FDA Approves H1N1 Vaccines, Paving Way For Large-Scale U.S. Vaccination Campaign

Main Category: Swine Flu
Also Included In: Immune System / Vaccines;  Regulatory Affairs / Drug Approvals
Article Date: 17 Sep 2009 - 4:00 PDT

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HHS Secretary Kathleen Sebelius announced Tuesday during a House Energy and Commerce Committee hearing that H1N1 (swine flu) vaccines produced by four manufacturers -- CSL Ltd., Novartis, Sanofi-Pasteur and Medimmune -- had won FDA approval, paving the way for a large-scale U.S. vaccination campaign, the Wall Street Journal reports. The application for GlaxoSmithKline PLC's vaccine is still being considered (Dooren/Favole, 9/15).

According to CQ HealthBeat, HHS anticipates having some supplies of H1N1 vaccine ready as early as October 5 (Attias, 9/15), but "[t]he bulk of vaccine will start arriving Oct. 15, and Sebelius said it should be available at 90,000 sites around the country," the Associated Press/TIME reports. "'We will have enough vaccine available for everyone' eventually, Sebelius said - everyone who wants it, that is," writes AP/TIME. The U.S. government currently has contracts to buy 195 million doses of the H1N1 vaccine, but will buy more if demand is high, Seblieus explained (Neergaard, 9/15).

The large-scale vaccination campaign, scheduled to begin in mid-October, will first target those at greatest risk from H1N1, including health care workers, pregnant women and young people ages 6 months to 24 years. Reuters writes: "H1N1 vaccines will be free, Sebelius said, but some healthcare providers may charge an administration fee. The federal government is planning to spend about $1.4 billion for states and hospitals to prepare for the virus, she added" (Heavey, 9/15).

Differences Between H1N1 and Seasonal Flu

In related news, Reuters reports on emerging details about the differences between H1N1 and the seasonal flu. Unlike the seasonal flu, characterized by upper respiratory disease, the patients who died from H1N1 "had infections deep in their lungs, Dr. Sherif Zaki of the U.S. Centers for Disease Control and Prevention told a meeting of flu experts," which resulted in "acute respiratory distress syndrome -- an often fatal development that leaves patients gasping for breath." Zaki reported the patients killed by H1N1, who number fewer than those killed by seasonal flu, also had "huge amounts of the virus in their blood," the news service writes. "This is almost exactly what we see with avian flu," Zaki said. "This looks like avian flu on steroids" (Fox, 9/15).

Tamiflu-Resistant H1N1 Is Less Transmissible Than Non-Resistant Form, Researchers Say

Researchers now believe that the same mutation that allows strains of the H1N1 virus to be resistant to the antiviral Tamiflu "also thwarts its transmission, so the infection isn't passed on to other patients," Bloomberg reports. "The findings may reassure public health officials worried that overuse of Tamiflu would render impotent one of the key weapons against the pandemic virus," according to the news service (Cortez, 9/15).

WHO Director-General Warns H1N1 Could Have 'Devastating Impact' In Countries With Weak Health Systems

Reuters/Washington Post reports on warnings made by WHO Director-General Margaret Chan during a WHO regional meeting in Copenhagen Tuesday of the devastating toll the H1N1 virus could have on developing nations. Chan said that those at high risk from the H1N1 virus "'will be in grave danger' in countries lacking adequate hospitals, doctors, nurses, antivirals, vaccines, and clean water," the news service writes. "The same virus that causes manageable disruption in affluent countries will almost certainly have a devastating impact in countries with too few health facilities and staff, no regular supplies of essential medicines, little diagnostic and laboratory capacity, and vast populations with no access to safe water and sanitation," Chan said (MacInnis, 9/15).

EU Starts Exploring What Countries Will Do With Excess H1N1 Doses

The news that a single-dose H1N1 vaccine, instead of a two-dose regimen, can protect adults against the H1N1 virus has led European states to begin exploring how they will divvy up excess stocks of the H1N1 vaccine, Reuters reports. "The European Union's executive arm said it would encourage 'a common approach to cross-border sharing and voluntary sale within the EU,'" the news service writes, adding, "Some countries have already included a provision in contracts with manufacturers stating that unused vaccines can be sold to other countries" (Hirschler/ Kelland, 9/15).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

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