| COVID-19: Vaccines Download (326.9 kB) Overview These WHO interim recommendations for use of the Cansino Ad5-nCoV-S vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below. CanSinoBIO Announces Approval for its Single-Dose COVID-19 Vaccine Convidecia in Chile. As of today, it has established a robust pipeline of 17 vaccines preventing 12 diseases, including the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) conditionally approved in . EUL procedure assesses the suitability of novel health products during public health emergencies. "We are pleased to have obtained the issuance of an Emergency Use Listing, as well as the usage recommendation from the Strategic Advisory Group of Experts on Immunization Committee and the Good Manufacturing Practices certificate," said Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO. Biotec Group (CNBG). As of Monday, 76.6% of seniors over 80 years old had received at least one dose, and 65.8% had received two, a health official said Tuesday. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker The publication of the analysis showed that a single dose of Convidecia is efficacious and safe with an efficacy of 96.0% in preventing severe COVID-19 disease and an overall efficacy of 63.7% 14 days post-vaccination for healthy adults aged 18 and above, without any reported vaccine-related serious adverse events. with other health interventions. The vaccine is ready to use and does not contain preservatives, adjuvants nor substances of animal origin. The Technical Advisory Group for Emergency Use Listing, convened by the WHO and consisting of regulatory experts from around the world, determined that Convidecia meets WHO standards for protection against COVID-19 and that the benefits of the vaccine far outweigh risks. CONVIDECIA is the 11th COVID-19 vaccine added to the growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2. Monday, February 21, 2022. China has become the first country to green-light an inhaled Covid-19 vaccine, paving the way for potential use of the needle-free product in the country, where suppressing the spread of . [9] [1] Convidecia is similar to other viral vector . So far, it has been approved as a heterologous booster vaccine in China, Argentina, Malaysia and Indonesia. Marks vaccine's first approval in South America, following Mexico, Pakistan, China and Hungary Safe, stable storage and transportation between 2C and 8C, accessible by under-developed regions. The Program helps COVAX deliver safe and effective COVID-19 vaccines to the high-risk and vulnerable populations in 92 low- and middle-income countries and economies. World Health Organization (WHO) on Thursday issued an emergency use listing (EUL) for CONVIDECIA, a vaccine manufactured by CanSino Biologics, China, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2. Wahyu Dwi Anggoro 20 May 2022 13:16. By Simone McCarthy and Brenda Goodman, CNN. SAGE is the principal advisory group to WHO for vaccines and immunization. As of today, it has established a robust pipeline of 17 vaccines preventing 12 diseases, including the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) conditionally approved in 2021, the Group A and Group C Meningococcal Conjugate Vaccine (CRM197) and the Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) approved in the same year. When autocomplete results are available use up and down arrows to review and enter to select. Despite these benefits, during the 2021-2022 flu season, only 57% of adults (ages 18 years and older) and 67.7% of . The EUL pathway involves rigorous assessment of late-stage clinical trial data as well as substantial additional data on safety, efficacy and quality by independent experts and WHO teams. It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China. The WHO based its decision on the totality of scientific evidence provided by CanSinoBIO, including its Phase III clinical trial results on the safety and efficacy of Convidecia, which were published in The Lancet. Today, let's take a glance at Qiming Venture Partners' portfolio company CanSinoBIO (SEHK:6185, SHSE:688185)'s inhaled COVID-19 vaccine Convidecia Air. . The one-shot . (8 January 2021), Moderna (25 January 2021), AstraZeneca (21 April 2021), and Janssen COVID (17 March 2021) vaccines, as well as issued a framework for access and population prioritization roadmap. It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks. The vaccine is ready to use and does not contain preservatives, adjuvants nor substances of animal origin. WHOis determined to maintain the momentum for increasing access to COVID-19 vaccines and will continue to support countries in accelerating vaccine delivery, to save lives and prevent people from becoming seriously ill. Countries should continue to work towards vaccinatingat least 70%of their populations,prioritizing the vaccination of 100% of health workers and 100% of the most vulnerable groups, including people who are over 60 years of age and those who are immunocompromised or have underlying health conditions. All rights reserved. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while April 8, 2021, 1:19 PM UTC. Sinovac Vaccine. In the context of COVID-19 and due the pressing need for vaccines, the Secretariat of SAGE and the EUL team have been working in parallel to allow WHO EUL and policy recommendations, based on the available evidence, to be issued in a synchronized manner. "Ongoing" refers to accelerated approval (AA) applications that have not yet converted to full approval, and not to the status of the AA postmarketing requirement (PMR). clinical trial registries) and information that were directly provided by vaccine developers to WHO. China's elderly vaccination rate is lower than the national level. Made by CanSino, it has similar ingredients to its injected vaccine, using a harmless adenovirus as a carrier for the . TIANJIN, China, May 19, 2022 /PRNewswire/ -- CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that the World Health Organization ("WHO") has granted Emergency Use Listing ("EUL") for Convidecia, CanSinoBIO's Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector). Heterologous boosters should take into account current vaccine supply, vaccine supply projections, and other access considerations, alongside the potential benefits . This was announced by Singapore's Ministry of Health (MOH) ahead of the country's first step in reopening the economy which includes group dine-in at restaurants up to 5 people starting this coming Tuesday. China has become the first country to approve an inhaled Covid vaccine. "This EUL will greatly contribute to the expansion of vaccine access to underserved populations around the globe, representing a significant milestone for CanSinoBIO and further demonstrating our efforts in the pandemic fight. In November 2021, the Ministry of Health of Argentina recommended CanSinoBIO's Convidecia as a booster for people who have received inactivated vaccine for at least one month, including those aged 50 years old and above. The vaccine maker, CanSino Biologics, said in a statement Sunday that China's medicines regulator had approved the inhaled dose for emergency use as a booster vaccine. Its easy storage requirements make it highly suitable for low-resource settings. WHOs Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. Explore Vaccines. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Share . Clinical trials and results of Heterologus booster dose 1. on thevaccine vialsthat change color as thevaccineis exposed to heat, letting health workers know whether thevaccinecan be safelyused. WHO's EUL procedure is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies. We have also published the criteria for prioritization of vaccines for clinical trials. SAGE has issued recommendations on Pfizer Approved Vaccines; Vaccine Candidates; Global Landscape; About Vaccines & Trials. according to the state council, for those aged 18 and above who have completed a 6-month vaccination schedule using inactivated covid-19 vaccines, and those who have not been administered a. The assessment is performed by the product evaluation group, composed by regulatory It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020; two AstraZeneca/Oxford COVID-19 vaccines on 15 February 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritised. adhering to stringent criteria of safety, efficacy and quality. It possesses five integrated platform technologies including viral vector-based technology, synthetic vaccine technology, protein structure design and recombinant technology, mRNA technology, as well as formulation and delivery technology. An EUL allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines, and is a prerequisite to supply vaccines to the global COVAX Facility, a global mechanism for pooled procurement and equitable distribution of COVID-19 vaccines. data suggest the vaccine is likely to have a protective effect in older persons. SAGE advises WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions. WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines . Earlier this month, CONVIDECIA was also reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine-specific policies and recommendations for. developed by Janssen (Johnson & Johnson) on 12 March 2021. WHO has also listed thePfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen and Moderna vaccines for emergency use. 19 May 2022 | COVID-19: Vaccines Download (1.2 MB) Overview This background document on the Cansino Ad5-nCoV-S vaccine against COVID-19 was prepared by the Working Group on COVID-19 Vaccines of the Strategic Advisory Group of Experts (SAGE) on Immunization to inform SAGE deliberations. TIANJIN, China, May 19, 2022 /PRNewswire/ -- CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that the World Health Organization ("WHO") has granted Emergency Use. These data are reviewed by independent experts and WHO Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. WHO's EUL procedure assesses the . Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity Convidecia is a vaccine developed by the Chinese company CanSino Biologics in partnership with the Institute of Biology at the country's Academy of Military Medical Sciences. WHO has published the target product profiles for COVID-19 vaccines, which describes the preferred and minimally acceptable profiles for human vaccines for long term protection of persons at high ongoing risk of COVID-19, and for reactive use in outbreak settings with rapid onset of immunity. WHO therefore recommends that Draft landscape of COVID-19 vaccine candidates, The draft landscape of COVID-19 vaccine candidates contains information on vaccine candidates collected through public information (e.g. The WHO based its decision on the totality of scientific evidence provided by CanSinoBIO, including its Phase III clinical trial results on the safety and efficacy of Convidecia, which were published in The Lancet. vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability. WHOs EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines as a prerequisite for COVAX vaccine supply. Currently, CanSinoBIO's Convidecia has received approvals in more than 10 markets: China, Mexico, Ecuador, Chile, Argentina, Hungary, Kyrgyzstan, Pakistan, United Arab Emirates, Indonesia and Malaysia. CanSino's vaccine named "Convidecia Air" is the inhaled . An EUL allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines, and is a prerequisite to supply vaccines to the global COVAX Facility, a global. In addition to shortening the vaccination cycle by leveraging the advantages of its single-dose regimen, Convidecia can be stably transported and stored between 2C and 8C, making it more accessible to developing countries with insufficient storage facilities and medical resources, reducing the burden placed on healthcare systems and medical workers, and contributing to building broad immune protection globally. The CanSino vaccine can be offered to people who have had COVID-19 in the past. Malaysia. to a vaccination campaign when the product has been listed or authorized for use. Convidecia vaccine is the only vaccine . It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China. 1. for the latest information on vaccines in clinical and pre-clinical development. Working closely with countries to understand bottlenecks to vaccination, the CoVDP offers access to urgent operational funding, technical assistance and political engagement to rapidly scale up vaccination and monitor progress towards targets. The approval "allows" the CanSino vaccine to be used on those aged 18 and above, three to six months after their first dose of the . SOLBIO is the ASEAN manufacturing partner of CanSino Biologics Inc (CanSinoBIO). Speaks about fears that the lorries . Moreover, the United States have sent 2.5 million doses of the AstraZeneca/Oxford vaccine to Mexico. Everyone, everywhere, should have access to COVID-19 vaccines. Recommendation for an Emergency Use Listing (EUL) of Convidecia COVID-19 Vaccine (Ad5/nCoV-5[recombinant]) submitted by CanSino Biologics Inc. (Published: 10 October 2022) Product description Pharmaceutical Form: Sterile solution for injection In February 2021, global data from Phase III trials and 101 COVID cases showed that the vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease. Convidecia provides protection against severe COVID-19 disease and prevention of COVID-19-related medical interventions for a broad range of age groups above 18, including those over the age of. An EUL allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines, and is a prerequisite to supply vaccines to the global COVAX Facility, a global. As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. "The flu vaccine is safe, effective, and can be given alongside other routine immunizations, including the COVID-19 vaccine and booster." Flu vaccination prevents millions of illnesses and flu-related doctor's visits each year. Convidecia AD5-nCOV, trade-named Convidecia, is a single-dose [1] viral vector vaccine for COVID-19 developed by CanSino Biologics. CONVIDECIA is the 11th COVID-19 vaccine added to the growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2. The WHO's EUL procedure assesses novel health products during public health emergencies to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. Convidecia is an adenovirus type-5 vector-based vaccine. recommended age groups, intervals between shots, specific groups such as pregnant and lactating women). SAGE and EUL are complementary but independent processes. The results also proved the safety of Convidecia for a broad range of age groups above 18, including those over the age of 60. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. 2. China's CanSino Biologics Inc (CanSinoBIO) (6185.HK), said on Monday its COVID-19 vaccine has been authorised for emergency use in Hungary, the second Chinese vaccine to receive approval in that . nCoV vaccine may. Pakistan. In November 2021, the Ministry of Health of Argentina recommended CanSinoBIO's Convidecia as a booster for people who have received inactivated vaccine for at least one month, including those aged 50 years old and above. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined. China has become the first country to green-light an inhaled Covid-19 vaccine, paving the way for potential use of the needle-free product in the . The product, known as. of three to four weeks. The target audience includes vaccine scientists, product developers, manufacturers, regulators and funding agencies. The results also proved the safety of Convidecia for a broad range of age groups above 18, including those over the age of 60. [8] It has similar efficacy to the Janssen vaccine, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial. The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. Countries should continue to work towards vaccinating at least 70% of their populations, prioritizing the vaccination of 100% of health workers and 100% of the most vulnerable groups, including people who are over 60 years of age and those who are immunocompromised or have underlying health conditions. So far, it has been approved as a heterologous booster vaccine in China, Argentina, Malaysia and Indonesia. 3,305,000 doses of the AstraZeneca/Oxford vaccine have been delivered through the COVAX mechanism, a global initiative that aims at equitable distribution for Covid-19 vaccines. The COVAX No-Fault Compensation Program for Advance Market Commitment (AMC) Eligible Economies is the worlds first and only international vaccine injury compensation mechanism. Convidecia Phase III Results Published in The Lancet Published: Dec 24, 2021 96.0% effective against severe disease 14 days post-vaccination for population aged 18 and above. When autocomplete results are available use up and down arrows to review and enter to select. National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. COVAX aims to accelerate the development and manufacturing of COVID-19 vaccines and guarantee fair and equitable access for every country. The World Health Organization (WHO) has authorized the first of China's COVID-19 vaccines for emergency use, and another could be listed in the coming days, opening the door to wide distribution. Researchers have found no association between COVID-19 vaccines approved . CONVIDECIA was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan, programmatic suitability and a manufacturing site inspection conducted by WHO. What are the benefits of COVID-19 vaccines? The Chinese-made CanSinoBIO vaccine has not been approved for use by the World Health Organization (WHO) or the European Medicines Agency (EMA) yet, which means that all countries that are not part of the above-mentioned list do not accept the vaccine as valid proof of immunity against the virus. The Technical Advisory Group for Emergency Use Listing, convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19 and that the benefits of the vaccine far outweigh risks. So far, it has been approved as a heterologous booster vaccine in China, Argentina, Malaysia and Indonesia. Statement of the Strategic Advisory Group of Experts (SAGE) on Immunization: Continued review of emerging evidence on AstraZeneca COVID-19 Vaccines, WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19, WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access, WHO lists Moderna vaccine for emergency use, WHO lists two additional COVID-19 vaccines for emergency use and COVAX roll-out, Independent Oversight and Advisory Committee, WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations. Source: Pharmaniaga In addition to shortening the vaccination cycle by leveraging the advantages of its single-dose regimen, Convidecia can be stably transported and stored between 2C and 8C, making it more accessible to developing countries with insufficient storage facilities and medical resources, reducing the burden placed on healthcare systems and medical workers, and contributing to building broad immune protection globally. WHO has approved nine vaccines for emergency use based on safety and efficacy data collected from various conducted clinical trials. WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The publication of the analysis showed that a single dose of Convidecia is efficacious and safe with an efficacy of 96.0% in preventing severe COVID-19 disease and an overall efficacy of 63.7% 14 days post-vaccination for healthy adults aged 18 and above, without any reported vaccine-related serious adverse events. Additional information: The CanSino Biologics Ad5-nCoV-S [recombinant] COVID-19 vaccine: What you need to know 19 May 2022 CONVIDECIA was found to have 64 per cent efficacy against symptomatic disease and 92 per cent against severe COVID-19. countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust. Copyright2022 Living Media India Limited. Covid vaccines were today approved for babies in Britain, in a move likely to spark huge controversy. experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions. CONVIDECIA was also reviewed earlier this month by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines' use in populations (i.e. The EUL process is centered on determining if a manufactured product is quality-assured, safe and effective. The World Health Organization (WHO) on Thursday issued emergency use listing (EUL) for another COVID-19 vaccine CONVIDECIA, manufactured by CanSino Biologics, China. Convidecia is a genetically engineered vaccine with the replication-defective adenovirus type 5 vector that expresses the SARS-CoV-2 coronavirus spike protein. 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