I was asked if any other vaccines have been approved that contain ASO3. The answer is yes, and no.
No licensed US vaccines have ever contained this adjuvant. I am not aware of its presence in vaccines used in any other countries, prior to the H1N1 adjuvanted vaccines.
However, ASO3 was approved by the European Medicines Agency (EMEA) for a
BIRD FLU (H5N1) vaccine. Actually, it was
approved for use in two bird flu vaccines in Europe: a "prepandemic" vaccine, called Prepandemrix, and a pandemic vaccine. A
Canadian briefing paper said it was also approved in Asia. I
blogged about prepandemic bird flu vaccines once before. What is a prepandemic vaccine? You might well ask.
Remember, those in the business of threat assessment and pandemic planning have to find threats and develop responses to them. That is what they are paid to do. And
BARDA is a US federal agency whose job is to support the research, development and procurement of such medical products that can serve as the response. BARDA was created to deal with bioterrorism initially, so it has a quasi-military, "can do" flavor, compared to our public health agencies, which have more grounding in clinical medicine and risk-benefit analysis. BARDA buys the pandemic vaccines.
Even though there never was a bird flu epidemic,
considerable planning and expenditures went into responding to the possibility of one. One result was the production of huge quantities of bird flu (aka
H5N1 influenza virus) vaccines, both in the US and elsewhere. GSK discusses its novel adjuvants and development of bird flu vaccine
here. Bird flu did kill over 50% of those infected. So our governments bought us vaccines. But they didn't know if the vaccines would work. That uncertainty helped make the case for adding a novel adjuvant. The adjuvants were billed as expanding the immune coverage provided. If they didn't work against whatever bird flu happened to emerge, they were still supposed to provide some initial immunity, such that a second, better targeted vaccine would generate much higher levels of antibody, specific to the right virus, than if there had been no initial vaccine.
Of course, this claim was very theoretical, but it gained traction nonetheless.
The next idea to gain some traction was that since a bird flu epidemic would be so devastating, maybe countries should just go ahead and give their citizens a first dose of bird flu vaccine to get us all primed in advance for the epidemic. After all, huge stores of vaccine had been produced. And all that would happen to those stores otherwise would be to reach their expiration dates.
This what what our worldwide pandemic vaccine experts had been nattering about when the swine flu appeared.
What else could they do with swine flu?
Naturally, they took their pandemic planning for bird flu and made it fit swine flu. When swine flu appeared, the administration was new and there was no appointed HHS secretary, so the pandemic guys likely had free rein to drive the program in the direction they chose.
And I suspect that is why a huge vaccine campaign was undertaken, and why novel adjuvants were going to be used, without much question, even in the early planning, even in the United States. Here is a
PPT presentation from Florida public health officials made in late spring, showing how H1N1 vaccines made by Sanofi-Aventis, CSL and GSK were all to be prepared for use with ASO3. The Novartis vaccine was to contain MF59. (I wonder if Novartis is "Company 3" described by Nicole Lurie in my last blog post, the swine flu vaccine manufacturer
that had trouble making an un adjuvanted vaccine.) Once swine flu is past, watch to see if the idea of "prepandemic" bird flu vaccinations catch the fancy of our public health agencies. If the swine flu vaccine program is successful, bird flu vaccines may be next. If there are serious safety or efficacy problems with swine flu vaccines, the bird flu vaccine will be shelved for awhile longer.
No licensed US vaccines have ever contained this adjuvant. I am not aware of its presence in vaccines used in any other countries, prior to the H1N1 adjuvanted vaccines.
However, ASO3 was approved by the European Medicines Agency (EMEA) for a BIRD FLU (H5N1) vaccine. Actually, it was approved for use in two bird flu vaccines in Europe: a "prepandemic" vaccine, called Prepandemrix, and a pandemic vaccine. A Canadian briefing paper said it was also approved in Asia.
I blogged about prepandemic bird flu vaccines once before. What is a prepandemic vaccine? You might well ask.
Remember, those in the business of threat assessment and pandemic planning have to find threats and develop responses to them. That is what they are paid to do. And BARDA is a US federal agency whose job is to support the research, development and procurement of such medical products that can serve as the response. BARDA was created to deal with bioterrorism initially, so it has a quasi-military, "can do" flavor, compared to our public health agencies, which have more grounding in clinical medicine and risk-benefit analysis. BARDA buys the pandemic vaccines.
Even though there never was a bird flu epidemic, considerable planning and expenditures went into responding to the possibility of one. One result was the production of huge quantities of bird flu (aka H5N1 influenza virus) vaccines, both in the US and elsewhere. GSK discusses its novel adjuvants and development of bird flu vaccine here.
Bird flu did kill over 50% of those infected. So our governments bought us vaccines. But they didn't know if the vaccines would work. That uncertainty helped make the case for adding a novel adjuvant. The adjuvants were billed as expanding the immune coverage provided. If they didn't work against whatever bird flu happened to emerge, they were still supposed to provide some initial immunity, such that a second, better targeted vaccine would generate much higher levels of antibody, specific to the right virus, than if there had been no initial vaccine.
Of course, this claim was very theoretical, but it gained traction nonetheless.
The next idea to gain some traction was that since a bird flu epidemic would be so devastating, maybe countries should just go ahead and give their citizens a first dose of bird flu vaccine to get us all primed in advance for the epidemic. After all, huge stores of vaccine had been produced. And all that would happen to those stores otherwise would be to reach their expiration dates.
This what what our worldwide pandemic vaccine experts had been nattering about when the swine flu appeared.
What else could they do with swine flu?
Naturally, they took their pandemic planning for bird flu and made it fit swine flu. When swine flu appeared, the administration was new and there was no appointed HHS secretary, so the pandemic guys likely had free rein to drive the program in the direction they chose.
And I suspect that is why a huge vaccine campaign was undertaken, and why novel adjuvants were going to be used, without much question, even in the early planning, even in the United States. Here is a PPT presentation from Florida public health officials made in late spring, showing how H1N1 vaccines made by Sanofi-Aventis, CSL and GSK were all to be prepared for use with ASO3. The Novartis vaccine was to contain MF59. (I wonder if Novartis is "Company 3" described by Nicole Lurie in my last blog post, the swine flu vaccine manufacturer that had trouble making an un adjuvanted vaccine.)
Once swine flu is past, watch to see if the idea of "prepandemic" bird flu vaccinations catch the fancy of our public health agencies. If the swine flu vaccine program is successful, bird flu vaccines may be next. If there are serious safety or efficacy problems with swine flu vaccines, the bird flu vaccine will be shelved for awhile longer.