&

Republicof the Philippines

Department of Health
OFFICE OF THE SECRETARY
March 4, 2021

DEPARTMENT CIRCULAR
No. 2021 - 0082,

TO : EN D TARIFE ANT
SECRETARIES; CENTERS FOR HEALTH DEVELOPMENT AND
ISTRY OF BANGSAMORO TONOMO REGION IN

SPECIAL TALTY HOSPITAL DIRECTORS;

_AND_SP CHIEFS O
MEDICAL CENTERS, HOSPITALS AND _SANITARIA;: AND
OTHER CONCERNED OFFICES
SUBJECT: A tion of the Philippin i f Allergy, Asthma Immunol
uidance on the Prevention, Diagnosis Managementand

f Immediate Severe Allergic Reactions ¢ VID-19 Vaccines

Department Memorandum (DM) No. 2021-0099 entitled, “Interim Omnibus

Guidelines for the Implementation of the National Vaccine Deployment Plan for COVID-19”
dated 23 February 2021 defines adverse event following immunization (AEFI) as any
untoward medical occurrence which follows immunization and which does not necessarily
have a causal relationship with the usage of the vaccine.

Interim guidelines on specific COVID-19 vaccines state that protocols for the
management of adverse events following immunization and adverse events of special interest
shall follow the provisions of the Emergency Use Authorization and other succeeding
guidelines of the Philippine FDA, the manufacturer, and other recognized professional
organizations and regulatory bodies, as new evidence arise.

In line with the above policies, this circular is being issued for the information and
guidance of all concerned stakeholders on the attached PSAAI protocol/ algorithm on the
prevention, diagnosis and management of immediate severe allergic reactions to COVID-19
vaccines.

For dissemination.

MARIA ROSARIO SINGH-YERGEIRE, MD, MPH, CESO IV

OIC-Underfecretary of Health

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila Trunk Line 8651-7800 local 1108, 1111, 1112, 1113
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph
 PSAAI Guidance on the Prevention, Diagnosis and Management of
Immediate Severe Allergic Reactions to COVID-19 Vaccines

February 9, 2021

This document and algorithm were developed by the Working Group on Anaphylaxis
of the Philippine Society ofAllergy, Asthma & Immunology (PSAAI).

Working Group members:

Julia C. de Leon, MD, Gwyneth Bautista-Velez, MD, Maria Carmen D.

Ang, MD,
Caroline C. Aquino, MD, Regina D. Capulong, MD, Mary Anne R. Castor, MD,
Aileen A. Elorde, MD, Caroline A. Tolosa-Gloria, MD, Roxanne Casis Hao, MD,
Aimee Lou M. Nano, MD, Irene Ngo-Liu, MD, Mary Ann Jean T. Patrimonio, MD,
Fatima Johanna T. Santos-Ocampo, MD, Felicia Racquel S. Tayag, MD, Marysia T. Recto, MD
INTRODUCTION

The COVID-19 pandemic has been the biggest global health challenge the world has faced. Globally, there are
more than 100 million reported cases with the death toll exceeding 2 million. In the Philippines, we have gone
beyond the 500,000 mark, leading to a major health and socio-economic crisis.

Scientists around the world have been working to develop, test and produce vaccines to address the spread
and decrease the mortality and morbidity of COVID-19. Several vaccines have already been rolled out in some
parts of the world. The Philippines has its own National COVID-19 Vaccination Program which is scheduled to
roll out before the end of the first quarter of 2021.

The first part of the document aims to present a model to stratify the risk for severe allergic reactions of
persons BEFORE receiving the COVID 19 vaccine based on their past medical and allergy history. Although any
person may develop an allergic reaction to a vaccine, based on current evidence, this model will define groups
of persons who will benefit from further evaluation prior to COVID 19 vaccination. This document and
algorithm was adapted from the 2021 statement ofthe European Academy of Allergy and Clinical Immunology!
on severe allergic reactions to COVID 19 vaccines and the German recommendations for allergy risk
assessment?,

The second part is an algorithm that enumerates the signs and symptoms of immediate allergic reactions.
Immediate medical and supportive management is described in a stepwise manner followed by
recommendations for disposition and further evaluation for future vaccination recommendations. Emergency
medications, supplies and equipment, as well as prompt recognition by trained emergency response personnel
are vital in the safe administration of the COVID 19 vaccines.

References:

1
Sokolowska M, et al. EAACI statement on the diagnosis, management and prevention of severe allergic
reactions to COVID-19 vaccines. Allergy. 2021 Jan 16.
2 Worm M, et al. Practical recommendations for the allergological risk assessment of the COVID-19
vaccination - a harmonized statement of allergy centers in Germany. Allergol Select. 2021 Jan 26;5:72-76.
 Allergy Risk Assessment for COVID 19 Vaccination

Those with immunodeficiency and Those with an immediate (within 4

Those with no history of allergic
autoimmune disease (e.g. Guillain- hours) allergic reaction, whether
— diseases or previous severe
Barre Syndrome, Bell's palsy) mild (eg rashes) or severe (e.g.
general reactions anaphylaxis) to COVID-19 vaccine
treated by a physician
after the first dose

Those with allergic reactions (of Those with an an allergic reaction

any severity) to food, inhalant/ or anaphylaxis (within 4 hours) to
environmental allergens, insects, any COVID 19 vaccine excipients
latex, oral medications, not such as polyethylene glycol
related to vaccines and their Those with uncontrolled asthma (PEG), also found in colonoscopy
or mast cell disorders
components preparation or laxatives; or to
polysorbate, also found in
vascular graft materials, surgical
Those with well-controlled
gels, PEGylated medications
asthma and on inhaled
corticosteroids, and those with
allergic rhinitis on intranasal Those with an immediate (within 4 hours)
corticosteroids allergic reaction, such as urticaria,
|__ angioedema, difficulty
of breathing,
regardless of severity, to any OTHER
vaccine or injected therapy
 DIAGNOSIS MANAGEMENT OF &
SEVERE ALLERGIC REACTIONS AFTER
COVID-19 VACCINATION
13 ma, anc

VACCINATION
Observe for at least 30 minutes

If patient develops the following SYMPTOMS:

progresses
in minutes

Ifisolated &
not ’
patient in a reclining po:
progressing ADMINISTER EPINEPHRINE (ADRENALINE)

+ Antihistamines
(oral/IV)
TT BURT
+
TIO ER EET
INTRAMUSCULARLY ONLY
+ Glucocorticoids !
+ thigh even
mid-outer
(oral/Iv)
Observation 4 hours
A

it throug! othing

% NaCl (10-20 mi/min)

OXYGEN via fa the LPM)

Discharge 4-8
ster

—
hours after full GLUCOCORTICOID (Hydr
Resolved ster

LUGE EVAL
eT
resolution of 5
l

+
symptoms
Refer to Allergy [TTT
Service for consult

Call emergency assistance

Not resolved depending on your location

| IF
| IF
| IF

Blood pressure dropsS

I :]
No improvement Bronchospasm
:
Cle) 3000 mi of @W
T

Bi EPINEPHRINE
INTRAMUSCULARLY
» +

+
Salbutamol MDI
4-10puffs via large
volume spacer

symptoms are
l symptoms
If If
fully resolved ! continue

Discharge after 24 hours Transfer to ICU

+
ADVISE AGAINST second planned SARS-CoV2
vaccination until cleared by Allergy Service

Adapted from: Sokokwska M, et al EAACI statement on the diagnosis, management and prevention of severe albergic reactions fo COVID-9 vaccines. Alergy. Jon 16, 2021