A lot of queries must be running in your mind regarding vaccines and vaccination. Put the doubts regarding vaccination to rest with the information down below.
What vaccines available in India?
1.COVISHIELD
2. COVAXIN
Who made what?
COVISHIELD: Developed by Oxford University and AstraZeneca, manufactured at Pune-based Serum Institute of India (SII).
COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
What kind of vaccines are these?
COVISHIELD is a vector vaccine that contains chimpanzee adenovirus, which does not infect humans and this adenovirus is genetically engineered to produce coronavirus spike proteins.
COVAXIN: It is an inactivated COVID-19 virus vaccine that will use adjuvant Alhydroxiquim-II to boost immune response and longer-lasting immunity.
Who are eligible to get vaccinated?
People above 18 years are eligible.
Why isn't the vaccine available for kids?
Children are not eligible because their immune systems are very different from adults, and their immune responses can be different at different ages, from infancy through the teenage years. So the research that’s been done on the COVID-19 vaccine for ages 18 and up needs to be repeated in children of younger ages. A full pediatric vaccine will soon be available after trials.
Which clinical phase trials did they complete and the controversies?
COVISHIELD- completed phase 3 trials but the vaccine has been tried and tested on the UK population. To release in India, they need to conduct studies on our population too, these are known as bridging trials. The controversy raised when the bridging trails number was very low.
COVAXIN: Still being studied under phase 3 clinical trials. It has been released under "clinical trial mode” for “restricted emergency use”.
Are the vaccines Food and Drug Administration approved?
NO. They are not FDA-approved. They have been released under Emergency Use Authorisation(EUA).
Is it mandatory to get vaccinated?
No. It's optional.
What is the route of administration?
Intra-muscular
The number of doses?
2 doses, 4 weeks apart.
Covishield can be given up to 12-16 weeks after the first dose.
When do I get immunized against COVID?
4-6 weeks after the second dose.
Do I get COVID upon vaccination?
The vaccine contains inactivated form of COVID virus/ COVID proteins, (which are powerful enough to stimulate immune response but cannot cause disease) against which the body produces antibodies and gets sensitized upon the first exposure. This is the reason why COVID symptoms are similar to the post-COVID vaccine. Next time when the virus enters, as the body is already sensitized and has knowledge of what antibodies to be released, this time it produces many antibodies and combats the COVID virus.
What if, you are COVID positive right now?
It has been suggested to take the vaccine after 4-6 weeks of recovery. The same applies to plasma recipients as well.
I took my first dose and at the time of the second dose, I got tested positive, what to do now?
First, get treatment for covid. After 4-6 weeks of recovery get your second shot. If the gap between the first shot and the second shot exceeds 8 weeks then start afresh vaccination schedule i.e you need to take the first shot again. The maximum duration allowed between two vaccine shots is 8 weeks.
Duration of vaccine immunity?
Not known.
Do you still take COVID precautions even after vaccination?
Big YES, both the vaccines have clearly stated in their fact sheets that their vaccines may not protect everyone. Receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed and it takes at least 4 weeks to form antibodies. Only 85% of people may not contract disease upon taking two doses of vaccine.
What is EUA?
It is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under a EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit a EUA request to FDA.
What are the criteria for EUA approval?
FDA expects a EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. In addition, FDA expects that a EUA request will include a phase 3 safety database of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.
What are the side effects?
COVAXIN:
Injection site pain
Injection site swelling
Injection site redness
Injection site itching
Stiffness in the upper arm
Weakness in injection arm
Body ache
Headache
Fever
Malaise
Weakness
Rashes
Nausea
Vomiting
Side effects that have been reported with the COVISHIELD™ Vaccine include:
Very Common (may affect more than 1 in 10 people)
feeling tired (fatigue)
tenderness, pain, warmth, redness, itching, swelling, or bruising where the injection is given
chills or feeling feverish
headache
feeling sick
joint pain or muscle ache
Common (may affect up to 1 in 10 people)
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 1 in 100 people)
feeling dizzy
decreased appetite
abdominal pain
enlarged lymph nodes
excessive sweating, itchy skin, or rash
Shortness of breath, chest tightness, trouble swallowing
Abdominal pain
Fainting
Convulsions
What if you face serious adverse effects?
Report to the healthcare provider. You can report side effects after vaccination to Serum Institute of India Pvt Ltd who is the manufacturer of the COVISHIELD™ vaccine (details are available in their fact sheets).
In case of serious adverse effects with COVAXIN, its sponsor would pay the compensation if it is approved that SAE is causally related to the vaccine.
What all do you need to mention to your healthcare provider before vaccination?
State if you have any -
Severe allergic reactions in the past to any components of the vaccine
Past history of the medications used
fever
Received any other covid-19 vaccine
State if you are immunocompromised i.e if you have taken any anti-cancer drugs.
Bleeding disorder, on a blood thinner
If you are pregnant/planning for pregnancy/ breastfeeding do mention it.
Vaccines abroad:
Pfizer-BioNtech: 2 doses, 21 days apart for people above 12 years, its an mRNA vaccine. The mRNA in the vaccine teaches cells how to make copies of the spike protein. If exposed to the real virus later, the body will recognize it and know how to fight it off.
Moderna: mRNA-based vaccine.2 doses, 1 month apart for individuals above 18 years. The nucleoside-modified mRNA in the Moderna COVID‑19 Vaccine is formulated in lipid particles, which enable the delivery of the nucleoside‑modified mRNA into host cells to allow expression of the SARS‑CoV‑2 Spike antigen.
Sputnik V: Recombinant adenovirus vaccine.Adenovirus is used as a “container” to deliver the coronavirus gene to cells and start the synthesis of the new coronavirus's envelope proteins, “introducing” the immune system to a potential enemy. It has reached the Indian market now.
DISCLAIMER: This article is intended for educational purposes only. It is not a substitute for a doctor's advice.
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