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The ideal time for a <keyword id="2825536" type="General" weightage="20" keywordseo="booster-dose" source="Orion">booster dose</keyword> for COVID-19 vaccine is six months after the second dose, <keyword id="10494595" type="General" weightage="20" keywordseo="Bharat-Biotech-Chairman" source="Orion">Bharat Biotech Chairman</keyword> and Managing Director Krishna Ella said on Wednesday, and also emphasised the importance of having a nasal vaccine. He also pointed out that his company was the first in the world to develop a <keyword id="3225534" type="General" weightage="20" keywordseo="Zika-vaccine" source="Orion">Zika vaccine</keyword>. Taking the <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword> vaccine by the Prime Minister Narendra Modi showed confidence in Indian Science, he said at the Times Now Summit 2021. "The ideal time for a booster dose is six months after the second dose," Ella stated. <keyword id="149108" type="General" weightage="100" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> is also looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin, he added. About the importance of nasal vaccine, he said the entire world is looking at nasal vaccines. That is the only way to stop transmission. Everyone is trying to figure out the immunology and fortunately, Bharat Biotech has figured it out. "We are coming out with a nasal vaccine, we are thinking that Covaxin can be given as first dose, the second dose can be given a nasal, that is also strategically, scientifically very important because with the second dose, if it is a nasal one, you stop the transmission of the virus...," Ella said. Nasal vaccine works well if someone has been infected or if someone has been vaccinated with one dose, he added. About the PM taking the Covaxin shot, he said, "What would a scientist like to have? A country head taking his vaccine. That is the best satisfaction a scientist can get... It shows confidence in the Indian science, confidence in the startup, and confidence in our innovation...". Speaking about a vaccine for Zika, Ella said Bharat Biotech is ready with a vaccine for Zika virus. Phase I is complete. The government has to take up more trials because there are more cases now. "We were the first company in the world to develop the Zika vaccine in 2014... We were the first one to file for a global patent for Zika vaccine", he added. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/heres-how-you-can-protect-your-smartphone-from-exploding/slidelist/87625685.cms">Here’s how you can protect your smartphone from exploding</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/union-cabinet-approves-declaration-of-november-15-as-janjatiya-gaurav-diwas/articleshow/87629229.cms">Union Cabinet approves declaration of November 15 as Janjatiya Gaurav Diwas</a>

Ideal time for COVID-19 booster shot is six months after the second dose, says Bharat Biotech MD

Hyderbad, Global <keyword id="6354750" type="COMPANY" weightage="20" keywordseo="health">health</keyword>care company GSK, non-profit agency working to end health inequity PATH, and <keyword id="9254290" type="UNKNOWN" weightage="20" keywordseo="vaccine-maker-bharat-biotech">vaccine maker Bharat Biotech</keyword> on Wednesday announced the signing of a product transfer agreement for malaria vaccine RTS,S/AS01E1. The agreement includes the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to Hyderabad-based <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> International Ltd (BBIL). GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to Bharat Biotech. BBIL was selected through a comprehensive, competitive process undertaken by GSK and PATH, working in consultation with the <keyword id="6356311" type="COMPANY" weightage="20" keywordseo="World-Health-Organisation">World Health Organisation</keyword> (WHO), the vaccine maker said in a statement here. The RTS,S/AS01E malaria vaccine, developed by GSK for more than 30 years, and in partnership with PATH since 2001, is currently being piloted in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme (MVIP). Ministries of Health concerned are leading the implementation of the vaccine, which is being given to young children through the three countries' routine immunisation programmes, with WHO providing technical and scientific leadership, playing a coordinating role, and working in collaboration with GSK, PATH, and a range of <keyword id="10662236" type="UNKNOWN" weightage="20" keywordseo="other-partners">other partners</keyword>. RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received a positive review by regulatory authorities (positive scientific opinion from the <keyword id="114599" type="COMPANY" weightage="20" keywordseo="European-Medicines-Agency">European Medicines Agency</keyword> and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP). The first dose of the vaccine has reached more than 500,000 children since the pilots were initiated by Ministries of Health in the three participating countries in 2019. This agreement with BBIL is the result of efforts by GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a WHO policy recommendation for broader use and a commitment of sustained funding. This builds on existing GSK commitments to donate up to 10 million RTS,S/AS01E doses for use in the pilot, and to supply up to 15 million doses annually until 2028 if the product is recommended for wider use by WHO. It is expected that by 2029, at the latest, BBIL will be the sole supplier of the vaccine, with GSK supplying the adjuvant AS01E to them. "With a child still dying of malaria every two minutes, helping secure the long-term future of the only vaccine available by working with an established leader like Bharat Biotech is vital for the continued fight against this devastating disease. GSK is delighted to sign this agreement with Bharat Biotech," said Thomas Breuer, GSK Vaccines Chief Medical Officer and Vaccines Global Health lead. "We at PATH are proud to be a part of this remarkable effort -- together with partners across Africa, GSK, and WHO -- to get to this point. Now, with the signing of this agreement with Bharat Biotech, we have an additional, new partner to help ensure that this vaccine can be more widely available for use in Africa, alongside other malaria interventions, in the years to come," said John Bawa, Africa Lead, Vaccine Implementation, PATH. "We salute the commitment by GSK, PATH, and partners, in developing a novel vaccine against malaria, a dreaded disease with more than 200 million cases worldwide. We are truly honoured to support this partnership and to provide global access to RTS,S/AS01E. With prior expertise in malaria research, WHO prequalified vaccines, supplied to more than 70 countries, Bharat Biotech is geared up for large-scale manufacturing, and to provide continuous long-term supply of this life-saving vaccine," Bharat Biotech Chairman and Managing Director Krishna M. Ella said. SEE ALSO: <a href="https://www.businessinsider.in/business/corporates/news/hindustan-unilever-third-quarter-profit-revenue-and-share-price/articleshow/80480554.cms?upcache=2">A timely deal with GSK closed during the lockdown has helped Unilever three quarters in a row in India</a> <a href="https://www.businessinsider.in/budget/news/a-playbook-for-budget-2021-to-boost-electronics-manufacturing-in-india/articleshow/80476759.cms">A playbook for Budget 2021 to boost electronics manufacturing in India</a> <a href="https://www.businessinsider.in/tech/news/bytedance-lays-off-employees-in-india-months-after-tiktok-ban-in-the-country/articleshow/80476721.cms">ByteDance lays off employees in India, months after TikTok’s ban in the country</a>

Bharat Biotech to make antigen for first-ever anti-malaria vaccine

<keyword id="149108" type="General" weightage="80" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> on Wednesday said a study has demonstrated that a booster dose of <keyword id="9485939" type="General" weightage="80" keywordseo="covaxin" source="Orion">Covaxin</keyword> has a neutralising effect on the <keyword id="1609796" type="General" weightage="80" keywordseo="omicron" source="Orion">Omicron</keyword> and <keyword id="6383835" type="General" weightage="80" keywordseo="delta" source="Orion">Delta</keyword> variants of COVID-19. The study conducted at Emory University demonstrated that subjects who received a booster dose of Covaxin (BBV152) six months after getting a primary two-dose series have witnessed neutralising of the SARS-CoV-2 Omicron and Delta variants, the vaccine major said in a statement. Earlier studies had demonstrated the neutralising potential of Covaxin against other SARS-CoV-2 variants -- Alpha, Beta, Delta, Zeta and Kappa, it added. Citing the study results, Bharat Biotech noted that more than 90 per cent of all individuals boosted with Covaxin showed neutralising antibodies. "As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern. Data from this preliminary analysis show individuals receiving a booster dose of Covaxin have a significant immune response to both the Omicron and Delta variants. "These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations," Emory Vaccine Center Assistant Professor Mehul Suthar, who led the laboratory analysis, noted. Bharat Biotech Chairman and Managing Director <keyword id="238082" type="General" weightage="20" keywordseo="krishna-ella" source="Orion">Krishna Ella</keyword> said the vaccine major is in a continuous state of innovation and product development for Covaxin. "The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi-epitope vaccine generating both humoral and cell mediated immune responses. "Our goals of developing a global vaccine against COVID-19 have been achieved with the use of Covaxin as a universal vaccine for adults and children," he added. The study conducted at Emory Vaccine Center in Atlanta was sponsored by Ocugen, Inc. Bharat Biotech provided the sera of the subjects from the Phase 2 study. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/enterprise/news/tcs-vs-infosys-vs-wipro-how-indias-three-it-giants-stack-up-against-each-other/slidelist/88860676.cms">TCS vs Infosys vs Wipro Q3 results – here’s how India’s three IT giants stack up against each other</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/tata-motors-tcs-paytm-and-other-hot-stocks-on-january-13/slidelist/88866954.cms">Tata Motors, TCS, Paytm, and other hot stocks on January 13</a>

Study shows booster dose of Covaxin has neutralising effect on Omicron, Delta variants, says Bharat Biotech

Leading vaccine maker <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> on Wednesday announced a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp-adenovirus, single dose intranasal vaccine for Covid-19. The Hyderabad-based company owns the rights to distribute the vaccine in all markets except USA, Japan and Europe. While the Phase I trials will take place in Saint Louis University's Vaccine &amp; Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley, Hyderabad. According to Bharat Biotech, this intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal ‘Cell' and in an editorial in ‘Nature'. "We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive," said Krishna Ella, Chairman and Managing Director of Bharat Biotech. "Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against Covid-19 reaches all citizens of the world," he added. David T. Curiel, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO said that the ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration. "An effective nasal dose not only protects against Covid-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can't do that," he said. This vaccine expands Bharat's portfolio of vaccines that are currently being developed and are in various stages of clinical development including Covaxin which is currently in Phase II human clinical trials in India, the company said. <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/reliance-jio-share-price-is-twice-as-valued-as-bharti-airtel-stock-while-vodafone-idea-vi-ranks-third/articleshow/78269261.cms">Reliance Jio is now twice as valued as Airtel that is down 25% from its peak in May</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/defense/news/china-has-hardened-its-stance-experts-decode-the-india-china-joint-statement-on-border-tensions/articleshow/78270081.cms">China has hardened its stance — experts decode the India-China joint statement on border tensions</a>

Bharat Biotech partners with Washington varsity for intranasal COVID-19 vaccine

<keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> got an approval for its COVID-19 vaccine and along with it came a lot of flak from critics who believe that the process was rushed for no valid reason. Dr Krishna Ella, the founder and chairman of Bharat Biotech, retaliated blaming everyone from the media to rival vaccine makers, except that his arguments hold no water. The drug regulator's approval for any new drug or vaccine is based on the understanding that the drug or vaccine's benefits outweigh its risks. However, considering that he admitted that Phase-III trials are still underway, there is no final estimate of <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword>’s efficacy, and without that number, the approval should not have been granted. Benefits like how effective the vaccine is in preventing disease, and risks such as high mortality rate if the vaccine is not given or vaccine side-effects, are critical data that inform the approval. This benefit-to-risk ratio changes based on the vaccine and disease being considered, but there is no escaping the need for this data. It is, therefore, strange that the vaccine candidate being explored by Bharat Biotech-ICMR, Covaxin, has<a href="https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1685678"> received</a> permission "for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains." Bharat Biotech has<a href="https://www.medrxiv.org/content/10.1101/2020.12.11.20210419v1"> shared</a> findings from their Phase I/II clinical trials as a pre-print on MedRxiv. These studies indicate safety and immunogenicity (i.e., the vaccine candidate's ability to generate an immune response) in human beings. However, Bharat Biotech<a href="https://www.livemint.com/science/health/bharat-biotech-begins-phase-3-trials-of-covid-19-vaccine-covaxin-in-india-11605570981150.html"> began</a> Phase III trials demonstrating the vaccine's efficacy instead of a placebo only on November 16. By December 22 they had<a href="https://www.business-standard.com/article/current-affairs/bharat-biotech-recruits-13-000-volunteers-for-covaxin-phase-3-trials-120122200562_1.html"> recruited</a> only 13,000 volunteers of the target 25,800 participants. The endpoints for the data collection on efficacy are Day 42 to Month 12, as per information<a href="http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=48057&amp;EncHid=&amp;userName=CTRI/2020/11/028976"> submitted</a> to CTRI. It is therefore unlikely that any robust data about the effectiveness of the vaccine is available. Reports<a href="https://theprint.in/health/bharat-biotechs-covaxin-given-conditional-nod-based-on-incomplete-phase-3-trial-results-data/578389/"> suggest</a> that approval was based on immunogenicity data for 10,000 people after they have received the first dose of the vaccine and for 10,000 people after two doses. However, none of this data is available in the public domain, nor has it been peer-reviewed by independent experts. The Subject Expert Committee (SEC) made the recommendation of approval – however, very little is known about the composition of the Committee or the process followed for this approval. It will be premature to determine that Covaxin's benefits outweigh the risks without data on its efficacy. The opaqueness of the approval process adds to the scepticism that is forming around this vaccine. On the other hand, the US Food and Drug Administration has been very transparent with their evaluation of approved vaccines. Its<a href="https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19"> announcement</a> for the Pfizer vaccine, for example, gave details on how many people had received the vaccine and placebo, the effectiveness of the vaccine, and, most importantly, the limitations of the vaccine. It provided a plan for vaccine monitoring and demarcated the company's responsibilities in the future. The discussions of the advisory panel that recommended approval of the vaccines were also<a href="https://www.statnews.com/2020/12/17/moderna-vaccine-fda-panel/"> made</a> public. Both Emergency Use Authorizations (EUA) were given based on Phase III data. In addition, both Moderna and Pfizer have published their trial data in peer-reviewed journals. China and Russia - which approved vaccines with insufficient Phase III data – have<a href="https://www.businesstoday.in/sectors/pharma/covid-19-crisis-scientists-flag-concerns-over-vaccines-from-russia-china/story/414747.html"> attracted</a> scepticism over this process. The constraints placed on the Indian economy and health crisis created by COVID-19 demand expedited approval processes; however, lack of efficacy data cannot be substituted in this fast-tracking process. So what more information do we need? Bharat Biotech and ICMR need to demonstrate the efficacy of the vaccine through published data. Phase III trials can take time, but it will be the correct and ethical way to get the vaccine approval. The government needs to be transparent on how approvals were given and what data were presented. Also, in future, government laws need to be clear on minimum standards that drugs/vaccines need to adhere to for approval. For example, FDA had mandated a minimum efficacy of 50% as a prerequisite for the EUA. It is therefore questionable how Covaxin was approved if Indian authorities followed a similar benchmark. A pandemic requires expedited decision-making, but moving the goalposts for different vaccines is not advisable. The government also needs to clarify the terminology used in their approval, primarily, the terms "restricted", "abundant precaution", and "clinical trial mode". A clinical trial requires constant follow up with participants, a special consent form explaining the risks of the vaccine, and a placebo group. It is unclear how those deemed eligible for Covaxin will be divided into these two groups or how the data will be collected and analysed. It is also unclear who will be responsible for this monitoring. The claim that the Bharat Biotech vaccine is more likely to be effective against mutant coronavirus strains is theoretical and needs to be backed by data. In this case, Bharat Biotech first needs to show efficacy against the original strain as well. In the absence of this data, investment in the vaccine may lead to no positive public health outcomes in India. It may be better to wait for the Phase III interim data and make an informed decision on including it for emergency use. The demand for vaccine efficacy data is not an attack on Bharat Biotech or its vaccine, it is simple scientific requirement that needs to be fulfilled. The impact of this opacity in regulation should go beyond Covaxin and Bharat Biotech. India is the largest vaccine manufacturer in the world. But we are behind in the technology and expertise in creating vaccines. For India to be a world leader in public health, we need to be ahead on indigenous vaccine research and manufacture. However, the scepticism generated by the ambiguity and double standards of the current approval process reduces confidence and credibility in locally made vaccines. The author, Shambhavi Naik, has a PhD in Cancer Biology and is a Fellow at Takshashila Institution, Bengaluru. SEE ALSO: <a href="https://www.businessinsider.in/india/news/bharat-biotech-sees-rivals-conspiracy-in-all-the-criticism-for-the-approval-for-covaxin/articleshow/80099818.cms">Bharat Biotech sees rivals’ conspiracy in all the criticism for the approval for Covaxin</a>

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Ideal time for COVID-19 booster shot is six months after the second dose, says Bharat Biotech MD

PTI

Bharat Biotech to make antigen for first-ever anti-malaria vaccine

IANS

Study shows booster dose of Covaxin has neutralising effect on Omicron, Delta variants, says Bharat Biotech

PTI

Bharat Biotech partners with Washington varsity for intranasal COVID-19 vaccine

OPINION: No matter what Bharat Biotech says, Covaxin is just not ready for approvals

Shambhavi Naik

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