ON COVID 19 VACCINES

JSA HARYANA Statement on Covid-19 Vaccines and Treatment Drugs

India must follow Transparent, Reliable Scientific Clinical Trials Protocols

          Development of vaccines and medicines that treat Covid-19 are extremely important elements in the ways to overcome the Covid-19 pandemic. Around 150 vaccine candidates are currently undergoing pre-clinical trials and clinical trials globally, though none are yet available. But such vaccine development cannot be at the expense of safety, which will not only endanger the fight against Covid-19 but also the larger vaccine programs against other infectious diseases. 

          ICMR’s directive to Bharat Biotech International Limited (BBIL) and the institutions ‘chosen’ in the trials to complete Phase1,2 and 3 trials by 15th August, that is in less than 6 weeks against the 15 month originally scheduled, is dangerous for the people and the reputation of Indian science. A desire to grandstand and please the political masters seems to have overtaken sanity within ICMR.  The recent letter by the Director General of the Indian Council of Medical Research (ICMR) very shockingly raises such a doubt.

          A relevant example here is the safe fast tracked development, without political stunts, of the globally leading vaccine candidate CoronoVac from Sinovac Biotech which started work with academic research institutes in January 2020. The vaccine which uses inactivated virus is now under Phase 3 clinical trials in Brazil since June 11, in partnership with Brazilian immunobiologic producer Instituto Butantan. Phase 1 and Phase two trials had been approved on April 13thand were completed within China in 60 days.

          In India, scientists working in the National Institute of Virology (NIV) under the ICMR and Hyderabad-based BBIL have developed an inactivated vaccine candidate, BBV152 COVID, using a virus strain isolated in NIV. Bharat Biotech got approval for Phase 1 and Phase 2 trials on June 29 from the Central Drugs and Standards Control Organisation (CDSCO) as part of the fast-tracking of the process even while pre-clinical animal trials are underway. According to the submission of BBIL with the Clinical Trials Registry of India (CTRI) under ICMR, the enrolment for Phase 1 was to begin from July 13th and the duration of the trial covering all the three stages was to be 15 months.

          On July 2nd, Dr. Balram Bhargava, Director General, ICMR, who is also the Secretary, Health Research, in the government, sent a letter to BBIL with copies to the 12 chosen hospitals saying that “it is envisaged to launch the vaccine for public health use latest by August 15th, 2020,” that is in less than 6 weeks compared to the planned 15 months as per the BBIL submission. The letter goes on to demand  that subject enrolment be initiated no later than 7th July 2020, even though the CTRI registration itself shows July 13th as enrolment initiation, leaving no time for proper consideration and approval by the respective institutional ethics committees. Finally, the letter threatens the concerned hospitals by stating that “non-compliance will be viewed very seriously,” and that the vaccine project is “being monitored at the top most level of the Government.”

Since “top most level of government” has been invoked, DG ICMR’s deadline appears for enabling the Prime Minister to announce “successful development of a Covid vaccine by India, before any other country,” from the ramparts of the Red Fort on Independence Day. However, as India’s premier scientific and medical research body, ICMR knows well the rigorous protocols required to be followed for vaccine trials and a deadline of 6 weeks to complete all the three phases of a vaccine trials is not only scientifically absurd, and if implemented would be downright dangerous. The criteria for ICMR choosing the 12 hospitals, a mixture of private and public hospitals, with a widely varying track-record and experience are entirely arbitrary and the selection non-transparent.

AIPSN deplores the emerging trend in India, of short-circuiting established protocols for trials of Covid19 vaccines and treatment drugs. Earlier, there was the instance of Patanjali Coronil. Baba Ramdev, a proponent of Hindutva, through his Patanjali enterprise tried to launch an untested ayurvedic mix as Coronil meant for treatment of Covid-19. The Patanjali enterprise has a business model which leads to roaring profits, based on tapping into, nationalist, obscurantist sentiments pushed by the BJP government. Due to the uproar in the press and media, the AYUSH ministry said Patanjali can sell Coronil but not as a treatment for Covid-19! Nothing was done about following the due process of clinical trials and approvals, and the sham trial reports that were presented were not subject to any scientific review, even from within the AYUSH fraternity. There was another case of Glenmark, which got approval from DCGI without any basis for the anti viral drug Favipiravir. At a cost of Rs 103 a tablet and needing 122 tablets for a course the company would make a killing in profits. The Lok Nayak Hospital in Delhi recently decided to stop using Favipiravir for treatment following observation of problems in heart rate and uric acid levels in patients on treatment.

AIPSN demands that the due process of scientific trials be followed strictly and transparently for all Covid19 candidate vaccines and treatment drugs, regardless of systems of medicine, and overcoming temptations to make haste prompted by either corporate greed or by national pride.

AIPSN calls for a globally coordinated effort that puts people before profits to make drugs and vaccines that will be available free to the public and with allocations made as per needs without any discrimination in the place of the perverted race to develop drugs and vaccines driven by jingoistic-nationalism and privatisation.

AIPSN demands that the efforts of the scientists who came up with the BBV152 COVID vaccine candidate, or others likely to come up in the near future, not be wasted by such unseemly political pressures which compromise the safety of people by not following due process and which is highly likely to bring Indian science and research into disrepute.