Pandemic vaccine--making capacity rising, but still short

Feb 24, 2009 (CIDRAP News) – The world's capacity to produce vaccines for an influenza pandemic has risen sharply in the past 2 years, but it would still take an estimated 4 years to meet the global demand if a pandemic emerged now, according to a report from an international strategy consulting firm.

The report was prepared by the New York City–based firm Oliver Wyman in collaboration with the World Health Organization (WHO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

"Pandemic vaccine production capacity has increased by 300 percent over the last two years, largely driven by improvements in production yields and dosage-sparing technologies," Oliver Wyman and the IFPMA stated in a news release. The company did not release the full report.

If a pandemic emerged this year, the most likely case is that manufacturers could produce 2.5 billion doses in the first 12 months after they received the production strain, the firm said. It would take 4 years to produce enough to meet total global demand, meaning two doses for each of the world's 6.7 billion people.

In the best case, the industry could produce 7.7 billion doses in the first 12 months of a pandemic and could meet global demand in 1½ years, the firm said.

The company predicts that annual pandemic vaccine production capacity will rise to somewhere between 5 billion and 14.5 billion doses over the next 5 years. That means the time needed to meet global demand could drop to 2½ years in the most likely case or 1 year in the best case.

The firm also expects that surplus vaccine production capacity—above and beyond the demand for seasonal flu vaccine and prepandemic vaccine stockpiling—will increase over the next 5 years, to between 2.6 billion and 5.4 billion annual doses. How much the capacity actually rises is likely to depend on the demand for both seasonal and prepandemic vaccines, officials said.

"I think this is a mixed story," Adam Sabow, the Wyman partner who led the preparation of the report, told CIDRAP News. "This is good if there's new seasonal [flu vaccine] demand or if there's demand for H5N1 vaccine during the interpandemic period for efforts such as stockpiling.

"However, if there isn't demand, there's a possibility that some of that capacity could be rationalized. By that we mean that capacity may either be shut down or may be redeployed for other purposes," which would reduce the ability to respond quickly to a pandemic.

He noted that there is some demand for H5N1 prepandemic vaccines, as some countries are stockpiling them, while the WHO is working on designing a global H5N1 vaccine stockpile. He said his firm is working with the WHO on that project.

Alicia D. Greenidge, director-general of the IFPMA, said member companies are committed to working with the WHO and governments to ensure the best use of surplus vaccine capacity to prepare for a pandemic. "The findings suggest that the use of stockpiled H5N1-based vaccines, followed by pandemic vaccine as soon as these become available, offers a realistic strategy to address this significant threat," she commented in the Wyman news release.

Agreement on numbers
Sabow said that to estimate vaccine production capacity, his firm included 44 existing and planned vaccine production facilities, representing "the vast majority" of such facilities.

He said the report marks a first: "This study is the first time that all the major actors have come together to agree on the capacity numbers for pandemic influenza. There's historically been a debate about the numbers that has taken away from the policy discussion. We're excited about this because the global health community has come together and agreed on the numbers and now can move on to the policy implications."

The report estimates that once a pandemic is recognized, it will take 4 months to develop, produce, and begin distributing a specific vaccine for it. Sabow said the estimate assumes the use of conventional egg-based production.

"We worked very closely with the WHO and the manufacturers to break down the individual parameters of that lead time, and a lot of work has been done to make that lead time as short as possible," he said. "This is currently the best information that our group has analyzed with regard to a realistic time at the point of a pandemic."

Egg-based and cell-based production
Although cell culture technology has been described as a faster and more flexible method for making flu vaccine, Sabow said the time needed to start making a pandemic vaccine would probably be about the same with cell culture production.

"We did model this for both egg-based and cell-based production, and the expectation is that cell-based production would have a relatively similar time frame," he said.

While most flu vaccine production remains egg-based, the amount of cell-based production capacity is expected to increase considerably in the next 5 years, Sabow noted.

One of the uncertainties is what will happen to egg-base production capacity as cell-based capacity comes on line, particularly if demand for seasonal and prepandemic vaccines is lacking. "If there isn't demand, some of that egg-based capacity may be rationalized," he said.

A chart released by Wyman gives more specific estimates of how much vaccine could be produced in the first few months of a pandemic. It indicates that once a pandemic is declared, it will take 3 to 4 weeks to create a reference strain for vaccine production.

In the most likely case, production would reach 340 million doses at 4 months after vaccine makers receive the reference strain, according to the chart. Production would reach 580 million doses at 5 months, 860 million doses at 6 months, and 2.45 billion doses at 12 months.

Possible constraints
Sabow said the Wyman analysis did not consider potential economic constraints on vaccine production and distribution or the possible effects of supply-chain disruptions, which many experts regard as likely during a pandemic.

"The intent of our work was to say, based on the production capabilities of those facilities, what do we think the overall production looks like at the point of a pandemic," he said. "We did not analyze what the financial implications would be or whether there would be funding for production or who would have access to it, and did not look at the possible supply-chain issues. That was not part of this analysis."

Sabow said the projections related to production of prepandemic vaccine stockpiling refer to H5N1 vaccines, but the estimates of production of actual pandemic vaccines do not assume that the next pandemic virus will be an H5N1 strain. "This is based on the history of producing a range of different influenza vaccine strains," he said.

See also:

Oct 26, 2007, CIDRAP News report "The pandemic vaccine puzzle, part 2: Vaccine production capacity falls far short"

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