SII | Business Upturn

Bombay High Court sent notice to the Centre, SII, and Bill Gates, after a petitioner claimed that her daughter died from the Covishield vaccine

Aryan Jakhar — Sat, 03 Sep 2022 05:10:39 +0000

In response to a lawsuit brought by a man who claimed that Covishield side effects were to blame for his daughter’s demise, the Bombay High Court has asked the Serum Institute of India (SII), Microsoft founder Bill Gates, and others for statements.

According to news agency ANI, the petitioner has asked for compensation from the vaccine maker in the amount of Rs 1,000 crore.

In his appeal, Dilip Lunawat claims that the government and other parties have distorted the truth about the COVID immunisation by making false claims about its safety and “forcing” doctors to get it.

Dilip Lunwat, a resident of Aurangabad, claimed that his daughter Snehal Lunawat, a medical student, was compelled to have the anti-Covid vaccination on January 28 of last year at her college in Nashik since she was a healthcare worker.

According to PTI, Snehal worked as a doctor and senior lecturer at the SMBT dentistry college and hospital in Dhamangaon.

She had received Covishield, a vaccination created by SII.

Days later, she complained of excruciating headaches and vomiting. She was taken to the hospital, where the doctors reportedly found bleeding in her brain. The claim states that Snehal passed away on March 1 as a result of negative vaccine side effects.

The petition was based on a report that the Center’s adverse events after immunisation (AEFI) committee presented on October 2.

The petitioner has also asked Bill and Melinda Gates Foundation, whose organisation has worked with the SII to hasten the production and distribution of 100 million doses of the vaccine, for a response. He also asked the state of Maharashtra, the Drug Controller General of India, and the Union government for their responses.

The petition stated that Lunwat sought justice for his daughter as well as “many more people who are going to be murdered” as a result of similar incidents with negative outcomes.

A division bench of Justices S V Gangapurwala and Madhav Jamdar served notice on all of the plea’s respondents on August 26. On November 17, there will be a hearing in this matter.

Serum Institute of India: 1 crore doses of Quadrivalent Human Papillomavirus vaccine by December 2022

Yakita Somani — Mon, 01 Aug 2022 13:53:23 +0000

According to government sources, the Serum Institute of India has notified the Center that it can provide 1 crore doses of its indigenously developed Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer by December 2022.

In a letter to the Union health ministry, Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum Institute of India (SII), confirmed the supply of 1 crore doses of qHPV by December 2022 for the National Vaccination Program.

Singh stated in his letter that SII will provide the vaccination at a reasonable price. He also mentioned that the price cannot be disclosed before the online tendering process begins.

The Cure: Quadrivalent Human Papillomavirus vaccine

On July 12, SII acquired market authorization from the Drugs Controller General of India (DCGI) to manufacture qHPV.

The phase 2/3 clinical trial of the vaccine has been completed with the support of the Department of Biotechnology.

It has recently been reported that the government advisory council NTAGI has also approved the qHPV vaccination after analysing the results of the vaccine’s clinical trials.

The qHPV vaccine CERVAVAC has shown a significant antibody response that is almost 1,000 times higher than the baseline against all targeted HPV types and in all dose and age categories, according to Singh’s statement in the application to DCGI.

Cervical Cancer history in India

According to the letter, thousands of women are diagnosed with cervical cancer each year, along with a few other cancers, and the death rate is also very high.

In India, cervical cancer is the second most common malignancy among women between the ages of 15 and 44. Also noteworthy is the fact that the nation is currently completely dependent on foreign manufacturers for the HPV vaccine.

Singh claimed in the application, “According to our group’s ideology and under the direction of our CEO, Dr Adar C. Poonawalla, it has always been our goal to provide high-quality “Made in India” vaccines for the people of our nation and the rest of the globe at reasonable prices.”

DGCI permits Serum Institute of India to manufacture vaccines against Omicron

Himanshu Mishra — Mon, 07 Feb 2022 16:25:33 +0000

The Drugs Controller General of India (DCGI) has accepted Serum Institute of India’s plan to produce a vaccine against omicron variant of coronavirus for research, test and analysis, official sources told PTI on Monday.

“With reference to your application, please find herewith the permission to manufacture SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein nanoparticle vaccine (omicron variant) for examination, test and analysis under the provisions of New Drugs and Clinical Trials Rules, 2019 to manufacture the test batches of the drug/drugs mentioned therein,” a permission order published on February 4 noted.

Director, Government and Regulatory Affairs at the SII, Prakash Kumar Singh had given in a request to the DCGI on January 6 expressing the Pune-based firm, in association with Novavax Inc, is functioning on the development of a vaccine against omicron, an official source notified, putting in that the SII has received permission and licence to produce SARS-CoV-2rS drug substance for research, test and analysis.

The PTI quoted the source saying the new coronavirus variant ‘omicron’ has already stood to be recorded in more than 60 countries and is spreading very rapidly worldwide and in our country also and so, Serum Institute worked on the progress of SARS-CoV-2 rS Protein (COVID-19) Recombinant Spike Nanoparticle Vaccine (omicron variant).

WHO approves SII’s Covovax for emergency use

Shifali Gorka — Sat, 18 Dec 2021 06:12:54 +0000

On Friday, The World health organization approved the COVID-19 vaccine Covovax which is developed by the Serum Institute of India for emergency use.

Covovax is the version of NVX-CoV2373, the protein-based coronavirus vaccine produced by Novavax, USA. Last year, the two companies had an agreement under which Novavax had given SII the license to produce and supply the vaccine to low-income countries including India.

“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from Sars-Cov-2,” said Mariângela Simão, WHO assistant-director general for Access to Medicines and Health Products. “This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”

SSI started the manufacturing of the Novavax COVID-19 vaccine (branded as Covovax in India) on 26 May 2021 after receiving permission from the Indian government. The vaccine appeared to have effective results and received a good response. The vaccine is given in two doses administered 21 days apart

India may resume the export of COVID-19 vaccines by the end of the year: SII CEO Adar Poonawalla

News Desk — Sat, 18 Sep 2021 05:31:10 +0000

Recently, Serum Institute of India (SII) CEO Adar Poonawalla stated that India may resume the export of COVID-19 vaccines by the end of the year. Poonawalla told Mint he expects export restrictions on COVID-19 vaccines to be lifted in one or months.

He additionally stated that SII, which prepares Covishield (the Oxford-AstraZeneca vaccine), is “significantly” escalating its capacities. “The export restrictions had been there temporarily to attend to our nation. In the subsequent month or, we expect it’s going to ease. Because in case you have to look and observe how many vaccines we’ve got delivered and others in India have delivered, we’re coming near to a level in which there’s greater than sufficient vaccine inventory, especially with us scaling up even further for this year,” Poonawalla told the publication.

“So, withinside the subsequent months, we do count on the gradual easement of exports. But you need to also check with the government; ultimately it is their decision, and we can go by what they see as appropriate,” he added.

India is nearing a level in which there’s enough inventory to maintain the vaccination drive, in step with Poonawalla. The country temporarily halted the export of vaccines all through the fierce 2nd wave of COVID-19 in India. Before that, India had exported doses to numerous countries.

Manufacturing and delivery of doses have ramped up considering then. India has administered a complete of greater than 77 crores (770 million) doses, in step with the health ministry’s update on September 17.

American information website Axios recently stated that the USA has requested India to renew vaccine exports. In 2020, SII pledged to offer 550 million doses of Covishield to COVAX, an international initiative to make a certain equitable distribution of COVID-19 vaccine doses to people in low- and middle-earnings countries.

Pune: Production of Covovax started at SII, shows 90.4 per cent efficacy

Aayushi Singh — Fri, 25 Jun 2021 16:12:15 +0000

The firm announced on Friday that the manufacturing of the first batch of Covovax vaccine has started at Serum Institute of India, Pune facility.

The company said that a new milestone had been reached, they began their first batch of Covovax at their facility this week in Pune.

Adar Poonawalla, CEO of The Serum Institute of India said that they were hoping to launch Novavax’s COVID-19 vaccine “Covovax” in India by September as the trials of the vaccine have been in advanced stage of completion.

Novavax announced in September 2020 about a manufacturing agreement with SII for it’s COVID-19 vaccine NVX-CoV2373. Poonawalla said that the trial of Novavax’s coronavirus vaccine in India was likely to conclude by November. He added that the pharmacy giant could apply for a vaccine license even before it’s trial concludes in the country on the basis of the global data of the trial.

On June 14, Novavax said in a statement stated that a vaccine candidate ’NVX-CoV2373’ demonstrated 100 per cent protection against the moderate and severe COVID-19 infection, the candidate showed 90.4 per cent efficacy overall, it also met the primary endpoint in its PREVENT-19 picotal Phase 3 trial.

The statement added that the study enrolled at least 29,960 candidates across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity of the vaccine.

Novavax said that the Covovax vaccine had showed 93 per cent efficacy against predominantly circulating variants of concern and the variants of interest.

SII to start clinical trials of Novavax COVID vaccine for kids in July

Aryan Jakhar — Thu, 17 Jun 2021 12:36:50 +0000

The Serum Institute of India (SII) plans to start clinical trials of the Novavax vaccine against Covid-19 for children in July, news agency ANI reported on Thursday citing people familiar with the matter. SII also hopes to introduce Covavax, which is a version of US firm Novavax’s Covid-19 vaccine candidate, in the country by September, ANI also said.

Novavax Inc, which has a vaccine manufacturing agreement with SII, said on Monday its Covid-19 vaccine candidate was highly effective with 90.4 per cent efficacy overall and also showed high efficacy against predominantly circulating variants. The vaccine demonstrated 93 per cent efficacy against predominantly circulating variants of concern and variants of interest, Novavax said.

Novavax said in a statement that the vaccine candidate, ‘NVX-CoV2373’, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate the efficacy, safety and immunogenicity of the vaccine, it added.

On Tuesday, the government said the efficacy data of the Novavax vaccine against Covid-19 is promising and encouraging and its clinical trials are in an advanced stage of completion in India. NITI Aayog member (health) VK Paul said the data available in the public domain also indicates the vaccine is safe and highly effective.

“What we are learning from the available data is that this vaccine is very safe and it is highly effective but what makes this vaccine relevant for today is the fact that this vaccine will be produced in India by Serum Institute,” he said during a press conference.

Paul said there is preparatory work already accomplished by the Serum Institute of India and that they are also conducting a bridging trial which is in advanced stages of completion.

“I am also hoping that they will also start trials on children which is of special interest to all of us. The pace of vaccination should see a renewed energy from next week onwards when we will realign our efforts, state efforts and effective scale-up at ground level are expected,” he added.

Bombay High Court discards a plea over security to SII CEO Adar Poonawalla

Himanjali Mahanta — Sat, 12 Jun 2021 07:19:01 +0000

The Maharashtra government has told the Bombay High Court that it would provide security to Adar Poonawalla, CEO of the Serum Institute of India (SII) which manufactures the Covishield vaccine against COVID-19 if he makes a request.

After the government’s statement, the court disposed of a petition seeking better protection for the Pune-based Industrialist. The Union government has already provided ‘Y’ category security to Mr Poonawalla.

The high court was hearing a petition filed by advocate Datta Mane, seeking a direction to the Union and State governments to provide ‘Z-Plus’ security to Mr Poonawalla after he reportedly said that he was receiving threats over the supply of the vaccine.

Public prosecutor Deepak Thakare told a division bench of Justices SS Shinde and NJ Jamadar that if Mr Poonawalla sought protection, the state government would provide him adequate security.

“We can’t keep entertaining such petitions. In view of the statement made by the prosecutor, we are of the view that this petition can be disposed of,” the court said.

The bench also noted that the petitioner was seeking protection for a person who may not even be aware of the plea. These are personal matters. “What if he (Adar Poonawalla) says that he does not want protection or he is not afraid. We cannot go behind the back of people and pass orders,” the court said.

Serum Institute CEO Adar Poonawalla to get Y category security cover

News Desk — Wed, 28 Apr 2021 17:00:26 +0000

Pune-based Serum Institute of India chief Adar Poonawalla will be provided Y category security across the country. The Union Home Ministry issued orders regarding this today after conducting a detailed threat assessment today. “Y Category” security involves the presence of 11 security personnel. One of two are commandos and the rest are security personnel. One or two of them are commandos and the rest of them are security personnel.

The Serum Institute of India chief had earlier notified that the subsidized rate for the Centre was only for a “limited” period of time.

“The average price is around $20 but because of Modi government’s request, we are providing at subsidized rates.”

As a philanthropic gesture, Mr Poonawalla said that on behalf of the Serum Institute of India, he will reduce the price of the dose from Rs 400 to Rs 300 effective immediately. This will save thousands of crores of state funds. “This will enable more vaccinations and save countless lives”, Mr Poonawalla tweeted today.

UK orders 10 million doses of AstraZeneca Vaccine from Serum Institute of India

Arnav Dogra — Wed, 03 Mar 2021 07:45:02 +0000

A spokesperson representing the Government of UK told Reuters that they have placed an order of 10 million doses of the Oxford-developed AstraZeneca Vaccine from the Serum Institute of India (SII), a Pune-based Private Limited company which is currently the world’s largest producer of vaccines by volume.

The government official also added that the total amount of vaccine doses that have been ordered by the UK is 100 million out of which 10 million are from the Serum Institute of India.

SII was mass-producing these vaccines with its sales targeted towards poor and middle-income countries and many of these nations like Bangladesh, Mauritius, Brazil depend on the vaccine producer to maintain their special prices. This move by the United Kingdom, which is a wealthy nation is expected to be seen critically as Western nations go on to procure these vaccines at the expense of poorer nations.

The UK Government, according to NDTV, said that this order does not break the SII’s commitment towards providing vaccines to poor countries.

Medicines and Healthcare products Regulatory Agency (MHRA), which is Britain’s drug regulator, is nearly done with its report on the Serum Institute of India’s manufacturing processes (which it had been auditing in February) and it is expected the SII-produced vaccine will soon be authorized for use in the UK.

Anand Mahindra tags SII CEO Adar Poonawalla in a spoof vaccine ad

Arnav Dogra — Fri, 12 Feb 2021 11:43:13 +0000

A parody version of a Valentine’s Day inspired advertisement was showcased on the American late-night talk show hosted by Jimmy Kimmel.

Yesterday, the Chairman of Mahindra Group, Anand Mahindra shared the comical Covid-19 vaccine advertisement video and tagged the Chief Executive Officer of Pune-based Serum Institute of India jokingly pointing out that he needn’t have another advertisement made.

The tweet stated – “Hilarious. ⁦@adarpoonawalla you have a readymade advertising brief. Vaccines are forever…”

https://twitter.com/anandmahindra/status/1359876941218803713

The advertisement is hilariously titled ‘one shot at the perfect gift’ for Valentine’s Day and shows a man proposing to his partner. When the man opens the ring case, instead of a ring, the box contains a vial of the Pfizer vaccine.

Mimicking major diamond ring advertisements, the narrator says, “don’t just be her somebody, be her anti-body,” and then tells the viewers to “inoculate yourself with COVID-19 vaccine.”

The video shared by Anand Mahindra has since been replayed over 110,000 times on Twitter and has 4800+ likes and 500+ retweets.

Anand Mahindra has a reputation for being funny and making comical statements in interviews and on his various social media handles.

India applauded for vaccination donation by US State Department

Arnav Dogra — Sat, 23 Jan 2021 08:01:49 +0000

India has been sending several consignments of Coronavirus vaccines produced under Serum Institute of India (SII) Pune and Hyderabad-based Bharat Biotech under a vaccine donation drive to small economies like Bhutan, Maldives, Nepal, Bangladesh, Myanmar, Mauritius and Seychelles.

Apart from SII being the world’s largest vaccine manufacturer, India claims the title as the “pharmacy of the world”, having a big 60% share in the global vaccine production.

The United States called India a “true friend” for its honorable task of providing vaccinations to countries that cannot afford to purchase big consignments.

This was expressed in a tweet by the South and Central Asia Bureau of the US State department quoting, “We applaud India’s role in global health, sharing millions of doses of COVID-19 vaccine in South Asia. India’s free shipments of vaccine began with Maldives, Bhutan, Bangladesh and Nepal and will extend to others.”

We applaud India’s role in global health, sharing millions of doses of COVID-19 vaccine in South Asia. India's free shipments of vaccine began w/Maldives, Bhutan, Bangladesh & Nepal & will extend to others. India's a true friend using its pharma to help the global community.

— State_SCA (@State_SCA) January 22, 2021

Second fire outbreak reported at SII Pune facility

Arnav Dogra — Thu, 21 Jan 2021 17:50:02 +0000

After a giant fire broke out at a Serum Institute of India Plant in Pune this afternoon taking the lives of 5 people, a second fire reportedly broke out in one of the compartments of the same facility.

As of current, it is unsure what the true cause of the fire was, with Maharashtra Chief Minister Uddhav Thackeray having stated that as per initial information, an electrical fault had caused the fire, while Maharashtra Health Minister Rajesh Tope had said that the fire was caused as a result welding sparks near some flammable material which was present at the site.

Presently, the fire has been brought under control. Prashant Ranpise, the Chief Fire Officer said that 15 water tankers had been engaged at the site and the fire was brought under control at around 4.30 pm.

As per Pune Mayor Murlidhar Mohol, the five persons, who died in the fire incident, were working on the building floor. Their bodies were found by fire officials. All of the 5 deceased were contractual labourers engaged in electrical work at the side.
SII CEO Adar Poonwalla tweeted at 5:57 pm expressing grief over the loss of his employees.

We have just received some distressing updates; upon further investigation we have learnt that there has unfortunately been some loss of life at the incident. We are deeply saddened and offer our deepest condolences to the family members of the departed.

— Adar Poonawalla (@adarpoonawalla) January 21, 2021

It was later also revealed that deceased workers’ families will be receiving Rs 25 lakh each as a compensation for their loss.

SII Chief Adar Poonawalla gets Covidshield vaccine shot

Ruchira Sonawat — Sat, 16 Jan 2021 08:50:35 +0000

Serum Institute of India (SII) CEO Adar Poonawalla shared a video on Twitter where he is seen taking a vaccine shot as India kicks off the biggest vaccination drive today.

The SII Chief received a shot of the Covishield vaccine which has been manufactured by his company.

Poonawalla, while wishing the country and Prime Minister Narendra Modi on taking a big step in fighting the pandemic wrote, “I wish India & Sri @narendramodi ji great success in launching the world’s largest COVID vaccination roll-out. It brings me great pride that #COVISHIELD is part of this historic effort & to endorse it’s safety & efficacy, I join our health workers in taking the vaccine myself.”

https://twitter.com/adarpoonawalla/status/1350338040321851392

Meanwhile, 1.11 crore doses of Covishield vaccine have been rolled out in India and there are plans to provide 5 to 6 crore more doses by February. Around 100 people will be vaccinated in each of the 3,006 centres across the country on the first day.

Co-developed by the University of Oxford and British-Swedish company AstraZeneca and known as Covishield in India, the vaccine was the first on which a scientific study was published based on Phase 3 clinical trials.

Emergency use authorization is given in the UK, Argentina, Mexico and India.

The Prime Minister, today, launched India’s COVID-19 vaccination drive and asserted that the made-in-India vaccines which are rolled out will ensure a “decisive victory” for the country over the Coronavirus pandemic.

Launch of the #LargestVaccineDrive. Let us defeat COVID-19. https://t.co/FE0TBn4P8I

— Narendra Modi (@narendramodi) January 16, 2021

Individuals cannot choose COVID-19 vaccine they prefer, says Health Ministry

Devanshu Singla — Wed, 13 Jan 2021 06:15:17 +0000

Health Secretary Rajesh Bhushan on Tuesday said that the Indian government has so far ordered 110 lakh doses from Serum Institute of India (SII) and 55 lakh doses from Hyderabad-based Bharat Biotech that will reach various centres by January 14. Due to the logistical limitations and availability of the vaccine, individuals cannot choose the COVID-19 vaccine they prefer.

“In no country is there is an option available regarding the choice of vaccines. We would be staggering our supply orders,” he said.

Bhushan said SII will be providing its Coronavirus vaccine at ₹200 per dose and Covaxin would cost ₹295 per dose excluding taxes.

Out of the total number of doses, Bharat Biotech is providing 16.5 lakh doses of Covaxin free of cost to the government.

Compared to the vaccines by SII and BB, Pfizer’s vaccine costs ₹2,800 for two doses while Moderna’s will cost anywhere between ₹2,300 to ₹2,700 per dose. A COVID-19 vaccine developed by China has been priced at ₹5,600 per dose while another Chinese vaccine will be made available in India at ₹1,200 per dose, Bhushan said.

The Health Secretary added that the Coronavirus vaccination rollout is expected to last beyond one year and in the beginning the vaccination it will be sequential.

India likely to deliver 24 million free COVID-19 vaccine doses to Kenya

Devanshu Singla — Mon, 04 Jan 2021 08:35:25 +0000

According to the Kenyan News Website The Standard, Kenya has applied for 24 million free doses through Covax and it may receive 1.4 million doses by June 2021 and the rest in the second half of 2021. Kenya has also ordered 12 million doses that will be paid for, which will be delivered in 2022.

Covax is an initiative supported by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi to help poor and/or developing countries gain access to COVID-19 vaccine.

Serum Institute of India (SII) has signed a deal with Gavi to manufacture up to 100 million doses of two different vaccines from AstraZeneca and US biotech company Novavax. AstraZeneca has contacted SII to make 1 billion doses of the vaccine for poor and developing nations.

Oxford-AstraZeneca vaccine has been approved in India and UK for emergency use.

SII CEO Adar Poonawalla has said it will prioritise India, where the government plans to inoculate 300 million people by mid-2021. The Indian government has currently not permitted SII to export vaccines against the Coronavirus, Poonawalla further added.

SII will play a crucial role in the supply of vaccine all over the country.

Government approves AstraZeneca/Oxford COVID-19 vaccine for emergency use

Devanshu Singla — Fri, 01 Jan 2021 16:42:33 +0000

Day after British drug regulator approved AstraZeneca’s COVID-19 vaccine for emergency public use India’s drug regulator on Friday approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, two sources with knowledge of the matter told Reuters.

A representative of India’s Central Drugs Standard Control Organization (CDSCO), whose experts were meeting for the second time this week, declined to comment.

India is also considering emergency-use authorisation applications for vaccines made by Pfizer Inc with Germany’s BioNTech, and by India’s Bharat Biotech.

India has reported the second highest number of Coronavirus cases after the United States, though its rate of infection has come down significantly from a mid-September peak. India has reported more than 1 crore COVID-19 cases till now.

Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’ probably to get nod by government today

Devanshu Singla — Wed, 30 Dec 2020 09:32:10 +0000

Indian Government is likely to approve Oxford AstraZeneca COVID-19 vaccine ‘Covishield’ today. Britain on December 30 became the first nation to approve the Oxford University-AstraZeneca COVID-19 vaccine. According to News18, “India approval of Oxford vaccine is expected today in all likelihood.”

The Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has scheduled a meeting on December 30 to consider the Serum Institute of India’s application for emergency use approval of its COVID-19 vaccine.

The Central Drugs Standard Control Organisation (CDSCO) had first reviewed three EUA applications on December 9 and sought more information from all vaccine makers, including Serum Institute of India (SII), which is making the AstraZeneca shots.

The United Kingdom government said that it has accepted a recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) “to authorise Oxford University/AstraZeneca’s COVID-19 vaccine for use”. The rollout is expected to begin as early as next week.