SeyedReza Banihashemi’s Post

COVID-19 Vaccination Breakthroughs in Long Lasting Protection with sa-mRNA Vaccines At the OPTIONS XII conference, CSL and Arcturus Therapeutics presented promising data showing that their self-amplifying mRNA (sa-mRNA) vaccines, ARCT-154 and ARCT-2301, offer superior and longer-lasting immune responses compared to the conventional mRNA vaccine, Comirnaty®. In a study conducted in Japan, ARCT-154 demonstrated better immunogenicity for up to 12 months post-vaccination, even at one-sixth the dose of Comirnaty®. Additionally, ARCT-2301 showed improved immune responses against Omicron BA.4-5 and Wuhan-Hu-1 strains for up to six months. These findings highlight the potential of sa-mRNA technology to provide more durable protection against emerging COVID-19 variants, with CSL and Arcturus Therapeutics focusing on broader regulatory approval and global implementation of their vaccines. For more details please click the link! https://lnkd.in/di_bUrik #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Safety of Simultaneous vs Sequential #mRNA #COVID-19 and Inactivated #Influenza #Vaccines: A Randomized Clinical Trial « this randomized clinical trial assessing simultaneous vs sequential administration of mRNA COVID-19 and IIV4 vaccines, reactogenicity was comparable in both groups. These findings support the option of simultaneous administration of these vaccines » https://lnkd.in/daf---vK

A recent Phase I clinical trial evaluated the safety and immunogenicity of an optimized self-replicating RNA (srRNA) rabies vaccine in healthy volunteers. Unlike previous srRNA vaccines, this study demonstrated that the optimized srRNA platform is both safe and capable of inducing a robust immune response at lower doses or with a single dose. The srRNA technology offers significant advantages over traditional mRNA vaccines, including approximately tenfold dose-sparing and more durable immune responses. This optimized srRNA platform holds promise for developing effective vaccines that require lower doses or fewer administrations, potentially enhancing vaccine accessibility and compliance. #Vaccines #virology #rabies https://lnkd.in/edKpteWR

#mRNA vaccines offer several advantages over traditional vaccines, including non-infectivity, scalability and cost-effective production, and rapid targeting of emerging variants. However, access to mRNA-based vaccines remains a challenge, particularly for low- and middle-income countries (LMICs). Transport and storage of mRNA vaccines require a subzero cold chain, which is not readily available in LMICs and is costly to implement. A recent samRNA (self-amplifying mRNA) vaccine (ARCT-154) from Arcturus Therapeutics and CSL received full approval as a COVID-19 booster in Japan. This approval was based on a Phase 3 study in which ARCT-154 administered at 5 μg resulted in higher immune responses than the 30 μg Comirnaty (Pfizer/BioNTech). Several companies worldwide are developing samRNA vaccine candidates against COVID-19 that are already in clinical trials. GEMCOVAC-OM, a monovalent, omicron-specific (BA.1) booster samRNA vaccine for COVID-19, differs from other FDA-approved mRNA vaccines in several ways. It is a self-amplifying mRNA vaccine, which allows for a lower dose to be administered. Unlike non-amplifying mRNA, GEMCOVAC-OM is lyophilized and stable at 2-8°C for 12 months. It is administered intradermally through a needle-free injection system using a device called Tropis (PharmaJet). GEMCOVAC-OM was well tolerated in both Phase 2 and Phase 3 with no related serious adverse events. In Phase 2, the safety and immunogenicity of GEMCOVAC-OM was compared to the prototype mRNA vaccine GEMCOVAC-19 (D614G variant specific) in 140 participants. On day 29, neutralizing antibody titers against the BA.1 variant of SARS-CoV-2 were significantly higher in the GEMCOVAC-OM group, but not in the ChAdOx1 nCoV-19 group. GEMCOVAC-OM was non-inferior to GEMOVAC-19 and superior to ChAdOx1 nCoV-19 in terms of neutralizing antibody titers and seroconversion rate. In summary, these results demonstrate that GEMCOVAC-OM is safe and elicits immunogenic responses when administered as a booster. This thermostable, self-amplifying mRNA platform administered intradermally provides a framework for next-generation vaccines that can improve accessibility and global equity. https://lnkd.in/evicQvNx

Moderna gets Blackstone backing for flu vaccine R&D An arm of the private equity firm has committed up to $750 million to support development Moderna’s mRNA-based vaccines for influenza. Dive Brief: - Blackstone Life Sciences will invest as much as $750 million on influenza vaccine research and development by Moderna, announcing Wednesday a private funding deal that gives the private equity firm rights to future payments and royalties. - Moderna has advanced an mRNA-based flu shot into late-stage testing and is also studying a combination flu and COVID-19 vaccine — part of a broad R&D strategy to follow the success of its standalone COVID shot. Later this year, the company intends to submit the flu shot for regulatory approval. - The funding agreement comes one day after Moderna revealed results for a “next-gen” COVID vaccine that it said showed higher immune responses than the biotechnology firm’s current product. This next-gen vaccine is being used in the combination flu and COVID vaccine that’s now in Phase 3 testing. https://lnkd.in/gWNaPtfS.

Vaxxas, a Brisbane-based clinical-stage biotechnology company commercialising a needle-free vaccination platform, has secured $3.2 million from the United States Biomedical Advanced Research and Development Authority to accelerate the advancement of its high-density microarray patch (HD-MAP) technology to administer a COVID-19 mRNA  vaccine. The move comes on the heels of Vaxxas last year being awarded a US Government contract worth $43 million to conduct a bird flu vaccine trial in Queensland and Victoria in the largest Phase 1 clinical study to date for the company. https://lnkd.in/guATfpXm

https://lnkd.in/dyd4vYnb Vaccines Beat GBS IMMUNE RESPONSE MEASUREMENT AND VACCINE DEVELOPMENT. For a GBS vaccine to be licensed using a serological approach, a direct comparison of vaccine-induced titers to titers from natural history studies is warranted. Such a comparison is possible if the serological assay in use is standardized across studies. After a vaccine is licensed, future effectiveness studies can help validate the anti-CPS IgG threshold that is likely to confer broad protection against GBS disease in newborns. Creation of a large volume GBS international reference standard for potential use with the 6-plex GBS IgG dLIA and a long-term proficiency panel to monitor the performance of the dLIA over time are key activities that are ongoing to support GBS research worldwide. Maintaining a standardized anti-CPS IgG assay and facilitating the development of key reagents to monitor the assay, an integral step taken for S. pneumoniae, would move the GBS scientific research field one step closer to bridging natural history data with vaccine immunogenicity data, and licensure of a GBS vaccine. Per Fischer Alejandro Cané

A milestone paper with the first data on a mRNA vaccine for Hookworm. More exciting challenge data on how mrna vaccines can protect from nematode infections to be shared soon. https://lnkd.in/gF2nCW6E Vaccines to protect from parasitic nematodes are urgently needed to improve quality of life of 100+ million people mainly living in tropical regions. While mass drug administration is a relatively inexpensive approach, its effectiveness is limited due to the rapid reinfection cycle. Vaccine development is challenging because of the size of the parasite and the complexity of the worm lifecycle. We have been exploring if mRNA vaccines may offer some technological solutions to get a more effective immune response.

It appears that Australia’s first mRNA Covid vaccine candidate could solve ‘immune imprinting’ problem. Researchers developing Australia’s first mRNA Covid vaccine say they may have solved the one of the biggest problems with boosters. Researchers developing Australia’s first mRNA Covid vaccine say they may have solved the “immune imprinting” issue that has contributed to the declining effectiveness of boosters as the virus mutates. Immune imprinting, also known as original antigenic sin, occurs when the body’s original immune response to a virus — either from vaccination or infection — becomes less effective against new variants of the same virus. The Australian-based vaccine candidate, being developed by the Monash Institute of Pharmaceutical Sciences (MIPS) in collaboration with the Doherty Institute, aims to tackle the problem by encoding the proteins on the surface of the receptor-binding domain — the tip of the virus ‘spike’. #Covid; #Virus; #Immunity; #Vaccine; #Health; #Protien; #mRNA; Read more here - https://lnkd.in/gjPf66qM

Increasing Vaccine Efficacy with Novel Adjuvants In this thought leader article WuXi Vaccines' Xinhao Y., and Hongbing Wu describe how vaccine adjuvants can help shape immunological responses.