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On Thursday June 11,the WHO raised its alert on swine flu (H1N1) to the Phase 6 pandemic level calling further spread of the virus inevitable. The Director- General of WHO Dr. Margaret Chan said, “Globally we have good reason to believe that this pandemic, at least in its early days,will be of moderate severity”. The world is now at the start of the 2009 influenza pandemic, the first in 41 years. Although the pandemic is moderate in terms of severity with the majority of patients experiencing only mild symptoms and a full recovery, the new strain is spreading easily from one person to the next, from one country to another in more than one region of the world. The WHO reported 28,774 cases in 74 countries including 144 deaths with a sharp jump in Australia where 1263 cases on Thursday and rising numbers in Britain, Japan and Chile. The U.S. has confirmed more than 13,000 cases with activity in all 50 states. At the present time scientists believe that swine flu is no worse that seasonal flu with weak virulence and no comparison to the deadly 1918 Flu pandemic.
The new H1N1 virus has occurred in individuals between the ages of 30-50 but overall most cases involve those under 25. Pregnant women are at increased risk for complications. Dr. Anne Schuchat of the CDC said the U.S, has already been on pandemic alert and that 57% of the cases are among people aged 5 to 24 with 41 % hospitalized.
The U.S. Government will invest $1B to kick-start the process of H1N1 vaccine development. GlaxoSmithKline will start production of a pandemic vaccine in July which can take 6 months and will donate 50 million doses to WHO for poor countries. The seasonal flu vaccine already in development won’t protect against the pandemic virus, so two flu shots may be needed for protection. Stepped-up production of the leading antiviral Tamiflu by Gilead (GILD) and Roche is already underway.
The virus can change quickly and could mix with its seasonal cousin and perhaps mixing with the H5N1 bird flu circulating widely in poultry. The swine flu virus is a mix of human, bird and pig flu gene segments. Vaccine makers are challenged by the constantly mutating HA surface protein of the virus and are looking for a conserved region of the protein that will make a vaccine with more lifelong immunity. Mutations in the HA molecule also affect its ability to bind to receptors in the human respiratory tract which are critical for viral transmission. The CDC has sequenced ten or more complete swine flu viral genomes and hope to have a prototype vaccine in a month.
The major drug companies focused on vaccines are Sanofi Aventis, Wyeth, Novartis and GlaxoSmithKline. A number of smaller companies have the technology and manufacturing to assist the government and larger drug companies such as Crucell (CRXL) NovaVax (NVAX), Vical (VICL). Tickerspy has already created a Swine Flu and Bird Flu Index of stocks with the ticker *RXFLU!
Last month the FDA issues warning letters were issues to three diagnostic manufacturers-Becton Dickinson, Luminex and Prodesse-for allegedly marketing Flu tests for H1N1 virus which had not yet been cleared by the agency but the companies have recently complied with FDA’s instructions. The diagnostic tests can detect Flu A+B but have not been evaluated for the identification and reporting of specific Flu strains such as H1N1. The CDC has the only molecular Dx test for H1N1 cleared by the FDA for Emergency Use only.Of the pure play diagnostic companies, Quidel (QDEL) and Inverness (IMA) have made the most significant stock rallies on swine flu news beginning last April. A rapid diagnostic test for H1N1 is urgently needed .
Coincident to the pandemic flu news, flu vaccine makers have rallied with European drugs showing good 5%+ moves over the past two days: AstraZeneca (AZN), GlaxoSmithKline (GSK), Novartis (NVS), and Sanofi-Aventis (SNY). U.S. drug stocks Abbott (ABT),Merck (MRK) and Pfizer(PFE) also rebounded. Novartis and SmithKline have stepped up vaccine efforts with Novartis announcing it has produced its first batch of experimental vaccine. Morgan Stanley upgraded selected drug stocks such as GSK on Thursday June 11.
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