Summary
Four manufacturers have received approval for their H1N1 vaccines: CSL, MedImmune, Novartis, and sanofi-pasteur.
FDA confirms single dose at 15 ug for injectable vaccine and standard dose for LAIV is adequate with robust immune responses.
Testing in pediatrics not yet complete.
GSK was not among those approved even though they are part of the government contract.
Analysis
FDA's news release confirms that 4 of the 5 manufacturers of the novel H1N1 vaccine, CSL, MedImmune, Novartis, and sanofi-pasteur have filed data adequate to license their novel H1N1 vaccines for use in adults.
In the release the FDA is basically confirming that the dose per strain used in the seasonal vaccine is adequate for the monovalent novel H1N1 vaccine, at least for adults and that a single dose is adequate in adults.
The agency acknowledges that additional pediatric dosing data for immune responses in children is pending. However, this should not prevent children from receiving their first dose of vaccine. Note that pediatric formulation of the injectable is coming from sanofi-pasteur.
There is limited data on safety discussed, but the agency comments that the reactions are "as expected" with the seasonal vaccine. While the small size of these studies cannot be used to estimate the rate of rare events, like Guillian Barre Syndrome, the lack of reports of such events is encouraging that these H1N1 vaccines will behave like seasonal vaccines.
The agency noted that they are working with interested parties to ensure appropriate post-marketing surveillance is in place to see any unusual events once broad use begins.
The fact that GSK was not among the list of those approved suggests they have issues in either production, release or clinical data. It is unlikely that this relates to clinical data since the injectable vaccines should be similar across manufacturers since they use basically the same manufacturing methods. It is more likely that they are having release issues and the main concern would be if they have had issues in production of seasonal vaccine that is interfering with moving into novel H1N1 vaccine production. Thus, best case, they are simply delayed.
Frank Malinoski consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
