For information purpose only

Covaxin Vaccine

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Store in a refrigerator (2 - 8°C). Do not freeze.
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Introduction

Prevention of SARS-CoV-2 infection is paramount to ending the Coronavirus Disease 2019 (COVID-19) pandemic. Covaxin Vaccine is amongst India’s first indigenous (local) vaccines that received emergency use authorization (conditional approval) for prevention of COVID-19 in individuals 18 years of age and older.

Covaxin Vaccine has been developed by Bharat Biotech along with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) in Pune. The clinical trials enrolled approximately 26,175 people, making it the largest clinical trial in India.

Covaxin Vaccine contains an inactive (dead) form of the virus itself. It is given as an injection into the muscle of the upper arm. Once injected, it provokes an immune response that can block or kill the virus's future infections/invasions, without actually causing the disease. Covaxin Vaccine is given in two doses. The second dose of the vaccine can be taken four to six weeks after the first dose. It is important to take both doses as the protective level of antibody response against COVID-19 develops only after 2 weeks of taking the second dose.

Covaxin Vaccine phase-3 interim results have shown an efficacy of 81%. However, it is still unclear how long the vaccine can protect you. Hence, to prevent and slow the spread of Covid-19, use masks, wash your hands frequently, maintain social distancing, avoid crowds, and monitor your health daily.

The possible side effects of Covaxin Vaccine include injection site reactions (such as pain, swelling, redness, and itching), stiffness in the upper arm, headache, fever, feeling of discomfort (malaise/body ache), nausea, vomiting, and rashes. Most of these side effects are temporary (subside within 2-3 days) and similar to those caused by any other vaccine. If required, you may take paracetamol to provide symptomatic relief. However, consult your doctor if any of these persist (symptoms continue beyond 2-3 days) or bother you.

Before receiving the vaccine, tell your doctor or vaccine provider about all your medical conditions. Let them also know about all the medications you are taking. It is advisable not to take the vaccine if you have any allergies, have a fever, have a bleeding disorder or are on a blood thinner, or are on a medicine that affects your immune system.

Children, pregnant women, and breastfeeding mothers have not been a part of any vaccine trials. Therefore, they should not get the vaccine at this time as the safety of the medicine for them is still not known. Also, individuals who have received another COVID-19 vaccine should not receive Covaxin Vaccine.

Uses of Covaxin Solution for Injection

  • Prevention of Coronavirus disease (COVID-19)

Benefits of Covaxin Solution for Injection

In Prevention of Coronavirus disease (COVID-19)

Covaxin Vaccine is used for preventing COVID-19. Moreover, getting vaccinated may also protect you from getting seriously infected, even if you get a COVID-19 infection. Vaccination helps to protect you as well as your loved ones from getting the deadly COVID-19 infection. Make sure you complete the doses of Covaxin Vaccine to get maximum benefit.

Side effects of Covaxin Solution for Injection

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them

Common side effects of Covaxin

  • Injection site reactions (pain, swelling, redness)
  • Headache
  • Fever
  • Feeling of discomfort
  • Nausea
  • Vomiting
  • Rash

How to use Covaxin Solution for Injection

Your doctor or nurse will guide you how to use this medicine.

How Covaxin Solution for Injection works

Covaxin Vaccine contains an inactivated form of the virus itself (made up of killed coronaviruses, making it safe to be injected into the body). When administered, the dead virus acts as an antigen and provokes an immune response that can block or kill the virus, without actually causing the disease. Thus, Covaxin Vaccine is incapable of infecting people but still able to instruct the immune system to promote a defensive reaction if a person becomes infected just like the natural body immune mechanism in case of other infections (such as common cold or flu).

Safety advice

Alcohol
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Covaxin Vaccine. Please consult your doctor. As per experts, there is no evidence of alcohol impairing the effectiveness of the vaccine.
Pregnancy
CONSULT YOUR DOCTOR
Information regarding the use of Covaxin Vaccine during pregnancy is not available. Please consult your doctor.
Breast feeding
CONSULT YOUR DOCTOR
Information regarding the use of Covaxin Vaccine during breastfeeding is not available. Please consult your doctor.
If you are breastfeeding, you should not get the vaccine as the effect of the vaccine has not been studied in nursing mothers.
Driving
CONSULT YOUR DOCTOR
It is not known whether Covaxin Vaccine alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
Kidney
CONSULT YOUR DOCTOR
There is limited information available on the use of Covaxin Vaccine in patients with kidney disease. Please consult your doctor.
Liver
CONSULT YOUR DOCTOR
There is limited information available on the use of Covaxin Vaccine in patients with liver disease. Please consult your doctor.

What if you forget to take Covaxin Solution for Injection?

If you miss a dose of Covaxin Vaccine, please consult your doctor.

All substitutes

For informational purposes only. Consult a doctor before taking any medicines.
No substitutes found for this medicine

Quick tips

  • Two doses of Covaxin Vaccine are given 4 to 6 weeks apart. Ensure that you complete the dosing schedule.
  • Do not get vaccinated on an empty stomach. Have a proper meal before visiting the vaccination site.
  • You may be observed at the vaccination center itself to guard against any immediate allergic reaction or side effects.
  • Do not interchange the vaccines. The second dose should also be of the same COVID-19 vaccine which was administered as the first dose.
  • A minimum interval of 14 days should be maintained between the administration of any other vaccine. However, if the benefits of vaccination outweigh the potential unknown risks of vaccine coadministration, COVID-19 and other vaccines may be administered within a shorter period (e.g., tetanus vaccine, rabies vaccine, etc.)
  • Defer vaccination for 14 days after symptoms resolution if you have confirmed or suspected COVID-19 infection.
  • Do get vaccinated even if you have recovered from COVID-19 infection in the past, as this will help in developing a stronger immune response.
  • Continue to follow other preventive measures such as social distancing, mask donning, and hand-washing even after getting vaccinated.

Fact Box

Chemical Class
Vaccines
Habit Forming
No
Therapeutic Class
VACCINES

FAQs

Q. Can Covaxin Vaccine be given to children?

COVID-19 vaccine trials for children are still underway. So, enough evidence is not available to recommend its use in children yet. This is because the morbidity and mortality rate is higher in the older population, particularly those older than 50 years of age. Both the available vaccines have not been studied for safety and effectiveness in the children/pediatric population so far. Therefore, it is advised not to give any COVID-19 vaccine to children till we have enough data available.

Q. I am a COVID-19 frontline worker and I got vaccinated already. When will my family members get vaccinated?

As per government of India guidelines, all the COVID-19 frontline workers will get vaccinated on priority. However, the other family members of these people will be vaccinated according to the age-specific prioritization by the Government of India.

Q. I already got infected with COVID-19 once. Do I still need to get vaccinated?

Yes. People who have already been infected with COVID-19 should still get vaccinated unless told otherwise by their healthcare provider. Even if you’ve had a previous infection, the vaccine acts as a booster that strengthens the immune response. There have also been some cases of people getting re-infected with COVID-19, which makes getting vaccinated even more important.

Q. What is the dosing schedule of Covaxin Vaccine?

As per the permission granted by the Drug Controller General (India), Covaxin Vaccine is to be administered in two doses, the second dose given on day 28, after the first dose. Additionally, studies are being conducted around a proposed booster dose, to be administered six months after the second dose. The protocol of giving a booster dose still needs a finalization as the study is being done on a small group of individuals only, as part of a Government of India clinical trial.

Q. Does vaccination with Covaxin Vaccine protect me against newer strains/mutated versions of COVID-19 virus?

Yes. All vaccines are expected to provide a reasonable amount of protection against the newer strains/mutated versions of the COVID-19 virus also. The body responds to vaccination by making more than one type of antibodies, that effectively destroy the virus. Based on the currently available data, the mutations as reported, are unlikely to make the vaccine ineffective and protect an individual against COVID-19 effectively.

Q. Which vaccine is better, Covaxin Vaccine or Covishield?

There is no comparison done between the two vaccines, Covishield or Covaxin Vaccine, being used in India so one cannot say which is better. Both the vaccines are effective in preventing the COVID-19 infection in all who take it, particularly, elderly people or those who have comorbidities such as diabetes or hypertension (high blood pressure).

Q. In how many days will Covaxin Vaccine create an adequate amount of antibodies to protect me against COVID-19?

It usually takes 2-3 weeks after completion of the entire vaccination schedule, i.e., after the second dose of Covaxin Vaccine.

Q. What are the expected side effects of Covaxin Vaccine?

Covaxin Vaccine may show some mild side effects like injection site reactions (such as pain, swelling, redness, and itching), headache, fever, malaise/body ache, nausea, vomiting, and rashes. However, these are usually mild and temporary and may resolve after some time. If they do not, please consult your doctor. No other serious side effects have been reported with Covaxin Vaccine.

Q. Who should not take Covaxin Vaccine?

Covaxin Vaccine should not be given to people with a history of anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine or any injectable therapies, pharmaceutical products, food items, etc. Additionally, pregnant and lactating women have not been part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy and lactating (breastfeeding) women should not receive the COVID-19 vaccine at this time. However, You must consult your doctor if you are not sure.

Q. Is it safe for a person suffering from hypertension/diabetes/chronic kidney disease/heart disease/lipid disorders etc., to take Covaxin Vaccine?

Absolutely. Covaxin Vaccine is safe and effective in adults with comorbidities such as hypertension/diabetes/chronic kidney disease/heart disease/lipid disorders, etc. The maximum benefit of getting Covaxin Vaccine is for those who have such comorbidities. However, if you are concerned for any specific reason, please consult your doctor.

Q. What should I tell my doctor before getting Covaxin Vaccine?

Before getting Covaxin Vaccine you should tell your doctor if you are on regular medication for any illness, for how long, and for which condition. Inform your doctor if you have any allergies, fever, a bleeding disorder or are on a blood thinner, or if you are immunocompromised or are on a medicine that affects your immune system. You must consult your doctor if you are pregnant or breastfeeding. Let your doctor know if you have received another COVID-19 vaccine earlier too.

Q. What are the storage or transportation conditions needed for Covaxin Vaccine?

Covaxin Vaccine needs to be stored and transported at 2⁰ to 8⁰ Celsius. The cold chain for Covaxin Vaccine is maintained through active and passive cold chain equipment available at approximately 29,000 cold chain points across India.

Q. How do I register myself online for an appointment for vaccination?

Online registration and appointment can be done through the Co-WIN portal. You will have to give some basic information about yourself and details of your photo identification card to get yourself registered online. From one mobile phone number, one can register 4 people, however, each person will need their photo identification document.

Q. What if I haven't pre-registered online? Can I still get vaccinated?

Yes. You can still get vaccinated even if you haven’t pre-registered online. Please ask your nearest Government health care worker to guide you about the nearest COVID-19 Vaccination Centre (CVC) where COVID vaccination will be available and the days of the week when this will be available. You need to carry your mobile phone and a photo identification document to get yourself vaccinated. The workers in the CVC will help you to register on the spot, get an appointment, and get vaccinated on the same day.

Q. Has Covaxin Vaccine undergone the necessary clinical trials before granting EUA?

Yes. Covaxin Vaccine has undergone the necessary clinical trials before granting EUA.

Q. What is Emergency Use Authorization?

Emergency Use Authorization (EUA) or permission for restricted use is a declaration issues by Indian regulators in alignment with global guidelines to use certain vaccines, medicines or devices to diagnose, treat, or prevent a serious medical condition (such as COVID-19 in the current scenario) in case there is an outbreak of such an illness that poses threat to public health. Regulatory authorities may not approve the use of any such medical measures but may still allow it to be used against the illness weighing the benefits against the risks involved. However, there are continuous lab assessments and clinical trials to check on the safety, effectiveness, and quality of the vaccines.

Q. Which COVID-19 vaccines are granted emergency use authorization in India?

Five vaccines that have been granted emergency use authorization by the Drug Controller General of India (DCGI) in India are Covishield (AstraZeneca's vaccine, manufactured by Serum Institute of India), Covaxin (manufactured by Bharat Biotech Limited), Sputnik V (Russia's vaccine, being manufactured by Dr. Reddy's laboratories in India), Moderna (US vaccine being imported by Cipla, India) and the most recent being Johnson and Johnson’s single dose Covid-19 Vaccine.

Q. What is COVID-19?

Coronavirus disease 2019, better known as COVID-19, is an illness of the lungs caused by a virus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2), which is seen to infect humans for the very first time. COVID-19 is a highly infectious viral disease that spreads from one person to another at a very fast pace. Persons suffering from COVID-19 are likely to have breathing difficulties, fever, and cough as the major symptoms.

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Tata 1mg's sole intention is to ensure that its consumers get information that is expert-reviewed, accurate and trustworthy. However, the information contained herein should NOT be used as a substitute for the advice of a qualified physician. The information provided here is for informational purposes only. This may not cover all possible side effects, drug interactions or warnings or alerts. Please consult your doctor and discuss all your queries related to any disease or medicine. We intend to support, not replace, the doctor-patient relationship.

References

  1. Bharat Biotech. COVAXIN [Fact Sheet for Vaccine Recipients & Caregivers]. [Accessed 03 Apr. 2021] (online) Available from:External Link
  2. Bharat Biotech. COVAXIN - India's First Indigenous COVID-19 Vaccine. [Accessed 03 Apr. 2021] (online) Available from:External Link
  3. Indian Council of Medical Research. COVID-19 Vaccine. [Accessed 03 Apr. 2021] (online) Available from:External Link
  4. Ministry of Health and Family Welfare. Government of India. Vaccination: Frequently Asked Questions. [Accessed 03 Apr. 2021] (online) Available from:External Link
  5. Ministry of Health and Family Welfare. Government of India. Common Side Effects (AEFI): Some common ailments that can be expected after vaccination. [Accessed 03 Apr. 2021] (online) Available from:External Link
  6. Ministry of Health and Family Welfare. Government of India. COVID-19 Vaccines: Operational Guidelines. [Updated 28th Dec. 2021]. [Accessed 03 Apr. 2021] (online) Available from:External Link
  7. Press Information Bureau. Government of India. Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine. [Updated 03 Jan. 2021]. [Accessed 03 Apr. 2021] (online) Available from:External Link
  8. Indian Council of Medical Research. Restricted Use of COVAXIN Under Clinical Trial Mode. [Updated 11 Jan. 2021]. [Accessed 03 Apr. 2021] (online) Available from:External Link
  9. Ministry of Health and Family Welfare. Government of India. Questions and Answers. [Accessed 03 Apr. 2021] (online) Available from:External Link
  10. Institute Of Preventive Medicine. Vaccination Appointment for International Travelers (VAIT). [Accessed 03 Apr. 2021] (online) Available from:External Link
  11. Panel Allows Bharat Biotech To Give 3rd Dose Of Covaxin In Trial: Report. NDTV. 2021 Apr. 02. [Accessed 04 Apr. 2021] (online) Available from:External Link
  12. Hartford Healthcare. These Are the Top 5 Vaccine Questions on Google. We Have the Answers. [Accessed 04 Apr. 2021] (online) Available from:External Link
  13. Moyer MW. When Will Kids Get COVID Vaccines? Scientific American. 2021 Mar. 30. [Accessed 04 Apr. 2021] (online) Available from:External Link
  14. Camero K. Don’t worry if you catch coronavirus when fully vaccinated — it can happen. Here’s why. Miami Herald. 2021 Apr. 01. [Accessed 04 Apr. 2021] (online) Available from:External Link

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Genome Valley Shameerpet, Hyderabad – 500 078 Telagana INDIA
Country of origin: India

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