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DCGI approves Serum, Bharat Biotech vaccine for emergency use (Ld)

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DCGI approves Serum, Bharat Biotech vaccine for emergency use (Ld)

Eleven months after the first case of deadly coronavirus was detected in India, Drug Controller General of India (DCGI) V.G. Somani on Sunday approved Serum Institute of India’s ‘Covishield’ vaccine and Bharat Biotech’s ‘Covaxin’ for emergency use, paving way for its roll-out and administration to millions.

“After adequate examination, the CDSCO has decided to accept the recommendations of the Subject Expert Committee and accordingly, vaccine of Serum and Bharat Biotech are being approved for restricted use in emergency situation,” the Drugs Controller General of India Dr. V.G. Somani said.

Covishield and Covaxin have to be administered in two doses and can be stored at 2-8 degree Celsius. The Drugs Controller General of India has also granted permission to Cadila healthcare for phase 3 clinical trial in India.

This is a major relief for India which has the second highest number of infections in the world after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.

The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

On Saturday, Union Health Minister Harsh Vardhan had announced that one crore healthcare workers, along with two crore frontline workers will get the vaccine for free.

The Subject Expert Committee, tasked with vetting the vaccine proposals, had recommended Oxford-Astra Zeneca’s ‘Covishield’ and Bharat Biotech’s indigenous ‘Covaxin’ for emergency use approval on January 1 and 2, respectively. The final call was to be taken by the DCGI.

The expert panel recommended granting permission for restricted emergency use of ‘Covaxin’ in “public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains.

The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

Pune-based Serum Institute of India has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’, while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’.

Serum and Bharat Biotech Pfizer had applied for the accelerated approval on December 6 and 7, respectively.

Serum Institute of India had submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged more or equal to 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent.

Further, Serum was granted permission to conduct Phase-II/III clinical trials on 1,600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

The UK and Argentina have already approved the Oxford-AstraZeneca vaccine. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, Serum Institute of India.

Oxford-AstraZeneca vaccine will play a major role in India’s plan to vaccinate its population against Covid-19 due to several factors — low-cost, ease of storage and transport.

Serum Institute of India this week said that it has a stockpiled 40-50 million doses of its Covid-19 vaccine. India is likely to receive a majority of these 50 million doses.

As far as Bharat Biotech’s Covaxin is concerned, it is India’s first indigenous vaccine for coronavirus. The inactivated virus vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The firm had generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.

All this data was shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response.

The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

AIDAN asks DCGI to withdraw approval for Bharat Biotech’s Covaxin

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AIDAN asks DCGI to withdraw approval for Bharat Biotech’s Covaxin

The All India Drug Action Network (AIDAN) said it is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in “clinical trial mode” and “specially in the context of infection by mutant strains”.

“In light of the intense concerns arising from the absence of efficacy data and hence the limited regulatory review of the vaccine candidate, the implications of public rollout of an untested product, and lack of transparency we urge the DCGI to reconsider the recommendations of the SEC in granting the REU approval to COVAXIN,” it said.

Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR.

The only data for humans, available through publication pre-prints, are for safety and immunogenicity from Phase 1 and Phase 2 trials, across a total of 755 participants. In the interest of transparency it will be in the fitness of things that the trial data on the basis of which decisions have been taken by the SEC are immediately made public. It is also not clear under which provisions of the extant law the SEC has recommended for grant of REU approval and in “clinical trial mode” at that, AIDAN said.

“It is not clear if there is any scientific basis to claim that COVAXIN will be effective in the “context of infection by mutant strains” when its efficacy has not been established and is currently unknown against any strain of the virus”, it said.

“The hypothesis being propagated that the whole virion inactivated vaccine is likely to be effective against mutations of the virus is not being supported by any efficacy from the trial because no data have as yet been generated in the Phase 3 trial. Yet this appears to have been used to justify the totally non-sequitur decision which has no basis in the science of rational vaccine development”, it said.

“We are baffled to understand what scientific logic has motivated the top experts in the SEC to approve this vaccine posthaste. Moreover this is a violation of the criteria in the draft regulatory guidelines for development of Covid-19 vaccines published by CDSCO on September 21, 2020. The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers and likely will not reinforce faith in our scientific decision making bodies.

On the Covishield vaccine, AIDAN said it wants to know the efficacy estimates for the dosing regimen and dosing schedule that will be followed in India as concluded by the SEC, the specific data and analysis of the foreign trials of the AstraZeneca/Oxford vaccine that was the basis of the SEC’s decision, the extent of the data for safety and immunogenicity from the Phase 2/3 bridging study in India that was submitted and reviewed by the SEC, the “multiple regulatory conditionalities” proposed by the SEC.

Any REU granted by the DCGI on the recommendation of the SEC must be accompanied by the legal provisions under which the approval is granted, the specific approved use of the vaccine candidate and details of restrictions/conditions, it said.

“In the interest of transparency and public welfare, we ask that the regulator share the detailed rationale for the decision along with disclosure of the data, evidence and information that was reviewed by the SEC and the data and analysis on the basis of which the REU approval is granted. This is particularly important given the lack of adequate information regarding the UK MHRA’s review of the AstraZeneca/Oxford vaccine and the fact that interim data for safety and immunogenicity from the Serum Institute/ICMR Phase 2/3 study have not been made publicy available”, it said.

“Bear in mind that the objective of a bridging study to assess the vaccine candidate in an Indian population would be undermined if the data generated from the trial is not reviewed in the process of regulatory approval”, it added.

Telugu360 is always open for the best and bright journalists. If you are interested in full-time or freelance, email us at Krishna@telugu360.com.

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