The HTAC recommends the DOH financing and inclusion of Covaxin  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. 

Covaxin was issued an EUA last 21 June 2021: https://www.fda.gov.ph/whole-virion-inactivated-corona-virus-vaccine-covaxin/

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

The HTAC recommends the DOH financing and inclusion of Covaxin in the Philippine National Deployment and Vaccination Plan for COVID-19 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 for 2022.

Based on current available evidence, Covaxin 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 characteristics desired by key stakeholders, according to national surveys and based on conducted focus group discussions

Is Covaxin affordable for the implementation among the general population in 2022?

HTAC cannot assess the afforability of Covaxin due to lack of information on the allocated budget and target number of doses to be procured. The HTAC deems, however, that the health, economic, and social benefits of using Covaxin may lessen the negative impacts of COVID-19, such as deaths, medical costs, loss of productivity, social disruption and unprecedented challenges in the health system.

Who may receive the vaccine?

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

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 fever and severe infection
• Pregnant and lactating women
• Children and adolescents below the age of 18 years

What is the composition of the vaccine?

Covaxin is composed of the following ingredients (per 0.5 mL):

Whole Virion Inactivated Corona Virus Antigen (Strain NIV-2020-770) )(6µg), Aluminium hydroxide gel equivalent to Al+3 (250 µg), TLR 7/8 Agonist (15 µg), 2-phenoxyethanol (2.5mg), Phosphate buffered saline (as much as is sufficient)

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

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

• Injection site reactions: pain, induration, swelling, redness
• General side effects: fever, muscle pain, headache, fatigue, rash, pruritus or acute allergic reaction

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, 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.
• Before use, Covaxin should be shaken well to obtain a uniform, whitish translucent suspension. 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

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. 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.

1. Choose the correct equipment and needle size. Make sure to use a new, sterile needle and syringe for every injection.
2. Extract 0.5 mL of the vaccine into the prepared syringe (0.5 mL per dose).
3. Bring the dose of vaccine from the preparation area to the administration area immediately following preparation. 
4. Immediately administer the vaccine by intramuscular (IM) injection into the deltoid muscle. 
5. The vaccine must be administered in two doses, on Day 0 and Day 28.

References:

Whole virion, Inactivated Corona Virus Vaccine [Covaxin] [Internet]. Food and Drug Administration Philippines. 2021 [cited 2021 December 15]. Available from: https://www.fda.gov.ph/whole-virion-inactivated-corona-virus-vaccine-covaxin/

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: Whole Virion, Inactivated Coronavirus [Covaxin] for the Prevention of COVID-19

Guidance for the General Public:  HTAC Recommendation: COVID-19 Vaccine Covaxin