Sep 29, 2010 (CIDRAP News) – Speaking at a Senate committee hearing today, US Health and Human Services (HHS) Secretary Kathleen Sebelius said a cell-based seasonal influenza vaccine from Novartis could be on the US market in time for the 2011-12 flu season.
With the help of a $487 million HHS contract, Novartis Vaccines and Diagnostics recently built a facility in Holly Springs, N.C., to make cell-based flu vaccines and vaccine adjuvants. No cell-based flu vaccine has yet been licensed in the United States, though such vaccines have been approved in Europe.
Referring to the Novartis facility, Sebelius said, "It's scheduled to be online to apply for licensing early in 2011 for cell-based seasonal vaccine, and a licensed vaccine is expected to be marketed for the 2011-112 flu season."
But in response to a query from CIDRAP News after the hearing, Novartis officials took a more cautious stance.
"Novartis opened its Holly Springs, North Carolina, facility in November 2009 in collaboration with the US Department of Health and Human Services (HHS)," the company said in a statement. "Novartis plans to file for cell-based vaccine technology in the US in the first half of 2011, but approval is contingent upon FDA [Food and Drug Administration] review, so we cannot confirm when cell-based vaccines would be on the market in the US."
When the North Carolina plant was unveiled in 2009, Novartis officials said the earliest it could start making flu vaccine was 2011, with full commercial production expected in 2013.
Sebelius made her comments at a hearing of the Senate Appropriations Committee's Labor-HHS Subcommittee on "Defending against public health threats." The session focused on HHS efforts to develop medical countermeasures against biological weapons.
Cell culture technology—growing vaccine viruses in mammalian cells, such as canine kidney cells—is regarded as more flexible and somewhat faster than the decades-old method of growing flu vaccines in chicken eggs. Cell-culture technology is used to make certain other vaccines, such as polio and rabies.
Commenting on Sebelius's prediction, Andrew Pavia, MD, of the Infectious Diseases Society of America (IDSA), who also spoke at the hearing, told CIDRAP News afterward, "It seems optimistic to me, but if true it's good news." Pavia, a pediatric infectious disease specialist at the University of Utah, chairs the IDSA's Pandemic Influenza Task Force.
Pavia commented further, "As best we can tell, FDA has already given Novartis a reasonably clear signal of what it's going to take to get [the vaccine] licensed, and it's reasonably similar to regular flu vaccine. They were going to be using fairly similar potency assays and demonstrating efficacy in clinical trials."
Sebelius also told the subcommittee that a recombinant flu vaccine from Connecticut-based Protein Sciences Corp. may also be licensed in time for the 2011-12 flu season. The company's application for approval of the vaccine is currently being reviewed by the FDA, according to the firm's Web site. The vaccine is made by using a baculovirus to grow the antigen in insect cells.
Sebelius talked about the Novartis and Protein Sciences vaccines in response to questions from Sen. Tom Harkin, D-Iowa, chair of the subcommittee. He said the subcommittee has provided $15 billion for pandemic flu preparedness since 2006. That includes the money for the Novartis facility, he said, but "I hear it won't operate until 2013."
"There's no cell-based vaccine in the US, but they're currently licensed in Europe," Harkin said. "What's the problem with getting them licensed in the US if they're licensed in Europe and why aren't we further along?"
In response, Sebelius noted that HHS has stockpiled a vaccine for H5N1 avian influenza, before discussing the Novartis and Protein Sciences vaccines.
In her prepared statement to the panel, Sebelius discussed five initiatives that were described in a major HHS review, released in August, of civilian biodefense efforts. The review was prompted by the delays in production of the 2009 H1N1 flu vaccine and by the general perception that countermeasures development has been slow.
The HHS initiatives include, among others, improving the FDA's science capabilities, establishing advanced development and manufacturing centers for medical countermeasures, and speeding flu vaccine production by providing seed strains that grow better and improving sterility testing methods.
Sebelius said HHS released a draft solicitation this month for the proposed centers for advanced development and manufacturing and plans to issue the final request for proposals by the end of the year. The intention is that each center could produce more than one type of countermeasure, she reported.
Eric Rose, MD, co-chair of the Alliance for Biosecurity and head of a biotechnology company, defended the record of HHS's Biomedical Advanced Research and Development Authority (BARDA), the agency charged with developing biodefense tools.
"The BARDA advanced development program is bearing fruit," said Rose, who is CEO of Siga Technologies, which is developing an antiviral for smallpox. "While many have criticized the slow pace, our experience is that the program is leading to important novel countermeasures less than 7 years" after it was launched. "There is a trickle, but the pipeline is beginning to flow."
Pavia said the IDSA wants to see the countermeasures program get a consistent stream of funding. "We support at least $1.7 billion for BARDA for new countermeasures in 2011," he said. He told CIDRAP News this amount is well above what the Obama administration is proposing.
Considerable discussion at the hearing focused on the FDA's heavy workload and its ability to evaluate new countermeasures.
Harkin predicted that a food safety reform bill will soon pass, which will increase the demands on the FDA. "We're going to ask them to do more, and we're not going to give them the funds or personnel to do that," he said. "It seems to me that FDA has so much on their plate that they can't give this the kind of focus it needs." He suggested that the FDA may need some restructuring.
Rose had a specific recommendation: "I propose that FDA create a Center for Biodefense, like CDER [the Center for Drug Evaluation and Research] and CBER [the Center for Biologics Evaluation and Research]. I think having a full-blown center where there's a leader responsible for signing off would be valuable."
Subcommittee hearing agenda and witnesses
Aug 19 CIDRAP News story "HHS sees greater federal role in building biodefense tools"