PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

[Malcolm]

http://online.wsj.com/article/SB120362217503883593.html?mod=googlenews_wsj

European Regulators Approve
Glaxo's Bird-Flu Vaccine
By JEANNE WHALEN
February 21, 2008 3:41 p.m.

European regulators have given preliminary approval to a vaccine designed for use in advance of a bird-flu pandemic to help people build immunity against the lethal H5N1 virus.

The vaccine, made by GlaxoSmithKline PLC, is the first vaccine designed to be used before an outbreak occurs. The European Medicines Agency recommended Thursday that the vaccine be approved for sale; the European Commission must still give final approval. A Glaxo spokesman said the company plans to submit the vaccine for U.S. Food and Drug Administration approval by the end of this year.

In a statement, Glaxo said that a "number of national governments" have expressed interest in stockpiling the vaccine, called Prepandrix. The Glaxo spokesman declined to comment on whether the shot would be sold directly to consumers.

The H5N1 virus has been circulating for several years, killing thousands of birds and hundreds of people, but has not yet mutated into a strain that could be easily passed from person to person. If that does happen, it would spark a pandemic.

Prepandrix is designed to raise immunity against several strains of the H5N1 virus. If a pandemic were to happen, vaccine makers would attempt to isolate the strain causing the outbreak and make a more precise vaccine to protect people against it.

A number of other companies are developing bird-flu vaccines, including Sanofi-Aventis SA, Novartis AG, CSL Ltd. of Australia and Baxter International Inc., of Deerfield, Ill.

Last year, the FDA approved a Sanofi vaccine that targets an early strain of H5N1 but has some drawbacks: it showed limited efficacy in clinical tests and must be taken in two large doses. Public health officials worry that vaccines requiring large doses of the active ingredient, or antigen, aren't practical because there is limited manufacturing capacity worldwide. The U.S. government has stockpiled doses of the Sanofi vaccine until more advanced shots are available.

Glaxo's vaccine, Prepandrix, contains an extra ingredient known as an adjuvant, which allows a low level of active ingredient to be used in each shot.

[gsgs]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

let's organize a group-buy

[AlaskaDenise]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

Committee for Medicinal Products for Human Use Summary of Positive Opinion for Prepandrix



Common Name: Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

LONDON, Feb. 21, 2008-On 21 February 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Prepandrix, 3.75 Micrograms of haemagglutinin (HA), Suspension and emulsion for emulsion for injection intended for active immunisation against H5N1 subtype of Influenza A virus, in accordance with official guidance. The applicant for this medicinal product is GlaxoSmithKline Biologicals S.A. Belgium.

The active substance of Prepandrix is composed of purified antigen fractions of inactivated split virions A/Vietnam/1194/2004 NIBRG-14 (H5N1), an Influenza vaccines, ATC Code J07BB02. It is an adjuvanted vaccine that induces an immune response (circulating antibodies) against the H5N1 antigen.

The benefits with Prepandrix are that it can mount an appropriate immune response in individuals that are immunologically na?ve against the vaccine strain and the assumption that vaccination with Prepandrix will provide a clinically useful degree of cross-protection against the strain that causes the next pandemic. The most common side effects are injection side reactions, headache, tiredness, fever, aching muscles and joint pain.

A pharmacovigilance plan for Prepandrix, as for all medicinal products, will be implemented as part of the marketing authorisation.

The approved indication is: ?Active immunisation against H5N1 subtype of Influenza A virus?.

Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for Prepandrix and therefore recommends the granting of the marketing authorisation.

* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 67 days from adoption of the Opinion.

** Applicants may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.

http://www.pharmalive.com/News/index.cfm?articleid=517287&categoryid=51

[tropical]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

let's organize a group-buy

Hm, it's not a such bad idea ...
in the light of:
"The Glaxo spokesman declined to comment on whether the shot would be sold directly to consumers."

In a world of marketing trying to sold many un-necessary things, the EU (and the others) policy MUST be "sold directly to consumers, ALSO".
If a consumer have a possibility to buy it, it must also have a possibility to achieve it individualy, not only wait for the gov. sky "manna".

Obviously, it will be good, that such an pre-pandemic vaccine have (in future times, or now) an self-injecting tool, or the new "under tongue" system for individuals, in the case of nurses lack.

Also, the side effects must NOT be concealed.
It's obvious looking the seasonal vaccine production list, that there are possibilities of many other serious side effects.

Especialy because of the adjuvant - what kind of adjuvant are used in the Glaxo "Prepandrix"?
_
"The most common side effects are injection side reactions, headache, tiredness, fever, aching muscles and joint pain."

[AlaskaDenise]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

Anti-pandemic vaccine backed by RCGP

26-Feb-08


The DoH should consider vaccinating all patients in at-risk groups with a pre-pandemic H5N1 vaccine to help protect against an influenza pandemic, the RCGP has advised.

The call comes after GlaxoSmithKline received the first positive opinion from the European Medicines Agency for the use of its H5N1 pre-pandemic vaccine, Prepandrix.

Results from a series of clinical trials have shown that Prepandrix can offer protection against a number of H5N1 variant strains currently circulating.
Dr George Kassianos, RCGP immunisation spokesman and Berkshire GP, welcomed the decision to approve Prepandrix for use against an influenza pandemic.

?The threat of a pandemic is very real, so we need to be prepared for it.'

.

[tropical]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

The DoH should consider vaccinating all patients in at-risk groups with a pre-pandemic H5N1 vaccine to help protect against an influenza pandemic, the RCGP has advised.

New policy is asked:

The DoH MUST reserve the vaccine for the "at-risk groups".

For the rest of the humans (the not-at-risk groups):
the shot MUST be sold directly to consumers.
That will be good policy, because the non-vaccinated will be the main spreaders of the pandemic, probably.

[gsgs]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

New policy is asked:

The DoH MUST reserve the vaccine for the "at-risk groups".

For the rest of the humans (the not-at-risk groups):
the shot MUST be sold directly to consumers.
That will be good policy, because the non-vaccinated will be the main spreaders of the pandemic, probably.

Glaxo refused to commend, whether the vaccine will be sold to privates

[tropical]

Re: PRE-Pandemic H5N1 multi-strain vaccine approved in Europe

Glaxo refused to commend, whether the vaccine will be sold to privates

I readed it, but:
a new WHO/govs policy of vaccines for: "the not-at-risk groups - vacc. directly to consumers", will be better - that way it will be not loting at the "at risk groups vaccine depot" from the other group, and pushings from the "bigger", in the near-pandemic mist.