Ever since Virologist Gagandeep Kang has called for people to register for CMC Booster Dosing Study who’ve had two doses of Covaxin around three to six months ago to volunteer for a ‘booster dosing’ study, the study site is struggling to recruit Covaxin participants. The greatest impediment is the study will look at the impact of mixing Covaxin and Covishield as the booster dose.
This could be a major cause for CMC being unable to recruit participants to take the jab. Different possible boosters, randomized and blinded is what Dr. Gangandeep replied in a tweet to a Twitterati asking whether he will be getting Covaxin for his 3rd dose if he registers.
The demand for booster doses grows in the aftermath of the new Omicron variant, Christian Medical College (CMC) Vellore has announced plans to conduct a study to test the efficacy of a booster dose on those who have already received two doses of Covaxin.
In a recent statement, Dr. Ganadeep had claimed that it was easy to recruit Covishield double jabbed for the booster study as there seems to be a greater inclination of people to take Covaxin which has been recommended by leading experts and studies.
Need volunteers for a clinical trial. People with 2 doses of Covaxin 3-6 months ago are eligible to enroll in a booster dosing study. Folks in Vellore, Chennai, Bangalore or Delhi willing to consider participating – Dr. Gagandeep tweeted.
In August, the Drug Controller General of India (DCGI) had given its approval to CMC Vellore to conduct the clinical trials for booster doses.
Questions to ponder about the CMC booster dosing study
What people are asking on social media after the tweet by Dr. Kang
- Will the participants get the same vaccine or another vaccine as a booster?
- Has CMC Vellore ethics committee approved the protocols, and what does the trial protocol say
- Are the trial participants incentivized in any manner for participating in this trial, will they also be counseled about the outcome or possible reactions if mixing of vaccine is conducted
- Has CMC Vellore and the Welcome Trust research laboratory taken approval from DCGI for advertising on Twitter !!! Soliciting volunteers
- Who is funding this study?
Among the questions asked by people are
And what’s the guarantee of their health after the boosters are given? Who’s responsible for any reactions? Any compensation you will be giving? What in the event of a death?
Another possible cause that COVAXIN double-dosed participants might not be willing to take the mix shot of Covishield.
According to a top virologist Shahid Jameel:
Quite recently, The Subject Expert Committee (SEC) which was reviewing the application of the Serum Institute of India (SII) Covishield for the booster dose has said COVID-19 that booster doses cannot be recommended without clinical trials in a meeting that took place in December 2021.
TheNewsFacts team reached out to a number of individuals across age groups who have taken the double dose of Covaxin, asking are they ready for a booster dose study, with a probability of getting the booster shot which could be either Covaxin and covishield in a randomized test – the response was surprisingly loaded with reluctance with many saying they would rather have COVAXIN as their third shot and not any other vaccine.
They said we believed in the Covaxin platform and that is why we took the vaccine, why would we go and take the third dose of another vaccine that we did not take in the first place.
According to sources, there is preliminary consensus in the country’s top technical advisory body on Covid-19 vaccination that the third — booster — dose, when administered, should be of a vaccine based on a platform different from that of the first two doses. This could also be the reason that Covaxinated is reluctant to participate in the booster study by CMC Vellore.
The newer technology “mRNA vaccines make only spike proteins so they can be used as boosters in people who got them earlier,” Jameel had expressed. Around 88 percent of Indians have received the Covishield vaccine.
Earlier in a media interview, Dr. Krishna Ella said People will need booster doses of the COVID-19 vaccine if the COVID-19 virus gets mutated. His company is also pursuing nasal vaccines which have shown great promise to not only prevent covid but also contain the transmission.
“The sooner we recruit, the sooner data will be available! Needs a month after all recruitment is complete for the first complete set of samples and a week after that, finish testing,” Dr. Kang said. Not finding any takers Dr. Gagandeep took to a microblogging site to call for participants now.
Doctors and health researchers voice that a mix-and-match strategy where a different vaccine is given as a booster might be a way to go forward, as the results in tests do look promising in a few studies conducted in other nations.
Booster likely for COVAXIN recipients
Covaxin recipients in India, not those who have taken Covishield, may become eligible for booster doses of the Covid-19 vaccine first, sources in the country’s expert panel on immunization told this newspaper. They cite a new WHO recommendation.
The WHO has recommended that in the wake of the Omicron threat, whole inactivated virus-based vaccine recipients should get booster doses, along with those identified as most immuno-compromised.
The WHO’s Strategic Advisory Group of Experts on Immunisation had said that those who are immuno-compromised, such as those on dialysis or immuno-suppressants or have received an inactivated Covid-19 vaccine — vaccines based on killed SARS CoV 2 — should receive booster shots.
“Given our policy of following WHO advice on vaccinations which includes booster doses, we are considering their latest recommendations and will discuss the matter formally in the expert group,” said a source in the National Technical Advisory Group on Immunization.
Virologist T. Jacob John warned that the government must not drag its heels in deciding on booster doses. “By the time you do studies and find it is an excellent defense against the Omicron, it will be too late.