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"Covaxin Has Not Completed Phase 3 Trials": Saket Gokhale Moves Bomaby High Court Seeks Publication Of Safety & Efficacy Trial Results

Akshita Saxena
16 Jan 2021 6:29 AM GMT
Covaxin Has Not Completed Phase 3 Trials: Saket Gokhale Moves Bomaby High Court Seeks Publication Of Safety & Efficacy Trial Results
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Activist Saket S Gokhale has moved the Bombay High Court against the Drugs Controller General of India, urging that the safety and efficacy trial results of Bharat Biotech's Covid-19 vaccine "Covaxin" be made public. The petition states that whereas vaccinations in India are to begin from January 16, and it is being claimed that Covaxin is safe and provides a robust immune response,...

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Activist Saket S Gokhale has moved the Bombay High Court against the Drugs Controller General of India, urging that the safety and efficacy trial results of Bharat Biotech's Covid-19 vaccine "Covaxin" be made public.

The petition states that whereas vaccinations in India are to begin from January 16, and it is being claimed that Covaxin is safe and provides a robust immune response, the data submitted by the Company in this behalf has not been made available in the public domain.

He contends that the vaccine is still in phase 3 of clinical trial and hence, there remains a great possibility of harm to the life of members of the general public that are being administered this vaccine.

Covaxin still under clinical trial

In this context, the Petitioner has referred to a press note issued by the Government of India on January 3, whereby it is stated that Covaxin has been approved for "restricted use in emergency situation". The press note also mentions that whereas Phase I and Phase II clinical trials demonstrated that the vaccine is safe and provides a robust immune response, Phase III trials for the same is still ongoing.

"Thus, from the press release of Respondent, M/s Bharat Biotech's "Covaxin" has not been granted a full approval but a restricted use approval in clinical trial mode while the company's Phase 3 trials are ongoing.

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 3 trials and monitored accordingly as per the rules of Phase 3 trial process," the plea sates.

In this backdrop, the Petitioner has urged that trial results of Bharat Biotech's "Covaxin" be made public, for peer-review by independent scientists or evaluation by external subject matter experts.

No informed consent for vaccination

The plea states that since the approval granted to Bharat Biotech's Covaxin is for "restricted use in an emergency situation," any person receiving Covaxin is first required to sign a mandatory consent form.

Further, the Central Government has stated that people receiving vaccines will not have a choice as to which vaccine they receive. Therefore, people receiving M/ s Bharat Biotech's "Covaxin" will be required to either sign a consent form or forego the vaccination entirely.

The petitioner argues that with lack of information in the public domain regarding the safety & efficacy of clinical trials of Covaxin, it is impossible for anyone to provide an informed consent thus exposing receipients to 2 risks:

(1) either take the vaccine & bear the consequences or

(2) remain unvaccinated and make yourself susceptible to a Covid-19 infection.

Highlighting the nature of urgency of this case, the Petitioner submitted that a participant in Biotech's Covaxin trials has already died due to cardio respiratory failure arising from suspected poisoning.

"This incident is one example which shows the potential threat to life for recepients of Covid-19 vaccines especially when the efficacy and safety data of the vaccines has not been released in the public domain for scrutiny by independent experts which would only help in providing better feedback and making the final vaccine safer," the plea states.

No response to an RTI concerning 'life and liberty'

The Petitioner submitted that vide RTI application dated January 4, 2020, the Petitioner had sought relevant data wrt Covaxin and other Covishield, however no response for the same is forthcoming from the concerned Information officer.

The plea states,

"The Respondent, however, did not provide the information requested by the Petitioner in his RTI application within the stipulated 48 hours. In fact, as of today 16/01/2021, the Respondent has not replied to the Petitioner's RTI request."

The plea adds,

"The Respondent in failing to provide a response to his RTI request under Sec 7(1) of the RTI Act, 2005 within 48 hours for a matter concerning "life and liberty" is a violation of the fundamental rights guaranteed to the people of India under Article 21 of the Constitution of India.

Further, the petitioner also contends that his "right to know" which forms a part of the fundamental right to expression under Article 19 of the Constitution of India has been violated by the Respondent by neither replying to the Petitioner's RTI request within the stipulated time nor intimating the Petitioner about any objections which would've allowed him to file an appeal."


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