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What DCGI’s emergency approvals for COVID-19 vaccines really mean

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DCGI’s New Year gift of approvals for Covishield, Covaxin for restricted emergency use and ZyCoV-D to start Phase III clinical trials mark the next phase in India’s COVID-19 strategy

D G Somani, Drugs Controller General of India (DCGI) came through on his hint/promise that “Probably we will have a very happy New Year”, by granting restricted emergency approvals for two COVID-19 vaccines. And for good measure, also approving Phase III trials of a third one.

In his press statement on Sunday morning, January 3, the DCGI read out the processes that the three applications went through over the last few days. The Subject Expert Committee (SEC)of the Central Drugs Standard Control Organisation (CDSCO) had met on January 1 and 2 and made recommendations on the proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of Cadila Healthcare.

Significantly, Serum and Bharat Biotech vaccines have to be administered in two doses, while ZyCoV-D is being trialled as a three dose regime. All the three vaccines have to be stored at 2-8° C, which means that the same cold chain network can be used for all three vaccine candidates.

Bharat Biotech’s vaccine candidate Covaxin is being positioned “to have more options for vaccinations, especially in case of infection by mutant strains”, clearly alluding to the mutations in the virus that were recently discovered in UK, Nigeria and subsequently other countries, including India, primarily in travellers returning from the UK.

In his statement, the DCGI emphasised that the SEC consisted of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc. This is clearly to assuage doubts that the vaccine candidates have been rushed through the trial process without adequate due diligence.

“We’ll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” said Somani.

Risks we took with Covishield paid off: Adar Poonawala

Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 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 trial on 1600 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. After detailed deliberations SEC had recommended the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.

Tweeting post DCGI’s approval, Adar Poonawala, CEO, Serum Institute of India said: Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.

Covaxin approval a kickstart to India’s innovation ecosystem: Dr Krishna Ella

Covaxin is a Whole Virion Inactivated coronavirus vaccine developed in collaboration with ICMR and NIV (Pune), from where the company received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country and globally, as per the DCGI’s statement.

The DCGI’s statement detailed that the firm has 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 these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approximately 800 subjects and the results have 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.

The SEC has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue. The DCGI accepted these recommendations as well.

Reacting to the approval, Dr. Krishna Ella, CMD, Bharat Biotech said, “The approval of Covaxin for emergency use is a giant leap for Innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”

ZyCoV-D Phase III a critical milestone: Pankaj Patel

Cadila Healthcare’s ZyCoV-D is a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally.

Accordingly, the firm sought permission from the CDSCO to conduct Phase-III clinical trial in 26000 Indian participants, which was recommended by the SEC and accepted by DCGI in today’s statement.

Post the approval for Phase III trials Pankaj Patel, Chairman, Zydus Group said, “We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe and efficacious vaccine. The launch of the Phase 3 trial will determine the efficacy of our vaccine in preventing COVID-19 which continues to pose a major threat, the world over.”

Concerns still to be addressed

While DCGI’s New Year gift of approvals mark the next phase in India’s COVID-19 strategy, we are clearly not out of the woods yet.

While there have been doubts expressed on the approval for Bharat Biotech’s Covaxin, and the company is reportedly behind schedule to recruit the targeted 26000 volunteers for its Phase III efficacy trial, DCGI’s reference to “infection by mutant strains” is a hint of the regulator’s strategy to prepare for more mutations in the virus and have an indigenous backup at hand.

While the first wave of vaccinations for frontline workers will most probably use Serum’s stock pile of Covishield, this will allow for more data to emerge and be evaluated from Bharat Biotech’s ongoing Phase III trial. It also gives time for Bharat Biotech to ramp up production for India’s vaccination campaign.

In an update on the recruitment for the trial, a statement on January 2, had Suchitra Ella, Joint Managing Director, Bharat Biotech thanking all volunteers who have taken the time to participate in this trial. “Their volunteering spirit is a great morale boost for India and the world. We thank all the Principle Investigators, Doctors, medical staff & the hospitals for their cooperation and support in taking the phase III trials forward in 26,000 volunteers in India. We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin.”

In a media report, Dr Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) has also alluded to the fact that as Covaxin contains the whole virus in an inactivated form, it is more likely to be effective against the mutant strain.

Clearly, the days ahead hold more promise but also need more caution as these vaccines are subjected to rolling reviews as the vaccination roll out starts.

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