The Drugs Controller General of India or DCGI grants permission for conducting a study (Phase-4 clinical trial) based on the mixing of Covaxin and Covishield – the two primary Covid-19 vaccines in India. The study is said to be conducted by CMC or Christian Medical College in Vellore and will involve around 300 healthy volunteers.
The initiative or recommendation about the need for this study was initiated by the Subject Expert Committee of the Central Drugs Standard Control Organisation or CDSCO on 29th July 2021.
Why is the study being conducted?
As per the leading Covid doctors in Kolkata and around India and researchers, the purpose of this study is to assess the possibility of whether an individual can receive different vaccine shots, which is, one shot of each – Covaxin and Covishield, to complete the vaccination course for Covid-19.
To note: Earlier this year, a group of people were accidentally given different doses of vaccine in Uttar Pradesh, however, the study for this incident is being conducted by ICMR or Indian Council of Medical Research and differs from the study by CMC.
Affirming the purpose of the vaccine, a similar trial in the UK has also been carried out to check the feasibility of mixing two vaccines and their immune response. Around 1,050 people volunteered and more than 800 people in the UK around this time (while the research was taking place) have received two doses of either Pfizer, AstraZeneca or a mix.
New York also seeks participation in this study. As per a lab test, people who received one jab of each vaccine produced 37 times more SARS-CoV-2 neutralizing antibodies and 4 times more SARS-CoV-2-specific immune cells, than the ones who received just one dose of the Oxford–AstraZeneca.
What is the result of the study by ICMR?
Some details of the research –
- The research involved 98 people
- Out of which 18 of them received Covishiled as their first and Covaxin as their second dose
- 40 of them received two doses of Covishiled
- The rest 40 received two doses of Covaxin
The result: ICMR states that combining these two vaccines (one dose of each) prompted better immunogenicity or immune response than receiving two shots of the same vaccine.
Nevertheless, scientists and researchers are still seeking evidence and answers on real-world efficacy and rare side effects. But, mixing up of the vaccines provides a sense of relief to the unpredictable supplies, and questions on safety. An adept immunologist Leif Erik Sander at Charité University Hospital in Berlin also affirms that people can now get a bit more comfortable with the mix-and-match of the vaccines as it renders better results and boosts more immunity than taking two shots of the same vaccine.
Are there any adverse effects?
Studies have found that the combination of two vaccines are safe and the adverse effects experienced are similar to that of the effects noticed upon being vaccinated with two doses of the same vaccine. ICMR also stated that mixing both the vaccines yields better results against Covid-19.
The safety concerns still remain as some study goes against the statement of safety and fewer side effects. However, the study to derive a final answer is still going on and India awaits the results that will be declared sooner.
How are people reacting to this research?
As the nationwide vaccination drive is still going on. India entered into the 4th month of the vaccination programme when the mixing of the vaccines took place. This incident generated an atmosphere of panic and anxiety and held the potential to contribute to vaccine uncertainty.
However, with the help of the leading media houses, as the news spreads, people are becoming more aware of the study on the mixing of both vaccines and their safety. There is still no concrete details on when the mixing will be approved and the vaccination drive will change its route.
Both the doses of the same vaccine are still being received by people. Many of them are still not open to receiving one shot of each vaccine and feel it might affect their health.
My take on the matter
With hands-on experience in treating Covid-19 patients, I would like to affirm that no adverse effects have been accounted for till now on combining the doses of both the vaccines. The study is being conducted to clear the air of fear and anxiety that took place after the Uttar Pradesh incident.
Nevertheless, the leading Covid doctors in Kolkata request the citizens of India to follow the Covid-19 safety protocols. There is still time until the country sees the end of Covid-19 and thus to combat the spread of the infection strict protocols must be maintained.
- Keep wearing masks
- Use sanitizers as necessary
- Step outdoors only if extremely necessity
- Stay away from the crowd
- Avoid touching your eyes and mouth when outdoors
- Cover your mouth with your elbow when coughing or sneezing
Also, seek medical help immediately upon noticing the slightest symptoms of Covid-19. Do not delay as the situation can turn adverse. Get vaccinated as soon as it is available to you.
For further information get in touch with Dr. Amitabha Saha.