H1N1 Vaccine Orders Top 1B, WHO Says

"Northern hemisphere countries have so far ordered more than one billion doses of swine flu vaccine, the World Health Organisation said Tuesday, sparking warnings over shortages," Agence France-Presse reports. While some countries, including Greece, The Netherlands, Canada and Israel, have ordered enough vaccine to inoculate their citizens, "[o]thers, such as Germany, the United States, Britain and France, have put in orders that would cover between 30 and 78 percent of people," the news service writes.

"In the early days, there will be a very limited supply of vaccine. There won't be sufficient supply to vaccinate whole populations, or even huge proportions of populations," WHO spokeswoman Melinda Henry explained, which, in turn, will force governments to prioritize those first in line for the vaccine. As Henry noted, it remains unclear whether the H1N1 vaccine will be delivered in one or two doses to be effective (Hood, 8/18).

U.S. Looks For Ways To Avoid Vaccine Packaging 'Logjam'

The Associated Press/Boston Globe reports on the U.S. government's efforts to mitigate manufacturing delays in the production of the H1N1 vaccine. "'We're trying to bring on more manufacturing' for the packaging step that has emerged as a logjam, said Dr. Robin Robinson, the Department of Health and Human Services official in charge of vaccine procurement. 'Hopefully, there are ways to bring that number up,'" the newspaper writes (Neergaard, 8/19).

Bloomberg Examines Vaccine Effectiveness

"Swine flu vaccines under development by drugmakers may not provide immunity until the last week of November, too late to hold off outbreaks triggered by infected students returning to schools in the U.S. and Europe," Bloomberg reports. The article includes information about the H1N1 vaccine development, planned distribution efforts and the progression of the virus around the world, which according to the WHO, has "reached more than 170 countries and territories in the four months since being identified" (Randall, 8/19).

Chinese Pharmaceutical Company Says Clinical Trials Show One Vaccine Dose Effective

The Chinese pharmaceutical company Sinovac reported Tuesday that results of clinical trials of its H1N1 vaccine show a single dose of the vaccine produces "a good immune response," the Canadian Press reports. However, "the company did not reveal key details, including the size of the dose or the formulation of the vaccine, information that would be needed to determine whether other vaccine makers could expect to see similar results," according to the news service (Branswell, 8/18).

Reuters adds: "Until now, experts have predicted that two shots will be needed to provide swine flu immunity. But Sinovac, which is the first company worldwide to complete clinical trials for an H1N1 vaccine, said a single dose of its vaccine proved sufficient." The clinical trials, which included 1,614 participants over the age of 3, ran from July through August 15. The company reports the participants experienced no severe adverse side effects as a result of the vaccine (Hirschler, 8/18).

MedImmune Starts Clinical Trials Of Vaccine; NIAID Starts Testing Vaccine In Children

The Washington Business Journal reports the company MedImmune recently began enlisting volunteers from around the U.S. to participate in the clinical trials of its nasal H1N1 vaccine. The company "is running two trials simultaneously, one on children aged 3 to 17 and another on adults from 18 to 49 years of age, signing up 300 healthy individuals for each trial," and hopes to have preliminary results within a few weeks, the newspaper writes.

The company expects its H1N1 vaccine production to exceed current orders by HHS. "[MedImmune spokeswoman Perla] Copernik said the company was asked to manufacture 12.8 million doses, but it actually expects to produce 200 million doses by next March," the Washington Business Journal reports (Sinha, 8/18).

A representative from the National Institute of Allergy and Infectious Diseases (NIAID) announced Tuesday early trials of an H1N1 vaccine "did not show immediate safety concerns for adults," paving the way for the vaccine to be tested in children, CQ HealthBeat reports. Two clinical trials, each with "650 children between the ages of six months and 17 years old," will test the vaccine. "One trial will test the dosage of the H1N1 vaccine and the other will test whether the vaccine can be administered at the same time as the seasonal flu vaccine, according to NIAID," the news service writes (Kim, 8/18).

Roche Recommends Countries Extend Tamiflu Shelf-Life; India Attemps To Negotiate Lower Prices On Tamiflu

In related news, the WHO on Tuesday said "it was up to national regulatory authorities to decide whether to extend the shelf life of the flu drug Tamiflu by two years, as recommended by Swiss drug maker Roche," Reuters reports (Nebehay, 8/18). The Associated Press adds: "Authorities including the World Health Organization have decided to extend the medicine's shelf life by two years to fight the swine flu pandemic. It should preserve the stockpiles of the drug that governments started to build up five years ago in response to an outbreak of bird flu" (8/18).

The Financial Express reports that sources in India's health ministry say the government is in talks with Roche to purchase Tamiflu at a reduced price (Das, 8/19).