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Representational Image

Ahead of the nationwide inoculation exercise against coronavirus disease (COVID-19) across India, the Serum Institute has issued a fact-sheet to answer all the Frequently Asked Questions (FAQs) that vaccine beneficiaries might have in preparation of the drill.

As with any other necessary fact-sheets of the sort, it contains information to help you understand the risks and benefits of the vaccine, which most citizens are set to receive soon as the long-promised cure against the disease caused by SARS-CoV-2.

The 'Covishield' vaccines have already reached some states. Till 4 PM, about 54,72,000 doses were received by the states and Union Territories, the Union Ministry of Health and Family Welfare had said earlier on this day. By January 14, 100 per cent doses will be received.

Here's every query of yours regarding the 'Covishield' vaccine, answered:

"What is the 'Covishield' vaccine?"

AZD1222, also known as the Oxford–AstraZeneca vaccine, Covishield, or ChAdOx1 nCoV-19 is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1. It is aimed at preventing the Coronavirus Disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

In India, AZD1222 is being manufactured by the Serum Institute of India (SII) under the name 'Covishield'. The vaccine has been given restricted use license for emergency situation. This approval grants permission for the vaccine to be used for active immunization of individuals aged 18 years and older.

"What should I mention to my healthcare provider before getting the Covishield vaccine?"

Tell the healthcare provider about all of your medical conditions, including:

⦁ If you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine or any ingredients of the Covishield vaccine

⦁ If you have fever

⦁ If you have a bleeding disorder or are on a blood thinner

⦁ If you are immunocompromised or are on a medicine that affects your immune system

⦁ If you are pregnant or plan to become pregnant

⦁ If you are breastfeeding

⦁ If you have received another COVID-19 vaccine

You should consult your healthcare provider before deciding to take the vaccine.

"Who should get the Covishield vaccine?"

The vaccine has been approved for restricted use in an emergency situation in individuals 18 years of age and older.

"Who should NOT get the Covishield vaccine?"

You should not get the Covishield vaccine if you:

⦁ had a severe allergic reaction after a previous dose of this vaccine

⦁ had a severe allergic reaction to any ingredient of this vaccine

If you are pregnant or breastfeeding, you may discuss your options with the healthcare provider.

"What are the ingredients in the Covishield vaccine?"

The vaccine includes the following ingredients:

L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, Disodium edetate dihydrate (EDTA), Water for injection.

"How is the Covishield vaccine administered?"

The vaccine shot will be given to you as an intramuscular (IM) injection only, preferably in the deltoid muscle. The vaccination course consists of two separate doses of 0.5 ml each.

The second dose should be administered between 4 to 6 weeks after the first dose. However, there is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies.

Keep your vaccination card ready. When you get your dose, please discuss with your healthcare provider regarding the option of your vaccination record on digital platform, if available.

"What if I miss the second dose?"

If you forget to go back at the scheduled time, ask your healthcare provider for advice. It is important that you return for your second dose of the Covishield vaccine

"Has the Covishield vaccine been used before? Is it safe?"

The vaccine has been used in clinical trials, and a number of participants have received one or two doses in overseas and Indian trials. The expert panel constituted by the Drugs Controller General of India has deemed the vaccine to be safe, following which it has been granted emergency use approval.

"What are the benefits of the Covishield vaccine?"

In ongoing clinical trials, the Covishield vaccine has been shown to prevent COVID-19 disease following 2 doses given between 4 and 12 weeks apart.

The duration of protection against COVID-19 disease is currently unknown. You may get protective immune response four weeks after the second dose of the Covishield vaccine.

"What are the risks of the Covishield vaccine?"

Side effects that have been reported with the COVISHIELD™ Vaccine include:

Very Common (may affect more than 1 in 10 people):

⦁ tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given

⦁ generally feeling unwell

⦁ feeling tired (fatigue)

⦁ chills or feeling feverish

⦁ headache

⦁ feeling sick (nausea)

⦁ joint pain or muscle ache

Common (may affect up to 1 in 10 people):

⦁ a lump at the injection site

⦁ fever

⦁ being sick (vomiting)

⦁ flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills

Uncommon (may affect up to 1 in 100 people):

⦁ feeling dizzy

⦁ decreased appetite

⦁ abdominal pain

⦁ enlarged lymph nodes

⦁ excessive sweating, itchy skin or rash

These may not be all the possible side effects of the Covishield vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials.

"What should I do about the side effects, if experienced?"

If you experience a severe allergic reaction, call or go to the nearest hospital. Call the healthcare provider if you have any side effects that bother you or do not go away. In addition, you can report side effects after vaccination to the Serum Institute of India Pvt Ltd who is the manufacturer of Covishield vaccine as below.

⦁ 24 x 7 Call Center Toll-Free Number (For Medical and Adverse Event-Related Queries Only): +91-1800 1200124

⦁ pharmacovigilance@seruminstitute.com

"What if I decide not to get the Covishield vaccine?"

Vaccination isn't mandatory in India. It is your choice to receive or not receive the Covishield vaccine. You may prefer to consult your healthcare provider.

"Can I receive the Covishield vaccine with other vaccines?"

There is no information on the use of the Covishield vaccine with other vaccines.

"Will the Covishield vaccine give me COVID-19 infection?"

No. The Covishield COVID-19 vaccine does not contain SARS-CoV-2 and cannot give you COVID-19 infection.

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All the above information has been sourced from the fact-sheet issued by the Serum Institute of India on the Covishield vaccine.

India will launch its COVID-19 vaccination drive from January 16 with priority to be given to nearly three crore healthcare and frontline workers.

(To download our E-paper please click here. The publishers permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

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