COVID-19 vaccine Covaxin phase-3 trial begins at AIIMS-Delhi; decision on night curfew soon, says AAP

FP Staff
·13 min read

With 44,489 more testing positive in a day, India's coronavirus caseload on Thursday increased to 92,66,705 while the toll mounted to 1,35,223 with 524 new fatalities, said the Union health ministry.

While total recoveries surged to 86,79,138, active cases reached 4,52,344, an increase of 7,598 cases from Wednesday, though the number of such cases remained below five lakh for the 16th consecutive day.

In Delhi, which has been witnessing a surge in numbers, the high court termed as alarming that the number of deaths due to COVID-19 in the National Capital crossed 2,000 in November and sought answers from the state government on steps it was taking on various fronts.

It said the police and the authorities concerned should avoid collecting fines in cash for violation of COVID-19 norms and asked if a method for online payment of such fines had been worked out.

The Delhi government also told the court that a decision on imposing night curfew in the National Capital would be take in three or four days.

Meanwhile, the phase three trials of the indigenously developed vaccine candidate Covaxin began at AIIMS-Delhi. The trial will be conducted in around 25 sites across 10 states and has already started at a few other sites.

Health ministry says 60.72% new cases from 6 states

The health ministry on Thursday said that of 44,489 fresh COVID-19 cases registered in 24 hours, 60.72 percent are from six states and UTs, with Kerala leading the tally followed by Maharashtra, Delhi, West Bengal, Rajasthan and Uttar Pradesh.

Kerala registered the highest of 6,491 new COVID-19, while Maharashtra has reported 6,159 new cases followed by Delhi with 5,246 new cases.

It further said that 60.50 percent of the 524 latest fatalities are concentrated in six states and Union territories €" Delhi, Maharashtra, West Bengal, Haryana, Punjab and Uttar Pradesh.

Delhi with 99 deaths reported the maximum new fatalities. Maharashtra saw a fatality count of 65 followed by West Bengal with 51 deaths, the ministry said.

At present, active COVID-19 cases, at4,52,344, comprise 4.88 percent of the total coronavirus cases in the country, the data showed.

Moreover, according to the ministry, 65 percent of the active cases are in eight states and UTs which have contributed the most to daily new cases and deaths.

The ministry also said that 61 percent of the total COVID-19 deaths are concentrated in these eight states/UTs.

The case fatality rates of Punjab (3.16 percent), Maharashtra (2.60 percent), West Bengal (1.75 percent) and Delhi (1.60 percent) are higher than the national average of 1.46 percent, the ministry said.

Uttar Pradesh, Haryana, Rajasthan and Kerala have a case fatality rate of 1.43 percent, 1.02 percent, 0.87 percent and 0.37 percent, respectively.

The cases per million population in four states €" Delhi (29,169 cases per million population), followed by Kerala (16,201 cases), Maharashtra (14,584) and Haryana (7,959 cases) €" are higher as compared to the national average of 6,715, the ministry highlighted.

While the national fatality rate stands at 1.45 percent, the recovery rate is now 93.66 percent with 36,367 recuperating in a span of 24 hours in the country, as per the ministry's 8 am update.

Fifteen states and UTs have a recovery rate more than the national average, the ministry said.

Decision on night curfew in 3-4 days, says Delhi govt

Meanwhile, citing official data, news agency PTI reported that the National Capital has witnessed 2,364 deaths due to the viral infection since 28 October.

Amid a surge in COVID-19 cases and deaths, 99 more fatalities on Wednesday pushed the city's total toll due to the disease to 8,720. It was after five days that Delhi recorded single-day deaths below 100. The city reported 98 deaths on 19 November, 118 on 20 November, 111 on 21 November, 121 each on 22 and 23 November, and 109 fatalities on 24 November, according to official data.

While Delhi recorded its single highest day figure of 131 COVID-related deaths on 18 November, the city registered its highest single-day spike of 8,593 cases on 11 November.

The Delhi High Court, while hearing a petition seeking increase in the COVID-19 testing numbers in the National Capital and getting speedy results, said it was alarming that the number of deaths had crossed 2,000 in November.

The court also sought to know from the Delhi government what random checks or protocols it has in place to prevent violation of the cap of 50 attendees at weddings.

It also asked the Delhi government to ensure that there was a portal in place for payment of fines for flouting COVID-19 norms as "cash transactions need to be avoided" in the present time and day.

With regard to Delhi government's submission that it has increased RT/PCR test numbers to 40,000 per day, the bench remarked that it came after much pushing and prodding by the court and after loss of a lot of lives.

The AAP government also told the court that a decision on imposing night curfew in the National Capital, as had been done in other states, would be taken in three or four days.

In its fresh guidelines for the month of December, the Centre said that states and Union Territories (UTs) may impose local restrictions, including night curfews, based on their assessment of the situation on the ground.However, for imposing lockdowns outside containment areas, the states and UTs will need to take the approval of the Centre.

With regard to the restricted opening of market areas, the Delhi government said the issue was before the Central government and it was awaiting its approval.

Delhi government also told the court that it has met with market associations and resident welfare associations (RWAs) for inviting suggestions to curtail the spread of COVID-19 infections.

To this the bench remarked that the meeting "would only get the ball rolling" and the Delhi government "needs to take concrete and tangible steps to involve the market associations and RWAs for handling the situation at the ground level and to spread message to all concerned with regard to maintaining social distancing, wearing masks and taking all kinds of measures to prevent spread of COVID-19".

The MHA had also said in the guidelines that awareness shall be created in communities on COVID-19 appropriate behaviour.

Door-to-door-survey in Delhi's containment zones finds 1,178 cases

Also, a door-to-door survey carried out in Delhi's containment zones and densely populated pockets threw up 1,178 positive cases with a positivity rate of 6.4 percent, reported PTI quoting officials.

The five-day survey, carried on the Centre's direction, covered over 57 lakh people in the city's containment zones and thickly populated areas, and identified 13,560 symptomatic people, out of which, 11,790 were tested. Also 8,413 contacts of these symptomatic people were traced, out of which, 6,546 people were tested, they said.

The RT-PCR test reports of a total of 18,336 symptomatic cases and their contacts gave up 1,178 positive results, a Delhi government official said.

The survey data showed that the highest number of symptomatic people (3,796) were found in the south-west district followed by east Delhi (2,744), north-west (1,957) and west (1,330). The maximum positive cases (288) were found in Central district followed by 275 in New Delhi, 197 in west, 196 in south-west and 118 in south-east Delhi.

"The number of positive cases found were lower than expected which means the positivity rate is going down, but there could be other reasons for it that will require in-depth analysis of the survey results," the official said.

About 9,000 three-member teams equipped with oximetres and thermal scanners surveyed people in 4,456 containment zones and surrounding areas across 11 districts for five days beginning 20 October.

Seekin got quell social media rumours, Gujarat chef minister Vijay Rupani, said there are no plans to impose any day-time curfew or lockdown in Gujarat or some of its cities.

At present, night curfew between 9 pm and 6 am is going on in Ahmedabad, Surat, Vadodara and Rajkot.

"Rumours are being circulated on social media. At present, there are no plans to impose any day-time curfew or lockdown. We will take a decision regarding it at an appropriate time," Rupani said, adding that the coronavirus situation was under control in the state.

Covaxin's phase-3 trails begin at AIIMS, Delhi

In another development, the phase-three human clinical trial of Bharat Biotech's Covaxin began at the AIIMS in Delhi on Thursday with Dr MV Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose of 0.5 ml of the intra-muscular injection.

The volunteers were under observation for two hours and will be monitored for the next few days, a source told PTI. Around 15,000 volunteers will be given the shot at the AIIMS over the next few days, sources said. As part of the trial application, a dose of 0.5 ml would be given on day 0 and on day 28, sources said.

The phase-three randomised double-blind placebo-controlled multi-centre trial would cover around 28,500 subjects aged 18 years and above. It would be conducted in around 25 sites across 10 states. The trial has already started at a few sites.

On Wednesday, Gujarat deputy-chief minister Nitin Patel said Sola civil hospital in Ahmedabad has been selected for the trial and it has received 500 doses, which are being kept in cold storage.

According to reports, the phase-three trials have also begun at the Infectious Diseases (ID) Hospital in Andhra Pradesh's Guntur. As per a report in The Times of India, a vaccine dose was given to a volunteer at the hospital on Wednesday.

The trials at ID Hospital would cover 1,000 patients in a month and the detailed report would be sent to ICMR, which has sent the vaccine doses. Those willing to participate in the trials would have to give their written consent, as per a report in The Hindu.

Besides, Covaxin, four other vaccines are under different phases of clinical trial in India with the Serum Institute of India conducting phase-three trial of the Oxford-Astrazeneca COVID-19 vaccine while the 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 clinical trials of the Russian COVID-19 vaccine Sputnik V in India. Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate, officials had said last week.

Vaccine major Serum Institute of India on Thursday said the COVID-19 vaccine developed by AstraZeneca and Oxford University is safe and effective, and the Indian trials are progressing smoothly with strict adherence to all protocols.

The comments came after AstraZeneca and Oxford University's acknowledgment of a manufacturing error raised doubts over the preliminary results of their experimental COVID-19 vaccine, reported news agency AP.

Asking people to be patient and not panic, the Serum Institute of India (SII) said in a statement, "The AstraZeneca-Oxford vaccine is safe and effective. Even the lowest efficacy results are at 60-70 percent, making it a viable vaccine against the virus."

That said, varied age groups with different dosage forms will result in slight variations and efficacy. "We must be patient and not panic," it added.

SII is conducting clinical trials of AstraZeneca-Oxford's COVID-19 vaccine candidate in India.

The Indian trials are running smoothly with strict adherence to all the necessary processes and protocols. So far, there are no concerns. However, we are going through the data that is available and will make further statement, if needed," SII said.

A statement describing the error came days after the company and the university described the shots as "highly effective" and made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 percent effective. In the group that got two full doses, the vaccine appeared to be 62 percent effective. The drugmakers said the vaccine appeared to be 70 percent effective combining the results of both groups.

The partial results announced on Monday are from large ongoing studies in the UK and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.

In a statement on Wednesday, Oxford University said some of the volunteers got a half dose as some of the vials used in the trial didn't have the right concentration of vaccine. The university said that it discussed the problem with regulators, and agreed to complete the late-stage trial with two groups. The manufacturing problem has been corrected, said to the statement.

But this has led to questions from experts, including on the results seen among the low dosage group and the decision to pool results from two groups of participants who received different dosing levels.

Form block-level task forces for vaccine roll-out, Centre tells states

The Centre has asked states to constitute block-level task forces to monitor COVID-19 vaccine roll-out and to maximise the involvement of local influencers, including religious leaders, for countering misinformation and rumour-mongering regarding coronavirus immunisation.

As per a letter dated 24 November by Union health secretary Rajesh Bhushan, listed the activities of the block task force, such as monitoring the progress of database of beneficiaries to be shared with a district for upload on Co-WIN software, monitoring the progress on key activities such as microplanning, communication planning, cold chain and vaccine logistics planning and fixing accountability for each activity.

The block task force will ensure the supervision of COVID-19 vaccination sessions and implement communication plan while addressing the local context and needs to address rumour-mongering as well as vaccine eagerness.

"Maximizing use of local influencers (including religious leaders) for countering misinformation and ensure an adequate number of IEC material pertaining to COVDI-19 vaccination is displayed at prominent places and at session sites," the terms of reference stated.

With inputs from agencies

Also See: ICMR, Serum Institute complete enrollment of phase 3 clinical trials of COVID-19 vaccine COVISHIELD

Oxford-Astrazeneca trial data show vaccine is at least 70 percent effective and easy to store as well

Oxford-AstraZeneca COVID-19 vaccine will be available at cost price across world, says pharma head Olivier Nataf

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