Monday, June 29, 2009

Swine Flu Vaccine Being Produced in advance

Almost 18,000 cases of swine flu and 45 confirmed deaths have been reported within the U.S. As the swine flu runs its course, Health and Human Services Secretary Kathleen Sebelius has reported that vaccines for swine flu are currently being tested in preparation for the possibility of an outbreak later this year. She stated that the government is making every effort to be prepared and is working with governors and health and school officials in case a major vaccination program is needed.


Sebelius said that currently the main focus is on the Southern Hemisphere where the flu season unfolds prior to the normal flu season for the U.S. She also noted that health officials are closely monitoring what occurs when swine flu virus intermingles with the common flu and that, thus far, the swine flu virus does not appear to be very dangerous. However, if a vaccine program is recommended, full production could begin in late summer to prepare for the start of the flu season in the Northern Hemisphere as winter approaches.

According to the Associated Press, the U.S. Department of Health and Human Services placed a $289 million order for swine flu vaccine with European drug maker Novartis in May of this year. Novartis announced on June 12, 2009 that the first vaccine batch of H1N1 Swine flu vaccine has been produced much earlier than first projected. This is due to the fact that the vaccine was created in cells instead of using the typical egg-based method. The company said that this first batch is for evaluation and testing, and possibly for clinical trials, and also indicated that it could produce millions of doses of the vaccine weekly if the need arises.


On the heels of the announcement by Novartis, Protein Sciences Corporation (PSC), a privately held biopharmaceutical company based in Meriden, Connecticut, announced that it has begun manufacturing a vaccine to protect humans against the H1N1 swine flu. PSC estimates production of at least 100,000 doses per week if needed. The vaccine, known as PanBlok, is being made with the use of PSC’s proprietary baculovirus and insect cell manufacturing technology. Once produced, the vaccine will undergo quality tests that could last for up to one month, and will then be ready for use in clinical trials as well as in vaccines for those countries that grant regulatory clearance.


PSC’s Chairman, President and CEO, Daniel D. Adams said, “We are in the process of transferring our proprietary manufacturing technology to facilities in other countries and we are setting up a foundation to ensure vaccine availability for U.N.-member countries consistent with the commitment we made to the World Health Organization and the United Nations in Geneva, Switzerland on May 19, 2009.” He also noted, “Using our proprietary technology, licensees could be producing vaccine in as little as two to three weeks if they are currently working with insect cells, and in a few months if they are now producing monoclonal antibodies.”

Due to the rapid widespread outbreak of the H1N1 swine flu virus, the World Health Organization has recently declared the first flu pandemic since 1968. The virus ran rampant through North America, Australia, South America, Europe and even regions beyond. However, since the onset of the outbreak in April, U.S. health officials have reported that for the most part, infections have been mild with most people recovering fairly quickly. In addition, testing has shown that the H1N1 swine flu virus continues to be susceptible to both Tamiflu and Relenza, two common antiviral drugs


In a statement, Dr. Pascal James Imperato, a former New York City health commissioner and dean of public health at the State University of New York’s Downstate Medical Center, said, “A World Health Organization level 6, which in effect states that H1N1 infections are now worldwide in distribution, is simply a declaration of the extent of geographic spread, and not a statement of severity of the clinical disease.” He also acknowledged, “The disease remains relatively mild in most people. A positive consequence of this declaration is that it empowers countries to move forward with vaccine production.”


Meanwhile, scientists from the Centers for Disease Control and Prevention (CDC) will be monitoring the swine flu virus for possible mutations and antiviral medication resistance that could cause the disease to become more widespread.

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