Covid-19: Bharat Biotech MD asks for a week for confirmed data after row over third phase trials

10.45 pm: Brihanmumbai Municipal Corporation files a first information report against actor Sohail Khan, his brother Arbaaz Khan and son Nirvaan for violating coronavirus norms, reports ANI. The civic body says they were asked to quarantine at a hotel after their return from the United Arab Emirates but went home instead.

10.42 pm: Jharkhand registers 160 new coronavirus cases, pushing the tally in the state to 1,15,689, reports ANI. The toll climbs by one to 1,036. There are 1,13,125 recoveries and 1,528 active cases in the state.

10.38 pm: The number of coronavirus cases in Mumbai’s Dharavi rises by five to touch 3,826 but the active cases remain at 24, reports PTI. A total of 3,490 have been discharged.

10:33 pm: Union Health Minister Dr Harsh Vardhan says the Centre has initiated a series of actions to prevent the spread of coronavirus and that it is now taking up the vaccination drive in a big way, reports PTI.

“Prime Minister (Narendra Modi) himself interacted with the chief ministers of all states and Union territories and all stakeholders to regularly understand issues and collaborate with them for effective Covid-19 management,” he adds.

10.30 pm: Maharashtra reports 2,765 new coronavirus cases, 29 deaths and 10,362 recoveries in the last 24 hours, reports PTI. The overall tally in the state is 19,47,011, including 49,695 fatalities, 48,801 active cases and 18,47,361 discharges.

10.27 pm: The coronavirus tally in Madhya Pradesh rises to 2,44,647 with 621 fresh Covid-19 infections, reports PTI. The toll climbs to 3,648 after the state reports four new fatalities. There are 8,609 active cases and 2,32,390 recoveries in the state.

10.25 pm: Chhattisgarh reports 1,147 new coronavirus cases, taking the tally in the Union Territory to 2,83,515, reports PTI. The toll climbs to 3,412 with 12 new deaths.

7.38 pm: Maharashtra Health Minister Rajesh Tope says eight passengers who arrived from Britain have been found positive for the new strain of Covid-19, reports ANI. “Five of them are from Mumbai and one each from Pune, Thane and Mira Bhayander,” he adds. “Contact tracing is under way.”

7.32 pm: Tamil Nadu reports 838 new Covid-19 cases, 985 recoveries, and 10 deaths in 24 hours, reports ANI, citing the state Health Department’s bulletin. The overall cases stand at 8,21,550, with 8,01,414 recoveries, and 12,166 deaths.

7.20 pm: Ella adds that Covaxin is a vaccine and “not a backup”, reports ANI. “People should be responsible before making such statements,” he adds.

All India Institute of Medical Sciences Director Dr Randeep Guleria on Sunday said that the Covaxin shot developed by Bharat Biotech will be used in an emergency situation or as a backup, once the immunisation process against coronavirus begins in the country.

7.16 pm: Bharat Biotech MD Krishna Ella asks for one weeks’ time, adding: “I will give you confirm[ed] data.” He adds that the vaccine rollout will happen as early as possible and that batches have been sent to a government testing laboratory in Kasauli.

5.58 pm: Bharat Biotech Managing Director Krishna Ella defends data published by his company for the Covaxin shot.

“Many people say that I am not transparent in my data,” he says, according to ANI. “I think people should have patience to read on the internet and how many articles we have published. More than 70 articles have been published in various international journals.”

5.56 pm: Bharat Biotech Managing Director Krishna Ella says Indian companies do not deserve “gossip and backlash”, responding to controversy over granting approval to the company’s Covaxin shot before completion of third phase human trials, reports ANI.

“Merck’s Ebola vaccine got authorisation for emergency use even before completion of phase 3 trial,” says Ella. “Johnson & Johnson did trials on 87 people and got emergency licence.”

2.00 pm: Britain inoculates the first patient in the world with Oxford and AstraZeneca’s coronavirus vaccine, AP reports. The first patient to receive the dose is 82-year-old Brian Pinker.

12.50 pm: The Tamil Nadu government permits to increase the seating capacity of cinemas, theatres, and multiplexes from existing 50% to 100% by following the necessary coronavirus guidelines, reports ANI.

12.47 pm: Madhya Pradesh Chief Minister Shivraj Singh Chouhan says he will not get coronavirus vaccination for now as others in the priority groups should get it first, reports ANI.

“I have decided that I will not get vaccinated for now, first it should be administered to others,” he says. “My turn should come afterwards, we have to work to ensure that priority groups are administered with the vaccine.”

12.45 pm: The health ministry says that the decline in India’s daily new cases has ensured a consistent fall in the active caseload, which constitutes 2.36% of the total infections. It also says higher testing has led to the positivity rate further going down to 5.89% in the country. One crore tests were conducted in the last 11 days.

“With a sustained, pro-active and calibrated approach, the daily new cases in India are on a sustained decline,” says a statement. “With the rising recoveries and decline in daily new cases, India’s cumulative recoveries are moving closer to 1 crore. The total recovered cases are nearing 99.5 lakhs, which translates to a recovery rate of 96.19%.”

12.20 pm: Modi says people must ensure that “Made in India” products not only have global demand but also global acceptance. “Quality is as much important as quantity, our standards should rise with our scale in our quest for Aatmanirbhar Bharat,” he adds.

12.08 pm: The Kerala government has asked the Centre to give it priority in distribution of the coronavirus vaccines amid rise in new cases, The Indian Express reports.

“Though we were the first state to report the disease, the cases in the state has peaked just now,” says Mohammad Asheel, executive director of Kerala Social Security Mission under the Social Justice Department. “Despite our population’s vulnerability and susceptibility, we have succeeded in our strategy. So in order to get the best out of our strategy, we need to get the vaccine first.”

12.02 pm: The prime minister says that Indian scientists have been successful in coming up with two “made in India” vaccines, reports ANI.

The Drugs Controller General of India on Sunday approved coronavirus vaccines developed by AstraZeneca and Oxford University and the other one by Bharat Biotech. India, which has the second-highest number of coronavirus infections in the world after the United States, is expected to start its massive immunisation programme within weeks now.

12 pm: Prime Minister Narendra Modi says that the world’s biggest coronavirus vaccination programme is set to begin in India, adding that the country is proud of its scientists, reports PTI. He is speaking at the inaugural address of the National Metrology Conclave.

10.52 am: A Brazilian association of private health clinics says that it is negotiating with pharmaceutical firm Bharat Biotech to buy five million doses of its coronavirus vaccine, reports AFP. India approved this vaccine for emergency use on Sunday.

10.50 am: The active cases in India continue to remain below the 3-lakh mark for the 14th consecutive day, according to PTI.

10.45 am: The Drugs Controller General of India gives permission to Serum Institute of India to manufacture its coronavirus vaccine.

9.48 am: India registers 16,504 new coronavirus cases on Monday, taking the tally to 1,03,40,469. The country’s toll rises by 214 to 1,49,649. The country’s active cases stood at 2,43,953, while the recoveries reached 99,46,867.

9.25 am: Sixty-five people have been arrested from two illegal hookah bars in Delhi’s Rohini after police raids, reports NDTV. The police found coronavirus-related restrictions violated at the bars.

9.19 am: The United States government is considering giving some people half the dose of Moderna’s coronavirus vaccine to speed up vaccinations, reports Reuters, citing the head of the federal vaccine programme.

“We know that for the Moderna vaccine, giving half of the dose to people between the ages of 18 and 55, two doses, half the dose, which means exactly achieving the objective of immunizing double the number of people with the doses we have,” says Moncef Slaoui, head of Operation Warp Speed.

9.15 am: Dr Gagandeep Kang, professor of microbiology at Christian Medical College, Vellore, tells CNBC-TV18 that she cannot understand the basis on which Covaxin has been approved for emergency use in the country.

9.10 am: Indian Council of Medical Research Director General Balram Bhargava refutes allegations that the phase 3 trials of Bharat Biotech’s Covaxin shot was not evaluated before India’s drug regulator accorded approval for restricted emergency use of the vaccine, reports The Times of India. Bhargava says emergency use authorisation was given after meticulous review of data of 22,500 persons which established safety of the shots.

9 am: Here is a quick look at the developments from Sunday:

• India on Sunday registered 18,177 new coronavirus cases, taking its tally to 1,03,23,965. The new cases were 4.7% lower than Saturday. The country’s toll rose by 217 to 1,49,435. The number of active cases stood at 2,47,220, while the recoveries reached 99,27,310.
• Drugs Controller General of India chief VG Somani announced that the coronavirus vaccines of the Serum Institute of India and Bharat Biotech have been approved for restricted emergency use in the country. Both the vaccines have to be administered in two doses and have to be stored at 2 to 8 degrees Celsius.
• Congress leaders expressed concerns over the permission granted for restricted use of the coronavirus vaccine developed by Bharat Biotech, even as the pharmaceutical company was yet to complete phase 3 trials.
• Soon after, the Bharatiya Janata Party hit out at the Congress for raising questions about the efficacy of Bharat Biotech’s coronavirus vaccine Covaxin. Civil Aviation Minister Hardeep Singh Puri directed his criticism at Congress leaders Shashi Tharoor and Jairam Ramesh and Samajwadi Party President Akhilesh Yadav. Tharoor and Ramesh had asked why Covaxin had been cleared before phase 3 trials. Yadav, on the other hand, had said that he would not get inoculated as the BJP’s vaccine could not be trusted.
• The Covaxin shot developed by Bharat Biotech will be used in an emergency situation or as a backup, once the immunisation process against coronavirus begins in the country, All India Institute of Medical Sciences Director Dr Randeep Guleria told ANI.
• A luxury hotel in Chennai emerged as an infection hotspot as nearly 85 people, including staff members, have tested positive for the infection there since December 15. Civic authorities have been directed to conduct oxygen saturation tests on all guests at the ITC Grand Chola.