The HTAC recommends the DOH financing and inclusion of Covovax 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.
Covovax was issued an EUA last 17 November 2021: https://www.fda.gov.ph/sars-cov-2-rs-protein-nanoparticle-vaccine-covovax/
What is the recommendation of HTAC for Covovax as part of homologous primary series vaccination?
The HTAC recommends the DOH financing and inclusion of Covovax in the Philippine National Deployment and Vaccination Plan for COVID-19 for the general population aged 18 years and above provided that there is sufficient budget to cover its implementation after pending supply negotiations in 2022.
Based on current available evidence, Covovax 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
- 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 Covovax affordable for the implementation among the general population in 2022?
The price of Covovax offered to the Philippine government is higher compared to the procurement cost of the COVAX Advance Market Commitment (AMC), but below the cost in Denmark (high income country), according to the UNICEF COVID-19 Vaccine Market Dashboard. As there is currently no information on the price offered to other ASEAN countries or other lower-middle income countries, the allocated budget, and target number of doses for procurement, HTAC cannot assess the affordability. Based on the computed cost per vaccinee by HTAC, Covovax is within the range of cost of vaccines in the National Government Procurement Portfolio.
Who may receive the vaccine?
Persons belonging to identified priority groups and individuals aged 18 years of age and older may receive Covovax.
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 living with HIV
- Immunocompromised individuals
- Persons with who have previously received antibody therapy for the treatment of COVID-19
- Pregnant and lactating women
- Children and adolescents below the age of 18 years
What is the composition of the vaccine?
Covovax is composed of the following ingredients (per 0.5 mL):
SARS-CoV-2 recombinant spike protein antigen (5 µg), Matrix-M1 adjuvant (15 µg)
What adverse reactions have been reported in the use of this vaccine?
Available evidence show the following reported adverse reactions with the administration of Covovax:
- Injection site reactions: pain
- General side effects: headache, myalgia, fatigue
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.
- 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.
- Covovax is a colorless to slightly yellow or clear to mild opalescent. Vial 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
- 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.
SARS-CoV-2 rS Protein Nanoparticle Vaccine [Covovax] [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 21]. Available from: https://www.fda.gov.ph/sars-cov-2-rs-protein-nanoparticle-vaccine-covovax/
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: https://bit.ly/HTACRecomm_Covovax_2021
Guidance for the General Public: https://hta.doh.gov.ph/2021/12/29/htac-recommendation-covid-19-vaccine-covovax/