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Here are 10 things to know about SII's Covishield vaccine from package insert & factsheet

The package insert and factsheet the comes with the vaccine includes information on indications and usage, dosage strength, clinical efficacy, contraindications, risks and benefits, and use in specific populations.

January 13, 2021 / 03:25 PM IST

Serum Institute of India (SII), which is rolling out its Covid-19 vaccine Covishield has released the package insert and fact sheet. While the package insert is for medical practitioners and hospitals, the fact sheet is for vaccine recipients. The package insert and factsheet comes with the vaccine, includes information on indications and usage, dosage strength, clinical efficacy, contraindications, risks and benefits, and use in specific populations. Here are some important things about the Covishield vaccine that was approved in India for restricted use in an emergency situation.

Dosage and administration

Covishield 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. It is recommended that individuals who receive the first dose of Covishiled should complete the vaccination course with the second one.

Who should get the Covishield vaccine
The vaccine has been approved for restricted use in an emergency situation for individuals 18 years of age and above. The safety and efficacy of Covishield in children and adolescents less than 18 years have not yet been established.

No data is available. Administration of Covishield in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.

Does the vaccine affect fertility?

Preliminary animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Who should not get the Covishield vaccine?

Individuals who had a severe allergic reaction after a previous dose of this vaccine and had a severe allergic reaction to any ingredients of the vaccine.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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What are the ingredients in the Covishield vaccine?

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

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. The vaccine may get a protective immune response 4 weeks after the second dose of the Covishield vaccine.

What is the efficacy of the Covishield vaccine?

The licensed regimen of two full doses of 0.5 ml each has generated an efficacy of 62.10 percent. However, when the second dose was given at 12 weeks interval after the first dose from the overseas studies, the efficacy was at 78.79 percent. The efficacy data is based on clinical trials conducted in the United Kingdom, Brazil, and South Africa

What are the possible side-effects of the Covishield vaccine?
Very common side-effects that may affect more than 1 in 10 people are tenderness, pain, warmth, redness, itching, swelling, or bruising where the injection is given, generally feeling unwell, fatigue, chills, headache, nausea, and joint pains.
Common side-effects that may affect up to 1 in 10 people are a lump at the injection site, fever, vomiting, and flu-like symptoms such as high temperature, sore throat, runny nose, cough, and chills.

Uncommon side-effects affecting up to 1 in 100 people are feeling dizzy, decreased appetite, abdominal pain, enlarged lymph nodes, excessive sweat, and skin rashes.

Will, the Covishield vaccine give Covid-19 infection?

The vaccine does not contain SARS-CoV-2, it cannot give Covid-19 infection.

What should one do about side effects?

If a vaccine recipient experiences a severe allergic reaction, he needs to call or go to the nearest hospital. Call the healthcare provider in case of any side effects that bother or do not go away. In addition, one can report side effects after vaccination to the Serum Institute of India the manufacturer of the vaccine. SII has opened 24 x 7 Call Center Toll-Free Number (For Medical and Adverse Event-Related Queries Only): +91-1800 1200124

What is the shelf life of the vaccine?
The expiry date of the vaccine will be indicated on the label and packaging. Once opened, multi-dose vials should be used as soon as possible or within 6 hours when kept between +2ºC and +25ºC.
All opened multidose vials of the vaccine should be discarded at the end of immunization session or within six hours whichever comes first.

The other precautions for storage include storing the vaccine at 2 to 8 degrees Centigrade. The vaccine shouldn't freeze and should be protected from light at all times.

Price of the vaccineWhile the package insert, the fact sheet doesn't mention the price. The 11 million doses of Covishield vaccine supplied to the Indian government was priced at Rs 200 per dose, excluding taxes. Adar Poonawalla, CEO of SII, hinted that the vaccine would be priced at Rs 1000 per dose in the private market.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jan 13, 2021 03:25 pm

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