Budget 2018-19

  Experts say more real-world studies are required now Bharat Biotech has updated the efficacy of Covaxin to 65.2% against the  De lta variant  in – Effectiveness Study on Delta Variant – Lancet Infectious Diseases, published on Nov 23 2021. “Bharat Biotech commends the investigators from the All India Institute of Medical Sciences (AIIMS) on the BBV152 study published in Lancet Infectious Diseases. These results provide evidence for effectiveness for Covaxin in real life settings,” Bharat Biotech said. It added that an effectiveness result of 50% achieved during the peak Covid-19 Delta variant wave in India, in a high risk study population of physicians and health care workers, in a hospital environment, and who are challenged repeatedly with high viral loads, provides insights into the efficacy and effectiveness of Covaxin.. “These results compare well with the 65.2% efficacy against the delta variant obtained during the controlled phase III clinical trials of  Cov...

  Research does not estimate vaccine effectiveness against hospitalisation, severe disease, and death. Two doses of Covaxin, the India-made vaccine, are 50 per cent effective against symptomatic Covid-19, said an independent study by researchers based on real-world assessment . Results of the interim study, which was published in The Lancet Infectious Diseases Journal, showed that two doses of the vaccine manufactured by  Bharat Biotech Covaxin , also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and present no serious safety concerns.. The study titled ‘Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study’ assessed 2714 hospital workers at the All India Institute of Medical Sciences (AIIMS) in Delhi, from April 15–May 15, who were symptomatic and underwent RT-PCR test for  Covid-19  detection. The researchers, including doctors Manish Soneja, Adil Rashid Khan, Devashish Desai,...

  The technical advisory group will now meet on November 3 for a final assessment. The World Health Organisation’s technical advisory group on Tuesday sought “additional clarifications” from  Bharat Biotech  for its Covid-19 vaccine Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine. The technical advisory group will now meet on November 3 for a final assessment. Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL). The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing of India’s indigenously-made vaccine. “The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said in an email response to a question by PTI on the decision re...

  Animal vaccine maker Hester Biosciences, on the other hand, is setting up a greenfield BSL-3 facility in Gujarat to make Covaxin Covaxin might soon be produced in the neighbourhood of Covishield after Hyderabad-based vaccine maker  Bharat Biotech  started engineering batches of Covaxin at Biovet’s Manjari plant near Pune. Meanwhile, Covaxin production will touch 55 mn doses a month from October.Biovet is an associate firm of Bharat Biotech. “At present engineering batches are on at the Manjari plant. Soon, commercial production will start,” said a source close to the developments. ngineering batches are run to test the functionality of the installed equipment. The Manjari plant spread over 12 hectares was acquired by Biovet. It is a ready to use vaccine plant that belonged to a Merck & Co subsidiary Intervet India. Intervet is exiting business operations in India and has thus sold the Manjari unit to Biovet. Meanwhile, Krishna Ella, chairman and managing director of...

  Covishield production to cross 120 mn doses a month, Covaxin 58 mn doses a month Production of both  Covishield  and Covaxin – Covid-19 vaccines from Serum Institute of India (SII) and Bharat Biotech – is set to rise from next month. The target of 1.35 bn vaccine doses between August and December, however, looks like a long haul. According to a response given in the Rajya Sabha, Health Minister Mansukh Mandaviya said recently that the monthly production capacity of Covishield is projected to increase from 110 mn doses to more than 120 mn doses a month, whereas the production capacity of Covaxin is projected to increase from 25 mn doses a month to around 58 mn doses a month. Mandaviya added that apart from this, the Centre has also facilitated further capacity augmentation of Covaxin at central public sector enterprises including Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited (IIL), Hyderabad and Bharat Immunological...

  The agency said the suspension – which put the EUA application on ice – was due to missing data from the vaccine’s clinical trials As controversy over the $324-million deal for 20 million doses of Covaxin with Brazil brews, on Monday some reports pointed out that the Brazilian regulator had not granted Bharat Biotech — the makers of Covaxin — emergency-use authorisation (EUA). The Hyderabad-based company’s website noted that on June 4, ANVISA — the Brazilian regulator — had authorised the “exceptional import of  Covaxin  by the health ministry for distribution and use under controlled conditions”. This is a departure from the June 30 press statement wherein the company had clarified it had not received any money from Brazil’s health ministry. On Monday, NDTV reported that ANVISA “suspended the deadline for evaluating the application for emergency use of Covaxin”. The agency said the suspension — which put the EUA application on ice — was due to missing data from the vac...

  US FDA has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application route with additional data, nixinghopes of Emergency Use Authorisation In setback that could potentially delay the launch of  Bharat Biotech’ s COVID-19 vaccine Covaxin in USA, the Food and Drug Administration there has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA is a “full approval” mechanism by the FDA for drugs and vaccines. The development may delay the  Covaxin  launch in the US, Ocugen said. “The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The ...

  When the pandemic ends, it will be with the tremendous assistance of India’s pharmaceutical industry. On April 11, India recorded almost 170,000 Covid-19 cases, a record for the country since the start of the pandemic. The day before, India crossed a different kind of milestone: Vaccinating 100 million people. It is this seesaw of despair and hope that India rides today, battling the outbreak with a healthcare system operating on the brink even as its pharmaceutical industry tries to fill the world’s prescription for vaccine doses. India reached the 100 million vaccination mark in 85 days, faster than the U.S. and China, which took 89 and 102 days respectively. But the task ahead is formidable: the government of Prime Minister Narendra Modi has set a target of fully vaccinating 300 million individuals by July. The arithmetic alone is daunting. India started with a stock of 100 million vaccine doses at the beginning of the year. Its two manufacturers– Serum Institute of India ...

 Covaxin demonstrates significant immunogenicity against the rapidly emerging variants, says Bharat Biotech CMD Bharat Biotech's homegrown Covid-19 vaccineç Covaxin, has shown an interim vaccine efficacy of 81% in late-stage clinical trials, the Hyderabad-based company said on Wednesday. That’s better than Bharat Biotech’s guidance last year of around 60% and India’s benchmark of 50% for vaccines targeting the novel coronavirus. The trials involved 25,800 participants and was conducted in partnership with Indian Council of Medical Research (ICMR), the Indian government's medical research body. This was the largest ever trial conducted in India "The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities," the company said in a statement. "Today is an important milestone in vaccine discovery, for science and our fight against coronavirus . With today's results from our Phas...

Ramaphosa said the vaccine would boost the fight against the pandemic South Africa has received the country’s first consignment of 1 million Oxford University-AstraZeneca vaccines which arrived from the Serum Institute of India (SII). President Cyril Ramaphosa, Deputy President David Mabuza and Health Minister Zweli Mkhize, among other officials, lined up on the tarmac of OR Tambo airport to welcome the vaccine cargo, Xinhua news agency reported on Tuesday. Ramaphosa said the vaccine would boost the fight against the pandemic. “Today marks a major milestone in our fight against the coronavirus pandemic as we receive our first consignment of the   Coronavirus vaccine . This batch will benefit our healthcare workers who have been at the forefront of keeping us all safe,” Ramaphosa said. “We thank all South Africans and all the researchers who have contributed toward ensuring the successful development of the vaccine,” he added. The vaccination program was said to be organised and coo...

  The vaccination drive will begin with 3,006 sites that will be virtually connected during the launch Prime Minister Narendra Modi will launch India’s Covid-19 vaccination programme through video at 10.30am on Saturday, the government said Thursday. The vaccination will begin with 3,006 sites that will be virtually connected during the launch. Each centre will inoculate 100 people a day to begin with. “This vaccination programme is based on the principles of priority groups to be vaccinated and health care workers, both in government and private sectors, will receive the vaccine during this phase,” said the government. It will use Co-WIN, an online digital platform developed by Health Ministry for real-time information of vaccine stocks, storage temperature and tracking of vaccine recipients. The government faces the daunting task of rolling out shots at an accelerated pace in a country of more than 1.3 billion people which has long struggled with limited health infrastructure and...

  The city’s Municipal Commissioner Iqbal Singh Chahal and his deputy Suresh Kakani, who’s in charge of the vaccination drive, spoke in separate interviews this week India’s business and financial hub Mumbai, once the country’s coronavirus hotspot, is building facilities to store 10 million doses of the vaccine as it aims to open fully from a strict lockdown. The city’s Municipal Commissioner Iqbal Singh Chahal and his deputy Suresh Kakani, who’s in charge of the vaccination drive, spoke in separate interviews this week before the start of a nationwide rollout on Saturday. Their responses are edited for clarity. Q. What’s the plan? Chahal:  Mumbai’s population that comes under the Municipal Corporation is about 15 million. We plan to create vaccine storage capacity of a little more than 10 million, which will be adequate as the vaccination will be done in phases. We have formed 500 teams, each having two vaccinators, two support staff and one security guard. They will initiall...

  Three temperature-controlled trucks rolled out of the Serum Institute gates shortly before 5 am and left for Pune airport A decisive phase in India’s fight against coronavirus began in the wee hours on Tuesday as the first consignment of Covishield vaccines left Serum Institute of India for Pune airport, four days ahead of the nationwide inoculation drive launch. Three temperature-controlled trucks rolled out of the Serum Institute gates shortly before 5 am and left for Pune airport, from where the vaccines will be flown across India. The trucks carried 478 boxes of the vaccines, each box weighing 32 kg, a source involved in the vaccine transport arrangements told PTI. The trucks left the Serum Institute of India premises at Manjari and reached the airport, located 15 km from the facility. From the airport, the vaccines will be dispatched to 13 locations across the country by 10 am, the source said. A ‘puja’ was performed before the vehicles left the facility. The locations where...

  The protection rate, confirmed by Sao Paulo state officials, was derived from Sinovac’s most advanced final-phase trials in Brazil involving about 13,000 participants The vaccine developed by China’s Sinovac Biotech Ltd. was found to be 78% effective against Covid-19 in late-stage trials in Brazil, the most definitive evidence so far on the shot’s efficacy after previous data sparked doubt and confusion. The protection rate, confirmed by Sao Paulo state officials, was derived from  Sinovac ’s most advanced final-phase trials in Brazil involving about 13,000 participants. Coming after data was withheld at a progress update in late December, the rate is still below the roughly 95% effectiveness seen in cutting-edge mRNA vaccines developed by Pfizer Inc. and Moderna Inc. and being deployed in the U.S. Sinovac’s CoronaVac vaccine was 78% effective in preventing mild cases of Covid-19 and 100% effective against severe and moderate infections, said Dimas Covas, director of the But...

  The Indian government may be looking to put pressure on Serum to lower its prices, as seen by its controversial decision to greenlight a rival vaccine As major countries like the U.S. and China race to vaccinate their populations with rapidly approved shots, tens of millions of doses prepared for India are sitting in storage despite having been authorized for use. While distribution in other nations started soon after approval with pricing deals signed ahead of time, New Delhi and Serum Institute of India Ltd. — the world’s biggest vaccine maker by volume and AstraZeneca Plc’s local partner — have engaged in months of haggling behind closed doors and are yet to sign a formal supply agreement. That has left at least 70 million vaccine doses in limbo despite the urgent need in a country facing the world’s second-largest outbreak. On Sunday, Serum’s billionaire Chief Executive Officer Adar Poonawalla said Indian officials have “orally” agreed to buy 100 million doses at a “special p...

  Adar Poonawalla and Krishna Ella issue joint statement saying they would work together to roll out Covid-19 vaccine After engaging in a war of words, the chiefs of two of India’s leading vaccine makers — Bharat Biotech and Serum Institute of India (SII) — called a truce on Tuesday and pledged to work together for a “smooth roll-out” of Covid-19 vaccines. In a joint statement,  Bharat Biotech  Chairman and Managing Director Krishna Ella and SII Chief Executive Officer Adar Poonawalla said the more important task in front of them was to save the lives and livelihoods of populations 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,” the statement read. “Now that two Covid-19 vaccines have been issued EUA (emergency use authorisation) in India, the focus is on manufacturing, supply, and distribution…Both companies are fully engaged in this activity and consi...

  Health personnel succh as doctors and nurses and frontline workers such as police personnel, home guards won’t have to register themselves online to get the vaccine The health ministry is prepared to roll out the Covid vaccine within 10 days of the emergency use authorisation, which was granted to two companies on January 3. While giving this information on Tuesday, Health Secretary Rajesh Bhushan told reporters that the final date would be decided by the government. The roll-out is being planned, including the logistics and technology network, based on the feedback from the recent dry run of the vaccination process, according to Bhushan. Aadhar verification too will be a part of the online vaccine delivery platform Co-Win. Addressing the weekly briefing on Covid, Bhushan said health workers including doctors and nurses as well as frontline workers such as police personnel and home guards would not have to register on the online platform to get vaccinated. Their data has already ...

  The media and opposition figures have justifiably asked why Bharat Biotech’s candidate was approved at the same time as AstraZeneca’s, when it hasn’t even finished or published results from Stage III The Indian state faces one of the world’s most formidable challenges: rolling out a Covid-19 vaccination program for 1.3 billion people. To succeed, many things have to go right in a country that usually gets a lot wrong. The government would be wise to enlist the country’s private sector in this gargantuan effort — and soon. The vaccine rollout is already off to a shaky start. The government last week announced emergency approval for two vaccines. The first, a joint effort from AstraZeneca PLC and Oxford University, is being produced by the Serum Institute of India, the world’s largest vaccine manufacturer. The other has been developed by the Indian company Bharat Biotech International Ltd. The media and opposition figures have justifiably asked why Bharat Biotech’s candidate was ap...

  While the Oxford-AstraZeneca vaccine made by Serum Institute here has 70.42% efficacy, Bharat Biotech’s still does not have efficacy data as trials are underway in India India’s drug regulator on Sunday gave its final approval to the Oxford-AstraZeneca and Bharat Biotech coronavirus vaccines for restricted use in an emergency situation, giving the country its first two shots for immunising its vast population in the coming weeks. While the Oxford-AstraZeneca vaccine, manufactured by Serum Institute of India (SII), has 70.42 per cent efficacy, the indigenous vaccine from Bharat Biotech does not have efficacy details because the trials are underway. It is doing a study of 25,800 volunteers and around 22,500 participants have been given at least one jab. Both vaccines can be stored at 2-8 degrees Celsius and the companies have been stockpiling them for dispatch once the approvals come. SII has a stockpile of over 50 million doses at the moment and can make 100 million doses per mont...