Bharat Biotech's indigenous COVID-19 vaccine, COVAXIN, was created in cooperation with the National Institute of Virology of the Indian Council of Medical Research (ICMR) (NIV). The biosafety level three (BSL-3) high containment facility at Bharat Biotech is where the locally produced, inactivated, indigenous vaccine Covaxin is designed and produced. You need to register on the Cowin vaccine registration app to book your slot for the Covaxin vaccination. After completing the vaccination, you can download your Cowin certificate.
The Covaxin vaccine is an inactivated virus that introduces harmless parts of the virus into the body to stimulate the immune system. The body then develops antibodies against the virus, which prevents it from causing illness if encountered in the future.
The following components are found in COVAXIN: The inactive ingredients of COVAXIN® include 6µg of whole-virion inactivated SARSCoV-2 antigen (Strain: NIV-2020-770), and the other inactive ingredients such as aluminium hydroxide gel(250 µg), TLR 7 /8 agonist (imidazoquinolinone) 15 µg, 2-phenoxyethanol 2.5 mg, and phosphate buffer saline up to 0.5 ml. The vaccine (COVAXIN) thus has been developed using the inactivated/ killed virus and the abovementioned chemicals.
The Phase 1 study had 375 participants and produced outstanding safety data without any reactogenicity. With two different SARS-CoV-2 strains, vaccine-induced neutralising antibody titers were seen. Only 15% of vaccination users had all adverse effects combined. 380 people between the ages of 12-65 were included in the Phase 2 research. COVAXIN produced tolerable safety results and improved humoral and cell-mediated immune responses.
Two Covaxin doses of the immunisation, spaced 28 days apart, are required. It is a vaccination that may be stored at room temperature (between 2 and 8 degree Celsius) and does not require reconstitution or sub-zero storage. It is advised that everyone who has been immunised receive two doses.
The dose can be repeated if the second dose is accidentally provided less than four weeks after the first. If the second dose is delayed for longer than four weeks, it should be administered immediately.
Following mounting evidence of the Covaxin vaccine's declining efficacy against mild and asymptomatic SARS-CoV-2 infection, the advantages of booster doses have come to light. SAGE advises giving a second vaccination dose to people with severe or moderate immunosuppressants. This is because people in this category have a lower likelihood of responding to immunization after a typical primary vaccination series and has a higher risk of developing severe COVID-19 disease for the highest-risk categories, such as older people, healthcare professionals, and those with co-morbidities, a booster dosage may be given 4-6 months after the initial series is finished.
By evaluating 130 confirmed cases, COVAXIN demonstrated 77.8% vaccine efficacy against symptomatic COVID-19 disease, with 24 cases found in the vaccine group and 106 in the placebo group. A 93.4% effectiveness rate against COVID-19 disease with severe symptoms has been demonstrated. The efficacy data shows 63.6% protection against asymptomatic COVID-19. The institution's vaccine database was used to gather vaccination information. If there was a discrepancy, the CoWIN site confirmed it (cowin.gov.in).
You shouldn't get vaccinated with Covaxin if you:
COVAXIN has been authorised for limited usage in emergencies in people at least 18 years old.
The following side effects have been connected to COVID-19 (COVAXIN) by Bharat Biotech:
There may be other COVAXIN adverse effects not included here. There could be severe and unexpected adverse effects. Clinical experiments are still being conducted to study COVAXIN.
Myth: Covaxin was created swiftly; hence it is dangerous.
Truth: It takes longer than a year to develop a vaccine. Covaxin or any other covid vaccine was created using cutting-edge research. The safety and efficacy of the vaccinations that have received approval have been established. Despite being created quickly, they underwent the same exacting development and licensing processes as earlier vaccines and met all safety requirements. No steps were included in the process. Although unprecedented, global funding and teamwork are to be commended for speeding up the development of COVID vaccinations. It took about the same amount of time for clinical trials and safety evaluations as it did for other vaccinations.
Myth: It is dangerous to take Covaxin while a girl is in her menstruation cycle.
Truth: There is insufficient information or proof to prove that Covaxin can interfere with your menstrual cycle. The vaccination has previously been administered to millions of women, and no side effect has been noted. Additionally, it is essential to understand that the menstrual cycle is a normal biological process that does not hinder or lessen your body's immune response. Hormonal changes brought on by menstruation may have little effect on how you react to adverse circumstances or illness. However, it has no impact on your immunity. It is safe to say that COVID vaccinations do not impact your menstrual cycle.
Myth: Covaxin will make one infertile.
Truth: On social media, they were erroneous assertions. Dr Harshavardhan, the Union Health Minister, has denied these allegations and reassured the public that Covaxin or any other covid vaccination, for that matter, won't cause any infertility. The Royal College of Obstetricians & Gynecologists and the Royal College of Midwives in the U.K released a statement regarding Covid vaccines, fertility, and pregnancy. The Royal College of Obstetricians and Gynecologists' president, Dr Edward Morris, stated in it: "We want to reassure women that there is no evidence to suggest that Covid-19 vaccinations would impair fertility. Covid-19 vaccine claims to affect fertility are hypothetical and unsupported by any evidence. We want to encourage all pregnant women and those planning a family to receive their Covid-19 vaccine when offered."
Myth: Covaxin is not safe for newborns and infants.
Truth: It was previously announced that Bharat Biotech's vaccine, Covaxin, is only authorised for adults over 18. However, trials are in progress to evaluate its efficacy and safety in newborns, infants, and children. Therefore, until results from the clinical trials are available, vaccines should only be administered to children below 18.
Covaxin is a safe and effective vaccine that has been approved for use in adults by the Drugs Controller General of India (DCGI). It has been shown to induce a robust immune response and protect against Covid-19. Despite the circulated myths, it is essential to remember that Covaxin has been through rigorous testing and clinical trials. It is safe to say that a vaccine is a powerful tool in fighting this pandemic.
Along with safety and efficacy, the WHO EUL methodology also analyses production quality. The WHO recommends the vaccination for people 60 years of age and above since the trial findings show that the vaccine has an acceptable safety profile for this age group. Covaxin is approved for usage in 23 countries worldwide, although distribution has primarily been restricted to India, where over 77 million doses have been given out and used. You can log into the Cowin portal and book your slot through Cowin slot booking in India. You need to register into the Cowin registration app to book your slot, and after the successful completion of the vaccination, you can download your Cowin certificate.
FAQs:
1. When Getting Covaxin®, What Should You Mention To Your Vaccination Provider?
All of your medical issues, including if you have diabetes, should be disclosed to the vaccinator or officer overseeing your immunisation.
You should mention the following:
2. How Is The Covaxin® (Bharat Biotech Covid-19 Vaccine) Given?
You will receive an injection of the Bharat Biotech COVID-19 (COVAXIN®) into the deltoid muscle of the biceps. Two doses of the COVAXIN® vaccine series are given four weeks apart.
3. What Are Covaxin®'s Benefits?
Following two doses given four weeks apart, COVAXIN® has been demonstrated to produce immunity in an ongoing clinical investigation. According to interim analysis results, vaccine efficacy was 78% in phase 3 clinical trials involving 25,800 individuals.
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