Glaxo to Limit Tests of Flu Vaccine, Citing Urgency

[sharon sanders]

via email -

Glaxo to Limit Tests of Flu Vaccine, Citing Urgency (Update1)
2009-07-22 15:24:56.527 GMT


(Adds French health minister?s comment in 15th paragraph.)

By Jason Gale and Trista Kelley
July 22 (Bloomberg) -- The swine flu shot that
GlaxoSmithKline Plc is developing will be tested on a limited
number of people as the U.K. drugmaker weighs the pandemic?s
danger against the risks of an unsafe shot.

?The total population studied in clinical trials will be
limited due to the need to provide the vaccine to governments as
quickly as possible,? the London-based company said in a
statement today. ?Additional studies will therefore be required
and conducted after the vaccine is made available.?

That may be risky, said Hugh Pennington, a retired
microbiologist and emeritus professor of bacteriology at the
University of Aberdeen, Scotland. By limiting clinical trials,
Glaxo raises the danger that the vaccine dose isn?t properly
calibrated, and could lead to shots that don?t protect people
from the virus or at worse are unsafe, he said.

?I don?t see any reason why you should fast-track it to
perhaps raise public concern about the safety of the vaccine,?
he said. The shot?s ability to trigger the body?s defenses is
crucial and requires tests to determine the best dose and
whether an adjuvant is needed to bolster immunity, he said.

Adjuvants are designed to boost a patient?s immune response
to make the vaccine more effective. Regulators, health officials
and drugmakers should bear in mind ?what happened in the U.S.
in 1976,? according to Pennington.

Fort Dix

In 1976, 13 soldiers in training at Fort Dix, New Jersey,
fell ill from swine flu and one died, prompting concern that a
pandemic would erupt. The disease didn?t spread, but a vaccine
developed to prevent it was given to 45 million Americans in 10
weeks. The shot was later linked with a paralyzing neurologic
condition that affected more than 1,000 people.

Glaxo in the end may decide to do more tests than currently
envisioned, Pennington said.

The swine flu that emerged in April in North America has
spread as far as New Zealand and Norway. The disease has killed
more than 700 people globally and sickened at least 125,000,
taking root across the globe faster than any previous flu, to
the World Health Organization said this week.

U.K. Health Secretary Andy Burnham said on July 20 a
vaccine against the virus, a new strain that?s evolved in pigs,
humans and birds, would be ready at the end of August, and the
process of administering doses will begin at the beginning of
September. The U.K. has ordered flu shots from Glaxo and Baxter
International Inc.

?The sense of urgency is obviously driven by governments
who put themselves in a position where they have a need for
preparedness,? Glaxo Chief Executive Officer Andrew Witty told
reporters on a conference call. ?The volume of orders is
unprecedented.?

Face Masks

Sanofi-Aventis SA, the French drugmaker developing its own
swine flu shot, will begin testing the product in early August.

Paris-based Sanofi estimates it will need as much as two
and a half months of tests before having a shot that?s ?both
safe and protective,? according to Albert Garcia, a spokesman
for the company?s vaccine unit. The vaccine will probably be
ready in November or December, Garcia said yesterday.

Baxter will produce a vaccine by early August, after which
it will perform clinical tests, said Chris Bona, a spokesman for
the Deerfield, Illinois, company.

France, which has ordered vaccines from Sanofi, Glaxo and
Novartis AG, sees no reason at this point to ask vaccine makers
to shorten or skip clinical trials, Health Minister Roselyne
Bachelot-Narquin said at a news conference.

?Necessary? Approval

?We want the vaccine the soonest possible but we don?t
want a product that isn?t of quality,? she said. ?We want the
vaccines to obtain the necessary regulatory approval? and have
?all the necessary guarantee before giving the vaccines to the
public.? France should begin receiving vaccine in October, she
said.

Glaxo, meanwhile, said it?s on track to meet government
orders for 195 million doses of vaccine and another 50 million-
dose donation to the World Health Organization and the first
supplies should be available in September.

Both Glaxo and Sanofi said they will be tailoring their
tests to meet regulators? demands. ?We?re following a playbook
which is defined by health authorities,? Witty said.

Glaxo also said today it?s developing a face mask coated
with antivirals to prevent infection and boosting production of
its Relenza drug for patients already suffering from swine flu.

 

[Vibrant62]

Re: Glaxo to Limit Tests of Flu Vaccine, Citing Urgency

I am more than a little surprised at GSKs willingness to supply vaccines for use where standard safety, dosaging and efficacy studies (at least preliminary ones) have not been conducted.

Whilst there are legal indemnity waivers in place to protect manufacturers in both the UK and US, the PR disaster of a poorly matched vaccine that gives rise to unacceptably high levels of serious side effects in both adults and children (which will become very evident during mass vaccination campaigns) would destroy thier reputation and markets for vaccines for decades to come and could cost them very dearly in future lost revenues.

And there is much evidence to suggest that the GSK vaccine could cause problems if they use the EMEA H5N1 pandemic vaccine reference dossier to achieve a licence without any dosage variation.

As we know, H5N1 is very poorly immunogenic and so far higher antigen dosages were used, and in the case of GSK vaccines, thie amount of antigen required was moderated by use of adjuvant.

There is no adjuvant safety data for the under 18s published anywhere, nor included in the EMEA reference dossier - and even this has very little safety and toxicology data included within it for any age group.

SO they are proposing to produce a vaccine for pandemic H1N1 without knowing how immunogenic it is, and issue it at dosages developed for the problematic H5N1 - so that children and young adults could have vaccine doses that are far more immunogenic than needed. That is a recipe for excessive and higher than normal side effects, by itself.

Adjuvanted influenza vaccines have not had good records in the past. a highly 'brave' decision on the part of governments and GSK for a virus that is still relatively 'mild' in at least some age groups they intend to be using this vaccine in, does it add up to be taking such risks?