COVID-19 Vaccines in India

COVID-19 Vaccines:

A vaccine is a medical or biological preparation that activates the immune system in an individual to fight pathogens that enter the body. Killed or deactivated forms of the pathogen, toxin, or surface protein are commonly used to prepare a vaccine. The process of administration of the vaccine is known as vaccination. For people to develop immunity or defense against the SARS-CoV-2 coronavirus (the virus that causes COVID-19) and put an end to this pandemic, various COVID-19 vaccines have been developed, and some have also been approved for emergency use.

Basic knowledge and understanding of these vaccines are necessary before choosing to vaccinate. Educating ourselves about these vaccines advantages, disadvantages, precautions, and side effects of these vaccines will avoid unnecessary panic. Currently, 12 vaccines are approved for use in India, and they include the following:

1. Serum Institute of India- Covishield (Oxford/ AstraZeneca formulation).

2. Bharat Biotech- Covaxin.

3. Zydus Cadila- ZyCoV-D.

4. Moderna- Spikevax.

5. Gamaleya- Sputnik Light.

6. Gamaleya- Sputnik V.

7. Janssen (Johnson & Johnson)- Ad26.COV2.S.

8. Oxford/AstraZeneca-Vaxzevria.

9. Serum Institute of India- COVOVAX (Novavax formulation).

10. Biological E Limited- Corbevax.

11. Gennova biopharmaceutical limited - GEMCOVAC - 19

12. Bharat Biotech - iNCOVACC

An individual's medical history and health condition should be greatly considered before getting these vaccines. Some people fear that COVID-19 vaccines can make them prone to COVID-19 infection. But these vaccines do not contain any live components of SARS-CoV-2 coronavirus and are relatively safe.

Who Are Eligible for COVID-19 Vaccines?

On January 16, 2021, the Indian Government started administering two vaccines against SARS-CoV-2 coronavirus, Covaxin and Covishield (developed by Bharat Biotech and Serum Institute of India, respectively). These vaccines have been granted restricted use because of the pandemic. The Government of India selected healthcare workers and frontline workers as the first group to get vaccinated as they were at higher risk. The second group was people over 45 years and adults with comorbid conditions. The candidates who have the following conditions and are above 45 years of age can get vaccinated:

• Heart failure patients who were admitted recently (In the past year).
• Patients with left ventricular systolic dysfunction.
• Patients with a cardiac transplant or with left ventricular assistance.
• Valvular heart disease patients with mild or moderate intensity.
• Diabetes patients on treatment.
• Coronary artery disease.
• Congenital heart disease.
• Angina and hypertension.
• Pulmonary artery hypertension.
• Hematopoietic stem cell transplant.
• Liver transplant.
• Kidney transplant.
• HIV infection.
• Cirrhosis.
• Lymphoma.
• Leukemia.
• Myeloma.
• Bone marrow failure.
• Prolonged use of oral corticosteroids or immunosuppressive medication.
• Primary immunodeficiency diseases.
• Multiple disabilities, including deafness and blindness.
• Aplastic anemia.

This was followed by vaccinating all adults over the age of 18. On January 3rd, 2022, children between 15 to 18 years of age were eligible for vaccination with Covaxin. COVID-19 vaccines are now recommended for pregnant women, women who are trying to get pregnant, and those who are breastfeeding. Research states that the benefits of receiving the COVID-19 vaccine during pregnancy outweigh the risks. And there is still no evidence that COVID-19 vaccines can cause fertility problems in women or men.

Data have shown that breastfeeding women who have received COVID vaccines have antibodies in their breast milk; therefore, it can protect the babies. But more data are required to determine the level of protection these antibodies can provide to the baby.

What Are the Contraindications for COVID-19 Vaccines?

The various contraindication for COVID-19 vaccines are:

• Patients with a history of an allergic reaction to an earlier dose of the COVID-19 vaccine should avoid getting another dosage of the same vaccine. The ingredient of the vaccine that caused the allergic reaction should be identified.

• It is not advisable to give COVID-19 vaccines along with another vaccine. A time interval of six to eight weeks is required for getting vaccinated with two different vaccines.

• It is recommended that the first and the second doses of the COVID-19 vaccine should be the same. Interchanging COVID-19 vaccines is not allowed.

• COVID-19 vaccination is contraindicated for individuals who are younger than 18 years of age.

What Are the Precautions for COVID-19 Vaccines?

• If a patient is showing active symptoms of COVID-19, such as cough, fever, breathing difficulties, etc., it is better to avoid the COVID-19 vaccine. Get vaccinated only if the cause of the symptoms is determined to be other than COVID-19.

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• People with confirmed COVID-19 infection should not get vaccinated as they have an increased risk of spreading the infection to others while getting vaccinated. So infected patients should wait for at least three months to get vaccinated.

• The vaccine can be delayed in COVID recovered patients as symptomatic reinfection is unlikely for upto 6 months after infection. This criteria can be followed especially when the vaccine supply is limited allowing others who are in priority to get vaccinated.

• A patient who is sick and hospitalized.

What Information Should You Provide Doctors Before Getting the COVID-19 Vaccine?

In case you are planning to get vaccinated, inform the doctor if you have any of the following medical conditions:

• If you are pregnant or trying to conceive.

• If you are a breastfeeding mother.

• If you have a fever.

• If you are consuming anticoagulant medications. It is also better to discuss and talk about your past medication history with the doctor.

• If you have any allergic reaction to any particular food or drug.

• If you have already received a different COVID-19 vaccine.

What Is Covishield?

Covishield or the Oxford-AstraZeneca vaccine is a vaccine developed in the UK. It is a vaccine that is approved for emergency usage in India. It is currently provided to prevent COVID-19 in people who are 18 years or older at an interval of 12 to 16 weeks. The Covishield vaccine is administered in two separate doses. Each dose contains 0.5 ml of the vaccine. After the administration of the first dosage, the second dose is given after six to eight weeks. If you miss the second dose, contact your healthcare provider and ask for their advice. This vaccine is given as an intramuscular injection. This intramuscular injection is administered in the deltoid muscle. The reason for the administration of vaccines in the deltoid muscle of the arm are:

• The immunogenicity of the vaccine is enhanced.

• Adverse reactions are reduced at the site of injection.

What Are the Ingredients of the Covishield Vaccine?

The ingredients that are present in the Covishield vaccine are:

• L-Histidine hydrochloride monohydrate.

• L-Histidine.

• Polysorbate 80.

• Magnesium chloride hexahydrate.

• Water for injection.

• Sucrose.

• Ethanol.

• Disodium edetate dihydrate (EDTA).

• Sodium chloride.

What Are the Side Effects of Covishield?

The common side effects of the Covishield vaccine are listed below. These side effects are seen in one person out of ten.

• Joint pain.

• Muscle ache.

• Nausea.

• Headache.

• Feeling tired.

• Chills.

The other common symptoms that the person might experience after getting vaccinated are:

• Vomiting.

• Fever.

• Lump at the injected site.

• Flu-like symptoms, such as runny nose, fever, sore throat, chills, cough, etc.

The rare side effects of Covishield, which affects only one out of 100 people, are:

• Abdominal pain.

• Enlargement of lymph nodes.

• Dizziness.

• Loss of appetite.

• Itchiness and skin rashes.

• Excessive sweating.

This is not a comprehensive list of the side effects, and as the vaccine is new, other severe and unexpected side effects might also occur. Inform your doctor immediately if you develop any unusual signs or symptoms after getting vaccinated.

What Is Covaxin?

Covaxin is another vaccine for COVID-19, just like Covishield. It is a locally produced vaccine by the company Bharath Biotech that was approved for emergency use with certain restrictions. The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) says that the vaccine’s efficacy against COVID-19 of any severity was 78 %, 14 or more days after the second dose. The efficacy of vaccines against severe disease is 93 %. Adults under aged less than 60 years had a 79 % efficacy rate, while those aged 60 and up had a 68 % efficacy rate.

What Are the Ingredients of the Covaxin Vaccine?

The ingredients of Covaxin are:

• NIV-2020-770 strain.

• Aluminum hydroxide gel.

• Imidazoquimolinone.

What Are the Side Effects of Covaxin?

The possible side effects of Covanix are:

• Swelling in the injection site and pain.

• The injection site appears red.

• Itchiness in the affected site.

• Stiffness of the upper arm.

• Headache.

• Fever.

• Body pain.

• Weakness.

• Nausea and vomiting.

There are also chances for the individuals to experience a severe allergic reaction after getting the vaccination. To avoid such situations, the person receiving the vaccine would be asked to stay for 30 minutes after receiving the dosage. The severe side effects caused by Covaxin are:

• Multiple rashes all over the body.

• Swelling in the throat and face.

• Difficulty in breathing.

• Weakness and dizziness.

What Is Sputnik V?

Sputnik V, the vaccine against COVID-19, was created in Russia by the Gamaleya National Research Institute of Epidemiology and Microbiology. Sputnik V vaccine is also called as Gam-COVID-Vac. The vaccine uses two different viruses, adenovirus 26 (Ad26) and adenovirus 5 (Ad5). It follows a heterologous recombinant adenovirus procedure. These two component-based adenoviruses help fight against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein and are administered three weeks apart. These are aimed at getting over any preceding adenoviruses making them weak, so they cannot cause the disease. Unlike the other approved COVID vaccines, the Sputnik V COVID-19 vaccine uses different viruses for both shots.

What is Co-WIN?

Co-WIN is an online portal that helps people to register for receiving the COVID-19 vaccination. There is no separate application for completing the registration. You can make use of the ArogyaSetu App for registration purposes. People over 60 years of age can register themselves through the online Co-WIN portal. Individuals with other health conditions can also register if they are between 45 years and 59 years. These individuals can use the medical certificates from a doctor for registration.

Scheduling the Appointment: Scheduling the appointment is very easy. You can use the same Co-WIN portal and get your appointment. The appointment slip can be downloaded from the site. You have a record of your appointment date on your mobile phone. After you confirm, you will receive a confirmation SMS on your mobile number. You can also locate your vaccination center with the help of your pin code. If you miss your appointment, there are facilities for rescheduling your appointment dates. You can also cancel your appointment if you cannot go on the scheduled date.

For guidance on the registration process and appointment schedule, you can call 1075 for additional information and help. Registering through the online site for vaccination is not mandatory, but it is highly recommended for a disturbance-free environment. You can register upto four people using a single mobile number. For the convenience of the older people, on-the-spot registrations are also made available. There are no additional charges required for registrations. You might require a few documents for your registration. They are:

• Aadhaar card.
• PAN card.
• Driving license.
• Pension passbook.
• Passport.
• Voter ID Card (EPIC).
• NPR smart card.

Second Dose: It is very important to receive your second dose. Make sure you receive the same vaccination as your first dose. The procedures for receiving the second dose are the same. The information on the first dosage date and the type of the vaccine should be remembered well and informed at the time of your next vaccination. You are requested to carry the vaccine certificate that was issued to you during the first dose. A recent update from the Health Department emphasizes that the time interval between the two doses should be adjusted for a minimum of six to eight weeks. Also, the antibodies could provide immunity for the people only after 28 days.

Third or booster dose: Those eligible for the third vaccination dose can register via the CoWIN portal and receive the booster dose. The main reason for receiving the third dose is to boost immunity. According to the official CoWIN website, "Citizens should carry their Final Certificate of vaccination (with details of both earlier doses). In addition, citizens should use the same mobile number and ID card used for earlier doses" "frontline workers, healthcare workers, and senior citizens aged above 60 years of age shall continue to receive precaution dose vaccination at any CVC, including free of charge vaccination at Government Vaccination Centers."

What Are Other Vaccine Projects Underway in India?

1. Bharat Biotech Intranasal Vaccine BBV154 -

Bharat biotech worked on the first intranasal vaccine for COVID-19 in India. It collaborated with Precision Virologics and Washington University School of Medicine in the US. The vaccine is made from a weakened common cold virus (adenovirus). After the phase I clinical trials, the vaccine showed promising efficacy and protection against the coronavirus SARS-Cov-2. The BBV154 does not require a needle for its administration. The vaccine is sprayed inside the nose, where triggering an immune response is triggered. It is particularly suitable for both adults and children with needle phobia. Nasal vaccines have the upper hand regarding ease of administration, no needle hassles, pain-free, and non-invasiveness. Bharat Biotech's intranasal COVID-19 vaccine, BBV154, has currently received DCGI approval for phase-3 clinical trials.

2. Gennova mRNA HGCO19 Vaccine -

It is India’s first homegrown mRNA vaccine developed by the Gennova pharmaceutical company. The phase I trial monitored by The Central Drugs Standard Control Organisation (CDSCO) concluded that the vaccine was safe and produced a good immunogenic response. The HGCO19 vaccine works by self-amplifying the mRNA, quickly producing viral proteins. This vaccine can be stored in regular refrigerators, unlike Pfizer and Moderna vaccines which require sub-zero temperature storage. Patients also need a lose-dose regime because of the advantage of self-amplification. However, the recently approved mRNA vaccines have a few inherent negatives, such as the supply of raw materials, scalability, manufacturing, ultra-low temperature logistics, and technology transfer.

Additionally, the vaccine can be tweaked to combat new variants. The Gennova mRNA vaccine is also potent against the Omicron variant. In addition, mRNA-based vaccines can be administered multiple times to individuals with low immunity. Gennova has currently submitted phase 2 and 3 clinical trial data to the Drugs Controller General of India (DCGI). The regulator is currently reviewing the vaccine, and if approved, it could be available in the Indian market soon.

Charge of the Vaccine: In government hospitals, the vaccines are provided free of cost. The private hospitals might charge a fee for vaccination. At present, individuals cannot choose their own vaccines.

Reporting of Side Effects: The person who received the vaccination recently should be aware of any minor changes in the body. In case of any side effects, you can report to the 1075-guideline number.

The other vaccines still in clinical trials in India are

1. Novavaz - Nuvaxovid.

2. Biological E Limited Corbevax.

3. Serum Institute of India - COVOVAX (Novavax formulation).

4. University Medical Center Groningen - AKS - 452.

5. Zydus Cadila - ZyCoV-D.

6. Gennova Biopharmaceuticals Limited - GEMCOVAC-19.

7. Bharat Biotech - iNCOVACC.

8. Gamaleya - Sputnik Light.

9. Gamaleya - Sputnik V.

10. Oxford/AstraZeneca - Vaxzevria.

11. Serum Institute of India - Covishield (Oxford/AstraZeneca formulation).

12. Bharat Biotech - Covaxin.

13. Biological E Limited - BECOV2B.

14. Biological E Limited - BECOV2C.

15. Biological E Limited - BECOV2D.

Conclusion:

After receiving two doses of the COVID-19 vaccine, the patient will be followed up for three months. If the patient is experiencing any unusual symptoms after receiving the vaccine, they have to report to the doctor immediately. Even if you have been vaccinated, pay attention to the usage of face masks and gloves. It is also our social responsibility to maintain distance from others, as not everyone is vaccinated, and it might take some time until the general population starts getting vaccinated.

For more help, contact a physician on icliniq.com.