Many vaccines have highly specific storage requirements that if not met can reduce their potency significantly, even rendering them completely ineffective. Vaccines must be stored correctly from the moment they are manufactured until they are ultimately administered, and this is the shared responsibility of the manufacturer, distributor, and healthcare provider. What are the most common storage conditions? The vast majority of vaccines should be stored at between 2-8⁰C in a refrigerator, with a preferred average of 5⁰C, though some should remain frozen in a range between -15 to -50⁰C. Additionally, many should be protected from light and are packaged appropriately, as UV-light can damage them. Many live-virus vaccines can tolerate freezing temperatures and rapidly deteriorate once defrosted, while inactivated vaccines more commonly require stable temperatures of 2-8⁰C and are damaged at temperature extremes. The commonly administered measles, mumps, rubella (MMR) vaccine can be stored either frozen or refrigerated, while the MMRV vaccine ...
Vaccines must be stored in specific conditions to avoid degradation, usually defined specifically by the manufacturer. Across the stages of manufacture, distribution, storage, and ultimately administration, these conditions must be adhered to, and this process is known as the cold chain. Should the cold chain be broken at any point during transport or storage, via exposure to temperate extremes, then the potency of the vaccine risks being reduced, or the vaccine is even rendered completely ineffective. The vast majority of vaccines must be refrigerated at between 2-8⁰C, with a preferred average of 5⁰C with minimal fluctuations. Specially designed lab refrigerators are usually used for this purpose, which has comparatively minimal temperature fluctuation across days and seasons, do not present any temperature extremes on any interior surface, and may bear an external temperature display that automatically logs the internal temperature at particular time intervals. Many live vaccines tolerate freezing, and depending on the ...
ATCC, the world’s premier biological materials management, and standards organization, today announced the introduction of its new SARS-CoV-2 External Control Kit for clinical laboratories and test manufacturers. Image Credit: ATCC The ready-to-run kit provides controls in the rapidly changing COVID-19 testing landscape as a workflow-optimized kit with complete genome coverage that’s widely compatible with most commercial and laboratory-developed tests. Federal regulation requires that clinical laboratories assess the performance of their testing applications. This new ATCC kit is a practical, kitted solution clinical laboratories can use to meet this requirement. Validated, convenient, and ready-to-use, it offers a universal, full-process positive control (a heat-inactivated virus) and negative control (human cell line) that allow clinical laboratories to easily and accurately verify and assess the quality of their molecular diagnostic assays. The SARS-CoV-2 External Control Kit is compatible with most molecular diagnostic tests being used today. This broad compatibility is critical as surveys from the ...
The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020. This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, ...
The unpredictability of Alzheimer’s disease may be partly caused by changes in star-shaped cells in the brain called astrocytes, find scientists from South Korea. AsianScientist (Dec. 1, 2020) – Despite decades of scientific research, Alzheimer’s disease and its causes still largely remain a mystery. Now, scientists from South Korea have identified a key indicator associated with neurodegeneration in Alzheimer’s. Their findings was published in Nature Neuroscience. Poignantly depicted in Hollywood films like The Notebook and Still Alice, Alzheimer’s disease is a brain disorder that accounts for a majority of cases of dementia, the progressive loss of memory and other cognitive abilities. Over the years, numerous hypotheses regarding the cause of Alzheimer’s have been presented. Perhaps the most prominent is the amyloid hypothesis, which pins the progression of Alzheimer’s on the build-up of beta-amyloid (Aβ) plaques in the brain. These plaques block cell signalling—potentially triggering inflammation and leading to brain cell ...
30 November 2020 The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has ...
Researchers in Canada have conducted a study suggesting that novel Cannabis sativaextracts may decrease levels of the host cell receptor that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses to gain viral entry to target tissues. SARS-CoV-2 is the agent responsible for the current coronavirus disease 2019 (COVID-19) pandemic that continues to sweep the globe threatening public health and the worldwide economy. The team – from the University of Lethbridge and Pathway Rx Inc., Lethbridge – developed hundreds of new C. sativa cultivars and tested 23 extracts in artificial 3D human models of the oral, airway and intestinal tissues. As recently reported in the journal Aging, 13 of the extracts downregulated expression of the SARS-CoV-2 host cell receptor angiotensin-converting enzyme 2 (ACE2). “The observed down-regulation of ACE2 gene expression by several tested extracts of new C. sativa cultivars is a novel and crucial finding,” say the researchers. “While our most effective extracts require further large-scale validation, ...
The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and rare diseases. It is also aiming to bolster the competitiveness and the innovative capacity of the EU’s pharma industry. Enhancing crisis preparedness and response mechanisms, and addressing security of supply, drawing lessons from the COVID-19 crisis, are also namechecked as top policy priorities in the strategy, as well as a need to guarantee a strong EU voice on the global stage by promoting a high level of quality, efficacy and safety standards. “The COVID-19 pandemic has, and continues to have, a very serious impact on Europe. Though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines or the availability ...
BioNTech and InstaDeep are creating a joint AI innovation lab in Europe to develop novel immunotherapies. “We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” says BioNTech. One of the key research areas will be the development of next generation vaccines and biopharmaceuticals – including for COVID-19 – as well as for the treatment of cancer and prevention and therapy of infectious diseases. The partnership between Mainz-headquarted BioNTech (which is collaborating with Pfizer on one of the leading mRNA-based COVID-19 vaccine candidates) and London-based InstaDeep will create a joint AI innovation lab between the two cities. The lab will advance a portfolio of initiatives across drug discovery and design, protein engineering, manufacturing and supply chain optimization. Founded in 2014, InstaDeep has already developed collaborations in the global AI ecosystem: such as Google DeepMind, Nvidia and Intel. It was nominated by CB ...
A COMPARISON OF NEUTRALIZATION TITERS AND PROTECTION DATA ACROSS CANDIDATES AND AGE GROUPS BY SELINA KOCH, EXECUTIVE EDITOR NOV 20, 2020 | 10:34 AM CST UPDATED ON NOV 20, 2020 AT 11:03 AM CST A pressing question about COVID-19 vaccines is how well they will perform in the elderly, who are at higher risk for severe disease. Wednesday’s report of strong efficacy in subjects over 65 given Pfizer and BioNTech’s mRNA vaccine could portend good news for several of the next candidates. In early-stage clinical trials, at least four other vaccines produced neutralizing antibody levels in non-elderly adults that were in line with those of BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and for the most part, the vaccines’ titers fell less with age than BNT162b2. Only Ad5-nCoV from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) produced somewhat lower neutralization titers that fell farther with age than BNT162b2 in a live virus assay. Moderna Inc. ...
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