Paul Kueng’s Post

Pfizer and BioNTech IMFS recently unveiled preliminary results from a Phase 3 clinical trial for their innovative mRNA vaccine, tackling both influenza and COVID-19. The trial, with over 8,000 participants aged 18-64, showcased strong immune responses against influenza A and comparable responses for COVID-19. The vaccine is being refined to boost immunity against influenza B, following some primary objectives not being met. In a separate Phase 2 trial, Pfizer's standalone trivalent influenza mRNA vaccine demonstrated positive immunogenicity in adults aged 18-64. Co-administering licensed influenza and COVID-19 vaccines exhibited robust immune responses for both diseases, with no safety concerns identified. Pfizer and BioNTech are dedicated to creating combination vaccines to efficiently combat respiratory infections. They are optimistic about the potential of their combined COVID-19 and influenza vaccine program, aiming to enhance immune responses against influenza B based on the trial findings. Explore more about the study here: https://lnkd.in/g5uM8y_d Benjamin Küttner Andrea Schilz

Great development! #Moderna's announcement of positive Phase 3 data for its combination vaccine, mRNA-1083, marks a significant advancement in our fight against influenza and COVID-19. For Ontario pharmacists and pharmacies, this innovation offers promising benefits that could reshape our vaccination approach. The combination vaccine's ability to elicit higher immune responses against both viruses, compared to current licensed vaccines, suggests a potential for enhanced protection, particularly for older adults. This advancement is critical, as individuals over 50 are more vulnerable to severe complications from these respiratory illnesses. From an operational standpoint, administering a single vaccine instead of two separate shots simplifies the process, making it more efficient for pharmacies and less burdensome for patients. This convenience is likely to boost vaccination rates, addressing one of the persistent challenges in public health. Moreover, the safety profile of mRNA-1083, with predominantly mild to moderate adverse reactions, aligns well with existing vaccines, ensuring patient confidence. Pharmacists, trusted health advisors, will play a crucial role in educating patients about the benefits and safety of this new combination vaccine. As we look to the future, the integration of such combination vaccines could significantly alleviate the seasonal strain on healthcare systems and improve overall public health outcomes. #Pharmacy #Vaccines

https://lnkd.in/dNrVRCmV CORRELATES OF PROTECTION FLU VACCINES NEW SCENARIOS HI titers can be used for accelerated approval of influenza vaccines in the United States, and CoPs are extremely useful from a regulatory perspective when expanding vaccine licensure into new populations or when changing vaccine formulations. However, for consideration by regulatory agencies, novel CoPs will need to be measured with high quality assays and linked to outcomes in clinical trials. There is growing recognition that multiple immune mechanisms contribute to inhibit viral infection, replication or spread to provide “layered” levels of protection. Therefore, there is a need for collaborative clinical studies that collect serial serum and mucosal samples and peripheral blood to evaluate the full spectrum of immune responses that may confer protection. CoP discovered by academic laboratories, for example, in cohort studies cannot automatically be used for regulatory purposes, creating a disconnect between regulatory agencies/vaccine developers and academic research. Bridging this disconnect in the future with additional dialogue and more harmonized and standardized assays may help to accelerate vaccine development and licensing.

Pfizer Inc and BioNTech SE recently announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza A and B), of which one was met. In a separate Phase 2 trial, Pfizer evaluated trivalent (“tIRV”) influenza mRNA standalone vaccine candidates which demonstrated robust immunogenicity in individuals 18-64 years of age. Read More: https://lnkd.in/d7vaHiPv “The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine program against influenza and COVID-19. We are committed to drawing on our experience in developing mRNA-based vaccine candidates against multiple antigens and believe we can successfully accomplish this task in collaboration with our partner Pfizer,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. #mededgemea #mRNA #VaccineResearch #PfizerBioNTech #Influenza #COVID19 #ClinicalTrials Annaliesa A. Albert Bourla

COVID vaccines: efficacy and safety. While anti-vaxxers have claimed that these vaccines have killed hundreds of thousands of individuals, it is somewhat reassuring to see that from an adverse event aspect, vaccines were comparable to placebo on such. But efficacy wise, mRNA vaccines were the best. 22 vaccines were examined in 25 RCTs, none demonstrated a higher incidence of SAEs than the placebo. Inactivated virus vaccines appeared to be the safest, with a Surface Under the Cumulative Ranking Curve (SUCRA) value of 0.16. BIV1-CovIran exhibited the highest safety index (SUCRA value: 0.13), followed by BBV152, Soberana, Gam-COVID-Vac, and ZF2001. There were no significant disparities among the various vaccine types regarding efficacy in preventing symptomatic SARS-CoV-2 infection, although a trend toward higher efficacy was noted for mRNA vaccines (SUCRA value: 0.09). BNT162b2 demonstrated the highest efficacy (SUCRA value: 0.02) among the individual vaccines, followed by mRNA-1273, Abdala, Gam-COVID-Vac, and NVX-CoV2373. In the elderly population, BNT162b2 showed the highest efficacy (SUCRA value: 0.08), while CVnCoV, CoVLP + AS03, and CoronaVac did not significantly differ from the placebo. https://lnkd.in/em8qJ5tN

Publication alert! https://lnkd.in/e9WpPhMw In this research article, we devised a vaccine adjuvant tailored for subunit vaccines. Subunit vaccines are renowned for their low toxicity, yet adjuvants are crucial for enhancing their immunogenicity. However, utilizing the same adjuvant can lead to adjuvant specific immune responses, which could be mitigated by offering alternative adjuvant options for subunit vaccines. In our study, we enhanced the suspendability of a metal-based adjuvant by incorporating Mannan, a polysaccharide. This modified adjuvant demonstrated robust humoral and cellular immune responses in the protein OVA mouse model.

#molecularbiology #vaccination #vaccine The second #mRNA product received a marketing authorization date. After the successful experience of the Corona vaccine based on mRNA technology, Maderna received the license to use its second product. This product is actually the second product of its kind in the world of mRNA. The new product of Maderna company that was unveiled last night is called mRESVIA and it is against #respiratory #syncytial #virus or RSV. #RSV is a highly #contagious seasonal respiratory virus and a major cause of lower respiratory tract infections and pneumonia, causing a large burden of disease in infants and the elderly. In fact, for many years, the medical world was looking for a safe and effective vaccine against RSV, but due to technical reasons, it was not possible to develop it. Recently, the two companies GSK and Pfizer for their new #vaccines against RSV, but based on recombinant protein technology, received a license for adults from the US #FDA, but due to technical reasons, including the better efficiency of mRNA vaccines, especially in the induction of both humoral and cellular immunity, experts They have predicted that the sales of Maderna products based on mRNA technology will soon overtake GSK and #Pfizer. Maderna's success in delivering its second product bodes well for a bright future for the all-important mRNA technology. It should be noted that the researchers of Renap Group have been developing this strategic technology in Iran since about seven years ago. The first product of this company named COReNAPCIN against Corona vaccine and similar to Maderna and Pfizer vaccines was developed in Iran and has entered the clinical phase. found and it is hoped that this vaccine against circulating strains will be available to compatriots this year after the completion of the clinical trials. Also, Renap company is developing the ReSVoReNPCIN vaccine, which is similar to Maderna's vaccine against RSV, which has had very good results in animal studies so far and will be informed about its progress in the near future.

Pfizer, BioNtech say combined flu-COVID vaccine misses a main goal of Phase 3 trial By Deena Beasley Pfizer (PFE.N), and BioNTech (22UAy.DE), said a late-stage trial of their experimental mRNA vaccine to protect against influenza and COVID-19 found the combination shot failed to meet one of the study's two main goals and they are evaluating next steps. The drugmakers said on Friday the Phase 3 trial showed the vaccine elicited a robust influenza A immune response, compared to a standard flu vaccine, but showed weaker results against the influenza B strain. The formulation showed similar responses against SARS-CoV-2 as the companies' COVID-19 vaccine. "We remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps," Annaliesa Anderson, Pfizer's head of vaccine research and development, said in a statement. The companies said they are discussing the findings with health authorities and evaluating adjustments to the candidate. The trial, which compared the experimental vaccine to a licensed influenza vaccine and the companies' COVID-19 vaccine given at the same visit, enrolled 8,000 healthy adults. The drugmakers said no safety issues with the combination vaccine have been identified. Pfizer also said a Phase 2 trial of its second-generation mRNA flu vaccine candidate showed that the formulation elicited robust influenza A and B responses, with no safety issues reported. Continued.....please click on the banner image below to access the entire article. Posted by Larry Cole

#Osivax begins phase 2a booster trial for #influenza #vaccine First participant vaccinated in study of ovx836 booster dose Osivax, a biopharmaceutical company developing vaccines for broad-spectrum protection against infectious viruses, has vaccinated the first participant in its phase 2a clinical trial of OVX836. This broad-spectrum influenza vaccine candidate is being evaluated as a booster for participants who received OVX836 three to five years ago. The trial is being conducted at the Center for Vaccinology (CEVAC) at Ghent University Hospital, Belgium, and aims to enrol over 150 participants. Prof Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University, commented, “We are pleased to support the ongoing evaluation of OVX836 through this Phase 2a influenza booster study. We anticipate important insights that could significantly impact long-term influenza prevention.” Dr Nicola Groth, CMO of Osivax, added, “This milestone is a significant step forward in our mission to develop a truly broad-spectrum, lasting flu vaccine capable of addressing the ever-evolving threat of influenza. By studying the effects of a booster dose, we aim to deepen our understanding of OVX836’s potential to provide robust and sustained immune protection.” The single-center trial is a randomised, double-blind study evaluating the immunogenicity and safety of a single dose of OVX836 administered intramuscularly at either 180μg or 480μg. Participants aged 20-64 who previously received OVX836, Influvac Tetra, or placebo in prior studies will be included. Topline results from the trial are expected by the end of 2025. OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, NP is less likely to mutate, providing a broader immune response. Osivax’s oligoDOM technology enables the design and production of a recombinant version of NP which self-assembles into a nanoparticle, triggering powerful T- and B-cell immune responses. So far, OVX836 has been tested in five clinical trials with 1,200 participants, showing promising safety, immunogenicity, and efficacy results.

Promising results for Moderna’s bivalent vaccine to protect against influenza and Covid-19. Moderna announced today the results of a randomized, observer-blind, active control phase III study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083. The vaccine contains the components of the mRNA-1010 (vaccine candidate for seasonal influenza), and mRNA-1283 (against COVID-19). mRNA-1283 is a next-generation SARS-CoV-2 messenger RNA vaccine encoding two segments of the spike protein. The study evaluated about 4000 adults. When compared in adults over 65 years old to the influenza vaccine Fluzone (Sanofi) and Moderna’s Covid-19 vaccine Spikevax, or Fluarix (GSK) together with Spikevax (in a cohort 50 to 64y old), in both cases the bivalent vaccine elicited a stronger immune response against 3 strains of influenza and SARS-CoV-2 (XBB.1.5 variant). #influenza #covid19 #health #globalhealth #publichealth #medicine #biotechnology #medicine #pharmaceuticals #FDA #Moderna #GSK #Sanofi #Pfizer #vaccines