Covaxin use in clinical trial mode, clarifies health minister after DCGI approval; India's COVID-19 cases rise to 1.03 cr
Drug firm Zydus Cadila also received the go-ahead to conduct phase-3 trails for its vaccine candidate ZyCoV-D — the country's first DNA vaccine candidate against the novel coronavirus infection.
As India's coronavirus case count mounted to 1.03 crore the Drug Controller General of India (DCGI) on Sunday gave approval to Oxford-AstreZeneca's COVID-19 vaccine Covishield, manufactured by the Serum Institute of India, and indigenously developed vaccine Covaxin of Bharat Biotech for restricted emergency use in the country.
The approval by the DCGI was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Drug firm Zydus Cadila also received the go-ahead to conduct Phase-3 trails for its vaccine candidate ZyCoV-D — the country's first DNA vaccine candidate against the novel coronavirus infection.
While the approval to the two vaccines was welcomed by many, including Prime Minister Narendra Modi, various BJP leaders as well as World Health Organisation, Congress leaders raised questions around the approval granted to Covaxin, asking the Union health minister to explain why mandatory protocols and verification of data "had been dispensed with".
Union health minister Harsh Vardhan hit back over the criticism, claiming that no serious adverse effects were seen in Phase-2 trials of Coxavin and that Bharat Biotech's vaccine was more likely to work against newer variants like the UK variant.
The minister also clarified that the authorisation for Covaxin was different from that for Covishield as the former would be used in clinical trial mode and all recipients would be tracked and monitored and described the approval as a strategic decision for vaccine security.
Meanwhile, the Madhya Pradesh government came under criticism for ordering the closure of all COVID centres in the state, except those in Bhopal, over the low occupancy of beds.
The Odisha government announced that physical classes for final year graduate and postgraduate students in the state's universities and colleges will resume from 11 January.
DCGI approves two vaccines for restricted emergency use
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situations," DCGI VG Somani told the media. This clears the way for the roll-out of at least two vaccines in India in the coming days.
"Serum and Bharat Biotech vaccines have to be administered in two doses," Somani said, adding these vaccines have to be stored at 2-8 C.
Pune-based SII's shot is 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 percent," Somani said.
Further, SII was granted permission to conduct Phase-2/3 clinical trials on 1,600 participants within the country, he said.
On Covaxin, Somani said, "Bharat Biotech has developed a Whole Virion Inactivated coronavirus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country and globally."
Phase 1 and Phase 2 clinical trials were conducted on approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response, he said.
The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 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, Somani said. "The clinical trial ongoing within the country by the firm will continue," he said.
The Department of Biotechnology confirmed that Zydus Cadila's ZyCoV-D vaccine, has been approved by the DCGI for the Phase III clinical trials. Zydus Cadila completed Phase-I/II clinical trials of this DNA vaccine candidate in more than 1,000 participants and "interim data indicated that the vaccine is safe and immunogenic when three doses were administered intradermally", the DBT said.
"Based on the recommendations of the Subject Expert Committee, which reviewed the interim data, the DCGI has accorded permission for conducting Phase-III clinical trial in 26,000 Indian participants," the DBT added.
SII had applied to the DCGI seeking nod for its vaccine on 5 December, while Bharat Biotech submitted its application on 6 December. Pfizer had also applied for regulatory approval for its vaccine on 4 December, but not much progress has been made on it after that.
The approval given to two COVID-19 vaccines is a "decisive turning point" in the spirited fight against the pandemic, said Prime Minister Narendra Modi.
A decisive turning point to strengthen a spirited fight!
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) January 3, 2021
Union Health Minister Harsh Vardhan termed it a "watershed moment" in India's battle against COVID-19 and called the vaccines a fitting tribute to the corona warriors.
The World Health Organisation too welcomed the much-anticipated approval to Covishield and Covaxin for restricted emergency use, saying it will help "intensify" and "strengthen" India's efforts to combat the coronavirus .
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with Oxford-AstraZeneca to manufacture Covishield.
"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," Serum Institute of India CEO Adar Poonawalla tweeted.
The approval of Covaxin is a giant leap for innovation and novel product development in India, Krishna Ella, chairman and managing director of the Hyderabad-based pharmaceutical firm Bharat Biotech said in a statement. Ella said it was a proud moment for the nation, a great milestone in India's scientific capability, and a kickstart to the innovation ecosystem in India.
Ruling BJP leaders and Union ministers including party chief JP Nadda, Amit Shah and Rajnath Singh saluted the scientists and congratulated the prime minister for striving towards a coronavirus -free India.
Applauding the scientists for the domestically manufactured vaccines, Union home minister and senior BJP leader Amit Shah said, "Nation will always remain grateful to them for their selfless service towards mankind."
Delhi, Kerala ready for vaccine roll-out
Delhi health minister Satyendar Jain welcomed the approval given for emergency use of two COVID-19 vaccines, and asserted that the city government is all set for the vaccination roll-out as soon as any of them arrive. He said, in the first phase, about three lakh healthcare workers and nearly six lakh frontline workers, totalling about nine lakh, will get the vaccine.
Kerala health minister KK Shailaja said the state was ready to distribute the vaccine once the Centre gives the nod. "We will use the vaccine as instructed by the Central Government. We are fully prepared for the distribution of the vaccine once the Centre gives the permission. The Ice Lined Refrigerator (ILR), cold box etc are ready and the state has also finalised the places to distribute the vaccine," she told the media.
Maharashtra home minister Anil Deshmukh said health workers, including paramedics, doctors, and police personnel will be administered a COVID-19 vaccine on priority and added the government will take steps to prevent black marketing of the vaccines. He said the people aged over 60 years and those above 60 years with the existing comorbidies will be the second priority group for vaccination in the state.
India, which has recorded 1.03 crore coronavirus cases and 1.49 lakh deaths, conducted a dry run on Saturday involving all states and union territories in preparation for a major inoculation drive.
Congress leaders raise concern
While Congress' chief spokesperson Randeep Surjewala lauded scientists and researchers of Bharat Biotech for the indigenous vaccine, some party leaders like Anand Sharma, Jairam Ramesh and Shashi Tharoor raised concern over the grant of approval to it without the phase 3 trials, saying it is "premature" and can prove dangerous.
"We are baffled to understand what scientific logic has motivated the SEC (subject expert committee) to approve this vaccine posthaste... in violation of the criteria in the draft regulatory guidelines for the development of COVID-19 vaccines published by CDSCO on 21/9/20," Tharoor tweeted, referring to Covaxin.
Ramesh had earlier said that Bharat Biotech is a first-rate enterprise while adding that it is puzzling that internationally-accepted protocols relating to phase three trials are being modified for Covaxin and asked the Union Health Minister to clarify.
Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister @drharshvardhan should clarify. pic.twitter.com/5HAWZtmW9s
— Jairam Ramesh (@Jairam_Ramesh) January 3, 2021
Anand Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the matter of granting authorisation for vaccine use needs to be taken up carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.
'Covaxin more likely to work against virus variants'
Asking the Congress and other Opposition parties not to do politics on the vaccine issue, BJP national president JP Nadda accused them of trying to cause panic among people to further their "failed politics and nefarious agendas"
Vardhan said Bharat Biotech's vaccine is more likely to work against newer variants of coronavirus , including the UK variant, and asked politicians not to "discredit" the approval protocol.
COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other that may arise due to antigenic drift as it contains immunogens (epitopes) from other genes in addition to those from Spike protein
Inactivated virus from NIV also had D614G mutation pic.twitter.com/337EsOQMhG
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90%
However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to spike protein
So,it’s likely to have similar protective efficacy reported for others pic.twitter.com/AOIONrxZcd
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
In a series of tweet, Vardhan said: "The data from COVAXIN Phase I and II clinical trials reveals that it not only produces neutralizing antibodies in all participants but also sensitises CD4 T lymphocytes that imparts durable immune response."
"Our experience with inactivated vaccines not having serious adverse events was also observed in Phase II done among 380 study participants in BBV152 trial in 21280 Person days follow up. No serious adverse events seen. Only 7 percent persons receiving 6 microgram dose had mild symptoms," the health minister further stated adding that were no seroconversions in those who were provided vaccines in Phase 1, 2 trials."
ICMR director general Balram Bhargava also said Covaxin is based on an inactivated whole virus, having potential to target mutated coronavirus strains including the UK variant, which was a major ground for giving it a conditional nod. He, however, said no clear data regarding the efficacy of the vaccine is available so far.
The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation. The ongoing clinical trial is the largest trial on 25,800 subjects, in which already 23,000 volunteers have been enrolled including subjects with comorbid conditions, and the vaccine has demonstrated safety till date, Bhargava said.
Covaxin approval strategic decision for vaccine security
In another tweet, Vardhan said that the approval for Covaxin was a monitored approval and it was a strategic decision for vaccine security. Vardhan said that the emergency use authorisation for Covaxin is different from Covishield because its use will be in clinical trial mode. "All COVAXIN recipients to be tracked,monitored as if they’re in trial," he said.
COVAXIN approval is ‘Monitored Approval’ with strict follow-up & rolling review
This approval ensures India has an additional vaccine shield in its arsenal esp against potential mutant strains in a dynamic pandemic situation -
A strategic decision for our vaccine security ✔️ pic.twitter.com/TgP7BZNWHf
— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021
Earlier in the day, speaking to news channels, AIIMS director Dr Randeep Guleria too said that the approval for Covaxin was different that the authorisation for SII's Covishield. Covaxin had been authorised for "emergency situations" and was a "back-up" in case the country witnessed a surge in cases due to the new virus variant or in case of uncertainty of the protection provided by the other vaccine against the UK strain, Guleria had told CNBC-TV18.
Speaking to CNN-News18, Guleria said any person who develops side-effects after receiving Covaxin will be eligible for compensation. “India will start procuring Covaxin if the UK virus variant situation explodes or after the trials are completed, whichever happens first. Any person receiving Covaxin will get compensation in case of side effects just the way it happens in clinical trials,” he said.
The AIIMS chief also told CNBC-TV18 that the regulators must have found the vaccine to be safe based on available data. He added that the clinical trials of Covaxin will continue till more data was available and then the approval for it could be upgraded to what Serum has received.
Congress criticises move to shut Covid care centre in MP
A political row also ensued in Madhya Pradesh where Congress leader Kamal Nath questioned the rationale behind the state government's decision to shut COVID care centres across the state except in Bhopal from 1 January.
प्रदेश में कोरोना से मौतें जारी , संक्रमण का आँकड़ा प्रतिदिन बढ़ता जा रहा है।
विधानसभा का सत्र तक कोरोना के भय से निरस्त और शिवराज सरकार ने भोपाल को छोड़कर प्रदेश के सभी कोविड केयर सेंटर बंद किये ?
— Office Of Kamal Nath (@OfficeOfKNath) January 3, 2021
Chief Minister Shivraj Singh Chouhan defended the decision, saying the pandemic is under control in the state and there is no justification to keep the COVID care centres open "just for the sake of keeping them open".
"If needed, these COVID care centres will be opened again, but there is no justification to keep them open for the sake of keeping them open," Chouhan said in a statement.
Odisha colleges varsities to re-open for final year students
Considering the improvement in COVID-19 situation in the state and the huge academic loss of students due to the pandemic situation, the Odisha government on Sunday announced that physical classes in colleges and universities in the state will resume from 11 for the students of final year undergraduate and post-graduate courses. The penultimate semester exams for the students of UG/PG courses will be held from 16 to 31 March and the final semester examinations will take place between 16 an 30 June a notification issued by the Higher Education department said.
The government also issued a guideline for the conduct of classroom teaching, prescribing measures such as mandatory use of facemasks and recording lessons for absentee students. Teachers, students and staff residing in active containment zone shall not come to their institutes and hostels will be opened from 10 January only for 2020- 21 final year UG/PG students as well as Ph.D., M.Phil. and other research scholars.
The Uttar Pradesh government said a dry run to assess the readiness of the mechanism laid out for the imminent COVID-19 immunisation drive will be undertaken in six sites from 5 January. In a statement, the government said the dry run will start at 10 am in three urban and as many rural sites with a minimum of two sessions.
Active case in India below 2.5 lakh
India's COVID-19 case count climbed to 1,03,23,965 with 18,177 new cases in a day, while 99,27,310 people have recuperated so far pushing the national recovery rate to 96.15 percent on Sunday, according to the Union Health Ministry data.
There are 2,47,220 active cases of coronavirus infection in the country, comprising 2.39 percent of the total caseload, the data showed. The death toll climbed to 1,49,435 with the novel coronavirus virus claiming 217 lives in a span of 24 hours in the country, as per the data updated at 8 am. The COVID-19 case fatality rate stood at 1.45 percent.
Kerala has reported the maximum number of single-day recoveries with 4,985 newly recovered cases. A total of 2,110 people have recovered in Maharashtra followed by 1,963 in Chhattisgarh, the ministry said.
Ten States/UTs account for 69.59 per cent of new deaths. Maharashtra saw the maximum casualties (51). West Bengal and Kerala follow with 28 and 21 daily deaths, respectively, it stated.
With inputs from agencies
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