Background on vaccine info I provided

[Guest guest]

Someone pointed out I had not provided context to the material on H1N1

vaccine and vaccine adjuvants, so here it is--Meryl

All non-live vaccines need adjuvants to stimulate sufficient immunity

in recipients. All adjuvants in currently- licensed US vaccines are

aluminum-based.

Many other vaccines adjuvants have been developed, and most are

stronger than those in current use, but their safety is not established.

Pandemics provide vaccine manufacturers with a major opportunity to

get these new adjuvants into use. New diseases can provide the excuse

to abbreviate testing of new vaccines; and the need to use the

vaccines soon after development means there will be NO long-term data

on safety available before mass use.

Into this setting come two squalene-based adjuvants whose owners have

been struggling to get them into the US market. The prize --

licensure--will be worth billions of dollars, and if such adjuvants

attain routine use, many new, poorly-immunogenic vaccine antigens will

become components of marketable vaccines. If no high-quality, long-

term safety studies are performed by those without a vested interest

(this is a major problem with current vaccines: no one is looking for

problems), we may never know the injuries caused by such vaccines.

Friday, July 3, 2009

H1N1 vaccines with novel adjuvants being developed for potential mass

use

The US government has contracted with at least 5 pharmaceutical

manufacturers to develop and produce H1N1 vaccines, using a variety of

platforms and manufacturing methods. This is an excellent approach,

since at this point no one knows which will succeed and how long it

will take to obtain desired quantities of vaccine.

A novel feature of the two H1N1 vaccines being developed by companies

Novartis and Glaxo- Kline is the addition of squalene-containing

adjuvants to boost immunogenicity and dramatically reduce the amount

of viral antigen needed. This translates to much faster production of

desired vaccine quantities.

Each company has its own proprietary adjuvant, acquired in each case

at high cost and intended for the high-stakes business of rapidly

producing vaccines for novel pandemics or biological warfare threats.

Novartis' adjuvant is named MF-59, and Glaxo's is ASO3. We know they

work beautifully to strengthen vaccine efficacy. But how safe are they?

That is a very difficult question to answer. Novartis claims MF-59 has

been used safely by over 40 million people. However, FDA has not seen

fit to approve even a single US vaccine that contains these novel

adjuvants.

One European vaccine contains MF-59, and two European vaccines contain

ASO4, which is a Glaxo adjuvant related to ASO3. Fluad (with MF-59) is

only licensed for use in the over-65 population. This age group

responds weakly to standard flu vaccines, and whether standard flu

vaccines actually reduce flu cases in this age group is controversial.

So a stronger vaccine may be indicated for this group. And as we age,

we are much less likely to develop autoimmune disorders, so potential

autoimmune side effects should also be less in this age group.

However, in the 12 years since Fluad was approved in Italy for older

adults (and later in the EU) I am not aware of any other vaccine

containing MF-59 that has been licensed... even though MF-59 has been

used in a large number of vaccine trials. Virtually all the scientific

literature on this adjuvant has been produced by scientists working

for the manufacturer, precluding an unbiased assessment of safety at

this time.

Glaxo's ASO4 is used in Fendrix (a Hepatitis B vaccine). Fendrix may

only be used for people with kidney disease. Patients on kidney

dialysis have a high rate of Hepatitis B infection, and a weak immune

system. So they are good candidates for an especially potent vaccine

against a disease to which they are highly susceptible, and these

recipients are unlikely to develop autoimmune complications.

Cervarix is a vaccine directed against several strains of human

papilloma virus (HPV), licensed in both Europe and Australia, which

contains ASO4. It is difficult to assess Cervarix' safety at this

point in time, as data are limited. It is worth noting that FDA has

delayed giving Cervarix a US license at least twice.

The June 19, 2009 Science magazine discusses use of these " next-

generation, " antigen-sparing adjuvants for an H1N1 pandemic. It quotes

Norman Baylor, director of FDA's Office of Vaccine Research and

Review, who noted that antigen-sparing strategies benefit populations,

not individuals. " You have to think about those trade-offs, " Baylor

said.

Saturday, July 4, 2009

H1N1 update: Australia/Hong Kong/US

While CDC has not committed to a strategy beyond Tamiflu (to which

some viral strains in Hong Kong have resistance), Australia faces a

major H1N1 outbreak, as the southern hemisphere winter just began. But

mathematical modelling suggests the US has already experienced 1

million H1N1 cases.

On May 17, Australia moved to a new national health alert level,

called “protect,” to focus on the early treatment of those vulnerable

to [severe illness from] the flu, including pregnant women, people

with respiratory disease, heart disease, diabetes and obesity. And on

July 2, Australia's Health Minister, Nicola Roxon, reassured parents

that swine flu does not pose a greater danger to children than

seasonal flu.

Separately, Sydney immunisation specialist Booy said swine flu

was likely to kill twice as many children over the next 12 months as

regular influenza. The professor estimated 10-12 children could die

from the virus, compared with five or six from normal flu strains in a

typical year.

In the US, normally under 100 children die each year as a result of

seasonal influenza infections. To prevent an estimated 100 excess

deaths (this is a very rough estimate), up to 75 million children

might receive a vaccine containing novel adjuvants, for which testing

was limited.

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

W 207 288-5081 ext. 1220

C 207 522-5229

H 207 244-9165

pager 207 818-0708

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