Where is India, rest of world in Covid-19 vaccine race?

NEW DELHI: India is gearing up for the rollout of Covid-19 vaccine across the country and a two-day dry run is currently under way in Andhra Pradesh, Assam, Gujarat and Punjab. The frontrunner Oxford-AstraZeneca candidate is already under regulatory review and sources have indicated that the emergency use approval may come in the next few days.

Here's where India and the rest of the world stand in the global race to fight and end the pandemic:
Dry run in 4 states
India plans to inoculate around 30 crore “priority” population in the first phase of the vaccination drive that is expected to roll out in the first week of January and end latest by July.

This will include healthcare and frontline workers and those at higher risk of infection such as people over 50 years of age and others below 50 years but with severe co-morbidities that can lower immunity and increase chances of death due to Covid-19 infection.

The government has already trained participants who will administer the vaccine.

To assess readiness of the mechanism laid out for the Covid-19 inoculation drive, a dry run has been planned by the Centre on December 28 and 29 in the four states.

The exercise will include necessary data entry in Co-WIN, an online platform for monitoring of vaccine delivery, testing receipt and allocation, deployment of team members, mock drill of session sites with test beneficiaries, a well as reporting and evening meeting, the Union health ministry had said last week.

It will also include testing of cold storage and transportation arrangements for COVID-19 vaccine, management of crowd at session sites with proper physical distancing, it added.

Regulatory approval 'in days'
Meanwhile, India is likely to see the Oxford-AstraZeneca vaccine being approved for emergency use in the next few days as the updated data submitted by Serum Institute of India (SII) appears “satisfactory”, top government sources said.

Serum CEO Adar Poonawalla on Monday said that the company has nearly 40-50 million doses of Covishield, the local name of the

Oxford

vaccine, stockpiled. He added that he is expecting regulatory approval "in days".

Meanwhile, the government has indicated that once evaluation of data is complete, the Indian regulator may not wait for the vaccine to get approval from UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

“We can take our regulatory decisions independently. The company has submitted the same data here from clinical trials in the UK and Brazil and rolling reviews are going on. The updated information shared by Serum Institute also appears satisfactory. We are hopeful that based on regulatory assessment, the vaccine will be approved in a day or two,” a senior official told TOI.

However, it is quite possible that the UK may also meanwhile grant the emergency use authorisation as MHRA is already reviewing the data for the vaccine developed by Oxford University and pharma major

AstraZeneca

.

A PTI report said the drug major's CEO Pascal Soriot has reported the Covishield vaccine to have achieved a “winning formula” for efficacy. Soriot’s comments were carried in an interview with the Sunday Times newspaper. He added that he believes trials will show his firm has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5 per cent.

“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” the chief executive said, while only adding that data would be published at “some point”. He also said that the vaccine “should be” effective against the new highly transmissible variant of the coronavirus.

The global vaccine race
While India is on the brink of administrating the first shots to its people, the European Union has launched a mass vaccination campaign after giving a go-ahead to the Pfizer vaccine.

Who is furthest along in the vaccine?
US drugmaker Pfizer and German partner BioNTech are the Covid-19 vaccine trailblazers so far.

On November 18, they became the first in the world to release full late-stage trial data. Britain was the first to approve the shot for emergency use on December 3, followed by Canada on December 9 and the US Food and Drug Administration (FDA) on December 11. Several other countries including Saudi Arabia and Mexico have also approved it.

The European Medicines Agency (EMA) approved the shot on December 21 and India is accelerating its review.

The World Health Organization could decide whether to give its emergency use approval for the Pfizer candidate by the end of the year as part of its Covax programme aimed at providing shots 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 showing a 94.1% efficacy rate for its vaccine. Canada approved the shot 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 late-stage trial data on November 23. It had an average efficacy rate of 70% and as much as 90% for a subgroup of trial participants who got a half dose first, followed by a full dose.

However, it is not clear how the regulator will deal with the different dosages in the efficacy data in its assessment. AstraZeneca is also in discussions with the EMA, which is conducting a rolling review of the vaccine.

US drugmaker Johnson & Johnson plans to deliver trial data in January 2021, teeing it up for US authorization in February if its shot is effective. It reduced the enrolment target for its clinical trial to 40,000 volunteers from 60,000 on December 9, potentially speeding results which are tied to how quickly participants become infected.

US firm Novavax is running a late-stage trial in Britain with data due in the first quarter of 2021. It expects to start a large-scale trial in the United States this month.

France's Sanofi and Britain's GlaxoSmithKline, however, announced a setback on December 11 in their attempts to develop a vaccine. The drugmakers said it showed an insufficient immune response in older people in mid-stage trials and that they would start a new study in February.

What happens in the trials?
The companies typically test their vaccines against a placebo - typically saline solution - in healthy volunteers to see if the rate of Covid-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

How are volunteers infected?
The trials rely on subjects becoming naturally infected with Covid-19, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

How well are the vaccines supposed to work?
The World Health Organization ideally wants to see at least 70% efficacy. The FDA wants at least 50% - which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The EMA has said it may accept a lower efficacy level.

What about Russia and China?
While Pfizer's shot was the first to be rolled out following the publication of full Phase III trial data, Russia and China have been inoculating their citizens for months with several different vaccines still undergoing late-stage trials.

Russia said on November 24 its Sputnik V vaccine, developed by the Gamaleya Institute, was 91.4% effective based on interim late-stage trial results. It started vaccinations in August and has inoculated more than 100,000 people so far.

India plans to make 300 million of the shots next year and Argentina has given the greenlight for emergency use of the shot, with some 300,000 doses arriving in the country on December 24.

China launched an emergency use programme in July aimed at essential workers and others at high risk of infection. It has vaccinated about one million people as of mid-November using at least three shots - 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 its CoronaVac shot is 91.25% effective, while researchers in Brazil say the shot was more than 50% effective.

The United Arab Emirates, meanwhile, said on December 9 that one of the CNBG vaccines was 86% effective based on interim results from a late-stage trial in the Gulf Arab state.

(With inputs from agencies)

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