COVID-19

Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine

The COVID-19 subcommittee of the World Health Organization (WHO) Global Advisory Committee on Vaccine Safety (GACVS) have released an interim statement on vaccine safety on AstraZeneca COVID-19 vaccine.

The subcommittee met on April 7^{quần què}, 2021, and reviewed the latest information on rare cases of blood clots with thrombocytopenia from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and other Health products Regulatory Agency (MHRA).

They found that a causal relationship between the vaccine and cases of blood clots with thrombocytopenia is plausible (but not confirmed) and warrants further studies. They will continue to review data and note the rarity of this condition, with low numbers reported in the 200 million people who have received this vaccine globally. The subcommittee further noted that 2.86 million people have died of COVID-19 around the world and rare events such as this should be assessed in the context of the risk of death from COVID-19 and the potential for the vaccine to prevent infection and death.

The subcommittee noted mild side effects are common in the 2-3 days post vaccination, however people with severe symptoms between 4-20 days post immunisation such as shortness of breath, chest pain, leg swelling, neurological symptoms or persistent abdominal pain should seek medical attention immediately. They note active surveillance should be considered and have developed template protocols for countries to adopt.

The subcommittee will continue to monitor the rollout of COVID-19 vaccines and note the importance of addressing and investigating safety concerns.

To read the full statement, please refer to the link below:

Interim statement of the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety on AstraZeneca COVID-19 vaccine

qua Alice đen

The Age: AstraZeneca decision adds to need for vaccine rollout clarity

On Thursday evening, the Australian Government made amendments to Australia’s vaccine program based on international evidence linking a rare blood-clotting condition to the AstraZeneca vaccine in younger people, with Pfizer now being the preferred vaccine for people under the age of 50.

The Australian government has chosen not to be definitive in their advice; instead they have left the choice regarding which vaccine should be administered to individual Australians in consultation with their GP. The AstraZeneca vaccine will still be available for people under the age of 50 on a case-by-case basis, with vaccinations of elderly Australians continuing as planned.

As evidenced by these recent changes, providing timely, factual and transparent information – even if this information does not include clear rules or definitive advice – remains paramount in ensuring public trust in the Australian vaccination program.

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The Age: AstraZeneca decision adds to need for vaccine rollout clarity

qua Alice đen

ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns

Following investigations nationally and internationally into a rare blood clotting condition known as Huyết khối với Hội chứng giảm tiểu cầu (TTS) occurring in people who have received COVID-19 AstraZeneca, ATAGI have provided updated advice for the administration of COVID-19 vaccines in Australia.

ATAGI recommends that Comirnaty™ is the preferred brand for immunisation of those under 50 years of age who have not already received dose 1 of COVID-19 AstraZeneca, with COVID-19 AstraZeneca available for immunisation of those over 50 years of age. Individuals who have had their first dose of COVID-19 AstraZeneca without any serious adverse events can proceed with the second dose. COVID-19 AstraZeneca can continue to be used in adults aged under 50 years where the benefits are likely to outweigh the risks for an individual (an informed decision can be made following a discussion on the risks and benefits).

TTS is a newly described serious condition, which presents with unusual blood clots (thrombosis) in the brain or other parts of the body, accompanied by a low number of platelets (thrombocytopenia). It has been noted to develop 4-20 days following vaccination with COVID-19 AstraZeneca. Global reports show TTS may occur in approximately 4-6 people per million doses delivered, with 1 case recorded in Australia to date. It is noted to predominantly occur in younger adults however there have been some cases reported in older vaccine recipients. So far there has been no pre-existing conditions or biological factors identified that may predispose or decrease the risk of someone developing TTS.  The exact mechanism leading to this condition is not fully understood however antibodies (anti-PF4 antibodies) that activate platelets have been detected in some people who have developed TTS. These antibodies have also been detected in people with similar symptoms following administration of the drug heparin (heparin induced thrombocytopenia).

ATAGI has made this recommendation after considering the current level of community transmission of COVID-19 disease in Australia, as well as the likely severity of disease according to age if exposed to COVID-19. Should the level of risk change or more information becomes available these recommendations may change. ATAGI continues to recommend all adults be vaccinated against COVID-19 as the virus continues to cause severe disease globally.

To read the advice in full refer to:

ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns

qua Rachel McGuire

The Age: Victorian hospitals search for rare blood clots linked to AstraZeneca

Victorian hospitals are retrospectively reviewing patient records to determine if there have been further cases of patients presenting with a rare blood clotting disorder, temporally associated with the administration of COVID-19 AstraZeneca. A 44 year old health care worker in Victoria recently presented with abdominal pain, low platelet count and thrombosis, 12 days after being immunised. This follows reports of similar cases internationally where investigations by medical regulators are ongoing.

Professor Jim Buttery from SAEFVIC (Victoria's vaccine safety service) suggests that it is unlikely that there would be many undetected cases due to the clotting disorder being so rare.

The TGA and ATAGI have recommended the continued rollout of the AstraZeneca vaccine whilst investigations continue, and considers the benefit of vaccination outweighs any potential risks. ATAGI has urged anyone receiving COVID-19 AstraZeneca to be on alert for severe persistent headaches that are not resolved with over the counter pain relief. Health care professionals are advised that the threshold for reporting adverse events is low, with all serious adverse events thoroughly reviewed by an expert panel.

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The Age: Victorian hospitals search for rare blood clots linked to AstraZeneca

qua Alice đen

Updated ATAGI statements on a specific clotting condition being reported after COVID-19 vaccination

Following a report in Australia of a rare blood clotting condition in a person who received COVID-19 AstraZeneca, ATAGI have released a statement for consumers and an updated statement for health providers.

Internationally, a small number of cases of thrombosis (blood clots) with associated thrombocytopenia (low platelet count) have been reported in the time period 4-20 days following vaccination. These cases have either presented as central venous sinus thrombosis (CVST) or thrombosis in other sites, such as intra-abdominal venous systems.

Vaccination against COVID-19 disease continues to be of high importance in groups who are most at risk of disease exposure or disease complications. Common or expected side effects of vaccination include headache, muscle aches, fever and chills, with onset typically beginning within the first 24 hours and symptoms lasting 1-2 days.

Health care providers and vaccine recipients are encouraged to be alert for any new, severe, persistent headache or other significant symptoms, such as severe abdominal pain, features of raised intracranial pressure (severe headache, vomiting, confusion) or neurological deficits with an onset between 4 to 20 days after vaccination. In suspected cases a referral to hospital is recommended and the appropriate investigations (full blood count, D-dimer, fibrinogen) and imaging completed.

Patients suspected to have this condition should not receive heparin or platelets.

As a precaution, anyone with a past history of CVST or heparin induced thrombocytopenia (HIT) is not recommended to receive the COVID-19 vaccine until further information is available. Investigations internationally and within Australia are ongoing.

To read the statement for consumers in full please refer to the link below:

ATAGI statement for consumers on a specific clotting condition being reported after COVID-19 vaccination

To read the the updated advice for health providers please refer to the link below:

Updated ATAGI statement for healthcare providers on a specific clotting condition being reported after COVID-19 vaccination

qua Rachel McGuire