Manufacturers Look to Vaccines for Growth and Innovation - Pharmaceutical Technology

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Manufacturers Look to Vaccines for Growth and Innovation
Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.

Pharmaceutical Technology
Volume 34, Issue 2, pp. 30-37

Pandemic pitfalls

Coverage matters
Still, the vaccine business carries considerable risks. Pfizer has run into delays gaining FDA approval of its improved Prevnar 13 vaccine for pneumococcal disease in children, despite its priority-review status and strong recommendation for approval by an advisory committee last November. Merck has found it hard to sell its shingles vaccine Zostavax largely due to Medicare reimbursement complications (see sidebar, "Coverage matters").

The H1N1 swine-flu vaccine shortage in October and November brought home the perils involved in influenza vaccine development and production. Last July, US government officials predicted that vaccine makers would produce 80–120 million doses by mid-October 2009, and public health agencies ramped up for a major vaccination drive. The government, along with vaccine producers, lost considerable credibility when only 40 million doses were available in September, and some 20 million Americans had already been hit by the new flu.

Health and Human Services (HHS) Secretary Kathleen Sebelius said she relied on industry predictions that turned out to be wildly overly optimistic. Meanwhile, vaccine makers claimed they kept health officials informed of technical problems and resulting delays at various steps in the manufacturing process.

The 2009 pandemic flu was supposed to demonstrate the viability of US government plans for responding to health emergencies. The 2004 closure of a Chiron vaccine-manufacturing plant in Liverpool, England, which cut off half of the US flu vaccine supply that year, had ignited concerns about the nation's ability to ramp up its emergency response to biological attacks and global pandemics, resulting in multiple programs to deal with such crises.

Speedy production of the H1N1 vaccine, however, was hampered by a very tight development timeline. Manufacturers first had to complete production of millions of doses of seasonal flu vaccine for the regular 2009 flu season. Even though scientists had plenty of eggs to inject with the H1N1 seed virus in late May, vaccine production took longer than expected because the yield in each egg was much lower than with the seasonal influenza viral strain, a problem not immediately recognized due to difficulties developing a suitable potency test for the new product.

FDA received some of the blame for delays in providing an effective H1N1 vaccine, and Commissioner Margaret Hamburg admitted to being disappointed and frustrated that the production process was not smoother. But she told the author in November that she prefers to regard the response from FDA and industry as "quite remarkable in terms of how much has been mobilized in response to a previously unrecognized strain of flu virus." Some of the disappointment may stem from over-optimism in predicting how much vaccine would be available when. "Sadly, we know that it's the nature of manufacturing vaccines to have some unexpected delays, and it's the nature of science to have unanticipated problems emerge."

One initial unknown was whether one dose would provide sufficient protection to patients, or if re-vaccination would be necessary. Clinical-trial results indicated that the new H1N1 vaccine was sufficiently potent to support a single dose in adults and two doses in young children. But low potency remained a problem for vaccine makers: AstraZeneca's (London) MedImmune had to recall nearly 5 million doses of its nasal-spray vaccine in December 2009, while sanofi-aventis pulled 800,000 doses in pre-filled syringes for young children.

By then, the flu plague was ebbing, and manufacturers faced a new problem: more vaccine than anyone wanted. Last month, the French government moved to sell millions of doses to countries in the Middle East and Latin America and to cancel sizeable orders from sanofi, GSK, Novartis (Basel, Switzerland), and Baxter (Deerfield, IL). Germany and other European countries quickly followed suit.


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