Bharat Biotech developed covaxin, a vaccine against the COVID-19 virus, in partnership with the Indian Council of Medical Research and the National Institute of Virology. Bharat Biotech.
The company obtained the sample from the National Institute of Virology, isolated the SARS-COV2 stain from the sample, and used the dead or weakened virus to create Covaxin, which was generated in Bharat Biotech's BSL-3 facility. It is a double-dose vaccine.
After preclinical trial results were submitted regarding safety and efficacy, the Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare allowed Bharat Biotech to begin Phase 1 and Phase 2 trials on human subjects.
Covaxin is approved and associated for use in emergency critical COVID-19 cases.
Patients who should receive covaxin
Since the vaccine is approved for emergency use, it can only be given to patients who are 18 years or older.
Dosage and dosing schedule
Covaxin is administered intravenously to the deltoid muscle of the upper arm in two doses, with the second dose given four weeks after the first.
What patient should mention to the doctor before vaccine administration
Whether or not the patient is taking some kind of daily treatment for any disease, and for how long.
The vaccine is not recommended in any of these circumstances.
1. If they have allergies,
2. If they have a fever,
3. If they have a bleeding disorder or are taking a blood thinner.
4. If the patient is immunocompromised or taking an immunosuppressive medication.
5. Expecting a child
7. If a patient has already been vaccinated against COVID-19.
Side effects of covaxin
First dose Side effects
The side effects that occur after the first dose are:
1.Pain, Swelling, Redness, and Itching at the site of injection
4.Malaise or body ache
Second Dose side effects
The intensity of the side effects increases after the second dose
1.Severe pain, Swelling, Redness, and Itching at the site of injection
4.Severe malaise or body ache
Administration of covaxin with other vaccines
The administration of covaxin along with any other vaccine has not been studied yet so it is not advisable to administer any other vaccine along with Covaxin as it can lead to side effects.
Pregnancy and breastfeeding
Since the vaccine's effect on the fetus and newborn has not been studied, it is not recommended for use during breastfeeding or pregnancy.
Patients who are taking a blood thinner or an anti-coagulant
The vaccine can be provided intramuscularly to patients who are starting new anticoagulants and whose international normalized ratio is below the therapeutic range's upper limit. Patients on anticoagulants that are in stable condition may obtain the vaccine, but bleeding can take longer to stop in these patients, resulting in upper arm bruising. Since patients with bleeding problems are at risk of developing hematomas, a fine needle is used for the procedure. In case of any query, the patient should consult a doctor who prescribed anticoagulant therapy.
Patients with allergy to covaxin ingredients
Patients with serious allergies to any of the covaxin ingredients should not be vaccinated.
Patients that have other allergies, such as environmental allergies, food allergies, pet allergies, venom allergies, or latex allergies, but do not have an allergic reaction to vaccine ingredients, may be vaccinated. Patients who have had allergic reactions to oral drugs in the past or who have a family history of allergy may also be vaccinated.
Patients with a weakened immune system or who are on immunosuppressive therapy, such as in the case of organ transplantation, may develop severe COVID-19 infection as a result of the vaccine, but there is no evidence on the vaccine's safety and effectiveness in these patients.
Efficacy of covaxin
Covaxin from Bharat Biotech has been shown to be 81% effective against coronavirus infection. The Phase III study involved 2,433 people over the age of 60 and 4,500 people with comorbidities, and the clinical trial data was collected from 25,800 people aged 18 to 98. A preliminary review of the data from the clinical trials revealed that out of 43 cases, 36 cases were found in the placebo group and seven cases in the Covaxin group. This vaccine was found to be 80.6% effective.
How long does covaxin vaccine
Last it was seen that Bharat biotech covaxin developed antibodies after first dose vaccine administration and provided immunity against Covid-19 for 9-12 months.
Effect of vaccine on new & mutant variants of the virus
When a virus continues to circulate or spread in a large population, the virus's genome changes to adapt to the changing conditions of the global population. This process is known as mutation, and the new virus is known as a variant or mutant.
Since the effectiveness and safety of covaxin have not been completely developed, it may provide some defence against new variants due to a large immune response caused by the production of antibodies in the body. If any of the one or two variations or mutants are found to be ineffective, the vaccine's composition or ingredients may be changed to protect the population from the new variants.
When creating and booster shots, it is important to use more than one strain of the virus in the vaccine. To get good efficacy and protection of the vaccine on a wider population with various variants to avoid the spread of the disease, the efficacy of all strains should be studied in the study.