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...

  One of the reasons for the success of India’s Covid-19 inoculation campaign was the trust that people developed in the vaccine and the process followed, writes Prime Minister Narendra Modi. India completed vaccination of 100 crore (one billion) doses on October 21, 2021, in just about nine months since starting vaccination. This has been a tremendous journey in dealing with Covid-19, especially when we recall how things stood in early 2020. Humanity was dealing with such a pandemic after 100 years and no one knew much about the virus. We remember how unpredictable the situation appeared then, as we were faced by an unknown and invisible enemy mutating rapidly. The journey from anxiety to assurance has happened and our nation has emerged stronger, thanks to the world’s largest vaccination drive. It has been a truly ‘bhagirath’ effort involving multiple sections of society. To get a sense of the scale, assume that each vaccination took just two minutes for a healthcare worker. At t...

  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 ...

  The study was aimed at analysing the antibody response after two complete doses of Covishield and Covaxin in Indians Indian health care workers who were administered Covishield have shown better antibody response than the Covaxin recipients, revealed a recent study. The study, published in an online archive for unpublished manuscripts in medical sciences medRxiv, showed that after two shots of the vaccines, 98 per cent recipients of Covishield showed antibody response, while the same was 80 per cent among Covaxin recipients. The study published by a group of doctors – Awadhesh Kumar Singh, Sanjeev Ratnakar Phatak, Ritu Singh, Kingshuk Bhattacharjee, Nagendra Kumar Singh, Arvind Gupta, and Arvind Sharma – has not been peer-reviewed yet. The researchers have declared no competing interest and that no funding was received for this cross-sectional study. The study was aimed at analysing the antibody response after two complete doses of Covishield and Covaxin in Indians. “We assessed ...

  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...

  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...