Tag: Serum Insitute of India (SII)

COVID-19 vaccine: Serum Institute’s Novavax shot launch may get delayed in India, reports

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Even as the raw material issue for manufacturing Serum Institute of India’s (SII) local version of Novavax vaccine has been sorted out after the United States lifted its export ban on raw materials last month, the launch may still get delayed in India.

The United State-based vaccine maker Novavax, with whom SII has partnered, said that its worldwide launch of the COVID-19 shot will get pushed beyond Q3 2021 (July to September), the Economic Times reported.

SII’s launch of its Novavax version, named Covovax, is likely to happen after the global launch, as its trial is based on comparing immunogenicity and safety data with the Novavax candidate, ET reported quoting officials aware about the matter.

Novavax, one of the first players to make a vaccine against the COVID, said that its highly protective vaccine candidate would not be authorised in the US or Britain until at least July and that it would not reach peak production until the year-end, a report in The New York Times mentioned.

During an earnings call with investors on May 10, the company’s President and Chief Executive, Stanley C Erck, said that the delay was due to the regulatory and manufacturing hurdles, which, however, had been resolved.

Meanwhile, its Indian manufacturer will have to demonstrate that its version of the vaccine is similar to Novavax’s in terms of clinical features.

According to its filings with the clinical trial organisation on May 5, SII started a phase-2/3 observer-blinded, randomised, active-controlled trial this month with 1,600 participants over the age of 18 across 15 centres.

The US government granted up to $1.6 billion to the Maryland company last year for the vaccine which showed robust results in clinical trials.

Earlier, Adar Poonawalla, the Chief Executive Officer of SII, had complained that the manufacturing of the Novavax vaccine was getting delayed in India due to a shortage of raw materials caused by the US export ban.

Earlier, in March Adar Poonawalla, CEO of SII, had announced the company’s plans to launch Covovax in India by September 2021.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Reports saying Centre has not placed fresh order for COVID-19 vaccines incorrect: Health Ministry

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Centre placed a fresh order of 16 crore COVID-19 vaccines with Serum Institute of India (SII) and Bharat Biotech India Ltd (BBIL) on April 28, the Ministry of Health and Family Welfare said on Monday while refuting certain “media reports” which claimed it didn’t place any fresh order after March.

The government said that the SII has delivered 8.744 crore doses of its Covishield vaccine against the March order of 10 crore jabs to the Centre while Bharat Biotech has delivered 88.13 lakh doses of Covaxin against an order of 2 crore shots till May 3.

“A 100 percent advance of Rs 1,732.50 crore was released to SII on April 28 for 11 crore doses of Covishield vaccine during May, June and July. A 100 percent advance of Rs 787.50 crore was released on April 28 to BBIL for 5 crore Covaxin doses for the same period”, the official press release mentioned.

The Union Health Ministry’s statement clarified that “incorrect” news reports were doing the rounds, suggesting that the March order of 10 crore doses with the SII and 2 crore with Bharat Biotech was the last that the Centre placed with the two vaccine makers.

“There have been some media reports alleging that the Centre has not placed any fresh order for the COVID-19 vaccines. These media reports are completely incorrect and are not based on facts,” said the statement.

It added that the Government of India has provided another batch of 16.54 crore vaccine doses to the states/Union Territories (UTs) free of cost till May 2. “More than 78 lakh doses are still available with the states/UTs. They will receive another 56 lakh doses in the next three days,” said the ministry.

It assured the state governments of continuing to provide the vaccines, cleared by Central Drugs Laboratory, free of cost like earlier from its 50 percent share of the monthly doses under the Liberalised Pricing and Accelerated National COVID-19 Vaccination Strategy.

Various states/UTs like Delhi and Maharashtra have been complaining about vaccine shortage along with a scarcity of oxygen and ICU beds.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

COVID-19 vaccine shortage: Uncertainity over vaccination for those above 18 from May 1

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Uncertainty continues to hover over the Central government’s announcement of opening vaccination for people between 18-45 years from May 1 due to the immediate shortage of COVID-19 vaccines, people in the know told CNBC-TV18 on Tuesday.

However, efforts are on to ramp up vaccine manufacturing. The current capacity of Serum Institute is 6-7 crore doses per month. From July onwards, SII is expected to increase its production capacity to 10 crore per month.

Similarly, the current production capacity of Covaxin by Bharat Biotech is likely to be increased from a crore vaccine doses in April to 6-7 crore vaccine dose per month in July–August. Bharat Biotech is in fact expected to reach nearly 10 crore doses per month by September 2021.

Last week, Adar Poonawalla of Serum Institute of India (SII) told CNBC-TV18 that he hopes to start supplying Covishield vaccine to states and the private sector post-May 15.

Experts say that there is a need for clarity on the supply and pricing of vaccines. Many states have expressed intent to procure vaccines but no purchase orders have been signed by any vaccine manufacturers yet.

Several states including Assam, UP, Arunachal, Punjab, Rajasthan, Delhi, Maharashtra, Punjab, Jharkhand, Karnataka are in talks with vaccine manufacturers for the procurement of COVID-19 vaccines.

The Central government on Monday asked SII and Bharat Biotech to lower the prices of their vaccines ahead of the third phase of the nationwide vaccination drive from May 1.

The Hyderabad-based Bharat Biotech has fixed the price of its COVID-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals.

SII has announced a price of Rs 400 per dose for Covishield for state governments and Rs 600 per dose for private hospitals.

Last week, the government had announced that vaccine manufacturers would make an advance declaration of the price for 50 percent supply that would be available to state governments in the open market before May 1.

Based on this price, states, private hospitals, industrial establishments may procure vaccine doses from manufacturers, the government said.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

India blessed to have a major manufacturer of global vaccines: World Bank Prez on SII

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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World Bank President David Malpass has said that with the Serum Institute, India is blessed to have a major manufacturer of global vaccines and he is encouraged by the country’s ramping up of its domestic vaccination programme. Malpass made the comments on Monday during a media roundtable ahead of the spring meeting of the International Monetary Fund and World Bank.

I’ve had substantial contact with the Serum Institute. India is blessed with having a major manufacturer of global vaccines in India, he said. Responding to a question, Malpass said that he has encouraged more transparency in terms of what the national requirements are for local production, and that extends to countries around the world.

It hasn’t been clear, whether in the United States or in Europe, or in South Africa, or in India, what the requirements are of their local production to meet local demands. I’ve been encouraged by India’s ramping up of its domestic vaccination programme, and we’re working with them on that. This is a high priority for the world, Malpass said. Because capacity constraints are immense, it takes a lot of people to do the scale of vaccination campaign that we are conducting, he said.

The Health Ministry on Saturday said that the India has administered a total of 7,06,18,026 COVID-19 vaccine doses till Friday. As such, Malpass said it is important and vital to have early delivery of vaccines to developing countries because it’s going to take a long time to actually do the vaccinations.

So, I think one of the highest priorities for the world is to begin allowing the supply of vaccines to go to developing countries themselves, including the poorest countries so that the vaccination process can get underway, Malpass said. of this year, he said, the World Bank will have 50 countries with the financing contracts in place that allow the funding to be used to buy vaccines as those become available from around the world. The bank is working actively on that, he said.

India, he said, is the World Bank’s biggest programme, and as such he mentioned climate change issues. As we work with India and the transitions that are done in order to have cleaner, lower-carbon fuels for electricity, all forms of energy is going to be one of the world’s highest challenges, and I know India is working directly on that itself. It’s an important country within the world’s mix in terms of both greenhouse gas emissions and in terms of adaptation, Malpass said.

Also Read: With rise in COVID-19 cases, India likely to make less availability of vaccines globally: Gavi

According to the Johns Hopkins University data, there are 131,666,045 COVID-19 cases worldwide with 2,858,491 deaths.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

India delays big exports of AstraZeneca shot, including to COVAX, as infections surge

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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India has put a temporary hold on all major exports of the AstraZeneca coronavirus shot made by the Serum Institute of India (SII), the world’s biggest vaccine-maker, to meet domestic demand as infections rise, two sources told Reuters.

The move will also affect supplies to the GAVI/WHO-backed global COVAX vaccine-sharing facility, through which 64 lower-income countries are supposed to get doses from SII, the programme’s procurement and distributing partner UNICEF told Reuters.

”We understand that deliveries of COVID-19 vaccines to lower-income economies participating in the COVAX facility will likely face delays following a setback in securing export licences for further doses of COVID-19 vaccines produced by the Serum Institute of India (SII), expected to be shipped in March and April,” UNICEF said in an email.

”COVAX is in talks with the Government of India with a view to ensuring deliveries as quickly as possible.”

India’s foreign ministry and the SII did not reply to requests for comment.

COVAX has so far received 17.7 million AstraZeneca doses from the SII, of the 60.5 million doses India has shipped in total, and many countries are relying on the programme to immunise their citizens.

There have been no vaccine exports from India since Thursday, the foreign ministry’s website shows, as the country expands its own immunisation effort.

”Everything else has taken a backseat, for the time being at least,” said one of the sources. Both sources had direct knowledge of the matter, but declined to be named as the discussions are not public.

”No exports, nothing till the time the India situation stabilises. The government won’t take such a big chance at the moment when so many need to be vaccinated in India.”

SOME DELAYS ALREADY

The SII has already delayed shipments of the AstraZeneca drug to Brazil, Britain, Morocco and Saudi Arabia. British authorities are in touch with New Delhi to get its second batch of 5 million doses ordered from SII.

COVAX has a deal to buy 1.1 billion doses of the AstraZeneca and Novavax shots that the SII is making in bulk, mainly for low- and middle-income countries.

UNICEF in Vietnam said in a statement on Wednesday that vaccine production issues had led to delays in deliveries to all countries that were due to receive vaccines through COVAX.

UNICEF told Reuters that COVAX had informed participating countries they would receive lower than expected volumes in March of the AstraZeneca-Oxford shot produced in South Korea.

”In line with the challenges of the current global supply environment, this is due to challenges the company faces in rapidly scaling up supply and optimising production processes for these early deliveries,” it said.

AstraZeneca has told COVAX it would make up for the delayed volumes in April and May, UNICEF said.

Indian Prime Minister Narendra Modi’s cabinet decided this week to widen its inoculation drive by including everyone above 45 from April 1, and many states battling a surge in infections have demanded that all adults be covered.

With 11.7 million cases, India has reported the highest number of coronavirus infections after the United States and Brazil.

Currently, only the elderly and those over 45 with other health conditions are eligible for vaccinations in India. Health and frontline workers were first in line when India began its drive in mid-January. India has so far administered more than 52 million doses, of which 47 million are the SII’s locally-made version of the AstraZeneca vaccine. The rest is the COVAXIN vaccine developed in India by Bharat Biotech.

The government has so far asked the SII to supply around 141 million doses. The company has also accounted for nearly all of India’s vaccine exports.

The SII plans to boost monthly production to 100 million doses from April/May, from up to 70 million now, Reuters reported earlier this month.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

First Pfizer COVID-19 vaccines to Africa under COVAX go to Rwanda

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The first doses of the Pfizer COVID-19 shots to be dispatched to Africa under the global COVAX vaccine-sharing scheme were to arrive in Rwanda on Wednesday, as efforts to inoculate the world’s poorest nations accelerate. The batch of 102,960 doses were due in Kigali hours after a flight landed carrying 240,000 AstraZeneca doses from the Serum Institute of India, the health ministry said.

Rwanda plans to start its vaccination drive on Friday, prioritising frontline health workers and others at high-risk.

”We will receive additional doses until we reach 7 million doses under COVAX, but also we will be getting them through other mechanisms like African Union,” Health Minister Daniel Ngamije said during a ceremony to receive the consignment.

Also Read: ‘How coronavirus infection interferes with heart function decoded’

The East African nation hopes to vaccinate 30% of its roughly 12 million people before the end of this year.

Rwanda’s economy, dependent on agriculture and services like hospitality, is projected by the International Monetary Fund to contract 0.2% in 2020, hurt by the pandemic. The total number of COVID-19 cases in Rwanda is 19,111, including 265 deaths as of March 2.

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Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Serum Institute pegs losses due to fire at over Rs 1000 crore; Maharashtra CM says probe in blaze on

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Serum Institute of India (SII) on Friday said it has suffered losses of over Rs 1,000 crore due to the devastating fire that erupted a day before at its premises here, even as Maharashtra Chief Minister Uddhav Thackeray said that whether the blaze was an accident or sabotage will be known once the probe gets over. Five contractual labourers died in the fire that broke out in a five-storey building in the SII’s Manjari premises in Pune on Thursday.

The chief minister visited the SII on Friday to take stock of the damages. He later addressed a press conference, where Adar Poonawalla, Chief Executive Officer (CEO) of the SII was also present. Talking to reporters, Poonawalla said, “The extent of the damage is more than Rs 1,000 crore because of the equipment and products over there that were to be launched.” He, however, reiterated that the Covishield vaccine production has not been impacted due to the blaze.

“Fortunately, we have got multiple facilities and as CM sir has explained, the COVID-19 vaccine’s supply will not be affected due to the incident,” Poonawalla added. “We were very lucky that the incident took place in the building where the COVID-19 vaccine was not being stored.

It has happened where other vaccines are being produced and we will make up that production,” he said. He added that the facility meant for Rotavirus and BCG vaccines has suffered major damages in the fire.

“But we will try and make up the supply gap in our other facilities. Mainly, the loss is financial and there will not be any loss in terms of supplies,” the SII CEO said. Poonawalla said this was a new building where additional production capacity was being put in place.

He added that the fire incident took place at the filling line and bulk production line. “These new filling lines and bulk production lines were under installation. This was brand new facility. The incident happened when the installation and other things were going on and no actual vaccine was being made there that time and it was for the future so the losses are for the future,” he said.

The Manjari facility is where Covishield, the SII vaccine against COVID-19 which is being used in the nationwide inoculation drive, is manufactured. The building where the fire broke out is one km from the Covishield vaccine manufacturing unit.

Thackeray told reporters that the stock of Covishield vaccines is safe and the fire has not hampered their production. “The probe to ascertain the cause of the fire has started and after it is complete, we will come to know whether it was an accident or sabotage. Let the investigation get complete. It is not correct to say anything now,” the CM said.

“Last week, there was a ray of hope when the vaccination drive began, but the news about the fire at the centre that is manufacturing the vaccine, came as a cause of concern. Unfortunately five people died in it,” he said. The manufacturing of COVID-19 vaccines has remained unharmed, he said.

“The first two floors of the building, where the fire erupted, were in use. The blaze occurred on other two floors above them where new facilities were being created. The Covishield vaccine manufacturing unit is located at a distance from the site of the fire,” the chief minister said. “The Serum Institute has taken up the responsibility of looking after the kin of those killed in the fire. The state government will also do whatever it can,” he said.

When Poonawalla was asked about his tweet that he posted immediately after the fire, in which he had said that the incident did not claim any life, he said, “We were relieved and happy to know that nobody has been received any injury and that is why I tweeted that information. However, after some time, the five bodies were found.” He said that all the deceased workers were employed by a contractor and the SII did not have the details about them. Dr Cyrus Poonawalla, Chairman of the Poonawalla Group said that no production of vaccines was taking place in the affected building.

“The production was to start in the building. The floors were being readied. No vaccine or any other product has been received any damage in that structure,” he said. Meanwhile, the SII issued statement saying, “The fire broke in an under-installation building of the SII plant at Manjari.” It added that it has suffered financial losses due to the fire and the incident will impact the production of BCG and Rotavirus vaccines in the future.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Wanted to be involved in India’s fight against COVID-19: Spicejet

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Spicejet has played a key role in the transport of vaccines across the country via its aircraft.

CNBC-TV18’s Anu Sharma spoke to Ajay Singh, the Chairman and Managing Director at Spicejet, to know more about their role in vaccine logistics as well as expectations from the budget.

“We wanted to be involved in India’s fight against the COVID-19 and we have started with that pretty early. We are right at the start of this crisis, we were involved in transporting COVID-19 material, PPE kits, equipment and machines etc that were required by the government in February and March of 2020 and we continue to do that through this phase,” he said.

Spicejet has been the largest carrier of vaccines. “On the first day of the vaccine transport, Spicejet carried about little more than 4 million vaccine doses, this is about 80 percent of whatever vaccines were carried out of the Serum facility,” he said.

“We continue to play a large part and hopefully we will be able to help in transporting vaccines not only throughout our country but countries around the world,” Singh mentioned.

In terms of budget, he said, “We have requested that the excise duty on ATF be removed at least for a short period of time, we have requested that IGST on reimport of parts that should be removed – it has been imposed in the past two-three years – and of course we have requested for infrastructure status for the industry. We hope that the government can look at some of these issues positively.”

“We hope that government will look at the important role that the aviation has played during the crisis crisis both in the transport of COVID-19 materials to now the transport of vaccines and the connectivity that aviation has provided, its role in opening up the economy. We hope that the government will be able to help us mitigate this crisis,” he said.

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Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Mumbai receives over 1.39 lakh Covishield vaccine doses: BMC

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Mumbai received over 1.39 lakh doses ofthe Oxford COVID-19 vaccine, Covishield, from the Pune-based Serum Institute of India (SII) early Wednesday morning, the Brihanmumbai Municipal Corporation said. This first batch of doses will be delivered across the city at designated vaccination centers for the inoculation drive set to begin on January 16, the BMC said in a statement.

The civic body said it received 1,39,500 doses of the Covishield vaccine from the SII around 5.30 am. Health department staffers of the BMC brought the vaccines from neighbouring Pune under the security of two police vehicles, it said.

”The vaccine doses are being stored at a facility in F-South ward office situated in Parel,” it stated. The civic body has also created a centralised cold storage facility for vaccines in Kanjurmarg.

Nearly 1.30 lakh health workers from Mumbai have so far registered for vaccination, according to BMC officials. Mumbai will have 72 inoculation centres, state Health Minister Rajesh Tope said in a release on Tuesday.

A minimum of 100 people will be vaccinated against COVID-19 at a single centre which will have a team of five personnel who will verify the SMS sent to the person to be inoculated, her or his identity and administer the vaccine. ”The necessary arrangement of electricity, Internet and webcasting service has been made at all these centres,” Tope said in the release.

Also Read: Mumbai airport begins COVID-19 vaccine transportation; 2,400 vials airlifted to Goa

A massive pan-India inoculation drive against COVID-19 has been set in process with more than 56 lakh doses of the Covishield vaccine leaving Pune for 13 cities across India on Tuesday. With the addition of 473 fresh cases on Tuesday, Mumbai’s cumulative COVID-19 count has reached 2,99,796, while the death toll has gone up to 11,202, as per official figures.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow