US Planning For H1N1 Vaccine Production Problems
17 Juli 2009 - 8:51PM
Dow Jones News
Federal health officials said Friday they are planning to test
H1N1 influenza vaccines that contain additional material known as
adjuvants in order to boost vaccine effectiveness amid reports from
vaccine makers about potential production problems.
On Thursday top officials from Baxter International Inc. (BAX)
and Novartis AG (NVS) said so far that the viruses used to make the
vaccine isn't yielding as much active ingredient typically seen for
seasonal influenza vaccines. Novartis said the yield of active
ingredient - or antigen - so far is about 30% to 50% of what the
company normally sees for seasonal flu vaccines. If similar
scenarios hold true for all vaccine makers, that could limit the
amount of H1N1 influenza vaccine.
However, the addition of other materials known as adjuvants
designed to boost the body's response to a vaccine, could
potentially reduce the amount of antigen necessary for the body to
recognize and fight a virus. The antigen is the active ingredient
in a vaccine that causes the human body's immune system to develop
antibodies that help fight an invading virus.
Anne Schuchat, the director of the Centers for Disease Control
and Prevention's Immunization and Respiratory Diseases Center, said
reports of low yields so far hasn't "changed our expectation for
vaccine ability in the fall" because officials expected possible
production problems.
Indeed, Jesse Goodman, the Food and Drug Administration's acting
chief scientist, said there are plans to test H1N1 influenza
vaccines that are made in the same manner as seasonal vaccines
along side vaccines that contain adjuvants.
In a document posted on FDA's Web site, the agency said it was
considering adjuvants made by GlaxoSmithKline PLC (GSK) and
Novartis in clinical studies. The FDA is holding a meeting next
week to discuss the details of such studies. The studies are
expected to start next month and the first doses of a vaccine could
be available by mid-October.
Goodman explained that the FDA views the H1N1 vaccines being
developed as essentially a strain change typically seen in seasonal
vaccines from year-to-year, so there's already an established
pathway to approving the vaccines. However, there aren't any
licensed adjuvants in the U.S., so if those are used they would
have to be approved under an emergency-use authorization that
allows for a fast-track approval process.
Last week, the government signed contracts worth $884 million
with U.S. units of Sanofi Aventis (SNY) and AstraZeneca PLC (AZN)
along with GlaxoSmithKline and Novartis to purchase ingredients
used to make H1N1 vaccines. A unit of CSL Ltd (CSL.AU) is also
expected to supply some vaccine to the U.S. market.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com