ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)
COVISHIELD™
1 NAME OF THE MEDICINAL PRODUCT
COVISHIELD™ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) 5 × 1010 viral particles (vp)2 QUALITATIVE AND QUANTITATIVE COMPOSITION*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein.Produced in genetically modified human embryonic kidney (HEK) 293 cells.This product contains genetically modified organisms (GMOs).Solution for injectionThe solution is colourless to slightly brown, clear to slightly opaque and particle free with a pH of 6.6.One dose (0.5 ml) contains:Both COVISHIELD™ (manufactured by Serum Institute of India Pvt Ltd) and COVID-19 Vaccine AstraZeneca (manufacturedby AstraZeneca) are ChAdOx1 nCoV- 19 Corona Virus Vaccines (Recombinant).4 CLINICAL PARTICULARSWhat should you mention to your healthcare provider before you get 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 COVISHIELD™ vaccine
* If you have a 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?
Covishield vaccine has been approved for restricted use in 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 receive one dose of the Covishield vaccine, then 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.
If you miss your 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 Covishield vaccine.
Has the Covishield vaccine been used before?
The Covishield™ is used in clinical trials, a number of participants received one or two doses in overseas and Indian trials.
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 4 weeks after the second dose of 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. Covishield vaccine is still being studied in clinical trials.
