AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN) has received approval from the US Food and Drug Administration (FDA) for its FluMist influenza vaccine to be self-administered, marking a significant shift in how individuals can receive their flu vaccinations.
The announcement made today highlights that FluMist is the only influenza vaccine approved for self- or caregiver administration at home for adults up to 49 years of age and for individuals aged 2-17 years.
The FDA's decision was informed by a comprehensive submission, including a usability study showing that individuals over 18 could self-administer FluMist or administer it to eligible individuals between 2-49 years of age.
This approval aims to enhance vaccine accessibility and convenience, potentially increasing influenza vaccination rates, which have declined among US adults since the 2020-21 flu season.
Dr. Ravi Jhaveri, an infectious disease specialist at Northwestern (NASDAQ:NWE) University, emphasized the importance of having additional tools to increase access to vaccinations and reduce disparities, especially given the annual impact of influenza on health systems and society.
Iskra Reic, Executive Vice President at AstraZeneca (NASDAQ:AZN), stated that the approval of FluMist for self-administration is a pivotal step in making vaccines more accessible and fighting the high annual burden of influenza.
Upon availability, adults 18 and older will have the option to have FluMist delivered directly to their homes through an online pharmacy service called FluMist Home. After completing a questionnaire reviewed by a pharmacist, eligible individuals can receive the vaccine for shipment. FluMist will also remain available in traditional healthcare settings.
Seasonal influenza can lead to severe outcomes, including hospitalizations and deaths, and has been shown to affect school attendance and employment significantly. The new self-administration option for FluMist could potentially improve vaccination uptake, especially among those who do not regularly attend well-care visits.
FluMist, a live attenuated influenza vaccine (LAIV) administered as a nasal spray, has been an available flu vaccine option in the US since 2003. The updated label for FluMist includes additional instructions for ordering and administration for eligible self and caregiver use.
In other recent news, AstraZeneca has made significant strides in the pharmaceutical industry. The FDA approved Fasenra for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis, a rare immune-mediated vasculitis. This approval was based on the MANDARA Phase III trial results, demonstrating that nearly 60% of patients treated with Fasenra achieved remission.
Moreover, AstraZeneca's HIMALAYA Phase III trial indicated that its immunotherapy regimen extended the survival of patients with unresectable hepatocellular carcinoma. The trial showed a 24% reduction in the risk of death compared to sorafenib, a standard treatment.
Michel Demaré, the Non-Executive Chair of the Board, purchased 2,000 shares of AstraZeneca, indicating his personal investment in the company's future.
On the analyst front, Deutsche Bank downgraded AstraZeneca stock from Hold to Sell due to concerns over the company's TROP2 asset datopotamab. However, BMO Capital, Erste Group, TD Cowen, and BofA Securities maintained positive outlooks on AstraZeneca shares, citing the company's strong financial structure and above-average growth projection.
Lastly, AstraZeneca and Daiichi Sankyo's ENHERTU showed significant progression-free survival rates in patients with HER2-positive metastatic breast cancer who have brain metastases. These developments highlight AstraZeneca's ongoing advancements in the pharmaceutical industry.
InvestingPro Insights
Following the FDA's approval of AstraZeneca's (LSE/STO/Nasdaq: AZN) FluMist for self-administration, the company's strategic positioning within the pharmaceutical industry remains robust. InvestingPro data indicates a solid market capitalization of $242.55 billion, reflecting AstraZeneca's significant market presence. The company's commitment to innovation and accessibility in healthcare is further underscored by its revenue growth, which stands at 10.45% over the last twelve months as of Q2 2024, showcasing its ability to expand in a competitive sector.
InvestingPro Tips suggest that AstraZeneca's net income is expected to grow this year, which could signal a positive outlook for investors following the recent FDA approval. Additionally, the company's stock is currently in oversold territory according to the Relative Strength Index (RSI), potentially indicating an opportunity for investors. It's also worth noting that AstraZeneca has maintained dividend payments for 32 consecutive years, reflecting financial stability and a commitment to shareholder returns.
For those seeking a deeper dive into AstraZeneca's financial health and future prospects, InvestingPro offers additional insights, with a total of 14 tips available on their platform, including earnings revisions by analysts and the company's performance within the pharmaceutical industry. These insights can be explored in detail at https://www.investing.com/pro/AZN.
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