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For information purpose only
Covishield Vaccine
Prescription Required
Product introduction
Covishield Vaccine has been given an emergency use authorization (conditional approval) for active immunization of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19). COVID-19 is a highly infectious disease that is caused by the coronavirus (SARS-CoV2).
Covishield Vaccine has been developed by AstraZeneca with Oxford university in the UK and is being manufactured by the Serum Institute of India (SII) in Pune. Successful clinical trials have been conducted in S.Africa, Brazil, and the UK with bridging study results in the Indian population based on which the approval was granted by DCGI (Drugs Controller General of India)
Covishield Vaccine is given as an injection into the muscle of the upper arm. The vaccination course consists of two separate doses. The government of India has extended the gap between the first and the second dose to 12-16 weeks. Taking just a single dose is not enough as it is insufficient to produce a protective level of antibodies in the body to prevent the infection. So make sure you turn up for the second dose.
Initially, the recommended doses were given 4 to 6 weeks apart. However, clinical trials showed that Covishield Vaccine has an average efficacy of 54% when the 2 doses are administered 4 to 6 weeks apart. Furthermore, the efficacy has been reported to increase to around 79% if the gap between 2 doses is increased. Therefore, according to the new directives, the gap between the 2 doses has been raised to 12-16 weeks.
The possible side effects of Covishield Vaccine include reactions at the site of injection (such as pain, swelling, and redness), headache, nausea, vomiting, muscle pain, joint pain, fatigue, malaise (general discomfort), fever, chills, and flu-like symptoms. Most of these side effects are mild and temporary (subside within 2-3 days) that subside on their own. If required, you may take paracetamol to provide symptomatic relief. However, if these persist (symptoms continue beyond 2-3 days) or get worse, let the doctor know.
To make sure the vaccine is safe, before receiving the vaccine, it is important to let your doctor or vaccinator know if you have any other illnesses, history of any allergy, fever, or bleeding disorders. You should also tell the doctor about all the medicines you are taking, especially blood thinners or any medicines affecting your immune system.
Children, pregnant women, and breastfeeding mothers have not been a part of the 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 Covishield Vaccine.
Covishield Vaccine has been developed by AstraZeneca with Oxford university in the UK and is being manufactured by the Serum Institute of India (SII) in Pune. Successful clinical trials have been conducted in S.Africa, Brazil, and the UK with bridging study results in the Indian population based on which the approval was granted by DCGI (Drugs Controller General of India)
Covishield Vaccine is given as an injection into the muscle of the upper arm. The vaccination course consists of two separate doses. The government of India has extended the gap between the first and the second dose to 12-16 weeks. Taking just a single dose is not enough as it is insufficient to produce a protective level of antibodies in the body to prevent the infection. So make sure you turn up for the second dose.
Initially, the recommended doses were given 4 to 6 weeks apart. However, clinical trials showed that Covishield Vaccine has an average efficacy of 54% when the 2 doses are administered 4 to 6 weeks apart. Furthermore, the efficacy has been reported to increase to around 79% if the gap between 2 doses is increased. Therefore, according to the new directives, the gap between the 2 doses has been raised to 12-16 weeks.
The possible side effects of Covishield Vaccine include reactions at the site of injection (such as pain, swelling, and redness), headache, nausea, vomiting, muscle pain, joint pain, fatigue, malaise (general discomfort), fever, chills, and flu-like symptoms. Most of these side effects are mild and temporary (subside within 2-3 days) that subside on their own. If required, you may take paracetamol to provide symptomatic relief. However, if these persist (symptoms continue beyond 2-3 days) or get worse, let the doctor know.
To make sure the vaccine is safe, before receiving the vaccine, it is important to let your doctor or vaccinator know if you have any other illnesses, history of any allergy, fever, or bleeding disorders. You should also tell the doctor about all the medicines you are taking, especially blood thinners or any medicines affecting your immune system.
Children, pregnant women, and breastfeeding mothers have not been a part of the 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 Covishield Vaccine.
Side effects of Covishield 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 Covishield
- Injection site reactions (pain, swelling, redness)
- Headache
- Nausea
- Vomiting
- Muscle pain
- Joint pain
- Fatigue
- Feeling of discomfort
- Fever
- Chills
- Flu-like symptoms
How to use Covishield Solution for Injection
Your doctor or nurse will guide you how to use this medicine.
How Covishield Solution for Injection works
Covishield Vaccine contains a non-replicating virus (a weakened chimpanzee adenovirus that causes common cold), that is genetically engineered to produce coronavirus proteins in the body, but the virus is weakened and cannot cause the disease. It provides active immunization against Covid-19 infection that helps you fight the virus if exposed. This means there is a reduced risk of developing the illness and its consequences.
Safety advice
Alcohol
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Covishield Vaccine. Please consult your doctor. As per experts, there is no evidence of alcohol impairing the effectiveness of the vaccine
Pregnancy
SAFE IF PRESCRIBED
Covishield Vaccine is safe to use during pregnancy. Most studies have shown low or no risk to the developing baby.
Breast feeding
SAFE IF PRESCRIBED
Covishield Vaccine is safe to use during breastfeeding. Human studies suggest that the drug does not pass into the breastmilk in a significant amount and is not harmful to the baby.
Driving
SAFE
Covishield Vaccine does not usually affect your ability to drive.
Covishield Vaccine has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions may temporarily affect the ability to drive or use machines.
Covishield Vaccine has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions may temporarily affect the ability to drive or use machines.
Kidney
CONSULT YOUR DOCTOR
There is limited information available on the use of Covishield Vaccine in patients with kidney disease. Please consult your doctor.
Liver
CONSULT YOUR DOCTOR
There is limited information available on the use of Covishield Vaccine in patients with liver disease. Please consult your doctor.
What if you forget to take Covishield Solution for Injection?
If you miss a dose of Covishield 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
- Covishield Vaccine is a 2-dose vaccination regimen. The second dose is administered between 12 to 16 weeks after the first dose.
- Covishield Vaccine is usually given into the muscle (intramuscularly) of the upper arm.
- Getting vaccinated is voluntary. However, it is advisable to complete the vaccination schedule to restrict the spread of the virus.
- Have a proper meal before visiting the vaccination site. Do not get vaccinated on an empty stomach.
- Individuals with confirmed or suspected COVID-19 infection should defer vaccination for 14 days after symptoms resolution as they may increase the risk of spreading the infection to others at the vaccination site.
- 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.)
- You may be observed at the vaccination center itself to guard against any immediate allergic reaction or side effect.
- In addition to vaccination, observe other control measures such as social distancing, mask donning, and hand-washing.
- Covishield Vaccine is currently not meant to be administered in children as safety and efficacy are not yet established.
Fact Box
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Vaccines
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No
Therapeutic Class
VACCINES
FAQs
Can Covishield Vaccine be given to children?
Covishield 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, Covishield Vaccine as well as Covaxin 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.
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.
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.
What is the dosing schedule of Covishield Vaccine?
As per the permission granted by the Drug Controller General (India), the second dose of Covishield Vaccine is to be administered 12-16 weeks after the first dose. This is because, the protection offered by the vaccine increased to 79% if the second dose was given at least 12 weeks after the first dose. While it was 54% if the gap between the 2 doses which was 4-6 weeks as per initial recommendation being followed earlier. After analyzing this data, Indian government has increased the gap between both doses from 4-6 weeks to 12-16 weeks.
Does vaccination with Covishield 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.
Which vaccine is better, Covishield Vaccine or Covaxin?
There is no comparison done between the two, Covishield Vaccine or Covaxin 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).
In how many days will Covishield 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 Covishield Vaccine or Covaxin, whichever has been administered to you.
What are the expected side effects of Covishield Vaccine?
Covishield Vaccine may show mild side effects like injection site tenderness or pain, headache, fatigue, myalgia (muscle pain), malaise, fever, chills, joint pain, and nausea. Very rarely, a few events of demyelinating disorders have been reported following vaccination with this vaccine but without the causal relationship establishment.
Who should not take Covishield Vaccine?
Individuals 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, should not take Covishield Vaccine. 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, consult your doctor if you are not sure.
Is it safe for a person suffering from hypertension/diabetes/chronic kidney disease/heart disease/lipid disorders etc., to take Covishield Vaccine?
Absolutely. Covishield 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 Covishield Vaccine is for those who have such comorbidities. However, if you are concerned for any specific reason, please consult your doctor.
What are the storage or transportation conditions needed for Covishield Vaccine?
Covishield Vaccine needs to be stored and transported at 2⁰ to 8⁰ Celsius. The cold chain for Covishield Vaccine is maintained through active and passive cold chain equipment available at approximately 29,000 cold chain points across India.
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.
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 healthcare 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.
Has Covishield Vaccine undergone the necessary clinical trials before granting EUA?
Yes. Covishield Vaccine has undergone the necessary clinical trials before granting EUA.
What is Emergency Use Authorization?
Emergency Use Authorization (EUA) or permission for restricted use is a declaration issued 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.
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.<br>
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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Disclaimer:
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 everything about particular health conditions, lab tests, medicines, all possible side effects, drug interactions, warnings, alerts, etc. 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
- COVISHIELD [Package Insert]. Pune, Maharashtra: Serum Institute of India Pvt Ltd. [Accessed 03 Apr. 2021] (online) Available from:
- COVISHIELD [Fact Sheet for Vaccine Recipient]. Pune, Maharashtra: Serum Institute of India Pvt Ltd. [Accessed 03 Apr. 2021] (online) Available from:
- Ministry of Health and Family Welfare. Government of India. Vaccination: Frequently Asked Questions. [Accessed 03 Apr. 2021] (online) Available from:
- COVISHIELD [Product Monograph Including Patient Medication Information]. Mississauga, Ontario: Verity Pharmaceuticals Inc.; 2021. [Accessed 03 Apr. 2021] (online) Available from:
- World Health Organization. Safety of COVID-19 Vaccines. [Accessed 03 Apr. 2021] (online) Available from:
- World Health Organization. Getting the COVID-19 Vaccine. [Accessed 03 Apr. 2021] (online) Available from:
- 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:
- Ministry of Health and Family Welfare. Government of India. Questions and Answers. [Accessed 03 Apr. 2021] (online) Available from:
- Ministry of Health and Family Welfare. Government of India. Letter from Additional Secretary Ministry of Health and Family Welfare regarding Contraindications and Factsheet for COVID-19 vaccines [Accessed 03 Apr. 2021] (online) Available from:
- Hartford Healthcare. These Are the Top 5 Vaccine Questions on Google. We Have the Answers. [Accessed 04 Apr. 2021] (online) Available from:
- Moyer MW. When Will Kids Get COVID Vaccines? Scientific American. 2021 Mar. 30. [Accessed 04 Apr. 2021] (online) Available from:
- 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:
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Name: Serum Institute Of India Ltd
Address: 212/2, Hadapsar, Off Soli Poonawalla Road, Pune 411028 India
Country of origin: India
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