The vaccine is the third to be approved by Health Canada following the December approval of vaccines developed by Pfizer Inc with BioNTech SE and Moderna Inc.

“With Pfizer, Moderna, and now AstraZeneca, Canada will get more than 6.5 million doses before the end of March,” Prime Minister Justin Trudeau told reporters. “And there will be tens of millions more doses to come between April and June.”

Canada has ordered 20 million doses of the vaccine from AstraZeneca, and is due to receive 1.9 million through COVAX – the international initiative set up to provide equitable access to vaccines – in the first half of the year.

On Friday, Canada said it had secured an additional 2 million doses through its agreement with Verity Pharmaceuticals Canada Inc and the Serum Institute of India.

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As the vaccines reached Brazil early on Saturday, External Affairs Minister Jaishankar said, “Made in India vaccines arrive in Brazil.”

Brazil President Jair Bolsonaro thanked PM Narendra Modi for the vaccines and said, “Namaskar, Prime Minister Narendra Modi. Brazil feels honoured to have a great partner to overcome a global obstacle by joining efforts. Thank you for assisting us with the vaccine exports from India to Brazil. Dhanyavaad.”

To this, PM Modi replied, “The honour is ours, President Jair M. Bolsonaro to be a trusted partner of Brazil in fighting the Covid-19 pandemic together. We will continue to strengthen our cooperation on healthcare.”

Bolsonaro referred to the Covid-19 vaccine from India as ‘sanjeevni booti’ from Ramayana.

The Indian ambassador to Brazil said, “Today is a historic day in India-Brazil relations. Brazil is the first country to get such a consignment. PM Modi said we’ll make vaccine available to all countries and we’ll continue to work towards that and I wish you good luck in your efforts.”

Two flights, each carrying 2 million doses of Covishield vaccine, departed from the Mumbai airport for Brazil and Morocco in the early hours of Friday.

India is one of the world’s biggest drugmakers, and an increasing number of countries have already approached it for procuring coronavirus vaccines.

Since Wednesday, India has begun sending Covid-19 vaccines under grant assistance to Bhutan, the Maldives, Bangladesh, Nepal, Myanmar and Seychelles.

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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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The total coronavirus cases climbed to 96,77,203 with 32,109 new infections being reported in a day, while the death toll crossed to 1.4 lakh with 391 new fatalities.

At 3,96,729, the Covid-19 active caseload in India is now below the 4-lakh mark.

As per Union Health Ministry data on Monday, total discharged cases in India stands at 91,39,901 with 39,109 new discharges in the last 24 hours.

India’s Covid-19 tally had crossed the 20-lakh mark on August 7, 30 lakh on August 23 and 40 lakh on September 5.

It went past 50 lakh on September 16, 60 lakh on September 28, 70 lakh on October 11, crossed 80 lakh on October 29, and surpassed 90 lakh on November 20.

According to the Indian Council of Medical Research (ICMR), a cumulative total of 14,77,87,656 samples have been tested for COVID-19 up to December 6 with 8,01,081 samples being tested on Sunday.

The Union health ministry had said earlier that the country does not need to vaccinate all of its 1.3 billion people if it manages to break the transmission of coronavirus disease.

Meanwhile, the Serum Institute of India have become the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford Covid-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large.

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Now, the total cases in the country stands at 93,92,920.

With 496 deaths in a day, the toll has mounted to 1,36,696. The country has 4,53,956 active cases of coronavirus, the Union health ministry said on Sunday.

In the past 24 hours, 42,298 patients were discharged across the country, taking the total recovered patients to 88,02,267.

The total number of samples tested up to Saturday stood at 13,95,03,803, including 12,83,449 samples tested yesterday itself, the Indian Council of Medical Research (ICMR) said on Sunday.

The ICMR has also approved a “simple and fast method for Covid-19 testing, the Council for Scientific and Industrial Research (CSIR) said on Saturday. This method can not only increase the number of RT-PCR tests, but can also bring down costs, the CSIR said.

Serum Institute of India (SII) CEO Adar Poonawalla said that the Pune-based pharma company is in the process of applying for emergency use authorisation of ‘Covishield’ in the next two weeks.

‘Covishield’ is the experimental coronavirus vaccine developed by the University of Oxford and AstraZeneca in affiliation with the SII.

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A Food and Drug Administration advisory committee is set to meet on December 10 to discuss Pfizer Inc.’s request for an emergency use authorisation for its developing Covid-19 vaccine.

US drug maker Pfizer Inc, has claimed that they developed a 95% effective vaccine against coronavirus. They are now seeking the emergency use tag from US government for its dosage. Pfizer has said the emergency use tag could start the process early and the coronavirus vaccine doses could be available as early as next month.

Dr. Moncef Slaoui, head of Operation Warp Speed, the coronvirus vaccine program said that their plan is able to ship vaccines to the immunisation sites within 24 hours from the approval.

Meanwhile leaders of the 20 biggest economies vowed to spare no effort to supply Covid-19drugs, tests and vaccines affordably and fairly to ‘all people”, reflecting worries that the pandemic could deepen divisions between the world’s rich and poor.

Meanwhile Niti Ayog member and National Expert Group on Vaccine Administration for COVID-19, Vinod Paul said that Pune-based Serum Institute (SII) may be granted emergency use authorisation of the Oxford AstraZeneca coronavirus vaccine if AstraZeneca get approval from the UK government. He also said that if the clinical trials of the coronavirus vaccine in India go as per the script, phase III trials should be over by January-February 2021.

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Earlier ICMR and SII have further collaborated for the clinical development of development of COVOVAX, developed by American company Novavax and upscaled by SII.

SII said it has enrolled 1,600 participants in India for late-stage trials of AstraZeneca’s candidate, and also plans to seek regulatory approval to run late-stage trials for Novavax vaccine.

Covishield is the AstraZeneca-Oxford University COVID-19 vaccine candidate and is the most advanced in human testing in India. SII and ICMR is planning to pursue early availability of the shot in India.

The ICMR had funded the clinical trial site fees for Covishield. SII and ICMR are currently conducting mid-stage clinical trials of the shot at 15 centres across India.

The two frontrunner coronavirus vaccines developed by Pfizer Inc and Russia have shown positive results and are said to be effective by over 90% against COVID-19. Now Moderna is also getting closer to releasing the data on its late-stage trials of the corona vaccine candidate.

Meanwhile, in India, experts have said that Pfizer news may not be of much use in India as the Pfizer coronavirus vaccine needs storage at extreme cold temperature (-70 degree Celsius) and arranging such cold chains would be a huge logistical issue.

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The total coronavirus cases mounted to 83,64,086 and the deaths have climbed to 1,24,315 with the virus claiming 704 lives in the last 24 hours in the country.

The COVID-19 case fatality rate was recorded at 1.49 percent. So far, there are 5,27,962 active cases of COVID-19 which comprises 6.31 percent of the total caseload.

According to the ICMR, a cumulative total of 11,42,08,384 samples have been tested up to November 4, with 12,09,425 samples being tested on November 5.

Adar Poonawalla, chief executive officer (CEO) of Pune-based pharmaceutical company Serum Institute of India (SII) said that the covid vaccine is likely to be available in the country by January 2021 provided approvals from regulatory bodies are in place and only if its proven immunogenic and efficacious.

The SII is working in collaboration with British- Sweden pharma major AstraZeneca to produce the potential covid-19 vaccine Covishield.

The CEO of the world’s largest drug manufacturing firm also said that the firm is in talks with the government over the pricing of the vaccine and assured that it will be available at a reasonable price.

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The phase-III human clinical trial began at the Sassoon General Hospital in Pune on September 17. King Edward Memorial (KEM) Hospital in Mumbai on September 23 began the phase II and III trials of the coronavirus vaccine.

Some participants in the trials for the coronavirus vaccine have also received their second doses and have not reported any adverse side-effects.

However, some did develop a fever after the dose of the coronavirus vaccine, but top scientists said that those are mild reactions and should not be worried about.

Some investigators also said that developing a fever is considered a common and mild side-effect of vaccines.

In September, Aztra Zeneca Plc said it has paused a late-stage trial of one of the leading coronavirus vaccine candidates after an unexplained illness in a study participant. After reviews the safety of the vaccine and its procedures, the human trials were resumed.

The Pune-based Serum Institute of India (SII) has partnered with British-Swedish pharma company AstraZeneca for manufacturing the coronavirus vaccine candidate, being developed by the University of Oxford, UK.

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The announcement came as part of the collaboration between eh SII, Gavi, Vaccine Alliance and the Bill & Melinda Gates Foundation. This brings the total now to be delivered by the partnership to up to 20 crore doses of Covid-19 vaccines.

It will accelerate the manufacturing and delivery of up to an additional 10 crore doses of future safe and effective Covid-19 vaccines, priced at a maximum of US$ 3 or Rs.250 per dose for low- and middle-income countries in 2021

The SII is the leading vaccine manufacturer in the world and has partnered with the pharmaceutical company AstraZeneca for producing the Covid-19 vaccine being developed by the scientists of the Oxford University.

The announcement by the SII came days after British Prime Minister Boris Johnson said that the AstraZeneca reached an agreement with the SII to supply 1 billion doses of Oxford University’s Covid-19 vaccine to low and middle-income countries. Johnson announced this during his speech at the 75th high-level debate of the United National General Assembly (UNGA) on Saturday.

The Oxford vaccine, being produced under brand name of Covishield is now in Phase-III of clinical trials in a multi-national vaccine development programme. The SII is conducting the trials in India.

Serum Institute of India is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe.

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Now the country’s total coronavirus case stands at 51,18,253.

COVID-19 Testing Update. For more details visit: https://t.co/dI1pqwfbRz @MoHFW_INDIA @DeptHealthRes #ICMRFIGHTSCOVID19 #IndiaFightsCOVID19 #CoronaUpdatesInIndia #COVID19 pic.twitter.com/joQaGm2E7R

— ICMR (@ICMRDELHI) September 17, 2020

According to Union health ministry update on Thursday morning, the number of active cases crossed the million mark and currently stand at 10,09,976 whereas 40,25,079 patients have been discharged from hospitals.

The recovery rate has further improved to 78.53 per cent, the health ministry said.
It further said that nearly 59 per cent of the new recoveries came from five states – 23.41 per cent from Maharashtra (19,423 recoveries); and a cumulative 35.5 per cent from Andhra Pradesh (9,628 recoveries), Karnataka (7,406), Uttar Pradesh (6,680) and Tamil Nadu (5,735).

Twenty-seven states and union territories are reporting recovery rates of more than 70 per cent, the ministry highlighted.

Meanwhile, Pune-based Serum Institute of India (SII) on Wednesday received the approval from the Drugs Controller General of India (DCGI) to resume clinical trials for the Covid-19 vaccine candidate developed by United Kingdom’s Oxford University and AstraZeneca.

The trials in India were paused last week after a trial subject in the United Kingdom developed an unexplained severe adverse reaction.

On September 16, the Supreme Court said that the central government has approved the use of Remdesivir and Fabiparivir as medicines to treat the coronavirus disease.

The top court was hearing a plea by the CBI against ten Indian pharmaceutical firms for manufacturing and selling these two medicines to treat the coronavirus disease.

Globally, nearly 30 million people have been infected with as many as 939,427 fatalities. The United States continued to the worst affected followed by India and Brazil. India, however, remained on top of the recoveries chart.

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“We are reviewing the situation and pausing India trials,” Serum said in a brief statement.

The Drug Controller of India had demanded that the Serum Institute of India, which is conducting Phase-3 trials on people in India involving UK-based AstraZeneca’s COVID-19 vaccine candidate, explain why tests have not been paused in India too until safety has been established.

AstraZeneca on Tuesday put global trials on hold after reports emerged of “severe adverse reaction” in a volunteer being injected with the vaccine, probably in the United Kingdom. The nature of the event was not known.

This pause would prevail, pending a review by a data safety monitoring board, AstraZeneca said in a statement in response to medical news website, Stat News.

Pune-based SII, which is testing a COVID-19 vaccine, said on September 9 that so far there had been “no issues” with its trials.

“It has been widely reported in the national and international media that sponsor of the aforesaid vaccine, M/s AstraZeneca has paused the ongoing trial as a volunteer developed an unexplained illness….Serum has not informed the Central Licensing Authority regarding pausing the clinical trial and also not submitted causality analysis of the reported severe adverse event,” said a letter signed by Dr.V.G. Somani, Drug Controller General (India), “I [Somani] give you an opportunity to showcause why permission granted to you should not be suspended till patient safety established.”

Last month, SII began Phase-2/Phase-3 trials to compare the safety and immunogenicity of its vaccine candidate COVISHIELD (SII-ChAdOx1), with the Oxford vaccine (Oxford/AZ-ChAdOx1).

Both vaccines are similar in structure and the early-human-trial data of Oxford/AZ-ChAdOx1 from studies in the United Kingdom was used to approve Phase-2 and Phase-3 trials in India, Renu Swarup, Secretary, Department of Biotechnology told The Hindu.

According to information on India’s clinical trial registry, where all human trials of vaccine and drugs must be registered, 1,600 adults would be enrolled in the study. Of these, 400 participants will be part of an immunogenicity cohort and will be randomly assigned either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively. The remaining 1,200 participants from the safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or a placebo, respectively. Immunogenicity is to test if a vaccine can coax the immune system to launch a protective response that can shield against future infection.

Regarding the show-cause notice issued by the DCGI, SII, told The Hindu, “We are going by the DCGI’s direction and, so far, were not told to pause the trials. If the DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”

SII last month announced a partnership with Gavi, the Vaccine Alliance, and the Bill & Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of the vaccine to India and other Low and Medium Income countries.

“Adverse events in the process of vaccine development are not an unexpected outcome. There doesn’t seem to be complete information on what exactly is the adverse event. Probably, the regulator might take a call, if need be, on whether this requires to be paused in India. So far, the DBT does not have any additional information,” Dr. Swarup said.

AstraZeneca is testing the candidate vaccine in the United Kingdom, Brazil and South Africa. It announced plans on August 31 to begin recruiting 30,000 volunteers across the United States.

The vaccine candidate has been developed on a chimpanzee adenovirus vector platform, which is still experimental in that it has not been used in a commercial human vaccine for any disease.

Other potential vaccines being tested in India are ones by Bharath Biotech, which is based on an inactivated virus from the Indian Council of Medical Research’s National Institute of Virology, and one by Zydus Cadilla, which is testing a DNA-based vaccine. Both are in smaller human trials testing for safety and immunogenicity.

In July, AstraZeneca had reported results of early Phase-1/2 trials in the peer-reviewed journal The Lancet of acceptable safety and immunogenicity basis, with which it was proceeding to larger Phase-3 trials. It reported that 60 per cent of volunteers reported some kind of reaction such as a fever, headache and muscle pain, which were deemed to be minor reactions that are routine in vaccine inoculations.

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Government officials said that the approval for conducting Phase II and Phase III clinical trials by the SII was granted by DCGI Dr V.G. Somani late on Sunday after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19
“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials,” a senior official said

“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, ‘Covishield’, on healthy adults in India,? the officials said.??

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July?28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi,?B J Medical College in Pune, Rajendra Memorial?Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh,?AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore

“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official said

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July?25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.?

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said

To introduce the vaccine, SII, the world’s largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.
Vaccine by end November, says Serum Institute director

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That the first stage trials of vaccines being developed in the United States and the United Kingdom have been successful is a good indication that a vaccine for the infection would soon be available. 

There are reports that the first stage trails of the vaccine being developed by AstraZeneca PLC in association with Oxford University have been successful. Last week, US-based biotech company Moderna Inc had released the results of the first level experiments. Experiments are under way in many countries, including India. 

The results of the experiments of the vaccine developed by Oxford University published in The Lancet medical journal reveal that the vaccine doesn’t have any dangerous side effects. It has been found that antibodies and T-cells have developed in the people who have undergone treatment with the vaccine. It shows that the vaccine has been successful. Last stage experiments are under way in Brazil and South Africa and second stage experiments will start in the US soon.

In the US, vaccine production has started along with the testing of the vaccine. This is to make the vaccine available to the public at the earliest if the experiments are successful. Steps for production have been adopted not even considering the initial monetary losses.

Research and experiments are under way in India too to develop a vaccine. The Serum Institute of India has sought permission for the procedures. The institute has said that production of the vaccine will start without much delay. The institute has entered into contract with the many companies that are conducting experiments in the world including the British Company AstraZeneca. Serum institute has entered into a deal for production of the vaccine in India if the experiments being conducted by these companies are successful. This would help avoid any delay. 

The authorities have later withdrawn the statement that the vaccine being developed by Bharat Biotech in association with National Institute of Virology would be ready by August 15. Experts had pointed out that taking into account the time needed for experiments this would be practically impossible to meet. 

Many states in India are facing the threat of community spread even if they haven’t officially declared it. It was quite shocking to learn that 23.48% of the population in Delhi has been affected by the infection. The news of the success of the first level of experiments comes as a relief at this stage.

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