Tag: Serum

SII’s Phase-2 and 3 clinical trials of Covovax will reportedly be conducted in 920 children — 460 each in 12-17 years and 2-11 years groups, media reports said…reports Asian Lite News

The Pune-based Serum Institute of India (SII) has begun manufacturing Novavax’s protein-based vaccine Covovax, CEO Adar Poonawalla has said.

The company will also begin clinical trials of Novavax for children starting July.

“Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune,” he shared in a tweet on Friday.

In the recently released Phase -3 trials, Covovax has shown overall 90 per cent efficacy against Covid-19. The US-based trials also demonstrated the two-shot vaccine 100 per cent protection against moderate and severe disease.

“The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team,” he said.

SII’s Phase-2 and 3 clinical trials of Covovax will reportedly be conducted in 920 children — 460 each in 12-17 years and 2-11 years groups, media reports said.

In August 2020, Novavax and SII had announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries.

In March 2021, CEO Poonawalla said Covovax will be launched by September this year.

“Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India,” said Adar Poonawalla. “Hope to launch by September 2021!” the CEO of the world’s biggest Covid-19 vaccine maker had said.

Recently, the Centre stated that Novavax Covid vaccine efficacy data in a large trial are promising and that clinical trials are being conducted and are in an advanced stage of completion in India.

“What we’re learning from data available in the public domain is that this vaccine is very safe and highly effective,” Dr V.K. Paul, NITI Aayog Member (Health) said earlier this month.

The company intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.

Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.

Hyderabad-based Bharat Biotech has also two vaccines that are being tried on children, Covaxin and BBV154, a one-shot nasal vaccine.

ZyCov-D, the Zydus’ Covid-19 vaccine has also started trials on children in the age group 12-18 years.

The government is also considering providing legal indemnity to Pfizer and Moderna to roll out their vaccines in India. Pfizer has announced that its vaccine is safe for children above 12 years of age.

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Says SII has delivered more than 200 million doses, even though it received Emergency Use Authorisation two months after US pharma companies did, reports Asian Lite News

Serum Institute of India (SII) CEO Adar Poonawalla has said he never exported vaccines at the cost of Indians.

Defending the move to export vaccines earlier this year, he said, “Another important factor that people do not tend to realise is that we are amongst the two most populous countries in the world, a vaccination drive for such a large population cannot be completed within 2-3 months, as there are several factors and challenges involved. That said, it would take 2-3 years for the entire world population to get fully vaccinated.”

“We would like to reiterate that we have never exported vaccines at the cost of the people in India and remain committed to do everything we can in the support of the vaccination drive in the country,” Poonawalla said.

The statement comes amidst criticism to export vaccines, which, some say led to a shortage in India.

“Firstly, in January 2021 we had a large stockpile of vaccine doses. Our vaccination drive had started successfully and the number of daily cases being recorded were at an all-time low. At that stage, most people including health experts believed that India was turning the tide on the pandemic,” he added.

Around the same time, many other countries in the world were facing an acute crisis and were in desperate need of help. “Our government extended support wherever possible during this period. It is this spirit that had initially led to cooperation between countries when the virus first emerged in the beginning of 2020. The cooperation between countries also forms the basis for us getting access to technology and aid for healthcare. Today, it is this reciprocity, where India has helped other countries with the supply of HCQ and vaccine exports, that has in turn led to support from other countries,” he added.

Poonawalla said, “We must also understand that this pandemic is not limited by geographic or political boundaries. We will not be safe until everyone globally is able to defeat this virus. Further, as part of our global alliances, we also had commitments to Covax, so that they could distribute the vaccines around the world to end the pandemic.”

He said SII has delivered more than 200 million doses, even though it received Emergency Use Authorisation (EUA) two months after US pharma companies.

“If we look at total doses produced and delivered, we rank amongst the top three in the world. We continue to scale up manufacturing and prioritise India. We also hope to start delivering to Covax and other countries by end of this year,” he added.

India tops the list

According to the Ministry of External Affairs, India has supplied 66 million doses to over 95 countries across the world. Of this 10 million vaccines were grants from the Indian government and 20 million were sent as part of the global Covax facility. The rest 36 million doses were commercial exports. Meanwhile, China has exported 80 million vaccines doses to 60 countries. The European Union on the other hand has exported 113.5 million vaccine doses to 43 countries. In April, India was the fastest country in the world to give more than 100 million jabs to its citizens, the feat was achieved in just 85 days time.

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