Covid-19: Boost for India as Oxford vaccine candidate shot up to 90% successful
The University of Oxford and pharma major AstraZeneca on Monday said their coronavirus vaccine was up to 90% effective in late-stage clinical trials, announcing what may be the most crucial development for India to realistically begin expecting by the end of the year the first shots to prevent Covid-19 infections.
Known as AZD1222, the vaccine has long been the best hope for India — it is cheaper to make, easier to store and distribute, faster to scale up than its two rivals that have shown promise till now, and its principal manufacturer is Pune-based Serum Institute of India (SII), which has committed to reserving half of what it produces for India.
On Monday, the inventors of the inoculation announced that their clinical trials showed it worked in both the doses they were testing. When people got two shots of equal strength, it was 62% effective, but when the initial dose was halved, the efficacy rose to 90%. The weighted average of the two was 70.4%.
“These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regimen is used, more people could be vaccinated with planned vaccine supply,” said Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial.
“The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by Sars-CoV-2,” added his colleague, Sarah Gilbert, professor of Vaccinology at the University of Oxford.
The difference in performance of the vaccine when initial dose was halved was not immediately explained. “I think all of us expected that the two high doses would be the best response,” said Pollard. “We think that by giving a smaller first dose, that we’re priming the immune system differently. We’re setting it up better to respond.”
Gilbert said the better result with a smaller initial dose could be because this better “mimics what happens in a real infection”. One of the objectives of Phase 3 tests is to determine the right dosage.
The makers of the vaccine will now approach regulators with the full data from the trial to seek an emergency use licence, which will allow for it to be given to people who need it at the earliest: health care workers at the frontlines of the pandemic and people vulnerable to serious illness.
SII’s CEO said at the Hindustan Times Leadership Summit last week that his company would do the same as soon as the UK permissions came through. He reiterated his position to two TV channels on Monday, and said that at this rate the vaccine should be available for emergency use by the end of the year, and to the general public by around March 2021.
In early June, Oxford-AstraZeneca announced a deal with SII to produce a billion doses of the vaccine for low- and middle-income countries (LMIC), which now makes this vaccine the only one yet that appears to be affordable as well as effective for billions of people who live in these countries.
“This means we have a vaccine for the world,” Pollard added during a press conference in London.
The Pfizer-BioNTech and Moderna vaccines, which showed efficacy of about 95% each, are significantly more expensive than the Oxford vaccine and require much more stringent transportation and storage norms because they remain effective in much lower temperatures.
The June deal also represented a leap of faith that now appears to have paid off for SII. Poonawalla said at the HT Leadership Summit that the company invested in retooling and stockpiling millions of doses even before it had proven effective. “I felt it was my moral responsibility to take the decision then because if I didn’t, countless lives would be lost next year,” he said, expecting the gamble to pay off, which it now appears to have.
SII has produced around 40 million doses as of now and the company will be able to supply 100 million doses by January, Poonawalla said. The latest news was “certainly better than what we expected it to be”, he told two TV channels on Monday.
He also reiterated cost estimates he first made during HTLS last week: The vaccine will be priced around $3-4 (Rs 250-Rs 300) per dose for the Indian government. “In the private market, it will be priced around ₹1,000 after taking into account commissions to distributors,” he told the TV channels.
It is not clear whether the government will allow direct sales of vaccines since it has taken over all aspects related to procurement in India. Individual state government too are not allowed to source these, according to Union government orders.
This was the third consecutive Monday this month for vaccine makers to announce that their shots had shown to work in initial findings from their trials. The first was by American drugmaker Pfizer and German partner BioNTech, who on November 9 said their shot was 94.5% effective in reducing Covid-19 infections. On November 16, another American company, Moderna, released similar results.
Both of these work on a new platform and cost close to 10 times more that AZD1222. The Pfizer-BioNTech vaccine requires temperatures as low as -70°C to store. The Oxford vaccine, in contrast, “can be easily administered in existing health care systems, stored at fridge temperature (2-8 °C) and distributed using existing logistics,” the university said in a statement.
Authorities in India said they will wait till any of the vaccine candidates are granted an approval in regions where they have applied. “As for following up on the progress made on vaccine research, the government is continuously in talks with the parties involved. However, the actual procurement process will begin the day any of these vaccines gets regulatory approvals. So far, none of these vaccines has secured emergency use authorization (EUA) so there is no question yet of vaccine procurement,” said Rajesh Bhushan, Union health secretary.
The subject expert committee at India’s Central Drugs Standard Control Organisation (CDSCO) will also be looking at the basis on which approvals are granted to vaccines in other countries.
Experts said that while it is important to fast-track approvals during a pandemic, it is not advisable to cut corners as far as safety data is concerned.
“Regulators need to scrupulously examine data when submitted — in India as well as other countries. Safety data as well as efficacy data are both important. Science should not be stampeded but regulation can move into the fast track while following all the traffic rules,” said Dr K Srinath Reddy, founder, Public Health Foundation of India and a member of the National Task Force on Covid-19 management.
Experts treating patients say 70% efficacy itself is good since most vaccines against respiratory illnesses do not have more than 50-60% effectiveness.
“Seventy per cent is quite decent, but our concern should be more towards the safety of the vaccine candidate. It should be safe as efficacy for influenza vaccine is also about 50%,” said Dr GC Khilnani, former head, pulmonary medicine department, New Delhi’s All India Institute of Medical Sciences.
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