Centre considers emergency use guidelines for COVID-19 vaccine; next wave 'like tsunami', warns Uddhav

As research and trials of COVID-19 vaccines continues, the Centre is exploring the modalities of emergency authorisation and usage of anti-coronavirus vaccines pending completion of phase-three clinical trials and regular licensure.

These developments assume significance against the backdrop of Pfizer seeking emergency use authorisation of its COVID-19 vaccine from the US regulators. Another US-based biotechnology giant, Moderna, said it also intends to apply for an emergency use authorisation (EUA) with the US Food and Drug Administration (USFDA) in the coming weeks.

Meanwhile, as authorities have mobilised to combat the recent COVID-19 wave in Delhi, the government on Sunday said that more than 400 ICU beds have been added to COVID-19 wards.

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A total of 1,650 ICU beds being set up in the city to help tackle the surge in cases, of which 250 will be in private hospitals, 650 in Delhi government facilities, and 750 in those run by the Centre.

Overall, a snapshot of the countrywide COVID-19 situation showed that the total caseload rose to 90.95 lakh with 45,209 new cases on Sunday. The Union health ministry added that recoveries surged to 85,21,617, pushing the national recovery rate to 93.69 percent.

On the other hand, the toll rose to 1,33,227 with 501 more fatalities. However, the ministry added that the COVID-19 case fatality rate has declined to 1.46 percent.

The number of active cases remained below five lakh for the 12th consecutive day, the ministry said, adding that there are 4,40,962 active cases in the country as on date. This comprises 4.85 percent of the total caseload.

As part of the Centre's efforts to aid state governments in curbing the COVID-19 spread, high-level central teams were deputed to Uttar Pradesh, Punjab and Himachal Pradesh on Sunday.

These states have been either reporting a rise in the number of active cases — those who are hospitalised or are in home isolation under medical supervision, or demonstrating a rise in the daily new cases of coronavirus infections, the ministry said.

"These three-member teams will visit districts reporting a high number of COVID-19 cases and support the state efforts towards strengthening containment, surveillance, testing, infection prevention and control measures, and efficient clinical management of the positive cases.

"The central teams shall also guide in effectively managing the challenges related to timely diagnosis and follow up," the ministry added.

Centre exploring modalities of emergency authorisation of vaccine

NITI Aayog Member (Health) Vinod Paul, Principal Scientific Advisor to the government K VijayRaghavan and Union Health Secretary Rajesh Bhushan were among those who attended a meeting on the COVID-19 vaccine development this week, PTI reported.

The issue of advance purchase commitment for vaccines, including pricing, was also discussed in the meeting.

"It was decided that the PMO-constituted Vaccine Task Force (VTF) will lay down the principles for emergency use authorisation while the National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) should take the lead in setting the principles for advance market commitment, including vaccine pricing," PTI quoted sources as saying.

Five vaccines are under different phases of clinical trials in India. The Serum Institute of India is conducting the phase-three trial of the Oxford-AstraZeneca COVID-19 vaccine, while Bharat Biotech and ICMR has already started the phase-three trail of the indigenously developed COVAXIN jab.

An indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial in the country. Dr Reddy's Laboratories will soon start combined phase two and three trials of the Russian COVID-19 vaccine Sputnik V in India.

According to the source, an urgent meeting of the vaccine task force (VTF) with experts will be convened to review the scientific status of vaccines globally and whether, if so how and when should the decision on emergency authorisation of vaccines be taken.

The terms of references for two major bodies dealing with vaccine introduction — the National Technical Advisory Group on Immunisation (NTAGI) and the Central Drug Standards and Control Organisation (CDSCO) — will be set and their roles clearly defined for authorisation and emergency authorisation.

Uddhav Thackeray warns against slacking in COVID fight

Maharashtra chief minister Uddhav Thackeray said that while the COVID-19 spread has been curbed in the state due to the "restraint and discipline" by people, complacency in adhering to precautionary protocol can cause a second or third wave "like a tsunami".

"In the past we celebrated all our festivals with caution. Be it Ganeshotsav or Dussehra. You all are cooperating with me. Even while celebrating Diwali, I requested you to not burst crackers and you followed it. And because of this, the war against Covid is in our control," he was quoted by NDTV as saying.

"But I am a bit angry with you all. I had already said after Diwali there will be overcrowding. Don't think COVID is over. I have seen many people not wearing masks. Don't be so careless. Be in western countries, Delhi or Ahmedabad. This second and third wave is strong like a tsunami. Ahmedabad has even enforced night curfews," Thackeray added.

Delhi govt says 400 ICU beds added, more soon

Delhi officials on Sunday said that 29 ICU beds were added on Tuesday, 100 on Wednesday, 76 on Thursday and 206 on Saturday, PTI reported. Health minister Satyendar Jain said that more ICU beds will be set up in the next few days.

The AAP government had on Thursday directed private hospitals to increase the percentage of non-ICU COVID-19 beds from 50 to 60. It had also ordered 42 private hospitals to reserve with immediate effect 80 percent of their ICU beds for coronavirus patients.

As the number of COVID-19 deaths mount in the National Capital, reports of burial sites running out of space have also emerged, the PTI report said. Jain said he spoke with municipal corporation officials in this regard.

"They have assured that adequate measures are being taken and there will be no problem in conducting the last rites of those dying due to COVID-19," he said.

Delhi, which has been reeling under the third wave of the coronavirus outbreak, has reported a death rate of 1.58 percent as compared to the national fatality rate of 1.48 percent.

In the month of November alone, Delhi has recorded 1,759 fatalities till 21 November, which is around 83 deaths per day.  The number of deaths breached the 100-mark four times in the last 10 days.

Colleges may be shut if cases rise: Karnataka govt

Barely six days after the degree and engineering colleges were reopened in the state, Karnataka health minister Dr K Sudhakar on Sunday said they may be shut again if the coronavirus cases go up.

The degree, engineering and diploma colleges were reopened on 17 November after eight months of closure due to coronavirus-induced lockdown.

Under the circumstances, reports emerged that at least 130 students got infected by COVID-19.

"If the cases go up, then, as you have said in your (media) reports, we will have to go for a shutdown once again. There is no alternative," Sudhakar told reporters in Dharwad while responding to queries about the rising coronavirus cases among students.

The minister's statement came ahead of Karnataka government's crucial meeting on Monday to decide reopening of schools. Sudhakar said that the schools have not been reopened yet in the state for the fear of coronavirus.

Stating that about 120 to 130 students were infected with the coronavirus as per media reports, Sudhakar said he will ask for more information from senior officials.

Rajasthan districts set for first phase of panchayat polls tomorrow

All preparations have been made for the first phase of the elections to panchayat bodies in 21 Rajasthan districts on Monday, PTI reported.

According to state Election Commissioner PS Mehra, around 72.38 lakh people will be eligible to vote in the panchayat samiti and zila parishad polls on Monday, for which nearly 25,000 EVMs will be used at 10,131 polling stations.

Around 50,000 employees will be deployed for the polls, he said, adding that people will be able to vote from 7.30 am to 5 pm.

Mehra has appealed to the candidates and their supporters to strictly follow coronavirus-related guidelines issued by the authorities.

In the first phase, the elections will be held in districts of Ajmer, Banswara, Barmer, Bhilwara, Bikaner, Bundi, Chittorgarh, Churu, Dungarpur, Hanumangarh, Jaisalmer, Jalore, Jhalawar, Jhunjhunu, Nagaur, Pali, Pratapgarh, Rajsamand, Sikar, Tonk and Udaipur.

Rajasthan chief minister Ashok Gehlot reviewed the COVID-19 situation and told officials the government's top priority was to save lives and to ensure strict compliance of anti-pandemic precautions by people.

"Also gave instructions to closely monitor the containment efforts in areas where the infection rate is high & to ensure that people comply with the rule to wear masks when outside," he said in a series of tweets.

In accordance with an order issued on Saturday, markets, restaurants, shopping malls and other commercial establishments in the urban areas will be closed by 7 pm and night curfew will be imposed from 8 pm to 6 pm in eight district headquarters of: Jaipur, Jodhpur, Kota, Bikaner, Udaipur, Ajmer, Alwar and Bhilwara.

Meanwhile, the Uttar Pradesh government has reportedly decided to conduct mandatory COVID-19 tests on travellers from Delhi as the National Capital combats a surge in cases.

"We will be testing people coming from Delhi via flight, bus or train, in the wake of surge in COVID-19 cases in the national capital," UP Chief Secretary RK Tiwari was quoted as saying by reports. "We are discussing on the number of people allowed to attend weddings or other events," he added.

Uttarakhand governor Baby Rani Maurya on Sunday said she has tested positive for COVID-19. Reports said that she had met Maharashtra governor Bhagat Singh Koshiyari at his Doon residence on Saturday.

US to begin 'sweeping' vaccinations from Dec

The United States hopes to begin a sweeping program of COVID-19 vaccinations in early December, the head of the government coronavirus vaccine effort said Sunday.

"Our plan is to be able to ship vaccines to the immunization sites within 24 hours of approval" by the US Food and Drug Administration, Moncef Slaoui told CNN. "So I expect maybe on Day Two of the approval, on the 11th or the 12th of December."

FDA vaccine advisors reportedly will meet December 8 to 10 to discuss approving vaccines which Pfizer and Moderna say are at least 95 percent effective.

State-wise details

India's COVID-19 tally had crossed the 20-lakh mark on 7 August, 30 lakh on 23 August and 40 lakh on 5 September. It went past 50 lakh on 16 September, 60 lakh on 28 September, 70 lakh on 11 October, crossed 80 lakh on 29 October, and surpassed 90 lakh on 20 November.

According to the ICMR, over 13.17 crore samples have been tested up to 22 November with 10,75,326 samples being tested on Saturday.

The 501 new fatalities on Sunday include 111 from Delhi, 62 from Maharashtra, 53 from West Bengal, 25 each from Kerala and Haryana, 24 from Uttar Pradesh, 23 from Punjab, 22 from Chhattisgarh and 20 from Karnataka.

A total of 1,33,227 deaths reported so far in the country include 46,573 from Maharashtra followed by 11,641 from Karnataka, 11,586 from Tamil Nadu, 8,270 from Delhi, 7,976 from West Bengal, 7,524 from Uttar Pradesh, 6,927 from Andhra Pradesh, 4,595 from Punjab and 3,846 from Gujarat.