WHO’s advisory group to deliberate on Covaxin EUL approval

SWITZERLAND – The World Health Organization (WHO) has announced that experts will meet on October 26 to decide whether to grant emergency use status to Bharat Biotech’s Covid-19 vaccine Covaxin. Harsh Vardhan Shringla, India’s foreign secretary, expressed optimism that the WHO will soon approve Hyderabad-based Bharat Biotech’s Covid vaccine Covaxin. “It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come…

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Zydus Cadila’s needle-free COVID-19 vaccine gets emergency use approval in India

INDIA – Zydus Cadila indigenously developed needle-free COVID-19 vaccine (ZyCOV-D) has received an emergency use authorization from the Drugs Controller General of India (DCGI) and it will be administered to people aged 12 years and above. ZyCoV-D is a first-of-its-kind DNA vaccine developed in collaboration with the Department of Biotechnology that produces the spike protein of the SARS-CoV-2 to elicit an immune response, which is critical for disease protection and viral clearance. As an intradermal vaccine, it must be applied with a ‘needle-free injector,’ according to the manufacturer, which will…

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Dr Reddy’s, Zydus recall products in US market as Bharat seeks out vaccine partners

USA – Leading drug makers Dr Reddy’s Laboratories and Zydus Pharma are recalling bottles of a product each, in the US market, for different reasons, according to the latest report of the US health regulator. Dr Reddy’s Laboratories, Inc, the US arm of Dr Reddy’s Laboratories, is recalling 37,560 bottles of Tizanidine HCl tablets, USP 4 mg, the latest enforcement report by the US Food and Drug Administration (USFDA) said. The tablets are manufactured by Dr Reddy’s Laboratories Ltd at its Srikakulam facility, it added. They are used to treat…

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India likely to resume export of Covid-19 vaccines following jump in supply

INDIA – India’s rising output of COVID-19 vaccines and the inoculation of more than half its adult population with at least one dose are raising hopes the country will return as an exporter within months, ramping up from early next year. After donating or selling 66 million doses to nearly 100 countries, India barred exports in the middle of April to focus on domestic immunisation as infections exploded, upsetting the inoculation plans of many African and South Asian countries. However, India’s daily vaccinations surpassed 10 million doses on Friday, with…

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IVI,Bharat Biotech start global Phase II/III clinical trial of Chikungunya vaccine

INDIA – The International Vaccine Institute (IVI) and Bharat Biotech has announced the beginning of Phase II/III clinical trial of Chikungunya vaccine candidate (BBV87) in Costa Rica. IVI is leading the Global Chikungunya vaccine Clinical Development Program (GCCDP) consortium in partnership with Bharat Biotech and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India. The Global Chikungunya Vaccine Clinical Development Program (GCCDP) seeks to develop and manufacture an affordable Chikungunya vaccine with the aim of achieving WHO prequalification…

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Bharat Biotech’s nasal COVID-19 vaccine advances into next stage of trials

INDIA – Indian vaccine maker Bharat Biotech’s nasal COVID-19 vaccine candidate has received regulatory approval for mid- to late-stage trials, the government’s ministry of science and technology said in a statement. Early stage trials of the vaccine candidate, BBV154, has been completed in subjects aged 18 to 60 years, and the doses were found to be well tolerated, the statement said. This stage involves testing the vaccine on a large pool of participants, typically running into thousands or even tens of thousands of people. “Bharat Biotech’s BBV154 Covid Vaccine is…

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Bharat Biotech’s Rotavirus vaccine new formulation gets WHO prequalification

INDIA – Bharat Biotech has announced that the World Health Organization (WHO) has awarded prequalification to its rotavirus vaccine, Rotavac 5D to prevent rotavirus diarrhea. Rotavac 5D, new variant of Rotavac, is a unique rotavirus vaccine formulation that can be administered without a buffer and its low dose volume (0.5 mL) facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination, the company said in a press statement. Rotavac vaccine is used for the prevention of rotavirus infection, which is prevalent in infants and young children. “WHO…

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Booster COVID jab may be crucial with new COVID-19 variants emerging

INDIA – With the pandemic still far from over and mutations of the virus still expected to emerge in the near future, a need for a booster dose of the second generation COVID-19 vaccination might be adopted. The chief of All India Institute of Medical Science (AIIMS), Dr Randeep Guleria has called for the need of India to adopt a second-generation booster jab as he believes that the human immunity tends to fall as time progresses. The second- generation vaccines were developed to protect the population from the new emerging…

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Covaxin trials now set to be conducted on children across six hospitals as also Glenmark plans to roll out its phase 3 trials of its nasal COVID-19 treatment

INDIA – The Indian government is aggressively trying to curb the COVID -19 pandemic with the roll out of various programs across the state. Currently the state has embarked on two programs in a bid to curb the spread of the virus with the first one being conducting vaccine trials on children (Covaxin trials) and the second one involving phase 3 trials of a nasal therapy meant to cure COVID-19 symptoms. The Covaxin trials will be conducted on 175 children aged 2-6, 6-12 and 12-18 who will be given the…

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Breakthrough as phase 1 clinical malaria vaccine trial results come positive with proof to give strong lasting protection against malaria

US – The National Institute of Allergy and Infectious Diseases’ (NIAID) phase 1 clinical trials of its malaria vaccine, Sanaria (PfSPZ), have found that the regimen conferred unprecedentedly high levels of durable protection when volunteers were later exposed to disease-causing malaria parasites. Trials were conducted at the National Institutes of Health (NIH) Clinical Centre in Bethesda, Maryland led by Patrick E. Duffy, M.D., of the NIH National Institute of Allergy and Infectious Diseases (NIAID), and Stephen L. Hoffman, M.D., CEO of Sanaria Inc., Rockville, Maryland. In the CVac trials, healthy…

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