U.S. decision on use of adjuvants could reduce world supply of H1N1 vaccine, says Lancet editorial

Jul 31 2009

"A U.S. plan to rely on swine flu vaccines without ingredients to stretch the supply [known as adjuvants] would reduce the number of available shots just when other countries need them most, the British journal Lancet said in an editorial," Bloomberg writes.

On July 7, the WHO recommended the use of adjuvants - "mixes of oil and water that trigger a stronger response in the body to antigen, the substance that induces immunity" - to increase the global vaccine supply. Though adjuvants are not approved for flu vaccines in the U.S., HHS' decision to declare the H1N1 flu a public health emergency in April gave the FDA the go-ahead to use "unapproved medical products including adjuvants," according to Bloomberg.

Acknowledging that the global manufacturing of the H1N1 vaccine will not be able to meet worldwide demand, the editorial authors write, "The USA must support the use of dose-sparing strategies to avoid depletion of an already short vaccine supply." The article includes comments by HHS spokesman Bill Hall about future plans in the U.S. to test the safety and effectiveness of adjuvants, and says, "The additives may not be necessary if enough shots can be produced without them, HHS officials said. Authorities at the CDC said July 29 that 40 million shots of unadjuvanted vaccine may be available to the U.S. in September, earlier than previously reported, with 80 million more doses ready in October" (Randall, 7/31).

The Lancet editorial also appeals for countries to "assess carefully the risks and benefits of rapid approval of an H1N1 vaccine, especially since the disease has so far been mild with most patients making a full recovery. They must also ensure that they have strong post-marketing surveillance in place before rolling out a vaccine" (8/1).