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Tag: Adar Poonawalla

  • COVID-19: Covovax to get approval as booster in 10-15 days, says SII CEO Adar Poonawalla 

    By PTI

    PUNE: Serum Institute of India chief executive officer Adar Poonawalla on Sunday said its Covovax vaccine will get approval as a booster in the next 10 to 15 days, adding it works very well against the Omicron variant of coronavirus.

    Speaking to reporters on the sidelines of an event at Bharti Vidyapeeth University here, Poonawalla, when asked about states and districts not getting Covishield vaccines, said there are ample stocks with the Union government for supply.

    “Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield,” said Poonawalla.

    He said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic.

    “This was all possible because of the leadership of our Central government, our state governments, healthcare workers, manufacturers, all of whom worked together with one common goal,” he said.

    On the occasion, Poonawalla was conferred with the first Dr Pantangrao Kadam Memorial Award at the hands of NCP Chief Sharad Pawar and Deputy Chief Minister Devendra Fadnavis in an event to mark the birth anniversary of the late minister and education baron from western Maharashtra.

    Appealing to students who wished to pursue education abroad, he said there was no place like India to fulfil dreams due to the presence of institutions like Bharti Vidyapeeth and others.

    “Even if you have to go abroad, come back as soon as possible,” he said.

    PUNE: Serum Institute of India chief executive officer Adar Poonawalla on Sunday said its Covovax vaccine will get approval as a booster in the next 10 to 15 days, adding it works very well against the Omicron variant of coronavirus.

    Speaking to reporters on the sidelines of an event at Bharti Vidyapeeth University here, Poonawalla, when asked about states and districts not getting Covishield vaccines, said there are ample stocks with the Union government for supply.

    “Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield,” said Poonawalla.

    He said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic.

    “This was all possible because of the leadership of our Central government, our state governments, healthcare workers, manufacturers, all of whom worked together with one common goal,” he said.

    On the occasion, Poonawalla was conferred with the first Dr Pantangrao Kadam Memorial Award at the hands of NCP Chief Sharad Pawar and Deputy Chief Minister Devendra Fadnavis in an event to mark the birth anniversary of the late minister and education baron from western Maharashtra.

    Appealing to students who wished to pursue education abroad, he said there was no place like India to fulfil dreams due to the presence of institutions like Bharti Vidyapeeth and others.

    “Even if you have to go abroad, come back as soon as possible,” he said.

  • Millions of COVID vaccines unsold; stopped production since December 2021: Adar Poonawalla

    By PTI

    MUMBAI: The Serum Institute of India has stopped producing the COVID-19 vaccine since the last day of December 2021 as it has been sitting on millions of unsold vaccines after the vaccination momentum has ebbed, its chief executive officer Adar Poonawalla said on Friday.

    Poonawalla also warned against the return to “the business as usual” approach of the administration in the national capital, saying “we can’t afford to put a price tag on the life of a citizen” as the pandemic is “not behind us yet nor we know by when it will be”.

    He also called for speeding up the decision to vaccinate young kids and said if they can be given other immunisation vaccines why not for the COVID-19, the end of which nobody knows as of now.

    “Since the vaccine intake has been coming down, there has been a lot of unsold inventories with us. We stopped production on December 31, 2021. Currently, we are sitting on over 200 million doses. I have offered this to anyone willing to pick them up for free. But there hasn’t been a good response to that also. Seems there is vaccine fatigue among the people now as even after the price was slashed to Rs 225, there has been no major uptake,” Poonawalla said at the Times Network India Economic Conclave.

    Defending his call for lowering the gap between second and third doses to six months from nine months at present, he said it’s needed for one “we can’t put a price tag on the life of a person be it an adult or a child. Another important reason is that after six months the antibodies come down so it is better to go for the third dose within six months”.

    ALSO READ| Public complacency responsible for low uptake of booster dose of vaccines: Experts

    “This is something many studies have verified and therefore many foreign governments have made the booster dose mandatory. Already, many counties have made booster doses mandatory for travel. This means those who were vaccinated by August or September last will not be able to travel outside the country. Therefore, my suggestion to the government for six months gap for the third dose,” he said.

    On the need for vaccinating kids in the 5-11 age bracket, he said, “My point is we can’t put a price tag on the life of a person. Also if an additional dose of vaccine can prevent a 1,000 hospitalisation, so let’s do that as was evident from the third wave.”

    On the delays in decision making, Poonawalla rued that it seems the urgency is no longer there. Unfortunately for the key people who are supposed to be taking decisions on time, the committees supposed to be meeting on time, it seems there is no urgency any longer.

    “The momentum of the past that brought us so far here is lost. As you said it seems for them, it’s business as usual. That’s why there is no decision on the emergency use of Covovax is coming in. What is more surprising is that the same vaccine has been approved by the regulator long ago and have also been in use in many European nations and in Australia,” he said.

    However, Poonawalla quickly added that the government at the highest level is fully seized of the matter, but “yes at the ground level there seems the urgency is lost”.

  • DCGI’s EUA nod to SII’s Covovax for 12-17 years age group

    By PTI

    NEW DELHI: India’s drug regulator has granted restricted emergency use authorisation to Serum Institute’s COVID-19 vaccine Covovax for the 12-17 years age group subject to certain conditions.

    Confirming the 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.”

    It is the fourth vaccine to receive the regulator’s nod for use among those below 18 years.

    However, only one vaccine –Bharat Biotech’s Covaxin– is used for the 15-18 years age group in the vaccination drive in the country after the government approval.

    The Drugs Controller General Of India’s (DCGI) approval comes after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17.

    The government has still not taken a decision on vaccinating those aged below 15 years and the health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.

    In the EUA application to DCGI on February 21, Prakash Kumar Singh, director (government and regulatory affairs) at SII had stated that the data from two studies on about 2707 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group of children.

    Singh in his application had said,”this approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our prime minister’s vision of ‘making in India for the world’.

    “In line with the philosophy of our CEO, Dr Adar C Poonawalla, we are sure that Covovax will play an important role to protect the children of our country and the world at large against COVID-19 disease and will keep our national flag flying high globally”, according to an official source.

    The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country’s vaccination drive.

    The DCGI on February 21 granted restricted EUA to Biological E’s COVID-19 vaccine Corbevax for the 12-18 years age group subject to certain conditions.

    Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO on December 2017, 2020.

    ZyCov-D is the first vaccine cleared by India’s drug regulator for inoculation of those aged 12 years and above in August last year.

    Indigenously developed Covaxin received approval for emergency use in 12 to 18 in December last year.

  • Serum Institute’s Covovax vaccine gets WHO emergency use nod, Poonawalla hails decision

    By PTI

    NEW DELHI: Serum Institute of India (SII) CEO Adar Poonawalla on Friday hailed WHO’s approval for emergency use of Covovax vaccine for children “as yet another milestone” in the fight against COVID-19.

    The World Health Organization (WHO) on Friday listed the Covovax as the ninth COVID-19 vaccine for emergency use with an aim to increase the access to vaccination in lower-income countries.

    It is produced by the Serum Institute of India under the licence from Novavax.

    Reacting to the development, Poonawalla tweeted, “This is yet another milestone in our fight against COVID-19, Covovax is now WHO approved for emergency use, showing excellent safety and efficacy. Thank you all for a great collaboration…..”

    He tagged Novavax, WHO, Gavi, the Vaccine Alliance, its CEO Seth Berkley and the Gates Foundation.

    Earlier this week, Poonawalla had said that SII planned to launch Covovax, a COVID-19 vaccine for children in the next six months.

    He had stated that Covovax which is under trial would offer protection to children all the way down to three years as it had shown excellent data during the trials.

    Currently, Covishield and other COVID -19 vaccines are approved for people above the age of 18.

    Poonawalla had asserted that there was enough data to show that the vaccine would work and protect children against the infectious disease.

    According to WHO, Covovax was assessed under its emergency use listing (EUL) procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India.

    “The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally,” it said.

  • Biocon and Serum Institute come together with strategic alliance to increase vaccine access for developing countries

    By Express News Service

    Two leading biotech players, Bengaluru based Biocon Biologics Limited and Pune based Serum Institute Life Sciences Private Limited have come together with a strategic alliance in a bid to increase vaccines and antibody therapeutics access for developing countries, for infectious diseases including Covid-19, dengue and HIV among others.

    As part of the deal, the BBL has offered 15% stake to SILS at a post money valuation of $4.9 billion in exchange for committed access to 100 million doses of vaccines per annul for 15 years.

    Announcing this at a joint press meet held on Friday, Biocon founder Kiran Mazumdar Shaw and SII chief executive Adar Poonawalla said, the partnership aims to complement the strengths and resources of the two leading players and make a significant impact on global healthcare through vaccines and biologics.

    “BBL will commercialise Serum institute’s vaccine portfolio including COVID 19 vaccines for global markets and this would also be an additional growth driving for BBL. Research and manufacturing infrastructure will also be leveraged by this partnership for various opportunities in infectious diseases, ” Shaw said.

    Speaking at the press meet, Poonawala said SII had to delay its plans to work on and produce monoclonal therapies for Covid due to the huge demand of Covishield vaccine production, and the new tie-up aims to address this. 

    More in the pipeline

    The duo stressed that the synergistic future oriented deal will help growth of both companies, as it will provide Biocon an opportunity to enter into the vaccine space, whereas Serum can leverage BBL’s expertise in areas like monoclonal antibodies (mABs), m-RNA technologies and biosimilars.

    Adding that there is more to the partnership than just the 100 million vaccines that has been talked about, Poonawala said that, “The opportunities are limitless and we will look at monoclonals and other therapeutics. Additional business partnerships and alliances in addition to the 100 million vaccines we have talked about will also be looked into,” Poonawala said.

    Biocon Biologics will also establish a vaccine research and development division to support the alliance in developing both vaccines and biologics for communicable diseases.

    Additionally, wherever possible, it will make available its cell culture and sterile fill and finish capacities for vaccine production under the alliance. 

    He also stressed that both the partners also wanted to make investments in strengthening the raw material chain, as many of these raw materials manufacturers are finding it hard to scale up and match the vaccine manufacturing supply.

    “We will make investment in raw material manufacturing as well — so that we are fully self-reliant,” Poonawala said, adding that these supply chains will be established in the country.

    Mazumdar-Shaw said the long term partnership will try to ensure that Indian drug manufacturers do not face supply chain disruptions in future. 

    Initial focus on COVID 

    Meanwhile Poonawala made it clear that the initial additional capacities will be focused on COVID vaccines for the obvious reason of demand to provide to not just India but other countries too.

    “Initially it would make sense that whatever firepower and additional capacity we can leverage from biocon biologics including the first 100 MN doses annually will be focused on COVID vaccines but there is a huge pipeline of vaccines for malaria, HPV etc, thereafter that will benefit from the partnership,” Poonawala explained.

    He added that Biocon has extensive marketing infrastructure in developed markets, an area Serum can explore to take its vaccines and other products to those markets through this alliance. At present most of Serum’s products are supplied across the world through public health agencies like WHO-UNICEF and other such agencies

  • Booster dose ‘unethical’ now, may be needed later: Adar Poonawalla

    Express News Service

    BENGALURU: While some countries have started rolling out booster shots, and the jury in India is still out on this, Serum Institute of India’s CEO Adar Poonawalla termed it “unethical” to roll out a booster dose in the country when a big section of the population is yet to be administered both doses. Several people in other countries are yet to get their first dose.

    Adar Poonawalla’s comments come weeks after his father and SII Chairman Cyrus Poonawalla said a third dose of the vaccine is a “must” and should be taken six months after the second dose. Clarifying his father’s statement during a press conference to announce the strategic alliance of SSI with Biocon, Adar said, “I think what he meant was some vulnerable sections could do with booster shots.

    He said there is no evidence so far that a third dose is required, and it has not been recommended officially. Answering a question whether SSI is coming out with a booster shot, Adar said booster shots may be required annually down the line, but are not the need of the hour now.

    He said, “It will be unethical to think of a booster shot now. However, the decision will be taken by the Drugs Controller General of India (DCGI) and Indian Council of Medical Research (ICMR), based on data collected.” He said that Serum Institute will ramp up production of Covishield to 200mn doses a month by October. He also hinted that export restrictions on Covishield may be eased soon. 

    “There were some export restrictions temporarily, and rightly so, to take care of our nation’s need first. We will slowly ease it in the next month or two. We are coming close to a point where there is more than enough vaccine stock,” he explained. He expects easing of exports in the next couple of months. 

  • PM Modi, Mamata, Banerjee, Adar Poonawalla among Time Magazine’s 100 ‘most influential people of 2021’

    By PTI

    NEW YORK: Prime Minister Narendra Modi, West Bengal Chief Minister Mamata Banerjee and Serum Institute of India CEO Adar Poonawalla have been named among the world’s 100 most influential people of 2021 by TIME magazine.

    TIME on Wednesday unveiled its annual list of ‘The 100 Most Influential People of 2021’, a global list that includes US President Joe Biden, Vice President Kamala Harris, Chinese President Xi Jinping, Duke and Duchess of Sussex Prince Harry and Meghan, former US president Donald Trump and co-founder of the Taliban Mullah Abdul Ghani Baradar.

    TIME’s profile of Modi says that in its 74 years as an independent nation, India has had three pivotal leaders – Jawaharlal Nehru, Indira Gandhi and Modi.

    “Narendra Modi is the third, dominating the country’s politics like no one since them. The profile written by noted CNN journalist Fareed Zakaria alleges that Mod has “pushed the country away from secularism and toward Hindu nationalism.”

    It also accuses the 69-year-old leader of “eroding the rights” of India’s Muslim minority and imprisoning and intimidating journalists.

    On Banerjee, her profile for the 100 most influential list says that the 66-year-old leader “has become the face of fierceness in Indian politics.”

    “Of Banerjee, it is said, she doesn’t lead her party, the Trinamool Congress – she is the party. The street-fighter spirit and self-made life in a patriarchal culture set her apart,” the profile says.

    Poonawalla’s TIME profile says that from the beginning of the COVID19 pandemic, the 40-year-old head of the world’s largest vaccine maker “sought to meet the moment.”

    “The pandemic is not over yet, and Poonawalla could still help end it. Vaccine inequality is stark, and delayed immunisation in one part of the world can have global consequences, including the risk of more dangerous variants emerging,” it says.

    The Time profile describes the Taliban co-founder Baradar as a “quiet, secretive man who rarely gives public statements or interviews.”

    “Baradar nonetheless represents a more moderate current within the Taliban, the one that will be thrust into the limelight to win Western support and desperately needed financial aid. The question is whether the man who coaxed the Americans out of Afghanistan can sway his own movement,” says Baradar’s profile.

    The list also includes tennis player Naomi Osaka, Russian opposition activist Alexei Navalny, music icon Britney Spears, executive director of the Asian Pacific Policy and Planning Council Manjusha P.

    Kulkarni, Apple CEO Tim Cook, actor Kate Winslet and the first African and first woman to lead the World Trade Organization Ngozi Okonjo-Iweala.

  • Hopeful of launching Covovax for adults in October this year, for children in Q1-2022: Serum CEO

    By PTI

    NEW DELHI: Serum Institute of India CEO Adar Poonawalla on Friday said he is hopeful that Covovax, another COVID-19 vaccine being manufactured by his company in India, will be launched in October for adults and for children by the first quarter of 2022.

    He also thanked the government for all the support provided to Serum Institute and said the company is always trying to expand its Covishield production capacity to meet the demand.

    Poonawalla met Home Minister Amit Shah in Parliament and the meeting between the two lasted for 30 minutes.

    “The government is helping us and we are facing no financial crunch. We are thankful to Prime Minister Narendra Modi for all the cooperation and support,” Poonawala told PTI after his meeting.

    When asked about vaccines for kids, he said, “The Covovax vaccine for kids will be launched in the first quarter of the next year most likely in January-February.”

    Poonawala said he is hopeful that for adults Covovax will be launched in October, depending on DCGI approvals.

    It will be a two-dose vaccine and the price will be decided at the time of launch, he added.

    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.

    Earlier in the day, Poonawalla also met Health Minister Mansukh Mandaviya.

    The minister tweeted that he had a productive discussion on the supply of the Covishield vaccine with Poonawalla.

    “I appreciated their role in mitigating #COVID19 & assured continued Government support in ramping up vaccine production,” Mandaviya said.

    Last month, an expert panel of India’s Central Drug Authority recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions, official sources had earlier said.

    The trials would cover 920 children, 460 each in the age group of 12-17 and 2-11 across 10 sites.

    The Pune-based pharmaceutical company had submitted a revised protocol for inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer-blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab.

    In the revised application, SII director (government and regulatory affairs) Prakash Kumar Singh and director Dr Prasad Kulkarni had stated that globally, all adults aged 18 and above are being vaccinated and after this population is protected against COVID-l9, children will remain the most susceptible group.

    Currently, only those who are 18 or above are eligible for vaccination against the coronavirus.

    The SII is learnt to have informed that their collaborator, Novavax, Inc, US has already generated a large amount of data in adults in different countries and that the safety, efficacy and immunogenicity data on the Novavax COVID-I9 vaccine are very robust which includes a safety database of more than 50000 adults with data from Australia, South Africa, UK and USA and preliminary safety data in 2248 children.

    “Further in the ongoing Phase 2/3 study in India, more than 1400 participants have received at least first dose of the vaccine with no safety concerns reported so far,” the application stated.

    “This will ensure that a life-saving vaccine can be brought at the earliest for our pediatric population also in addition to the adult population immediately after the grant of Emergency Use Authorisation.

    The SEC on June 30 had recommended against granting permission to SII for conducting phase 2 and 3 trials of Covovax on children aged 2 to 17 years following which the company had submitted a revised study protocol last week.

    In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.

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  • Confident of getting EMA’s approval in a month for Covishield: Adar Poonawalla

    By PTI
    NEW DELHI: Vaccine major Serum Institute of India is confident of receiving approval from the European Medicines Agency (EMA) for its COVID-19 vaccine Covishield in a month, company’s chief executive officer Adar Poonawalla said on Wednesday.

    He also said the issue of vaccine passports should be on the basis of reciprocity between the countries.

    “The EMA is absolutely correct in asking us to apply, which we have through AstraZeneca, our partners, a month ago, and that process has to take its time.

    An approval process even with UK MHRA, WHO took its time and we have applied to the EMA,” Poonawalla said at India Global Forum 2021.

    “We are quite confident that in a month EMA will approve Covishield. There is no reason why not to, because it is based on AstraZeneca data and our product is identical to AstraZeneca more or less and it has been approved by WHO, UK MHRA. So it’s just a matter of time. It is not really going to hinder anything,” he added.

    ALSO READ | EU nations will have option to accept WHO authorised jabs like Covishield to issue green pass: Official

    But the reason why it was flagged is because if the issue is not addressed now, and when India gets off the red list and when citizens want to travel they should not be refused in a given country just because they have a Covishield certificate.

    On the issue of vaccine passports, Poonawalla said that it was a slightly different issue.

    “The issue with vaccine passports is slightly different.

    What I am trying to say is that let us take a manufacturer outside of India.

    Let’s say they have been approved by WHO and everyone in that country gets vaccinated taking that product and now when those citizens need to travel, what good is their vaccine certificate if it is not acknowledged and reciprocity is not there between the countries,” Poonawalla said.

    It is that level of reciprocity that is expected between all these nations, he added.

    On the issue of waiving of intellectual property rights on vaccines to increase the supply, Poonawalla said waiving of IP is perhaps not going to solve the immediate shortage of vaccines.

    However, it is a good strategy in the long term, to be prepared for future pandemics.

    Stating that it was difficult for the company to stop the export of Covishield as it had prior commitments, he however said Serum did it in the wake of the second wave of the pandemic hitting India.

    Decision of stopping the exports was particularly stressful, “because it was not just our partner AstraZeneca that needed vaccines for the other parts of the world, it was COVAX, it was other countries that we had commitments with, we had taken advance funding, we had to return some of that funding, and really explain to other world leaders as well that there was really no choice at that moment ,” Poonawalla said.

    We had to tell them that ,”we really had to support our nation at that moment for a few months and that we would get back to them,” he added.

    It was really difficult for everyone to digest that , but slowly as they realised what was going on in India everyone was really supportive and understanding, Poonawalla said.

    ALSO WATCH:

  • Hope to resolve issues faced by Indians vaccinated with Covishield travelling to EU soon: Poonawalla

    I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries, Poonawalla said in a tweet.