Analyst: Adjuvanted H1N1 vaccines helped stir Europe's debate

Jan 15, 2010 (CIDRAP News) – The use of adjuvanted vaccines, an unfamiliar technology, helped spark mistrust that may have contributed to the recent allegations in Europe that pharmaceutical companies manipulated governments and international agencies by hyping the H1N1 pandemic threat, according to a British market analyst who follows infectious disease issues.

Some members of the 47-nation Council of Europe's Parliamentary Assembly have proposed a resolution charging that pharmaceutical companies, aiming to boost vaccine and drug sales, worked to "alarm" governments about the pandemic and prompt them to waste money on inefficient vaccine strategies and expose people to inadequately tested vaccines.

National and international health officials, along with the World Health Organization, have vigorously denied the allegations, which will come before the council on Jan 26.

Hedwig Kresse, MPhil, MSc, a London-based senior analyst on infectious diseases at the independent market analysis firm Datamonitor, said today the decision to use adjuvanted vaccines might have contributed to the controversy in Europe. She also said that when H1N1 emerged, it was the press and government officials, not pharamaceutical companies, that voiced alarm and pushed for a vaccine.

Off to a bad start
"I think in Europe the entire pandemic vaccine supply situation got off to a bad start because European regulators opted for adjuvanted vaccines, which resulted in a lot of negative publicity across Europe" and reduced the public's interest in getting vaccinated, Kresse told CIDRAP News.

In the United States, she noted, authorities decided not to use adjuvants (which have never been used in US flu vaccines) and to stick with the standard technologies that have been used in seasonal flu vaccines for many years, she noted. (The US government bought a supply of adjuvants for possible emergency use but has not used them.)

"It wasn't the same kind of debate as in Europe," she said. "That led to a bigger acceptance of the vaccine."

The pandemic H1N1 vaccines approved in Europe are GlaxoSmithKline's Pandemrix, containing the adjuvant ASO3, and Novartis's Focetria, which contains the company's MF59 adjuvant. Also approved in Europe is Baxter's Celvapan, which contains no adjuvant but is made in cell culture, a newer technology, rather than in eggs.

Kresse noted that one adjuvanted flu vaccine, Novartis's Fluad, was approved in Europe back in 1997, but it is used only in the elderly.

Since most Europeans were unfamiliar with adjuvanted flu vaccines, "it was a new technology and there was no long-term record regarding reactogenicity," Kresse said. "And since H1N1 has so far been a clinically mild pandemic, it just didn't seem logical to a lot of people that you needed this new technology. So a lot of people saw it as an unnecessary risk to take."

The safety record of the European vaccines has been good so far, Kresse said. She said they cause a slightly higher rate of local reactions, such as pain and itching, and possibly a higher rate of fever, than flu vaccines with no adjuvants. "I'm not aware of any major safety concerns in Europe," she added.

H5N1 threat set stage for adjuvants
Kresse noted that pandemic vaccine efforts in Europe were predicated on the H5N1 avian flu virus. Vaccine versions of this virus have grown poorly in eggs and have been poorly immunogenic. As a result, she said, the general view has been that adjuvants are needed to make H5N1 vaccines work.

Manufacturers developed mockup vaccines based on H5N1, with adjuvants, with the understanding that when a pandemic emerged, the pandemic virus could replace the H5N1 and the vaccine could gain rapid regulatory approval.

Concerning the charge that vaccine manufacturers hyped the pandemic threat to boost their profits, Kresse said it doesn't fit her perception of how things evolved.

"I think these questions have to be treated very, very carefully," she said. "Without a doubt the pharmaceutical companies did benefit from the pandemic. But when I look back, it was more the government and the press" that talked a lot about the threat and pressed for a vaccine. "It was more the pharmaceutical companies being on the receiving end and being asked to deliver it as fast as they possibly could."

She said it seems unlikely that the current controversy would make drug companies unwilling to produce pandemic vaccines in the future, but she wouldn't rule out that type of outcome.

"If it really comes to a very nasty public discussion and results in a big loss of reputation for the pharmaceutical companies, then it's another matter," she commented. "Then as a company I might calculate very carefully what I'd gain and lose in terms of reputation."

On the other hand, she said it's unlikely that companies would completely withdraw from pandemic supply efforts: "There's a very vital political interest in keeping the sector attractive for pandemic supplies."

Tommy Thompson defends US vaccine efforts
Also today, former US Health and Human Services (HHS) Secretary Tommy Thompson added his voice to those defending the pandemic vaccine programs, saying it would be a terrible outcome if critics succeeded in scaring companies away from vaccine development. Thompson served as HHS secretary through President George W. Bush's first term.

In a telephone interview, Thompson, now a senior partner in the Washington, DC, law firm Akin Gump, said the nation's preparedness for disease outbreaks has improved and that the progress must be maintained.

"In the past we've not been prepared and we haven’t had companies that wanted to be in the vaccine business," he said. "For the first time in our long history, we've got companies that are interested in preparing vaccines for flu. . . . The worst thing in the world would be to say this was contrived and therefore scare away vaccine companies from getting scientists to do research on infectious viruses."

As for the assertion that the pandemic threat was exaggerated, Thompson said, "The only way to prove our concerns beyond a reasonable doubt is to have a lot of people die, and I don't know anyone who's advocating more lethality from flu viruses."

"You're always going to have critics, but people in the scientific community believe we're doing the right thing and I certainly believe that," he added. "I think it was the right thing to do, to get started down this path, and I'm glad that it continues to be expanded."

He also commented that while the H1N1 virus is not as lethal as was feared, the pandemic may not be over and the virus could mutate into a more dangerous form.

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