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Zydus Cadila agrees to reduce its Covid vaccine price to Rs 265 a dose, final decision soon: Sources

Zydus Cadila has agreed to bring down the price of its COVID-19 vaccine to Rs 265 a dose following persistent negotiations by the government but a final deal is yet to be reached, sources said on Sunday.

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

To administer the needle-free vaccine, a disposable painless jet applicator costing Rs 93 is required for each dose, which would take the price to Rs 358 per dose.

The Ahmedabad-based pharma company earlier had proposed a price of Rs 1,900 for its three-dose regimen, sources said.

“The company has brought down the price to Rs 358 for each dose which includes Rs 93, the cost of a disposable jet applicator, following repeated negotiations by the government…. A final decision in the matter is likely to be taken this week,” a source in the know of developments told PTI.

The three doses are to be administered 28 days apart, with each dose comprising a shot in both arms.

The indigenously developed world’s first DNA-based needle-free COVID-19 vaccine ZyCoV-D received emergency use authorisation from the drug regulator on August 20.

Meanwhile, the government is still waiting for the recommendations from the National Technical Advisory Group on Immunisation (NTAGI) for introducing ZyCoV-D in the inoculation drive for adults and children with co-morbities.

NTAGI will provide the protocol and framework for the introduction of this vaccine in the COVID-19 immunisation drive.

Official sources earlier had said that the pricing of ZyCoV-D would be different from that of Covaxin and Covishield as apart from being a three-dose vaccine, it requires a special pharma jet injector that has to be used for administering the vaccine.

That pharma jet injector can be used for administering around 20,000 doses.

“The jet applicator helps the vaccine fluid to penetrate the skin to enter cells of the recipient,” the source said.

Zydus Cadila can provide around two crore doses in November, a source had said.

The government is currently procuring two other vaccines — Covishield at Rs 205 per dose and Covaxin at Rs 215 per dose — for the national COVID-19 immunisation programme.

Covishield, Covaxin and Sputnik V are being given to only those above 18 years of age and unlike ZyCoV-D, these are two-dose regimens.

Biological E seeks DCGI’s nod for phase-3 trial of Corbevax as booster dose in those vaccinated with Covis

Hyderabad-based pharmaceutical company Biological E has sought permission from India’s drug regulator to conduct the phase-3 clinical trial for its COVID-19 vaccine Corbevax as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin.

Currently, phase 2/3 clinical trials of the second indigenously developed Corbevax, an RBD protein sub-unit vaccine to be administered in adults aged 18 years to 80 years, is underway and the results are likely to be declared this month.

The company, meanwhile, has put in an application seeking the nod of the Drugs Controller General of India (DCGI) to conduct the phase-3 clinical study of Corbevax as a single booster dose in those fully inoculated with either Covishield or Covaxin.

“Currently there are several literatures indicating the decline in antibodies in the vaccinated inpiduals, and that several countries have begun or are in the process of administering booster dose to the people who have completed the primary vaccination,” it said.

“In view of this, we are herewith submitting the application for grant of NOC to conduct a phase-3 clinical study to evaluate the immunogenicity and safety of Corbevax when administered to COVID-19-negative adult volunteers primed with either Covishield or Covaxin,” stated the application submitted to DGCI last week.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) is likely to take up the matter in its next meeting.

The DCGI in September also granted permission to the Biological E to conduct phase 2/3 clinical trials of the vaccine in children aged between 5 and 18 years with certain conditions.

The government last week said that the science relating to the use of booster doses of COVID-19 vaccines is still evolving and the developments are being closely watched.

At a press conference, NITI Aayog Member (Health) Dr V K Paul had said there are several studies that are looking into the subject of booster doses.

“This is an evolving science and a paradigm of information…that data is still emerging. We are watching this science very very carefully through our NTAGI system.

“We know that Covaxin has done a study on booster doses and those results can be available anytime…We also know that WHO has not given a clear-cut recommendation on the matter…we are watching science as it emanates and in India also, there are studies which are looking at this aspect,” he had said.

Biological E will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The Union Health Ministry finalised arrangements with Hyderabad-based vaccine manufacturer to reserve 30 crore COVID-19 vaccine doses, an official statement had said.

The Biological-E’s COVID-19 vaccine candidate has been developed with support from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC) from the preclinical stage to phase-3 studies.

Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological-E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a health ministry statement earlier had stated.

Covishield may offer over 90% protection against death from Delta variant: Study

Two doses of Covishield and

Pfizer

COVID-19 vaccines may be 90 per cent effective at preventing deaths from the Delta variant of the SARS-CoV-2 virus, according to a study published in the New England Journal of Medicine on Thursday. The study, using data from the Scotland-wide EAVE II COVID-19 surveillance platform, is the first to show across an entire country how effective vaccines are at preventing death from the Delta variant, the dominant form of the virus in many other countries.

The research team from Universities of Edinburgh and Strathclyde and Public Health Scotland analysed data from 5.4 million people in Scotland between April 1 and September 27, 2021.

During this period, 115,000 people tested positive for COVID-19 through a PCR test conducted in the community, rather than in hospital, and there were 201 deaths recorded due to the virus.

The study found that the Pfizer-BioNTech vaccine is 90 per cent effective and the Oxford-AstraZeneca vaccine, known as Covishield in India, is 91 per cent effective in preventing deaths in people who have been double vaccinated, but who have tested positive for coronavirus in the community.

“With the Delta variant now the dominant strain in many places worldwide and posing a higher risk of hospitalisation than previous variants seen in the UK, it is reassuring to see that vaccination offers such high protection from death very shortly after the second dose,” said Professor Aziz Sheikh, Director of the University of Edinburgh’s Usher Institute, and EAVE II study lead.

“If you still have not taken up your offer to be vaccinated, I would encourage you to do so based on the clear benefits it offers,” Sheikh said.

The researchers defined death from COVID-19 as anyone who died within 28 days of a positive PCR test, or with COVID-19 recorded as a cause of death on their death certificate.

The study analysed a dataset as part of the EAVE II project, which uses anonymised linked patient data to track the pandemic and the vaccine roll out in real time.

The researchers said to increase confidence in these early findings, the study needs to be repeated in other countries and settings, and with longer follow-up time after full vaccination.

They noted that because of the observational nature of the study, data about vaccine effectiveness should be interpreted with caution and it is not possible to make a direct comparison between both vaccines.

“Our findings are encouraging in showing that the vaccine remains an effective measure in protecting both ourselves and others from death from the most dominant variant of COVID-19,” said Professor Chris Robertson, from the University of Strathclyde and Public Health Scotland.

“It is very important to validate these early results in other settings and with a longer follow-up study,” Robertson added.

Covishield may offer over 90% protection against death from Delta variant: Study

Two doses of Covishield and

Pfizer

COVID-19 vaccines may be 90 per cent effective at preventing deaths from the Delta variant of the SARS-CoV-2 virus, according to a study published in the New England Journal of Medicine on Thursday. The study, using data from the Scotland-wide EAVE II COVID-19 surveillance platform, is the first to show across an entire country how effective vaccines are at preventing death from the Delta variant, the dominant form of the virus in many other countries.

The research team from Universities of Edinburgh and Strathclyde and Public Health Scotland analysed data from 5.4 million people in Scotland between April 1 and September 27, 2021.

During this period, 115,000 people tested positive for COVID-19 through a PCR test conducted in the community, rather than in hospital, and there were 201 deaths recorded due to the virus.

The study found that the Pfizer-BioNTech vaccine is 90 per cent effective and the Oxford-AstraZeneca vaccine, known as Covishield in India, is 91 per cent effective in preventing deaths in people who have been double vaccinated, but who have tested positive for coronavirus in the community.

“With the Delta variant now the dominant strain in many places worldwide and posing a higher risk of hospitalisation than previous variants seen in the UK, it is reassuring to see that vaccination offers such high protection from death very shortly after the second dose,” said Professor Aziz Sheikh, Director of the University of Edinburgh’s Usher Institute, and EAVE II study lead.

“If you still have not taken up your offer to be vaccinated, I would encourage you to do so based on the clear benefits it offers,” Sheikh said.

The researchers defined death from COVID-19 as anyone who died within 28 days of a positive PCR test, or with COVID-19 recorded as a cause of death on their death certificate.

The study analysed a dataset as part of the EAVE II project, which uses anonymised linked patient data to track the pandemic and the vaccine roll out in real time.

The researchers said to increase confidence in these early findings, the study needs to be repeated in other countries and settings, and with longer follow-up time after full vaccination.

They noted that because of the observational nature of the study, data about vaccine effectiveness should be interpreted with caution and it is not possible to make a direct comparison between both vaccines.

“Our findings are encouraging in showing that the vaccine remains an effective measure in protecting both ourselves and others from death from the most dominant variant of COVID-19,” said Professor Chris Robertson, from the University of Strathclyde and Public Health Scotland.

“It is very important to validate these early results in other settings and with a longer follow-up study,” Robertson added.

‘Vaccinating class 12 students before board exams important but impractical at present’

The demand by several states, including Kerala and Delhi, to vaccinate class 12 students before conducting board exams is a pertinent point but seems to be impractical at present, several health and education experts have said. During a high-level meeting called by Ministry of Education to decide the fate of pending class 12 board exams, Delhi Deputy CM Manish Sisodia had demanded that students be vaccinated before conducting class 12 board exams.

Noting that around 95 per cent class 12 students are above the age of 17.5 years, Sisodia had suggested that the Centre should consult experts on whether Covishield and Covaxin jabs can be given to them.

He had also recommended consulting

Pfizer

for getting vaccines for children since their trials for children have already concluded.

Assam, Maharashtra, Madhya Pradesh, Haryana and Meghalaya have also urged the central government to vaccinate teachers and students on priority to ensure their safety during their time at the test centre.

A medical expert from a leading private healthcare facility, requesting anonymity, said, “Unless you have a vaccine that is licensed for that age group, you cannot administer it. The trials for Covaxin have begun and we don’t know about Covishield’s trials for the 2 -18 years age group. Only Pfizer is the one available for aged above 12”.

“The firm is supplying vaccines to countries and it is not yet approved here and it should agree to provide vaccines to India. Even if the Indian vaccines trials are successful, there is already a shortage of them for the existing age groups eligible for vaccination. Practically, it is not feasible in the time lines,” he said.

Dr Gurpreet Sandhu, President, Council for Healthcare and Pharma, said “as we slowly move towards normalcy and with the active vaccination drive, resumption of normal activities have become a possibility, it would become important to inoculate our younger population”.

“Although it has been observed all around the world that infections in children are nearly always mild or asymptomatic as opposed to what happens in the adult population. There are very less evidence of potential for transmission in young children and therefore vaccinating can have an impact on overall transmission,” said Sandhu.

Dr Gauri Agarwal, Founder- Genestrings Diagnostic Center and Seeds of Innocence said vaccinating students ahead of exams is a pertinent point which is the need of the hour.

“It will enhance protection against severe COVID-19 infection and related complications, including MIS-C, a rare but dangerous illness in children exposed to COVID-19.

“Whenever the vaccine (Pfizer) is authorised for use in India, we must also initiate a mass awareness drive to educate parents so they don’t believe in misleading reports against vaccinating kids,” Agarwal said.

According to Akshay Budhraja, Consultant, Department of Pulmonology, students are in the vulnerable group and need to be protected from Covid.

“Trials must be done on the Indian vaccines. Covaxin’s trials are set to start. Even one shot of vaccine is very efficacious and it gives more than 80 per cent protection. The booster dose gives us protection for a long time,” he said.

Education experts are also pided on the issue with some feeling it is an impractical plan to execute ahead of exams while others advocating it as the need of the hour.

“Ideally, it would be great if we could vaccinate all the students going for their board exams. However, if we look at the current scenario, it doesn’t seem feasible. Since there aren’t enough vaccines to go around, I don’t see how all the students in the urban and rural areas will get vaccinated,” Alka Kapur, Principal, Modern Public School, Shalimar Bagh.

“Then there is the anti-vaccine lobby, comprising people who do not trust vaccines. Even though 45 plus people are being vaccinated on priority, not many have come forward. Amid such confusion and chaos, I don’t think it will be possible to vaccinate all the students appearing for the board exams,” she added.

Rajat Goel, Director, MRG School, Rohini, said in order to vaccinate the entire population of Class 12 students before making them appear for offline exams, we need at least 14-16 weeks from now and the vaccination infrastructure has to be accordingly ramped up on national level by next week for them.

“This needs quick action on the part of the government amid the time of health crisis our country is facing. Not only students but the invigilating staff must also be vaccinated fully for complete safety.

“Therefore, it is only viable to look out for an alternate mode for conducting exams rather than the pen and paper mode,” he added.

Serum Institute of India says will ship AstraZeneca Covid-19 vaccine to Canada in ‘less than a month’

Pune-based Serum Institute of India (SII) is awaiting approval from Canada’s regulatory authority to export Covishield, its vaccine against Covid-19.

“As we await regulatory approvals from Canada, I assure you, SII will fly out Covishield to Canada in less than a month. I’m on it,” Adar Poonawalla, CEO and owner SII tweeted on Monday.

In an official statement to ET, Serum said that they have applied for registration with Health Canada with the help of Toronto-based Verity Pharmaceuticals.

SII has been authorised by Oxford-AstraZeneca to make supplies in certain territories including Canada.

The government has authorised supply of 24 million doses of Covid-19 vaccines to 25 countries on a commercial basis this month.

The Ministry of External Affairs (MEA) would oversee the export of the vaccine on a commercial basis to foreign countries and international organisations.

India has so far supplied 16.7 million doses of the Oxford-AstraZeneca vaccine manufactured by SII to 20 countries.

This includes approximately 6.3 million doses that were supplied free to 13 countries — Bangladesh, Myanmar, Bhutan, Nepal, Afghanistan, Sri Lanka, Bahrain Oman and in the Caribbean. About 10 million more doses were exported on a commercial basis to Brazil, Morocco, South Africa, Algeria and Egypt among others. Commercial supplies in February will include Saudi Arabia, Myanmar, Nepal, Nicaragua, Mauritius, Serbia, UAE and Qatar.

The Trudeau government plans vaccination of all residents by September 2021 but has faltered in its goal. Cases have been on the rise in Toronto, the largest city in Canada. Canada has recorded over 800000 cases so far.

Canada though has advance purchase agreements with all vaccine makers the country has been slow in its vaccine roll out because of supply delay by companies such as Pfizer and Moderna.

Spokesperson for Health Canada said the regulator been reviewing

AstraZeneca

’s vaccine since it was submitted on October 1, 2020, and is expediting the review of all COVID-19 vaccines. This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer.

The approval it said is being done under the interim order pathway for COVID-19-related drugs and vaccines.
“An interim order is one of the fastest mechanisms available to the federal government for putting in place temporary regulations to help make health products available to address large-scale public health emergencies.

This interim order facilitates timely access for Canadians to drugs and vaccines that have demonstrated the ability to diagnose, prevent, treat or cure COVID-19. The interim order introduces temporary regulations to expedite the authorization for importing, selling and advertising COVID-19-related drugs without compromising patient safety.”, said André Gagnon Media Relations Advisor, Health Canada in an email response to ET.

( Originally published on Feb 15, 2021 )

Serum seeks marketing nod for Covishield

New Delhi: Pune-based Serum Institute of India (SII) has approached India’s drug regulator once again seeking marketing authorisation for its potential Covid-19 vaccine. The firm has submitted updated data as required by the expert panel, people in the know told ET. “SII has submitted full dose efficacy data of the UK trials and safety data from its own phase-3 trials which are ongoing in India,” said one of these people.

The SII application appears to be lacking the immunogenicity data from the phase-3 trials which experts say as per timelines would not have been ready by now. However, this was one of conditions to consider them for giving them an emergency approval.

Pfizer, too, has approached the drug regulator seeking time for making a presentation with respect to its market authorisation application. In the earlier subject expert committee (SEC) meeting on December 9 , the US company did not make a presentation to the panel and sought more time to do so.

The drug regulator is yet to fix a date for the SEC meeting, said the people mentioned earlier.

The SEC, tasked with vetting the coronavirus vaccines, had not cleared the Covid 19 vaccine market approval applications of SII and Bharat Biotech at its earlier meeting and had sought updated data from the companies.

The ten member panel said Serum Institute should submit the outcome of the assessment of the AstraZenca Oxford University trials done by the UK drug regulator.

It noted that Serum Institute had been granted approval to conduct phase-2 and 3 trials in the country on the condition that the data generated from these trials shall be considered along with the data generated from the Oxford trials. AstraZeneca-Oxford University proposal for emergency use authorisation is currently under evaluation with the UK regulator.

The committee further said Serum Institute has submitted safety data till November 14 and asked for updated safety data as well as immunogenicity data from clinical trials in India and UK.

People in the know said that Serum has submitted the required data. The moves paves the way for the company to get an approval for its potential Covid-19 vaccine, even as the subject expert committee in India is also awaiting a nod from the UK’s regulator, MHRA, to sign off on the marketing authorisation for SII to deliver the vaccines in India.

Niti Aayog member, Vinod Paul had earlier said that the Indian drug regulators were in touch with the MHRA on the approval process.

As reported by ET earlier, Covishield, the potential vaccine against Covid-19 by SII has already passed the quality test at government’s Central Drug Laboratory (CDL) Kasauli, which means that these batches can be rolled out immediately once it gets the approval from India’s drug regulator.

Covid-19: Most vaccines may cost Rs 700-1,000 per dose

(This story originally appeared in on Apr 21, 2021)

Most companies are expected to price the Covid-19 vaccines around Rs 700-1,000 per dose, when they roll out the jabs in the private market later this year, up from the government-mandated price of Rs 250 per dose.

Serum Institute CEO Adar Poonawalla had told TOI earlier in an interview that Covishield will be priced around Rs 1,000 per jab in the private market. Dr Reddy’s, which will import Russia’s Sputnik V, is expected to price it under Rs 750, though a final decision is yet to be taken.

Companies when contacted said they were yet to firm up prices as there are multiple dynamics at play. It will also depend on the quantity which they can sell in the private market, export consideration and supply chain issues.

They are also awaiting clarity from the Centre in terms of fixing the vaccine price mandated for states.

“The government procurement price (around Rs 150 per dose) is unrealistically low. We will work out a sustainable price, keeping in mind the quantity for the private market, and those which are earmarked for state governments. We have to bear in mind that the technology platforms, cell lines and equipment of each company vary, and there is also a dependence on imported raw materials (for some companies), so prices will differ,” a player which is yet to enter the market said.

Since companies have made substantial capital investments, there will also be pressure to generate better revenue and reasonable profits both through private sale and exports. In case the vaccine is imported, there are different factors to be con-sidered. In case the vaccine is foreign-manufactured and imported into the count-ry, there are different factors to be considered.

Covishield price for states slashed from Rs 400 to Rs 300 per dose: Adar Poonawalla

Serum Institute of India (SII) cut the price of its Covishield vaccine to Rs 300 from Rs 400 following calls for a reduction.

Calling it a “philanthropic gesture,” CEO Adar Poonawalla tweeted that the move “will save thousands of crores of state funds going forward… This will enable more vaccinations and save countless lives.”

It is learnt that the Centre had asked SII and Bharat Biotech, which makes Covaxin, to reduce prices.

“On Tuesday, a meeting was held between senior health ministry officials and manufacturers,” a government official told ET.

The move comes ahead of India’s plan to lower the threshold for vaccines to 18 from May 1. In this next phase, half of domestic vaccine production will go to the Centre and the rest to state governments and private hospitals.

The decision by SII is expected to build pressure on Hyderabad-based Bharat Biotech to lower prices. It 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, the world’s largest vaccine maker in terms of volume, had earlier announced a price of Rs 400 per dose for its Covid-19 vaccine for state governments and Rs 600 for private hospitals.

Both vaccines are available to the central government at Rs 150 per dose.

Many states have objected to the price differential, with Delhi chief minister Arvind Kejriwal saying this is not a time for profiteering.

In Video: Serum Institute reduces price of Covishield to Rs 300 from Rs 400 for states: Adar Poonawalla

Barbados PM requests PM Modi for access to Oxford-AstraZeneca vaccine being manufactured in India

BRIDGETOWN [BARBADOS]: Amid the rising health and economic woes caused by the pandemic, Barbados Prime Minister Mia Mottley has requested India for access to vaccines to provide immunisation coverage for their country, which has been ravaged by COVID-19.

In a letter addressed to Prime Minister Narendra Modi, Barbados PM has asked access to 200,000 doses of the Oxford-AstraZeneca vaccine being manufactured in India.

“We are in urgent need of your assistance and support at this very difficult time. Barbados is very much in need of access to vaccines to provide the necessary immunization coverage for a large segment of our population of 287,000,” the letter said.

“It is in this regard, that I am urgently soliciting the assistance of your Government to have access to 200,000 doses (for 100,000 citizens) of the Oxford-AstraZeneca vaccine being manufactured in your country. We would appreciate your kind consideration of half of the supply and, if necessary, we would be willing to purchase the other 100,000 doses should it meet your favorable consideration,” the letter further said.

Talking about the coronavirus impact, Barbados PM wrote: “We have had a 90 per cent reduction in our tourist arrivals over the last year, leading to a significant reduction in Government revenue and economic activity nationally.”

“If we are to keep control over containing the pandemic and its deleterious impact on our health services and our national security situation, it means that persons who are on the front-line of our response to COVID-19 across the medical, protective services and border agencies will need to get immediate access to vaccines,” the letter said.

This letter comes at a time when the international community has praised India’s support to the global COVID-19 response.

World Health Organization chief Tedros Adhanom Ghebreyesus today expressed gratitude to India and Prime Minister Narendra Modi for continued support for the fight against the pandemic.

“Thank you India and Prime Minister Narendra Modi for your continued support to the global COVID-19 response. Only if we #ACTogether, including sharing of knowledge, can we stop this virus and save lives and livelihoods,” Tedros tweeted.

In a bid to fight the pandemic, India has supplied COVID-19 vaccines to its neighbours including Bhutan, Malpes, Nepal, Myanmar and Bangladesh.

Large consignments of Covishield vaccine doses were flown in special Indian aircraft to Seychelles, Mauritius and Myanmar on Friday. Contractual supplies are also being undertaken to Saudi Arabia, South Africa, Morocco, Bangladesh and Myanmar.

The United States on Friday “applauded” India for gifting COVID-19 vaccines to several countries including the Malpes, Bhutan and Bangladesh, saying New Delhi is a “true friend”, which is using its pharma industry to help the global community.