FDA approves vaccine for 2009-2010 seasonal influenza
ROCKVILLE, Md. The Food and Drug Administration announced Monday 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 on June 11. 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% effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths, the FDA said.
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.
“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 FDA commissioner Margaret Hamburg, M.D. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”
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.
According to the CDC, between 5% and 20% 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.
Senate panel votes in favor of healthcare reform bill
NEW YORK After decades of fruitless efforts, activist lawmakers in a Democratically controlled Congress finally may be on the verge of pushing through one of the most elusive policy goals of the past half-century: a massive reform of the U.S. healthcare system that aims to extend health coverage to most Americans and put a clamp on federal healthcare spending.
That bill, the Affordable Health Care Choice Act of 2009, is a long way from passage. Republicans on the Senate HELP Committee object to several key provisions in the bill – including language that would impose higher taxes on the wealthiest Americans to help pay the bill’s estimated trillion-dollar 10-year tab, a new government-run insurance provider to compete with private-sector insurers and a provision that would penalize employers who don’t offer health benefits to their workers – and that opposition is sure to play out when the House of Representatives and the full Senate debate the measure in coming days.
Nevertheless, even staunch conservative lawmakers acknowledged that the climate for health reform is ripe. Spurred by public alarm over the rising cost of health care and dire projections about the future of Medicare and Medicaid, the Obama administration and the President’s allies in Congress have made overhauling the healthcare system a top legislative priority, and are pushing for fast-track passage of a bill before the end of the current session.
It’s too soon to tell just what impact the bill would have on some of the biggest issues of concern to retail pharmacy, such as Medicaid reimbursement. But concerns over costs and employer mandates aside, chain and independent pharmacy advocates have found much to like in the Affordable Health Care Choice Act.
As envisioned by HELP Committee chairman Sen. Edward Kennedy, the bill, if passed in its current form, would advance the concept of pharmacy care, elevate the role of pharmacists as patient-focused community health practitioners and exempt retail pharmacies from accreditation requirements for the sale of durable medical equipment, a cause long sought by pharmacy leaders.
Needless to say, the bill also would swell the roles of prescription drug customers by expanding affordable coverage to most of the estimated 45 million to 50 million uninsured Americans.
Among the pharmacy-friendly provisions championed by Kennedy and other supporters of the bill:
- The establishment of community health teams to set up the “medical home” model of individualized health care for patients – a model that could include retail pharmacies as “homes;”
- Funding of a pioneering grant program to implement medication therapy management for the treatment of chronic diseases;
- Greater incentives to spur generic drug switching and the adoption of health information technology;
- A greater emphasis on disease prevention through healthier lifestyle and nutrition, and closer coordination between health counselors (including pharmacists, presumably) and patients; and
- The creation of an approval pathway for biogenerics at the Food and Drug Administration.
EU approves Pfizer’s pending acquisition of Wyeth
NEW YORK Pfizer on Friday announced that the European Commission has approved under the European Union Merger Regulation the company’s pending acquisition of Wyeth. The commission’s decision includes Pfizer’s commitment to divest certain animal health assets in the European Union.
“We are pleased to have achieved another significant milestone for the pending acquisition with the EC’s approval of the transaction,” stated Amy Schulman, SVP and general counsel of Pfizer.
In addition, Pfizer announced that China’s Ministry of Commerce has extended its review of Pfizer’s regulatory submission beyond the initial thirty-day period. The completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, governmental and regulatory approvals in certain other jurisdictions, and approval by the stockholders of Wyeth.
“We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close at the end of the third quarter or during the fourth quarter of 2009,” Schulman said.