COVID-19 Vaccine Moderna Guidance for Patients
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 COVID-19 mRNA Vaccine (Nucleoside Modified) (COVID-19 Vaccine Moderna) to reduce the burden of COVID-19 among individuals aged 18 years of age and older.
The Council in its interim analysis and recommendation considers best available scientific evidence, which has since revealed the COVID-19 mRNA Vaccine (Nucleoside Modified) (COVID-19 Vaccine Moderna) 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 COVID-19 Vaccine Moderna.
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 Moderna COVID-19 Vaccine contains the messenger ribonucleic acid (mRNA) that codes for the spike protein of the SARS-CoV2 virus. The mRNA is packaged using lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose for safe delivery into the circulatory system.
What adverse reactions have been reported in the use of this vaccine?
There is a remote chance that the Moderna 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 Moderna COVID-19 Vaccine. For this reason, The vaccination provider should ask the vaccine recipient to stay at the place where they received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Side effects that have been reported in a clinical trial with the Moderna COVID-19 Vaccine include:
- Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
- General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
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.