Plea Filed In Supreme Court Seeking Directions With Regard To Voluntary Re-Vaccination Of Individuals Who Have Been Administered COVAXIN

(Judicial Quest News Network)

A public Interest Litigation on the subject of the flawed vaccination system prevailing in the country has been file in Supreme Court seeking directions with regards to voluntary re-vaccination of individuals who have been administered COVAXIN.

The petition is preferred by Advocate Kartik Seth and drawn by Ms

 Shriya Gilhotra, Advocate, the PIL states that under the present scenario, a person is not allowed/permitted to get vaccinated with Covishield by registering on the official website of Government of India,” COWIN” after having been fully vaccinated with COVAXIN.

It is further submitted that all the individuals fully vaccinated with COVAXIN are being treated by all major countries as un-vaccinated

individuals and are made to either quarantine or are not completely allowed within their borders. How has the Government of India tried to help these certain individuals, especially students and medical patients for whom it is of utmost necessity to travel without any inconvenience and additional cost?

In addition to the same, the Petitioner highlights herein that administration of both the vaccines, i.e., Covishield and COVAXIN was commenced on the very same day by the Respondents for the reasons best known to themselves despite pending third phase trials of COVAXIN along with pending WHO approval while relying merely on interim efficacy analysis generated from first and second phase trials.

In the above-stated manner, there has been major latent lacuna in the entire vaccination system across the country which involves lack of awareness attributable to the Respondents mainly.

The respondents, at the time of rolling out of COVAXIN for use in the market, failed to make the public aware that it was not approved by the WHO and that it had not even submitted an application before WHO for approval which was submitted as late as in April, 2021.

It was only in May, 2021 (five months after the commencement of vaccination drive) that it rolled out into the news that several nations are not allowing entry of people vaccinated with vaccines other than those enlisted in WHO’s emergency use list. Another blemish in the vaccination drive was that until 1st May, 2021 (i.e., up to first and second phase of vaccination drive), no choice of vaccination was made available to the public in India and it was the discretion and prerogative of the Government to administer whatever vaccine was available to the persons eligible for it. It was only from 1st May, 2021 (i.e., commencement of third phase of vaccination in India) that the public was allowed to choose the vaccine as per their own wish.

It has been submitted in the plea that in a meeting chaired by PM Narendra Modi, an important decision of allowing vaccination to Vaccine manufacturers incentivized to further scale up their production, as well as attract new national and international players everyone above the age of 18 from 1st May has been taken. PM said that the Government has been working hard from over a year to ensure that maximum numbers of Indians are able to get the vaccine in the shortest possible of time. He added that India is vaccinating people at world record

Pace & we will continue this with even greater momentum.

The Manufacturers of COVAXIN (BHARATH BIOTECH) had claimed earlier that it has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

The petitioner has pointed out that it is humbly submitted that the manufacturers of COVAXIN, Bharat Biotech and the Government of India have failed to procure/obtain the WHO’s Emergency Use Listing (EUL) despite starting with the administration of COVAXIN on exactly the same date as Covishield, i.e., 16th January, 2021 when the vaccination process commenced in India.

The time gap of two COVAXIN doses coupled with consistent and repeated assurances of the manufacturer and the government of WHO emergency use approval was a major factor moving a good chunk of the population to opt for COVAXIN as COVID-19 vaccine. Another reason of a shift from Covishield to COVAXIN was the Hon’ble Prime Minister’s endorsement and support for the home-grown vaccine. It was right after Hon’ble Prime Minister, Mr. Narendra Modi’s COVAXIN vaccination that a major part of the population flocked to COVAXIN instead of Covishield as a matter of trust and ardent following of the Hon’ble Prime Minister, who as per rough data, is one of the most followed world leaders on twitter. As a result of this apparent shift and support, more than 7 crore COVAXIN doses have been administered up to August, 2021 within India.

The petitioner has further submitted that It is relevant to mention here that another vaccine, Pfizer was granted emergency use authorization by WHO on 31.12.2020 and the manufacturers of Pfizer were inclined to enter into the Indian market, however entry of the same met with various hurdles created by the Government of India and eventually it was not allowed by the Government of India for reasons best known to themselves despite the fact that Pfizer had WHO approval and was proven as highly effective vaccine.

This also pointed out that the pending approval of COVAXIN has left the

entire population of the country that has got vaccinated with COVAXIN with a consistent uncertainty with respect to its international recognition and in pursuance of the same, lifting of travel ban for COVAXIN administered persons.

THAT the manufacturer of COVAXIN, i.e., Bharat Biotech International Ltd. and the Government have been repeatedly giving assurances to the public with respect to approval of the COVAXIN within the shortest time frame possible, however the same has been the situation for the past five months and till date WHO has not granted approval to the vaccine despite the phase three trials results along with all the relevant documents having been submitted by 09.07.2021. Here it is pertinent to mention that final trials of Covishield were concluded in November-December, 2020 and it received WHO approval on 15.02.2021 whereas COVAXIN’s final trials were finished in early July, 2021,

Expression of Interest was sent to the WHO on 19.04.2021 and till date there is no time frame or surety with respect to approval of the vaccine.

The filed through Chambers of Kartik Seth and drawn by Ms

 Shriya Gilhotra, Advocate, has sought for issuance of directions to the Centre and Ministry of Health and Family welfare to issue a revised standard of procedure and guideline allowing re-vaccination of fully vaccinated persons with another vaccine on voluntary payment of the person at his own risks and costs.