Prime Minister Narendra Modi on December 7 said that the country will not have to wait too long for the coronavirus vaccine even as he cautioned people that there should be no laxity as far as prevention of the infection is concerned.
Meanwhile, Neeraj Nischal, Associate Professor of Medicine, All India Institute of Medical Science (AIIMS) warnned that “seeing the vaccine as a magic bullet is fraught with danger”. He explains that social vaccines and biological vaccines will have to go hand in hand in the long fight ahead.
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Timelines for issue of licence for emergency use
ICMR DG Balram Bhargava on timelines for issue of licence for emergency use. He said "Various countries have provisions for approval processes. In US, the phrase used is "expanded access program"; "special access scheme" in Australia, "temporary use authorisation" in France; hardship case programme in Germany, temporary use authorisation in Spain, earlier access to medical scheme in UK; compassionate care in Israel; special access program in Canada; compassionate use in Turkey; clinical access programme in South Africa; conditional approval and regenerative medicine in Japan."
"The regulator probably has to be satisfied with risk-benefit ratio in this emergency situation to take a decision. Safety and immunogenicity data of the past several months are available for the vaccines...the WHO has talked about more than 50% efficacy," said Dr. Bhargava on a query about the data being replied upon for possible issue of emergency use approval.
We should be cautious of 'mischievous' virus, says V.K. Paul
Government of India and Member (Health) NITI Aayog, V.K. Paul said "The pandemic situation has stabilised and there is a clear cut declining trend, it is a matter of satisfaction. However, we should be cautious of this "mischievous" virus.
He said "There has been a significant progress on vaccine front, three candidates are before the regulator seeking permission for emergency use, it is possible that they may get early licence.
"Other vaccines may also come. Ground preparations are very comprehensive in close cooperation with the States/UT governments. It will be the world's largest immunisation programme. Please have faith on the regulators' decision with respective to vaccine, based on science. Don't succumb to fake news, come back to us, we will clarify, have faith in our institutions."
Mr. Bhushan said "Not all countries' regulatory framework make mention of the phase "emergency use authorisation". However, it does not mean that that specific country does not have an enabling provision to accord an approval which is early and distinct from regular market approval. India's regulatory framework has a specific provision for grant of emergency use authorisation, although the specific phrase is not used. The legal framework is New Drugs and Clinical Trial Rule, 2019, which provides that under specific special situations mentioned in the rule, relaxation, abbreviation omission, or deferment of data, including local clinical trial data, may be considered for approval. Similarly, other countries also have laws. Timeline for issuing licence is under the national regulator's domain."
1.54 lakh vaccinators to be used for COVID vaccination, says Health Secretary
Additional vaccinators: Presently, there are 2.39 lakh vaccinators across the country, only 1.54 lakh of them to be used for Covid vaccination. Therefore, the drive will have minimal impact on routine health services, including routine immunisation. Additional vaccinators being arranged in collaboration with States/UTs.
Implementation Preparedness: Additional procurement for syringes, needles, etc, are on track; implementation of SOPs in final stages; training materials being finalised; detailed implementation plans being finalised with States governments in coming days
Co-WIN platform has a mobile application, which can be downloaded for free by all, for vaccination delivery. The mobile app will record vaccine data, the platform facilitates remote real time monitoring.
On the software, vaccination sessions — involving all necessary details about vaccinators and those to be vaccinated — can be created.
It facilitates verification of beneficiary details and update of vaccination status of the beneficiaries. The beneficiaries will get an SMS alert after registration, to be issued OR based e-vaccination certificate.
Under the transparent, effective and sustained communication programme, the government to address challenges like disinformation campaigns, raising doubts, anti-vaccine lobby, rumours (quality, safety and efficacy). The government to focus on good communication and education of people, explain the implementation plan to them, and prepare people to accept some adverse effect as happens with all vaccines
Multi-level coordination mechanism
Mr. Bhushan said "Under multi-level coordination mechanism: At the national level is NEGVAC, at the State level, State Steering Committees are chaired by the respective Chief Secretaries, there are State Task Force chaired by Principal Secretary (Health) and State Control Rooms are also being set up.
"At the district level, there are district task forces chaired by respective Collectors, Urban Task Forces chaired by Municipal Commissioners, and district Control Rooms. Block (Level) Task Forces and Control Rooms are there.
"State Steering Committee meetings and State Task Force meetings to be held by December 8. The District Task Force meetings in all districts to be held by December 12, and at the block level, the meetings are to be concluded by December 15."
Cold Chain Infrastructure Augmentation: "Vaccines are temperature sensitive and need to be stored at a specific temperature. Presently, cold chain system consists of 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country. Curent cold chain is capable of storing additional quantity of Covid-19 vaccine required for first three crore, health care workers and Front Line workers."
He said "Ministry, in consultation with States/UTs, has assessed the additional requirement for cold chain storage. Additional supplies would be available to States/UTs to begin by December 10."
COVID precautions must be undertaken even after vaccination
Mr. Bhushan said "Even after vaccination, COVID precautions must be undertaken. The WHO and CDC-Atlanta and other scientific organisations have also reiterated the same.
"On April 14, the Central Government had set up a Vaccine Task Force charged by the Principal Scientific Advisor to the Government of India and Member (Health) NITI Aayog, V.K. Paul."
Mr Bhushan also said "The Centre, on August 7, also set up a National Expert Group on Vaccine Administration chaired by Dr. Paul."
"It's mandate is to provide guidance on prioritisation of population groups, procurement and inventory management, vaccine selection, and vaccine delivery and tracking mechanism.
"The third measure is consultative process for roll-out of Covid-19 vaccine through multi-level coordination mechanism," he said.
"Centre, in collaboration with States/UTs, to prepare list of prioritised population groups for vaccination, strengthen cold chain infrastructure, provide for additional vaccinators, ensure effective communication strategy on vaccine safety, effectiveness, etc,. A digital platform, Co-WIN, also set up for vaccination delivery."
Five key strategic principles to govern vaccination process:
- Orderly, smooth implementation driven by technology, the process may go on for a year or more
- No compromise of existing healthcare services, especially national programmes and primary care, 3. Utilise experience of elections and universal immunisation programme, ensure people's participation, 5. No compromise on scientific and regulatory norms, other SOPs
- Categories: Healthcare Workers (about 1 crore); Frontline Workers, including personnel from States and Central police department, armed forces, home guard and civil defence, organisation, also disaster management volunteers and municipal workers (about 2 rore); Prioritised age group of above 50 and persons with associated comorbidities (about 27 crore)
- Every single Indian who needs to be vaccinated will be vaccinated.
- These are the recommendations of NEGVAC.
These are not sequential, they may be vaccinated simultaneously depending upon availability of vaccines.
Progress of Health Care Workers data collection
Process of collecting database has begun across States/UTs and Central Ministries, data collected by respective States/UTs from government health facilities and private health facilities, the data is being uploaded on Co-WIN software, the process is being monitored and verified at different levels.
Eight vaccine candidates are in various stages in India
Union Health Secretary Rajesh Bhushan said "Vaccination efforts are guided by the laid down principles as said by the Prime Minister on August 15."
"There are eight vaccines in the country. The first is Covishield by Indian manufacturer Serum Institute of India, Pune, collaborator is Astra Zeneca, it is in Phase II-III, applied of emergency use.
"The second one is Covaxin by Bharat Biotech, collaborating with Indian Council of Medical Research, it is in Phase-III, has applied for emergency use."
Mr. Bhushan added "ZyCoV-D of Cadila Healthcare Limited is the third vaccine, collaborating with Dept of Biotechnology (India), it is in Phase-II. The fourth vaccine is Sputnik V by Dr. Reddy's Lab, collaborating with Gamaleya National Centre, Russia, its Phase-II trial is over, the Phase-III is to start next week.
"The fifth vaccine is NVX-CoV2373 by Serum Institute of India, Pune, collaboration with Novavax, its Phase-III trial is under consideration in India.
"Recombinant Protein Antigen based vaccine is the sixth one by Biological E Limited, Hyderabad, in collaboration with MIT-USA, its pre-clinical animal studies have concluded, Phase-I plus II human clinical trials have started," Mr. Bhushan said.
"The seventh vaccine is HGCO 19 by Genova (Pune), in collaboration with HDT-USA, its pre-clinical animal studies are over, the clinical trials (Phase-I&II) to start
"The eighth vaccine is Inactivated rabies vector platform by Bharat Biotech International Limited (Hyderabad), in collaboration with Thomas Jefferson University -USA, it is in advanced pre-clinical trial stage," he said.
Mr. Bhushan said "Multiple vaccine candidates are in different stages of development, some may get licensed in next few weeks, the vaccine require 2-3 doses, three to four weeks apart."
Cumulative case positivity is 6.5%, says Health Secretary
Union Health Secretary Rajesh Bhushan says "Total cases have reached 97.03 lakh, active cases are now 3.83 lakh, total deaths are 1.40 lakh, so far 14.8 crore tests have been conducted. There are 7,031 cases per million population, which is among the lowest in the world. The contribution of active cases are 3.96% of the total cases, deaths per million are 102, which is also among the lowest."
"The case positivity is 6.5% (cumulative), in last one week it is 3.2%, the case fatality rate is 1.45% overall, in the last one week it was 1.3%."
Mr. Bhushan says "The situation in US, Russia and Brazil, the cases are increasing. There is a huge surge in Turkey. In India, the cases are on continuous decline. Cases are also declining in France and Spain, after a spike."
"Maharashtra (76,852); Kerala (59,607); Karnataka (24,786), West Bengal (23,829); and Delhi (22,486) are the top States/UTs contributing to total active cases, accounting for 54% of total active cases in the country."
Para-athletics coach Gajender tests positive for COVID-19
Para-athletics coach Gajender has tested positive for COVID-19 and is under home quarantine, the Sports Authority of India (SAI) said on Tuesday.
Gajender is the coach and husband of para-athlete Simran, who is training at the Jawaharlal Nehru Stadium here.
“Gajender who is the coach as well as husband of Para-athlete Simran training at New Delhi’s Jawaharlal Nehru Stadium tested positive for the coronavirus,” SAI said in a release.
- PTI
Mobile technology to be used for vaccination drive, says PM Modi
With the chances of a COVID-19 vaccine being available soon increasing, Prime Minister Narendra Modi on Tuesday said the mobile technology will be used for mass inoculation against the pandemic.
Speaking at the India Mobile Congress, the Prime Minister said mobile technology has enabled benefits worth billions of dollars to reach the deserving and also helped the poor and vulnerable during the pandemic.
“It is also with the help of mobile technology that we will embark on one of the world’s largest COVID-19 vaccination drive,” he said.
87-year-old Indian-origin man first to get COVID-19 vaccine in U.K.
An 87-year-old Indian-origin man from the north east of England will become one of the first people in the world to get a vaccine against COVID-19 when he receives his Pfizer/BioNTech jab at a hospital in Newcastle on Tuesday.
Hari Shukla from Tyne and Wear said he feels it is his duty to receive his first of the two-dose vaccine, a moment UK Prime Minister Boris Johnson hailed as a huge step forward as Tuesday was dubbed V-Day or Vaccine Day in the UK.
"I’m so pleased we are hopefully coming towards the end of this pandemic and I am delighted to be doing my bit by having the vaccine, I feel it is my duty to do so and do whatever I can to help, " said Mr. Shukla.
Having been in contact with the NHS (National Health Service), I know how hard they all work and the greatest respect for them — they have a heart of gold and I am grateful for everything they have done to keep us safe during the pandemic, he said.
Mr. Shukla was notified by the NHS based on the criteria set by the UK’s Joint Committee on Vaccination and Immunisation as part of a phased rollout plan based on those at the highest risk of death from the deadly virus. People aged 80 and over, care home workers as well as NHS workers who are at higher risk will be first in line to receive the “life-saving jab“.
Today marks a huge step forward in the UK’s fight against coronavirus, as we begin delivering the vaccine to the first patients across the whole country. I am immensely proud of the scientists who developed the vaccine, members of the public who took part in trials, and the NHS who have worked tirelessly to prepare for rollout, said Mr. Johnson.
COVID-19 tests in city using Feluda paper strip test
The Delhi government has decided to conduct a part of the total COVID-19 tests in the city using Feluda paper strip test. It is expected to start within a week to 10 days, according to officials. The test gives faster results than RT-PCR test.
The government has also gone ahead with the training of personnel for COVID-19 vaccination drive to be conducted, once it is available.
CDSCO expert panel to review COVID vaccine applications on December 9
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates, official sources said on Monday night.
The decision was taken late on Monday evening after the Hyderabad-based Bharat Biotech became the third pharmaceutical firm to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine Covaxin.
Lack of seroprevalence data may prove costly for Kerala
As Kerala is preparing to roll out the COVID-19 vaccine, lack of seroprevalence data, either amongst the population or the subgroup of health-care workers in the State, is likely to indirectly affect the optimal use of the vaccine, which is being conserved for specific at-risk populations.
Despite recommendations from various public health experts and the State-appointed expert committee on COVID-19, the government appears disinclined to conduct a seroprevalence study across the State or among the health-care workers.
HC directs govt. to follow CPCB norms for waste disposal
The Delhi High Court on Monday said it expects the city government to scrupulously follow the guidelines issued by the Central Pollution Control Board (CPCB) for handling and disposal of waste generated during diagnosis and treatment of COVID-19 patients.
A Bench of Chief Justice D.N. Patel and Justice Prateek Jalan’s observation came after the Delhi government said protocols are in place for handling and disposal of COVID-19 test kits and swabs and action would be taken against those not following the same.
Third phase of Covaxin trial begins at SRM hospital
After completion of two phases of human trials, the third phase trial of Covaxin – one of the COVID-19 vaccine candidates – was launched at SRM Medical College Hospital and Research Centre at Kattankulathur on the outskirts of Chennai on Monday, December 7, 2020.
P. Sathyanarayanan, pro-Chancellor (Academics), said over 1,000 persons would be part of the final phase of trials. “Until now, we have received 500 volunteers. We will be taking in more volunteers till the month-end,” he said, according to a press release.
(With inputs from our Correspondents, agencies)
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