Plea in Bombay HC seeks info on safety, efficacy of ‘Covaxin’ from DCGI

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

RTI activist Saket Gokhale on Saturday moved a writ plea before the Bombay High Court seeking direction to the Drug Controller General of India (DCGI) to bring in 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 that 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.

“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,” the plea said.

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

In light of this, the activist 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, it has been submitted to the central government, which was considered for the vaccine approval process and conditional approval to ‘Covaxin’ thereon.

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 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 vaccine with consequences or remain unvaccinated and remain “susceptible to Covid-19 infection”.

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

Following this, the petitioner had filed a Right To Information (RTI) 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 High Court.

The petitioner has prayed to the court seeking directions to the DGCI to furnish information requested in RTI application on ‘an urgent and immediate basis,’ in the interest of general public’s ‘life and liberty.’

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