The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
The Covid-19 vaccine demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, reports Sohini Das
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
'The US has invoked the Defence Act and banned export of raw materials.' 'This is as good as banning vaccines.'
India currently does not have any XBB 1.5 variant-based vaccines available.
SII would be scaling up its AstraZeneca-Oxford vaccine manufacturing capacity to 200 million doses a month from 100 million a month now, reports Sohini Das.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
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.
'I understand some people are comfortable getting a Covishield shot as their third dose.'
An expert panel of India's Central Drug Authority on Tuesday recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covid vaccine Covovax on children aged 2 to 17 years with certain conditions, official sources said.
While Bharat Biotech's Covaxin is in trials among children already, Serum Institute of India will begin Novavax vaccine trials on children from July, whereas the Pfizer vaccine has been approved for adolescents in the United States; and Cadila Healthcare's ZyCoV-D has done trials on 12 year-olds and above already, reports Sohini Das.
On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
While the vaccine could be available at $3-6 (Rs 225 to Rs 550) per dose, herd immunity might be two years away due to implementation challenges, it said, adding the experience in large scale adult vaccination programmes is thin.
Serum Institute of India (SII) and Bharat Biotech have also stopped producing the Covishield and Covaxin vaccines respectively.
'I don't think anybody would want to be in my position today where every head of State has to be explained that I am prioritising my country because there is a surge in cases.'
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
'In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible'
'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.'
Following up first doses of the AstraZeneca or Pfizer vaccines with second doses of the Moderna or Novavax jabs generates robust immune response against COVID-19, according to a study published in The Lancet journal.
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.
Adar Poonawalla says it took a five-minute chat with his father Cyrus before making the decision to manufacture Covishield. The bet paid off, and handsomely. Serum Institute now has the capacity to make 4 billion doses of Covishield annually.
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
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.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said Zydus Cadila, Sputnik V, Biological E and Gennova are other vaccines also in the pipeline which are in advanced clinical trials in India.
Under the partnership, Bharat Biotech will use the patented virus like particle technology platform of Novavax to develop the single dosage pandemic influenza vaccine and undertake clinical trials before manufacturing and marketing the same.\n\n
865 million Indian adults require vaccination.
These vaccines are Sputnik V vaccine (in collaboration with Dr Reddy's), Johnson & Johnson vaccine (in collaboration with Biological E), Novavax vaccine (in collaboration with Serum India), Zydus Cadila's vaccine, and Bharat Biotech's Intranasal Vaccine.
