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Friday, February 26, 2021

Activist moves Bombay HC seeking info from DCGI on safety & efficacy of Covaxin

"Lack of information exposes recipients to risk of taking vaccine with consequences," activist's plea says.

By: Express News Service | Mumbai |
Updated: January 16, 2021 10:19:20 pm
Covaxin will be used in the government's mass vaccination programme against Covid-19 that starts on Saturday. (Twitter/BharatBiotech)

RTI activist Saket Gokhale on Saturday moved a writ plea before the Bombay High Court seeking directions to the Drugs Controller General of India (DCGI) to bring in the public domain all information pertaining to the safety and efficacy trial results of Bharat Biotech’s Covid-19 vaccine ‘Covaxin

The plea stated that while the vaccination drive in India begins from January 16, and Covaxin is safe and provides a “robust immune response”, the data from the company given to the DCGI has not been made available in the public domain.

“With a trial vaccine that has not completed Phase III trials as in the case of M/s Bharat Biotech’s Covaxin, there remains a great possibility of harm to the life of members of the general public that are being administered this vaccine,” stated the plea.

The petitioner referred to the January 3 press note issued by the DCGI, which said Covaxin has been approved for “restricted use in an emergency situation” and that while Phase I and Phase II clinical trials demonstrated that the vaccine was safe, Phase III trials are still ongoing.

In light of this, Gokhale stated in his plea, “This means that every person that is administered M/s Bharat Biotech’s Covaxin will technically be seen as a participant in the company’s Phase III trials and monitored accordingly as per the rules of Phase III trial process.”

The petitioner went on to say, “The approval granted to M/s Bharat Biotech’s Covaxin is not a full approval and is merely a green signal to provide its vaccine to the Govt of India while treating every recipient of a vaccine as a participant in its Phase III human clinical trials.”

Gokhale further alleged that the company has not published findings and data of their Phase II and ongoing phase III trials in any paper and the same data, however, has been submitted to the central government, to be considered for the vaccine approval process and conditional approval to Covaxin.

The activist further said that any person receiving Covaxin is first required to sign a mandatory consent form with “lack of information in public domain” or “forego the vaccination entirely”.

Further, the Centre has stated that people receiving vaccines will not have a choice as to which vaccine they receive, the petition noted.

In view of this, the plea claimed that with the absence of information in the public domain related to safety and efficacy of Covaxin clinical trials, it is impossible for anyone to provide an informed consent, thus exposing recipients to risks of taking vaccines with consequences or remain unvaccinated and remain “susceptible to Covid-19 infection”.

The petitioner, referring to news reports, claimed that a participant in Covaxin trials had died in Madhya Pradesh due to cardio-respiratory failure arising from suspected poisoning, as per the post-mortem report.

Following this, the petitioner had filed a Right To Information application with the DCGI, seeking information on Covaxin, including data submitted by the vaccine manufacturer companies and final report of the expert committees on the same, which remain unanswered, prompting Gokhale to move the High Court.

The petitioner has sought directions to the DCGI to furnish information requested in the RTI application on “an urgent and immediate basis”, in the interest of general public’s “life and liberty”.

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