The HTAC retains its recommendation for DOH to finance and include Sputnik V in the Philippine National Deployment and Vaccination Plan for COVID-19 for the general population aged 18 years and above.

COVID-19 Vaccines under Emergency Use Authorization (EUA)

The Food and Drug Administration (FDA) issues Emergency Use Authorization (EUA) for vaccines and drugs during public health emergencies which allows a shorter period for effective and efficient review of health technologies so that they can become available to affected populations. Before the EUA is issued, regulatory agencies consider quality, safety, and efficacy of the technology.

Following the issuance of an EUA, a positive HTAC recommendation means that the National Immunization Program can finance implementation of the technology and PhilHealth can include it in the COVID benefit package. 

Sputnik V was issued an EUA last 19 March 2021: 

https://www.fda.gov.ph/sputnik-v-gam-covid-vac-covid-19-vaccine/

What is the recommendation of HTAC for Sputnik V as part of homologous primary series vaccination?

Based on the updated evidence summary of Sputnik V last 14 December 2021, the HTAC retains its recommendation for DOH to finance and include Sputnik V in the Philippine National Deployment and Vaccination Plan for COVID-19 for the general population aged 18 years and above. However, the relatively high cost of this vaccine, documented issues of delayed deliveries, and challenges experienced during roll out (e.g.,  stringent and longer time of preparation for the administration of the vaccine and decreased viability due to ambient air requirement) need to be considered in the procurement plans.

Based on current available evidence, Sputnik V has the following characteristics for use in the general population aged 18 years and above:

• Efficacious in reducing severe and symptomatic COVID-19
• Has potential in reducing a significant number of symptomatic infections, assuming sufficient vaccine coverage;
• Safe, although more data is needed to establish its long-term safety
• Can reduce the out-of-pocket expenses due to averted costs of isolation and treatment from COVID-19 infection
• Affordable and feasible in terms of vaccine implementation

• Possess most characteristics desired by key stakeholders, according to national surveys and based on conducted focus group discussions
• Does not aggravate health inequities due to non-stringent logistic requirements

Is Sputnik V affordable for the implementation among the general population in 2022?

The price of Sputnik V offered to the Philippine government is equal to or better than the price offered to all countries outside Russia, and lower than the price range for which it is available among low to middle income countries, according to the Department of Finance (DOF) and the UNICEF COVID-19 Vaccine Market Dashboard. Based on the costing analysis of HTAC, Sputnik V is considered affordable since the budget for the purchase and use of  Sputnik V for the target number of vaccinees has been allocated.

Who may receive the vaccine?

Persons belonging to identified priority groups and individuals aged 18 years of age and older may receive Sputnik V.

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 uncontrolled comorbidities
• Persons with acute infectious and non-infectious diseases, and flares of chronic diseases
• Individuals with immunosuppressive  or immunodeficient state
• Pregnant and lactating women
• Children and adolescents below the age of 18 years
• For component II: persons with severe post-vaccination complications (anaphylactic shock, severe generalized allergic reactions, convulsive disorder, temperature above 40°C, etc.) after administering the vaccine Component I

What is the composition of the vaccine?

Sputnik V is composed of the following ingredients (0.5 mL per component):

Component I:

recombinant serotype 26 adenoviral particles, containing the SARS-CoV-2 protein

S gene ((1.0±0.5) x 1011 particles per dose), tris-(hydroxymethyl)aminomethane (1.21 mg), sodium chloride (2.19 mg), sucrose (25.0 mg), magnesium chloride hexahydrate (102.0 µg), EDTA-disodium salt dihydrate (19.0 µg), polysorbate (80 – 250 µg), ethanol 95% (2.5 µL), water for injections up to 0.5 mL

Component II:

recombinant serotype 5 adenoviral particles, containing the SARS-CoV-2 protein S gene ((1.0±0.5) x 1011 particles per dose). tris- (hydroxymethyl)aminomethane (1.21 mg), sodium chloride (2.19 mg), sucrose (25.0 mg), magnesium chloride hexahydrate (102.0 µg), EDTA-disodium salt dihydrate (19.0 µg), polysorbate (80 – 250 µg), ethanol 95% (2.5 µL), water for injections up to 0.5 mL

What adverse reactions have been reported in the use of this vaccine?

Available evidence show the following reported adverse reactions with the administration of Sputnik V:

• Injection site reactions: irritation, pain, swelling, pruritus, nodules, warmth, rash
• General side effects: fever, body pain, erythema, fatigue, headache, chills, insomnia,  nausea and vomiting, lymph node enlargement, diarrhea, gastric symptoms, asthenia, joint pain, malaise, hyperthermia, shivers, drowsiness, depression

There should be continuous safety surveillance and monitoring of all adverse events especially severe allergic reactions and adverse events following vaccination.

What precautions should be considered before administering the vaccine?

• The vaccine must only be administered intramuscularly, preferably in the deltoid muscle. Intravenous injection is strictly prohibited.
• Supervision and appropriate medical treatment should always be available to treat any anaphylactic reactions following immunization.
• 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 persons 59 years old and older, vaccination may be subject to physician advice and supervision.
• The vaccinee should remain under medical supervision for at least 30 minutes after vaccination. Vaccination clinics should keep epinephrine and other drugs for first aid in case of severe allergic reactions.
• Sputnik V (both components) is a dense solidified mass that is whitish in color, if frozen. When thawed, it is a homogenous solution that is colorless, with a yellowish hue and is slightly opalescent. Vials should be visually checked for the presence of any particulate matter or any coloration, if any, prior to its administration. If in doubt, do not use the contents of the vial.

How should the vaccine be prepared before administration?

Preparing the vaccine

1. Assess recipient status. Screen for potential contraindications and precautions, and review their vaccination history.
2. Observe aseptic techniques. Perform hand hygiene before preparing the vaccine, between recipients, when replacing gloves*, and at any other time hands become soiled.
3. NEVER use expired vaccines. Check expiration dates before use. 
4. 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.
5. Store in a dark place at a temperature not exceeding -18°C. Storing thawed product in 0.5 mL vials (ampoules) is not allowed. The thawed drug can be stored in 3.0 mL vials for 2 hours at most. Re-freezing is not allowed.

*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.

1. Choose the correct equipment and needle size. Make sure to use a new, sterile needle and syringe for every injection.
2. Prior to vaccination, take a vial or ampoule with Component I or Component II out of the freezer and leave at room temperature till completely thawed. No ice inclusions are permitted.
3. Clean the vial or ampoule of residual moisture with an alcohol wipe. 
4. Stir the contents carefully by rocking the container. Shaking of the vial or ampoule is not allowed. 
5. Remove the protective plastic overlay from the vial and treat the rubber stopper with an alcohol wipe. 
6. Extract 0.5 mL of the vaccine into the prepared syringe (0.5 mL per dose). If subsequent injections are postponed for some reason, an open 3.0 mL vial may be stored for at most 2 hours at room temperature. Storing an open 0.5 mL vial (ampoule) is not allowed. Re-freezing of a vial with the drug is not allowed. 
7. Bring the dose of vaccine from the preparation area to the administration area immediately following preparation. 
8. Immediately administer the vaccine by intramuscular (IM) injection into the deltoid muscle. 
9. The vaccine must be administered in two doses (Component I and II), on Day 0 and Day 21.

References:

Sputnik V Gam-COVID-Vac Covid-19 Vaccine [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 21]. Available from: https://www.fda.gov.ph/sputnik-v-gam-covid-vac-covid-19-vaccine/

FAQs: Vaccines: Department of Health Website [Internet]. Philippine Department of Health. 2021 [cited 2021 December 16]. Available from: https://doh.gov.ph/faqs/vaccines 

Vaccine Recommendations and Guidelines of the ACIP [Internet]. Centers for Disease Control and Prevention. 2021 [cited 2021 December 16]. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html

Guidance to the General Public:  HTAC Recommendation: COVID-19 Vaccine Sputnik V

Link to Evidence Summary:  Sputnik V Gam-COVID-Vac COVID-19 Vaccine for the Prevention of COVID-19 (December Reassessment)