Moderna Vaccine Update India Status

Moderna Vaccine Update India Status

Moderna is an unapproved vaccine and is authorized by the US Food and Drug Administration as an Emergency use authorization (EUA) vaccine to prevent the spread of COVID-19 disease. Moderna is a Nucleoside-modified mRNA that encodes for viral spike (S) that is a glycoprotein of SARS-CoV-2 and also contains other ingredients.

Dose and Dosage regimen
0.5 ml dose of the vaccine is administered and the multi-dose vials contain 10 doses per vial without diluents.
The vaccine is administered in 2 doses and the second dose is administered 28 days after the administration of the first dose.

Mode of Administration
0.5 ml of the dose should be administered. The presence of any particulate matter in the vaccine and discoloration of the vaccine should be avoided if present the vaccine should not be administered and the vaccine should be administered intramuscularly on deltoid muscle.

Side effect

Moderna vaccine side effects after First Dose

After the first dose following adverse reactions are being reported as the first dose is considered the prime dose and helps the body to recognize the virus.
a. Clinical trials
1. Pain at the site of injection
2. Fatigue, 
3. Headache, 
4. Myalgia, 
5. Arthralgia, 
6. Chills, 
7. Nausea, 
8. Vomiting, 
9. Axillary swelling or tenderness
10. Fever, 
11. Swelling at the site of injection
12. Erythema at the site of injection 

b. Post Clinical Trials 
  Severe allergic reactions including anaphylaxis with symptoms like 
1. Difficulty breathing
2. Face and throat swelling 
3. Fast heartbeat 
4. Bad rash all over your body 
5. Dizziness 
6. Weakness 

Moderna vaccine side effects after Second dose

After the second dose, the side effects that occur after the initial dose becomes more intense and severe as the second dose is called the booster dose that further cements the immune response or exaggerates the existing response after the first dose.
1. Severe pain at the site of injection 
2. Difficulty breathing
3. Severe fatigue 
4. Severe headache 
5. Severe myalgia 
6. Severe arthralgia 
7. Severe chills
8. Severe nausea 
9. Severe vomiting
10. Severe axillary swelling or tenderness 
11. Severe fever 
12. Severe swelling at the site of injection
13. Severe erythema at the site of injection 

Is Moderna vaccine effective  against new COVID Mutant ?

Moderna vaccine is 94.1% effective in the prevention of COVID-19 disease in people who received two doses and were not previously infected. The vaccine is proven to work more effectively in clinical trials among people of various ages, races, gender, and ethnicity with signs and symptoms of COVID-19. Very few people got hospitalized after moderna vaccine administration in clinical trials compared to placebo.

Moderna first dose efficacy
Moderna vaccine is proven to be 92% efficacious in preventing COVID-19 infection starting after 14 days of the first dose.

How long does moderna vaccine lasts?

A report in New England journal of medicine in Boston showed that moderna vaccine induces immunity for at least 6 months. The study was done in new variants of COVID-19.

Details that need to be given to the health care providers by patients before vaccine administration
1. If the patient receiving the vaccine has any type of allergy, fever, bleeding disorder or is on a blood thinner, immunocompromised, or is on a medication that affects immunity. 
2. Pregnant or breastfeeding women
3. If any patient receiving moderna vaccine already received another COVID-19 vaccine.

Special Population

1. Pediatric population 
The safety and efficacy of moderna vaccines in children and adolescents less than 18 years of age have not yet been studied so no data is available hence vaccination should be avoided. 

2. Elderly population 
No dose adjustment is necessary for the elder population ≥65 years of age but adequate data is not available on the elder population so vaccination should be avoided.

3. Hypersensitivity and anaphylaxis 
After vaccine administration anaphylactic reactions can occur so special medical attention should be given to such individuals and hence an individual should be observed for 15 minutes after vaccination. The individuals who experienced hypersensitivity reaction after the initial dose should not be administered the second dose of vaccine.

4. Anxiety-related reactions 
After vaccination anxiety-related reactions like vasovagal reactions (syncope), hyperventilation, or stress‐related reactions can occur after vaccine administration as a psychogenic response to injection, and hence precautions are necessary to avoid injury because of fainting.

5. Concurrent illness 
Patients suffering from acute severe febrile illness or acute infection should not be administered the vaccine as it can cause serious side effects but vaccination should not be avoided in a low-grade fever of infection.

6. Thrombocytopenia and coagulation disorders 
The patients receiving anticoagulant therapy who have thrombocytopenia or any coagulation disorder like hemophilia should be administered with vaccine cautiously because it can lead to bleeding at the site of injection.

7. Immunocompromised individuals 
The efficacy and safety of the vaccine have not been established in immunocompromised individuals or the patients receiving immunosuppressant therapy for example patients having organ transplantation should avoid getting vaccinated. The efficacy of the moderna vaccine may be lower in immunocompromised individuals.

8. Interaction with other medicinal products and other forms of interaction 
Vaccine interaction with any other vaccine or medicinal product is not studied or established yet hence vaccination should be avoided or administered cautiously.

9. Pregnancy 
The safety data of vaccines on pregnant women and fetuses are not known and animal studies do not indicate direct and indirect side effects so vaccination in pregnancy should only be done if benefits outweigh risks for mother and fetus.

10. Breast-feeding 
It is not known that whether the Moderna vaccine is excreted in human milk or not as studies have not been established so vaccination should be done cautiously. 

11. Fertility 
Animal studies do not indicate direct or indirect side effects concerning fertility or reproduction.

Case Report
A 60-year-old African American male patient presented with multiple symptoms including generalized weakness, shortness of breath, leg edema, nausea, vomiting, abdominal pain, chest pain, and generalized rash in the first week of March 2021. The patient has a history of chronic kidney disease with a creatinine level of 3 mg/dl. The patient also had a history of untreated systemic hypertension and systolic congestive heart failure. The patient was not on any medications for any of his co-morbidities. He has a social history of smoking, currently smoking 1 pack of cigarettes per day.  The patient received the first dose of the moderna mRNA 1273 vaccine and experienced thrombocytopenia and related purpuric rash with signs and symptoms like a low-grade fever, chills, nausea, and few loose stools. He was tested negative for COVID-19 in February 2021. 

The treatment of thrombocytopenia involves corticosteroids, intravenous immunoglobulin (IVIG), and IV Rh anti-D while the second-line therapy includes dapsone and rituximab and in severe life-threatening hemorrhage surgical intervention like splenectomy is suggested.

Is moderna vaccine effective against variants?

Recent studies showed that new variants of SARS-COV-2 like B.1.1.7 and the 501Y.V2 do not alter the effect of moderna vaccine that is moderna vaccine is effective against these variants while data analysis on efficacy and safety of moderna vaccine on variants is still under trials.

Concluding note
Moderna vaccine is approved for the emergency to prevent COVID-19 disease and have different indications and contraindications like in case of allergic reactions, pediatric, elderly groups, Anxiety-related reactions, Pregnancy, Breastfeeding, and fertility, etc and hence can have different types of adverse reactions or side effects which could be proven fatal to the individual receiving vaccine, therefore, the vaccine should be administered cautiously in the vulnerable groups. The Health care workers are required to report the side effects or adverse events occurring due to vaccines to protect the patients from serious or fatal conditions.