Published on: June 4, 2021

The HTAC recommends the emergency use of Janssen Ad26.COV2.S (COVID-19) Vaccine to prevent COVID-19 for persons aged 18 and older.

Introduction (nature and purpose of EUA)

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 Janssen Ad26.COV2.S (COVID-19) Vaccine to reduce the burden of COVID-19 among individuals 18 years of age and older. 

The Council in its interim analysis and recommendation considers best available scientific evidence, which has since revealed the Janssen Ad26.COV2.S (COVID-19) Vaccine 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 individuals aged 18 years of age and older may receive Johnson and Johnson COVID-19 Vaccine Janssen.

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 under 18 years of age

What is the composition of the vaccine?

The Janssen COVID-19 Vaccine includes the following ingredients:

recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-βcyclodextrin (HBCD), polysorbate-80, sodium chloride.

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

There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination.

  • Injection site reactions: pain, redness of the skin and swelling.
  • General side effects: headache, feeling very tired, muscle aches, nausea, Difficulty breathing, and fever.

Healthcare professionals and persons who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.

Healthcare professionals should inform the vaccine recepient to seek medical attention if they develop:

  • symptoms of blood clots such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
  • severe and persistent headaches and blurred vision
  • petechiae beyond the site of vaccination after a few days.

COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.

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 0.5 mL 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. 

References

FAQs: 

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

Janssen COVID-19 Vaccine – EUA Fact Sheet for Recipients and Caregivers. Philippine Food and Drug Administration. Retrieved from https://www.fda.gov.ph/wp-content/uploads/2021/04/19a.-Janssen-COVID-19-Vaccine-Recipient-fact-sheet-English.pdf.

Adverse Effects of Janssen COVID-19 Vaccine: https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html

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

Precautions on administering the vaccine.

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 Janssen

Evidence summary: Janssen Ad26.COV2.S (COVID-19) Vaccine for the prevention of COVID-19