The economics and pricing of the Covishield vaccines and the government's own decision to pay higher prices raise more than a few questions, observes Prosenjit Datta.
The WHO said the four current 'Variants of Concern' being monitored closely - Alpha, Beta, Gamma and Delta - are widespread and have been detected in all WHO regions.
The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
The New York Times on Tuesday said Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.
A technical advisory group of the World Health Organisation was on Tuesday reviewing data on Covaxin for the emergency use listing of India's indigenously-made vaccine and it could pronounce its decision within the next 24 hours or so, a spokesperson said.
The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
The government should take measures to promote innovation and R&D while simplifying regulations for the sector in the upcoming Union Budget, as per pharmaceutical industry bodies. Outlining the wish list for the sector in the upcoming Union Budget, Indian Pharmaceutical Alliance (IPA) secretary general Sudarshan Jain said the domestic pharma industry is currently around $50 billion in size and aspires to grow to around $130 billion by 2030 and $450 billion by 2047. "To achieve this vision, the Union Budget 2023-2024 should help fuel innovation and R&D, which will set the pace for propelling the pharmaceutical industry forward," he told PTI.
The Medicines and Healthcare Regulatory Agency, which had been formally tasked by the UK government last month with the process of clearance after the jab emerged "safe and effective" against the novel coronavirus in human trials, is expected to authorise the vaccine by December 28 or 29 after the final data is provided on Monday, 'The Daily Telegraph' quoted senior government sources as indicating.
"We have started the phase-III trials of the vaccine (candidate Covishield). We will administer dose to 150 to 200 volunteers," said Dr Muralidhar Tambe, Dean, Sassoon General Hospital.
Two doses of Pfizer and AstraZeneca COVID-19 vaccines generate lower levels of antibodies against the Omicron variant of coronavirus, according to a study which suggests that those previously infected or vaccinated may be at an increased risk of infection.
The technical advisory group will now meet on November 3 for a final assessment.
Poonawalla, however, did not specify the quantity of the doses that will be kept for the community, which is grappling with a shrinking population.
Serum Institute of India plans to make 300 million doses of AZD1222 by December, and will begin phase-2 trials soon. It has also tied up with Novavax for development and commercialisation of its candidate.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
While it is not clear whether the volunteer had received the vaccine or a placebo shot during the trial, Anvisa has refused to reveal any more information citing reasons of medical privacy, CNN reported.
Pune's Serum Institute of India, the world's largest vaccine maker by volume, is placing its bets on the Oxford-AstraZeneca vaccine candidate AZD1222 with CEO Adar Poonawalla stating he would start manufacturing at personal risk.
Serum Institute already has two deals of 100 million each to supply the Oxford-AstraZeneca and the Novavax vaccine to Gavi-Covax at $3 per dose.
"The phase-III trial of 'Covishield' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. "Around 150 to 200 volunteers will be administered the vaccine candidate dose," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe said.
Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.
The development comes after requests for indemnity and exemption from bridging trials have been made by Pfizer and Moderna to the Indian government.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
'All the vaccines that are available in most countries, right now, are all highly effective and safe.'
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
Initial data has shown immunity triggered by the two mRNA vaccines -- Pfizer-BioNTech and Moderna -- lasts for at least six months
'We're clear Covishield is not a problem. The UK is open to travel and we're already seeing a lot of people going from India to the UK, be it tourists, business people or students,' Alex Ellis, British high commissioner to India, said.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
'SII has started stockpiling the vaccine and now has roughly 40 million doses ready. It is using some of the capacities it had for under development products for the COVID-19 vaccine and by January we will have a capacity to make 100 million doses per month and a stockpile of 200 million doses.'
By January-February, it's expected to have at least 100 million doses for the Indian government, reports Sohini Das.
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
In its weekly bulletin of December 27, released on Monday, the Indian SARS-CoV-2 Genomics Consortium (INSACOG) said global outbreaks of SARS-CoV-2 are increasingly shifting from Delta to Omicron.
A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets. While R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth of generics and injectable products, concerns such as price control and customs duties on medical equipment will continue to bother the healthcare industry in 2023. The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage, improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.
The DCGI said it has no objection in respect of 'Extension of Shelf Life of Covishield Vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
This new trial, a single-blind, randomised Phase II trial, will enrol 300 volunteers, with up to 240 of these volunteers receiving the ChAdOx1 nCoV-19 vaccine and the remainder a control meningitis vaccine, which has been shown to be safe in children but is expected to produce similar reactions, such as a sore arm.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
With variants cropping up at regular intervals, Jha acknowledged that they are a concern as a very rapid evolution of this virus is being seen over the time.
The Covishield maker's forte throughout the past half a century has been a combination of affordable vaccines and high volumes. Its tetanus, diphtheria and measles vaccines are known throughout the world, reports Sohini Das.
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