VativoRx, LLC’s Post

🚨 New #COVID19 Vaccine Update: The FDA has approved the Novavax® Vaccine, Adjuvanted (2024-2025 Formula) for individuals 12+! This updated formula targets the Omicron variant JN.1 and is designed for both unvaccinated individuals and those needing a booster. 💉 Unlike mRNA vaccines, Novavax uses a protein-based technology, offering another effective option against COVID-19. Full details on dosage schedules for various groups are available on the EUA fact sheets. Vaccines are expected to be available soon! More details from our partner VativoRx, LLC: https://lnkd.in/eKQtpcdF #Novavax #PublicHealth #VaccineUpdate #FightCOVID19

Moderna applies for review of updated Covid-19 vaccine Moderna CEO Stéphane Bancel stated: “For four years, Moderna has consistently delivered vaccines that offer protection against Covid-19, and work is well underway to provide a vaccine targeting JN.1. Staying up to date with your Covid-19 vaccine remains one of the best ways to protect yourself during the upcoming respiratory illness season.” - https://lnkd.in/dZkvxCWF #pharma #covid #covidvaccine #vaccine #covid19

For the 2024-2025 Covid vaccine to be available in September 2024, the FDA is asking vaccine manufacturers to use the use the newer (and now more prevalent) KP.2 strain of the JN.1 lineage if feasible, rather than the original JN.1 strain. KP.2 has the "FLiRT" mutation that MIGHT make people vaccinated with or infected by earlier strains less likely to fight off KP.2 infections. My assumption is that because of manufacturing timelines the mRNA vaccines from Moderna and Pfizer are likely to have the KP.2 strain and the protein subunit vaccine from Novovax is likely to have the JN.1 strain. https://lnkd.in/gsM_JXbh

FDA Update on COVID-19 Vaccine for Fall 2024 On June 5, 2024, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended a monovalent JN.1-lineage vaccine composition for the 2024-2025 COVID-19 vaccines. The unanimous vote highlighted a strong preference for the JN.1 strain, considering the latest data on virus variants, vaccine effectiveness, and immunogenicity. However, based on rising COVID-19 cases and the latest data on circulating strains, the FDA updated its advice to vaccine manufacturers on June 6, 2024. The preferred strain for the 2024-2025 COVID-19 vaccine formula is now KP.2, if feasible, to ensure a closer match to circulating variants. This change is not expected to delay vaccine availability in the U.S. The FDA remains committed to monitoring vaccine safety, effectiveness, and the evolution of SARS-CoV-2. #COVID19 #VaccineUpdate #FDA #JN1 #KP2 #PublicHealth #SARSCoV2 #Healthcare #VaccineInnovation

🚩 FDA Approves Updated COVID-19 Vaccines 🔆 Key Points: 🟢New formulation: Updated mRNA COVID-19 vaccines (Pfizer and Moderna ) target the Omicron variant KP.2. 🟢Improved protection: Offer better protection against severe illness, hospitalization, and death. 🟢Eligibility: All ages are eligible, with specific dosing recommendations based on vaccination history. 🟢Side effects: Similar to previous versions. 🟢Annual updates: Vaccines may need annual updates to address new variants. ✨️ Healthcare professionals should: 🟠Educate patients about the updated vaccines and their benefits. 🟠Advise patients on eligibility and appropriate dosing. 🟠Address patient concerns and questions. 🟠Ensure availability of the updated vaccines in their practices. below #FDA site link for your kind reference:

Hey LinkedIn fam, Big news in the vaccine world today! AstraZeneca has decided to pull the plug on its COVID-19 vaccine application globally. What You Need to Know: **Key Points:** 🎯AstraZeneca has decided to withdraw its COVID-19 vaccine globally due to a surplus of other updated vaccines. 🎯The company's application to withdraw the vaccine from the EU was made on March 5 and came into effect on May 7. 🎯In India, Serum Institute of India, which manufactures the vaccine under the brand name Covishield, stopped production in December 2021 due to decreased demand. 🎯The decision to withdraw the vaccine is not related to the recent court documents admitting the potential for rare side effects (Thrombosis with Thrombocytopenia Syndrome (TTS). **Reasons for Withdrawal:** * **Surplus of Updated Vaccines:** The development of multiple, variant-specific COVID-19 vaccines has led to a surplus of available options, making the original AstraZeneca vaccine less necessary. * **Sales Decline:** With the pandemic waning and vaccination rates increasing, sales of the AstraZeneca vaccine have declined, prompting the company to shift focus to other areas like respiratory syncytial virus vaccines and obesity drugs. **Impact on India:** * The Indian government has not purchased any COVID-19 vaccines in the last two years and does not plan to do so in the near future. * Serum Institute of India stopped manufacturing Covishield in December 2021 due to decreased demand. **Side Effects:** * The decision to withdraw the vaccine is not related to the recent court documents admitting the potential for rare side effects like Thrombosis with Thrombocytopenia Syndrome (TTS). * This information was previously disclosed in clinical trial reports. **Conclusion:** The withdrawal of the AstraZeneca COVID-19 vaccine is a result of market dynamics and the availability of newer, updated vaccines. It is not related to safety concerns. In India, the impact of this withdrawal is minimal as the government has sufficient vaccine stocks and Serum Institute has stopped production. What are your thoughts on this news? 💬 #AstraZeneca #Vaccine #COVID19 #Withdrawal

JULY 2024 COVID-19 Vaccine CDC has officially recommended that everyone ≥6 months of age, whether or not they have ever previously been vaccinated with a COVID-19 vaccine, receive an updated 2024-25 vaccine this fall. Detailed guidelines will be published as soon as the new vaccines are available. Antigenic composition: KP.2 for Moderna and Pfizer mRNA vaccine. JN.1 for Novavax recombinant protein vaccine (not approved for age <12 years). The current 2023-2024 vaccine formulation and guidelines should be followed until then.

Annually, almost 2 billion vaccines are produced in 11 European countries. Having 12 high-end sites, Europe is at the forefront of next-generation vaccine R&D efforts. "#Vaccines are one of the greatest medical achievements of our time, saving 2-3 million lives globally each year by preventing #infectiousdiseases." Vaccines Europe, a specialized group within the EFPIA - European Federation of Pharmaceutical Industries and Associations, advocates for broader access to #immunization, to better protect #publichealth and reduce the burden on #healthservices. https://lnkd.in/eTnKK4Si

Pfizer and BioNTech IMFS's Omicron JN.1-adapted COVID-19 vaccine, COMIRNATY® JN.1, has received a positive recommendation for marketing authorization from the European Medicines Agency’s CHMP. This vaccine targets the SARS-CoV-2 variant JN.1 and is intended for individuals six months and older. Clinical and non-clinical evidence supports the safety and efficacy of this vaccine, including an enhanced response against Omicron JN.1 sublineages. The European Commission is set to review this recommendation soon, with distribution to EU member states upon approval. Pfizer and BioNTech have proactively manufactured this adapted vaccine to meet the anticipated rise in demand during the fall and winter. Rolling applications are also being submitted to the U.S. FDA for the Omicron KP.2-adapted COVID-19 vaccines. Both companies remain dedicated to global public health needs through vaccine development and distribution. Find out more at: https://lnkd.in/d9_7eAmZ Andrea Schilz