Republički zavod za zdravstveno osiguranje (RZZO) je po hitnom postupku pokrenuo javnu nabavku za kupovinu tri miliona vakcina protiv novog gripa.

RZZO je u utorak uputio javni poziv za učešće na tenderu farmaceutskim kućama koje imaju registrovane vakcine u Evropi. Poziv su dobili „Novartis”, „Glakso Smit Klajn” i „Sanofi Paster”, iako vakcina te farmaceutske kuće tek u decembru treba da bude registrovana u Evropi.

"Proizvođači imaju rok da do ponedeljka podnesu ponudu. Uslov je da se vakcina isporuči do kraja godine", rekla je za Blic direktorka RZZO, Svetlana Vukajlović.

"Ukoliko dozu budemo plaćali osam evra, iz budžeta države za nabavku cepiva biti izdvojeno oko 24 miliona evra. Vakcina se mora kupiti samo od jednog proizvođača.
Po tome je jasno da ćemo vakcinu kupiti od „Novartisa” koji već krajem ovog meseca može da isporuči tri miliona doza, s obzirom na jasnu poruku iz „Sanofi Pastera” da ne mogu vakcinu da obezbede pre januara i to samo milion i po doza.

Koje vakcine pravi NOVARTIS?

(za prevod teksta sa engleskog na srpski koristite Google translator u gornjem desnom uglu stranice)

Basel, November 5, 2009 - Novartis announced today that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland.
Celtura is manufactured in Marburg, Germany and is an MF59® adjuvanted inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus. The vaccine contains 3.75 micrograms (ug) of antigen and 0.125 ml of MF59®. It will be offered in multi-dose vials and in single-dose pre-filled syringes.
Clinical studies conducted with more than 1,850 subjects evaluated Celtura's tolerability and immunogenicity. The studies showed that even with the lowest antigen content (3.75 ug) a single Celtura dose can induce immune responses associated with protection against influenza in individuals from 3 to 50 years of age. Safety and tolerability profiles were as expected. Local injection site (redness, swelling and pain) and systemic complaints of mild fever, headache and fatigue were the most frequent side effects reported.
Celtura uses a validated cell culture line for production of viral antigen components rather than traditional chicken eggs. The technology has previously been licensed in Europe for the production of the seasonal flu vaccine, Optaflu®.
"Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats", said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany to respond to the need for a pandemic vaccine. Also we are close to completion of a second cell culture-based influenza vaccine manufacturing site in the US[1], which is being built in partnership with the US Department of Health and Human Services (HHS)."
MF59 is an adjuvant with an established safety profile supported by more than 12 years of clinical safety data in Europe and more than 45 million doses of commercial use in the influenza vaccine Fluad® (licensed in Europe but not the US).
Novartis has already begun delivery of the company's egg-based pandemic vaccines, Fluvirin® A(H1N1) monovalent vaccine to the US, and Focetria® A(H1N1) monovalent vaccine to countries around the world. The US Food and Drug Administration approved the Fluvirin A(H1N1) vaccine on September 15, 2009, and the EMEA approved the Focetria A(H1N1) vaccine on September 29, 2009.

U Nemačkoj je odobrena Celtura, u Americi Fluvirin, a u ostalim državama Focetria. Zašto različite vakcine i u čemu je problem?

Suština je u upotrebi sastojka koji se naziva Adjuvant MF59 i oko čije upotrebe u H1N1 vakcini se lome koplja medju hemičarima, doktorima, naučnicima, farmaceutima, a mi verujemo i političarima.

Adjuvanti su sastojci dodati vakcini koji stimulišu imunološku reakciju. Koriste se onda kada nema dovoljno antigena za vakcine, ili kada se ne indukuje dovoljan broj antitela. U slučaju 2009 H1N1 virus gripa se ne reprodukuje u dovoqnoj meri u jajašcima pa je preporučeno da skoristi ovaj adjuvent radi obezbedjivanja dovoljne količine vakcine za predstojeće vakcinacije.

Adjuvant MF59 se koristi u Evropi već 12 godina, kao dodatak sezonskim vakcinama protiv gripa, i smatra se sigurnim adjuvantom. Medjutim u SAD nije dobio odobrenje ni za jednu vrstu takve vakcine, pa ni za H1N1 vakcinu. Postoje mnoge tvrdnje da kombinacija vakcina+adjuvant nije nikada pouzdano istražena niti testirana. Pod izgovorom da vakcine neće biti dovoljno ukoliko se ne doda i adjuvant, američka Food and Drug Administration (FDA)je odobrila upotrebu ovakve vakcine, bez ikakvih dokaza o njenoj bezbednosti! Zbog takvog pristupa su u SAD pokrenuti sudski procesi protiv FDA. Američki ministar zdravlja se takođe pridružio naporima da se dopusti vakcina sa djuvantima:

HHS Purchases Additional H1N1 Vaccine Ingredients.
FOR IMMEDIATE RELEASE - July 13, 2009
Kathleen Sebelius – Secretary of the U.S. department of HEALTH & HUMAN services (HHS) announced; the department will commit $884 million to purchase additional supplies of two key ingredients for H1N1 vaccines. The funds will be used to place additional orders for bulk H1N1 antigen and adjuvant. The vaccine ingredients will become part of the pandemic stockpile, for use in the vaccination campaign.
www.hhs.gov/news/press/2009pres/07/20090713b.html

Evo kako na takve odluke reaguje jedan od američkih advokata koji je pokrenuo sudski spor protiv FDA:

“What has been tested?” asked attorney Jim Turner. “Where has it been tested? Who reviewed the test? Who looked at the test and said yes they proved safety and efficacy? There is no record that we can find that shows these things have been done.”
By approving the four vaccines in the absence of such safety testing, the FDA itself stands in direct violation of federal law. “There is a law that they’re supposed to follow and they are not following it,” Turner added.
http://www.naturalnews.com/027205_vaccines_swin...

Okej, Amerikanci biju svoju bitku. A kako je u Evropi?

Evropska Medicinska Agencija EMEA je odobrila 3 vrste H1N1 vakcine: Celvapan, Focetria i Pandermix. Od njih je Focetria preporučena za proizvodnju u NOVARTISU, od kojega će i Srbija kupiti vakcine, po rečima gdje Vukajlović.

How does Focetria work?

Focetria is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This helps to protect against the disease.

Focetria contains small amounts of ‘surface antigens’ (proteins on the outer membrane of the virus that the body recognises as foreign) of a virus called A(H1N1)v that is causing the current pandemic. The virus has been first inactivated so that it does not cause any disease. The outer membranes that contain the surface antigens have then been extracted and purified. The vaccine also contains an ‘adjuvant’ (a compound containing oil) to stimulate a better response.

Which measures are being taken to ensure the safe use of Focetria?

The company that makes Focetria will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.

Other information about Focetria:

The European Commission granted a marketing authorisation valid throughout the European Union for the H5N1 mock-up vaccine for Focetria to Novartis Vaccines and Diagnostics S.r.l. on 2 May 2007. The commission decision for the H1N1 vaccine was granted on 29 September 2009.

opširnije na adresi http://www.emea.europa.eu/influenza/vaccines/focetria/focetria.html

Kao što se vidi iz informacije sa Novartisovog sajta, oni prodaju Focetriu van SAD, a u Nemačkoj su dobili odobrenje za upotrebu još novije verzije vakcine koju su nazvali Celtura.

Adjuvanti su Big Biznis

Kada ne bi bilo pandemije, i kada bi se vakcine proizvodile bez adjuvanta, tada bi Novartis ostao uskraćen za oko 400 miliona dolara porudžbine samo od SAD, a GlaxoSmithKline za oko 100 miliona $, za proizvodnju adjuvanta za H1N1 vakcine. Medjutim kada se proglasi pandemija i kada su potrebe za vakcinom ogromne, tada je neophodno obezbediti količine za vakcinacije, a to podrazumeva "adjuvantovane" vakcine sa aditivima na bazi nafte i vode. Ovaj adjuvat praktično utiče na smanjenje potrebe za količinama antigena u vakcinama, jer podstiče imune rekacije i stvaranje antitela. Medjutim prethodni adjuvanti su imali izražene neželjene posledice (primer vojnika u Zalivskom ratu) i sasvim je opravdana potreba za transparentnijim dokazima o bezbednosti ovih aditiva. No kao što vidimo, farmaceuti vešto izbegavaju ovakve dokaze koji bi bili podložni javnoj analizi stručnjaka ( ne, ja to nisam ) već se sve svodi na časnu reč proizvodjača.

Antigeni se takodje proizvode u laboratorijama i prodaju kroz vakcine. Novartis je dobio porudžbinu od Američke administracije za 400 miliona $ u antigenima i još toliko za adjuvante.  U Kanadi i Americi sada vlada euforija oko toga da li primati vakcinu uopšte, a ukoliko se prima da li tražiti onu bez adjuvanta ili sa njima. Naročito su zabrinuti roditelji za svoju decu, trudnice itd, jer nema dovoljno argumenata o bezbednosti ovakvih vakcina na ovu vrstu populacije. Naravno, to uopšte ne smeta našem ministru zdravlja da saopšti ovakav stav:

Ministar zdravlja, Tomica Milosavljević, rekao je da su već određene prioritetne grupe za vakcinaciju

"To su bebe od šest meseci i starija deca, hronični bolesnici, zaposleni u javnim ustanovama, tako da će u prvom trenutku biti moguća vakcinacija polovine stanovništva, a potom i ostalih, što će sprečiti dodatne komplikacije koje novi grip izaziva", objašnjava dr Milosavljević.

Sarkazam: Ako Novartis još uvek nije dovoljno detaljno ispitao uticaj adjuvantovane vakcine na bebe, decu, evo prilike da to ustanove preko srpskih zamorčića! Plus zarada od oko 8 evra po ubodu :(