Mar 1, 2011 (CIDRAP News) – The US Department of Health and Human Services (HHS) yesterday announced that it has awarded $215 million in contracts to two companies to further the development of recombinant technology, a move designed to improve and speed production of pandemic and seasonal flu vaccines.
It awarded $97 million to Novavax, Inc., based in Rockville, Md., to develop its virus-like particle (VLP) vaccine that uses insect cells to express influenza proteins. The HHS awarded a separate contract, for $117.9 million, to VaxInnate, Inc., of Cranbury, N.J., which is developing a recombinant approach that combines influenza and flagellin bacteria proteins to induce an immune response against influenza.
Kathleen Sebelius, HHS secretary, said in a statement yesterday that the 2009 H1N1 pandemic showed that the nation needs better technology to more rapidly produce flu vaccine. The production timeline for current egg-based technology is about 6 months. During the pandemic the vaccine came out too late to blunt the fall wave of infections.
"These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months, which can save more lives during a pandemic as well as during seasonal flu outbreaks," she said.
Yesterday's grant announcement was part of the federal government's plan for producing new countermeasures, which was unveiled in August 2010. The new approach is aimed at supporting flexible, robust, and innovative technologies to boost capacity and produce more quickly a host of vaccines and other treatments that can be used during a pandemic or other health emergency, such as a bioterror attack.
The federal plan also called for steps to improve the Food and Drug Administration (FDA) regulatory process for new countermeasures and advocated for increased efforts to help translate new discoveries into usable biodefense products. The plan was released alongside a report from the President's Council of Advisors on Science and Technology (PCAST) on how to speed up influenza vaccine manufacturing to guard against future pandemics.
The National Institutes of Health (NIH) supported both of the recombinant vaccines during their early development. Yesterday's grants were awarded by the HHS Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response.
The Novavax portion of the grant covers 3 years, which can be extended 2 more years for a contract total of $179.1 million for the advanced clinical and manufacturing development of its recombinant vaccines against seasonal and pandemic flu.
In a press release today, the company said activities included by the base contract will include:
- Three clinical trials using its pandemic influenza VLP vaccine candidate with adjuvants, including Novavax's own proprietary version
- A phase 2 dosing trial and a phase 3 registration trial of its seasonal flu VLP vaccine candidate
- Development of a manufacturing facility plan to produce finished seasonal and pandemic influenza vaccine within 12 weeks and at least 50 million doses within 6 months of an influenza pandemic declaration
Dr Rahul Singhvi, Novavax's president and CEO, said in a statement that the company is pleased to work with BARDA to speed the development of a recombinant flu vaccine and help the US government prepare for influenza pandemics. "This is a unique opportunity for our company to apply the knowledge we have gained over the past 5 years to address a critical public health need," he said.
VaxInnate's contract also covers 3 years, with the possibility of extending the contract for 2 more years for a total of $196 million.
Clinical trials will evaluate the components and combinations of several different pandemic flu vaccines and a seasonal quadrivalent flu vaccine produced using VaxInnate's proprietary technology, the company said today in a press release. It has already completed a series of phase 1/2 trials using VAX 125 and VAX 128, which are prototypes vaccines against seasonal and pandemic flu.
Thomas Hofstaetter, PhD, president and chief executive officer of VaxInnate, said in the statement that the company is gratified to receive the award and is looking forward to working with BARDA to develop the next generation of flu vaccines.
Alan Shaw, PhD, VaxInnate's chief scientific officer and chairman of the board, told CIDRAP News that the BARDA grant will cover a multitude of small and large manufacturing campaigns for various clinical phases of both the pandemic and seasonal flu vaccine candidates. The seasonal flu vaccine that VaxInnate is developing would have two influenza B strains, he said.
Selecting which influenza B strain to recommend for seasonal flu vaccines can be difficult, because circulation of the two distinct lineages—Victoria and Yamagata—is notoriously unpredictable. There isn't much cross-protection among the B strains, a fact that has led producers to consider putting both lineages in the seasonal flu vaccine, though the process could have an effect on manufacturing, supply, and cost.
"Since B strains are difficult to grow, current manufacturing processes only allow one, but that's not a problem for us," he said. "Why guess when you can put both in the vaccine and be confident?"
"The contract is an endorsement of VaxInnate's proprietary technology, which makes it possible to produce hundreds of millions of doses of safe, effective flu vaccine rapidly and at low cost. It also demonstrates the potential of our technology to meet other critical and emerging public health threats in the future," he said.
Feb 28 HHS press release
Mar 1 Novavax press release
Mar 1 VaxInnate press release
Aug 19, 2010, CIDRAP News story "HHS sees greater federal role in building biodefense tools"