There’s Vaccine Out There
“We’re seeing a season unfold where H3N2 is the strain that is circulating the most, and in years past, when that strain has circulated, we tend to see more moderate to severe flu, as far as level of activity—more hospitalizations, more deaths. It tends to impact young children and the elderly more,” CDC spokesman Tom Skinner told GEN. “When that happens, sometimes demand for vaccine goes up.”
“The bottom line is there’s vaccine out there. There should be enough vaccine out there to meet demand, but people who want to get vaccinated may have to look around several places for it,” Skinner acknowledged.
Skinner said CDC is tracking vaccine supply, surveying where shortages are occurring, speaking with retailers so they can reorder vaccine if needed, and sharing information with professional groups like doctors and pharmacies. CDC, he added, continues to urge vaccination of all people six months old and up: “We’ve got to continue to push these messages, so that more and more people each year step forward to get vaccinated. Only then will the manufacturers make more and more vaccine to meet the demand.”
After the 2009 H1N1 flu pandemic, CDC expanded its flu vaccine recommendations beyond seniors and people with some chronic diseases. “It encouraged some in private industry to say, ‘Well, the U.S. market is going to expand a little bit.’ But it really in a significant way did not happen,” Adel Mahmoud, M.D., Ph.D., professor of molecular biology and public policy at Princeton University, told GEN. “When you look at the uptake of the vaccine in our country, year in and year out, it’s about 60% in targeted age groups that have historically been the focus of the effort, and 30–40% in the other groups if not less. You have a lot of room to expand the vaccination effort.”
Government is unlikely to do so, Dr. Mahmoud added, by stoking more vaccine production, either by fiat or by buying the doses, given the economic risk to manufacturers and political risk of promoting vaccine waste.
It’s too soon to predict how this year’s outbreak will affect plans for next flu season. It’s not too soon, however, to know FDA will have new flu vaccines to consider. The agency approved 10 new flu vaccines in 2012, and one already this year. Two can be produced rapidly during outbreaks since they involve alternatives to the decades-old methods of growing, then inactivating a flu virus in the eggs of chickens.
Protein Sciences won FDA approval January 16 for Flublok, consisting of three full-length, recombinant flu hemagglutinin (rHA) proteins designed to fight influenza virus A strains, H1N1 and H3N2, and an influenza virus B strain in adults ages 18 to 49. Two months earlier, FDA approved Novartis’ Flucelvax®, the first cell-culture-derived vaccine using mammalian cells. Both vaccines were developed with funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA).
“The company expects full launch for Flucelvax in the 2013–14 flu season,” Powers of Novartis said.
Also new are the four-flu-strain vaccines two manufacturers plan to roll out next season. GlaxoSmithKline’s Fluarix® Quadrivalent last month became the first intramuscular vaccine designed to fight two A and two B strains in adults and children three years and older.
AstraZeneca’s MedImmune subsidiary will market the first FDA-approved quadrivalent vaccine, the nasal spray FluMist Quadrivalent for patients ages 2 to 49. “It will completely replace the trivalent formulation here in the U.S. The trivalent formulation will be available in several ex-U.S. markets” including Canada and the Europe-Middle East-Africa region, where it will be sold as Fluenz®, Constantino said.
FDA approving even one or two of the new vaccines for 2013–14 should reduce the prospects of spot shortages, absent a particularly virulent flu strain. And since authorities can only predict what strains will cause flu next season, health authorities will need to continue promoting new vaccine R&D as strongly as preventive vaccination for the foreseeable future.