Fast-tracked H1N1 vaccines will not compromise safety, WHO says

Aug 6 2009

Efforts to fast-track the approval of H1N1 (swine) flu vaccines will not compromise the safety or quality controls of vaccine production, the WHO said in a written statement Thursday, the Mail & Guardian reports.

Even so, "the WHO said safety issues could arise during a pandemic when a vaccine is administered on a mass scale, even if they did not show up in safety trials," the newspaper writes (8/6). "For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans in place for doing so," according to the WHO statement (WHO Pandemic (H1N1) 2009 briefing note 6, 8/6).

Drugmakers Move Forward With H1N1 Vaccine Production, Testing

On Wednesday, the drugmaker Novartis announced that the company launched the first human trials of its H1N1 vaccine 10 days ago, the Associated Press reports. According to Novartis spokesman Eric Althoff, the yearlong trial will involve 6,000 people from Britain, Germany and the U.S. (Cheng, 8/5).

Also on Wednesday, the drugmaker Baxter International announced "it had completed its first commercial batches of H1N1 vaccine in late July and is discussing distribution plans with national health authorities," Reuters reports. "The swine flu vaccine … is made using Baxter's cell culture process, which is designed to be faster than traditional vaccine production methods, where virus samples must be put into specially raised chicken eggs to grow" (Beasley, 8/5).

Little Can Be Done To Stop The Spread Of H1N1, Experts Say

"Closing schools, stopping large gatherings and other such measures are unlikely to do much to prevent the spread of the H1N1 swine flu pandemic, a team of experts predicted on Wednesday," Reuters reports, adding, that the current H1N1 situation "closely resembles the pandemic of H2N2 influenza in 1957 when it quickly became apparent that there was little officials could do to stop it." The statements come two days before the U.S. federal government is to issue recommendations on school closures in response to the H1N1 flu. "At the height of the epidemic in May, more than 700 schools closed in the U.S., according to the Department of Education," the news service writes (Fox, 8/6).

Politico Explores Obama's Move To Overhaul Federal Quarantine Regulations

Politico reports that by September, the White House's Office of Management and Budget is expected "to complete the first major overhaul of the quarantine regulations in about three decades" – an approach "[t]hat would have at least some of the rules in place if swine flu returns with a vengeance later this year, though officials are reluctant to make that link publicly." While "White House officials aren’t saying what their rules might ultimately require," Politico looks at previous efforts by the Bush administration and reaction from public health experts, the travel industry and civil liberties groups (Gerstein, 8/5).