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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
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.

Sanofi Accelerates Flu Vaccine Production for 2025-26 Season Amid Severe Current Outbreak

• Sanofi has begun manufacturing influenza vaccines for the 2025-26 season, adopting strains recently selected by the FDA that match those already in production. • The US is experiencing one of its worst flu seasons in decades with 40 million illnesses, 520,000 hospitalizations, and 22,000 deaths reported through early March 2025. • Sanofi plans to ship its vaccine portfolio, including FLUZONE High-Dose, FLUBLOK, and FLUZONE, to healthcare facilities this summer to ensure timely administration at the onset of the next flu season.

Sanofi's Combination Flu and COVID-19 Vaccines Receive FDA Fast Track Designation

• The FDA has granted Fast Track designation to Sanofi's two combination vaccine candidates for influenza and COVID-19 in adults aged 50 and older. • The vaccine candidates combine already licensed vaccines, Fluzone High-Dose or Flublok with Novavax's COVID-19 vaccine, aiming for simplified immunization schedules. • Phase 1/2 trials (NCT06695117 and NCT06695130) are underway to assess the safety and immune response of the combination vaccines. • The Fast Track designation recognizes the potential of these vaccines to reduce the burden of both influenza and COVID-19, especially in older adults.

2024-2025 Respiratory Vaccine Guidelines: Key Updates for COVID-19, Flu, RSV, and Pneumococcal Vaccines

• CDC data indicates rising COVID-19 cases and predicts seasonal respiratory disease burden for 2024-2025 to be similar or slightly lower than previous season, emphasizing urgent need for vaccination. • New COVID-19 vaccine formulations target Omican JN.1 and KP.2 variants, with updated recommendations including second doses for those 65+ and immunocompromised individuals. • Significant changes include transition to trivalent flu vaccines, expanded RSV vaccination guidelines for 75+ age group, and lowered pneumococcal vaccination age recommendation to 50 years.
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