European Agency Declares HPV Vaccines Safe, But Denmark, Japan Skeptical
A handful of countries, like Denmark and Japan, remain skeptical about human papillomavirus (HPV) vaccines, even though the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee’s (PRAC) safety review in 2015 did not change the agency’s position that the benefits of HPV vaccinations outweigh the risks. In July 2015, the PRAC in Europe launched a probe to investigate the safety of the three HPV vaccines available both in the United States and to countries in the European Union—Merck and Co.’s Gardasil and Gardasil 9 and GlaxoSmithKline’s Cervarix. Continuing reports of several HPV-related adverse events prompted the investigation.
NVIC Questions FDA Fast Tracking of Squalene Adjuvanted Flu Vaccine
The non-profit National Vaccine Information Center (NVIC) is questioning the basis for the fast tracked licensure by the U.S. Food and Drug Administration (FDA) of a squalene-adjuvanted influenza vaccine for use in seniors over age 65. The Novartis MF59 adjuvanted Fluad vaccine was approved for accelerated licensure by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Sept. 15, 2015 primarily using limited…
Sanofi Pasteur Will Deliver 65 Million Doses of Flu Vaccine to U.S.
Vaccine maker Sanofi Pasteur SA of France announced that it has released to the U.S. Food and Drug Administration (FDA) the first dozes of its Fluzone influenza vaccine for the 2015-2016 flu season. In a press released picked up by MarketWatch, the company said that it will ultimately produce more than 65 million doses of Fluzone for the U.S. market. Health care providers…
The French National Debate on Vaccine Safety
In response to growing skepticism in France about the safety and effectiveness of vaccines, the French Minister of Social Affairs and Health Marisol Touraine has called for a national debate this fall on the future of vaccination in that country. Touraine, who is concerned that there is greater suspicion and “even defiance” toward vaccines among the French people, seems…
CDC Advisory Committee Votes Against Universal Use of MenB Vaccines
The Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) met on June 24 and voted against universal recommendations for MenB vaccines. These vaccines were recently approved by the U.S. Food & Drug Administration (FDA) for use in adolescents and young adults. Considerations used by the ACIP when making universal (Category A) recommendations for vaccines include disease incidence, and benefit…
Japan, U.S. Poles Apart on Harmful HPV Vaccine
Over the last few years, Japan has experienced a sharp decline in their fertility rate—one of the lowest rates in the world. Coupled with its low fertility rate is an aging population that continues to grow rapidly. For obvious economic reasons, it comes as no surprise that Japan’s government has expressed legitimate concerns over its declining population. In response to this predicament, in 2009, the government began offering monetary incentives to women that bear children…