Published on: May 5, 2021

The HTAC recommends the emergency use of SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] (commonly known as Sinovac) to prevent COVID-19 for persons aged 18 to 59 with low risk of exposure to the disease, and within identified priority groups

SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] 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 SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] to reduce the burden of COVID-19 among individuals aged 18 to 59, and with low exposure to COVID-19 infection. 

 The Council in its interim analysis and recommendation considers best available scientific evidence, which has since revealed the SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] 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 to 59  with low exposure to COVID-19 infection may receive SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac].

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
  • Persons under 18  or over 59 years old. 

What is the composition of the vaccine?

SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] contains an inactivated SARS-CoV-2 virus (CZ02). The vaccine is non-infectious as it does not contain active viral particles.

The product is manufactured by inoculation of SARS-CoV-2 virus into African Green Monkey Kidney Cell (Vero Cell), then the virus is incubated, harvested, inactivated, concentrated, purified and adsorbed by aluminum hydroxide.

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

Reported adverse reactions

After receiving a  dose of inactivated vaccine or any of its components,  The following adverse reactions have been observed:

  • Pain and reaction (rash, redness) in the injection site, chills, discomfort
  • Dizziness, Headache, Syncope
  • Increased blood pressure, increased heart rate

The following are reported side-effects for persons with a history of severe hypersensitivity reactions:

  • Severe allergic reaction or anaphylaxis 
  • Hypersensitivity (such as lymphadenopathy localized in the injection site, rashes, purpura, or hives) or allergic reaction of any severity to previous inactivated vaccine dose or its components, occurring 4 hours after administration

What precautions 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 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 0.5mL of the vaccine into the prepared syringe.
  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. 

How many days apart and what restrictions should be considered in administering doses?

  • Persons aged 18 to 59 may receive 2 vaccine doses at least 14 days apart.
  • Both doses must be SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] 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 14 days before administering any other injection therapy. If inadvertently administered within 14 days of any other vaccine, doses need not be repeated for either intervention.

References

FAQs: Vaccines. Philippine Department of Health. Retrieved from https://doh.gov.ph/faqs/vaccines.

SARS-CoV-2 Vaccine (Vero cell), Inactivated [CoronaVac] package insert. Philippine Food and Drug Administration. Retrieved from https://www.fda.gov.ph/wp-content/uploads/2021/03/Package-Insert-v.10.pdf.

Vaccine cold chain storage. Retrieved from https://www.facebook.com/OfficialDOHgov/posts/4092275030783718.

Precautions on administering the vaccine. Retrieved from https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html

Guidance for the General Public: HTAC Guidance for the General Public: COVID-19 Vaccine Sinovac

Evidence summary: SARS-CoV-2 Vaccine (Vero Cell), Inactivated [CoronaVac] for the prevention of COVID-19