Panflu 1, single shot H1N1 pandemic influenza (swine flu) vaccine from Sinovac Biotech Ltd has been granted approval in Mexico.
Panflu H1N1 vaccine was issued a Certificate of Approval from the Secretaria de Salud for distribution in Mexico, Sinovac Biotech said in a press release.
The certificate granted to Sinovac Bio’s Panflu1 is valid through October 13, 2014.
Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company with operations in Mexico since 1935, is the exclusive distributor of Sinovac’s vaccine products including Panflu1 in the Mexican market
Sinovac Bio had signed a distribution agreement with Laboratorios Imperiales S.A. de C.V. in 2005 with its affiliate.
Sinovac Bio’s application for its flu vaccine Anflu in currently under review in Mexico
Panflu 1 is the first China-developed vaccine approved for human use in Mexico and the first H1N1 vaccine to be registered in Mexico.
Sinovac’s seasonal influenza vaccine Panflu was released by China SFDA and commercially launched at the end of July 2009.
In June 2009, the Beijing municipal government made its first purchase of its H1N5 vaccine Panflu from Sinovac, with an initial order of four million doses that are expected to be delivered by the end of September 2009.
Sinovac has tested the vaccine shots in 1,614 volunteers and found that the vaccine is safe and protects people against the pandemic virus after a single shot, the company claimed.
Sinovac began the clinical trials of its one-shot H1N1 vaccine on July 22, 2009. The volunteers included 101 elders, 706 adults, 404 juvenile and 403 children. All 1614 volunteers had received the first shot of the vaccine through July 25.
Panflu’s clinical trial was organized by China’s Center for Disease Control (CDC), and undertaken by Beijing CDC. The Ministry of Health (MOH) and State Food and Drug Administration (SFDA) were paying close attention to this clinical trial. Deputy Director General of MOH Disease Control Department, Director of SFDA Registration Section, and other relevant experts visited the clinical trial site to observe the clinical trial.
Swine flu vaccines are currently prescribed and administered in two dozes to ascertain the expected immunity level against the lethal H1N1 virus.
Even WHO was recommending two dozes of swine flu vaccine to give sufficient protection against pandemic H1N1 strain. Because it is a new strain, infectious disease experts had said people would likely need two doses to get full immunity against the virus.
Two studies, however, published a leading medical journal confirmed that a single dose of swine flu vaccine can protect people from the new pandemic H1N1 virus.
Australia’s leading biopharmaceutical company CSL Limited announced that preliminary data from the first study of its candidate pandemic H1N1 vaccine demonstrated a robust immune response in healthy adults after a single unadjuvanted 15mcg dose.
Swiss drug maker Novartis is the other company came out with studies supporting the efficacy of single dose vaccines.
Novartis said studies confirmed that its vaccine worked at an even lower dose when boosted with an immune system compound called an adjuvant.
Novartis vaccine, to be called Celtura, was tested with 100 healthy volunteers, aged between 18 and 50. The trial evaluated the tolerability and immunogenicity of the vaccine.
Novartis’ data showed that the serum antibody responses were highest among subjects who received two doses of vaccine, however a single vaccine dose also induced responses associated with protection against influenza.Sinovac Biotech Ltd is focusing on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac’s commercialized vaccines include Healive (hepatitis A), Bilive (combined hepatitis A and B), Anflu (influenza) and Panflu (H5N1). Sinovac is currently developing Universal Pandemic Influenza vaccine and Japanese encephalitis vaccine Sinovac is the first and currently the only company in the world to have been granted permission to begin clinical trials for a vaccine to prevent SARS.