FDA Approves New Seasonal Influenza Vaccine 'Flublok'

Vaccine Manufactured With Novel Technology

After the FDA announced it approved a new seasonal influenza vaccine this week, Health and Human Services Assistant Secretary Nicole Lurie explained some of the details.

Lurie is an M.D., as well as the Assistant Secretary for Preparedness and Response, at the U.S. Department of Health and Human Services. She is principal advisor to Secretary Sebelius on public health emergencies (and bioterrorism).

Lurie said FDA approval of this vaccine is a landmark event. Flublok, this new seasonal flu vaccine, was created using novel technology. Recombinant DNA, plus a modified baculovirus, a virus that infects insects, surprisingly produces a safe, effective human influenza vaccine.

Lurie said it is "one of the most significant improvements in flu vaccine technology in the past 50 years."

The breakthrough came by way of a public-private partnership between the government's Biomedical Advanced Research and Development Authority (BARDA), and Protein Sciences Corporation.

Since its inception in 2006, BARDA has worked steadily with private industry to advance influenza vaccine technology and develop flu vaccines with these modern technologies that are FDA approved, ultimately providing more domestic pandemic vaccine capacity. As part of these national pandemic preparedness efforts, the National Institute of Allergy and Infectious Diseases supported early stage development of this vaccine and in 2009, when the vaccine reached an advanced development stage, BARDA began a partnership with Protein Sciences Corporation to reach the results we are seeing today: a new flu vaccine made with modern technology.

Demand for influenza vaccine can increase with little warning in a pandemic and in years when the flu is especially widespread. The method used to manufacture Flublok may help meet the increased demand for flu vaccine quickly because it has the potential for faster start-up of the manufacturing process than traditional egg-based vaccine methods. The process is nimble enough to be used for seasonal as well as potentially for pandemic flu vaccine because the technology does not depend on an egg supply or on the availability of modified influenza virus for production like traditional egg-based vaccine manufacturing does.

This new way of making flu vaccine is an example of the Obama administration partnering with industry to move innovative technology forward to the market. Our goal in ASPR is to drive innovative development of effective and cost-efficient vaccines, drugs, diagnostics, and medical equipment to protect public health during emergencies. Many of these innovations also hold potential day-to-day uses, as is often the case with seasonal and pandemic flu technology.

BARDA also worked with its partners to achieve FDA approval for the first flu vaccine manufactured using a cell-based technology and, through a public-private partnership, opened the first cell-based flu vaccine manufacturing plant in the United States. This past year, BARDA engaged private partners around the country in a new way through three Centers for Innovation in Advanced Development and Manufacturing that will support pandemic as well as biodefense readiness.

This HHS record of progress shows the power of public-private partnership. By working together - industry, non-government organizations and all levels of government - we can help save lives, improve public health preparedness and potentially increase health security for our nation. FDA approval of Flublok is an important step toward that goal.