Covaxin Manufacturer in India
India’s First Indigenous COVID-19 Vaccine
Covaxin is India’s first indigenous COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The vaccine received DCGI approval for Human Clinical Trials and the trials commenced across India from July 2020. According to Bharat Biotech, Covaxin will be at least 60 percent effective based on earlier trial results.
The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine is developed using Whole-Virion Inactivated Vero Cell-derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead viruses, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
Why develop Inactivated Vaccine? Conventionally, inactivated vaccines have been around for decades. Numerous vaccines for diseases such as Seasonal Influenza, Polio, Pertussis, Rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines with a safe track record of >300 million doses of supplies to date. It is the well-established, and time-tested platform in the world of vaccine technology.
COVAXIN® is included along with immune-potentiators, also known as vaccine adjuvants, which are added to the vaccine to increase and boost its immunogenicity.
It is a 2-dose vaccination regimen given 28 days apart.
It is a vaccine with no sub-zero storage, no reconstitution requirement, and ready to use liquid presentation in multi-dose vials, stable at 2-8oC.
Pre-clinical studies: Demonstrated strong immunogenicity and protective efficacy in animal challenge studies conducted in hamsters & non-human primates. For more information about our animal study, please visit our blog page on Non-Human Primates.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials in July 2020.
A total of 375 subjects have been enrolled in the Phase 1 study and generated excellent safety data without any reactogenicity. Vaccine-induced neutralizing antibody titers were observed with two divergent SARS-CoV-2 strains. The percentage of all the side effects combined was only 15% in vaccine recipients. For further information, visit our blog page on the phase 1 study.
In the Phase 2 study, 380 participants of 12-65 years were enrolled. COVAXIN® led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses. Know more about our phase 2 study.
A total of 25,800 subjects have been enrolled and randomized in a 1:1 ratio to receive the vaccine and control in an Event-Driven, randomized, double-blind, placebo-controlled, multicentre phase 3 study.
The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of COVAXIN® in volunteers aged ≥18 years.
Of the 25,800 participants, >2400 volunteers were above 60 years of age and >4500 with comorbid conditions.
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COVAXIN demonstrated 77.8% vaccine efficacy against symptomatic COVID-19 disease, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. The efficacy against severe symptomatic COVID-19 disease is shown to be 93.4%. The efficacy data demonstrates 63.6% protection against asymptomatic COVID-19.
Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events.
COVAXIN® Effective Against Variants of Concern:
It has proven to neutralize the variants – B.1.1.7 (Alpha) first isolated in UK, P.1- B.1.1.28 (Gamma) & P.2 – B.1.1.28 (Zeta) first isolated in Brazil, B.1.617 (Kappa) first isolated in India, B.1.351 & B.1.617.2 (Beta & Delta) first isolated in RSA & India.
Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.
Cowin application is used to register and book the appointment for Vaccination. Here you can find the process of registration.
Q. Where can I register for the COVID-19 vaccination?
Ans. You can log into the Co-WIN portal using the link www.cowin.gov.in and click on the “Register/Sign In Yourself” tab to register for the COVID-19 vaccination.
Q. Is there a mobile app that needs to be installed to register for vaccination?
Ans. There is no authorized mobile app for registering for vaccination in India. You need to log into the Co-WIN portal. You can also register for vaccination through the ArogyaSetu App.
Q. Which age groups can register for vaccination on the Co-WIN portal?
Ans. At present all citizens above 60 years of age and those between the age of 45 and 59 years with one of the specified comorbidities can register for vaccination.
Q. Is online registration mandatory for Covid 19 vaccination?
Ans. No. Vaccination Centres also provide for a limited number of on-spot registration slots every day. However, it is recommended to register online and schedule vaccination in advance for a hassle-free vaccination experience.
Q. How many people can be registered in the Co-WIN portal through one mobile number?
Ans. Up to 4 people can be registered for vaccination using the same mobile number.
Q. How can citizens with no access to smartphones or computers manage online registration?
Ans. Up to 4 people can be registered for vaccination using the same mobile number. Citizens can take help from friends or family for online registration. Your own feature phone can also be used to register through a smartphone of your friend or register on the Portal. Facility for on-the-spot registration is also available.
Q. Can I register for vaccination without an Aadhaar card?
Ans. Yes, you can register for the Co-WIN portal using any of the following ID proofs:
1. Aadhaar card
2. Driving License
3. PAN card
5. Pension Passbook
6. NPR Smart Card
7. Voter ID Card (EPIC)
Q. Are there any registration charges to be paid?
Ans. No. There is no registration charge.
Q. What is the documentation required for registration by citizens with comorbidity?
Ans. No documents need to be uploaded at the time of registration. Citizens in the age bracket of 45 and 59 years, can register themselves after recording confirmation of any specified comorbid conditions. You need to carry a medical certificate from any Registered Medical Practitioner at the time of vaccination, which will be verified and uploaded at the Vaccination Center.
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Cowin Slot Booking – Covaxin Registration
Q. Can I book an appointment for vaccination in the Co-WIN portal?
Ans. Yes, you can book an appointment for vaccination through the Co-WIN portal after logging in to the Co-WIN Portal through your registered mobile number.
Q. Can I download the appointment slip?
Ans. Yes, the appointment slip can be downloaded after the appointment has been scheduled.
Q. How can I find the nearest vaccination center?
Ans. You can search in the Co-WIN portal (or Arogyasetu) for the vaccination center nearest to your location by either searching through PIN code or by choosing the State and the District.
Q.. What if I cannot go for vaccination on the date of appointment? Can I reschedule my appointment?
Ans. The appointment can be rescheduled at any time. In case you do not go for vaccination on the date of appointment, you can reschedule the appointment by clicking on the “Reschedule” tab.
Q. Do I have an option for the cancellation of an appointment?
Ans. Yes, you can cancel an appointment already scheduled. You can also reschedule the appointment and choose another date or time slot of your convenience.
Q. Where will I receive confirmation of the date and time of vaccination?
Ans. Once an appointment is scheduled, you will receive the details of the vaccination center, date, and time slot chosen for appointment in an SMS sent to your registered mobile number. You can also download the appointment slip and print it or keep it on your smartphone.
Q. Can I get a vaccination without an appointment?
Ans. Vaccination Centres also provide for a limited number of on-spot registration slots every day. However, fixing an online appointment using the Co-WIN portal is recommended to avoid wasting time and queue in the vaccination center, as in each center only limited slots are made available for on-spot registration.
Remdesivir is a broad-spectrum antiviral medication being sold under the brand name Veklury. Remdesivir has been developed by the biopharmaceutical company Gilead Sciences. It is given via injection into a vein.
Remdesivir has been approved for emergency use to treat COVID-19 in around 50 countries including India.
On November 20, 2020, World Health Organization has issued a conditional recommendation against the use of Remdesivir in hospitalized patients, regardless of disease severity, as there is currently no evidence that Remdesivir improves survival and other outcomes in these patients.
This recommendation, released on 20 November 2020, is part of a living guideline on clinical care for COVID-19. It was developed by an international guideline development group, which includes 28 clinical care experts, 4 patient-partners, and one ethicist.
Amid the Covid-19 pandemic in India, the country is facing an acute shortage of Remdesivir. The Centre has banned its export, states are sending special flights to get it from the manufacturers, and there have been protests against the shortage.
Here are some of the frequently asked questions about usage of Remdesivir in the treatment of viral infections including Covid-19:
Is Remdesivir effective in the treatment of COVID-19?
According to Randeep Guleria, director of All India Institute of Medical Science (AIIMS), Remdesivir is not a magic bullet and it’s not a drug that is reducing mortality in cases of Covid-19 patients. “Remdesivir is an anti-viral drug that has been repurposed from the Ebola pandemic. It works by incorporating itself into the genetic material of the virus and prevents the replicating enzyme from making new copies of the virus. The mechanism appears very promising, but the actual effect on patients is not so,” says Dr. Neeraj Nischal, additional professor, internal medicine at AIIMS.
Do all Covid-19 positive patients need Remdesivir?
Remdesivir was given emergency-use authorization for its use in the management of Covid. It is beneficial only in a very small subset (in terms of shortening the time to recovery by approximately five days) of patients early in the disease and on low-flow oxygen. Outside this group of patients, Remdesivir really is not much better than a placebo for Covid.
What happens if someone who doesn’t need Remdesivir is given the drug?
Remdesivir may cause an allergic reaction, which may be life-threatening in some people. It has side effects on the heart and liver, which so far seem to be reversible, but we cannot be sure as the mechanism is not known. The WHO also says there is still no evidence that Remdesivir is beneficial in treating hospitalized coronavirus patients. The jury is still out.
What are the side effects of Remdesivir?
Remdesivir is an injectable drug, and some people might have an infusion reaction to it. This usually manifests as some mild rashes or itching. However, in rare cases, it may lead to breathing difficulties and cardiovascular collapse as well.
It may have very specific side effects on the heart where it can cause bradycardia (low heart rate), which may sometimes be wrongly attributed to Covid. It can cause pain in the abdomen, nausea, and vomiting. It can cause derangement of blood sugar, liver enzymes as well as kidney function tests. This is not necessarily a complete list of possible side effects and data is still emerging. The interaction of this drug with other drugs is still not well defined.
Which COVID-19 vaccines are licensed in India?
Covishield (AstraZeneca’s vaccine manufactured by Serum Institute of India) and Covaxin (manufactured by Bharat Biotech Limited) are the two vaccines licensed in India.
Why vaccination is not provided to children who are the usual target?
Children have either asymptomatic or mild infection of Covid-10 whereas morbidity & mortality is several times higher in adults particularly in those above the age of 50 years. Also, the currently available vaccines have not been evaluated in children so far.
What is the composition of both vaccines?
Composition of Covishield includes inactivated adenovirus with segments of Corona Virus, Aluminium Hydroxide Gel, L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, and Disodium edetate dihydrate (EDTA). Composition of Covaxin includes inactivated Corona Virus, Aluminum Hydroxide Gel, TLR 7/8 agonist, 2-Phenoxyethanol and Phosphate Buffered Saline[NKA1].
Is Covishield the same as the vaccine been given in the UK by Astra Zeneca?
Yes, the Covishield vaccine, manufactured by the Serum Institute of India, is based on the same patent technology as the Astra Zeneca vaccine.
What is the dosing schedule of both vaccines?
As per the permission granted by the Drug Controller General (India), for Covisheild the second dose is to be administered 4-6 weeks after the first dose and Covaxin is to be administered in two doses interval of day 0 & day 28.
Do I have a choice of vaccine I will receive?
The vaccine will be supplied to various parts of India as per availability and distribution plan, beneficiaries load and so at present the option of choice of vaccine is not available.
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