The SII, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval
Ahead of an expert panel meeting slated for 1 January, Drug Controller General of India VG Somani on Thursday hinted at approval for COVID-19vaccine, saying “…probably we will have a very happy New Year with something in hand.”
Stepping up its preparations for the vaccine rollout, the Union health ministry said administrations of all states and union territories will conduct COVID-19vaccination dry runs on 2 January.
“We are fully prepared to launch the world’s biggest vaccination drive,” asserted Prime Minister Narendra Modi but urged people to maintain caution even after inoculation, giving the slogan “Davai bhi, kadaai bhi (yes to medicine and yes to caution)”.
The number of cases of the new coronavirus variant in the country rose to 25, with five more cases being detected. Restrictions in view of New Year’s celebrations were imposed in several places across the country while Tamil Nadu extended lockdown restrictions, albeit with more relaxations.
Odisha imposed a night curfew across the state from 10 pm on Thursday till 5 am on 1 January (Friday) while the Delhi government announced curbs from 11 pm to 6 am on 31 December and 1 January. West Bengal chief secretary Alapan Bandyopadhyay said a night curfew will not be imposed but the state government will take all precautionary measures to prevent large gatherings on the occasion.
DCGI hints at vaccine approval in New year
At a webinar organised by the Department of Biotechnology, the DCGI hinted that India is likely to have a vaccine in the new year. He talked about the efforts made by the Department of Biotechnology and said vaccine candidates have got funding. “…and probably we will have a very happy New Year with something in hand. That’s what I can hint at,” Somnai said.
An expert panel in the Central Drugs Standard Control Organisation (CDSCO) will meet on Friday, the first day of the year, to further deliberate on the matter to consider emergency use authorisation applications by Serum Institute of India (SII) for the Oxford COVID-19 vaccine and Bharat Biotech’s ‘Covaxin’.
The Subject Expert Committee (SEC) on COVID-19 had on Wednesday deliberated and analysed the additional data and information submitted by the SII and Bharat Biotech. The SII, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19vaccine candidates and are awaiting approval.
Somani said the approval process was fast-tracked in view of the pandemic by quickly processing all applications, allowing parallel phase 1 and phase 2 trials without waiting for complete data. For restricted emergency use authorisation, he said, “There are certain parameters that if we get limited data or partial data of reasonable safety and efficacy, we will allow that vaccine to come into the immunisation programme into the market.” The DCGI sought to assure that “there is no compromise at all in the safety, efficacy and quality except for accepting the partial data for emergency use authorisation.”
Vaccine dry run in all states on 2 Jan
In another related development, Union Health Secretary Rajesh Bhushan on Thursday chaired a high-level meeting to review the preparedness at session sites for COVID-19vaccination with principal secretaries (Health) and other health administrators of all states and UTs through video-conferencing.
The health ministry said a dry run for COVID-19 vaccination will be conducted in all state capitals in at least 3 session sites on 2 January to test the linkages between planning and implementation and to identify the challenges. For each of the three-session sites, the Medical Officer In-charge will identify 25 test beneficiaries (healthcare workers).
Some states will also include districts that are situated in difficult terrain/have poor logistical support, while Maharashtra and Kerala are likely to schedule the dry run in major cities other than their capital, the Union Health Ministry said.
“The objective of the dry run for COVID-19 vaccine introduction is to assess operational feasibility in the use of Co-WIN application in the field environment, to test the linkages between planning and implementation and to identify the challenges and guideway forward prior to actual implementation. This is also expected to give confidence to programme managers at various levels,” the ministry said.
The Central government has also asked all states and UTs to ensure effective preparedness for the COVID-19 vaccine roll-out.
Dont believe in rumours regarding vaccine, says Modi
Prime Minister Narendra Modi, speaking after laying the foundation stone of the All India Institute of Medical Sciences in Rajkot via video conferencing, exuded confidence that India is ready to roll out the world’s biggest vaccination drivphae against coronavirus.
People should not believe in rumours and unfounded claims regarding the vaccine, Modi said and claimed that some persons have already started spreading such lies.
Efforts to make a ‘Made in India’ vaccine available to every eligible beneficiary in the country are in the final stage, Modi said, noting that new coronaviruscases are decreasing in the country.
Moderna vaccine show 94.1% efficacy: study
Results from the primary analysis of the ongoing phase-3 clinical trial of US biotechnology company Moderna’s COVID-19 vaccine have revealed 94.1 percent efficacy of the therapeutic in preventing symptomatic infections and severe illness, according to a peer-reviewed study, published on Wednesday in The New England Journal of Medicine.
It found that among over 30,000 participants randomised to receive the vaccine or a placebo, 11 in the vaccine group developed symptomatic COVID-19 compared to 185 participants who received the placebo. The researchers said this demonstrates 94.1 percent efficacy in preventing symptomatic COVID-19, adding that cases of the severe disease occurred only in participants who received the placebo.
The study enrolled 30,420 adult participants at 99 sites in the US. Eligible participants were 18 years old or more with no known history of SARS-CoV-2 infection, and whose locations or circumstances put them at appreciable risk of the infection and high risk of severe COVID-19, the researchers said.
The participants received their first injection between 27 July and 23 October, followed by a second shot 28 days later. Each jab, given intramuscularly, had a volume of 0.5 millilitres (mL), containing 100 micrograms (g) of mRNA-1273 vaccine or saline placebo.
The researchers said overall, reactions to the vaccine were mild — about half of the recipients experienced fatigue, muscle aches, joint pain, and headaches, more so after the second dose.
The co-principal investigator for the study and lead author of the paper Lindsey Baden said while these results are encouraging, they are limited by the short duration of follow-up so far.
India registers 21,822 new cases
India’s COVID-19 caseload on Thursday rose to 1,02,66,674 with 21,822 new infections being reported in a day, while the number of people who have recuperated from the disease surged to 98.60 lakh pushing the national recovery rate to 96.04 percent, according to the Union Health Ministry’s morning update. The toll increased to 1,48,738 with 299 new fatalities, the data updated at 8 am showed
With a net decline of 4,616, active cases stand at 2,57,656 active coronavirus infections in the country and comprise 2.51 percent of the total caseload, the ministry said.
Of the new recovered cases, 77.99 percent are observed to be concentrated in 10 states and UTs. At 5,707, Kerala has reported the maximum number of single-day recoveries, while 4,913 people recovered in Maharashtra followed by 1,588 in Chhattisgarh.
The ministry further said that 79.87 percent of the new cases are from 10 States and UTs. Kerala has reported the highest daily new cases at 6,268. It is followed by Maharashtra with 3,537 new cases.
Also, ten states and UTs accounting for 80.60 percent of the 299 new deaths. Maharashtra reported maximum casualties with 90 new fatalities. Kerala and West Bengal both follow with 28 daily deaths, it said.
Tally of new virus strain cases rises to 25
Separately, the health ministry said a total of 25 people in the country have tested positive for the new UK variant genome of SARS-CoV-2 so far. These 25 people include the 20 who were found positive with the mutated strain on Tuesday and Wednesday. “All 25 persons are in physical isolation in health facilities,” the health ministry said.
Among the new five cases, the mutated UK strain was detected in four at the National Institute of Virology (NIV), Pune and one new case was sequenced at theInstitute of Genomics and Integrative Biology (IGIB), Delhi, it said. Comprehensive contact tracing has been initiated for co-travellers, family contacts, and others.
Delhi Health Minister Satyendar Jain said a total of 38 people have been found positive since coming to the National Capital from the UK recently and kept in a separate institutional isolation unit in the LNJP Hospital premises. “Four such patients have been found infected with the new UK strain of COVID-19. The persons who came in their contact have been also traced and tested, and it is not in them. So, only these four cases of the new strain in Delhi so far,” he said.
Karnataka Health Minister Dr K Sudhakar exuded confidence that the 199 UK returnees who went untraceable will be tracked by the end of the day. “Of the 199 people, 24 were identified on Wednesday. Most probably, we will find out the rest of the people by the evening,” the minister said.
Kerala Health Minister KK Shailaja said as many as 32 people, who recently returned from the UK, have tested positive for COVID-19in the state and their samples have been sent to NIV Pune.
Restrictions for new year
Meanwhile, restrictions were imposed in various states and cities to avoid large gatherings for new years celebrations. In Delhi, night curfew will be imposed from 11 pm on 31 December to 6 am on 1 January, and again from 11 pm on 1 January to 6 am on 2 January, said an order issued on Wednesday by Vijay Dev, Delhi Chief Secretary and chairman of the Executive Committee of Delhi Disaster Management Authority (DDMA). It stated that not more than five people will be allowed to assemble at public places in Delhi during night curfew to avoid large gatherings.
However, there will be no restriction on the interstate and intrastate movement of people and goods during night curfew in Delhi, the chief secretary said in the order. The Delhi Police said no gatherings will be allowed in open public places like Connaught Place and India Gate during the night curfew.
The civic body in Mumbai permitted delivery of food from restaurants post 11 pm on Thursday in a bid to encourage people to celebrate at home.”Don’t Stop The Party, Mumbai – Just Take It Indoors After 11:00! Restaurants are allowed to home deliver food in the city post 11:00 pm,” the BMC tweeted.
The civic body further stated that COVID-19 prevention norms will have to be followed to ensure that Mumbai rings in the new year safely.
The Maharashtra government has put in place a night curfew between 11 pm and 6 am, prohibiting the gathering of five or more persons in view of the COVID-19 pandemic. Parties will not be allowed at any hotel, bar, pubs, restaurants after 11 pm and the Mumbai Police too has announced a slew of restrictions.
Odisha Special Relief Commissioner (SRC) PK Jena on Twitter said, “Govt (Government) of Odisha imposing night curfew from 10 pm of tonight to 5 am tomorrow across the state. The general public requested to cooperate. All essential services and movements are allowed to continue during the curfew hours.”
The Kerala government has imposed restrictions saying celebrations should come to a close by 10 pm and public gatherings should be avoided. Drones would be used to track any violations, state Police chief Loknath Behera said, adding action would also be initiated against those indulging in noisy celebrations. Everyone should ensure strict compliance of COVID protocol in such gatherings.
West Bengal chief secretary said the current situation is not conducive to imposing a night curfew but urged people to cooperate with the administration and the police. “There will be special assistance booths at places like Park Street and Victoria Memorial where a large turnout is expected,” he said.
The Kolkata Police has also taken measures to ensure that all COVID-19 safety protocols are adhered to and large gatherings on New Year’s eve are prevented, as per the Calcutta High Court’s order to check a spike in infections.
Tamil Nadu extends lockdown but with relaxations
The Tamil Nadu government has extended lockdown restrictions in the state till 31 January, while announcing relaxations (except in containment zones) such as lifting time restrictions on places of worship and allowing indoor and outdoor shootings for films and serials to be held without a limit on the number of participants, said reports.
As per a report by The News Minute,the state government has also increased the cap on visitors to 200 persons or 50 percent capacity of the indoor arenas where religious, social, political, sports, entertainment and cultural meetings are held.
According to the Indian Express, the government has denied permission for the public to gather at the beaches for Kaanum Pongal on 16 January. The E-registration process will continue for those entering the state, except from Puducherry, Andhra Pradesh, and Karnataka.
Schools in Kerala will reopen partially on 1 January while strictly following COVID protocols. The classes for 10th and 12th standards would begin with limited hours and a restricted number of students, official sources told news agency PTI.
The state health minister said that the academic year, which comes at a time of the COVID pandemic, should be dealt with confidence but caution. “Students should not be afraid to go to schools. The government has made all arrangements,” she said, urging everyone to strictly follow the guidelines issued by the health and the educations departments.
With inputs from PTI
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