DDA Approved COVISHIELD COVID-19 Vaccine for Emergency Use Authorization in Nepal

COVISHIELD COVID – 19 Vaccine has been Approved by DDA for Emergency Use Authorization of in Nepal

It is to notify to all concerned that the conditional permission has been granted for Emergency Use Authorization of COVISHIELD vaccine against COVID-19 in Nepal as per the departmental decision dated 15th Jan 2021.

DDA Approved COVISHIELD COVID-19 Vaccine for Emergency Use Authorization in Nepal prepared by Serum Institute of India Pvt. Ltd.

COVID-19 Vaccine AstraZeneca efficacy against COVID-19 is 95.85%

At present, this vaccine is being administered to the leading health workers in Nepal by the Government of Nepal

WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

WHAT IS THE SIIPL COVISHIELD™ VACCINE?
The COVISHIELD™ is approved for restricted use in emergency situation vaccine that may prevent COVID-19 disease in individuals 18 years of age and older.

WHAT 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 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 breastfeeding
If you are pregnant or plan to become pregnant
If you have received another COVID-19 vaccine

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

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.

WHAT ARE THE INGREDIENTS IN THE COVISHIELD™ VACCINE?
The COVISHIELD™ 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™ GIVEN?
The COVISHIELD™ Vaccine will be given to you as an intramuscular (IM) injection only, preferably in the deltoid muscle.
The COVISHIELD™ vaccination course consists of two separate doses of 0.5 ml each.

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.