LOW-ADDITIVE INFLUENZA VACCINES
An influenza vaccine lacks at least three of: a mercurial preservative; an antibiotic; formaldehyde; and egg-derived materials. In some embodiments, the vaccine includes none of these four components.
1 - 12 . (canceled)
13 : An inactivated influenza vaccine comprising a split or subunit influenza virus antigen, wherein the vaccine lacks an antibiotic, formaldehyde, and a mercurial preservative, wherein the vaccine is sterile and contains no egg derived materials, wherein the influenza was inactivated with β-propiolactone, UV light, methylene blue, psoralen, carboxyfullerene (C60), binary ethylamine, acetyl ethyleneimine, or gamma irradiation.
14 : The vaccine of claim 13 , having less than 0.1 IU/ml of endotoxin.
15 : The vaccine of claim 13 , having less than 10 ng of host cell DNA per 15 μg of haemagglutinin.
16 : The vaccine of claim 13 , wherein the antigen is a split virus antigen.
17 : The vaccine of claim 13 , wherein the antigen is a subunit influenza virus antigen.
18 : The vaccine of claim 13 , including antigen from more than one influenza virus strain.
19 : A process for preparing an influenza virus antigen, comprising the steps of:
(i) growing influenza virus in a cell culture system, in the absence of egg-derived materials and of antibiotics;
(ii) inactivating the influenza viruses grown in step (i), in the absence of formaldehyde, wherein inactivating is performed with β-propiolactone, UV light, methylene blue, psoralen, carboxyfullerene (C60), binary ethylamine, acetyl ethyleneimine, or gamma irradiation; and
(iii) preparing a split or subunit vaccine antigen formulation from the inactivated influenza viruses, in the absence of thimerosal.
20 : The vaccine of claim 13 , wherein the vaccine is pharmaceutically acceptable for administration to human patients or has been approved for use in humans.
21 : An inactivated influenza vaccine comprising a split or subunit influenza virus antigen, wherein the vaccine lacks an antibiotic, formaldehyde, and a mercurial preservative, wherein the vaccine is sterile and contains no egg derived materials, wherein the influenza was inactivated with β-propiolactone, methylene blue, carboxyfullerene (C60), binary ethylamine, acetyl ethyleneimine, or gamma irradiation.
22 : The vaccine of claim 21 , having less than 0.1 IU/ml of endotoxin.
23 : The vaccine of claim 21 , having less than 10 ng of host cell DNA per 15 μg of haemagglutinin.
24 : The vaccine of claim 21 , wherein the antigen is a split virus antigen.
25 : The vaccine of claim 21 , wherein the antigen is a subunit influenza virus antigen.
26 : The vaccine of claim 21 , including antigen from more than one influenza virus strain.
27 : A process for preparing an influenza virus antigen, comprising the steps of:
(i) growing influenza virus in a cell culture system, in the absence of egg-derived materials and of antibiotics;
(ii) inactivating the influenza viruses grown in step (i), in the absence of formaldehyde, wherein inactivating is performed with β-propiolactone, methylene blue, carboxyfullerene (C60), binary ethylamine, acetyl ethyleneimine, or gamma irradiation; and
(iii) preparing a split or subunit vaccine antigen formulation from the inactivated influenza viruses, in the absence of thimerosal.
28 : The vaccine of claim 21 , wherein the vaccine is pharmaceutically acceptable for administration to human patients or has been approved for use in humans.
29 : An inactivated influenza vaccine comprising a split or subunit influenza virus antigen, wherein the vaccine lacks an antibiotic, formaldehyde, and a mercurial preservative, wherein the vaccine is sterile and contains no egg derived materials, wherein the influenza was inactivated with 3-propiolactone, methylene blue, carboxyfullerene (C60), binary ethylamine, or acetyl ethyleneimine.
30 : A process for preparing an influenza virus antigen, comprising the steps of:
(i) growing influenza virus in a cell culture system, in the absence of egg-derived materials and of antibiotics;
(ii) inactivating the influenza viruses grown in step (i), in the absence of formaldehyde, wherein inactivating is performed with β-propiolactone, methylene blue, carboxyfullerene (C60), binary ethylamine, or acetyl ethyleneimine; and
(iii) preparing a split or subunit vaccine antigen formulation from the inactivated influenza viruses, in the absence of thimerosal.
31 : The vaccine of claim 29 , including antigen from more than one influenza virus strain.
32 : The vaccine of claim 29 , wherein the vaccine is pharmaceutically acceptable for administration to human patients or has been approved for use in humans.