Usage
- Medical Conditions: COVAXIN® (BBV152) is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals 18 years of age and older. It was also permitted for restricted use in emergency situations for ages 6-18.
- Pharmacological Classification: Vaccine (inactivated virus vaccine).
- Mechanism of Action: COVAXIN® utilizes an inactivated (killed) SARS-CoV-2 virus. This presents the virus’s antigens to the immune system, triggering the production of antibodies and preparing the body to fight against a live SARS-CoV-2 infection. The vaccine includes an aluminum-based adjuvant to enhance the immune response and 2-phenoxyethanol as a preservative.
Alternate Names
How It Works
- Pharmacodynamics: COVAXIN® stimulates both humoral and cellular immune responses. The inactivated virus triggers an adaptive immune response, leading to the production of antibodies that neutralize the SARS-CoV-2 virus. It also stimulates T-cell responses, further contributing to long-term immunity.
- Pharmacokinetics: Administered intramuscularly, the vaccine components are gradually released from the injection site. The aluminum adjuvant enhances antigen presentation to immune cells. The pharmacokinetic parameters of individual components are not routinely studied, as the primary outcome is the immune response.
- Mode of Action: The inactivated virus displays surface antigens identical to the live virus. These antigens are recognized by antigen-presenting cells (APCs), which process and present them to lymphocytes (B cells and T cells). B cells differentiate into plasma cells, producing specific antibodies against SARS-CoV-2. T cells differentiate into cytotoxic T lymphocytes that can eliminate infected cells.
- Elimination Pathways: The inactivated virus particles are processed and eliminated by the immune system. Aluminum hydroxide gel is slowly absorbed from the injection site and eliminated renally. 2-Phenoxyethanol is primarily metabolized in the liver and excreted in urine.
Dosage
Standard Dosage
Adults:
- 0.5 mL intramuscularly (IM) administered on Day 0 and Day 28 (4 weeks apart).
Children:
- Previously permitted for restricted use in emergency situations in the 6-18 age group with the same dosage and schedule as adults, but official guidelines should be consulted for current recommendations.
Special Cases:
- Elderly Patients: Same as standard adult dosage.
- Patients with Renal Impairment: No specific dosage adjustments are indicated.
- Patients with Hepatic Dysfunction: No specific dosage adjustments are indicated.
- Patients with Comorbid Conditions: Consult official guidelines or individualize based on the specific comorbidity.
Clinical Use Cases
COVAXIN® is intended for preventive immunization against COVID-19 and is not indicated for use in the clinical settings mentioned (intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations).
Dosage Adjustments
No formal dosage adjustments are typically made based on patient factors, but consult recent guidelines.
Side Effects
Common Side Effects:
- Pain, swelling, redness, or itching at the injection site
- Headache
- Fatigue
- Fever
- Myalgia
- Chills
- Nausea
Rare but Serious Side Effects:
- Allergic reactions (anaphylaxis)
Long-Term Effects: Long-term safety data is still being collected and analyzed.
Adverse Drug Reactions (ADR): Any severe allergic reaction should be considered an ADR and managed accordingly.
Contraindications
- Hypersensitivity to any component of the vaccine.
- Acute severe febrile illness or acute infection (postpone vaccination).
- Previous severe allergic reaction to any vaccine.
Drug Interactions
- No specific drug interactions have been identified. However, co-administration with other vaccines should be done with caution and according to current immunization guidelines.
Pregnancy and Breastfeeding
Consult updated official guidelines regarding pregnancy and breastfeeding. Earlier recommendations advised against the use of COVAXIN® in these populations.
Drug Profile Summary
- Mechanism of Action: Inactivated virus vaccine stimulating an immune response against SARS-CoV-2.
- Side Effects: Common: Injection site reactions, headache, fatigue, fever, myalgia. Rare: Anaphylaxis.
- Contraindications: Hypersensitivity, acute illness, pregnancy and lactation (refer to updated guidelines).
- Drug Interactions: Limited data available, caution with concomitant vaccines.
- Pregnancy & Breastfeeding: Consult updated guidelines.
- Dosage: 0.5 mL IM on Day 0 and Day 28.
- Monitoring Parameters: Observe for allergic reactions, especially after the first dose.
Popular Combinations
COVAXIN® is typically not used in combination with other vaccines at the same injection site, but refer to current recommendations.
Precautions
- General Precautions: Screen for contraindications and potential allergic reactions. Ensure resuscitation equipment and personnel are available in case of anaphylaxis.
- Specific Populations: Refer to latest guidelines.
- Lifestyle Considerations: No specific lifestyle restrictions are typically associated with COVAXIN®.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Whole Virion, Inactivated Corona Virus vaccine (COVAXIN®)?
A: The standard dosage is 0.5 mL administered intramuscularly on Day 0 and Day 28.
Q2: Can COVAXIN® be given to children?
A: Refer to updated official guidelines for current recommendations on childhood vaccination with COVAXIN®.
Q3: Can pregnant or breastfeeding women receive COVAXIN®?
A: Consult updated official guidelines. Earlier recommendations advised against use during pregnancy and lactation.
Q4: What are the most common side effects of COVAXIN®?
A: Common side effects include pain at the injection site, headache, fatigue, fever, myalgia, and chills.
Q5: What should be done if a patient experiences a severe allergic reaction after receiving COVAXIN®?
A: Immediately manage the anaphylactic reaction with epinephrine, antihistamines, and other supportive measures as per established protocols.
Q6: Does COVAXIN® interact with other medications?
A: No specific drug interactions have been identified.
Q7: Can COVAXIN® be given at the same time as other vaccines?
A: Consult current immunization guidelines regarding co-administration with other vaccines.
Q8: How long does immunity last after receiving COVAXIN®?
A: The duration of immunity is still being studied. Booster doses may be recommended based on future research and evolving public health guidance.
Q9: How effective is COVAXIN® against different variants of SARS-CoV-2?
A: Effectiveness against different variants is under ongoing evaluation. Consult current research and public health advisories for the most up-to-date information.
