MedPath

Influenza A virus A/Michigan/45/2015 X-275 (H1N1) antigen (formaldehyde inactivated)

Generic Name
Influenza A virus A/Michigan/45/2015 X-275 (H1N1) antigen (formaldehyde inactivated)
Brand Names
Fluzone High-dose, Fluzone Quadrivalent
Drug Type
Biotech
Chemical Formula
-
CAS Number
-
Unique Ingredient Identifier
8KSK0802BP
Background

A seasonally-specific component of the influenza vaccine. The influenza vaccine, also known as the "flu shot", is a vaccine that protects against infection from the influenza viruses. Vaccines provide protection from influenza by exposing the immune system to the virus (or parts of the virus) which stimulates an immunological defence against future exposure to the virus, or "antigen". This defence includes the production of humoral immunity through the development of antibodies (through memory B cells) and of cell-mediated immunity through the production of T-lymphocytes. Upon re-exposure to infectious influenza virus, the immune system is prepared to identify and destroy the virus as there are circulating antibodies that recognize that particular component of the virus that it was previously exposed to.

There are two basic types of vaccines available: inactivated influenza vaccine (IIV) and live attenuated influenza vaccine (LAIV). Inactivated vaccines contain a virus particle that has been grown in media and then subsequently killed, or inactivated, through exposure to heat or chemicals such as formaldehyde 3. Inactivated virus cannot replicate, and therefore cannot cause disease from infection, even in immunocompromised individuals. In contrast, live vaccines are produced from "wild-type" or disease-causing viruses that have been attenuated, or weakened, through various laboratory techniques. Live vaccines maintain their replicative ability.

Associated Conditions
-
Associated Therapies
-
ajmc.com
·

Combination Influenza and COVID-19 Vaccine Candidates Granted Fast Track Designation

The FDA granted Fast Track designation to two non-mRNA combination vaccine candidates for flu and COVID-19 prevention in individuals 50+ to address health burdens, aiming for simpler scheduling and fewer injections. The candidates include Fluzone High-Dose + Novavax COVID-19 vaccine and Flublok + Novavax COVID-19 vaccine. Both vaccines have shown efficacy and tolerability, with studies underway to evaluate safety and immune response. Combination vaccines streamline immunization, potentially boosting uptake, especially among older adults.

FDA grants fast track status to Sanofi's flu-Covid vaccine candidates

Sanofi's two combination flu-Covid vaccines for people aged 50+ received FDA fast track status. Both candidates combine proven vaccines, showing favorable tolerability. One pairs Fluzone High-Dose with Novavax Covid-19, the other Flublok with Novavax. Sanofi aims for simpler scheduling and high efficacy, safety, and tolerability.
pmlive.com
·

Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

Sanofi's COVID-19 and flu combination vaccines for individuals aged 50+ received FDA fast track designation. The vaccines combine Sanofi's Fluzone High-Dose or Flublok with Novavax's adjuvanted COVID-19 vaccine, aiming to simplify immunization and boost uptake. Clinical trials show efficacy and tolerability, with Sanofi initiating phase 1/2 studies. The partnership with Novavax includes a $1.2bn licensing agreement.
wfmz.com
·

Monroe County's Sanofi plant fast-tracked for combination COVID/flu vaccine approval

Sanofi's two non-mRNA combination vaccine candidates for flu and COVID-19 in individuals 50+ received FDA Fast Track designation. The candidates combine existing vaccines with proven efficacy and favorable tolerability, aiming for simpler scheduling and fewer injections. Studies show potential for increased vaccine uptake and reduced healthcare burden.
pharmacy.biz
·

Sanofi's flu-COVID combo vaccines gain FDA Fast Track designation

The FDA granted Fast Track designation to two Sanofi combination vaccine candidates for flu and COVID-19 prevention in individuals aged 50 and older. The candidates combine existing vaccines with proven efficacy and tolerability. Sanofi aims to develop a combined vaccine offering simpler scheduling and high efficacy, safety, and tolerability.
sanofi.com
·

Two combination vaccine candidates for prevention of influenza and COVID

Sanofi's two non-mRNA combination vaccine candidates for flu and COVID-19 received Fast Track designation in the US. The candidates combine licensed vaccines Fluzone High-Dose/Flublok with Novavax COVID-19 vaccine. Phase 1/2 studies are ongoing to assess safety and immune response. The vaccines aim for simpler scheduling and fewer injections while maintaining efficacy and tolerability.
finance.yahoo.com
·

FDA Grants Fast Track Tag to SNY's Two COVID & Flu Vaccine Candidates

Sanofi's two combination vaccine candidates, NCT06695117 and NCT06695130, received Fast Track designation from the FDA for preventing influenza and COVID-19 in people aged 50+. These candidates combine Sanofi's Fluzone High-Dose or Flublok with Novavax's NVXC19 vaccine. Sanofi and Novavax have a deal for co-marketing NVXC19 from 2025, with Sanofi having sole rights to develop and market the combination with its influenza vaccines. Novavax's NVXC19 shows better tolerability and high efficacy. Sanofi's Vaccines unit has strong sales growth, expecting over €10 billion in annual net sales by 2030.
© Copyright 2025. All Rights Reserved by MedPath