FDA APRUEBA NUEVA VACUNA PARA LA GRIPE ESTACIONAL 2009-2010

LA NUEVA VACUNA ESTACIONAL NO PROTEGERA CONTRA LA NUEVA INFLUENZA A H1N1 (NUEVA GRIPE O GRIPE PORCINA) DECLARADA EN PANDEMIA POR LA ORGANIZACION MUNDIAL DE LA SALUD

Entre otros comentarios por comisarios de la Agencia Federal de Drogas de los EEUU se afirmo que "Una nueva vacuna de gripe estacional cada año es una herramienta fundamental en la protección de la salud pública"

Adicionalmente comento que la vacunación del personal de salud es importante para protegerse ellos y los demás de la influenza.

Mayor detalle abajo en inglés.


FDA Approves Vaccine for 2009-2010 Seasonal InfluenzaThe U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

an A/Brisbane/59/2007 (H1N1)-like virus
an A/Brisbane/10/2007 (H3N2)-like virus
a B/Brisbane/60/2008-like virus
There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

For more information:

FDA Web Page on Influenza Vaccine Safety & Availability
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm

FDA List of Strains Included in the 2009-2010 Influenza Vaccine
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm162050.htm

U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza Resources for Health Professionals
http://www.cdc.gov/flu/professionals/vaccination/

U.S. Centers for Disease Control and Prevention Web Page with Key Fact About Seasonal Flu Vaccine
http://www.cdc.gov/flu/protect/keyfacts.htm

#

RSS Feed for FDA News Releases [what is RSS?]

LIMITADO BENEFICIO CLINICO Y CON REDUCCIÓN DE LA RESPUESTA A LAS VACUNAS CON LA ADMINISTRACION PREVENTIVA DE ACETAMINOFEN

Amigos y amigas,

La administración profilactica al momento de la vacunación disminuye significativamente la reacción febril y no afecta realmente la ocurrencia de fiebre mayor de 39 grados centígrados. Sin embargo, disminuye la respuesta inmune a algunos antígenos de la hexavalente y de la vacuna antineumocóccica. Asi, la indicación rutinaria preventiva previos a la vacunación de antipireticos, tipo acetaminofén, debe ser eliminada a menos que este prescrita por otra razón medica.

Muy interesante la conclusión de una investigación muy importante que se realizo en Checoslovaquia por un grupo liderizado por el Dr. Prymula, ver abajo. Tuve el gusto de conocerlo en la presentación y discusión de su poster hecha en el EUROPEDIATRICS 2009celebrado en la ciudad de Moscu, Rusia, el pasado 2 al 6 de julio. Me informo el Dr. Prymula que la publicación del trabajo fue aprobada por LANCET para los próximos números.

R455
LIMITED CLINICAL BENEFIT BUT REDUCED ANTIBODY RESPONSES TO PEDIATRIC VACCINES FOLLOWING PROPHYLACTIC PARACETAMOL ADMINISTRATION

Prymula R., Siegrist C., Chlibek R., Zemlickova H., Vackova M., Smetana J.,
Lommel P., Kaliskova E., Dorota B., Schuerman L.
Faculty of Military Health Sciences, University of Defence, Hradec Kralove,
Czech Republic Center for Vaccinology and Neonatal Immunology, University of Geneva,
Geneva, Switzerland Centre of Epidemiology and Microbiology, National Institute of Public Health, Prague, Czech Republic Global Clinical Development Center,GlaxoSmithKline Biologicals, Rixensart, Belgium
GlaxoSmithKline Biologicals, Prague, Czech Republic

Background. Fever is frequently part of the normal inflammatory response after immunization in young children. Although generally benign and self limiting, it is frequently of concern for parents and physicians.

Aim. Evaluation of impact of prophylactic antipyretic administration on reactogenicity and immunogenicity.

Patients and methods. Paracetamol (acetaminophen; AP group) was prophylacticly administered in 3–4 doses at 6–8 h intervals within the first 24 h after each vaccination dose of the licensed DTPaHBVIPV/Hib vaccine coadministered with a 10valent pneumococcal conjugate vaccine at 3–4–5 months of age (107017/NCT00370318)
followed by a booster dose at 12–15 months (107137/NCT00496015). Reactogenicity/immunogenicity was compared with a group of vaccinees not receiving prophylactic antipyretics (NAP group).

Results. Fever within 4 days after vaccination was statistically significantly reduced in the AP group; 41.6% (94/226)subjects with rectal temperature  38°C vs 66.1% (154/233) after primary vaccination; 36.0% (64/178) vs 58.1% (100/172) after booster. No effect was observed on the occurrence of fever > 39.5°C or requiring medical attention. Seroprotection/seropositivity rates were high (> 96%), within similar ranges for both groups at all time points, and also in line with previous experience with DTPaHBVIPV/Hib vaccine. However lower geometric mean antibody
concentrations (GMCs) were observed in the AP group for some antigens (D, T, PRN, PRP) after priming. Seroprotection rates were not impacted for most antigens and boostability was maintained. Only antitetanus GMC remained lower after the booster. A reduction was also observed for most antipneumococcal responses in these
studies, as well as in posthoc analyses (across several studies) for primary vaccination with the licensed 7valent pneumococcal conjugate vaccine.

Conclusions. Even if prophylactic administration of paracetamol at the time of vaccination significantly reduced febrile reactions, no effect on the occurrence of fever > 39.5°C was observed. However, decreased immune responses
to some antigens of different paediatric vaccines were observed. Therefore, routine prophylactic administration of antipyretics should be discouraged unless medically justified.

531