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Bharat Biotech on Wednesday announced the first interim analysis of Covaxin, which shows the efficacy of the Covid-19 vaccine to be at 81 percent. The Hyderabad-based vaccine maker said the whole virion inactivated Covid-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 percent in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research (ICMR).
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our Covid-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants.
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Covaxin demonstrates a high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants,” said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech. BBV152 (Covaxin) contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at 2 to 8oC (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
BBV152 has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30 percent, the vaccine maker said. BBV152 is based on an established manufacturing platform with a better safety profile when compared to other vaccine platforms. The inclusion of the Algel-IMDG adjuvant enhances T-cell immune responses to Covid-19, leading to long-term protection.
“I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery,” said Suchitra Ella, Joint Managing Director, Bharat Biotech.
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 primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) Covid-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
The first interim analysis is based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus 7 cases observed in the BBV152 group, resulting in a point estimate of vaccine efficacy of 80.6 percent. The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
The trial’s conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA. Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.
Bharat Biotech expects to share further details of the trial results as additional data become available. Additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication, Bharat Biotech said. More than 40 countries globally have expressed their interest in Covaxin. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity, it added. (IANS/SP)
High drama was witnessed in Kanpur Dehat for over an hour when a man, upset over his wife's alleged affair with a local man, climbed the tower with his children and threatened to commit suicide. The incident took place on Monday near Gandhi Nagar in Akbarpur, when the man threatened to commit suicide after throwing his kids down from a height of nearly 40-feet. Chaos prevailed around the area and the locals informed the police that rushed to the spot.
After about half-an-hour of convincing, the police managed to bring him and his children down. The man told the police that his wife's affair was going on with his neighbor. He had complained to the police, but no action was taken. Police said that as per the man, his wife had developed an illicit relationship with a man, living nearby their house. "As per the man, in his absence, his neighbor visited his house often. He said that he had reprimanded his neighbor many times, but to no avail," said the police.
The man had complained to the police, but no action was taken. | Pixabay
The man had also lodged a complaint with the police but no action was taken. On the other hand, Akbarpur police said that on the basis of the complaint, action for breach of peace has been taken against the neighbor accused of luring his wife. Circle officer (CO) Akbarpur Arun Kumar said that the police are trying to sort out the issue. "Whatever action is appropriate will be taken," the official added. (IANS/SP)
(Keywords : Kanpur, Uttar Pradesh, man, wife, alleged, affair, children, India, police, neighbor, complaint, suicide, accuse, drama.)
The US forces continued their bombardment of buildings and institutions in Syria's northeastern Hasakah province, as part of their alleged manhunt of Islamic State (IS) fugitives, state news agency SANA reported. The US forces are shelling buildings and public institutions on Tuesday in the vicinity of the Sina'a prison in the Gweiran neighborhood in Hasakah "on the pretext of hunting down IS militants who fled the prison," said SANA.
The Syrian Foreign Ministry has slammed the US airstrikes as civilian casualties have been reported. | Wikimedia Commons
The shelling came in tandem with waves of raids by the Kurdish-led Syrian Democratic Forces (SDF) to homes in the surrounding areas, rounding up many civilians and taking them to unknown locations, the state news agency added. On January 20, IS inmates inside the Sina'a prison, which is controlled by the SDF, started a riot that was coordinated with IS militants from outside, who detonated the prison's gates with two booby-trapped vehicles, succeeding to free some prisoners.
The incident triggered clashes between IS and the SDF as well as US airstrikes on the areas, where the IS fugitives could have sought shelter in, Xinhua news agency reported. The clashes and airstrikes are still ongoing as the SDF has so far failed to contain the situation and storm the prison. The Syrian Foreign Ministry has slammed the US airstrikes as civilian casualties have been reported. Hasakah province is largely controlled by the US-backed SDF, while certain areas, particularly in the city of Qamishli, are still under the control of the Syrian government. (IANS/ MBI)
(Keywords: US forces, shelling, bombarding, syria, islamic state, civilian casualties, qamishli, tandem, syrian democratic forces)
The circulating avian influenza outbreaks, including in India, do not seem to pose the 'high' risk but surveillance and biosecurity measures are necessary to reduce spillover risk between poultry and wild birds, a UN-backed scientific task force said. Throughout the past autumn and current winter in the northern hemisphere, multiple avian influenza outbreaks, caused predominantly by the H5N1 HPAI virus, plus other subtypes, including H5N8, have occurred in India, the UK, the Netherlands and Israel with the ever recorded mortality of the Svalbard barnacle geese in Solway Coast.
The Scientific Task Force on Avian Influenza and Wild Birds, co-convened by the Convention on the Conservation of Migratory Species of Wild Animals (CMS) and the UN's Food and Agriculture Organization (FAO), on Monday recommended that surveillance and biosecurity measures are reinforced to reduce spillover risk between poultry and wild birds. The Task Force has convened and produced recommendations and guidance for authorities and managers of countries affected or at risk. Wild birds, including globally threatened species, are victims of HPAI viruses causing avian influenza. Affected sites also include areas of international relevance for conservation such as protected wetlands.
More than 2,400 migratory water birds died in the Pong wetlands in Himachal last year because of avian influenza. | Unsplash
It is essential that authorities with responsibility for animal health apply the One Health approach for communicating and addressing avian influenza. That means recognising the health of humans, domestic and wild animals, plants, and the wider environment and acting with a coordinated and unified approach. The Task Force reminds authorities of their international obligations to ensure their response to the pathogenic virus does not include the culling of wild birds, nor actions that would cause damage to natural ecosystems, especially wetlands.
Ruth Cromie, who coordinated the work of the Task Force and the production of the statement, said: "Avian influenza represents a One Health issue threatening health across the board. The highly pathogenic viruses are still relatively new in wild birds and this winter's high levels of mortality remind us of their vulnerability and that working to promote healthy wildlife benefits us all." H5N1 is currently the avian influenza lineage most found in Africa and Eurasia in both poultry and wild birds. The wide range of wild birds affected include wildfowl, waders, gulls, cranes, grebes, herons, pelicans, gamebirds, corvids and raptors (diurnal and nocturnal), in addition to sporadic cases in mammals such as red fox (Vulpes vulpes), Eurasian otter (Lutra lutra) and harbor Phoca vitulina and grey seal Halichoerus grypus.
Consider occupational exposure, e.g. those working on poultry culling operations. | Unsplash
In terms of human health, the currently circulating H5N1 HPAI viruses do not seem to pose the same zoonotic risk as the 'original' Asian lineage H5N1 (clade 2.2 and their derivatives plus clade 22.214.171.124b H5N6 viruses currently in China). In general, the risk can be considered low, recognising that some agencies now consider occupational exposure, e.g. those working on poultry culling operations, as low or moderate. In India, several instances of bird flu were reported in 2021. More than 2,400 migratory water birds, and almost half of them being endangered bar-headed goose, died in the Pong wetlands in Himachal Pradesh last year and that avian influenza (H5N1) was the cause.
Besides the bar-headed goose, the other species that died were the shoveler, the river tern, the pochard and the common teal. An 11-year-old boy died at All India Institute of Medical Sciences in Delhi last year due to avian influenza, country's first fatality. India reported the first outbreak of avian influenza in 2006. RSPB Scotland is calling for an emergency local moratorium restricting shooting on the Solway for the rest of the wildfowling season. It calls for urgent action to reduce the devastating impacts of avian influenza. New statistics from the most recent counts show that the UK is this winter experiencing the worst outbreak of this deadly disease on record, with migratory geese which 'over winter' on the Solway being the hardest hit.
According to RSPB Scotland, the latest population counts of the Svalbard barnacle goose show a drop in numbers from 43,703 in November last year to 27,133 in this month's count. This represents a decline of 38 per cent in the Svalbard breeding population of this species from winter 2020-21. CMS Executive Secretary Amy Fraenkel said: "Through late 2021 and early 2022 there have been numerous outbreaks of highly pathogenic avian influenza H5N1, with severe impacts on migratory birds. "The CMS Secretariat responded by convening the Scientific Task Force on Avian Influenza and Wild Birds together with the FAO. We are pleased to share its advice and key recommendations for countries affected or at risk, and look forward to continuing our collaborative work to minimize risks to humans, poultry and wild populations of migratory birds." (IANS/SP)
(Keywords : avian, influenza, surveillance, United Nation, scientists, breeding, population, birds, affected, countries, poultry, migratory, health, issue, virus, responsibility, international, ecosystem.)