NEW DELHI: India is preparing to launch the Covid-19 vaccine across the country and a two-day trial is currently underway in Andhra Pradesh, Assam, Gujarat, and Punjab. Oxford-AstraZeneca’s front-runner is already under regulatory review and sources have indicated that approval for emergency use may arrive in the next few days.
This is where India and the rest of the world meet in the global race to fight and end the pandemic:
Dry run in 4 states
India plans to inoculate around Rs 30 million “priority” population in the first phase of the vaccination campaign which is expected to roll out in the first week of January and end no later than July.
This will include healthcare and front-line workers and those most at risk for infection, such as people over 50 and others under 50, but with severe comorbidities that can lower immunity and increase the chances of death. due to Covid-19 infection.
The government has already trained the participants who will administer the vaccine.
To assess the readiness of the mechanism established for the Covid-19 inoculation campaign, the Center has planned a trial test on December 28 and 29 in the four states.
The exercise will include the necessary data entry into Co-WIN, an online platform for tracking vaccine delivery, receiving and assigning tests, deployment of team members, a mock session sites with the Beneficiaries of the test, as well as a briefing and an evening meeting, the Union The health ministry had said last week.
It will also include cold storage testing and transportation arrangements for the COVID-19 vaccine, crowd management at session sites with adequate physical distance, he added.
Regulatory approval ‘in days’
India, meanwhile, is likely to see the Oxford-AstraZeneca vaccine approved for emergency use in the coming days, as updated data presented by the Serum Institute of India (SII) appears “satisfactory,” top government sources said.
Serum CEO Adar Poonawalla said Monday that the company has in stock between 40 and 50 million doses of Covishield, the local name for the Oxford vaccine. He added that he expects regulatory approval “in days.”
Meanwhile, the government has indicated that once the evaluation of the data is completed, the Indian regulator may not wait for the vaccine to gain approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company has presented the same data from clinical trials in the UK and Brazil here and ongoing reviews are underway. The updated information shared by the Serum Institute also appears satisfactory. We are hopeful that, based on the regulatory evaluation, the vaccine will be approved in one or two days, “a senior official told TOI.
However, it is quite possible that the UK will also grant emergency use authorization, as MHRA is already reviewing data from the vaccine developed by the University of Oxford and major pharmaceutical company AstraZeneca.
A PTI report said the drugmaker’s CEO, Pascal Soriot, reported that the Covishield vaccine has achieved a “winning formula” of efficacy. Soriot’s comments were published in an interview with the Sunday Times newspaper. He added that he believes the trials will show that his company has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5%.
“We believe we have discovered the winning formula and how to get an efficacy that, after two doses, is on par with all the others,” said the CEO, adding only that the data will be released “at some point.” He also said the vaccine “should be” effective against the highly transmissible new variant of the coronavirus.
The global vaccine race
As India is about to administer the first injections to its population, the European Union has launched a mass vaccination campaign after giving the green light to the Pfizer vaccine.
Who is further advanced in the vaccine?
American pharmaceutical company Pfizer and German partner BioNTech have pioneered the Covid-19 vaccine so far.
On November 18, they became the first in the world to publish full test data in the last stage. Britain was the first to approve the injection for emergency use on December 3, followed by Canada on December 9 and the United States Food and Drug Administration (FDA) on December 11. Several other countries, including Saudi Arabia and Mexico, also approved it.
The European Medicines Agency (EMA) approved the injection on December 21 and India is speeding up its review.
The World Health Organization could decide whether to grant its emergency use approval to the Pfizer candidate before the end of the year as part of its Covax program aimed at providing vaccines for poor and middle-income countries.
Who will approve Moderna next?
Moderna became a close second to Pfizer in many countries after it released a full data analysis for a late-stage trial on November 30 that showed a 94.1% efficacy rate for its vaccine. Canada approved the launch on December 23 and the EMA will do so on January 6.
Who else is in the running?
Britain’s AstraZeneca is seeking approval for its vaccine in Britain after announcing interim data from the last stage of the trial on 23 November. It had an average efficacy rate of 70% and up to 90% for a subset of trial participants who received half the dose first. followed by a full dose.
However, it is not clear how the regulator will treat the different doses in the efficacy data in its evaluation. AstraZeneca is also in discussions with the EMA, which is conducting an ongoing review of the vaccine.
US drugmaker Johnson & Johnson plans to deliver test data in January 2021, preparing it for US clearance in February if its injection is effective. He lowered the enrollment target for his clinical trial to 40,000 volunteers from 60,000 on Dec. 9, potentially accelerating results that are linked to how quickly participants become infected.
US firm Novavax is conducting a last-stage test in Britain with data expected for the first quarter of 2021. It expects to start a full-scale test in the United States this month.
However, France’s Sanofi and Britain’s GlaxoSmithKline announced a setback on December 11 in their attempts to develop a vaccine. Drug makers said it showed insufficient immune responses in older people in middle-stage trials and that they would start a new study in February.
What happens at trials?
Companies generally test their vaccines against a placebo, usually saline, in healthy volunteers to see if the rate of Covid-19 infection among those who received the vaccine is significantly lower than among those who received the sham injection.
How do volunteers get infected?
The trials are based on subjects being naturally infected with Covid-19, so the time it takes to generate results is highly dependent on how widespread the virus is where the trials are conducted. Each pharmacist has targeted a specific number of infections to trigger a first analysis of their data.
How well are vaccines supposed to work?
The World Health Organization ideally wants to see at least 70% effectiveness. The FDA wants at least 50%, which means there must be at least twice as many infections among volunteers who received a placebo than among those in the vaccine group. The EMA has said it can accept a lower level of effectiveness.
And Russia and China?
While the Pfizer injection was the first to be implemented following the publication of the full data from the phase III trial, Russia and China have been vaccinating their citizens for months with several different vaccines that are still in late-stage trials.
Russia said on Nov. 24 that its Sputnik V vaccine, developed by the Gamaleya Institute, was 91.4% effective according to interim results from the last stage of the trial. It began vaccinating in August and has so far inoculated more than 100,000 people.
India plans to make 300 million injections next year and Argentina has given the green light for emergency use of the vaccine, with some 300,000 doses due to arrive in the country on December 24.
China launched an emergency use program in July targeting essential workers and others at high risk of infection. It has vaccinated around a million people in mid-November using at least three injections, two developed by the state-backed China National Biotec Group (CNBG) and one by Sinovac Biotech.
Trial data on a Covid-19 vaccine developed by China’s Sinovac Biotech has varied: Interim data from a late-stage trial in Turkey showed that its CoronaVac injection is 91.25% effective, while researchers in Brazil say that the injection was more than 50% effective.
Meanwhile, the United Arab Emirates said on Dec. 9 that one of the CNBG vaccines was 86% effective based on interim results from a late-stage trial in the Arab Gulf state.
(With inputs from agencies)
This is where India and the rest of the world meet in the global race to fight and end the pandemic:
Dry run in 4 states
India plans to inoculate around Rs 30 million “priority” population in the first phase of the vaccination campaign which is expected to roll out in the first week of January and end no later than July.
This will include healthcare and front-line workers and those most at risk for infection, such as people over 50 and others under 50, but with severe comorbidities that can lower immunity and increase the chances of death. due to Covid-19 infection.
The government has already trained the participants who will administer the vaccine.
To assess the readiness of the mechanism established for the Covid-19 inoculation campaign, the Center has planned a trial test on December 28 and 29 in the four states.
The exercise will include the necessary data entry into Co-WIN, an online platform for tracking vaccine delivery, receiving and assigning tests, deployment of team members, a mock session sites with the Beneficiaries of the test, as well as a briefing and an evening meeting, the Union The health ministry had said last week.
It will also include cold storage testing and transportation arrangements for the COVID-19 vaccine, crowd management at session sites with adequate physical distance, he added.
Regulatory approval ‘in days’
India, meanwhile, is likely to see the Oxford-AstraZeneca vaccine approved for emergency use in the coming days, as updated data presented by the Serum Institute of India (SII) appears “satisfactory,” top government sources said.
Serum CEO Adar Poonawalla said Monday that the company has in stock between 40 and 50 million doses of Covishield, the local name for the Oxford vaccine. He added that he expects regulatory approval “in days.”
Meanwhile, the government has indicated that once the evaluation of the data is completed, the Indian regulator may not wait for the vaccine to gain approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
“We can make our regulatory decisions independently. The company has presented the same data from clinical trials in the UK and Brazil here and ongoing reviews are underway. The updated information shared by the Serum Institute also appears satisfactory. We are hopeful that, based on the regulatory evaluation, the vaccine will be approved in one or two days, “a senior official told TOI.
However, it is quite possible that the UK will also grant emergency use authorization, as MHRA is already reviewing data from the vaccine developed by the University of Oxford and major pharmaceutical company AstraZeneca.
A PTI report said the drugmaker’s CEO, Pascal Soriot, reported that the Covishield vaccine has achieved a “winning formula” of efficacy. Soriot’s comments were published in an interview with the Sunday Times newspaper. He added that he believes the trials will show that his company has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5%.
“We believe we have discovered the winning formula and how to get an efficacy that, after two doses, is on par with all the others,” said the CEO, adding only that the data will be released “at some point.” He also said the vaccine “should be” effective against the highly transmissible new variant of the coronavirus.
The global vaccine race
As India is about to administer the first injections to its population, the European Union has launched a mass vaccination campaign after giving the green light to the Pfizer vaccine.
Who is further advanced in the vaccine?
American pharmaceutical company Pfizer and German partner BioNTech have pioneered the Covid-19 vaccine so far.
On November 18, they became the first in the world to publish full test data in the last stage. Britain was the first to approve the injection for emergency use on December 3, followed by Canada on December 9 and the United States Food and Drug Administration (FDA) on December 11. Several other countries, including Saudi Arabia and Mexico, also approved it.
The European Medicines Agency (EMA) approved the injection on December 21 and India is speeding up its review.
The World Health Organization could decide whether to grant its emergency use approval to the Pfizer candidate before the end of the year as part of its Covax program aimed at providing vaccines for poor and middle-income countries.
Who will approve Moderna next?
Moderna became a close second to Pfizer in many countries after it released a full data analysis for a late-stage trial on November 30 that showed a 94.1% efficacy rate for its vaccine. Canada approved the launch on December 23 and the EMA will do so on January 6.
Who else is in the running?
Britain’s AstraZeneca is seeking approval for its vaccine in Britain after announcing interim data from the last stage of the trial on 23 November. It had an average efficacy rate of 70% and up to 90% for a subset of trial participants who received half the dose first. followed by a full dose.
However, it is not clear how the regulator will treat the different doses in the efficacy data in its evaluation. AstraZeneca is also in discussions with the EMA, which is conducting an ongoing review of the vaccine.
US drugmaker Johnson & Johnson plans to deliver test data in January 2021, preparing it for US clearance in February if its injection is effective. He lowered the enrollment target for his clinical trial to 40,000 volunteers from 60,000 on Dec. 9, potentially accelerating results that are linked to how quickly participants become infected.
US firm Novavax is conducting a last-stage test in Britain with data expected for the first quarter of 2021. It expects to start a full-scale test in the United States this month.
However, France’s Sanofi and Britain’s GlaxoSmithKline announced a setback on December 11 in their attempts to develop a vaccine. Drug makers said it showed insufficient immune responses in older people in middle-stage trials and that they would start a new study in February.
What happens at trials?
Companies generally test their vaccines against a placebo, usually saline, in healthy volunteers to see if the rate of Covid-19 infection among those who received the vaccine is significantly lower than among those who received the sham injection.
How do volunteers get infected?
The trials are based on subjects being naturally infected with Covid-19, so the time it takes to generate results is highly dependent on how widespread the virus is where the trials are conducted. Each pharmacist has targeted a specific number of infections to trigger a first analysis of their data.
How well are vaccines supposed to work?
The World Health Organization ideally wants to see at least 70% effectiveness. The FDA wants at least 50%, which means there must be at least twice as many infections among volunteers who received a placebo than among those in the vaccine group. The EMA has said it can accept a lower level of effectiveness.
And Russia and China?
While the Pfizer injection was the first to be implemented following the publication of the full data from the phase III trial, Russia and China have been vaccinating their citizens for months with several different vaccines that are still in late-stage trials.
Russia said on Nov. 24 that its Sputnik V vaccine, developed by the Gamaleya Institute, was 91.4% effective according to interim results from the last stage of the trial. It began vaccinating in August and has so far inoculated more than 100,000 people.
India plans to make 300 million injections next year and Argentina has given the green light for emergency use of the vaccine, with some 300,000 doses due to arrive in the country on December 24.
China launched an emergency use program in July targeting essential workers and others at high risk of infection. It has vaccinated around a million people in mid-November using at least three injections, two developed by the state-backed China National Biotec Group (CNBG) and one by Sinovac Biotech.
Trial data on a Covid-19 vaccine developed by China’s Sinovac Biotech has varied: Interim data from a late-stage trial in Turkey showed that its CoronaVac injection is 91.25% effective, while researchers in Brazil say that the injection was more than 50% effective.
Meanwhile, the United Arab Emirates said on Dec. 9 that one of the CNBG vaccines was 86% effective based on interim results from a late-stage trial in the Arab Gulf state.
(With inputs from agencies)
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