CDC: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) in the United States have recommended a pause in the rollout of the Johnson & Johnson (J&J) COVID-19 vaccine. This recommendation comes following 6 reports of a rare type of blood clot (cerebral venous sinus thrombosis) in combination with a reduced number of platelets (thrombocytopenia) in individuals who have received the vaccine.
All 6 reports involved women aged 18–48 years, with symptoms developing 6–13 days following vaccination. Sadly one patient has died.
The CDC is urging all health care professionals to be on alert for symptoms of thrombotic events or thrombocytopenia in individuals who have recently received the J&J COVID-19 vaccine. It recognises that based on studies involving similar thrombotic events in those who were vaccinated with COVID-19 AstraZeneca, the use of heparin when treating such conditions should be avoided.
The CDC and FDA are currently reviewing all available information and will convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday April 14 2021, to further review these cases and assess potential implications on vaccine policy.
For more information and read the alert in full please follow the link below:
ABC News: ATAGI have told the Prime Minister to pull back on the AstraZeneca vaccine for under 50s and use Pfizer, but who are they?
The Australian Government’s recent decision to amend Australia’s vaccine program was based on the recommendation provided by ATAGI, following international evidence linking a rare blood-clotting condition to the AstraZeneca vaccine in younger people.
ATAGI is the Australian Technical Advisory Group on Immunisation. They provide recommendations to the Minister for Health regarding the National Immunisation Program (NIP) and other immunisation issues including immunisation research and immunisation policies, procedures and vaccine safety. Comprising of 14 medical experts, the group is co-chaired by Associate Professor Christopher Blyth, a specialist in paediatric infectious diseases, and Professor Allen Cheng, who specialises in epidemiology and public health.
This article summarises the role of ATAGI, including their recent recommendations to the Government regarding the AstraZeneca vaccine.
To read more follow the link below:
For more information on ATAGI, please refer to our MVEC reference page:
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 7th, 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:
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.
To read more follow the link below:
The Age: AstraZeneca decision adds to need for vaccine rollout clarity
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.
To read more follow the link below:
The Age: Victorian hospitals search for rare blood clots linked to AstraZeneca
CVU mini event 12th April 2021 - Registrations closing soon
Our next Clinical Vaccinology Update (CVU) mini event: Hot topics in vaccine science, will be held virtually on Monday 12th April, 2021 at 7pm AEST.
To view the full program and to register for this FREE event, please visit our Events page.
A recording of Hot topics in vaccine science will be available on our Education Portal following the event.
Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas
The World Health Organization (WHO) have released a medical product alert pertaining to a falsified COVID-19 vaccine identified as "BNT162b2" that has been detected in Mexico in February 2021, and which has been confirmed as falsified to the WHO. This product has been supplied and administered to patients external to authorised vaccination programs.
The alert has been issued as this falsified COVID-19 vaccine may still be in circulation which poses a risk to public health. Further details of the falsified vaccine and advice from the WHO can be found via the link to the full medical product alert below:
WHO: Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas
New immunisation reference page: COVID-19 vaccines and allergy
Suspected hypersensitivity reactions, particularly non-urticarial skin rashes following immunisation, are common, however true vaccine allergy, where a person is contraindicated from being immunised with the same vaccine in the future, is rare (in most studies reported as less than 1 case per million doses).
Post-licensure surveillance of COVID-19 vaccines show anaphylaxis following administration of COVID-19 AstraZeneca occurring at similar rates to routine vaccines. Anaphylaxis following Comirnaty™ (Pfizer/BioNTech), while still extremely rare, occurs at a slightly higher rate of approximately 4.7 cases per million doses.
A confirmed vaccine allergy usually requires a specialist consultation with a vaccine allergy specialist, often with specific testing or a vaccine challenge under supervision.
Find out more about allergies to COVID-19 vaccines, allergies to components of COVID-19 vaccines, and management of these allergies in our new immunisation reference page, COVID-19 vaccines and allergy.
ATAGI statement for health care providers on suitability of COVID-19 vaccination in people with history of clotting conditions
ATAGI have released a statement for health providers (25 March 2021) on the suitability of COVID-19 vaccination in people with a history of clotting conditions.
ATAGI note the World Health Organization (WHO), European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) have reviewed data from the millions of people who have received the AstraZeneca COVID-19 vaccine worldwide which demonstrates no increase in rates of general thromboembolic events post receiving this vaccine. Investigations are ongoing into whether or not there is a link with cerebral venous sinus thrombosis (CVST).
There have been no reported cases of CVST in Australia to date following vaccination.
The statement emphasizes that the benefits of the vaccine far outweigh this potential risk.
ATAGI continues to recommend vaccination with the AstraZeneca COVID-19 vaccine or Comirnaty (the Pfizer COVID-19 vaccine), including for people with a history of clotting conditions such as deep vein thrombosis (DVT), pulmonary embolism, thrombocytopenia, thrombophilic disorders, people on anticoagulants, people with a history of cardiovascular disease or people with risk factors for thrombosis such as smokers or those taking oral contraceptives.
For now, as a precautionary measure until further information from investigations in Europe is available, ATAGI recommend vaccination with any COVID-19 vaccine is deferred in people with a confirmed medical history of CVST and people with confirmed medical history of heparin induced thrombocytopenia (HIT).
Healthcare workers should continue to be alert for persistent, unexpected and/or severe adverse events, particularly in the 1-2 weeks following immunisation as with any vaccine, and report to their local vaccine safety service as required.
Read the full statement via the link below
The BMJ opinion: Restoring confidence after the covid-19 Oxford/AstraZeneca vaccine pause will be an uphill battle
In the past week several countries suspended or delayed the rollout of the Oxford/AstraZeneca COVID-19 vaccine whilst the European Medicines Agency (EMA) safety committee investigated whether or not the vaccine was linked to reports of thromboembolic events.
The EMA’s investigation concluded that the vaccine is safe and effective and not associated with an increased risk of blood clots, and that they will continue to monitor this (whilst noting that there is a possible link with very rare cases of blood clots associated with thrombocytopenia).
Professor Julie Leask notes that people’s willingness to have a vaccine is influenced by its perceived safety, and the suspension of vaccination programs, even if temporary, has long-lasting effects on public confidence. Even if a causal link is found between the Oxford/AstraZeneca COVID-19 vaccine and these thromboembolic events, the risks of these are likely outweighed by the risks of COVID-19. Currently, approximately 20,000 people die from COVID-19 in the European WHO region each week.
She further notes the impacts suspensions like these can have beyond the aversion of harm that is behind them.
Professor Leask suggests early and frequent updates as events happen, communication with empathy, messaging that caters to different levels of health literacy and prioritisation of healthcare worker information and reiterates the importance of research and development into vaccine uptake.
Read more via the link below: