Facts you need to know about COVISHIELD COVID-19 vaccine

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There are mainly 3 types of vaccines used in India for immuning people against COVID-19.Which of them following are:-

  • COVISHIELD
  • COVAXIN
  • SPUNTNIK V

India initially approved the Oxford–AstraZeneca vaccine (manufactured under license by Serum Institute of India under the trade name Covishield) and Covaxin (a vaccine developed locally by Bharat Biotech). They have since been joined by the Sputnik V (manufactured under license by Dr. Reddy’s Laboratories, with additional production from Serum Institute of India being started in September).

1.COVISHIELDTM
COVISHIELD
1. What kind of vaccine is COVISHIELDTM?

It is a recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein. Following administration, the genetic material of part of corona virus is expressed which stimulates an immune response.

2. What excipients are present in COVISHIELDTM?

COVISHIELDTM contains the following excipients:

  • L-Histidine
  • L-Histidine hydrochloride monohydrate
  • Magnesium chloride hexahydrate
  • Polysorbate 80
  • Ethanol
  • Sucrose
  • Sodium chloride
  • Disodium edetate dihydrate (EDTA)
3. COVISHIELDTM regimen consists of how many doses?

It consists of two doses of 0.5 ml each.

4. Is there any difference between 1st and 2nd dose?

No. There is no difference between the 1st and 2nd dose. Each dose has the same content of viral particles.

5. Do I require any test (e.g. CRP, BTCT, RTPCR etc.) before getting the vaccine?

No. There are no such recommendations.

6. I have taken the 1st dose of COVISHIELDTM? What is the current Government recommendation for the 2nd dose.

The Indian government has recommended that the time interval between the 1st and 2nd dose should be between 12-16 weeks. (1)

7. Do I need to take the 1st dose again if more than 12 weeks have passed after my 1st dose?

You do not need to repeat the 1st dose even if more than 12 weeks have passed after the 1st dose.

8. Do I need to take both the doses of COVISHIELDTM?

Both doses of COVISHIELDTM need to be taken for optimum protection.

9. What are the contraindications for receiving COVISHIELDTM vaccine?

COVISHIELDTM is contraindicated in

  1. People with hypersensitivity to the active substance or to any of the excipients listed below:
    • L-Histidine
    • L-Histidine hydrochloride monohydrate
    • Magnesium chloride hexahydrate
    • Polysorbate 80
    • Ethanol
    • Sucrose
    • Sodium chloride
    • Disodium edetate dihydrate (EDTA)
  2. Patients who have experienced major blood clotting (venous and/or arterial thrombosis) in combination with low platelet count (thrombocytopenia) following any COVID-19 vaccine.
10. Are there any contraindications for receiving the 2nd dose in people who have received the 1st dose?

The contraindications to second dose of vaccine are:

  1. Severe allergic reaction after a previous dose of this vaccine. If your treating physician considered this event as a severe allergic reaction to the vaccine, then you should not take second dose of vaccine. If you experience any other adverse event (known or unknown) after first dose, you can take the second dose.
  2. Patients who have experienced major blood clotting (venous and/or arterial thrombosis) in combination with low platelet count (thrombocytopenia) following first dose of vaccine.
11. When should I expect adverse reactions to start? Till how many days after vaccination the adverse events should be monitored?

Most of the side effects with COVISHIELDTM occur on the day of vaccination (6 to 8 hours later) and resolve within 2 to 3 days. These are uncommon by Day 5 to 7 after vaccination, indicating that these effects are self-limiting and of short duration. Adverse reactions are relatively less after the second dose as compared to the first dose.

12. What adverse reactions can I get after vaccination?

Following side effects or adverse reactions have been reported with COVISHIELDTM vaccine.

  1. Very common (may affect more than 1 in 10 people) – tenderness, pain, warmth, or itching where the injection is given, generally feeling unwell, feeling tired (fatigue), chills or feeling feverish, headache, feeling sick (nausea), joint pain or muscle ache
  2. Common (may affect more than 1 in 10 people) – swelling or redness where the injection is given, fever, being sick (vomiting) or diarrhoea, pain in legs or arms, flu-like symptoms, such as high temperature sore throat, runny nose, cough and chills
  3. Uncommon (may affect up to 1 in 100 people) – sleepiness or feeling dizzy, abdominal pain, enlarged lymph nodes, excessive sweating, itchy skin, rash or hives
  4. Not known (the frequency cannot be determined from the available data) -severe allergic reaction (anaphylaxis), severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing or breathing)
  5. Rarest: Major blood clotting (venous and/or arterial thrombosis) in combination with low platelet count (thrombocytopenia) have been observed very rarely (with a frequency less than 1 in 100,000 vaccinated individuals)
13. When can I take second dose of vaccine if I get COVID-19 disease after first dose of vaccine?

As per the guidelines of the Ministry of Health and Family Welfare (MOHWF), you can take the 2nd dose of the COVID-19 vaccine 3 months after recovery from COVID-19 symptoms. (2)

14. When can I take 1st dose of vaccine after developing COVID-19?

As per the guidelines of the Ministry of Health and Family Welfare (MOHWF), COVID-19 vaccine can be deferred by 3 months after recovery in individuals having lab test proven SARS-2 COVID-19 illness. (2)

15. Whether a person after receiving vaccine can consume alcohol/ smoke?

There is no recommendation regarding avoidance of alcohol/ smoking following vaccination.

16. Are any animal products used in COVISHIELDTM?

No animal products are used in COVISHIELDTM

17. Can pregnant women receive COVISHIELDTM?

There is a limited experience with the use of the vaccine in pregnant women. Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofetal development, parturition or postnatal development; definitive animal studies have not been completed yet. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established. Administration of COVISHIELDTM in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Recently, Ministry of Health & Family Welfare, Govt. of India said that, ‘a pregnant woman who opts for vaccination, could be vaccinated at any time of the pregnancy. To help pregnant women make an informed decision to be vaccinated, they should be provided with information about the risks of COVID-19 infection in pregnancy, the benefits of vaccination, along with the likely side effects of vaccination’.(3)
For further details, please refer to
www.mohfw.gov.in/pdf/OperationalGuidanceforCOVID19vaccinationofPregnantWoman.pdf

18. What is the effect of COVISHIELDTM on fertility?

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

19. Can women on their periods (menstruating) receive COVISHIELDTM?

There is no correlation between menstruation and the effect of the vaccine.
Moreover, this is a physiological phenomenon and it has nothing to do with immunity. Women on their periods can take the vaccine.
In fact, there is no prohibition to take any vaccine during menstruation.

19. A person outside India, who has received first dose of AstraZeneca’s vaccine, whether he can take second dose of COVISHIELDTM in India?

Both COVISHIELDTM(manufactured by Serum Institute of India Pvt Ltd) and COVID-19 Vaccine AstraZeneca (manufactured by AstraZeneca) are ChAdOx1 nCoV- 19 Corona Virus Vaccines (Recombinant). There is no data available when both these vaccines are used interchangeably.
However, the World Health Organization (WHO) states that ChAdOx1-S [recombinant] products (AstraZeneca AZD1222, SII COVISHIELDTM) are considered equivalent and interchangeable for both doses and recommends that both doses should be administered with ChAdOx1-S product. (4)

20. Can I take 1 dose of COVISHIELDTM and 1 dose of another COVID-19 vaccine?

There is no safety, immunogenicity or efficacy data to support interchangeability of COVISHIELDTM with other COVID-19 vaccines. It is recommended that individuals who receive a first dose of COVISHIELDTM complete the vaccination course with COVISHIELDTM.

21. Can people still get COVID-19 even after receiving 2 doses of the vaccine?

Yes, no vaccine is 100% protective. People can get COVID-19 even after vaccination. However, the vaccination will help protect them from developing severe disease. Kindly note that people who get vaccinated should continue to follow all current guidance to protect themselves against COVID-19 after they are vaccinated. That means:

  • Wearing a mask
  • Staying at least six feet away from others
  • Avoiding crowds
  • Washing hands with soap and water or using hand sanitizer
22. Is it recommended to test antibodies after vaccination?

Our clinical trials have shown that after 2 doses of the vaccine almost all recipients developed antibodies. The Centre for Disease Control (CDC), USA does not recommend antibody testing to assess for immunity to SARS-CoV-2 following COVID-19 vaccination.

23. How long will the vaccine protect me against COVID-19?

The duration of protection has not yet been established.

24. Do I need to take 3rd dose of vaccine?

As of now, there are no such recommendations.

Stay tuned for information on COVAXIN and SPUNTIK V in future.

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