Newfoundland and Labrador has suspended its use of AstraZeneca vaccine in anyone under 55. REUTERS
By Peter Jackson, Local Journalism Initiative Reporter, The Telegram
March 29, 2021
Newfoundland and Labrador is joining other provinces in Canada in halting the administration of AstraZeneca vaccine injections while further investigation is undertaken into the potential for a rare blood-clotting disorder.
“At this time, we are pausing the provision of AstraZeneca vaccine to adults under 55 years of age pending further risk analysis from the U.K. and Europe,” Chief Medical Officer of Health Dr. Janice Fitzgerald said late Monday during a COVID-19 briefing in St. John’s.
Reports in Europe and the U.K., where at least 20 million doses have been administered so far, have found rare instances of a potentially deadly event called vaccine-induced prothrombotic immune thrombocytopenia (VIPIT)
Fitzgerald said the rate so far ranges anywhere from one in 100,000 to one in a million, but that no cases have been reported in Canada so far.
The type of AstraZeneca used in Canada is called COVIDSHIELD, and Health Canada has asked the manufacturer to provide more information.
Although the condition appears to be more common in women, Fitzgerald said it’s unknown whether that’s because more women have received the vaccine.
She said the adverse event does not appear to occur in those 55 and older, hence the decision to continue doses to that age group.
She said first responders who are booked for vaccines over the next week will still receive the “appropriate” vaccine, depending on age.
“For anyone who has already received their first dose, please remember that it is still a very effective vaccine that will protect from severe illness and hospitalization as a result of COVID-19,” She said. “The risk of an adverse occurrence is very rare.”
Anyone who has already received a dose will be contacted and given information on the situation, she said.
Anyone who received a dose within the last 20 days should seek attention if they expereience any of the following: shortness of breath; chest pain; leg swelling; persistent abdominal pain; sudden onset of severe or persistent worsening headaches; blurred vision; skin bruising (other than at the site of vaccination).
Simmering concerns
Concerns about blood clots have been simmering for weeks, although most health agencies have said the connection to AstraZeneca is very tenuous.
Two weeks ago, the assessment committee of the European Medicines Agency issued a review of the vaccine in which it said there was no provable risk of blood clot.
The Dutch government suspended its use two weeks ago and will reassess the situation this week. Ireland, Denmark, Norway, Bulgaria and Iceland also halted inoculations, while some European countries suspended the use of certain batches of the drug as a precautionary measure.
On Thursday, the European Medicines Agenecy announced it is convening an ad hoc expert group this week to provide additional input into the assessment. External experts in hematology (thrombosis and hemostasis), cardiovascular medicine, infectious diseases, virology, neurology, immunology and epidemiology will provide their views on aspects such as any plausible mechanism of action, possible underlying risk factors and any additional data needed to gain a deeper understanding of the observed events and the potential risk.
Meanwhile, Newfoundland’s Department of Health and Community Services issued the following background to clarify its actions.
Should people who have received the vaccine be concerned?
“Vaccine-induced prothrombotic immune thrombocytopenia is very rare. To date, there have been no cases of vaccine-induced thrombosis associated with the use of this vaccine in Canada. At this time, we do not know if certain patients are more likely to get VIPIT. So far, most of the cases from Europe have occurred in women under age 55 — but many of these countries used more of their initial AstraZeneca vaccine supply in women under age 55. We do not believe that VIPIT is more common in people who have had blood clots before, people with a family history of blood clots, people with low platelets or pregnant women, because VIPIT does not develop through the same process as usual types of bleeding or clotting problems.
Should someone who has received the AstraZeneca vaccine call their doctor?
“You should speak to a health-care professional if you have unusual or severe symptoms after (receiving) any COVID-19 vaccine. In the rare event that you develop symptoms starting four to 20 days after vaccination, those who have been vaccinated with AstraZeneca should seek immediate medical attention. Based on current evidence, for those individuals who have already been vaccinated with AstraZeneca more than 20 days ago there is no cause for concern.
What should you do if you have concerning symptoms after the AstraZeneca COVID-19 vaccine?
“You should speak to a health-care professional if you have unusual or severe symptoms after any COVID-19 vaccine. If your symptoms are not severe, you can see (virtually or in-person) your primary care professional. If you have severe symptoms, you should go to the nearest emergency department immediately. You should tell the health-care providers who see you that you received the AstraZeneca COVID-19 vaccine and give them the date you got vaccinated. If the health-care professional who assesses you is concerned, you may have scans and additional bloodwork collected.
Do health-care professionals know how to diagnose and treat vaccine-induced prothrombotic immune thrombocytopenia?
“Yes. Health-care professionals and scientists in Newfoundland and Labrador have been working with experts in Canada, and around the world, to better understand vaccine-induced prothrombotic immune thrombocytopenia. Public Health has summarized what we know about VIPIT right now and has published guides for health-care professionals outside and inside the hospital, to help them diagnose and treat VIPIT.
What do we know so far?
“The United Kingdom, European Union and Scandinavian countries have reported that the AstraZeneca COVID-19 vaccine appears to be associated with rare cases of serious blood clots, including blood clots in the brain. These blood clots have two important features: they occur four to 20 days after vaccination, and they are associated with low platelets (tiny blood cells that help form blood clots to stop bleeding). Doctors are calling this “vaccine-induced prothrombotic immune thrombocytopenia” (VIPIT). VIPIT seems to be rare, occurring in anywhere from one in every 125,000 to one in 1 million people.
“Health Canada has stated that the AstraZeneca COVID-19 vaccine continues to be safe and effective at protecting Canadians against COVID-19 and encourages people to get immunized with any of the COVID-19 vaccines that are authorized in Canada.
Will those who have received a first dose of AstraZeneca receive a second dose?
“Decisions on the type of second dose that will be offered to those who have been vaccinated with AstraZeneca vaccine will be determined based on the latest evidence and research. The National Advisory Committee on Immunization (NACI) will review evidence as it emerges to provide advice to public health programs on the potential for completing the vaccine series with other vaccine products. For now, you do not need a second dose for up to 16 weeks from your first dose.
Why is Newfoundland and Labrador still using the AstraZeneca COVID-19 vaccine?
“Health Canada reviewed the AstraZeneca COVID-19 Vaccine, as well as a similar vaccine called COVISHIELD. They have stated that the benefits in protecting Canadians from COVID-19 continue to outweigh the risks and encourage Canadians to get immunized with any of the COVID-19 vaccines that are authorized in Canada when they are eligible. Keep in mind that COVID-19 has killed over 22,000 Canadians so far, that about one in 100 Canadians who get COVID-19 end up needing intensive care, and that one in five Canadians who are hospitalized with COVID-19 develop blood clots. Currently Canada is experiencing a third wave of COVID-19. Vaccine-induced prothrombotic immune thrombocytopenia is very rare, while the AstraZeneca vaccine has proven effective at reducing severe illness from COVID-19. Health-care professionals, scientists and government agencies in Canada — and around the world — will continue to monitor the safety of this and all vaccines.
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Could other COVID-19 vaccines available in Newfoundland and Labrador cause vaccine-induced prothrombotic immune thrombocytopenia?
“There have been no confirmed cases of vaccine-induced prothrombotic immune thrombocytopenia with any other COVID-19 vaccine.”
