The Lancet peer-review has now corroborated Hyderabad-based Bharat Biotech's efficacy analysis regarding Covaxin, its coronavirus disease (Covid-19) vaccine, and confirmed that the shot demonstrates 77.8 per cent efficacy against patients symptomatic with the infectious disease, reports the Hindustan Times. 1 . In its new study, The Lancet noted that the Covid-19 vaccine made by Bharat Biotech is ‘highly efficacious’ and presents no safety concern, also inducing a “robust antibody response” two weeks after two doses of the shot are administered. 2. The Lancet journal, although it corroborated Bharat Biotech's efficacy analysis for Covaxin, also noted that more research is needed to understand more about Covaxin's long-term safety and effectiveness, as well as protection against hospitalisation. Read:Anti-Covid pill likely to get approved in India soon, DCGI reviewing data 3. Further research is also needed to effectively study Covaxin's effect on deterring Covid-19 deaths, and also its ability to fend off the Delta variant and other variants of concern of the coronavirus. 4. Only 684 suspected Covid-19 cases were identified at least 14 days after the second dose, among the total 24,419 participants who received both doses of the vaccine. 5. Of the confirmed cases, nine did not meet the case definition, being either seropositive for SARS-CoV-2 at baseline or only having one symptom, and thus 130 cases were included in the efficacy analysis. 24 (0.3 per cent) cases occurred among 8471 participants in the vaccine group and 106 (1.2 per cent) among 8502 participants in the placebo group, resulting in an estimated vaccine efficacy of 77.8 per cent. Notably, Covaxin was recently granted the much-coveted emergency use authorisation (EUA) by the World Health Organisation (WHO) and the shot has already been cleared for use in as many as 17 nations. With the recent green signal from the global health body, Covaxin has now joined a shortlist of anti-Covid vaccines approved by WHO – which include the shots manufactured by AstraZeneca/Oxford, Johnson&Johnson, Moderna, Pfizer/BioNTech, Sinopharm, and Sinovac. While approving Covaxin, WHO noted that this vaccine is “extremely suitable for low- and middle-income countries due to easy storage requirements”. Read: Pfizer asks FDA to OK COVID-19 booster shots for all adults Bharat Biotech had informed back in July that the safety and efficacy analysis data from the Phase-III clinical trials of Covaxin had shown an efficacy rate of 77.8 per cent against mild, moderate, and severe instances of Covid-19. Against severe symptomatic cases of Covid-19, on the other hand, Covaxin was found to be 93.4 per cent effective, the Hyderabad-based pharmaceutical firm had said. The Phase III trials for Covaxin were conducted on 25,798 subjects – aged between 18 to 98 years – across 25 sites in India.

Phase 2/3 trials of Bharat Biotech International Limited’s nasal vaccine against the coronavirus disease (Covid-19) are likely to begin “within a couple of weeks” at the All India Institute of Medical Sciences (AIIMS) in Delhi, reported Hidustan Times. The Hyderabad-based company received regulatory approvals to conduct the second and third phase trials of the intranasal vaccine, BBV154, in August.  For these two stages, mandatory permission from AIIMS Ethics Committee will be required for which an application has already been submitted. Upon receiving the panel’s nod, the exercise will be conducted by administering two doses to volunteers, with a gap of four weeks between the two. The trials will take place under the leadership of Dr Sanjay Rai. The third phase will commence only after the preceding stage has been fully completed. Also read: India’s Bharat Biotech says vaccine 93.4% effective against severe COVID-19  It is to be noted that BBV154 is the first of its kind Covid-19 jab to undergo human trials in the country. Phase 1 of the exercise was conducted on health groups volunteers in the age group of 18-60 and was “well tolerated,” the ministry of science and technology had said earlier. The vaccine has been developed with support from the department of biotechnology (DBT) and Biotechnology Industry Research Associate Council (BIRAC). BBV154 is the first intranasal jab in the country to reach late-stage trials, according to Dr Renu Swarup, secretary, DBT. Bharat Biotech has also developed India’s first home-made anti-Covid shot, Covaxin, which, along with Covishield, is the most-widely used vaccine in the nationwide inoculation drive, which began on January 16. In its Phase 3 clinical trials, Covaxin demonstrated 77.8% efficacy against symptomatic Covid-19 and 93.4% against severe form of the disease. Also read:  India may firm up plans to export Bharat Biotech’s Covaxin

India is likely to have its indigenous Covid-19 vaccine for children by September, Director of Indian Council of Medical Research (ICMR)'s National Institute of Virology (Pune) Priya Abraham said. Abraham's remarks come amid the ongoing phase II and III trials of Covaxin for the 2-18 age group. "Hopefully, the results (of the trials) are going to be available very soon. The results will be presented to the regulators. So, by September or just after it, we may have Covid-19 vaccines for children," Abraham told India Science, an OTT channel of the science and technology department. Read: Bangladesh- India flight operation to resume Aug 20: FM ICMR and Hyderabad-based vaccine manufacturer Bharat Biotech co-developed Covaxin, India's first indigenous Covid-19 vaccine. "Apart from Covaxin, Zydus Cadila's vaccine trial is also going on. This can also be applied to children and will be made available. Studies on booster doses have been going on overseas, and at least seven different vaccines have been tried for it," Abraham added. "Now, the World Health Organisation has put a stop to it till more countries catch up with vaccination. This is because there is an alarming vaccine gap between high-income and low-income countries. But, in future, recommendations for boosters will come," he said. Read: India hands over 31 ambulences, other medical equipment to Bangladesh The vaccination programme against Covid-19 started in India on January 16 for people above 18 years. With more than seven months into the drive, so far only 9% of the country's adult population has been fully vaccinated, the figures compiled by Our World in Data showed. The Indian government aims to vaccinate the entire population above 18 years of age by the end of this year. India needs to administer 10 million doses a day to achieve its aim of inoculating the adult population by December, experts say.

Indian company Bharat Biotech said on Saturday its late-stage testing of a COVID-19 vaccine has shown an overall efficacy of 77.8% and effectiveness against all variants. The company in a statement said it is now in discussions with the World Health Organisation to obtain emergency use listing for its vaccine, marketed as Covaxin, reports Gulf News. Read:India to maintain warships in Gulf zone to aid merchant ship The results set to rest questions raised by health experts over Bharat Biotech’s vaccine when it was given emergency use authorisation by the Indian government in January. They felt that the company didn’t have enough clinical trials, making it almost impossible for the firm to have analysed and submitted data showing that its shots are effective in preventing illness from the coronavirus. The company says the vaccine has already received emergency use authorizations in 16 countries including India, the Philippines, Iran and Mexico. Millions of Indian also have been inoculated with the same vaccine. Read:India: Modi govt inducts 43 new Ministers in major Cabinet rejig It says the late-stage trial showed the vaccine was 93.4% effective against severe symptomatic COVID-19 and showed effectiveness of 77.8% against symptomatic COVID-19. The data also demonstrated 65.2% protection against the delta variant, first identified in India. Last month, vaccine maker AstraZeneca Plc also said its vaccine was effective against the Delta and Kappa variants, citing a study. India has been administering the AstraZeneca vaccine, made domestically by the Serum Institute of India, which said last month it planned to step up monthly production from July, to nearly 100 million doses. Bharat Biotech now estimates it will make 23 million doses a month. Read: India gives aluminum battery a chance to take on lithium in electric vehicles The Phase-III data came as Ocugen Inc, which is co-developing Covaxin with Bharat Biotech for the US market, prepares to file a request for full US approval. India, with a tally of 30.45 million infections, is the second most affected nation after the United States, with 33 million. The south Asian nation’s death toll has now crossed 400,000.

Dhaka, May 24 (UNB)--India has received enquiries from other countries for the export of the indigenous Covid 19 vaccine Covaxin jointly developed by Bharat Biotech and the Indian Council of Medical Research (ICMR), according to government officials aware of the development. According to Hindustan Tims, New Delhi has been approached by at least two countries, Hungary and Paraguay for the commercial export of 1 million doses of Covaxin, with the first holding forth the possibility of access to the EU. To be sure, decisions on exprts are commercial ones that will have to be taken by Bharat Biotech. In February Bharat Biotech announced that it has signed a pact with Ocugen Inc, allowing the US-based biopharmaceutical firm to co-develop, supply, and commercialize the Indian vaccine maker’s Covid-19 vaccine Covaxin in the US market. According to the Union government’s affidavit in the Supreme Court, in May, Bharat Biotech has increased its capacity from 9 million to 20 million a month now, which will increase to 55 million units by July 2021. according to the government’s latest vaccine policy, half of these will be sold to the Centre and the other half to the states and private hospitals. Read:India virus death toll passes 300,000, 3rd highest in world “The govt of Hungary approached the government in mid- April for supply of 1 million doses for Covaxin by around May end on priority. It was also informed that they would grant EU Good manufacturing practice (GMP) certification to Bharat Biotech facilities that would also open India’s vaccine exports to the wider EU markets if the government would consider supplying the 1 million doses. This would not only open up India vaccine exports to the wider EU market (as certification granted by Hungary would be recognized in EU) in future but may also facilitate BBT’s negotiations with Brazil and other markets that they may be exploring as well…,” one of the officials said on condition of anonymity. “The Covaxin samples received from Bharat Biotech had already been approved by the National Institute of Pharmacy and Nutrition and the Hungarian National Drug Authority. We were informed that the expert team that visited India last month to audit BBT facilities had also returned and given its report. They were ready to grant emergency use authorization for Covaxin. It was also noted that certain issues were found during the expert team’s visit to BBT facilities. The Brazilian team that had visited BBT around the same time had also flagged these issues... ,” the official added. In March Brazilian health regulator Anvisa denied permission to import Bharat Biotech’s COVID-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Current Good Manufacturing Practice (CGMP) requirements. Bharat Biotech in February said it had signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin during the second and third quarters of the current year. The vaccine maker then said: “the requirements pointed out during inspection will be fulfilled,” and that the timelines for fulfilment were under discussion with the Brazil NRA and will be resolved soon.’’ Bharat Biotech did not respond to a detailed questionnaire sent on May 12. The government has also been approached for commercial contracts for Covaxin by Paraguay, according to a second official. According to the external affair ministry’s Vaccine Maitri portal. Paraguay has thus far received 2 lakh doses of vaccines as a gift. “ They (Paraguay) have thanked Prime Minister Modi for gifting the vaccines under its vaccine Maitri initiative. We were informed last month that negotiations were on between Paraguay, which is looking to sign a contract with Bharat Biotech for procurement million doses of Covaxin,” the second official added. A third official from the external affairs ministry confirmed this. On May 1 HT reported that Centre is also exploring the possibility of offering the locally developed coronavirus vaccine, Covaxin for production abroad through a technology transfer between commercial entities, according to government officials aware of the development. Read: India battles fatal fungal threat as virus deaths near 300K India’s indigenous vaccine, Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. In a statement issued on April 20, Bharat Biotech said it was exploring manufacturing partnerships with partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment. The company also said Covaxin has received Emergency Use Authorisation in several countries across the globe with another 60 in process. It has been granted EUAs in Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe, among several other countries. It is in the process of getting EUAs in the US and Europe, according to Bharat Biotech. Earlier this month, a joint statement on the India- EU leaders’ meeting said: “Recognising the role of extensive immunisation as a global public good and concurring that the vaccination process is not a race amongst countries but a race against time, we welcomed the EU’s and its Member States’ contribution to vaccines’ production and their substantial support to the COVAX Facility, as well as India’s efforts to produce and distribute COVID-19 vaccines to over 90 countries through its ‘Vaccine Maitri’...We are committed to working together to better prepare for and respond to global health emergencies. We agreed to cooperate on resilient medical supply chains, vaccines and the Active Pharmaceutical Ingredients (APIs), and on the application of international good manufacturing standards to ensure high quality and safety of products.”

Last year, Indian Prime Minister Narendra Modi told the United Nations his country would make enough COVID-19 vaccines “to help all humanity.” Now India is struggling to meet its own domestic needs for the shots amid a startling surge of infections. As the world’s largest maker of vaccines, India always was expected to play a pivotal role in global efforts to immunize against COVID-19. But a mixture of overconfidence, poor planning and bad luck has prevented that from happening. Read:India suffers double blow as black fungus declared epidemic amid COVID-19 surge Here’s a look at what went wrong: CAUGHT OFF GUARD Officials in India seemed to have been caught off guard by several things, including the speed at which vaccines were approved for use around the world. India like many other countries had been working under the assumption that vaccines wouldn’t be ready for use until mid-2021. Instead, they started being greenlit in some countries in December — upping the pressure to not only produce but deliver promised shots as soon as possible. India, which approved two vaccines in January, turned out to not be ready for the eventual demand either at home or abroad. The government’s plan had been to vaccinate 300 million of the India’s nearly 1.4 billion people by August. But it hadn’t actually reserved even close to enough shots to do so. It had just assumed — partly based on projections from the country’s vaccine makers — that there would be enough doses to both vaccinate people at home and fulfill promised orders abroad. There also was little domestic urgency because India’s infections had been declining consistently for months. In fact, in January, just days after India kicked off its domestic vaccination campaign and also started exporting shots, Modi declared victory over the pandemic at a virtual gathering of the World Economic Forum. Modi’s government seemed to bask in the early success of its so-called “vaccine diplomacy” and the Foreign Ministry reiterated time and again that exports were calibrated according to the needs of the domestic immunization program. Experts say that turned out to be a dangerous miscalculation as an explosion of domestic cases was just around the corner. Dr. Vineeta Bal, who studies immune systems at the Indian Institute of Science Education and Research in Pune city, said the government should’ve been planning for the future instead of celebrating its “victory” over the virus. “I’ve no idea why people didn’t think about it,” she said. “Did no one do the calculation ... of how many doses will be needed in India?” PRODUCTION PROBLEMS India has two main COVID-19 vaccine producers: the Serum Institute of India, which is making the AstraZeneca vaccine, and Bharat Biotech, which is making its own local vaccine. India allowed the companies to start producing their shots last year as they waited for formal approval from regulators. Both the government and the companies thought that by the time the shots were approved they would have larger stockpiles of the vaccines than they did. Read:India's COVID-19 tally rises to 26,289,290 with over 250,000 new cases Scaling up manufacturing has turned out to be a problem for both companies. Serum Institute’s chief executive, Adar Poonawalla, told The Associated Press in December that the target was to make up to 100 million shots monthly by January and to split them equally between India and the world. But the federal government told states last month that the company was producing just 60 million shots a month. The company has said that a fire in its facilities in January and a U.S. embargo on exporting raw materials needed to make the jabs has hobbled production. Poonawalla told AP that pivoting away from suppliers in the U.S. could result in a delay of up to six months. Bharat Biotech chairman Krishna Ella told reporters in January that the company was aiming to make 700 million shots in 2021. But India’s federal government told states last month that the company was producing just 10 million shots a month. The government said last month that it was giving the company millions of dollars in grants to try to help it ramp up production. Neither company nor India’s Health Ministry responded to requests for comment. WHAT NEXT? With India recording hundreds of thousands of new infections each day, the government on May 1 opened up vaccination to all adults. That caused a surge in demand that has laid bare the extent of the shortage. India has so far received just 196 million shots, including 10 million as a part of COVAX, a worldwide initiative aimed at providing equitable access to vaccines. Just 41 million people have been fully vaccinated, while 104 million more have received the first shot. But the number of shots administered has declined from an average of 3.6 million a day on April 10 to about 1.4 million a day on May 20. To help with the shortage, India has greenlit the Russian vaccine Sputnik V, and 200,000 doses of it arrived last week. Read:India to begin clinical trials for Covd-19 vaccine in children The government says supplies will improve soon and expects more than 2 billion shots to be available between August and December, according to Dr. V.K. Paul, a government adviser. That would include 750 million shots made by Serum Institute, 550 million shots made by Bharat Biotech and 156 million shots from Russia. There also are plans for five Indian companies to make the Russian vaccine locally and for Serum Institute to make a version of the Novavax vaccine and vaccines from five other Indian companies whose shots are still being tested. But experts warn that such estimates are once again too optimistic. “These are optimistic estimates ... there are many ifs and buts that one needs to consider,” said Bal.

Unable to cope with the growing demand for its Covid-19 jabs in India and abroad, the Serum Institute is reportedly planning to soon start the production of the Oxford-AstraZeneca vaccine in other countries as well. Serum's Covishield is being widely used in both India and Bangladesh's mega inoculation drives. Bangladesh has inked a deal with Serum to buy 30 million doses of Covishield, but a recent surge in Covid cases in India has made the delivery of the remaining doses uncertain. Read Will soon come out of uncertainty over vaccine availability: Minister   Serum's chief executive officer Adar Poonawalla revealed his plans to set up vaccine production units outside India in an interview with The Times newspaper. "There's going to be an announcement in the next few days," he told the British daily.  Poonawalla hoped to increase the Serum Institute's production capacity from the existing 2.5 billion to 3 billion doses a year within six months, the newspaper reported. Read Bangladesh approves emergency use of Russian Sputnik V vaccine India is currently witnessing a ferocious second wave of Covid-19. On Saturday, the country registered a record four lakh cases in a span of 24 hours, for the first time after reporting over three lakh daily infections for nine days in a row. Indian Prime Minister Narendra Modi rolled out the world's largest Covid vaccination drive on January 16. Covishield and local company Bharat Biotech's Covaxin are currently being given to citizens. However, several states in India have run out of Covid vaccines. Read PVA bats for suspension of intellectual property rights on Covid jabs

India's Covaxin, the homegrown government-backed vaccine, has an efficacy rate of 81%, preliminary data from its phase 3 trial shows.

Eight more Covid-19-related deaths and 585 new cases were reported in Bangladesh in the last 24 hours till Monday morning, showing a substantial rise in its daily infection rate.

India’s homegrown vaccine developer Bharat Biotech has warned people with weaker immunity and other medical conditions that include allergies, fever, or a bleeding disorder to consult a doctor before getting the shot — and if possible avoid the vaccine.