The HTAC recommends the DOH financing and inclusion of Sinopharm in the Philippine National Deployment and Vaccination Plan for COVID-19 (NDVP) 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 the implementation of the technology and PhilHealth can include it in the COVID benefit package.
The three versions of Sinopharm were issued an EUA on the following dates (https://www.fda.gov.ph/covid-19-vaccine-vero-cell-inactivated-covid-19-vaccine-sinopharm/):
- Sinopharm (Beijing) – 10 September 2021
- Sinopharm (Wuhan) – 19 August 2021
- Sinopharm (Hayat-Vax) – 07 October 2021
What is the recommendation of HTAC for Sinopharm as part of homologous primary series vaccination?
The HTAC recommends the DOH financing and inclusion of Sinopharm in the Philippine National Deployment and Vaccination Plan for COVID-19 Vaccines for the general population aged 18 years and above, given that it has passed the safety, efficacy and other criteria of HTAC and provided that there is sufficient budget to cover its implementation after pending supply negotiations in 2022.
Based on current available evidence, Sinopharm has the following characteristics for use in the general population aged 18 years and above:
- Is efficacious in preventing symptomatic COVID-19 and is likely to provide protection against severe 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 of the 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 Sinopharm affordable for the implementation among the general population in 2022?
The price of Sinopharm offered to the Philippine government is within the global market price range, and is lower compared to those in low to middle income countries where it is available, according to the Department of Finance (DOF) and the UNICEF COVID-19 Vaccine Market Dashboard. Based on the costing analysis of HTAC, Sinopharm is considered affordable, although its procurement and implementation will still depend on the available budget for 2022.
Who may receive the vaccine?
Persons belonging to identified priority groups and individuals aged 18 years of age and older may receive Sinopharm.
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 who had allergic reactions to any vaccine in the past
- Persons with uncontrolled epilepsy and other progressive nervous system diseases
- Persons with a history of Guillain-Barre syndrome
- Pregnant and lactating women
- For children and adolescents below the age of 18 years
What is the composition of the vaccine?
Sinopharm is composed of the following ingredients:
Inactivated antigen of SARS-CoV-2 WIV04 strain, Aluminium hydroxide, Sodium chloride, Disodium hydrogen phosphate, Sodium dihydrogen phosphate
What adverse reactions have been reported in the use of this vaccine?
Available evidence show the following reported adverse reactions with the administration of Sinopharm:
- Injection site reactions: pain, swelling, redness, induration, rash, itching
- General side effects: general weakness, fatigue, lethargy, headache, tenderness, malaise, fever, shivering, general body pain, pruritus, nausea, dizziness, constipation, runny nose, dyspnea, arthralgia
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 not be administered intravenously, intradermally, or subcutaneously.
- 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, severe chronic disease, thrombocytopenia and any coagulation dysfunction, for immunocompromised persons or those receiving immunosuppressive therapy, vaccination may be subject to physician advice and supervision.
- It should be used with caution for patients with diabetes, and those with a history or family history of convulsion, epilepsy, encephalopathy or mental illness.
- For pregnant and breastfeeding women excluded from other priority groups, vaccination may be subject to physician advice and supervision.
- For persons 60 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.
- Check the packaging container, label, appearance, and validity period before use. The product cannot be used if the glass container has cracks or there is any spot, stain or
scratch on the outer surface, or the label is unclear, or the product expires, or the appearance is abnormal.
How should the vaccine be prepared before administration?
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.
- 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.
- Keep the vaccine between 2°C and 8°C. Do not freeze the vaccine.
*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.
- Extract 0.5 mL of the vaccine into the prepared syringe (0.5 mL per dose).
- 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.
- The vaccine must be administered in two doses, on Day 0 and Day 21-28.
COVID-19 Vaccine (Vero Cell), Inactivated [COVID-19 Vaccine Sinopharm] [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 15]. Available from: https://www.fda.gov.ph/covid-19-vaccine-vero-cell-inactivated-covid-19-vaccine-sinopharm/
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
Link to Evidence Summary: bit.ly/HTACRecomm_Sinopharm_2021
Guidance for the General Public: https://hta.doh.gov.ph/2021/12/29/htac-recommendation-covid-19-vaccine-sinopharm/