FDA Must APPROVE Heplisav for Older Persons because There's NO REAL ALTERNATIVE
The FDA will have to approve Heplisav for immunization of people over the age of 40 because the currently available commercial vaccines are largely ineffective in this population.
In particular, diabetics, most of whom are above the age of 40, require hep-B vaccination because of the high risk of contracting the disease during dialysis.
Therefore, without Heplisav, the CDC recommendation for hep-B vaccination is toothless since the vaccinations with the current commercial vaccines will probably not be able to reach the required level of immunity.
In spite of all the negative NOISE about DVAX resulting from the overambitious FDA-supported attempt to achieve a quick FDA approval for Heplisav in all-ages, which nearly succeeded, there should be NO DOUBT that the FDA will approve Heplisav for hep-B immunization in people over the age of 40 (for which most of the Heplisav data apply).
After all, the FDA has no real choice for vaccinatiosn in this age group because the evidence suggests that the current commercial vaccines do not achieve adequate immunity in people over 40.
The benefits of an effective hep-B vaccine for this age group far outweigh the imaginary risks that were invented by some members of advisory commitee without any justification or indication in the clinical data.