Out of the total cases, active cases further dropped to 2.08 lakh while recoveries went up to 1,02 crore. With 145 deaths reported on January 17, the toll stands at over 1.52 lakh. Kerala recorded 5,005 new cases, more than 36 percent of all. Maharashtra reported 3,081 cases.

Now the total caseload in the country has mounted to 1,05,71,773. The active cases tally in India stands at 2,08,012 and total recovered/discharged cases at 1,02,11,342.

On January 17, active cases declined below 2 percent of the total cases reported in the country for the first time. Daily new COVID-19 cases have stayed below the 20,000 mark from the last 10 days.

Over 2.24 lakh priority group individuals have been vaccinated at the end of two days of India’s mega inoculation drive. Out of the beneficiaries, only 447 adverse events cases have been reported, 3 of them required hospitalization, with 2 being discharged already, the Union Ministry said.

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Addressing the nation, PM Narendra Modi said, “India’s vaccines enjoy much credibility across the world . We’ve earned this via our track record. Most children in the world get their vaccine shots of those made in India. The world’s trust is on our Made in India vaccines will rise soon. These Indian vaccines are cheaper than foreign shots and easy to use. Some foreign doses are close to 5000/dose and to be stored in -70 degrees.”

PM lauded doctors and scientists who worked tirelessly to create the vaccine. He also stressed the importance of taking two doses of covid vaccine.

On the inaugural day, around 3,006 session sites across the country will be virtually connected. Around 100 beneficiaries would be vaccinated at each session.

India has two vaccine candidates so far — Covishield by Serum Institute of India and Covaxin by Bharat Biotech. The Drugs Controller General of India (DCGI) approved the vaccines for emergency use on January 2.

All states and UTs will have multiple session sites or centres at the district level. There will be a registration and waiting room, a vaccination zone and an observation room.

Once the beneficiary reaches the site at the designated time and date, they will produce identification documents. When they are verified, they will be sent to the vaccination room where they will receive the shot. After the shot, the beneficiary will have to wait in the observation room and will be under observation for 30 minutes. There are emergency kits and ambulances on site.

In the first phase, 30 crore health workers, frontline workers and senior citizens will be vaccinated. All the beneficiaries will be registered on the CoWIN app. Only beneficiaries who have registered on the app will be allowed to visit the centre

COWIN APP

The vaccination process will use the online digital platform developed by the Union Ministry of Health and Family Welfare that will help the authorities keep track in real-time of vaccination stocks, storage temperature and track the beneficiaries.

COVID-19 VACCINE HELPLINE

A 24X7 call centre has been established to answer queries about the coronavirus pandemic, vaccine rollout and the CoWIN software.

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Prime Minister Narendra Modi will launch the pan-India inoculation of Covid-19 vaccine on Saturday at 10.30 am through video conferencing.

The coronavirus vaccination drive, one of the world’s largest vaccination programme, begins weeks after the DCGI approved Oxford coronvirus vaccine ‘Covishield’ manufactured by Pune-based Serum Institute, and indigenously developed ‘Covaxin’ of Bharat Biotech for restricted emergency use in the country.

In India, priority groups who are more exposed to the Covid-19 infection and are likely in the high-risk zone would be vaccinated first. Healthcare workers, both in the government and private sectors, including Integrated Child Development Services (ICDS) workers, will receive the vaccine during this phase. Adequate doses of both Covishield and Covaxin have already been delivered to all states/UTs with the active support of the Ministry of Civil Aviation.

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Dr V K Paul, a member(Health), NITI Aayog, said on Tuesday that Covishield of Serum Institute of India, and Covaxin are the two COVID-19 vaccines that have received Emergency Use Authorisation (EAU). He said that these vaccines are the safest vaccines and have been tested on thousands of people and side-effects are negligible.

The Union Health Ministry has said apart from Covishield and Covaxin, there are four more vaccines in the pipeline. Their manufacturers may soon apply for emergency use authorisation in India.

Union Health Secretary Rajesh Bhushan said Zydus Cadilla, Sputnik V, Biological E and Gennova are the COVID-19 vaccines that are in the pipeline and are currently in advanced clinical trials in Indian

About half a crore doses of Serum Institute of India (SII’s) Covishield vaccine were shipped out of Pune to cities across India on January 12, as the country launched its final phase of preparations for the mass inoculation drive against the novel coronavirus.

What one dose of Covid vaccines will cost in India?

Covishield: Rs 200 per dose (for first 100 million doses), Rs 1,000 per dose thereafter at private outlets
Covaxin: Rs 206 per dose
Pfizer-BioNTech: Rs 1,431 per dose
Moderna: Rs 2,348 to Rs 2,715 per dose
Sinopharm: less than Rs 5,650 per dose
Sinovac Biotech: Rs 1,027 per dose
Novavax: Rs 1,114 per dose
Gamaleya Centre: less than Rs 734 per dose
Johnson and Johnson: Rs 734 per dose

Meanwhile, India reported 15,968 new Covid-19 cases, 17,817 discharges and 202 deaths in last 24 hours, as per Union Health Ministry data. The total cases now stand at 1,04,95,147, active cases are 2,14,507 and overall recoveries is at 1,01,29,111. The total death toll is 1,51,529.

According to the Indian Council of Medical Research, a total of 18,34,89,114 samples tested for Covid-19 till 12th January, of which 8,36,227 samples were tested on January 12.

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This comes after drugmaker Pfizer on November 18 said that their coronavirus vaccine candidate has shown 95 percent efficacy in the late-stage trial. The efficacy of vaccine was consistent across age and ethinicity demographics and there were no major side effects.

The vaccine is developed with German partner BioNTech SE.

Moderna had also announced that its experimental Covid-19 vaccine ‘mRNA-1273’ was 94.5 percent effective in preventing coronavirus.

In India, the third phase trial of Indian vaccine candidate Covaxin is also set to start on November 20 in Haryana. The trials will take place at Post Graduate Institute of Medical Science, Rohtak in Haryana.

Covaxin is being developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Meanwhile, those worried whether the vaccines can protect against coronavirus mutation can relax. A new study involving a University of York virologist has said that vaccines currently being developed for Covid-19 should not be affected by recent mutation in the virus.

Most vaccines under development worldwide have been modelled on the ‘D-strain’ of the virus.
Since then, the virus has evolved to the globally dominant ‘G-strain’, which now accounts for about 85 per cent of published SARS-CoV-2 genomes.

There had been fears that the G-strain, within the main protein on the surface of the virus, would negatively impact vaccines under development. But the research by Australia’s national science agency – the Commonwealth Scientific and Industrial Research Organisation (CSIRO) – found no evidence that the change would adversely impact the efficacy of vaccine candidates.

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The pharma company’s immediate focus is to conduct the Phase 3 trials successfully across sites in the country.

The company’s vaccine candidate, Covaxin, has been developed in collaboration with the Indian Council of Medical Research-National Institute of Virology using inactivated Sars-Cov-2. The virus was isolated in an ICMR lab.

The price of the vaccine is yet to be determined, as the company is still looking at the cost of product development.

Bharat Biotech received approval from the Drugs Controller General of India to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate. The company has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November.

The trial is conducted in nealy 30 sites around 14 states. About 2,000 subjects are enrolled per hospital and will provide tow doses each of the vaccine and placebo recipients.

The pharma company is looking to supply for both government and private markets. It is also in its preliminary discussions with other countries for probable supply.

Nearly Rs 350-400 crore is invested for the development of vaccines and the new manufacturing facilities, which include investments for conducting the Phase 3 clinical trials, in the next three months.

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The Hyderabad-based firm is planning to test over 20,000 volunteers across 12-14 states.

Covaxin, developed in collaboration with the Indian Council of Medical Research’s National Institute of Virology, is an inactivated vaccine that is expected to work by injecting the “killed version” of the covid-19 virus into the body to develop an immune response.

Bharat Biotech plans to enroll 25,000 to 26,000 participants across the country, including Telengana, Tamil Nadu, Haryana, Maharashtra and Bihar.

As of now Bharath Biotech and Serum Institute of India(SII) got the nod to conduct phase-3 trials. SII is said to be in the process of recruiting and vaccinating participants for the third phase of testing its candidate, Covishield.

Other vaccine candidates in the fray are those of Zydus Cadila, which is close to completing phase-2 trials of ZyCov-D, and of Russia’s Gamaleya Research Institute, which will soon begin phase 2/3 trials of Sputnik V in collaboration with Dr Reddy’s.

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Covaxin, the indigenously developed Covid-19 vaccine, developed by the ICMR and Bharat Biotech International, is being tested at 12 institutes across India.

The Hyderabad-based firm said the data from the study on primates substantiate the immunogenicity of the vaccine candidate.

“Bharat Biotech proudly announces the animal study results of COVAXIN – These results demonstrate the protective efficacy in a live viral challenge model,” Bharat Biotech tweeted September 11.

Bharat Biotech proudly announces the animal study results of COVAXIN™ – These results demonstrate the protective efficacy in a live viral challenge model.

Read more about the results here – https://t.co/f81JUSfWpD@icmr_niv #BharatBiotech #COVAXIN #Safety #Vaccine #SARSCoV2 pic.twitter.com/fva1SOcLOr

— Bharat Biotech (@BharatBiotech) September 11, 2020

Bharat Biotech has said in a release that it developed and assessed the protective efficacy and immunogenicity of an inactivated Sar-CoV-2 vaccine (BBV152) or Covaxin in rhesus macaques. Twenty macaques were divided into four groups of five animals each, it said.

One group was administered with placebo, while three groups were immunized with 3 different vaccine candidates at 0 and 14 days. All the macaques were exposed to viral challenge 14 days after the 2nd dose.

BBIL’s #Covaxin(BBV152) found protective in Macaques: A two-dose vaccination regimen using 3µg dose of the vaccine with adjuvant B induce a significant immune response and provide effective protection in macaques challenged with #SARSCoV2 https://t.co/FgSnD2eCmA pic.twitter.com/hQHh2klAnX

— Vipin M. Vashishtha (@vipintukur) September 11, 2020

The results showed protective efficacy, increasing coronavirus specific IgG and neutralizing antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey.

No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group.

Remarkable immunogenicity and protective efficacy of BBV152, an inactivated SARS-CoV-2 vaccine in rhesus macaques https://t.co/b82dA6QlcW ICMR-NIV made very good effort to demonstrate potential immunogenicity in non-human✌️ Primate with BBV152. ! @ICMRDELHI @drharshvardhan

— Dinesh kumar (@Dineshk38263974) September 11, 2020

Adverse events were not seen in animals immunized with a two-dose vaccination regimen.

The vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live coronavirus.

Covaxin is one of the frontrunners in the race for a covid-19 vaccine in India. It is an “inactivated” vaccine – it works by injecting doses of the virus that have been killed aiming to prompt the body to build antibodies against it without the virus a posing a threat.

Each stage of a vaccine’s clinical trial tests its safety and ability to develop an effective immune response. Phase 1 focuses on determining safety and dosage in a small group of healthy participants, while Phase 2 looks at the vaccine’s effectiveness. Phase 3 looks into these aspects in a much larger population that would represent a wider demographic.

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More than 170 countries are in talks to participate in the COVID-19 Vaccines Global Access (Covax) Facility, which aims to speed vaccine development and secure doses for all countries and distribute them to the most high-risk segment of each population.

The plan, which is co-led by the WHO, the Coalition for Epidemic Preparedness Innovations and Gavi, the vaccine alliance, was of interest to some members of the Trump administration and is backed by traditional US allies, including Japan, Germany and the European Commission, the executive arm of the European Union.

But the United States will not participate, in part because the White House does not want to work with the WHO, which President Donald Trump has criticised over what he characterised as its “China-centric” response to the pandemic.

“The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organisations influenced by the corrupt World Health Organisation and China,” said Judd Deere, a spokesman for the White House.

The Covax decision, which has not been previously reported, is effectively a doubling down by the administration on its bet that the United States will win the vaccine race. It eliminates the chance to secure doses from a pool of promising vaccine candidates – a potentially risky strategy.

“America is taking a huge gamble by taking a go-it-alone strategy,” said Lawrence Gostin, a professor of global health law at Georgetown University.

Kendall Hoyt, an assistant professor at Dartmouth’s Geisel School of Medicine, said it was akin to opting out of an insurance policy.

The United States could be pursuing bilateral deals with drug companies and simultaneously participating in Covax, she said, increasing its odds of getting some doses of the first safe vaccine. “Just from a simple risk management perspective, this [Covax decision] is shortsighted,” she said.

The US move will also shape what happens elsewhere. The idea behind Covax is to discourage hoarding and focus on vaccinating high-risk people in every country first, a strategy that could lead to better health outcomes and lower costs, experts said.

US nonparticipation makes that harder. “When the US says it is not going to participate in any sort of multilateral effort to secure vaccines, it’s a real blow,” said Suerie Moon, co-director of the Global Health Center at the Graduate Institute of International and Development Studies in Geneva.

“The behaviour of countries when it comes to vaccines in this pandemic will have political repercussions beyond public health,” she said. “It’s about, are you a reliable partner, or, at the end of the day, are you going to keep all your toys for yourself?”

Some members of the Trump administration were interested in a more cooperative approach but were ultimately overruled.

Health and Human Services Secretary Alex Azar and Deputy Secretary of State Stephen Biegun had interest in exploring some type of role in Covax, a senior administration official said, speaking on the condition of anonymity because they were not authorized to discuss the decision-making.

But there was resistance in some corners of the government and a belief that the United States has enough coronavirus vaccine candidates in advanced clinical trials that it can go it alone, according to the official and a former senior administration official who learned about it in private discussions.

The question of who wins the race for a safe vaccine will largely influence how the administration’s ‘America first’ approach to the issue plays out.

An unlikely worst-case scenario, experts said, is that none of the U.S. vaccine candidates are viable, leaving the United States with no option since it has shunned the Covax effort.

Another possibility is that a US vaccine does pan out, but the country hoards doses, vaccinating a large number of Americans, including those at low risk, while leaving other countries without.

Experts in health security see at least two problems with this strategy: The first is that a new vaccine is unlikely to offer complete protection to all people, meaning that a portion of the US population will still be vulnerable to imported cases – especially as tourism and trade resume.

The second, related problem is that a US recovery depends on economic recovery elsewhere. If large parts of the world are still in lockdown, the global economy is smarting and supply chains are disrupted, the United States will not be able to bounce back.

Proponents of a multilateral approach to global public health would like to see all countries coordinate through Covax. Perhaps unsurprisingly, interest is strongest from poor countries, while some larger economies are cutting deals directly with drugmakers.

WHO officials have argued that countries need not choose — they can pursue both strategies by signing bilateral deals and also joining Covax.

“By joining the facility at the same time that you do bilateral deals, you’re actually betting on a larger number of vaccine candidates,” Mariângela Simao, a WHO assistant director for drug and vaccine access, said at an August 17 briefing.

If nothing else, the United States could pledge surplus vaccine doses to Covax to ensure they are distributed in a rational and equitable way, experts said.

Some cautioned against a focus on ‘winning’ the race. Given the complexity of supply chains, vaccine development will necessarily be a global effort, regardless of whether countries want to cooperate.

The decision to steer clear of Covax comes at a time of tremendous change for health diplomacy.

The United States has long been the biggest donor to the WHO and a major funder of vaccine initiatives.

In the early days of the coronavirus pandemic, Trump praised both China and the WHO for their handling of the outbreak. But as the crisis intensified in the United States, he turned on the UN health agency.

In April, he announced a freeze on new US funding. Not long after, the State Department started stripping references to the WHO from fact sheets and rerouting funds to other programs.

By July, the administration had sent a letter signalling its intent to withdraw from the WHO.

But untangling the United States from the agency it helped found and shape is not simple — and the terms of the separation are still being assessed.

It is not yet clear, for instance, whether a US withdrawal means the United States will just stop its contributions to the WHO or whether it will stop funding any initiative linked to the agency in any way.

For instance, the White House no longer wants to work with the WHO, but the United States is a major supporter of Gavi, which co-leads the Covax project.

Asked to comment on the Covax decision, a State Department spokeswoman pointed to US funding for Gavi, as well as money for such programs as UNICEF and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies, said the White House could still reverse course and join Covax, or at least let the Senate fund through Gavi – a political workaround.

“This just shows how awkward, contradictory and self-defeating all of this,” he said. “For the U.S. to terminate its relationship with the WHO in the middle of a pandemic is going to create an endless stream of self-defeating moments.”

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India’s first COVID-19 vaccine COVAXIN has got the Drug Controller General of India’s approval for phase I and II of human clinical trials. The two trials are designed to test whether the vaccine is safe, rather than whether it is effective.

The experimental vaccine has been developed by Hyderabad-based Bharat Biotech, in collaboration with the ICMR (Indian Council for Medical Research) and the National Institute of Virology (NIV). This could get underway across the country in July 2020. Results are expected to be out by October 2020, following which larger clinical trials will be conducted.

The trials are among many across the world. There are around 120 vaccine programmes under way worldwide. This is the first India-made vaccine and developed from a strain of the virus that was isolated locally and weakened under laboratory conditions.

Bharat Biotech, which has delivered more than 4 billion doses of vaccines worldwide, has developed vaccines for H1N1 and rotavirus, among other diseases.

The permission to initiate clinical trials came after the company submitted results that they had generated through pre-clinical studies, demonstrating safety and effective immune responses.

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