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

Coronavirus News Updates: In a statement, the state government said the dry run will start at 10 am in three urban and as many rural sites with a minimum of two sessions

FP Staff January 03, 2021 23:50:30 IST
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Coronavirus News Updates: COVID-19 vaccination dry run at six sites in Uttar Pradesh from 5 January

Representational image. PTI

Highlights

12:20 (ist)

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.

11:57 (ist)

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.

LIVE NEWS and UPDATES

Jan 04, 2021 - 17:01 (IST)

Bharat Biotech to address press conference soon

Amid concerns over approval to Covaxin, Bharat Biotech will hold a press conference at 5 pm today, said reports. As per CNN News18, Dr Krishna and Suchitra Ella will address the presser.

Jan 03, 2021 - 23:31 (IST)

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

Jan 03, 2021 - 23:25 (IST)

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
 

Jan 03, 2021 - 21:52 (IST)

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.

Jan 03, 2021 - 21:41 (IST)

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.

Jan 03, 2021 - 21:15 (IST)

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

Jan 03, 2021 - 20:44 (IST)

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.

Jan 03, 2021 - 20:33 (IST)

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.

Jan 03, 2021 - 20:18 (IST)

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

Jan 03, 2021 - 20:05 (IST)

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

Coronavirus News LATEST Updates:   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

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.

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 it was "disgraceful for anyone to politicise such a critical issue".

"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, " he claimed.

The health minister also said that Covaxin was more likely to be effective against new virus strains, including the UK variant, "as it contains immunogens (epitopes) from other genes in addition to those from spike protein".

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.

In the first phase, around nine lakh people — three lakh health workers and nearly six lakh front line workers — will receive the vaccine, the Delhi health minister said.

Speaking to news channels, AIIMS director Dr Randeep Guleria said that BHarat Biotech's coronavirus candidate Covaxin had received the nod for emergency situations and had not been granted emergency use authorisation. Guleria said the vaccine could be used as backup if cases surge due to the new virus strain or in case of uncertainty about the protection provided by the other vaccine against the new strain.

As the 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.

Congratulating the scientists and researchers for their 'untiring efforts', the Union health minister said that 'these vaccines are a fitting tribute to our corona warriors'

Expressing delight on DGCI's nod 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."

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.

Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' is ready to roll out in the coming weeks. Poonawalla's remarks came soon after India's drugs regulator approved Covishield for restricted emergency use.

Prime Minister Narendra Modi called DCGI’s emergency approval for 2 vaccines in India a “decisive turning point” in the country’s fight against the virus and expressed gratitude for all frontline workers in “adverse circumstances.”

The Drugs Controller General of India (DCGI) has granted emergency use authorisation for the Serum Institute of India (SII)’s ‘Covishield’ and Bharat Biotech’s ‘COVAXIN’ vaccines against COVID-19 , the disease caused by the novel coronavirus . This comes after clearances from the Subject Expert Committee (SEC)

The development comes after the subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended Oxford-AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Covaxin for restricted use.

India recorded 18,177 new COVID-19 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.

The total coronavirus cases mounted to 1,03,23,965 and the toll climbed to 1,49,435 with the novel coronavirus virus claiming 217 lives in a span of 24 hours in the country, the data updated at 8 am showed. The COVID-19 case fatality rate stood at 1.45 percent

An expert panel of India's central drug authority on Saturday recommended granting permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situation, especially in the context of infection by mutant strains, officials said.

The recommendation for Bharat Biotech's vaccine came a day after the panel cleared the Serum Institute of India's emergency use athorisation application for the Oxford-AstraZeneca vaccine Covishield.

This paves the way for the roll-out of at least two vaccines in India in the coming days, while two more are in advance stages of development.

At a press conference in New Delhi, Union minister Prakash Javadekar said India was probably the only country where four vaccines were in the pipeline.

Asked about some religious figures raising doubts over vaccines, Javadekar said "our vaccine is effective" and the rest of the world was also using it. He added that vaccines are introduced after tests and those that would be brought in would be safe.

Union Health Minister Harsh Vardhan appealed to people on Saturday not to be misguided by "rumours" regarding the safety and efficacy of the coronavirus vaccine, and said, "We will not compromise on any protocol before approving a vaccine."

The Union Health Ministry on Saturday said the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to the Serum Institute of Institute (SII) for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.

"The SEC of CDSCO met on January 1 and 2 and made the recommendations for the consideration and final decision of the Drugs Controller General of India (DCGI)," the ministry said.

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

The SEC again deliberated on the emergency use authorisation (EUA) application of Bharat Biotech on Saturday after it presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection.

It recommended "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech," the health ministry stated.

According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.

The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said. The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.

While granting the restricted emergency use approval for the Oxford COVID-19 vaccine on Friday, the panel had imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest.

Also, the Pune-based firm should submit the safety data including the data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country, according to the recommendations.

Thereafter, the firm should submit the safety data as per the provisions and standard procedures.

According to sources, the recommendations stated that the vaccine should be supplied along with fact-sheet and separate leaflet for the guidance of the healthcare provider.

The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.

According to sources, the firm had presented the details of the conditions and restrictions under which AstraZeneca was granted emergency use authorisation in the UK and the revised fact sheet and prescribing information in Indian context as required by the committee.

SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7.

Pfizer had applied for regulatory approval for its vaccine on December 4 has not yet turned for deliberation.

After detailed deliberations, the SEC has also recommended for grant of permission to Cadila Healthcare Ltd in Ahmedabad for conduct of phase-3 clinical trial protocol for its vaccine candidate.

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