quarantine facilities are at higher risk of contracting the virus, so it makes sense that they are prioritised.” High-risk frontline health care staff in aged and disability care will also be eligible.

Rollout begins on Monday.

Update: Tuesday, February 16

The Therapeutic Goods Administration (TGA) has approved the Oxford University AstraZeneca coronavirus vaccine for use within Australia, for people aged over 18 years. There’s no upper age limit for the vaccine at this time.

It’s the second vaccine the TGA has approved, following the Pfizer vaccine last month. As for administration, the advice is for people to receive two doses, 12 weeks apart. If that’s not possible, at least four weeks between the two jabs need to be observed.

AstraZeneca has been shown to prevent COVID, and a recent study from Oxford University found that the vaccine appeared to cut transmission of coronavirus by 67%. It only needs to be stored at four degrees Celsius and can be stored in the fridge overnight to be used the following day.

Dr Karen Price, President of the Royal Australian College of General Practitioners, said: “Today’s announcement is a welcome milestone in the vaccine rollout, and protection of our community. Most Australians will get the AstraZeneca vaccine.

“GPs across the country overwhelmingly want to vaccinate their patients. There was a huge response to the Department of Health’s expression of interest with over 5000 practices applying to be a vaccination clinic.

“Initially, not all practices will be able to be involved in the vaccination program, but eventually the expectation is that it will be rolled out more widely, and more practices will become involved as supply increases. For now while we are in Phase 1, it’s critical that we can vaccinate as many of the highly vulnerable people as efficiently as possible. The logistics of later phases will be addressed as the roll-out progresses.

“We know there will be high demand for the vaccine, and I urge everyone to please be patient and understanding.

“We ultimately would like to see every practice that wants to provide these vaccinations to be able to do so. We need to get to the stage where COVID-19 vaccinations are part of usual patient care as soon as possible – especially if we want to finish this job by October, as the Government has said they want to.”

Original: Monday, February 15

It’s been over a year since COVID-19 was first identified, and 11 months since it was officially declared a pandemic. This time last year, you were probably hearing the phrase “It’s just a cold.” Well, a lot can change in a year. International travel has essentially been banned from Australia; we’ve had COVID-safe Christmases; friendships have gone long-distance; masks have become commonplace.

And all this time, we’ve been wondering: “When will I get the COVID vaccine?”. And as a new strain of COVID starts to infiltrate Australia and people are double masking, as the government is looking at just how COVID has affected our mental health, as we watch it roll out in other countries like the UK and the US, we continue to wonder: “Where is Australia’s COVID vaccine?”

Health Minister Greg Hunt originally said it was due “sometime” this week, but 142,000 doses have just arrived in Sydney.

If you’re wondering why the COVID vaccine so delayed, we cover that here, but essentially as our COVID rates have been low in comparison to other countries, Australia has chosen to wait. Why? So we can see just how the vaccine programmes work in other parts of the world, and if there are any long-term repercussions from the vaccines

The first shipment of the vaccine was the Pfizer vaccine, with 142,000 doses. Now they’ve arrived, they’ll be examined by the Therapeutic Goods Administration (TGA), to ensure “numbers are correct, vials are intact, seals [aren’t] broken, haven’t [suffered] damaged quality,” according to Hunt, reiterating that the number one priority is “safety, safety, safety.”

As for how they’ll be stored? DHL — which we’ve all gotten to know better through our pandemic shopping — is one of two companies that is tasked with transporting the vials. The company acquired new freezers for the specific purpose of storing the Pfizer vaccine, as it has to be stored at freezing cold temperatures between minus 60 and minus 80 degrees (yes, in Celsius). A necessity, being as we keep experiencing heatwaves. Each freezer can hold up to 140,000 doses.

As for who will receive them first? The vaccine rollout is in phases, and Hunt said the government is on track to begin vaccinating vulnerable and priority groups before the end of February. As Australia has an agreement with Pfizer, we’ll be receiving another 2.858 million over April, May and June.

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