Heena Sharma Blog

  Bharat Biotech's Covaxin is effective against the Delta and Delta plus variant, a study by the Indian Council of Medical Research and National Institute of Virology has said. The study released on Monday showed that Covaxin provides 65.2 per cent protection against the Delta variant which was first detected in India. The Delta variant which has spread to 99 countries is a variant of concern and was also responsible for the second wave in India. The Delta variant has also been identified as the leading cause of breakthrough infections globally among vaccinated individuals, the study said. The study said that a minor reduction in the neutralising antibody titer in Covid-19 recovered cases and full BBV152 vaccinated and post immunized infected cases was observed but the vaccine was found to be effective against the Delta, Delta AY.1 and B.1.617.3 variants. The study published as a pre-print on bioRxiv said that Sera of vaccines among Covid naïve recovered cases with full vacc...

  The World Health Organisation , which is currently reviewing Bharat Biotech's application for an Emergency Use Listing (EUL) of its COVID-19 vaccine Covaxin , has said it is assessing the data of the jab. In an update on its website, the WHO, which began rolling data on July 6, said the date for a decision on the jab is yet "to be confirmed". Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process. Suchitra Ella, joint managing director of Bharat Biotech, had recently said the EUL process is a step closer to the final decision on Covaxin's 'global acceptance' as the rolling data was slated to begin in July. She also, in a tweet, said the company was working closely with the WHO for inclusion of Covaxin in its EUL and approval is not expected to be a long drawn process as cell line and majority of Bharat Biotech's facilities have already been audited and approved by...

  Bharat Biotech on Friday said it has dispatched COVID vaccine Covaxin to various states like Gujarat, Assam, Tamil Nadu, Karnataka and Odisha. The Hyderabad-based vaccine major, which has come under fire from the Delhi government over supply-related issues, said it has also dispatched Covaxin lots to Kerala and Uttarakhand. "Covaxin goes to Gandhinagar, Guwahati, Chennai, Hyderabad, Bengaluru & Bhuvneshwar. thank all our employees @ BHarat bio who worked thru the holy month of Ramzan..." Bharat Biotech Co-Founder and Joint Managing Director Suchitra Ella said in a tweet. Earlier in a late night tweet on Thursday, she tweeted informing supply of the much in demand vaccine to Kerala and Uttarakhand. "Covaxin sent to Kerala & Uttarakhand. Thanq for the concern, many offered to help. Our work is highly stringent, realtime & technical,no work from home! All Our employees will be taken care of, won't deter us from our mission! Let's be thankful...

  India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday. The trial will be conducted on 525 healthy volunteers. "The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12," the ministry said. Hyderabad based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) on COVID-19 mee...

  Bharat Biotech has commenced direct supply of its COVID-19 vaccine ' Covaxin ' to 14 states, including Delhi and Maharashtra, with effect from May 1, according to the company's Joint Managing Director Suchitra Ella. The Hyderabad-based firm has started supplying its COVID-19 treatment vaccine to the states based on the allocations received by the central government. "Bharat Biotech confirms direct supplies of COVAXIN to the following state govt's since 1/5/21, based on the allocations received by GoI. Requests have been received from other states, & will be processed for distribution based on availability of stocks 24x7," Ella tweeted. The company is supplying vaccines to Andhra Pradesh, Assam, Chhattisgarh, Gujarat, Jammu & Kashmir, Jharkhand, Madhya Pradesh, Odisha, Tamil Nadu, Telangana, Uttar Pradesh and West Bengal. Read More  

  In a much-awaited move, India has allowed Covid vaccination for all above 18 years of age, starting May 1. The decision, taken at a meeting chaired by Prime Minister Narendra Modi on Monday, is expected to change the course of the pandemic currently raging through the country. India Inc and political parties have for long demanded the opening up of vaccination for all adults. In a departure from the current policy, the government has also allowed states to procure additional vaccine doses directly from the manufacturers. Vaccine supply to open market and industries has been permitted as well with conditions. In fact, the government will allow the imported ready-to-use vaccines to be entirely utilised in the open market. While the pricing arrangements have not been revealed, the latest announcement clubbed with the recent proposal to fast-track clearances could attract a host of foreign vaccine-makers, according to officials. Vaccination would continue free of cost in governm...

  In a major step to ramp up vaccine production amid the Covid-19 second wave , the Centre has approved production of Corona vaccines from the Maharashtra government-owned Haffkine Institute in Mumbai. Since the past month, Chief Minister Uddhav Thackeray had repeatedly requested Prime Minister Narendra Modi to allow production of vaccines in the renowned institution in central Mumbai. The central approval came late on Thursday night green-flagging the 122-year-old Haffkine Institute , Parel, to produce the Bharat Biotech's Covaxin for one-year under a technology transfer agreement. Shortly after the announcement, Thackeray thanked the PM for the formal nod, sent by the Department of Science & Technology Secretary to state Chief Secretary Sitaram Kunte of the approval for a period of 12 months. Read More

  Following a sluggish start, India’s Covid-19 vaccination drive -- one of the world’s biggest -- has jumped nearly four-fold after the country opened it up to more people and got a crucial public endorsement from the inoculation of Prime Minister Narendra Modi. Almost 21 million shots have been administered in India so far, up from 5.4 million a month ago, according to data compiled as of Sunday by Bloomberg and Johns Hopkins University. The number of doses per 100 people has also climbed to 1.56 from 0.41. A record 1.6 million Indians received a Covid-19 vaccine on Saturday, data show. After an initially lukewarm response -- due in part to the controversial approval of a homegrown vaccine before it had completed clinical trials -- the vaccination drive gained some momentum after Modi took the injection on March 1 and urged others to follow suit. India also opened the rollout to all citizens above 60 years of age and those 45 and older with co-morbidities, either for free fro...

  The second phase of India’s Covid-19 vaccination started on Monday and the Co-WIN portal also started a self-registration process for the 270 million people eligible for these shots. Under this phase, people above 60 years of age – and those over 45 years of age and with co-morbidities – are to be inoculated. The registration portal could be accessed at https://selfregistration.cowin.gov.in/ . The government has issued a list of 20 specified co-morbidities to determine the eligibility of people who can be administered a vaccine shot on priority. If someone is more than 45 years old and suffers from conditions like diabetes or has suffered a heart attack in the past year, they will be eligible to get a Covid-19 vaccine shot. Here’s the full list of specified co-morbidities: 1. Heart failure with hospital admission in the past one year. 2. Post cardiac transplant/ Left Ventricular Assist Device (LVAD). 3. Significant left ventricular systolic dysfunction (LVEF < 40%)....

  India's Bharat Biotech is in the process of filing regulatory documents for approval of its COVID-19 vaccine , COVAXIN , in more than 40 countries, the company told Reuters late on Wednesday. "We have submitted our documentation in Brazil and other countries and await their approval. We plan to export several million doses to Brazil," the company said in an emailed statement. "Pricing of COVAXIN for international markets will be based upon supply timelines, purchase commitments and procurement volumes," it added. Bharat Biotech, which last Tuesday had told Reuters it may export doses of COVAXIN to Brazil and the United Arab Emirates by the end of the week, did not name other countries and did not give exact figures on doses it expects to export. The company has also entered into an agreement with U.S. drug developer Ocugen Inc for the commercialization of COVAXIN in the United States, which has seen the most number of infections in the world. Read More

  Bharat Biotech's fact sheet on COVID-19 vaccine Covaxin , has advised pregnant or breastfeeding women, besides people with high fever or bleeding disorders, not to take the antidote. The vaccine maker in the fact sheet on Covaxin , posted in its website, said the clinical efficacy of the vaccine is yet to be established and is being studied in Phase 3 clinical trial and hence it is important to appreciate that receiving the vaccine does not mean other precautions related to COVID- 19 need not be followed. "You should not get Bharat Biotech's COVID-19 vaccine Covaxin if you have any history of allergies. Have high fever. Have bleeding disorder or are a blood thinner. Immune compromised or are a medicine that affects your immune system. Are pregnant. Are breast feeding. Read More

  Like many things in India nowadays, the science of vaccine approval has also run into the politics of chest-thumping nationalism. Alongside authorising Covishield, the Covid-19 protection developed by Oxford University and AstraZeneca Plc and manufactured by the Serum Institute of India Ltd., the country’s drugs regulator on Sunday gave a go-ahead to an indigenous vaccine for which critical phase three trial data isn’t yet available. The hasty nod for Bharat Biotech International Ltd.’s Covaxin , developed in collaboration with the Indian Council of Medical Research and National Institute of Virology, has raised eyebrows in the scientific and healthcare communities about a “public rollout of an untested product,” according to a national network of nongovernment organizations. This is unfortunate. With more than 10 million coronavirus infections, India is the world’s second-worst-affected nation after the U.S. New Delhi’s strategy for vaccinating 1.3 billion people will mat...

  Bharat Biotech has claimed that amongst all the vaccine platforms such as an mRNA-based vaccine, DNA-based vaccine, vector-based vaccine, or live attenuated vaccines, etc., the inactivated vaccines being developed by it for Covid 19 are safest, and hence, the adverse reactions are lesser. In a series of frequently asked questions (FAQs) for its trials, Bharat Biotech said BBV-152 is a whole-virion inactivated SARS-CoV-2 vaccine. Amongst all the vaccine platforms such as an mRNA-based vaccine, DNA-based vaccine, vector-based vaccine, or live attenuated vaccines, etc., the inactivated vaccines are safest, and hence, the adverse reactions are lesser. It said about 755 participants have been vaccinated in phase 1 & 2 clinical trials. No serious adverse events have been reported to be related to the vaccine in phase 1 and 2 clinical trials. It said vaccination with BBV-152B may protect the participants only after 14-days post-second dose of vaccination. Hence, the particip...

The human trial of Bharat Biotech's anti- Covid-19 vaccine Covaxin began at Rohtak's Post-Graduate Institute of Medical Sciences on Friday, Haryana Health Minister Anil Vij tweeted. Human trial with Corona vaccine (COVAXIN) of Bharat Biotech started at PGI Rohtak today, Vij, who is also the Home and Science & Technology minister said. Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse effects, Vij further said in his tweet. Bharat Biotech got the country's drug regulator's approval to start clinical trials of its anti-Corona vaccine Covaxin recently. Read More

India's pharmaceutical industry will be able to produce Covid-19 vaccines not just for the country but also for the entire world, according to Microsoft co-founder and philanthropist Bill Gates. A lot of "very important things have been done" in India and its pharma industry is doing work "to help make the coronavirus vaccine building on other great capacities that they have used for other diseases", said the Co-Chair and Trustee of Bill and Melinda Gates Foundation. Speaking in a documentary -- Covid-19: India's War Against The Virus -- to be premiered on Discovery Plus Thursday evening, Gates said India also faces a huge challenge due to the health crisis because of its gigantic size and urban centres with a lot of population density. Read More