Swine flu vaccine on fast track and out by September

By Sheilah Downey

In an attempt to alleviate concerns about the safety of the H1N1 vaccine, which has been officially put on the fast track, the World Health Organization said today safety and quality won't be compromised.

The race to produce the swine flu vaccine is based on the woefully underprepared health officials throughout the world who got caught with their test tubes down, so to speak, in previous pandemics.

"During the 1957 and 1968 pandemics, vaccines arrived too late to be used as an effective mitigation tool during the more severe phases of the pandemics," stated a WHO briefing released today.

The 1957 Asian flu pandemic killed 2 million people worldwide, with about 70,000 deaths in the United States alone, according to the Health and Human Services. Although the virus was quickly identified by scientists, vaccine supplies were limited.

The 1968 Hong Kong flu, called the mildest pandemic of the 20th century, caused 33,800 deaths in the U.S. but left health officials lacking in vital vaccine.

Though rushing through regulations at a breakneck pace, the WHO stated "The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls."

In a virtual webcast from WHO headquarters in Geneva, officials there said that after a worrisome start in the pandemic H1N1 vaccine production, the race to get a pandemic vaccine is "on track" and should be ready by September.

Early yields of the H1N1 vaccine were "quite disappointing" and were only producing one-half to a third of what is ususally produced, said Marie-Paule Kieny, WHO director of the initiative for vaccine research.

Researchers, she said, found a way to solve that problem, if only temporarily.

"So, I don't want to say too early that the question has been resolved but it really seems that we have found a way to go around this problem," Kieny stated. "So really, in conclusion, in terms of development, we are on track..."

In a "best-case scenario," as many as 94 million doses a week of the pandemic vaccine would be produced, said Kieny.

In order to expedite the production of the H1N1 vaccine, approval procedures are similar to those applied to "strain changes" -- changes made each year when producing seasonal flu vaccines. This allows manufacturers to use fewer data to get licensing for the vaccine because it's not considered a "new" virus.

For that reason, said Kieny, "The vaccine will be registered without clinical trials. Clinical trials will be used to recommend if one or two doses is needed."

Results from the first clinical trials are expected early next month.

Addressing safety concerns, Kieny said the vaccines being produced are based on proven technology, the same that is used to produce the seasonal vaccines.

But in any large-scale vaccination program -- Greece is considering vaccinating the entire country -- adverse reactions are to be expected.

"There is no vaccine that induces zero safety concerns," she said. "So there is no doubt that if and when there will be a large-scale vaccination campaign, there will be people who have an adverse event."