GSK Begins Shipping Influenza Vaccine Doses for 2024-25 Season
GSK has initiated the shipment of its trivalent influenza vaccines, FLULAVAL and FLUARIX, for the 2024-25 flu season across the US. This follows the FDA's licensing and lot-release approval, aligning with WHO's recommendation for the removal of the B/Yamagata strain. The vaccines will contain strains A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Thailand/8/2022 (H3N2)-like virus, and B/Austria/1359417/2021 (B/Victoria lineage)-like virus. GSK anticipates distributing over 36 million doses and the vaccines are suitable for individuals aged six months and older. The CDC underscores annual flu vaccination as the optimal protection against influenza, with vaccination ideally completed by the end of October.
- GSK has begun shipping its trivalent influenza vaccines for the 2024-25 flu season.
- FDA has approved the licensing and lot-release of these vaccines.
- GSK expects to distribute over 36 million doses in the US.
- The vaccines will help protect against three recommended flu strains.
- None.
Insights
The initiation of shipping trivalent influenza vaccines by GSK ahead of the 2024-25 flu season underscores the company's proactive approach in public health preparedness. The removal of the B/Yamagata strain, following WHO recommendations, aligns with current epidemiological data. This decision reflects a meticulous adjustment to the vaccine composition, catering to the circulating influenza virus strains expected in the upcoming season.
For investors, this proactive measure underscores GSK's commitment to staying ahead in the vaccine market, potentially enhancing its market share. The availability of over 36 million doses indicates significant production capabilities, which is a positive signal for the company's operational efficiency. The pre-filled syringe format ensures ease of administration, potentially increasing the uptake among the public.
From a financial perspective, maintaining a robust vaccine portfolio with high demand can drive steady revenue streams, particularly in the flu season. However, investors should consider the competitive landscape, where other pharmaceutical giants are also vying for a share in the flu vaccine market.
GSK's preparedness for the 2024-25 flu season by shipping its influenza vaccines early is a strategic move. The preemptive stockpiling and distribution align with market demand cycles, ensuring that healthcare providers have ample supply as the flu season approaches. This can potentially lead to higher sales volumes as the company meets market demand seamlessly.
Moreover, the annual flu vaccination statistics provided by the CDC highlight the enormous market potential. With millions of flu cases and substantial hospitalizations annually, the market for flu vaccines remains robust. By positioning itself early, GSK can leverage this demand, potentially stabilizing its earnings within its vaccine segment.
However, investors should be cognizant of potential risks, such as variability in flu season severity and the effectiveness of the vaccines against circulating strains, which can impact public trust and uptake. Monitoring these factors can provide insights into potential sales fluctuations.
- GSK supports annual flu immunization by getting FLULAVAL and FLUARIX to patients in advance of flu season
In February 2024, the World Health Organization (WHO) recommended the removal of B/Yamagata strains from seasonal influenza vaccines.1 The WHO recommends that egg-based trivalent vaccines for the 2024-2025 northern hemisphere influenza season contain the following:1
- A/Victoria/4897/2022 (H1N1)pdm09-like virus
-
A/
Thailand /8/2022 (H3N2)-like virus -
B/
Austria /1359417/2021 (B/Victoria lineage)-like virus
In partnership with regulatory bodies, GSK worked quickly to ensure production, approval and availability of trivalent influenza vaccines with the recommended composition for the 2024-25 flu season.
GSK expects to distribute over 36 million doses of its trivalent influenza vaccines in the US this season. Both FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months of age and older.
According to the US Centers for Disease Control and Prevention (CDC), annual influenza vaccination is the best way to help protect against the flu. Ideally, vaccination should occur by the end of October, but people should continue to get vaccinated as long as the flu poses a threat.2 CDC recommends an annual flu vaccination for anyone aged six months or older who does not have contraindications.2
CDC estimates that from October 1, 2023, through June 15, 2024, there have been 35 – 65 million flu illnesses, 390,000 – 830,000 flu hospitalizations and 25,000 – 72,000 flu deaths.3
About Influenza
The flu (influenza) is a contagious respiratory illness caused by influenza viruses that infect the nose, throat and sometimes the lungs. It can cause mild to severe illness and at times can lead to death.4
Anyone can get the flu, however, it can be serious for young children, adults 65 years and older, pregnant women and people with pre-existing chronic health conditions, such as asthma, diabetes and heart disease.5
For more information about the flu, visit https://www.cdc.gov/flu/about/keyfacts.htm.
Indication for FLUARIX and FLULAVAL
FLUARIX and FLULAVAL are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccines. FLUARIX and FLULAVAL are approved for use in persons aged 6 months and older.
Important Safety Information for FLUARIX and FLULAVAL
- Do not administer FLUARIX or FLULAVAL to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.
- If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX or FLULAVAL should be based on careful consideration of the potential benefits and risks.
- Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX and FLULAVAL. Procedures should be in place to avoid injury from fainting.
- Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUARIX and FLULAVAL.
- If FLUARIX or FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
- The most common solicited local adverse reactions with FLUARIX in adults were pain and redness, and the most common systemic adverse reactions were muscle aches, fatigue, and headache. In children aged 5 through 17 years, the most common solicited local adverse reactions were pain, redness, and swelling, and the most common systemic adverse reactions were muscle aches, fatigue, and headache. In children aged 3 through 4 years, the most common solicited local adverse reactions were pain, redness, and swelling, and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children aged 6 through 35 months who received FLUARIX QUADRIVALENT, the most common solicited local adverse reactions were pain and redness, and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness.
- The most common solicited local adverse reactions with FLULAVAL in adults were pain, redness, and swelling, and the most common solicited systemic adverse reactions were fatigue, headache, and muscle aches/arthralgia. In children aged 3 through 17 years, the most common solicited local adverse reaction was pain. In children aged 3 through 4 years, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children aged 5 through 17 years, the most common solicited systemic adverse reactions were muscle aches, headache, and fatigue. In children aged 6 through 35 months who received FLULAVAL QUADRIVALENT, the most common solicited local adverse reaction was pain, and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite.
- Vaccination with FLUARIX or FLULAVAL may not result in protection of all vaccine recipients.
Please see full Prescribing Information for FLUARIX and for FLULAVAL.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors” in the company's Annual Report on Form 20-F for 2022, and Q1 Results for 2023 and any impacts of the COVID-19 pandemic.
| References | |
1. |
World Health Organization. Recommendations announced for influenza vaccine composition for the 2024-2025 northern hemisphere influenza season. Available at: https://www.who.int/news/item/23-02-2024-recommendations-announced-for-influenza-vaccine-composition-for-the-2024-2025-northern-hemisphere-influenza-season. Accessed June 17, 2024. |
2. |
Centers for Disease Control and Prevention. Influenza (Flu) Preventative Actions. Available at: https://www.cdc.gov/flu/prevent/prevention.htm. Accessed June 17, 2024. |
3. |
Centers for Disease Control and Prevention. 2023-2024 Preliminary In-Season Burden Estimates. Available at: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed June 17, 2024. |
4. |
Centers for Disease Control and Prevention. Key Facts About Influenza (Flu). Available at: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed June 17, 2024. |
5. |
Centers for Disease Control and Prevention. About Flu. Available at: https://www.cdc.gov/flu/about/index.html. Accessed June 14, 2024. |
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FAQ
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