Bharat Biotech | Business Upturn

India’s first nasal covid-19 vaccine gets nod from DCGI

Pranay Maniar — Tue, 06 Sep 2022 10:15:44 +0000

The DCGI approved Bharat Biotech’s first intranasal Covid vaccine on Tuesday for use as the primary immunisation against the infection in adults above 18.

Lauding the achievement, Health Minister Dr Mansukh Mandaviya said, it is a ‘Big Boost to India’s Fight Against COVID-19’

Mandaviya tweeted, Big Boost to India’s Fight Against COVID-19! Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in the 18+ age group for restricted use in an emergency situation.

Big Boost to India's Fight Against COVID-19!

Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.

— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022

Bharat Biotech stated last month that it had conducted two separate trials for its intranasal Covid vaccine, one as a primary dose schedule and another as a booster dose, for subjects who have been double vaccinated with the two commonly administered Covid vaccines in India. These trials were phase-III and booster dose trials for the intranasal Covid-19 vaccine.

According to a statement from BBIL, it has been shown in controlled trials to be secure, well-tolerate any-to-administer in participants.

According to the firm, national regulatory authorities have received the data from both of the Phase III human clinical trials that have been filed for approval.

“If approved, this intranasal vaccine will make it easier to deploy in mass immunisation campaigns with an easy to administer formulation and delivery device. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern,” Bharat Biotech joint managing director Suchhitra K Ella said.

Japan lists Bharat Biotech’s Covaxin as recognized COVID-19 vaccine

Keertiman Upadhyay — Thu, 07 Apr 2022 12:55:19 +0000

On Thursday, April 7, the government of Japan has listed India’s indigenously made Covaxin as a recognised vaccine. Covaxin is developed by Bharat Biotech.

The Indian Embassy in Japan informed the development on Twitter. “Government of Japan includes the indigenously developed and manufactured COVID-19 vaccine Covaxin by Bharat Biotech of India, as one of the recognised vaccines for 1st and 2nd dose with effect from 10 April 2022 to further facilitate travel from India to Japan,” tweeted the embassy.

Government of Japan includes the indigenously developed and manufactured COVID-19 vaccine COVAXIN by Bharat Biotech of India, as one of the recognised vaccines for 1st and 2nd dose with effect from 10 April 2022 to further facilitate travel from India to Japan#IndiaJapanat70 pic.twitter.com/6Rk7iAXLxb

— India in Japanインド大使館 (@IndianEmbTokyo) April 7, 2022

The World Health Organisation (WHO) has recently halted the supply & procurement of Covaxin citing some issues at the company’s facility. WHO has further recommended the countries that are using Covaxin to “take actions as appropriate.”

Bharat Biotech has said that appropriate action will be taken to resolve the issues soon. The company has also slowed down its production after WHO’s statement but the recognition by Japan can be good news for the company.

Bharat Biotech’s MD Krishna Ella & Joint MD Suchitra Ella awarded Padma Bhushan award

Keertiman Upadhyay — Mon, 28 Mar 2022 12:33:34 +0000

On Monday, March 28, Bharat Biotech’s Managing Director Krishna Ella & joint MD Suchitra Ella were awarded Padma Bhushan by President Ram Nath Kovind. A total of 74 distinguished personalities were conferred with Padma awards.

Bharat Biotech has made noteworthy achievement by developing the first indigenous COVID-19 vaccine, Covaxin. The company has made every effort to provide the vaccine at the cheapest rate all over the world.

Dr. Krishna Ella was born in 1969, in a Telugu speaking agricultural family. Ella started his career with a pharmaceutical company, Bayer. In 1996, he set up a lab in Hyderabad & named it Bharat Biotech. Suchitra Ella wife of Krishna is the joint MD of the company. She oversees the operation of the company & has played a crucial role to make Bharat Biotech a leading vaccine maker.

Actor Victor Banerjee, Odia writer Dr Pratibha Ray, Acharya Vashishtha Tripathi are the others who received the Padma Bhushan. Padma Bhushan is awarded for the distinguished service of a high order. The Union Home Ministry had announced the name of the recipients in January of this year.

FDA approves Bharat Biotech’s Covaxin for clinical trials in adults in US

Sathvika Chelakani — Mon, 07 Mar 2022 15:32:00 +0000

The US Food and Drug Administration has approved Bharat Biotech’s COVID-19 vaccine Covaxin for clinical trials in adults (FDA). Bharat Biotech and its US partner Ocugen expressed their commitment to bringing Covaxin to the US and Canada for all age groups in a statement issued on Monday.

According to the statement, Covaxin has been cleared by the US FDA for adult clinical trials.
“Recently, the US Food and Drug Administration (FDA) approved Ocguen’s phase 2/3 investigational drugs application for Covaxin for conducting clinical trials in adults,” according to the statement. It also stated that Ocugen intends to continue working with the FDA to evaluate the regulatory pathway for Covaxin’s pediatric use.

Notably, Hyderabad-based Bharat Biotech previously announced that Covaxin will be tested as a vaccine candidate for the disease in the United States.

“Ocugen, Inc. (NASDAQ: OCGN) announced that the US Food and Drug Administration (FDA) has lifted its clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, also known as Covaxin outside the US. In the United States and Canada, Ocugen, Inc is co-developing Bharat Biotech’s Covaxin vaccine candidate for COVID-19 with Bharat Biotech,” read the statement from Bharat Biotech.

CDSCO extends Covaxin’s shelf-life to 12 months from the date of manufacturing

Cheryll Jain — Wed, 03 Nov 2021 12:37:35 +0000

Vaccine maker Bharat Biotech on Wednesday, November 3 revealed that the shelf-life of its COVID-19 vaccine Covaxin has been extended to 12 months from the date of manufacture. Prior to this, the shelf-life of Covaxin had been set at 6 months from the date of manufacture, subject to its storage at two to eight degrees Celcius.

In a statement, Bharat Biotech announced that the Central Drugs Standard Control Organisation (CDSCO) approved its request to extend the shelf-life of the vaccine based on additional stability data that the vaccine maker provided to the regulatory body.

The announcement comes just in time as the World Health Organisation has reportedly approved Bharat Biotech’s Covaxin for its Emergency Use Listing after deliberating on the additional data provided to the Technical Advisory Group of the WHO by the Hyderabad-based company.

Bharat Biotech had been looking to increase Covaxin’s shelf-life to 24 months from the date of manufacture and had sought permission for the same from the Drug Control General of India (DCGI) earlier this year in July.

Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech had earlier stated that it has concluded the final analysis of Covaxin efficacy from Phase three trials.

Covaxin is currently one of two COVID-19 vaccines being widely administered in India and has been a crucial factor in the accelerated vaccination drive of India. Outside of India, the vaccine has received regulatory clearance in countries such as Iran, Mexico, Mauritius, Nepal, Oman and Greece.

Australia became the latest country to join the list of nations to have recognised people administered with Covaxin as fully vaccinated on Monday, November 1.

Cannot play with lives of people by ordering revaccination with Covishield without any data: SC

Ayisha Farah — Fri, 29 Oct 2021 15:24:21 +0000

On Friday, The Supreme Court said that it could not play with people’s lives by ordering the Centre to revaccinate people with Covishield who are completely vaccinated by Covaxin to allow them to travel overseas during the COVID-19 pandemic.

The top court was trying a petition that said that Covaxin was not recognised by the World Health Organisation (WHO). People here are encountering challenges in obtaining approval to travel overseas. A bench of Justices DY Chandrachud and BV Nagarathna said that the court does not have any data on the people’s impact, and it cannot simply address the Centre to revaccinate people with Covishield.

“We cannot play with the lives of people by directing Centre to revaccinate. We don’t have any data with us. We have read in newspapers that Bharat Biotech has filed an application with the World Health Organisation for recognition. Let us wait for the response of WHO. We will take up this matter post-Diwali vacation,” the bench said.

Advocate Kartik Seth, arriving in person, disputed that some students and people are ready to go overseas every day. Still, they are refused entrance as the WHO does not acknowledge Covaxin.

He said that under the existing mechanism, a person vaccinated with Covaxin could not register themself on the CoWIN portal to receive the Covishield vaccine, and a command can be assigned to the Centre in this concern.

“We cannot pass a direction to administer another vaccine without any data. We understand your concern but let’s wait for the WHO’s response,” the bench said.

The highest court said that there is also concern that opponents may try to take benefit of the litigation in the form of the PIL. Seth said that his PIL is completely a Public Interest Litigation as many students who go abroad to study are denied entry in multiple countries.

The plea registered by Seth said that at the time of working out of Covaxin, the government did not make the public conscious that WHO did not recognise it. It said that Bharat Biotech had submitted its application for approval as late as April 2021, and in May, people came to know many countries are not allowing entry of those who are vaccinated with vaccines other than those listed in WHO’s emergency use list.

The plea pleaded for a command to the concerned department and published official data and reasons for the lag in receiving approval to Covaxin produced by Bharat Biotech.
It also asked for directions for revealing the actual data and records to WHO to obtain consent in favour of Covaxin.

Covaxin approval delayed as WHO asks for additional data from Bharat Biotech

Cheryll Jain — Wed, 27 Oct 2021 05:45:07 +0000

World Health Organisation’s Technical Advisory Group (TAG) on Tuesday, October 26 sought additional clarification from Hyderabad-based vaccine maker Bharat Biotech to evaluate a final risk-benefit assessment of its domestically developed COVID-19 vaccine Covaxin.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India. However, Covaxin has yet to receive the recommendation of WHO for its Emergency Use Listing (EUL).

Additional data from the vaccine maker by the Technical Advisory Group was necessitated just hours after WHO official Dr Margaret Harris had claimed that Covaxin’s recommendation was expected under 24 hours on accounts of all assessments going well.

“Now if all is in place, and all goes well, and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so,” she stated earlier on Tuesday. The TAG will now reconvene on November 3 for the final EUL assessment if the data asked of Bharat Biotech is provided by them soon.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides guidance to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.

Bharat Biotech had submitted an Expression of Interest (EOI) to the World Health Organisation on April 19 to be granted approval for Covaxin to be administered under Emergency Use Listing. The WHO has so far approved COVID-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

Covaxin has so far proved 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent protection against the new Delta variant. In June, Bharat Biotech had confirmed that it had concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech’s Covaxin gets approval for emergency use for children aged 2-18 years

Ayisha Farah — Tue, 12 Oct 2021 08:46:32 +0000

The Subject Expert Committee (SEC) of the drug regulator has suggested allowing an emergency use authorisation to Bharat Biotech’s Covaxin for children aged between 2-18. The SEC has presented its proposal to the Drugs Controller General of India.

The data of Phase 2/3 clinical trials had been recently presented by Bharat Biotech to the DCGI. Two doses of Covaxin are expected to be distributed to children with a gap of 28 days. The government has set an interval of 4-6 weeks for adults between the two shots.

This is the second COVID-19 vaccine to receive approval for children in India. “After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the subject expert panel said in a statement.

However, the emergency use authorisation is subjected to specific circumstances. The developer of Covaxin will maintain the research as per Whole Virion, Inactivated Corona Virus Vaccine, the approved clinical trial protocol. It will have to present updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet.

Furthermore, the firm should present safety data, which includes the data on AEFI and AESI, with the due examination every 15 days for the first two months and months after that and as per New Drugs & Clinical Trials Rules, 2019, it said. The drugs regulator had initially recommended ZyCoV-D for children aged 12 and above as well as adults. However, the distribution has not taken place.

Phase 2/3 trials of Bharat Biotech’s Chikungunya vaccine begins

News Desk — Wed, 25 Aug 2021 07:47:12 +0000

On August 25, The International Vaccine Institute (IVI) has announced that the first participant received Bharat Biotech’s Chikungunya vaccine candidate (BBV87) in a Phase 2/3 clinical trial in Costa Rica.

The development is the start of a multi-country study led by IVI in partnership with Bharat Biotech and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India, it said.

Krishna Ella, Chairman and Managing Director of Bharat Biotech International Limited, said–Epidemic preparedness is a vital step in public health care. Bharat Biotech’s vaccine candidate is an ingenious, well-researched vaccine, and we thank the first volunteer from Costa Rica for participating in this study. The IVI-led multi-country scale human trial has begun an important trial phase in furthering the evaluation of safety and immunogenicity. The announcement furthers CEPI’s USD 3.5 bn plan, launched in March 2021, to tackle future epidemics and pandemics, which includes advancing vaccine candidates against known high-risk pathogens such as Chikungunya.

CEPI first partnered with IVI and Bharat Biotech in June 2020, providing up to USD 14.1 million for vaccine manufacturing and clinical development of the BBV87 vaccine candidate. The funding is supported by the European Union’s (EU’s) Horizon 2020 programme through an existing framework partnership agreement with CEPI. The consortium was also supported with a grant of up to US D2.0 million from the Indian Government’s Ind-CEPI initiative to fund the set-up of GMP manufacturing facilities for the vaccine in India and subsequent manufacture of clinical trial materials, release added.

Bharat Biotech’s COVAXIN to get WHO approval by August-end: Report

Sneha Sengupta — Wed, 11 Aug 2021 11:29:06 +0000

Bharat Biotech manufactured Covaxin most probable to be globally authorised by August-end, according to the latest reports by CNN News 18. The vaccine is seeking to get World Health Organisation (WHO)’s approval for emergency use on global terms.

As per News18, WHO officials and Health Minister Mansukh Mandaviya will meet today to negotiate on WHO’s approval for Covaxin. The government has reportedly followed due diligence for the authorization, appealed during the first week of July.

On July 28, the Minister of State for Health Bharati Pravin Pawar told Rajya Sabha that all the required documents for Emergency Use Listing (EUL) have been duly submitted by Bharat Biotech to WHO.

Earlier today, the Drugs Controller General of India (DCGI) had passed a trial of a mix of Covishield and Covaxin, conducted in Christian Medical College, Vellore.

The approval comes after 11 days once the Subject Expert Committee (SEC) of the CDSCO (Central Drugs Standard Control Organisation) suggested the grant for the mix-and-match test and trial.

A thorough study conducted by ICMR with 98 people, 18 of whom incidentally received the Covishield vaccine earlier as the first dose and Covaxin as the second dose in Uttar Pradesh showcased that this combination of vaccines has proved to be more propitious with improved immunogenicity of both the vaccines.

This study also featured immunisation that was secure wherein the adverse effects were discovered to be similar to the same dose regimen.

Brazil discards Covaxin’s application for emergency use

Diya S. — Sun, 25 Jul 2021 11:48:39 +0000

As reported by The Wire, National Health Surveillance Agency i.e. Agencia Nacional de Vigilancia Sanitaria (ANVISA) has decided to discard Bharat Biotech-manufactured Covaxin’s application for emergency use authorization (EUA).

On Friday, the Indian pharmaceutical company had informed Brazil’s regulator that Precisa Medicamentos was no longer authorized to represent it in the country. It had also claimed that it would continue to work with ANVISA to obtain the required approvals for Covaxin’s use in Brazil.

According to The Wire, the exaggerated claim became transparent after health regulator’s announcement on 23rd July i.e. Friday about the reassessment of applications for two processes namely EUA approval and clinical trails in the Latin American nation.

The unanimous decision was announced after Hyderabad-based Bharat Biotech terminated its Memorandum of Understanding (MoU) with Precisa Medicamentos of Brazil. It has now set the stage for cancellation of contract worth $300 million for the supply of 20 million Covaxin doses from India to Brazil.

On July 24, Meiruze Freitas, who is the rapporteur of the process stated that due to the interruption of the commercial relationship between companies as well as moving forward with a technical evaluation of a petition would indicate a significant waste of the efforts and resources invested by the administration.

Presently, Bharat Biotech has no representative in Brazil along with its request for EUA getting scrapped and suspension of Phase 3 trails of the vaccine.

Government enhances steps for COVID-19 vaccines manufacturing in India

Aayushi Singh — Tue, 20 Jul 2021 13:34:59 +0000

On Tuesday, in a press release by the PIB Delhi, it had been mentioned that steps were taken by the Government to enhance the manufacturing of COVID-19 vaccines in the country.

Manufacturing permission has been granted to the private manufacturers for the three COVID-19 vaccines for restricted use in an emergency situation by the Central Drugs Standard Control Organisation (CDSCO).

The vaccines granted manufacturing permission are ChAdOx1 nCoV-19 Corona Virus Vaccine manufactured by M/s Serum Institute of India Pvt Ltd, Pune on 03.01.2021, Whole Virion Inactivation Corona Virus Vaccine manufactured by M/s Bharat Biotech International Ltd, Hyderabad on 03.01.2021, and, Gam-COVID-Vac Combined vector vaccine (SPUTNIK-V) manufactured by M/s Ra Panacea Biotech Ltd, New Delhi on 02.07.2021.

The Government of India had launched “Mission COVID Suraksha-the Indian COVID-19 Vaccine Development Mission” to support vaccine manufacturing in India which was being implemented by the Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking (PSU) of the department of Biotechnology (DBT).

In the mission, clinical trial lot manufacturing of promising vaccine candidates which include the DNA vaccine candidate; ZydusCadila, mRNA vaccine candidate; Gennova Biopharmaceuticals, and Intanasal vaccine candidate; Bharat Biotech, were being supported.

Under Mission COVID Suraksha, the capacity enhancement of Bharat Biotech was also being supported. The Department of Biotechnology is facilitating the technology transfer of Covaxin production from Bharat Biotech to Gujarat COVID Vaccine Consortium (GCVC), which comprises Hester Biosciences and OmniBRx Biotechnologies Pvt Ltd.

Shri Mansukh Mandaviya, the Union Minister of Chemicals and Fertilisers, gave this information to the Lok Sabha on Tuesday.

Chief Scientist of WHO said Covaxin’s data looks good

Aayushi Singh — Thu, 08 Jul 2021 17:25:57 +0000

Dr. Soumya Swaminathan, Chief Scientist of WHO, on Thursday said that data on the Bharat Biotech’s vaccine, Covaxin, looked good.

In an interview with CNBC-TV18, Dr. Soumya said that the pre-submission meeting was held on June 23 and the data packet was being assembled, and that the Phase-3 trial data looked good and that they’ve looked at the other variants as well. She added that the overall efficacy was quite high but the efficacy of the vaccine against the Delta variant was low yet still quite good. The scientists said that the safety profile met with the WHO’s benchmarks.

She added that they have to keep a close eye on all the vaccines which had received an emergency use listing as they continue to seek more data. Dr. Soumya said that most parts of the world had seen an uptick in coronavirus cases and no reduction in deaths.

She said that WHO would not recommend any booster shots anytime soon and the focus would remain on widening the scopes of primary vaccinations.

Dr. Soumya said that the increase in social mixing and relaxation of public health measures were also among the reasons for the rise of COVID-19 infections and deaths in the world. The low rate of vaccination leaves many people prone to infection.

Dr. Soumya said that as the virus mutates further, the world could be witnessing an increase in the cases of the virus, as the existing mutations had already seen variants due to mutations. She emphasized that there was a need to collect more data and evidence on the variants for the global collaboration of sequencing and research was required.

She added that there was a need to maintain the social distancing norms and to wear masks as even if 70 percent of the population was vaccinated, the remaining 30 percent were still vulnerable. She said that the government needs to keep on with the testing and tracking as at this stage of the pandemic vaccines were not enough.

AIIMS Director says more data needed for mixing of COVID-19 vaccines

Aayushi Singh — Thu, 01 Jul 2021 10:56:29 +0000

Dr. Randeep Gulleria, AIIMS Director, said that if COVID-19 appropriate behavior is followed then everyone would be safe against any of the emerging variants. The Delta Plus variant of COVID-19 has been said to be a variant of concern by the central government and spread fear among the citizens of the country.

Mr. Gulleria said that that there was not much data on the Delta Plus variant to suggest it’s more infectious which causes more deaths and has developed a significant immune escape mechanism.

He added that more data was required on mixing of doses as the studies showed that it might be effective but he clarified that more data was needed before saying that the mixing of COVID-19 vaccine doses policy should be tried.

These remarks came after a recent study by the Oxford University which revealed that alternating doses of the Pfizer BioNTech and AstraZeneca vaccines produced robust immune responses against the SARs-CoV-2 causing COVID-19.

In the study, the researchers who were working to know the feasibility of using a different vaccine doss for the prime vaccination than the one used for the booster vaccination discovered that mixing the doses of two different vaccines could generate stronger immunity.

The Delta Plus variant was first identified on June 11, is a mutated form of the Delta variant, and had been detected in 12 countries so far.

Over 51 cases of the variant have been found in India from over 45,000 samples that were tested.

Dr. NK Arora, of the National Technical Advisory Group on Immunisation (NTAGI), said that the Deta Plus variant of COVID-19 had a greater affinity towards lung problems however it doesn’t mean that it could cause major diseases or had higher transmissibility.

Dr. Arora said the Delta Plus had a greater affinity to the mucosal lining in the lungs, higher compared to other variants but it was not clear yet that it causes damage or not.

The chance of the virus mutating rises as the virus circulated in a population causing infections said WHO.

India’s December-end target to vaccinate everyone requires Bharat Biotech to raise its game

Faara Nadeem — Mon, 28 Jun 2021 08:55:10 +0000

An order of 19 crore doses to be supplied from August has been given to Bharat Biotech. It has already been provided with 30 per cent advance money.

To India to achieve its aim of vaccinating all its adults by this December, Bharat Biotech will have to raise its game over the next six months, according to the Union government’s affidavit in the Supreme Court on vaccine availability.

India is counting on Bharat Biotech to supply a total of 48 crore doses of COVAXIN out of the 187 crore. It is needed to vaccinate all 93-94 crore adults in the country.

On June 15, Bharat Biotech shared that it had supplied over four crore doses so far and has some doses in stock with states. As on date, about 3.8 crore COVAXIN jabs have been administered.

Since January till July, an order of 8 crore jabs was placed by the to Bharat Biotech. The company has only delivered half so far out of what it is to supply by end of July. A much bigger order of 19 crore doses to be supplied from August had been placed at Bharat Biotech. It had already been provided 30 percent advance money.

The question of the hour is if Bharat Biotech can increase its supply drastically by nearly nine times its present level. And can it supply nearly 44 crore doses between July and December, when it has struggled to supply four crore doses over last five months.

Bharat Biotech defends higher price for COVAXIN in private market

Aryan Jakhar — Tue, 15 Jun 2021 11:47:45 +0000

Hyderabad-based vaccine-manufacturing company Bharat Biotech on Tuesday said that the cost of one dose of Covaxin, the covid vaccine developed by it, is not viable.

In a statement, the company said that Rs 150, the rate at which the Indian government is selling the vaccine to the public, is a non-competitive price and is “clearly not sustainable in the long run”. It added that the price of the vaccine should be different for the government entities and private markets, implying that the price in the private markets should be higher

The company added that vaccines are something that is provided free of cost to the public by the government, hence, the private markets don’t need to procure them.

“Fundamental business reasons ranging from low procurement volumes, high distribution costs and retail margins among few others contribute to higher pricing of Covaxin,” Bharat Biotech said justifying the higher price when compared to other COVID-19 vaccines available for the private sector in India.

“The supply price of Covaxin to the government of India at ₹ 150 / dose, is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs,” it said, giving examples of other pharmaceutical products which are available at differential pricing.

“There are live examples of such pricing policies where Human Papillomavirus vaccine is priced for GAVI supplies at approximately $4.5 (about Rs 320) per dose but is also available in the private market at about Rs 3,500 per dose. Rotavirus vaccines are supplied to the government of India at about Rs 60 per dose, but it is also available in the private market for Rs 1,700 per dose. The prices of Covid-19 vaccines internationally have varied between $10 and $37 (about Rs 730 to Rs 2,700) per dose,” it added.

“In our view, the question of product pricing is only of extraneous interest to all concerned, especially when the same vaccine is made available free of cost,” the statement added.

The manufacturer said it had so far invested over Rs 500 crore “from its own resources” for product development, clinical trials and setting up of manufacturing facilities, and the price at which the government was buying the doses was not commensurate to the investment.

COVID-19 Vaccine: Bharat Biotech reduces price of COVAXIN for state from Rs 600 to Rs 400 per dose

News Desk — Thu, 29 Apr 2021 14:36:20 +0000

Bharat Biotech has reduced the prices of its COVID-19 vaccine COVAXIN for state-run hospitals from Rs 600 to Rs 400 per dose. The cost of the COVID-19 vaccine for private hospitals is changed to Rs 1200 per dose.

In what Adar Poonawalla called a “philanthropic gesture”, the Serum Institute of India cut the prices of COVISHIELD from Rs 400 to Rs 300.

Some political activist and leaders have demanded universal free vaccination. However, the company only recently asked for thousands of crores from the Centre to manufacture the vaccines.

The company run by Krishna M Ella said in a statement that Bharat Biotech was deeply concerned with critical pandemic circumstances that India is facing right now. Recognising the state government’s challenges right now, they have made the COVAXIN available to the state governments at Rs 400 per dose. The state government and private hospitals can order up to 50 per cent of COVISHIELD and COVAXIN to inoculate the younger population.

The Centre will continue to vaccinate those above 45 years of age free of cost. Serum Institute had said that it will continue to provide vaccine to the Centre at Rs 150 a shot. Some 1.33 crore people registered for the COVID-19 vaccination in the age group 18 to 44 on Wednesday as government dedicated website cowin.gov.in opened for registrations.

Meanwhile, the University of Delhi in a statement said, “The university is concerned with the health and of our

students which are our priority, We would ensure that the interest of the University Community is protected.

The University has been receiving request related to the examination of terminal semesters / final year

students, scheduled for May-June 2001. The university would take the stock of the situation and would come out with its decision as early as possible. Students are requeto sted fall prey to any • rumours and exclusively follow the notices and (www.du.ac.in)”.

Bharat Biotech claims vaccine effective against new UK COVID strain

Arnav Dogra — Wed, 27 Jan 2021 10:54:32 +0000

January 27, 2021: Hyderabad-based vaccine manufacturer Bharat BioTech today posted a tweet on its official Twitter handle in which it claimed that its vaccine was effective against the new more contagious and possibly deadlier UK strain of the coronavirus.

Neutralization of UK-variant VUI-202012/01 with COVAXIN vaccinated human serum https://t.co/v8Me4TzGgh #BharatBiotech #COVAXIN #bioRxiv #COVID19 pic.twitter.com/7R3FlsWAX3

— Bharat Biotech (@BharatBiotech) January 27, 2021

Along with the tweet, Bharat BioTech also attached the link to the papers of the scientific study done by scientists at the National Institute of Virology as the backing proof for its claim. A vaccine developed by US company Pfizer Inc and its German partner BioNTech are also the other two vaccines which are supposedly effective against the new strain.

Patrick Vallance, British government’s chief scientist commented that new the strain could be 30 to 40 per cent deadlier although there has not been enough time to have the required amount of data which will help doctors and scientists access whether this strain has a higher degree of mortality or not.

The amount of Covid-related deaths in the UK have increased by 16 per cent in just one week. The number of people currently hospitalized is nearly double of what it was last year when the country was only going through its first wave.

150 cases of the new UK strain of the COVID virus have been reported in India.

Bharat Biotech’s nasal vaccine likely to be ‘game-changer’ to end COVID-19

Sanah Shah — Tue, 19 Jan 2021 12:41:07 +0000

A panel of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has assembled to debate the permission sought out by vaccine developer Bharat Biotech to begin clinical trials for its intranasal vaccine for COVID-19.

The Union Health Ministry on 19th January 2021 has identified Bharat Biotech as a nasal vaccine candidate and termed it as a “game-changer”. The ministry requested citizens to terminate hesitancy related to the vaccine and assured both the vaccines for Coronavirus are safe.

On 16th January 2021, after the Drugs Controller General of India’s nod for confined emergency use of India’s engineered COVID-19 vaccine, Bharat Biotech had applied to the drug regulator for permission to begin Phase 1 and 2 trials for the nasal vaccine.

Dr V. K. Paul, NITI Aayog member said at a press briefing, “A nasal vaccine has been identified. It has come for consideration for Phase 1 and 2 trials. If it works then it could be a game-changer.”

The nasal vaccine is quite distinct from the intramuscular vaccine which began supply on 16th January 2021 as it is non-invasive, needle-free which eliminates risks with the needle, doesn’t need trained healthcare workers, comfortable for children and adults and has increased manufacturing.

Bharat Biotech’s ‘BBV154’ – a novel adenovirus vectored intranasal vaccine for COVID-19 – will be managed at several locations, a source close to the development told IANS. This vaccine will be single-dosed in comparison to the double-dosed vaccine with a gap of 28 days.

According to the firm, an intranasal vaccine leads to a broad immune response at the place of infection, in the nasal mucosa, which is required for blocking both infection and transmission of the Coronavirus.

Public health experts trust that the intranasal vaccines for COVID-19, given through the nose rather than muscles, can be a possible game-changer in fighting the pandemic.

Pune-based Serum Institute of India and Codagenix Inc had reported that they have received regulatory approval in the U.K. to begin an early-stage trial of their single-dose, intranasal Coronavirus vaccine.

A health ministry official made a statement that the side-effects of taking the intramuscular vaccines that are being distributed are insignificant. “Data shows that we are in a comfortable situation and we would like to reassure you that the two COVID-19 vaccines are safe. We would like to reassure with the data we have seen that the two vaccines are safe. The vaccine hesitancy should end. How will we defeat the pandemic then,” he said.

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 to begin COVID-19 vaccination drive from January 16, ‘A landmark step’ tweets PM Modi

Ruchira Sonawat — Sat, 09 Jan 2021 15:28:10 +0000

Prime Minister Narendra Modi, on Saturday, announced on Twitter regarding the start of India’s COVID-19 vaccination drive. India will begin a nationwide vaccination drive from January 16. This will be a landmark step in fighting the pandemic as it would be the world’s largest vaccination drive to be conducted.

The Prime Minister wrote, “On 16th January, India takes a landmark step forward in fighting COVID-19. Starting that day, India’s nation-wide vaccination drive begins. Priority will be given to our brave doctors, healthcare workers, frontline workers including Safai Karamcharis.”

On 16th January, India takes a landmark step forward in fighting COVID-19. Starting that day, India’s nation-wide vaccination drive begins. Priority will be given to our brave doctors, healthcare workers, frontline workers including Safai Karamcharis. https://t.co/P5Arw64wVt

— Narendra Modi (@narendramodi) January 9, 2021

Nearly 3 crore healthcare and frontline workers will be receiving the vaccine from next week. Then, those above 50 years of age will receive the dose followed by people younger than 50 years of age with associated comorbidities. The total number is estimated at 27 crore.

India has recently granted emergency authorisation to two coronavirus vaccines — Covishield by Serum Institute of India which the researchers claim that the vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given a half dose and the other is Covaxin by Bharat Biotech.

A digitalised platform called the COVID Vaccine Intelligence Network (Co-WIN) system will be used to track enlisted beneficiaries for the vaccination and anti-coronavirus vaccines on a real-time basis. It will provide real-time information of vaccine stocks, their storage temperature and individualized tracking of beneficiaries of the COVID-19 vaccine. This platform will assist the program managers across all levels through automated session allocation for pre-registered beneficiaries, their verification and for generating a digital certificate upon successful completion of the vaccine schedule. More than 79 lakh beneficiaries have been already registered on the platform.

For this mega drive, over 2,360 participants were trained during national level Training of Trainers which comprised state immunization officers, cold chain officers, IEC officials, development partners etc. More than 61,000 programme managers, 2 lakh vaccinators and 3.7 lakh other vaccination team members have been trained so far as part of training at states, districts and block levels.

Bharat Biotech and Serum Institute of India will work together to eliminate Coronavirus

Divya Joyce — Tue, 05 Jan 2021 11:01:15 +0000

A day after a war of words, Adar Poonawala and Krishna Ella, came together to issue a statement on behalf of the two companies on the combined intent and said, “The more important task in front of us (Bharat Biotech and Serum Institute of India) is saving the lives in India and the world.”

“Vaccines are a global public health good and they have the power to save lives and accelerate the return to economic normalcy at the earliest,” they added,

“Now that two COVID-19 vaccines have been issued for emergency use authorisation in India, the focus is on manufacturing, supply, and distribution, such that populations that need the most receive high quality, safe and efficacious vaccines,” they said.

I would like to clarify two matters; as there is confusion in the public domain, exports of vaccines are permitted to all countries and a joint public statement clearing up any recent miscommunication with regards to Bharat Biotech will be made.

— Adar Poonawalla (@adarpoonawalla) January 5, 2021

This comes after SII CEO Adar Poonawalla told reporters that there are only three vaccines globally that have proven their efficacy — Pfizer, Moderna and Oxford-AstraZeneca — while other COVID-19 vaccines have only proven to be safe, just like ‘water’ on January 3.

The following day, Bharat Biotech CEO Krishna Ella hit back, saying that there’s a conspiracy at hand. According to him, Poonawalla’s comments were just a ploy to create a backlash against Indian companies.

Ella also pointed out that the reason behind Serum’s speedy Emergency Usage Approval (EUA) was due to a large number of candidates it was able to test in the UK. Bharat Biotech, on the other hand, has a large repository of data for Indian participants with 25,000 people.

Today, Poonawalla highlighted that the tiff between him and Ella was only a ‘miscommunication’. He also clarified that while SII will be providing India with the Oxford-AstraZeneca COVID-19 vaccine; it will continue to hold true to its pledge of providing global access as well.

SII is a part of the COVAX, a global partnership launched by the World Health Organisation (WHO) in April, to ensure that people in all corners of the world have access to the COVID-19 vaccine.

However, critics have pointed out that the disparity between high-income countries and low-income countries is only widening. The most recent tally by the people’s vaccine alliance — a group which consists of Oxfam, Amnesty International, Global Justice Now and others — shows that wealthy nations account for 14% fo the global population, but have hoarded around 53% of the global COVID-19 supply of vaccines so far.

Private clinics of Brazil sign deal with India to get alternative COVID-19 vaccine

Ruchira Sonawat — Tue, 05 Jan 2021 07:55:26 +0000

A deal has been signed by Brazil’s private clinics for an alternative Coronavirus vaccine made by India’s Bharat Biotech. This comes as a result of a diplomatic push to ensure Indian-made shipment of AstraZeneca’s COVID-19 vaccine, Al Jazeera reported. Brazil has signed the deal despite “a lack of public results from late-stage trials” of the Indian vaccine.

This came a day after India’s health regulator gave its vaccine, Covaxin, a nod for emergency use. An association of private Brazilian clinics declared their intention to secure five million doses of Indian company Coronavirus vaccine. A memorandum of understanding has already been signed by Brazil with Bharat Biotech.

“Brazil will be able to secure only one million doses of AstraZeneca’s vaccine by the second week of February,” the head of Brazil’s Fiocruz Institute told Reuters last week.

Geraldo Barbosa, head of the Brazilian Association of Vaccine Clinics (ABCVAC) said that this should be the first vaccine available on the private market in Brazil and the doses should arrive by mid-March, to be sold by private clinics after regulators there approve the vaccine.

Meanwhile, Bharat Biotech is yet to publish efficacy data of its COVID-19 vaccine.

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.

AstraZeneca likely to get approval from India for emergency use by next week

Divya Joyce — Wed, 23 Dec 2020 05:53:07 +0000

The Coronavirus vaccine, developed by the University of Oxford and AstraZeneca, is likely to get approval from the Indian government for emergency use by next week, two people privy to the development told.

Serum Institute of India (SII), which is producing mass doses of the vaccine dubbed Covishield here, submitted the additional information sought by the government, Reuters reported.

On December 9, the Central Drugs Standard Control Organization (CDSCO) reviewed the applications and asked for more information from all three companies — SII, Pfizer, and Bharat Biotech. The last two organizations have also sought emergency use authorization.

SII submitted the details the government wanted. The authorities were still waiting for more details from Pfizer, a government health adviser told in a news briefing on Tuesday, while one of the sources said additional information was expected from Bharat Biotech.

Both sources said Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot and that there were “strong indications” an approval would come by next week.

The expected approval comes after data from AstraZeneca’s late-stage trials in the UK and Brazil released earlier this month showed the vaccine had an efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.

The Indian regulator is only considering the two full-dose regimens of the shot despite it showing a lower success rate, the sources said.

This could be the first country to give the regulatory green light for the British drugmaker’s vaccine as the British medicine regulator continues to examine data from the trials.

India, the world’s biggest vaccine-making country, wants to start inoculating its citizens next month and is also considering emergency use authorization applications for vaccines made by Pfizer Inc and local company Bharat Biotech.

Getting vaccines to the world’s second-most populous country with one of the highest infection rates will also be a big step in the battle against the pandemic.

The AstraZeneca-Oxford shot is considered vital for lower-income countries and those in hot climates because it is cheaper, easier to transport and can be stored for long periods at normal fridge temperatures.
“Serum is ready,” said one of the sources. “Initially, we may get around 50 million to 60 million doses.”

The sources declined to be named as deliberations were ongoing and the timeline could change.

India has not yet signed a vaccine supply deal with any company, but SII has already stockpiled more than 50 million doses of the AstraZeneca shot and plans to make a total of 400 million doses by July.

Bharat Biotech issues clarification post Haryana Home Minister Anil Vij testing positive

Sarthak Yadav — Sat, 05 Dec 2020 08:56:30 +0000

After 67 years old, Anil Vij Haryana’s Health Minister tested positive for COVID-19 two weeks after being administered to COVID-19 vaccine. Bharat Biotech released a statement for clarification.

As reported by CNBC, Bharat Biotech who is developing the vaccine, said the clinical trials of Covaxin are based on a two-dose schedule, given 28 days apart. “The vaccine efficacy will be determined 14 days post the second dose. Covaxin has been designed to be efficacious when subjects receive both doses,” the drugmaker said, reacting to the news of the Haryana minister testing positive.

Anil Vij who is also Haryana’s Health Minister announced on November 20 that he was administered a trial dose of a COVID-19 vaccine as part of the third phase trial of Bharat Biotech’s Covaxin. He had earlier reached out on Twitter saying that he will be the first volunteer in his state for the anti-COVID-19 vaccine.

Covaxin has been evaluated in about 1,000 subjects in the first two phases of clinical trials, with promising safety and immunogenicity data.

“The Phase-3 trials are double-blinded and randomised, where 50% of subjects (participants in the trial) receive the vaccine and 50% of subjects receive placebo,” the company said.

Haryana has reported over 2.4 lakh COVID-19 cases so far, including 2,539 deaths.

Government planning to procure Oxford-AstraZeneca vaccine (COVID) on half the price from MRP

Sarthak Yadav — Mon, 23 Nov 2020 07:09:35 +0000

India is planning to get hands on the first lot of anti-Covid shots in late January-early February which will be distributed among frontline workers like doctors, nurses and municipal staff.

India is planning to give Serum Institute of India (SII) emergency use approval for the Oxford-AstraZeneca vaccine candidate soon after it gets similar approval in the UK. SII is expected to apply for emergency use in December. The government will be making bulk purchases, has also negotiated a better price almost half that of the expected MRP Rs 500-600 for the two-shot vaccine.

According to an official ” if everything goes as per plan and the company (SII) manages to secure emergency authorization in December, we are expecting the first lot of vaccines by January-February and the first set of beneficiaries has been identified.”

The priority population of 25-30 crores is categorised into four different groups which will require around 50-60 crore doses according to the estimate. The limited stocks are expected to arrive by January-end which will be provided to 70 lakh healthcare professionals and over 2 crore frontline workers including police, municipal workers and armed forces.

Bharat Biotech’s Covaxin can be considered for emergency approval after the results of phase I and phase II trials.

“If Serum Institute submits its efficacy data from UK and applies for emergency authorization here, it can easily be granted But even in case of Bharat Biotech, if the company applies for emergency use approval after its data from phase I and phase II are published, the regulator can consider the same,” remarked by the officials .

The SII has almost completed its phase 3 trials in India and the follow up is expected to start soon.

National Technical Advisory Group initiating Immunisation and The Central Drug Standards and Control Organistaion to focus on grant of emergency authoristaion will be the two major bodies dealing with vaccine introduction.

Bharat Biotech’s Covaxin will be 60% effective, tentatively to launch in September 2021

Shlok Arya — Sun, 22 Nov 2020 09:41:47 +0000

A top official of Bharat Biotech confirmed that a potential vaccine, ‘Covaxin’, will be 60% effective against Coronavirus infection. The company is aiming to launch the vaccine in the second quarter of 2021.

Sai D Prasad, President, Quality Operations at Bharat Biotech, said the company is aiming for at least 60 percent effectiveness of the coronavirus vaccine candidate, however, it could also be more.

Covaxin is being developed in India by Bharat Biotech and ICMR. Several countries including the UK, the USA, and Russia is racing to provide the world a solution for COVID-19 infection.

Bharat Biotech, a Hyderabad based company is also one of them and has commenced Phase 3 trials of the vaccine earlier this month. The Phase 3 trials involved 26,000 volunteers across 25 centers in India. It is the largest clinical trial conducted for a coronavirus vaccine candidate in India.

Trial volunteers will receive two intramuscular injections in the difference of 28 days. Participants will be randomly assigned 1:1 to receive either two 6 micrograms (mcg) injections of Covaxin or two shots of a placebo.

The trial is double-blinded, meaning that the investigators, the participants, and the company will not be aware of who is assigned to which group. The vaccine earlier was evaluated in 1,000 subjects during Phase 1 and 2 clinical trials.

Union Health Minister Harsh Vadhan assures COVID-19 vaccine will be ready in next three-four months

Divya Joyce — Thu, 19 Nov 2020 11:02:55 +0000

Union Health and Family Welfare Minister Harsh Vardhan assured that COVID-19 vaccine will be available in the country by next 3-4 months. Minister Harsh Vardhan was addressing the FICCI FLO webinar on ‘The Shifting Healthcare Paradigm During and Post-COVID-19’ when he made the statement.

“I am confident that the COVID-19 vaccine will be ready in the next three-four months. Priority for the vaccine will be designed on the basis of scientific data. Health care workers and corona warriors will naturally be prioritized followed by elderly and disease-prone people. Very detailed planning is underway for vaccine dissemination. An e-vaccine intelligence platform has been created to discuss the blueprint for the same. Tracking and tracing of the vaccine would be neck-deep once it’s available for the public. Hopefully, 2021 should be a better year for all of us,” Health Minster quoted.

Vardhan further estimated that by July-August 2021, 400-500 million doses will be made available for 25-30 crore people.

“It is natural the vaccine distribution would have to be prioritized. As you know the healthcare workers, who are corona warriors, will be on priority. Then, people, who are above 65 years of age they have been prioritized, then those from 50-65 years of age have been prioritized,” Vardhan pointed out.

India’s coronavirus caseload mounted to 89,58,483 on Thursday with 45,576 infections being reported in a day, while the death toll climbed to 1,31,578 with 585 new fatalities.

The Phase-3 trial of the Oxford vaccine of the Serum Institute is almost near completion, while the phase-3 clinical trial of the indigenously-developed vaccine candidate of the Bharat Biotech and the Indian Council of Medical Research (ICMR) has already started.

Dr Reddy’s Laboratories will soon start the combined Phase-2 and Phase-3 clinical trials of the Russian COVID-19 vaccine, Sputnik V, in India. Also, Biological E Limited has started early phases 1 and 2 human trials of its COVID-19 vaccine candidate.

Pfizer Inc and BioNTech SE said their vaccine candidate was found to be more than 95 percent effective in preventing COVID-19, while Moderna on Monday said its vaccine candidate against COVID-19 found it to have an efficacy of 94.5 percent.

Bharat Biotech announces partnership with Washington University School to produce intranasal COVID-19 Vaccine

Anu Jain — Wed, 23 Sep 2020 12:52:55 +0000

On Wednesday, Hyderabad-headquartered Bharat Biotech announced that it will manufacture a billion doses of an intranasal COVID-19 vaccine, in collaboration with the Washington University School of Medicine in St Louis, Missouri.

The vaccine is peculiar as it will be procured via nose, the initial infected area. Researchers claim the nasal route for vaccination has often seen a stronger immune response.

“The intranasal vaccine will not only protect against COVID-19, but also prevent the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat,” said Dr David Curiel, Professor of Radiation Oncology at Washington University School of Medicine.

The company said in a release that phase-I human trials of the vaccine will be conducted at the Treatment Evaluation Unit of Saint Louis University in the United States and Bharat Biotech is expected to undertake further stages of clinical trials in India.

The company has entered into a license agreement with the university for the novel chimp-adenovirus candidate, single-dose intranasal vaccine. Bharat Biotech will own the rights to distribute it in all markets except for the United States, Japan, and Europe.

The agreement is expected to help overcome distribution difficulties, shortage and high cost of vaccination. The vaccine will nullify the need to administer the vaccine shot.