ICMR Urges Bharat Biotech To launch The Coronavirus Vaccine By 15 August

ICMR Urges Bharat Biotech To launch The Coronavirus Vaccine By 15 August

  • Step poses numerous ethnic concerns, as ICMR is in danger of seriously addressing non-compliance
  • The first vaccine to be tested globally was Moderna Inc’s RNA in April based in the United States and the vaccine is still in its second phase.
ICMR Urges Bharat Biotech To launch The Coronavirus Vaccine By 15 August
ICMR Urges Bharat Biotech To launch The Coronavirus Vaccine By 15 August

In order to expedite clinical trials for their jointly produced ‘Covaxine’ covid-19 vaccine, the The Indian Council of Medical Research (ICMR) sent a letter to Bharat Biotech India Ltd. This move might raise a number of ethical issues.

“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project,” Balram Bhargava, ICMR director general and health research secretary, wrote in the letter dated Thursday.

Through his letter, Bhargava ordered the company to commence the trial by Tuesday, latest, and to finish the trial by 15 August to prepare for launch.

“An impulse to follow through on all approvals for launching the clinical trial and to make sure topic registration is completed by 7 July 2020, despite the immediate public health emergency and the need to launch the vaccine,” said Bhargava.

ICMR Urges Bharat Biotech To launch The Coronavirus Vaccine By 15 August

The first vaccine candidate to receive the approval of the Indian Medicine Controller General for clinical trials. The letter has been written to Krishna Ella, President and CEO of Bharat Biotech and Krishna Mohan, Senior Vice President.

The inactivated, the indigenous vaccine was developed at Bharat Biotech’s Genome Valley facility in Hyderabad and the company said on Wednesday, that clinical human trials will begin this month throughout India.

The DGCI approved on Monday a Phase I and Phase II clinical trial of the company candidate for the vaccine ‘Covaxin,’ which is developed in cooperation with the National Institute for Virology of the Indian Council of Medical Research (NIV).

The trials will be carried out at 12 institutes, including the All India Institute of Medical Sciences in Patna and Delhi, Gillukar Multispeciality Hospital in Nagpur, Institute of Medical Sciences and SUM Hospital in Odisha, Jeevan Rekha Hospital in Belgaum, King George Hospital in Visakhapatnam, Nizam’s Institute of Medical Sciences in Hyderabad, PGIMS in Rohtak, Prakhar Hospital in Kanpur, Rana Hospital and Trauma Center in Gorakhpur, Redkar Hospital and Research Centre in Goa, and SRM Hospital & Research Centre in Tamil Nadu.

In the trials, a range of ethical issues have been raised, from the approval from ethics commissions of the twelve institutions and from the start of participants’ registration in a week to a pre-determination of the outcome in less than 45 days for the court.

Only five of the 12 institutions have received approval from their ethics committees according to the government’s registry of clinical trials. There are 1125 subjects for the two-phase study.

At present, about 150 applicants for vaccines are being screened worldwide. In April, the world’s first vaccine to be submitted for clinical trials was RNA vaccine from US-based Moderna Inc.

Together with the Moderna, the applicant for the vaccine from the Universities of Oxford and AstraZeneca plc is currently in phase 3.

“To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries. Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process,” Anant Bhan, a researcher and past president of the International Association of Bioethics, tweeted.

In summary, any action that takes place after a five-week duration can be unreasonable, if not immoral. In fact, a further ethical consideration already taken is that only five of the 12 approvals required from the 12 Committee on Ethics are marked “approved” by the registration. The other seven have ‘presented / reviewed’ status.

It is therefore unclear as to how Dr. Bhargava can insist that the selected institutes conduct the trials start participants’ registration “no later than 7 July.” Last but not least, it is also India’s Independence Day which seems arbitrary.

In his independence day address last year, Prime Minister Narendra Modi announced  Indian Space Research Organization would undertake the human spaceflight mission. Should it also try this year, even before ICMR has concluded its clinical trials, to develop a supposedly indigenous COVID-19 vaccine?

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