Adverse Reactions to COVID-19 Vaccines
by Prof. Stanley Fineman
Safety Management of COVID-19 Vaccines
by Prof Mariana Castells
PSAAI Public Information on COVID Vaccines
APAAACI TASK FORCE MODULE COVID-19 VACCINE ADVERSE REACTIONS
APAAACI COVID-19 ONLINE MODULE FOR PUBLIC
APAAACI 2021 RECOMMENDATIONS
ADVERSE REACTIONS TO COVID-19 VACCINES
1. The COVID-19 pandemic and its socio-economic fallout pose great risks to migrants in the Asia-Pacific, a new United Nations report reveals. They are more likely to be exposed to the virus, lack access to health care and other essential services, be stranded in countries without work or social protection and face rising xenophobia. However, as essential workers and remittance providers, migrants are also key to recovering better.
2. Globally, the virus has infected more than 74 million people and killed more than 1.6 million. More than 41.9 million people have recovered from the disease.
3. Allergic diseases are a major global health burden affecting both developed and developing countries. 
4. Although, allergic diseases and asthma are not a major comorbidity of COVID-19 , safety issues are a matter of concern in those with drug allergies or prior history of anaphylaxis to drugs /vaccines, and guidance on these safety aspects are crucial. 
5. Hypersensitivity and allergic disorders are classified internationally according to the World Allergy Organization (WAO) 2003 Nomenclature  and the International Classification of Diseases (ICD-11) Chapter .
6. The latest definition and classification of anaphylaxis has been published in the WAO Anaphylaxis Guideline 2020. Most vaccine adverse reactions are reported according to the classification of the Brighton Collaboration Working Group by various pharmacoregulatory agencies.
7. An international consensus on vaccine allergy and guidance have previously been published.
8. Allergic reactions including anaphylaxis as defined by the Brighton Collaboration Working Group was used as part of the Vaccine Adverse Event Reporting System (VAERS)  where based on spontaneous reporting, 21 cases of anaphylaxis after 1,893,360 first doses of Pfizer-BioNTech (11.1 cases per million doses) were reported, with 71% of cases occurring within 15 minutes of vaccination.
9. During December 21, 2020-January 10, 2021, monitoring by the VAERS detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million doses administered. In 9 cases, onset occurred within 15 minutes of vaccination. No anaphylaxis-related deaths were reported.
10. The United States Centres for Disease Control and Prevention (CDC) Guidelines dated 31 Dec 2020 lists the following vaccine contraindications: 
Severe allergic reaction to any ingredient in an mRNA COVID-19 vaccine
Severe allergic reaction after getting the first dose of an mRNA COVID-19 vaccine
An immediate allergic reaction (even if it was not severe) to any ingredient in an mRNA COVID-19 vaccine
An immediate allergic reaction after getting the first dose of an mRNA COVID-19 vaccine
Allergy to Polyethylene Glycol (PEG) or polysorbate. Polysorbate is not an ingredient in the mRNA COVID-19 vaccine, it is closely related to PEG, which is in the vaccines. 
11. CDC’s position on individuals with an immediate allergic reaction (even if not severe) to a vaccine or injectable therapy for another disease is to consult a doctor to help decide if it is safe to get vaccinated. 
12. The UK Medicines and Healthcare products Regulations Agency (MHRA) and National Health Services (NHS) England’s updated guidance on 30 Dec 2020 following close surveillance of the initial roll-out has allowed anyone with a severe history to food, an identified drug or vaccine, or an insect sting to receive the vaccine as long as they are not known to be allergic to any component (excipient) of the vaccine.
13. Other professional societies, e.g. European Academy of Allergy Asthma and Clinical Immunology (EAACI) ARIA have also published their statement on the diagnosis, management and prevention of severe allergic reactions to COVID-19 vaccines.
14. Erythema multiforme, Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rarely reported after vaccination, most commonly in the paediatric studies. There remains little evidence as to whether an individual with previous drug-induced SJS/TEN needs to avoid this mRNA vaccine.
15. Healthcare providers vaccinating against COVID-19 are required to be sufficiently prepared to recognize and treat anaphylaxis properly in line with current recommendations on standard of care.[17,18]
16. Observation period: Persons without contraindications to vaccination who receive an mRNA COVID-19 vaccine should be observed for 30 minutes after vaccination. 
17. The proposed diagnostic evaluation of persons with suspected mRNA vaccine allergic reactions include:
a) A detailed history of the temporal relationship between vaccination and onset of symptoms and signs of an acute allergic reaction
b) Detailed history of other potential triggers and cofactors for anaphylaxis
c) Detailed recall of exposure to PEG or polysorbate containing medications
d) Risk stratification to determine expanded skin testing for high-risk persons
e) Skin testing (skin prick and intradermal tests) using reference medications containing PEG3350 or polysorbate
18. Health agencies warn that mass vaccination will not stop the virus and that governments need to adopt a long-term mindset and approach when new cases are detected, including increased testing, contact tracing and quarantine measures.
19. However many questions remain to be answered. What are the correlates of protective immunity after natural infection or vaccination? How long will immunity last? Will widespread immunity limit the spread of the virus in the population? Which component of the vaccine is responsible for allergic reactions? Are some vaccines less likely than others to cause IgE- and non-IgE–mediated reactions? 
20. Careful vaccine-safety surveillance over time, paired with elucidation of mechanisms of adverse events across different SARS-CoV-2 vaccine platforms, will be needed to inform a strategic and systematic approach to vaccine safety. 
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10. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine – United States, December 14-23, 2020. MMWR Morb Mortal Wkly Rep. ePub: 6 January 2021, DOI: https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm?s_cid=mm7002e1_w
11. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine – United States, December 21, 2020-January 10, 2021. MMWR Morb Mortal Wkly Rep. ePub: 22 January 2021. DOI: https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm?s_cid=mm7004e1_w
12. CDC COVID-19 Vaccines and Allergic Reactions (updated 31 Dec 2020, accessed on 10 Jan 2021): https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html
13. ACAAAI Guidance on Risk of Allergic Reactions to mRNA COVID-19 Vaccines (updated 8 Jan 2021, accessed on 10 Jan 2021): https://acaai.org/news/acaai-provides-further-guidance-risk-allergic-reactions-mrna-covid-19-vaccines
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19. Banerji A, Wickner PG, Saff R, Stone CA Jr, Robinson LB, Long AA, Wolfson AR, Williams P, Khan DA, Phillips E, Blumenthal KG. mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. J Allergy Clin Immunol Pract 2020 Dec 31:S2213-2198(20)31411-2. https://www.sciencedirect.com/science/article/pii/S2213219820314112?via%3Dihub
APAAACI Task Force : Chairs: Ruby Pawankar and Bernard Thong
Members: Jiu Yao Wang, Amir HA Latiff, Marysia T Recto, Rommel Lobo,
Iris Rengganis, Randeep Guleria