This post has been updated

BY PAMELA FAYERMAN

In the last post by pharmaceutical expert Lu-Ann Murdoch, she reviewed proper inoculation techniques for deltoid injections. Since COVID-19 vaccinations are going into deltoid muscles, those doing the shots – and individuals getting them – should know exactly how it should be done, especially to avoid or minimize subsequent shoulder pain.

In the article below, Murdoch discusses the confusing matter of allergic reactions to the Pfizer-BioNTech vaccine and whether individuals who’ve had anaphylactic reactions to anything in the past should avoid that vaccine altogether.

In Britain, authorities have updated their instructions because of some reports of anaphylaxis after the Pfizer-BioNTech vaccine. Canada has made the matter more ambiguous for individuals, advising them to talk to their doctors first if they have a history of serious allergic reactions to anything or allergies to any of the ingredients in the vaccines. First, many individuals don’t have regular family doctors and second, most people would have no way of interpreting the medicinal or non-medicinal ingredients.

In the U.S., the CDC now recommends that anyone with a history of immediate allergic reaction of any severity to a previous dose of, or any component of, an mRNA COVID-19 vaccine, or to polysorbate, should not be vaccinated with either of the mRNA vaccines. That means that anyone who has developed a severe allergic reaction after a first dose of mRNA COVID-19 vaccine should not receive a second dose. Polysorbate is not an ingredient in the vaccine, but people who are allergic to it may potentially react to polyethylene glycol in the vaccine since it is closely related. The CDC vaccine fact sheets and many other online sources provide lists of ingredients for each vaccine.

The CDC defined an immediate allergic reaction as: hives, swelling away from the site of the injection, respiratory distress such as wheezing or shortness of breath, or passing out within four hours after the injection. Most allergic reactions occur within 15 to 30 minutes. Non-allergic side effects can include fever, chills or fatigue, usually one to three days after vaccination.

Canada should follow the lead of the U.K. and the U.S. to give clear advice. The federal government has posted some data about adverse events related to the vaccinations up to Jan. 8 when there were 24 reported, 10 of them considered serious. The serious reactions represent 0.003% of all doses delivered to individuals across Canada to that date – about 340,000.

The article below is republished with permission from The Medical Post.

BY LU-ANN MURDOCH

As immunization begins with the Pfizer-BioNTech COVID-19 vaccine for high-priority patients across Canada, some individuals may be hesitant to receive the vaccine due to media reports of two cases of anaphylaxis following use of the vaccine in Britain.

Both patients had a history of severe allergic reactions and carried epinephrine autoinjectors, and both received prompt treatment and fully recovered.(1,2)

U.K. guidance

On Dec. 9, 2020, Dr. June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. noted the agency has issued updated guidance to COVID-19 vaccination centres, subsequent to the two reports of anaphylaxis and one report of a possible allergic reaction following immunization with the Pfizer-BioNTech COVID-19 vaccine.(2)

The new U.K. guidance specifies that “Any person with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine. A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine.”(2)

Dr. Raine confirmed that, “Anaphylaxis is a known, although very rare, side effect with any vaccine. Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks. Anyone due to receive the vaccine should continue with their appointment and discuss any questions or medical history of serious allergies with the healthcare professional prior to getting the jab.”(2)

The U.K. MHRA stresses that vaccine recipients should be monitored for 15 minutes after vaccination, with a longer observation period when clinically indicated. In addition, a protocol for the management of anaphylaxis and an anaphylaxis kit must always be available whenever the Pfizer/BioNTech vaccine is given.(2)

Health Canada’s stance

In a Dec. 12, 2020 public advisory, Health Canada recommends patients with allergies to any of the ingredients in the Pfizer-BioNTech COVID-19 vaccine (COVID-19 mRNA vaccine) should not receive it. The full list of ingredients can be found in the vaccine’s Canadian product monograph.(1, 3)

Health Canada also advises patients to speak with their healthcare professional about any serious allergies or other health conditions before receiving the vaccine.(1) The agency points out that all vaccines in Canada carry a warning about the risk of serious allergic reactions, including anaphylaxis, and immunization clinics must be equipped to manage these rare events.(1)

Information in the product monograph

Health Canada concludes the current product monograph for the Pfizer-BioNTech COVID-19 vaccine contains appropriate guidance about the rare risk of anaphylaxis; therefore, no changes are currently being recommended to the product’s use. This means Health Canada is not specifically advising patients with a previous anaphylactic reaction to avoid the vaccine; rather, patients should notify their healthcare provider of any history of anaphylaxis and discuss the situation with their healthcare provider before receiving the Pfizer-BioNTech COVID-19 vaccine.(1)

Health Canada will continue to monitor for any adverse events of the Pfizer-BioNTech COVID-19 vaccine and will take action if any new safety issues are identified.(2, 4) The manufacturer (Pfizer Canada ULC and BioNTech Manufacturing GmbH) is legally required to submit reports of vaccine adverse events to Health Canada.(4)

Vaccine injury support program announced

In related news, on December 10, 2020, Canada’s federal government announced that the Public Health Agency of Canada will be implementing a pan-Canadian no-fault vaccine injury support program for all Health Canada-approved vaccines, in collaboration with the provinces and territories. The program will ensure that Canadians have access to support in the rare event they experience a serious adverse reaction to a vaccine.(5)

Initial vaccine supplies 

Health Canada has also announced that the Pfizer/BioNTech vaccine will initially be supplied with English-only labels on the cartons and vials in order to expedite the global distribution of the vaccine. The vial and/or carton labels include the statements “For use under Emergency Use Authorization,” which is U.S.-specific information that should be disregarded as it does not apply to Canada.(6) As Canadian-specific information is missing from the vial and carton labels, it’s important for healthcare providers to consult the Canadian product monograph for the vaccine to obtain complete product information.(3) Vaccine supplies with Canadian-specific labelling in French and English will be available as soon as feasible.(6)

References

  1. Government of Canada. Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies. December 12, 2020. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php (accessed December 14, 2020).
  2. Medicines and Healthcare products Regulatory Agency. Confirmation of guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine [press release]. December 9, 2020. https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine (accessed December 14, 2020).
  3. Pfizer Canada. Pfizer-BioNTech COVID-19 Vaccine (COVID-19 mRNA vaccine, suspension for intramuscular injection) product monograph. Kirkland, QC; December 9, 2020. https://pdf.hres.ca/dpd_pm/00059112.PDF (accessed December 14, 2020).
  4. Government of Canada. Pfizer-BioNTech COVID-19 vaccine: what you should know. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html#a4 (accessed December 14, 2020).
  5. Government of Canada. Government of Canada announces pan-Canadian Vaccine Injury Support Program. December 10, 2020. https://www.canada.ca/en/public-health/news/2020/12/government-of-canada-announces-pan-canadian-vaccine-injury-support-program.html (accessed December 14, 2020).
  6. Government of Canada. Authorization of Pfizer-BioNTech COVID-19 vaccine with English-only carton and vial labels. December 12, 2020. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74541a-eng.php (accessed December 14, 2020).