Coronavirus News Updates: COVID-19 vaccination dry run at six sites in Uttar Pradesh from 5 January

Covid-19 vaccination dry run in UP from Tuesday

 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 of Uttar Pradesh from 5 January, the state government said on Sunday. 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. Issuing necessary guidelines to the divisional commissioners and district magistrates, Additional Chief Secretary, Health, Amit Mohan Prasad asked them to ensure that syringes, vaccine, AEFI (Adverse Event Following Immunization) kit and other logistics reach the session sites in time.

The waiting and observation areas should have proper sitting arrangements. It has to be ensured that the vaccination team reaches the site 45 minutes in advance, he said. Prasad said sector officers will be appointed to ensure that the dry run sessions take place on time. These sector officers must inspect the sites one day in advance to ensure that the those are ready and have the necessary facilities. 

PTI

Mumbai reports three deaths

Mumbai on Sunday reported three COVID-19 deaths, which are the lowest in a single day since March last year, city civic commissioner I S Chahal said. In a statement, the city civic chief said the hard work of the Maharashtra government and teams of the Brihanmumbai Municipal Corporation (BMC) is paying off.

With three new fatalities, the overall toll in Mumbai has reached 11,135. The city reported 581 new coronavirus positive cases during the day, taking the overall case count to 2,95,241, the state government said in a release. Mumbai division, which includes Mumbai city and satellite towns, reported 1,148 new cases and seven deaths. With this, the cumulative caseload in the Mumbai division mounted to 6,64,295 and the death toll to 19,138, the department said. 

PTI

Covaxin approval a monitored approval, says health minister

Union health minister Harsh Vardhan said on Twitter that the approval for Covaxin was a monitored approval and it was a strategic decision for vaccine security. In another tweet, the health minister said that the emergency use authorisation for Covaxin is different from Covishield because the use of the former 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

Schools in Puducherry to reopen tomorrow

 All schools, including privately managed institutions, will reopen in Puducherry on Monday after remaining shut for nine months owing to COVID-19 pandemic.The Directorate of School Education in a release said schools reopening tomorrow would have half a day session from 10 am to 1 pm in Puducherry and Karaikal regions to start with.  Classes for standard 1 to 12 would be held from tomorrow with strict adherence to safety norms.  Official sources said that full day working of schools would be restored on 18 January.

Haryana registers 218 more cases, two deaths

Two more people succumbed to COVID-19 in Haryana, bringing the toll to 2,917 on Sunday, while 218 fresh cases pushed the infection count to 2,63,068, according to a state health department bulletin.  Faridabad and Kurukshetra districts recorded on Sunday a fatality each linked to the pandemic, the state health department’s daily bulletin said. Gurugram (63) and Faridabad (27) were among other districts which reported new cases of the novel coronavirus, it said. The state has 2,890 active COVID-19 cases while 2,57,261 people have so far been discharged after recovery. The COVID-19 recovery rate in Haryana stands at  97.79 percent, according to the bulletin.

PTI

Gujarat sees 715 new COVID-19 cases, 938 recoveries

Gujarat’s tally of coronavirus cases rose to 2,47,228 on Sunday with the addition of 715 new infections, the state health department said. With four more deaths, the number of people who have succumbed to the viral disease in the state went up to 4,318, it said.

A total of 938 patients were discharged from various hospitals during the day, taking the count of recoveries in Gujarat to 2,33,660, the health department said in a release.

Boris Johnson warns COVID-19 lockdown may get tougher

UK prime minister Boris Johnson on Sunday warned that the current tiered system of lockdown to arrest the spread of COVID-19 may have to be toughened further as the UK grapples with the new strain of the coronavirus.

As teachers’ unions have been calling for a countrywide closure of all schools for a few weeks due to the rapid spread of the new variation, Johnson insisted that parents should send their children to school from Monday in the areas where they remain open as the threat to young kids from the deadly virus is very small.

However, he admitted that even stricter restrictions for the wider public may be on their way in the coming weeks as the coronavirus cases in the country jumped by 57,725 this weekend, taking the death toll close to 75,000.

Kerala records 4,600 fresh cases

Kerala added 4,600 new COVID-19 cases and 25 deaths on Sunday, taking the tally to 7.75 lakh and the toll to 3,141, while no positive cases were
detected in U.K returnees, Health Minister KK Shailaja said. “No positive cases were reported in the last 24 hours from those who had returned from the United Kingdom,” she said.

The day also saw 4,668 people getting cured as the total recoveries rose to 7,07,244, while active cases stood at 65,278, she said in a release. The total COVID-19 cases in the state touched 7,75,852.

PTI

Uttar Pradesh records 769 new cases, 17 deaths

The COVID-19 toll in Uttar Pradesh rose to 8,403 on Sunday with 17 more fatalities, while 769 new cases pushed the infection tally to 5,88,171, an official statement issued said. Of the new deaths, two each were reported from Lucknow, Gorakhpur and Bijnor. Of the 769 fresh COVID-19 cases, Lucknow recorded 134 cases, the UP government said in the statement. In the last 24 hours, as many as 1,179 COVID-19 patients recovered from the disease, taking the overall recoveries to 5,66,910 so far. The count of active COVID-19 cases in the state stands at 12,858, it said

PTI

Momota tests COVID-19 positive, Japan pulls out of Thailand events

World number one Kento Momota’s long-awaited return to the international circuit got delayed after the Japanese tested positive for COVID-19, prompting his national team to pull out of upcoming events in Thailand, the Badminton World Federation (BWF) said on Sunday. “Badminton World Federation (BWF) and Badminton Association of Thailand (BAT) can confirm that Japan’s men’s singles world No.1 Kento Momota has tested positive for COVID-19 after undergoing a mandatory PCR test at Narita Airport in Tokyo en route to Bangkok, Thailand earlier today,” BWF said in a statement. “Nippon Badminton Association (NBA) has subsequently withdrawn all its singles and doubles players from the YONEX Thailand Open (12-17 January 2021) and TOYOTA Thailand Open (19-24 January 2021).

PTI

Covaxin more likely to work against UK virus variant, says Harsh Vardhan

In a series of tweets, Union health minister Harsh Vardhan claimed that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and “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,” he said.

“Vaccines approved globally based on gene encoding spike proteins have protective efficacy of over 90 percent 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.” he said in another tweet.

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

Harsh Vardhan counters criticism over Covaxin approval, says no serious adverse effect in phase-2 trials

Union health minister Dr Harsh Vardhan hit out at Congress leaders Shashi Tharoor and Jairam Ramesh for questioning the approval to Bharat Bitotech’s coronavirus vaccine Covaxin saying " 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". In a series of tweets, Vardhan asserted that no serious adverse events were seen and there were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials. " Only 7 percent persons receiving 6 microgram dose had mild symptoms," he claimed.

There were no seroconversions in those who were provided vaccines in Phase II as well as Phase I of COVAXIN clinical trials.@ICMRDELHI @MoHFW_INDIA @icmr_niv @DBTIndia @BharatBiotech pic.twitter.com/sBU8iKDSxO

— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021

Andhra Pradesh’s active coronavirus cases fall to around 3,000

The number of active COVID-19  cases in Andhra Pradesh fell to the 3,000 level even as the state added 232 fresh cases and saw 352 recoveries and four
deaths in 24 hours ending 9 am on Sunday. The state COVID-19 chart now has 8,83,082 confirmed positives, 8,72,897 recoveries and 7,115 deaths so far, a
health department bulletin said. The active caseload was 3,070, it said. Six districts reported less than 10 fresh coronavirus cases each in a day and three more below 20.

PTI

Colleges, universities in Odisha to resume for final year students from 11 Jan

The Odisha government announced that physical classes in colleges and universities in the state will resume from 11 January 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 March 16 to March 31 and the final semester examinations will take place between June 16 and June 30, a notification issued by the Higher Education department said. The government decided to reopen colleges and universities considering the improvement in COVID-19 situation in the state and the huge academic loss of students due to the pandemic situation. Classroom teaching has been suspended since March 2020.

PTI

All set for roll-out, inoculation to begin when vaccine arrives in Delhi, says Satyendar Jain

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.    Interacting with reporters, 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. “Drug Controller General of India has approved emergency use of two vaccines. Many congratulations to scientists and researchers who worked day and night to make this possible,” Jain said. “We are all ready with our preparations, from storage to logistics, and yesterday, a dry run was conducted at three sites to assess the preparedness for the vaccination roll-out. Vaccination can begin, soon as the vaccine arrives in Delhi, which we expect in few days,” he said.

Approval to vaccines ’turning point’ in India’s fight against COVID-19: Niti Aayog

Terming the approval given to two coronavirus vaccines for emergency use as"turning point" in India’s fight against COVID-19, Niti Aayog member V K Paul on Sunday said the speed with which scientists and the industry came together to meet this challenge epitomizes the spirit and potential of ‘Aatmanirbhar Bharat’. India’s drug regulator DCGI on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

“Today is a turning point in India’s fight against Covid-19 as two Made-in-India vaccines get approval for emergency use,” the Niti Aayog said in a tweet quoting Paul, who is also the Chairman of National Expert Group on Vaccine Administration. “The speed with which our scientists and industry came together to meet this challenge, epitomizes the spirit and potential of Aatmanirbhar Bharat,” it added.

A day of pride & inspiration for us all!

Today is a turning point in India's fight against Covid-19 as two Made-in-India vaccines get approval for emergency use: #NITIAayog Member & Chairman National Expert Group on Vaccine Administration Dr. VK Paulhttps://t.co/YSpYnEDRrg pic.twitter.com/Hen1knYpWZ

— NITI Aayog (@NITIAayog) January 3, 2021

Madhya Pradesh govt orders closure of COVID care centres

The Madhya Pradesh government has ordered closure of all COVID care centres in the state, except those in Bhopal, from 1 January in view of the low occupancy of beds, as per an official order made available on Sunday. This decision evoked a sharp reaction from the Opposition Congress, with its state unit president Kamal Nath questioning the rationale behind the order. Defending the decision, Chief Minister Shivraj Singh Chouhan said 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”.

As per the state government order dated 31 December, 2020 and directed to district collectors and health authorities, a policy decision has been taken to shut the COVID Care centres from the first day of New Year due to low occupancy of beds. These centres were set up across the state for lodging COVID-19 patients.

PTI

Health workers, police to be given priority for vaccine in Maharashtra, says health minister

Health workers, including paramedics, doctors, and police personnel will be administered a COVID-19 vaccine on priority in Maharashtra, state Home Minister Anil Deshmukh said on Sunday 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 comorbidities will be the second priority group for vaccination in the state.

PTI

Zydus Cadila gets nod for phase-3 trials of Covid-19 vaccine

 Drug firm Zydus Cadila on Sunday said it has received DCGI approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D.The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement. ZyCoV-D was found to be safe, well-tolerated and immunogenic in phase I and II clinical trials, it added. The phase II study of ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation, multi-centric, randomised, double-blind placebo-controlled study, the drug firm said.

PTI

Covaxin clinical trial to continue, says AIIMS chief

Guleria further said that the clinical trial for Covaxin will continue till more robust data becomes available and if such data becomes available then the authorisation will be the same as for SII. “Till then, if we have an emergency based on two factors, one is an increase in number of cases and an uncertainty in how one vaccine will provide protection against the variant strain, we will have two vaccine working through two different platforms,” the AIIMS chief told CNBCTV-18. Speaking to CNN-News18, Guleria said any person who develops side-effects after being administered 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 as the way if happens in clinical trials,” he said.

Covaxin to be used as back-up vaccine, says AIIMS chief

AIIMS Director Randeep Guleria, speaking to news channels, said that the DCGI has approved Bharat Biotech;s Covaxin not as emergency use authorisation but for emergency situations. Phase 3 trails are not yet over but the date avaialble from Phase-1,2 and animal studies and limited phase-3 studies is robust enough to show that the vaccine is safe, he said. Speaking to CNBCTV-18, Guleria said " Looking at the situation in the US, UK and Europe, I think the regulators felt that its’ better to have a back up vaccine in case there’s an emergency situation," Guleria said.

“So suddenly if there is a surge in cases in next 10 days or two weeks due to the variant strain.. we already have at least 29 individuals who have tested positive for the strain..we don’t have an effective treatment, there is no anti-viral drug is effective for coronavirus. The only option we have then is to vaccinate as many as people as we can as early as possible to decrease the number of people who get infected and therefore pass the infection in others.. and only then would Bharat Biotech vaccine be…”

Congress, Opposition not proud of anything Indian: JP Nadda

Hitting out at the Congress and other Opposition parties for raising questions over India’s approval to Bharat Biotech’s Covaxin, BJP national president JP Nadda, in a series of tweets, said " The Congress and the Opposition is not proud of anything Indian." “While the entire nation is happy about this, the Opposition led the Congress is filled with anger, ridicule and disdain,” he alleged.  He accused the Opposition and the Congress of trying to cause panic in the minds of people to further “their own failed politics and nefarious agendas.”

Congress and the Opposition is not proud of anything Indian. They should introspect about how their lies on the COVID-19 vaccine will be used by vested interest groups for their own agendas.
People of India have been rejecting such politics and will keep doing so in the future.

— Jagat Prakash Nadda (@JPNadda) January 3, 2021

Congress and the Opposition is not proud of anything Indian. They should introspect about how their lies on the COVID-19 vaccine will be used by vested interest groups for their own agendas.
People of India have been rejecting such politics and will keep doing so in the future.

— Jagat Prakash Nadda (@JPNadda) January 3, 2021

Kerala will use COVID-19 vaccine as instructed by Centre: Health Minister

 As India’s drugs regulator approved restricted use of Bharat Biotech’s COVID-19 vaccine and Oxford COVID-19 vaccine Covishield, the Kerala government on Sunday said the state was ready to distribute it once the Centre gave 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,” said Kerala health minister KK Shailaja.When asked about Covaxin and Shashi Tharoor’s criticism, the

minister said the state government was yet to receive official notification on the vaccines and would comment on it later. “We are yet to officially receive the notification on the two vaccines approved. We cannot comment without receiving any official details,” Shailaja said.

PTI

Momentous achievement for India, tweets Amit Shah

Union Home Minister Amit Shah shared the news of approval for two COVID-19 vaccines in India, said it was a momentous achievement for the country. 

A momentous achievement for India!

DCGI has granted approval to COVID vaccines of @SerumInstIndia and @BharatBiotech.

I salute our very talented and hardworking scientists for making India proud.

Congratulations to PM @narendramodi ji for striving towards a COVID free India.

— Amit Shah (@AmitShah) January 3, 2021

WHO welcomes India’s approval for COVID-19 vaccines

The World Health Organisation welcomed India’s decision to give emergency use authorisation to COVID-19 vaccines, saying it will help “intensify” and “strengthen” its fight against the ongoing pandemic.  India’s drugs regulator has approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country.

“WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region,” said Dr Poonam Khetrapal Singh, the regional director, WHO South-East Asia Region. “The use of vaccine in prioritised populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19,” she added.

PTI

Coronavirus News LATEST Updates

‘Where is official data on vaccine efficacy’: Experts question Bharat Biotech’s claims

As DCGI have the green signal to two COVID-19 vaccines for emergency use, several experts on social media took note of the fact that there has been “no official data released in the public domain by Bharat Biotech on COVAXIN’s efficacy”.

Senior journalist Shushant Singh in a tweet highlighted how Bharat Biotech’s COVAXIN’s Stage 2 trials were not peer-reviewed yet, as per Bharat Biotech’s own public statement on Saturday. “And Stage 3 trials, as per media reports, are still seeking more volunteers. No data, whatsoever, has been put out in public domain either.”

Another Twitter user, Dr Anant Bhan, who is a researcher in global health, bioethics, and health policy, also took note of the fact that were was no official date put out in the public domain. In a tweet, he asked: “Where is the efficacy data? Why not put it in the public domain. Why not make SEC (subject expert committee) discussions public and the membership known?”

COVAXIN has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR)

The Stage 2 trials are not peer reviewed yet, as per Bharat Biotech's own public statement on Saturday. And Stage 3 trials, as per media reports, are still seeking more volunteers. No data, whatsoever, has been put out in public domain either. Science doesn't work on 'faith'. https://t.co/BZIvLDifjp

— Sushant Singh (@SushantSin) January 3, 2021

But, where is the efficacy data?
Why not put it in the public domain.
Why not make SEC discussions public and the membership known. Including all data which is the basis for the decision

— Anant Bhan (@AnantBhan) January 3, 2021

Coronavirus News LATEST Updates

Shall be first to take vaccine to end trust deficit, says Harsh Vardhan

Health Minister Harsh Vardhan on Sunday said a coronavirus vaccine could be ready by the first quarter of 2021. In an online interaction under the programme “Sunday Samvad”, Vardhan said he would volunteer for receiving the COVID-19 vaccine if people have a “trust deficit” on the drug, as per NDTV.

He said frontline health workers, senior citizens, and those with comorbidities should be given the vaccine first whenever it becomes available.

Coronavirus News LATEST Updates

Govt should start vaccination after making concrete arrangements: Akhilesh Yadav

Samajwadi Party president Akhilesh Yadav on Sunday said the COVID-19 vaccination programme is a “sensitive process”, and the government should not to treat it as a “cosmetic” event as it is a matter of lives of people.

Yadav had on Saturday termed the anti-Covid vaccine to be rolled out in the country as a “vaccine of the BJP” and said he would not take the shot, prompting a sharp reaction not only from the ruling party but also from NC vice-president Omar Abdullah.

The fresh remarks by the SP chief come on a day when India’s drugs regulator approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

In a tweet in Hindi, Yadav said, “The anti-Covid vaccination is a sensitive process. Hence, the BJP Government should not consider this as a ‘sajaawati-dikhaawati (decorative-cosmetic) event, and commence it only after concrete arrangements are made. This is a matter of lives of people, so the risk of improvement at later stage cannot be taken. A specific date for vaccinating the poor people should be declared.”

कोरोना का टीकाकरण एक संवेदनशील प्रक्रिया है इसीलिए भाजपा सरकार इसे कोई सजावटी-दिखावटी इवेंट न समझे और अग्रिम पुख़्ता इंतज़ामों के बाद ही शुरू करे. ये लोगों के जीवन का विषय है अत: इसमें बाद में सुधार का ख़तरा नहीं उठाया जा सकता है.

गरीबों के टीकाकरण की निश्चित तारीख़ घोषित हो.

— Akhilesh Yadav (@yadavakhilesh) January 3, 2021

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Watershed moment in India’s battle for COVID-19: Harsh Vardhan

Welcoming the final approval for Oxford-AstraZeneca and Bharat Biotech vaccines against the coronavirus disease for emergency use, Union health minister Dr Harsh Vardhan in a series of tweets said it was a watershed moment in India’s battle against Covid-19 under the leadership of Prime Minister Narendra Modi.

“A watershed moment in India’s famed battle against Covid-19 under leadership of PM Modi. Our wait for the vaccine is over with Covishield from Serum Institute of India and Covaxin from Bharat Biotech approved for emergency use in India,” Vardhan tweeted.

Congratulating the scientists and researchers for their “untiring efforts”, Vardhan said, “These vaccines are a fitting tribute to our corona warriors! My heartfelt gratitude to all healthcare professionals and frontline workers for their exemplary efforts during these unprecedented times.”

“It’s now time to reap the benefits of the robust supply chain infrastructure we’ve put in place for quick & equitable distribution of the vaccine. Urge all citizens to entrust the stringent protocols followed for ensuring safety, efficacy & immunogenicity of the approved vaccines,” he added.

These vaccines are a fitting tribute to our corona warriors!

My heartfelt gratitude to all healthcare professionals & frontline workers for their exemplary efforts during these unprecedented times.

Congratulations to all the scientists & researchers for their untiring efforts.

— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021

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India’s COVID-19 active caseload drops below 2.5 lakh, says health ministry

The COVID-19 active caseload in India has dropped below 2.5 lakh with the recoveries exceeding new cases and a low number of fatalities per day, the Health Ministry said on Sunday.

“India’s present active caseload consists of just 2.39 percent of India’s Total Positive Cases. The new recoveries of 20,923 in the last 24 hours have led to a net decline of 2,963 in the Total Active cases,” the Health Ministry said in a statement.

“India’s trajectory of active cases continues to follow a steadily dipping path. The total Active Caseload has dropped below 2.5 lakh (2,47,220),” the Health Ministry said.

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, it said.

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Mayawati welcomes approval for COVID-19 vaccine

Bahujan Samaj Party supremo Mayawati on Sunday congratulated the scientists associated with the coronavirus vaccine and urged the Centre to make it available for the poor free of cost

India’s drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive

In a tweet in Hindi, Mayawati said, “The ‘swadeshi’ anti-Covid vaccine is welcome and congratulations to the scientists. A request to the Central government is that along with all the health workers, if the extremely poor people get the vaccine free of cost, then it will be appropriate.”

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Giant leap for novel product development in India, says Bharat Biotech’s chairman

Expressing delight on the Ministry of Health and Family Welfare announcement and the statement from DCGI – Central Standards Control Organization (CDSCO) Grant of permission for emergency use of its Covid-19 Vaccine on Sunday, the Chairman and Managing Director of Bharat Biotech Dr Krishna Ella in a statement 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.”

The Phase III human clinical trials of COVAXIN™️ began mid-November, targeted to be done in “26,000” volunteers across India, this is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, as per the statement issued by the company.

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Approval for Covaxin premature, tweets Shashi Tharoor

The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. @drharshvardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime. https://t.co/H7Gis9UTQb

— Shashi Tharoor (@ShashiTharoor) January 3, 2021

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Ready to roll out COVID-19 vaccine in India: Serum Institute of India

Serum Institute of India (SII) on Sunday said it is ready to roll out Covishield vaccine in the country in the coming weeks after receiving approval from the Indian drug regulator.

The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The company has already stockpiled around 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March next year.

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).

“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation,” DCGI Dr VG Somani told a press conference.

This paves the way for the roll-out of at least two vaccines in India in the coming days. The Oxford-AstraZeneca vaccine has already been approved by the UK government.

Coronavirus News LATEST Updates

Vaccines are safe and immunogenic: DCGI 

The Drugs Controller General of India in a press release stated that the interim data suggested that the vaccines are safe to use. 

• The vaccines are safe and immunogenic with three doses when administered intra-dermally. 
• For each person, Bharat Biotech’s Covaxin and Oxford Astrazenenca’s Covishield vaccines have to be administered in 2 doses. 
• Apart from these two vaccines, the drug regulator also allowed Cadila Healthcare to conduct its phase 3 trials.
• All three vaccines have to be stored at 2-8° C.

Coronavirus News LATEST Updates

Congress leaders raise concern over grant of permission for restricted use of vaccine

Senior Congress leader Anand Sharma on Sunday raised concerns over India’s drugs regulator granting permission for the restricted use of Bharat Biotech’s COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.

Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the issue of granting authorisation to the vaccine use needs to be taken carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.

As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, he said.

“The Health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category,” he told PTI.

“The DCGI statement is puzzling and the government must must reveal the final data of global efficacy trials and the final trials in UK which has been shared officially by UK’s MHRA following a government to government agreement signed between the two countries which should be put in public domain to avoid any confusiuon on the proven efficacy of the vaccine,” Sharma also said.

Another senior Congress leader Jairam Ramesh also raised concerns and asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials are being modified.

Coronavirus News LATEST Updates

WHO welcomes first emergency use authorisation to vaccines in South-East Asia Region

“WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region.  The use of vaccine in prioritized populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19," said Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia Region.

Coronavirus News LATEST Updates

Cadila Healthcare to conduct Phase-3 trails for vaccine candidates

As per a press release by DCGI, it has also granted permission to Cadila Healthcare for conducting phase-III clinical trial of their COVID-19 vaccine candidate.

Coronavirus News LATEST Updates

Decisive turning point: PM congratulates SII and Bharat Biotech 

In a series of tweets, Prime Minister Narendra Modi on Sunday congratulated Serum Institute and Bharat Biotech on getting the DCGI’s approval. “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators. DCGI approves restricted emergency use of Serum Institute, Bharat Biotech’s COVID-19 vaccines,” PM Modi said.

“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” PM Modi said in a another tweet.

It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.

— Narendra Modi (@narendramodi) January 3, 2021

We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.

— Narendra Modi (@narendramodi) January 3, 2021