Bharat biotech in collaboration with the Indian council of medical research and the National Institute of virology developed a vaccine called covaxin against the COVID-19 virus. Bharat Biotech Company collected the sample from the National Institute of virology and then isolated the SARS-COV2 stain from the sample and the dead or weakened virus was used for the development of Covaxin which was manufactured in Bharat Biotech's BSL-3.
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare permitted Bharat Biotech to start Phase 1 and Phase 2 trials on Human subjects after the preclinical trial results were submitted regarding safety and efficacy of the vaccine and then the trials started from July 2020.
Covaxin is approved and associated for use in emergency critical COVID-19 cases.
Patients who should receive covaxin
As the vaccine is approved for emergency use it is approved to be administered in patients of age 18 years or above.
Dosage and dosage regimen
Covaxin is given intravenously on the deltoid muscle of the upper arm and the 2 doses are administered the second dose is administered after 4 weeks of the first dose.
What patient should mention to the doctor before vaccine administration
Whether the patient is on any type of regular medication for any illness and for how long The Patients are advised to not take the vaccine in any of these conditions.
1.If they have allergies
2.If they have a fever
3.If they have a bleeding disorder or are on a blood thinner
4.If the patient is immunocompromised or is on a medication that affects immunity
7.If any patient has already received another COVID-19 vaccine
Side effects of covaxin
First dose Side effects
The side effects that occur after 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 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
The vaccine administration is prohibited in breastfeeding and pregnancy as the effect of the vaccine on the fetus and the newborn has not been studied.
Patients on blood thinner or anti –coagulant
Patients receiving new anti-coagulants and whose international normalized ratio is below the upper threshold of therapeutic range can be administered vaccine intramuscularly. The patients who are on simple blood thinners and have a stable condition can receive the vaccination but bleeding can take a longer time to stop n such patients leading to bruising on the upper arm. The patients suffering from bleeding disorders have the risk of development of hematoma therefore a fine needle is used for the vaccination in such patients. In case of any query, the patient should consult a doctor who prescribed anticoagulant therapy
Patients with allergy to covaxin ingredients
Patients who have a severe allergy to any of the ingredients of covaxin should not get vaccinated.
The patients who do not have an allergic reaction to vaccine ingredients but have other allergies like environmental allergy, food allergy, pet allergy, venom allergy, or latex allergy can be vaccinated. Patients who have a history of allergic reactions due to oral medications or a family history of allergy can also get vaccinated.
Patients who have a weak immune system or take immunosuppressive therapy like in the case of organ transplantation can develop serious COVID-19 infection due to vaccine but the safety and efficacy data on such patients is not known.
Efficacy of covaxin
Bharat biotech covaxin is proven to be 81% effective against coronavirus infection. The clinical trial data from a trial was performed on 25,800 subjects between 18-98 years of age while the Phase III trial included 2,433 people over the age of 60 and 4,500 who have comorbidities. A clinical trails interim data analysis showed that out of 43 cases, 36 cases were observed in the placebo group and seven cases in the Covaxin group. This proved vaccine to be 80.6% efficacious.
How long does covaxin vaccine Last
it was seen that Bharat biotech covaxin developed antibodies after first dose vaccine administration and provide immunity against Covid-19 for 9-12 months.
Effect of vaccine on new variants
When the virus keeps on circulating or spreading in a large population the genome of the virus changes to adapt to variable conditions of the worldwide population and this process is called mutation and the new virus is called variant or mutant.
As the efficacy and safety of the covaxin are not established fully but have a large immune response due to the development of antibodies in the body so it can provide some protection against the new variants. If the vaccine is proved to be ineffective on any of the one or two variants or mutant the composition or ingredients of the vaccine can be altered to protect the population from the new variants.
It is important to use more than one strain of the virus in the vaccine while developing and booster shots. The efficacy of all the strains should be studied in the trial to get good efficacy and safety of the vaccine on a larger population with different variants to stop the spread of the disease.