The HTAC recommends the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 for persons aged 16 and older within identified priority groups.
Pfizer-BioNTech COVID-19 Vaccine under emergency use
The Food and Drug Administration (FDA) issues emergency use authorization (EUA) for unregistered vaccines and drugs during public health emergencies. This authorization expedites the availability of interventions for affected populations. Before issuing EUA, regulatory agencies consider quality, safety, and efficacy criteria. All vaccines must first receive EUA before use for immunization. On the other hand, the HTAC needs to give a positive recommendation for the vaccine before it can be used in the National Immunization program or be included in the COVID benefit package of PhilHealth.
The Health Technology Assessment Council (HTAC) recommends the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to reduce the burden of COVID-19 among individuals 16 years and older, prioritizing the most at-risk and vulnerable populations. The Council considered the best available scientific evidence in this interim analysis and recommendation. The vaccine prevents symptomatic COVID-19 infection in the short term, with benefits outweighing risks. Researchers worldwide continue to collect and monitor data to establish its long-term efficacy, safety and its potential to reduce COVID-19 transmission.
Who should receive the vaccine?
Persons belonging to identified priority groups and aged 16 or older may receive the Pfizer-BioNTech COVID-19 vaccine.
Who should NOT receive the vaccine?
- Persons with history of anaphylaxis or allergic reactions (of any severity) to any mRNA COVID-19 vaccine ingredient (such as Polyethylene glycol [PEG] or other related molecules) that occur within 4 hours from vaccination
- Persons with history of anaphylaxis or allergic reactions (of any severity) that occur within 4 hours after receiving the first dose of the vaccine
- Persons under 16 years of age
What is the composition of the vaccine?
The lipid nanoparticle-formulated, nucleoside-modified mRNA Pfizer-BioNTech COVID-19 Vaccine encodes the pre-fusion spike glycoprotein unique to SARS-CoV-2 to trigger an immune response and prime our bodies against infection. The vaccine is non-infectious as it does not contain inactivated pathogen particles.
What adverse reactions have been reported in the use of this vaccine?
Reported adverse events
After receiving a previous dose of any mRNA vaccine or any of its components, reported side-effects for persons with a history of severe hypersensitivity reactions include:
- Severe allergic reaction or anaphylaxis
- Hypersensitivity (such as respiratory distress [wheezing, stridor], urticaria, or angioedema) or allergic reaction of any severity to previous mRNA vaccine dose or its components, occurring 4 hours after administration*
- Allergic reaction of any severity to polysorbate, occurring 4 hours after administration**
*such as PEG
**potential cross-reactive hypersensitivity with vaccine ingredient PEG
What precautions should be considered before administering the vaccine?
- For those with a history of immediate allergic reaction or hypersensitivity to any other injectable therapy, such as intramuscular, intravenous, or subcutaneous vaccines unrelated to a component of mRNA COVID-19 vaccines, treatment for severe allergic reactions must be made available.
- For those with concurrent moderate to severe acute illness, for immunocompromised persons, Persons Living with HIV (PLHIV), persons with other autoimmune conditions, and those with a history of Bell’s palsy, vaccination may be subject to physician advice.
- For pregnant and breastfeeding women excluded from other priority groups, vaccination may be subject to physician advice.
How should the vaccine be stored?
Our national COVID-19 vaccination program follows the World Health Organization (WHO)-prescribed cold chain storage protocol for mRNA vaccines.
- The Pfizer-BioNTech COVID-19 vaccine shall arrive in thermal shipping containers with dry ice, and diluent and ancillary supply kits packaged separately.
- Store vaccines within temperatures between -80°C and ‑60ºC using an ultra-cold freezer.
How should the vaccine be prepared before administration?
General Information and Preparation for Pfizer-BioNTech COVID-19 Vaccine
Diluent: 0.9% preservative-free sodium chloride or normal saline
Multidose vial: Up to 6 doses per vial
Dosage: 0.3 ml
The vaccine must be mixed with diluent before administration.
Thaw the Pfizer-BioNTech COVID-19 vaccine:
- At room temperature up to 25°C from 30 minutes to 2 hours (Must be mixed within the period or returned to the refrigerator); or
- In the refrigerator from 2°C to 8°C (fewer vials will take less time to thaw)
DO NOT refreeze thawed vaccine.
Preparing the vaccine
- Assess recipient status. Screen for potential contraindications and precautions, and review their vaccination history.
- Observe aseptic techniques. Perform hand hygiene before preparing the vaccine, between recipients, when replacing gloves*, and at any other time hands become soiled.
- Thaw the vaccine. Remove the vaccine from the freezer and allow it to reach room temperature for up to 2 hours before mixing. After 2 hours, return unmixed vials to the refrigerator. DO NOT refreeze thawed vials.
- NEVER use expired vaccines or diluent. Check vaccine and diluent expiration dates before mixing.
- Upon reaching room temperature, gently invert the vaccine 10 times. Do not shake the vial; otherwise, discard when shaken.
- NEVER use vials with discolored liquid. The vaccine appears white to off-white and may show opaque particles.
- Wipe off diluent and vaccine vial stoppers using new, sterile alcohol prep pads.
- Extract 1.8 mL of 0.9% sodium chloride (normal saline, preservative-free) with a 21-gauge (or narrower) needle into a mixing syringe.
- Discard any remaining diluent and its vial after use. Do NOT save the remaining vaccine diluent for mixing additional vaccines or any other use.
- Do NOT use diluents other than normal, preservative-free saline to mix the vaccine.
- Inject 1.8mL 0.9% normal, preservative-free sodium chloride diluent into the vaccine vial.
- Remove 1.8mL air from the vial using the mixing syringe to equalize internal pressure.
- Gently invert the vial containing the vaccine and diluent 10 times. The vaccine will appear off-white; do not use discolored vaccine, or if it contains particulate matter. Do not shake; otherwise, discard the shaken vial.
- Note on the vial the date and time the vaccine was mixed.
- Keep mixed vaccine between 2°C and 25°C and administer within 6 hours; otherwise, discard unused vaccine. Do not return to the freezer.
*Gloves are not recommended unless the vaccinator will likely come in contact with potentially infectious bodily fluids or open wounds. Where worn, follow aseptic technique. Perform hand hygiene and switch gloves between recipients.
How should the vaccine be administered?
Make sure to wear complete and correct personal protective equipment (PPE) before administering the vaccines.
- Choose the correct equipment and needle size. Make sure to use a new, sterile needle and syringe for every injection.
- Use a new, sterile alcohol prep pad to cleanse the mixed vaccine vial stopper. Extract 0.3mL mixed vaccine into the prepared syringe, making sure it is not cold to the touch.
- Remove air bubbles with the needle still inside the vial to avoid loss of vaccine. Use the same needle to extract and administer the vaccine, unless contaminated or damaged.
- Bring the dose of vaccine from the preparation area to the administration area immediately following preparation.
- Immediately administer the vaccine by intramuscular (IM) injection into the deltoid muscle.
How should adverse events be managed?
In case of immediate adverse events or reactions following vaccination, observe within:
- Persons with history of immediate allergic reactions (severity notwithstanding) to vaccines or other injectable therapy, and
- Persons with history of immediate allergic reactions due to any other cause
- All other persons
Persons administering the vaccines should closely monitor, record, and report adverse reactions through the Adverse Events following Immunization (AEFI) Committee, national pharmacovigilance and surveillance systems.
How many days apart and what restrictions should be considered in administering doses?
- Persons aged 16 and older should receive 2 vaccine doses at least 21 days apart.
- Second doses may be administered 17 or more days after the first dose (up to 4 days before recommended date). Doses administered earlier need not be repeated.
- Do not use the grace period to schedule second dose appointments. Administer second doses close as possible to the recommended interval.
- Both doses must be Pfizer-BioNTech COVID-19 vaccine only.
- Regulatory bodies have yet to assess the safety and efficacy of mixed-product dosage series. Both doses in the series must be completed using the same product. In case doses from different mRNA vaccines are inadvertently administered, the HTAC recommends no additional doses of either product at this time.
- Do not administer mRNA COVID-19 vaccines at the same time as others, and wait a minimum interval of 14 days before administering any other injection therapy. If inadvertently administered within 14 days of any other vaccine, doses need not be repeated for either intervention.
Read our guidance for the general public: https://hta.doh.gov.ph/2021/02/09/pfizer-biontech-covid-19-vaccine-under-emergency-use-authorization-eua/
Read the Evidence Summary: http://bit.ly/ESbiontechC19Pfizer
FAQs: Vaccines. Philippine Department of Health. Retrieved from https://doh.gov.ph/faqs/vaccines
Information about the Pfizer-BioNTech COVID-19 Vaccine. US Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html
Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing. World Health Organization. Retrieved from https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-BNT162b2-2021.1.
Pfizer-BioNTech COVID-19 Vaccine. US Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
Vaccine cold chain storage. Retrieved from https://www.facebook.com/OfficialDOHgov/posts/4092275030783718.