The US may not have as many H1N1 flu vaccines available from the get-go as originally anticipated, CBS News reported on Tuesday.

According to the report, approximately 45 million doses will be available in mid-October—that’s down from the original plan of 120 million doses. The new plan calls for an additional 20 million doses to be distributed each week after the first batch of vaccines are given.

GlaxoSmithKline announced last Friday that it had begun development for the new vaccine, and that it had locked up enrollment for the first clinical study.

“GSK is making good progress with the development of its pandemic vaccine.” Enrollment into the first study has been completed, and in total GSK will conduct 16 clinical trials of its pandemic vaccine in over 9,000 individuals across Europe, Canada, and the US,” stated Thomas Breuer, head of Global Clinical R&D and chief medical officer of GSK Biologicals. “We continue to work closely with regulators and governments to assess and develop this vaccine.”

Medimmune has also started clinical trials on its H1N1 vaccine, and told the Washington Business Journal that it expects to manufacturer far more vaccines than the 12.8 million doses the government asked it to produce.

Meanwhile, Novartis has already begun shipping its seasonal influenza vaccine to get that out of the way before the second wave of the H1N1 flu hits.

“With the (A) H1N1 influenza pandemic underway, it is important that we take every possible precaution to help protect US citizens from all circulating strains of influenza,” stated Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, in a release. “By receiving the seasonal influenza vaccine early, physicians and public health officials can better prepare for the upcoming flu season.”

The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest alert level), making it the first worldwide pandemic in 41 years.

According to WHO Director-General Margaret Chan, 30,000 cases of the swine flu have been reported in 74 countries, but there is a very good possibility that the number could be much higher in countries where there aren’t proper testing methods. The H1N1 flu strain, originally dubbed swine flu, first appeared in Mexico and the United States in March and is spread the same way as the traditional flu. However, since the H1N1 flu is so new, there is far less time for people to built an immunity to the virus, hence the flu has been passing briskly from person to person.

Chan stated in a release:

Worldwide, the number of deaths is small. Each and every one of these deaths is tragic, and we have to brace ourselves to see more. However, we do not expect to see a sudden and dramatic jump in the number of severe or fatal infections.

Although the pandemic appears to have moderate severity in comparatively well-off countries, it is prudent to anticipate a bleaker picture as the virus spreads to areas with limited resources, poor health care, and a high prevalence of underlying medical problems.

The AP noted that so far 141 deaths have been associated with H1N1 and that annually 250,000 to 500,000 people die of the regular seasonal flu. The difference is that most of the people dying from swine flu are young, in contrast to the seasonal flu which primarily hits the elderly the hardest.

Each year, the WHO and the Center for Disease Control and Prevention recommend three different seasonal flu strains that they think are most likely to circulate in the upcoming season, and they base their choice on what’s going on in the southern hemisphere and how the influenza will evolve into the northern hemisphere in the upcoming year.

The problem with seasonal flu vaccines and the H1N1 currently being testing for could very well mutate before a vaccine is finished. The 2007–2008 flu season was a particularly rough year as the vaccines produced proved to be only 44 percent effective in fighting the influenza.

A few month’s back, FDA announced that both GSK’s Relenza and Roche’s Tamiflu—both antiviral treatments—proved to be helpful in treating H1N1 if taken with 48-hours of first symptoms. Roche, today, sent us the following statement:

[Roche] continues to ramp up production of Tamiflu and fill orders as they come in. We have the capacity to make 400 million treatment courses a year. We announced last month that Tamiflu production can be up to 110 million courses over the next few months. Last month, we donated another five million treatment courses to the WHO for their use.

GSK spokesperson Jeff McLaughlin told Pharm Exec that GSK has begun the process necessary for development of the new vaccine in both its Canadian and US vaccine manufacturing sites. “The first step in manufacturing this vaccine is to prepare the seed strain for production, which takes several weeks,” he said. “We didn’t receive the seed strain until the end of the May, so we are into that process. The commencement of the production of the new canditate—an H1N1 influenza vaccine begins and first doses are expected to be available in four to six months time and thats subject to regulatory approval.

“Today’s announcement doesn’t change too much of what we have been doing,” McLaughlin said.

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