The HTAC recommends the emergency use of Sputnik V Gam-COVID-Vac to prevent COVID-19 for persons within identified priority groups aged 18 and older.
Gam-COVID-Vac under emergency use
The Food and Drug Administration (FDA) issues emergency use authorization (EUA) for 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 Gam-COVID-Vac to reduce the burden of COVID-19 among individuals aged 18 and older.
The Council in its interim analysis and recommendation considers best available scientific evidence, which has since revealed the Sputnik V Gam-COVID-Vac capacity to prevent symptomatic COVID-19 infection in the short-term, with benefits outweighing risks (fever, pain at injection site, etc.). Studies are continuing to determine its long-term efficacy and safety and its potential to reduce COVID-19 transmission.
Who may receive the vaccine?
Persons belonging to identified priority groups and aged 18 and older may receive Sputnik V Gam-COVID-Vac
Who should NOT receive the vaccine?
- Persons with history of anaphylaxis or allergic reactions (of any severity) to any vaccine component 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 with high risk of exposure to COVID-19 infection
- Pregnant and breastfeeding women
- Persons under 18 years of age
What is the composition of the vaccine?
Gam-COVID-Vac is non-infectious as it does not contain active viral particles. It contains two components: Component I and Component II. Component I includes a recombinant adenoviral vector that uses a serotype 26 human adenovirus carrying a SARS-CoV-2 protein S gene. Component II includes a serotype 5 human adenoviral vector carrying a SARS-CoV-2 protein S gene.
What adverse reactions have been reported in the use of this vaccine?
Reported adverse events
After receiving a previous dose of the 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 or allergic reaction of any severity to previous inactivated vaccine dose or its components, occurring 4 hours after administration
What precaution 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 inactivated COVID-19 vaccines, treatment for severe allergic reactions must be made available.
- For those with concurrent fever, acute illness or those currently experiencing acute chronic disease attacks, for immunocompromised persons or those receiving immunosuppressive therapy, or for persons with neurological conditions, vaccination may be subject to physician advice and supervision.
- For pregnant and breastfeeding women excluded from other priority groups, vaccination may be subject to physician advice and supervision.
- For persons 59 years old and older, vaccination may be subject to physician advice and supervision.
How should the vaccine be stored?
Our national COVID-19 vaccination program follows the World Health Organization (WHO)-prescribed cold chain storage protocol for vaccines.
- Store vaccines in temperatures within -18°C using a freezer.
How should the vaccine be prepared before administration?
General Information and Preparation for Gam-COVID-Vac
- Component I – 1st Dose: Each dose of 0.5 ml contains Serotype 26 (Recombinant) Adenovirus particles containing SARS-COV-2 protein S gene (1.0 ± 0.5) x 1011
- Component II – 2nd Dose: Each dose of 0.5 ml contains Serotype 5(Recombinant) Adenovirus particles containing SARS-COV-2 protein S gene (1.0 ± 0.5) x 1011
Preparing the vaccine
- Thaw the vaccine at room temperature and use within 2 hours. Do not freeze 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.
- Shake the vaccine gently and remove the cap to open the ampoule.
- NEVER use expired vaccines. Check expiration dates before use.
- Inspect the vaccine for precipitates and shake to disperse. NEVER use vaccines with foreign particles, or those stored in cracked bottles or in poorly marked containers.
*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.
- Withdraw 0.5mL of the vaccine into the prepared syringe.
- 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.
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 18 and older may receive 2 vaccine doses at least 21 days apart.
- Both doses must be Gam-COVID-Vac 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 vaccines are inadvertently administered, the HTAC recommends no additional doses at this time.
- Do not administer COVID-19 vaccines at the same time as others, and wait a minimum interval of 21 days before administering any other injection therapy. If inadvertently administered within 21 days of any other vaccine, doses need not be repeated for either intervention.
FAQs: Vaccines. Philippine Department of Health. Retrieved from https://doh.gov.ph/faqs/vaccines.
Updated Sputnik V Vaccine Guidelines. Pakistan Ministry of Health. Retrieved from https://ncoc.gov.pk/sop/92.%2020210401%20Guidelines%20for%20Sputnik%20V%20Vaccine_6101.pdf.
Package insert for Gam-COVID-Vac, combined vector vaccine for the prevention of coronaviral infection caused by the SARS-СoV-2 virus. Philippine Food and Drug Administration. https://www.fda.gov.ph/wp-content/uploads/2021/03/12.-Proposed-Philippine-package-insert-Instruction-Eng.pdf.
Vaccine cold chain storage. Retrieved from https://www.facebook.com/OfficialDOHgov/posts/4092275030783718.
Precautions on administering the vaccine.
Guidance for the General Public: https://hta.doh.gov.ph/2021/05/05/htac-guidance-for-the-general-public-covid-19-vaccine-gamaleya/
Evidence summary: http://bit.ly/ES-GamaleyaC19