What is ZyCoV-D® vaccine?
ZyCoV-D® is a DNA plasmid based vaccine for prevention of COVID-19.
It comprises of a DNA plasmid vector carrying full length gene of SARS-CoV-2 spike (S) protein.
ZyCoV-D® is approved for restricted use in emergency situation vaccine that may prevent COVID-19 disease in individuals 12 years of age and older.
How does the vaccine look like?
ZyCoV-D® is a sterile preservative free clear colorless liquid solution for intradermal injection.
ZyCoV-D® is supplied in a glass vial.
What are the active drug substances present in ZyCoV-D®?
ZyCoV-D® Vaccine includes the following ingredients:
Deoxyribonucleic acid (DNA) construct with spike protein gene region from SARS-CoV-2 virus
Phosphate buffered saline
Does ZyCoV-D® contain any preservative or excipient?
ZyCoV-D® vaccine contains purified concentrated DNA formulated in Phosphate buffered saline having no preservative
What is a pDNA?
A plasmid is a small, circular, double-stranded DNA molecule that is distinct from a cell’s chromosomal DNA. Plasmids naturally exist in bacterial cells, and they also occur in some eukaryotes. Scientists have taken advantage of plasmids to use them as tools to clone, transfer, and manipulate genes. Plasmids that are used experimentally for these purposes are called vectors. Researchers can insert DNA fragments or genes into a plasmid vector, creating a so-called recombinant plasmid.
Does this pDNA integrate into human genome?
No this is a myth.
The plasmid construct of ZyCoV-D® carrying the spike-S gene of interest enters host cells, where it remains in the nucleus as an episome; without getting integrated into the host cell DNA.
What to do if you miss your 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 2nd & 3rd dose of ZyCoV-D® vaccine.
If you receive one dose of ZyCoV-D® vaccine, then the 2nd / 3rd dose should be administered 28 days after the previous dose.
Would an individual be protected against COVID-19 if that individual could not complete all three doses of ZyCoV-D®?
If an individual receives one dose of ZyCoV-D® vaccine, then the 2nd / 3rd dose should be administered 28 days after the previous dose. It is imperative that an individual completes all 3 doses of ZyCoV-D® vaccine.
At present, there is no data on efficacy of vaccine with 1/2 doses (2mg) of vaccine till date
As per interim analysis, we have efficacy data after day 28 of the third dose.
For how long does ZyCoV-D® provide protection against COVID?
In phase 3 clinical trials, ZyCoV-D® Vaccine has been shown to prevent COVID-19 disease following 3 doses of 2mg each given 28 days apart. The duration of protection against COVID-19 disease is currently unknown.
You may get protective immune response 28 days after the 3rd dose of ZyCoV-D® vaccine.
What to do if a person contracts COVID in between the dosing regimen?
Please follow the specific guidelines laid down by MOHFW, Government of India and ask your healthcare provider for advice
Is it mandatory to take the vaccine?
Vaccination for COVID-19 is voluntary. However, it is advisable to receive the complete schedule of COVID-19 vaccine for protecting one-self against this disease and also to limit the spread of this disease to the close contacts including family members, friends, relatives and co-workers.
Will ZyCoV-D® vaccine give me COVID-19 infection?
No. ZyCoV-D® Vaccine does not contain SARS-CoV-2 virus and cannot give you COVID-19 infection.
What are the therapeutic indications of ZyCoV-D®?
ZyCoV-D® vaccine has been recieved approval for the restricted use in emergency situation that grants permission for the vaccine to be used for active immunization of individuals aged 12 years and older for the prevention of coronavirus disease 2019 (COVID-19).
What is the mechanism of action of ZyCoV-D®?
The plasmid construct of ZyCoV-D® carrying the spike-S gene of SARS-CoV2, enters host cells, where it remains in the nucleus as an episome; without getting integrated into the host cell DNA.
This pDNA would give instructions to our cells for how to make the harmelss spike protein that is unique to the virus. Our bodies recognize the foreign protein and start building T-cells and B-cells that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
What is the route and dose of administration of ZyCoV-D®?
ZyCoV-D® vaccination schedule consists of 3 separate doses to be given at an interval of 28 days each (day 0, day 28 and day 56).
Each dose consists of two shots of 0.1ml each given by needle free injector (Pharmajet Tropis device) via intradermal route at two separate sites (preferably deltoid region of both the arms).
Can ZyCoV-D® be injected in to the blood vessel?
No, it has to be given intradermally only, by using a needle free injector system (pharmajet tropis device)
How many doses of ZyCoV-D® have to be given to my child?
ZyCoV-D® vaccination schedule consists of 3 separate doses to be given at an interval of 28 days each (day 0, day 28 and day 56).
What is pharmajet tropis?
It is a needle free injector device (Pharmajet Tropis device), for administering ZyCoV-D® via intradermal route at two separate sites.
Is it necessary to give ZyCoV-D® with pharmajet?
ZyCoV-D® has to be given by intradermal route, using needle free injector (Pharmajet Tropis device) only.
How does pharmajet device work?
The spring powered Injector delivers the vaccine by means of a narrow, precise fluid stream, which penetrates the skin in about 1/10 of a second and gets the vaccine where it needs to be. No external power source is required.
What does the needle-free injection feel like ?
Not unlike traditional injections, individuals will respond differently to the needle-free injection. Some feel nothing, while others have reported feeling the pressure of the injection or a snap like a rubber band when the injection is administered.
What are the benefits of needle-free injection system- pharmajet tropis?
Needle-free technology significantly reduces patient fear and anxiety associated with getting a needle injection. It eliminates needle stick injuries to healthcare workers, greatly reduces the need for sharps disposal, eliminates needle reuse and the possibility of cross-contamination
How to ascertain that one pharmajet device has delivered 20000 shots and till how many shots the device could be function worthy?
There is no tracker in device to know the number of shots that have been delivered. This device is mechanical pressure device and this device either works or it will not work (there is no partial performance of device after 20000 shots) device is tested for more than 30000 shots & is ISO certified. We strongly recommend to use the device for 20000 shots only.
How many shots can be given with one device?
Pharmajet- tropis device is recommended for 20000 shots (10000 doses) of ZyCoV-D® vaccine. It’s ISO certified & single device is tested for more than 30000 shots.
Replacement and repair of device in case of any technical issue?
Zydus will take the responsibility to replace the device asap if there is any technical issue with the device. Device damaged due to mishandling will not be replaced.
Inoculation accuracy, spillage of dose – is there any issue?
The device is tested and needle free syringe ensures the accuracy of dose with no spillage. Millions of doses have been given world-wide through such devices.
Dataor experience – pain/reaction at site of injection, contamination?
ZyCoV-D® Interim study demonstrates 0.66% of pain at Injection site (Solicited response) after first dose, Please refer to the ZyCoV-D® Pack insert for more information. There was no contamination reported.
If there is wet patch after the dose, do we need to re vaccinate?
No, tropis ensures the right dose administration if right admistration technique is followed. for any wet patch seen, re-dosing is not recommended.
Storage condition for device? As India has extreme temperature condition
Device can be kept between 2° to 8°C. Follow the storage process and guideline for any other medical device as per local recommendation.
How can we clean the device?
You can use the alcohol swab to wipe the device. Device doesn’t come in contact with vaccine directly
Sterilisation process of vial top – one more step, which material should be used for sterilisation?
Sterilisation process should be as per MOHFW COVID 19 vaccine guideline if required.
Would there be any impact of alcohol usage ( while wiping device/ vial top) on Vaccine efficacy?
No study has been conducted regarding impact of alcohol wipe for sterilisation on ZyCoV-D® Multi-dose vaccine vial tip. We recommend to use MOHFW Covid-19 Vaccine operational guidelines.
For how many days, multi dose vial of ZyCoV-D® can be used?
ZyCoV-D® vial once opened (multi-dose vials) should be used as soon as practically possible and certainly within 14 days when kept between +2ºC and +8ºC. All opened Multidose vials of ZyCoV-D® should be discarded at the end of immunization session or within 14 days whichever comes first. Please refer to ZyCoV-D® Pack Insert for more information
How to treat discarded syringe?
Kindly follow the MOHFW Covid-19 operational guidelines. As ZyCoV-D® is administered through a needle free injection System, the hub-cutter process is not required. NFIS syringe used can be directly put in the red bag. Do not put the syringes on the table or on a tray after use.
Route of administration – ID or ID With Pharmajet device?
Each dose consists of two shots of 0.1ml each given by needle free injector (Pharmajet Tropis device) via intradermal route at two separate sites (preferably deltoid region of both the arms).
Is the vaccine freeze sensitive? Can we freeze it?
In case of unexpected freezing of vaccine at 2-8ºC storage, it can be administered after thawing.
What if the electricity issue & Cold-chain of 2-8 degree storage is not maintained?
It is recommended to store ZyCoV-D® at 2° to 8°C.
Is there any VVM on vial?
No as per MOHFW Covid-19 operational guidelines 7.2.1, there will be no VVM on the vial. Cold chain management for the all vaccine is the prime importance by the vaccination site supervisor.
Two shots – is this scientific or technical limitation of device?
ZyCoV-D® has to be given by intradermal route only using needle free injector (pharmajet tropis device). pharmajet tropis device has the limitation to administer 0.1ml ID dose with this device.
Can alternative route of ID needle be used?
No, ZyCoV-D® has to be given by intradermal route only using needle free injector (pharmajet tropis device).
Is there any study on cost of device versus standard ID route?
No, there is no study conducted till date. But feasibility study conducted on NFIS device in IPV in pakistan show better acceptability of NFIS among care givers with 0% vaccine loss.
Can adaptor be re-used for multiple vials?
1 filling adaptor is recommended to be used for only 1 multi-dose vial for 10 dose (20 shots) of ZyCoV-D®. There are chances of contamination during the process of re-use. Therefore, it is not recommended to use the filling adaptor for more than one multi-dose vials.
Will there be any issue of in filling syringe if vacuum is developed after few dosage.
As per process the vial has to be inverted to drive the vaccine in syringe. Chances of vacuum to be developed through filling adaptor in syringe are negligible. If vacuum is developed re-do the entire process.
Who should not get ZyCoV-D® vaccine?
You should not get ZyCoV-D® 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
- Had a severe allergic reaction to any other vaccine
For more details please refer to the fact sheet of ZyCoV-D®
Can we get pharmajet device demo usage & medication guide material for self training.
1. Yes, you can connect with the vaccine state immunisation officer/ vaccination
site supervisor. Training Kit’s is available with vaccination site supervisor/ state
immunisation officer on pharmajet device. For any query on vaccine follow Pack
Insert.
OR
2. Every Pack of ZyCov-D® has the printed medication guide.
3. Access QR code printed on ZyCov-D® Pack/ Pack insert /Medication guide to view
the medication guide for admistration of ZyCov-D® video in english & hindi.
OR
4. Visit website www.zycovd.co.in for more information & connect for any other
query.
What should you mention to your healthcare provider before you get ZyCoV-D® 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 ZyCoV-D® 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 not get ZyCoV-D® vaccine?
You should not get ZyCoV-D® 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
• had a severe allergic reaction to any other vaccine
Can ZyCoV-D® be administered to pregnant females?
The safety and efficacy of ZyCoV-D® in pregnancy has not been established
Can ZyCoV-D® be administered to breastfeeding females?
The safety and efficacy of ZyCoV-D® in lactating females has not been established.
Can ZyCoV-D® be prescribed for infants or children below 12 years of age?
Efficacy and safety data are currently limited in adolescents aged 12 to <18 years. No dosage adjustment is required in adolescents 12 to <18 years of age.
The safety and efficacy of ZyCoV-D in children (aged <12 years old) has not yet been established.
Has ZyCoV-D® been tested in Geriatric population?
Yes it has been tested. Efficacy and safety data are currently limited in individuals ≥ 60 years of age. No dosage adjustment is required in elderly individuals ≥ 60 years of age.
Can ZyCoV-D® be prescribed for immune-compromised individuals including HIV/AIDS?
It is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressant therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen.
Should ZyCoV-D® be administered to person who has been exposed to COVID?
Yes it may be given to people who have recovered from COVID-19, as per GOI guidelines
Is there any drug-drug interactions observed between ZyCoV-D® and other antibodies, vaccines, drugs etc?
No interaction studies have been performed.
Concomitant administration of ZyCoV-D® with other vaccines has not been studied
Can I take this product as a therapeutic drug against COVID-19?
No this is not a therapeutic drug against COVID-19.
ZyCoV-D® is a vaccine that has been recieved approval for the restricted use in emergency situation that grants permission for the vaccine to be used for active immunization of individuals aged 12 years and older for the prevention of coronavirus disease 2019 (COVID-19).
How it acts on the body?
The plasmid construct of ZyCoV-D® carrying the spike-S gene of SARS-CoV2, enters host cells, where it remains in the nucleus as an episome; without getting integrated into the host cell DNA.
This pDNA would give instructions to our cells for how to make the harmelss spike protein that is unique to the virus. Our bodies recognize the foreign protein and start building T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
Does the ZyCoV-D® vaccine bind to nCoV virus?
No it does not. ZyCoV-D® is a DNA plasmid based vaccine for prevention of COVID-19. This pDNA would give instructions to our cells for how to make the harmelss spike protein that is unique to the virus. Our bodies recognize the foreign protein and start building T-lymphocytes and B-lymphocytes that will remember how to fight the virus that causes COVID-19 if we are infected in the future.
Can a person become infertile after taking this vaccine?
There is no clinical data on effect of ZyCoV-D® on fertility
What is the efficacy of ZyCoV-D® vaccine?
ZyCoV-D® vaccine has shown efficacy of 66.6% in interim analysis.
Does ZyCoV-D® vaccine neutralize delta variant and other nCoV virus variants?
In clinical trials, ZyCoV-D® Vaccine has been shown to prevent COVID-19 disease following 3 doses of 2mg each given 28 days apart.
The phase 3 clinical trial of ZyCoV-D® that had been conducted during the peak of second deadly wave of pandemic that was attributed to delta variant for evaluating the efficacy of vaccine.
ZyCoV-D® has shown an overall efficacy of 66.6% in this clinical trial against symptomatic COVID-19 and an efficacy of 100% against moderate COVID-19 infection.
However specific neutralization assays against various variant needs to be conducted.
Do I need to follow any specific guidelines prior to or after vaccination with ZyCoV-D®?
Please follow the specific guidelines laid down by MOHFW on COVID appropriate behavior
Is there any drug-drug interactions observed between ZyCoV-D® and other antibodies, vaccines, drugs etc?
No interaction studies have been performed.
Concomitant administration of ZyCoV-D® with other vaccines has not been studied
Can ZyCoV-D® product be mixed with any other vaccine?
No interaction studies have been performed.
Concomitant administration of ZyCoV-D® with other vaccines has not been studied
Is there a requirement of a booster dose with this vaccine?
Long term immunogenicty evaluation is ongoing. Currently there is no information for need of booster dose.
What if I take more than a prescribed dose?
Experience of overdose is limited.
There is no specific treatment for an overdose with ZyCoV-D®. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.
Does ZyCoV-D® treatment lead to impairment of the ability to drive a vehicle or the ability to operate machines?
ZyCoV-D® 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.
If any individual have co-morbidities, can they take this vaccine?
Yes ZyCoV-D® can be administered to such individuals.
Safety and efficacy of this vaccine has been established in co-morbidities in our phase 3 CT
What is the effect of consumption of milk, alcohol or tobacco on administration of ZyCoV-D® vaccine?
Consumption of alcohol and tobacco is injurious to health and should be avoided in general.
ZyCoV-D® is a Liquid solution for injection via intradermal route by the accompanying needle free injector device only. Oral intake of milk or alcohol before or after the administration of ZyCoV-D® would not impact the safety or efficacy of the product.
For more details, please contact your healthcare provider
Is this Halal or Kosher certified?
ZyCoV-D® Manufacturing doesn’t involve use of any excipient acquired after animal sacrifice, so no such certification necessary
Can I take ZyCoV-D®, if I have previously taken a different vaccine?
No vaccine interchangeablity studies have been conducted till today.
What are adverse events observed after taking ZyCoV-D®?
Most commonly observed adverse events are:
• Injection site redness
• Injection site pain
• Injection site itching
• Injection site swelling
• Fever
• Muscle Pain
• Headache
• Nausea
• Fatigue / Tiredness
• Diarrhea
Most of the adverse events were mild or moderate in severity.
These may not be all the possible side effects of ZyCoV-D® Vaccine. Serious and unexpected side effects may occur.
Does skin lesion occur at the site of ZyCoV-D® vaccine?
Yes it can cause redness, swelling at the site of administration, however this susides quickly with or without symptomatic treatment
What should i do about side effects?
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 on toll free number 1800 419 1141 or visit www.zyduscadila.com
Can I buy this product online?
At present this vaccine would be available under national immunization drive against COVID 19
Where this product is being manufactured?
Cadila Healthcare Limited
Plot Survey No.: 23, 25/P, 37, 40/P, 42 to 47, Sarkhej-Bavla
N.H. No. 8A, Changodar, Tal: Sanand, Dist.: Ahmedabad-382213,
Gujarat
Why one would chose ZyCoV-D®?
ZyCoV-D® is based on a novel pDNA platform which belongs to third generation of vaccine.
Has proven efficacy of 66.6% against symptomatic COVID-19
In clinical trials, ZyCoV-D® Vaccine has been shown to prevent COVID-19 disease following 3 doses of 2mg each given 28 days apart. The duration of protection against COVID-19 disease is currently unknown.
Has proven safety profile
Has to be given intradermally by a using a needle free injector system
Is ZyCoV-D® available in countries other than India?
At present, it has been granted EUA only for use in India.
How can the authenticity of ZyCoV-D® be verified?
With increasing instances of counterfeit products in the market it has become important to ensure that a 100% genuine product is available to patients. So to safeguard patients against the counterfeit drugs Zydus’ has developed and launched a new tech enabled initiative known as Zydus Verify.
Zydus Verify can help in verifying the authenticity of ZyCoV-D® vaccine.
How does Zydus Verify work?
Each pack has a concealed secret code which comes with a scratchable surface
The individual who buys the pack, scratches the surface and finds a code
Individual downloads Zydus Verify App from Google Play store and Apple Store or visits the website www.zydusverify.com and enters the code on the pack
The App connects the code and flashes the brand name verifying a genuine purchase.