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Would vaccination drive in Canada be a mixed story for Ocugen?

OCGN-US India Canada

Ocugen Inc is the US-based partner for Bharat Biotech’s Covid19 vaccine-Covaxin. The company with HQ at Malvern, Pennsylvania has announced the payment of $15 million upfront to the Indian drug maker for extending the vaccine rights to Canada. In a regulatory filing, Ocugen said that it has agreed to pay another $10 million to Bharat Biotech. It has been agreed that the payment would be made a month from the commercial launch of Covaxin in the North American country.

On June 3, Bharat Biotech said that it has agreed to expand the agreement with Ocugen Inc to commercialise the jab in Canada also. Ocugen Inc and the Indian biotech company have entered into a definitive agreement to co-develop, supply, and commercialise Covaxin for the US market.

Also See: New mutants of Coronavirus

On Monday, June 7, 2021Ocugen said, “The company further agreed to pay to Bharat a milestone payment of $10 million within 30 days of the first commercial sale of Covaxin in Canada.”

Shankar Musunuri is a co-founder of Ocugen. The company is working towards the submission of the emergency use application in the U.S. As per Musunuri, the company will simultaneously seek authorisation under interim order for emergency use in Canada. On profit sharing agreement between the two companies, Bharat Biotech had said that similar to the U.S. arrangement, Ocugen will retain 45 percent of the profit from sales of Covaxin in Canada.

Suchitra Ella is the Joint MD of Bharat Biotech. She said that regulatory approvals for Covaxin is in over 60 countries including the US, Brazil and Hungary while Emergency Use Authorisation has been obtained in 13 nations. In a statement on twitter, she said, “Application for EUL has been submitted to WHO-Geneva & regulatory approvals are expected by July-Sept 2021.”

Also Read: Indemnity from liability to be granted to vaccine manufacturers like Pfizer and Moderna

Rise and fall of Ocugen share-price

Meanwhile, Ocugen’s work towards commercialisation of the Bharat Biotech’s near-to-market coronavirus vaccine in US & Canada has seen mixed outcomes. At first the shares have surged as much as 700% from the start of the year to a peak in February. But, as per S&P Global Market Intelligence data, the shares have recently dropped by 31.1% in May. It has been interpreted that the investors were concerned because of the downward trend in Covid-19 cases in the United States. Another factor can be that Canada is slated to receive a substantial number of Pfizer and Moderna shots from US, which may be problematic for Covaxin-plan of Ocugen.

Also Read: US President Joe Biden announced vaccine distribution plans; Kamala Harris dialed New Delhi

That could hurt the chances for the company’s vaccine, which it is developing with India’s Bharat Bioscience.

A master file has been submitted by Ocugen to the U.S.FDA. The company will request Emergency Use Authorization this month and said that it will “simultaneously” request emergency authorization in Canada.

Vaccination scenario in Canada

Vaccination rollout in Canada has not been particularly smooth. The country does not produce its own vaccines, and has therefore relied on importing doses. There it has faced a lack of supply. US-based Moderna has filed for Health Canada authorization, for its Covid-19 vaccine to be used in adolescents. In a statement on Monday, the pharna-giant has said that results from a clinical trial in the U.S. last month showed their two-shot vaccine was effective in adolescents between the ages of 12 and 17.

As more Canadians get their first and second jabs, Canada is scheduled to receive 2.4 million doses of the Pfizer-BioNTech Covid-19 vaccine, this week. Those shots of Pfizer are the only expected shipments in what should be a comparatively quiet week of vaccine deliveries to Canada.

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A preprint study said Covishield Produced More Antibodies than Covaxin

covishield

A preliminary study by Coronavirus Vaccine-induced Antibody Titre (COVAT) found out that the Covishield vaccine produced more antibodies than Covaxin. The study involved healthcare workers (HCW) who have received both doses of either of the two vaccines.

In Covishield recipients, the seropositivity rates to anti-spike antibody were significantly higher as compared to that in Covaxin recipients after the first dose, as claimed by the study.

It said that both vaccines Covishield and Covaxin elicited a good response after two doses. But seropositivity rate and median anti-spike antibody were significantly higher in Covishield.

Also Read: Get revaccinated; US universities tell Indian students who took jabs of Covaxin & Sputnik V

The study said, “Amongst the 552 HCW (325 Male, 227 Female), 456 and 96 received the first dose of Covishield and Covaxin respectively. Overall, 79.3 per cent showed seropositivity after the first dose. Responder rate and median (IQR) rise in anti-spike antibody were significantly higher in Covishield vs Covaxin recipient (86.8 vs. 43.8 per cent; 61.5 vs 6 AU/ml; both p<0.001).”

The study involved those HCWs who have been administered either of the two vaccines, Covishield and Covaxin, and are with or without past history of SARS-CoV-2 infection.

Also Read: An uncertain wait for vaccines by India despite a liberalized regulatory framework

The study also said, “This ongoing, Pan-India, Cross-sectional, Coronavirus Vaccine-induced Antibody Titre (COVAT) study is being conducted amongst HCW, with or without past history of SARS-CoV-2 infection. SARS-CoV-2 anti-spike binding antibody is being assessed quantitatively at four time-points between 21 days or more after the first dose to 6 months after the second dose.”

Also See: New mutants of Coronavirus

On immune responses generated, the study said, “While both vaccines elicited immune response, seropositivity rates to anti-spike antibody were significantly higher in Covishield recipient compared to Covaxin after the first dose. Ongoing COVAT study will further enlighten the immune response between two vaccines after the second dose.”

Important note

The study is a preprint and is being peer-reviewed. It has been submitted to a journal but appears as a preprint in MedrXiv, an online repository. It is among the few studies of the real-world effectiveness of vaccination in India. As of now, the study should not be used to guide clinical practice.

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1st dose of vaccine jab: India overtakes US

vaccine

As India finds itself caught amidst Covid scare and dearth of vaccines, the government has claimed that the country has overtaken the United States in terms of the number of people who have received the first dose of COVID-19 vaccine.

“As per the data, the number of people who have received at least one dose of vaccine in India is 17.2 crore. We have overtaken the US in terms of the number of people in our country who have received the first dose of vaccine,” said Member Health NITI Aayog Dr VK Paul.

Asserting that country needs more time to achieve high coverage of vaccination, he said: “When the peak is declining and we suddenly get into same behaviour as a society like in January and February, it (the virus) will come back again in a certain way. We have to buy time to ensure that we achieve high coverage of our vaccination.”

Meanwhile, Union Health Ministry’s Joint secretary, Lav Agarwal commented about the drop in the number of active cases, and said, “There has been a continuous decrease in districts reporting more than 100 average daily new cases; 257 districts report more than 100 daily cases.”

On the other hand, Prime Minister Narendra Modi on Friday said that the wastage figures of Covid vaccines continue to be on the higher side and asked authorities to take steps to tackle this issue.

“PM instructed that vaccine wastage numbers are still on the higher side and steps need to be taken to bring them down,” said the statement.

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Pfizer’s vaccine may arrive in India by July; agreement coming in final shape

After wasting almost a year in terms of vaccine procurement, central government is now gradually easing the norms for procurement of vaccines from pharmaceutical giants abroad. This comforting news comes as the Covid19 threat has amplified in the second wave and with the arrival of new mutants.

Also See: New mutants of Coronavirus

Steps are being taken for clearing the deck for the foreign-made vaccines for use in India and building an in-principle consensus on an indemnity waiver. As a result, the government officials expect that Pfizer’s vaccine supply can be made available by July. Price negotiation on Pfizer’s vaccine is underway between the firm and GOI.

The agreement between the government and the US-based drug maker is still to get its final shape, though both have arrived at an in-principle consensus.

GOI may give a complete waiver to foreign-made vaccines that have been approved for restricted use by the US FDA, EMA of EU, Medicines and Healthcare Products Regulatory Agency, UK, Pharmaceuticals and Medical Devices Agency, Japan.  Additionally, the waiver is expected for those vaccines which are mentioned in the WHO Emergency Use Listing.

Also Read: Indemnity from liability to be granted to vaccine manufacturers like Pfizer and Moderna

Pfizer, which promises to make 5 crore doses of vaccines available between July and October, is planning out a mechanism whereby a price can be fixed with the states and UTs. The centre is chalking out a price mechanism where the states can directly purchase the jabs from the firm at the fixed rate.

Final signing of the agreement may take a few days. For any company which intends to import the vaccines, a formal application has to be made, with documents of approval secured abroad. It also needs emergency use authorization from the drug regulator of the country where the vaccine would be imported.

Also Read: An uncertain wait for vaccines by India despite a liberalized regulatory framework

India firm Cipla with another US-based drug company, Moderna is looking forward to committing over USD 1 billion as advance for procurement of  Moderna’s single dose Covid19 booster vaccine in India. The American drug maker has begun the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults in US.

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Indemnity from liability to be granted to vaccine manufacturers like Pfizer and Moderna

Pfizer Moderna vaccine

After losing a substantial time since the Covid19 pandemic struck India last year, government is slowly doing the necessary to ramp up vaccination in the country.

Central government may grant a major concession demanded by pharmaceutical giants like Pfizer and Moderna. The vaccine manufacturing companies would be provided indemnity from liability. This would be done to speed up the approval of the companies in India, when the nation is staring at an uncertain future of vaccination.

Sources in Health ministry have stated that other countries have done it and that there is no problem in granting indemnity. The companies are looking for indemnity or legal protection from any claims linked to the use of the vaccine manufactured by them.

The sources said, “If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity.”

Also Read: An uncertain wait for vaccines by India despite a liberalized regulatory framework

In a parallel development, the drug regulator, Central Drugs Standard Control Organisation (CDSCO) has exempted the companies from India-specific trials for foreign vaccines. The vaccines which have been approved by specific countries and World Health organization have been made free of the requirement of India-specific trials for emergency use. Such trials are known as post-launch bridging trials. This was demanded by companies like Pfizer and Cipla.

Even with this rider given by DCGI, the head of CDSCO, it will take some time for pharma-firms like Pfizer and Moderna to join into Indian vaccination programme. It is because they have paid-orders from other countries to be fulfilled first.

It is worthwhile to note that as part of vaccine diplomacy, India has supplied around 60 million doses of vaccines to around 70 countries, and is now reeling in vaccine deficiency.

Between July and October, Pfizer would be providing 5 crore doses to India and has stressed on the manufacturer indemnity in its talks.

There was requirement that “every batch” of vaccine to be tested by the Central Drugs Laboratory (CDL) in Kasauli, provided “the vaccine batch/lot has been certified and released by the National Control Laboratory of the country of origin”. This condition has now been removed for the companies with WHO-approved vaccines, which are keen to join Indian vaccination drive.

Also See: New mutants of Coronavirus

On June 1, US-drug maker Eli Lilly said that it had received approval for restricted emergency use of its antibody cocktail drugs, bamlanivimab 700mg and etesevimab 1400mg, in India. This combination would be used for the treatment of patients with mild to moderate coronavirus disease (COVID-19). These two are in fact monoclonal antibodies, which mimic the spike protein on the surface (corona) of the Coronavirus. This helps trigger immune response in the body against the Covid19 virions.

Cipla is looking forward to committing over USD 1-billion as advance to the US major-Moderna’s single-dose Covid-19 booster vaccine in India. For this purpose, the company is seeking to fast track approvals for Moderna expeditiously. The Indian firm has requested the government for indemnification and exemptions from price capping, bridging trials and basic customs duty.

While it is close to a major vaccine-deal in India, Moderna has begun the process to win full US regulatory approval for the use of its COVID-19 vaccine in adults in US.

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Union health ministry said that mixing of Covid-vaccines is not a protocol yet

Covid-vaccines

Union Health Ministry on Tuesday said that the mixing of vaccines against Covid19 is not the protocol till further updates. The Ministry said, “The same vaccines (Covishield and Covaxin) will be administered for both doses. There is international research underway on the mixing of vaccines as the possibility of a positive effect is also plausible but a harmful reaction cannot be ruled out either. It is an unresolved scientific question, science will settle it.”

Also Read: An uncertain wait for vaccines by India despite a liberalized regulatory framework

Earlier, it was reported that India might soon begin testing the feasibility of a regimen that mixes two different Covid-19 vaccines to see if it helps boost immune response to the virus. Feasibility study for this purpose is being seriously contemplated by the central government.

The feasibility testing may be carried out both by using vaccines that are currently available in the country, and those that are in the pipeline.

 Also Read: Issues faced by India in dealing with Covid 19 resurge- Is it too late to contain the Second Wave

Dr N K Arora, chairman of the Covid-19 working group under the National Technical Advisory Group on Immunization (NTAGI) on Monday told a national daily that work is expected to begin “in a few weeks”.

As part of the process of feasibility study, approximately eight vaccines may be mixed and matched, Dr Arora said.

The eight vaccines include the three vaccines that are currently approved for use in the country, Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, and the Russian made Sputnik-V. Collaboration between bodies like the Indian Council of Medical Research and the companies that developed and produced the vaccines will carry out the clinical testing as part of the exercise. The feasibility tests will study different factors such as whether vaccines based on different platforms can be given together. The study would also cover which vaccines to administer in the first and second doses.

A consignment, comprising as many as three million doses of Russia’s Covid-19 vaccine-Sputnik V, the biggest tranche so far, landed at the Rajiv Gandhi International Airport in Hyderabad, earlier on Tuesday. Dr Reddy’s Laboratories and Russian Direct Investment Fund are in a pact to sell the first 125 million people doses (250 million vials) of Sputnik V in India. DRL has received approval from the Indian drug regulator (CDSCO) for restricted emergency use of Sputnik V.

Meanwhile, the Supreme Court has put forth some tough questions for centre, on vaccinations. It has raised question on the deadline declared by the GOI for immunizing the entire eligible population in the country. The Apex court has also asked on what basis the population in the 45+ age group is being chosen for free vaccination, when those in the age group of 18-44 continue to suffer the most.

The central government has pretty formidable tasks ahead in terms of vaccination against Covid19, when there is a talk of a third wave, and when it practically wasted the last 11 crucial months for preparation.

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Path from Vaccine maitri to waiting for Sputnik-V shipments from Russia- India set to receive first doses of Sputnik-V

As Covid-19 cases and deaths have surged in India, on Saturday, the country is set to receive its first doses of Sputnik-V, the Russian-made vaccine against the coronavirus disease. More than 300,000 new infections have been reported daily for nine days in a row, with 386,452 cases reported on Friday.

This delivery of Sputnik V is part of a larger partnership between Moscow and New Delhi to produce 850 million Sputnik vaccines. Priced at $10 a shot, this vaccine is a cheaper alternative to the Western substitutes. Further shipments could ease the current public health crisis, over the coming months, provided the government can administer the shots quickly.

Also See: New mutants of Coronavirus

On March 11 the ‘Vaccine Maitri’ programme completed 50 days. By that time, India had supplied around 60 million doses of Made-in-India Covid vaccines to 70 countries across the world. The central government was slurping its fingers in self-adulation and an unabashed dose of hubris. By April end, the situation changed to a diametrically opposite situation. India is now looking forward to vaccine shipments from other countries.

Also Read: Issues faced by India in dealing with Covid 19 resurge- Is it too late to contain the Second Wave

Shortage of vaccines and a high infection rate will likely hamper vaccination efforts. The Sputnik deal, in the medium-term, along with other foreign aid, will likely curb the second wave by Autumn. The second wave of Coronavirus may also delay India’s economic recovery if the government re-imposes lockdown restrictions. There would be economic dampening if the variant spreads to other countries, prompting further outbreaks and lockdowns that damage global trade.

Far from being a self-reliant source of vaccine, the international image of India has been transformed into that of desperation. Any country’s vaccine manufacturing capabilities is measured by its flu-shot producing capacity and the agility with which it can be used for Covid19 vaccines. Seasonal flu is not a common vaccine in India and consequently share of India to the global output is at around 21%. That far away from what it takes to be self-reliant or the hubristic atma-nirbhar in vaccine production. The scenario in medical Oxygen production is even murkier.

Therefore, India is now waiting for shipments, and aid from other countries like Russia, US, and other powers from EU.

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Covid19 News: Update of vaccine dry-runs in various states in India and resumption of flight operations and restrictions to prevent virus-spread

The flight operations between India and the United Kingdom will resume from January 8, Union Civil Aviation Minister Hardeep Singh Puri said on Friday. The operations will be restricted to 15 flights per week till January 23 for carriers of the two countries to and from Delhi, Mumbai, Bengaluru, and Hyderabad only, the Minister further said. Pune makes medical checkups mandatory for travellers from Europe and  South Africa.

Reuters quoted sources close to development as saying that the Drug Controller General of India (DCGI) on Friday approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use. The Oxford-AstraZeneca Covid19 vaccine Covishield, being manufactured by Serum Institute of India, was reportedly recommended to the drug controller by a Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO). The SEC will make appropriate recommendations to the DCGI which will take the final decision, the ministry said. Bharat Biotech is developing Covaxin in collaboration with the Indian Council of Medical Research.

As many as 20,035 new cases of coronavirus cases were detected in India on the last day of 2020, taking the total number of infections to 1 crore and 2.86 lakh. Of these, about 8.24 lakh were detected in December, the lowest since July. December has recorded the lowest number of infections since July.

Meanwhile, the World Health Organization has cleared the Pfizer-BioNTech coronavirus vaccine for emergency use, which means poorer countries may soon access the shot already available in Europe and North America. On late Thursday, the global body had said that the decision to issue its first emergency use validation for a coronavirus vaccine “opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.” The UN health agency said that its review found that the Pfizer-BioNTech vaccine, which has already received clearance in the United States, Britain, the European Union and a dozen other countries, “met the must-have criteria for safety and efficacy set out by WHO.”

Covid vaccination dry run to begin in seven Chhattisgarh districts on January 02

A dry run to assess preparedness to roll out the COVID-19 vaccination drive will be conducted in seven districts in Chhattisgarh on Saturday, an official said. The dry run will be conducted in three centres in each of the seven districts, namely Raipur, Surguja, Bilaspur, Rajnandgaon, Durg, Bastar and Gaurela-Pendra-Marwahi (GPM), as stated by state Mission Director of National Health Mission (NHM) Priyanka Shukla.

District hospital, community health centres (CHCs), and primary health centres (PHCs) have been selected as centres for the exercise which will start from 10 am onwards and 25 people will be part of the dry run in each centre, as said by Shukla, who is also the nodal officer for the state’s COVID-19 vaccination drive.

“During the mock drill, assessment of cold chain management, vaccine supply, storage and logistics along with management of entry, registration, vaccination and observation of persons who will be administered the vaccine, will be carried out,” Shukla informed.

Lucknow to hold the inoculation dry runs at 6 places on January 02

A total of 15 people died of Covid-19 and 871 tested positive for it in the 24 hours from morning December 31 to morning 8 am January 01 in Uttar Pradesh, taking the death toll due to the disease in the state on Friday to 8,379 and total cases of infection to 5,86,751. A dry run for vaccination against Covid-19 would be held at six places in the state capital on Saturday, Additional Chief Secretary (Health) Amit Mohan Prasad said in the state’s daily health bulletin. He also added that the government is making all preparations for administering vaccines.

The active cases in the state stood at 13,831 with 5,924 people recuperating at home and 1,291 in private hospitals, Prasad said. The number of those cured has gone up to 5,64,541 with the recovery rate clocking 96.21 percent now in the state, he added.

Restrictions to prevent virus-spread

In India, Delhi had announced night curfew on New Year’s Eve, restricting more than five people to assemble at a public place. Maharashtra had also announced night curfew. Restrictions in the city of Ahmedabad were placed on the New Year Eve from 10 pm on December 31 to 6 am on January 01.

(Source: PTI)

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Oxford vaccine to begin phase 3 trial soon. Here’s all you need to know

As India continues to log the highest number of coronavirus cases daily in the world since August 8, there comes a ray of hope as government’s think-tank Niti Aayog has said that a vaccine for coronavirus will enter the third phase of clinical trials in India anytime now.

The vaccine which will be tested is the one developed by UK’s Oxford University, Niti Aayog chief VK Paul said media.

The clinical trial document of the Serum Institute — which is in charge of mass manufacturing the vaccine of Oxford University, currently dubbed “Covishield” — shows that 1,600 subjects will be tested at 17 hospitals across the country including AIIMS Delhi and Jodhpur. The trial will take seven months.

Meanwhile, the Chinese vaccine developed by Sinopharm is said to be available by December 2020 and will cost Rs 10,000 for two doses, as per a Global Times report. Australian Prime Minister has assured that the COVID19 vaccine will be made available for free for its citizens.

He said that the central government has reviewed these experimental coronavirus vaccine candidates. He said that potential coronavirus vaccines are making good progress. He also said that the outline of the Coronavirus vaccine administration and supply chain is ready.

In his Independence Day address to the nation from the ramparts of Red Fort, PM Modi had promised that the vaccine, once developed, will reach every Indian.

“Three vaccines are in different stages of testing. When scientists give the go-ahead, we are ready with a plan for production. How the vaccine will reach every Indian in the least amount of time – we have a roadmap ready for that,” the Prime Minister had said.

India’s other two indigenous vaccines which are undergoing human trials. These are COVXIN and ZyCoV-D. Covaxin is being developed by Bharat Biotech, Indian Council of Medical Research (ICMR), and National Institute of Virology, Pune. COVAXIN already completed phase 1 human trials in just one month. It had begun its Phase 2 human trials. Human trials of COVAXIN are going on in 12 sites across India. Zydus Cadila is developing the other potential COVID vaccine ZyCoV-D. Meanwhile, the Pune-based Serum Institute is also beginning the phase 3 human trials of Oxford-AstraZeneca’s coronavirus candidate.

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Gates foundation ties up with Pune Serum Institute for 100 million Covid19 vaccines

After the deal with the American based vaccine developer – Novavax, the Serum institute of Pune has finalised a deal with the Gates Foundation and Gavi, the global vaccine Alliance. The deal has been made for 100 million doses of Covid19 vaccine for India as well as other low and middle income category countries (LMICs) by the year 2021.

The Gates foundation would provide at risk funding of $ 150 million to GAVI, which will then finance the Serum Institute (SII) to manufacture the vaccines. Gavi stands for global alliance for vaccines and immunisation, a public- private global health partnership with important contributions and inputs from the World Bank, the World Health Organization and UNICEF. To obtain the vaccine for other low and middle income countries, Gavi’s Covax AMC will work with the Serum institute. AstraZeneca and Novavax, the candidate vaccines from the Oxford University would be procured using the funding after getting required licences and WHO pre-qualifications. Subsequently the SII would start manufacturing the vaccine. A price ceiling has been kept at $3(approx. INR 225).

It should not be surprising given India’s track record in delivering high quality low cost research in medical field. In June, Gavi Covax AMC(Advanced Market Commitment), a financing instrument was launched to boost the production of sufficient number of vaccines for the LMICs. As of now, it is looking for a seed fund of $2 billion after finalising the list of 92 countries where it will make the vaccine available. If the AstraZeneca vaccine is successful, GC AMC will make it available in 57 countries which are Gavi eligible. If the Novavax is successful, then AMC will make it available to all the 92 countries. Any country’s gross national income data as available from World Bank sources determines whether it is Gavi eligible or not. Drugs controller general of India has already given a green signal to Serum institute to conduct Phase II and Phase III human clinical trials of the AstraZeneca candidate vaccine.