We have known about the H1N1 (Swine Flu), risk for many months now. We knew that last spring's outbreak would turn into a more virulent strain by this fall. That is all basic science. Concerned for our citizens, the government recognized the need to produce substantial volumes of vaccine. We have spent more than $2.2B for H1N1 Swine flu. To date, only a minor amount of this vaccine has been delivered, but concern seems muted. Despite new vaccine manufacturing technologies, we persist in using outdated methods and to spend huge sums of money in a wasteful manner. Why?
Here is a bit of background....
- Clinton (HRC) pushed the Vaccines for Children policy in 1993, which caused most manufactures to exit the industry
- In early part of Bush administration R&D in vaccine research was dramatically increased
- 2004 season: a combination of fewer manufactures and accusations of Bush incompetence resulted in ~40M dose short fall vs. plan of 100M doses for season flu
- Fear of Bird flu and other emerging pandemics led Democrats to accuse Bush administration of multiple failings. Budgets for pandemic research and preparedness were increased substantially (more than $4B over 2005-2007 time frame)
- Additional $1.5B was authorized in Spring of 2009 to produce H1N1 vaccine. Total spend for H1N1 Vaccine of approximately $2.2B
- By Fall of 2009, only 11.3M doses of a planned 250M doses have been delivered. HHS claims there have been minor "glitches", DHS claims all is per plan
- Critical study shows vaccine will arrive too late for impact on H1N1
- 1,000 3,900 people have died so far in US (if you recall 1,494 died in Katrina apparently because of Bush's failing and global warming, which is also Bush's fault)
- Main Stream Media is mum on whole issue, Fox (non) News is not
My frustration comes from a few issues. The historic process of making vaccines in egg shells is arcane and subject to numerous production risks that can result in last minute issues like contamination (cause of 40M dose shortage in 2004). Liability clauses discourage drug manufactures from manufacturing vaccine, and Government is unwilling to wave terms. Companies like Novavax (www.novavax.com) have had a novel technique, using virus like particles to make large volumes of vaccine, for many years, but government continues to buy from companies using old egg technique. Per the time line below, Democrats have put huge amount of effort and money into realigning national efforts for pandemic response (and ridicule of the past administration for its failures) but seem to deliver worse results.
So, we are spending dramatically more money. We have all the best minds focused on the subject. Every resources of government is focused on success. Obama has every resource he has requested. We have been spending the last 4 years realigning efforts for pandemic. And, we are 210M doses short of plan for H1N1. When the vaccine does become available, the pandemic will likely have run its course killing more people than died in the (supposed) last government lead disaster (Katrina). Is this smart government?
Frankly, had government instead focused less than a $1 billion on new production techniques like those of innovative companies (Novavax, etc), we would have all the vaccine we would ever need. Where are the hearings? Where is the outrage? Where is our money? Is this how stimulus is being spent? Does anyone in Congress actually think about a problem, look at the fundamentals, and perhaps question why we are still building vaccine the way we did in 1940? Great innovation guys, where are our coffins?
Timeline
1993
HRC (Clinton) implements Vaccines for Children program gutting profitability in the vaccine industry and imposing government control over a large share of revenue. Major players exit industry in response.
2001-2004
Bush administration raises vaccine funding from $39 million in 2001 to a proposed budget of $283 million in fiscal year 2005. The National Institutes of Health has increased its spending on new ways to make vaccines to $60 million from $20 million. (NY Times)
2004
January:Senators Bayh, Landrieu and Durbin introduced the Flu Protection Act (S. 2038) to strengthen the nation’s vaccine supply and establish a plan to prevent, prepare for, and respond to an influenza pandemic.
October:Vaccine production for 2004 season falls short ~40M of a planned 100M doses. Bush was accused of incompetence and insensitivity. The 40M dose shortage was associated with a contaminant found late in the manufacturing process. Senator Kennedy requested from Acting Commissioner of Food and Drugs Lester Crawford a complete record of all contact between FDA and Chiron Corporation, a major supplier of influenza vaccine to the United States. While Chiron had announced problems with vaccine production back in August 2004, FDA claimed to be surprised by the early October announcement that Chiron’s Liverpool facility had lost its license to produce vaccine. Kennedy expressed the great importance of a stable, effective vaccine supply to protect Americans from seasonal flu, which is also necessary to respond to a pandemic influenza outbreak.
2005
March 2005: Senator Obama successfully amended the Foreign Relations Committee Authorization Act to authorize $25 million for international efforts to combat avian influenza and called on then-President Bush to create an inter-agency task force composed of representatives of the Department of State, Department of Health and Human Services, Department of Agriculture, and other appropriate agencies.
April: then-Senator Obama introduced the AVIAN Act (S. 969), the first comprehensive bill addressing the threat of pandemic influenza.
May: Senate Democrats secured $58 million in the Supplemental Appropriations bill (P.L. 109-13)to purchase more antiviral medication for the Strategic National Stockpile to better prepare for pandemic influenza. This law also directed $25 million to USAID for programs to control the global spread of the avian flu.
August:1,464 people die in Hurricane Katrina
September:Senator Reid took to the Senate floor urging immediate action to prepare for the threat of pandemic influenza and expressing the importance of immediately committing the resources necessary to protect Americans. Senator Reid stated that the nation could not wait any longer for the Bush Administration to finalize its pandemic influenza preparedness plan and announced that Democrats would offer a pandemic preparedness amendment to the Department of Defense Appropriations bill. Senate Democrats, led by Senators Harkin, Obama, Reid, Durbin, Bayh, and Dodd, successfully amended the Fiscal Year (FY) 2006 defense and emergency supplemental appropriations bill (P.L. 109-141) $3.9 billion to the Centers for Disease Control and Prevention to fund pandemic flu preparedness.
October:the Senate approved an amendment by Senator Harkin to the Labor-HHS-Education appropriations bill adding $8 billion to prepare for and protect against the threat of an avian flu pandemic.
November: President Bush released a final pandemic influenza preparedness plan and requested $7.1 billion in emergency supplemental funding for pandemic flu preparedness, almost a billion dollars less than what Senate Democrats had successfully included in the Labor-HHS-Education appropriations bill.
December: the Republican-controlled Congress approved only $3.8 billion to prepare for a flu pandemic in the emergency supplemental appropriations bill (P.L. 109-148) – less than half of the $8 billion the Senate had passed through the Harkin amendment.
2006
February:Democrats fought to include $2.3 billion in additional funding for HHS in a second emergency supplemental appropriations bill passed during FY2006 (P.L. 109-234). 32 Senate Democrats sent a letter to President Bush, calling on him to make pandemic flu preparedness a priority in his Fiscal Year 2007 budget. President Bush released his budget proposal for Fiscal Year 2007, including a $2.3 billion allowance for pandemic influenza activities. The President did not include the $2.3 billion in pandemic flu funding in his emergency supplemental budget request to Congress. Fortunately, during the Appropriations Committee markup of the supplemental in early April, an amendment offered by Senator Harkin to add $2.3 billion in pandemic flu funding was approved by voice vote, and the funding was included in the version of the supplemental signed into law on June 15, 2006 (P.L. 109-234).
May: Senator Kennedy released a report entitled, “Too Little Too Late: The Bush Administration’s Record of Failure in Preparing for Pandemic Flu.” The report detailed failures of the Bush Administration and Republican-led Congress to adequately prepare the United States for pandemic influenza, due to limited appropriations, lack of coordination among government entities, and an overly narrow focus on only a few of the actions necessary to prepare the nation for pandemic influenza.
2007
May: President Bush vetoed legislation passed by the Democratic-led Congress which would have provided $625 million for pandemic flu preparedness at HHS (H.R. 1591).
November: President Bush vetoed the FY2008 Labor, Health and Human Services, and Education Appropriations bill (H.R. 3043). This legislation would have provided $870 million to prepare for and respond to an influenza pandemic, including funds for vaccines, antiviral medications, medical supplies, diagnostics and surveillance tools. In order to pass a bill the President would sign, pandemic flu funding was reduced to $302 million in P.L. 110-161.
December: Senator Clinton introduced the Influenza Vaccine Security Act (S. 2456) to improve and secure our nation’s supply of influenza vaccine, improve vaccine distribution, and improve stockpiling of supplies to prevent and treat pandemic influenza.
2009
January: the Senate Appropriations Committee approved the American Recovery and Reinvestment Act, which included $870 million for pandemic flu preparedness activities. Unfortunately, this funding was removed as a condition for final passage and, therefore, was not included in the final version of the legislation signed into law by President Obama (P.L. 111-5).
Spring:Major outbreak of H1N1 Swine flu suggests pandemic will emerge, stronger in Fall 2009
March: the Senate approved the Fiscal Year 2009 Omnibus Appropriations bill. Led by Democrats, this legislation (P.L. 111-8) included $818 million for pandemic flu preparedness.
April:President Obama requested $1.5 billion in emergency appropriations to respond to the H1N1 influenza virus, and Senate Democrats, including Majority Leader Reid and Labor-HHS-Education Appropriations Subcommittee Chairman Harkin, indicated the Senate was poised to comply with the President’s request.
May: President Obama’s Fiscal Year 2010 Budget Request included $584 million for pandemic flu preparedness. This funding is in addition to the $1.5 billion requested in April as part of the emergency supplemental appropriations. The Senate Appropriations Committee approved the Fiscal Year 2009 Supplemental Appropriationsbill, including $1.5 billion to prepare for and respond to a global disease pandemic, including the H1N1 influenza virus.
Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: May 22, 2009
Manufacturer
Bulk Vaccine Antigen
Oil-In-Water Bulk Adjuvant
Novartis
$150 million
$139 million
GlaxoSmithKline
$ 38 million
$144 million
Sanofi Pasteur
$191 million
CSL Biotherapies
$180 million
MedImmune
$ 90 million
Total
$649 million
$283 million
Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009
Manufacturer
Bulk Vaccine Antigen
Bulk Virus Concentrate/FFF
Oil-In-Water Bulk Adjuvant
Sanofi Pasteur
$61,425,000
0
0
GSK
$0
0
$71,400,000
Novartis
$346,334,450
0
$343,810,470
CSL
$0
0
0
MedImmune
$0
$61,008,000
0
Total
$407,759,450
$61,008,000
$415,210,470
September: With vaccine shortage becoming apparent, Government releases study showing less vaccine is required than orginally expected. This changes dosing requirment from 2 shots to 1 shot. Essentially doubling the expected capacity and eliminating major forecasted shortfall.HHS orders an additional 56 million doses of vaccine: September 21, 2009
Manufacturer
Total Cost
MedImmune
$295,660,000
Sanofi Pasteur
$143,483,025
Total
$438,143,025
October: CDC Defends Reliance on "Antiquated" H1N1 Vaccine Production Despite Shortage. Government's original modified order of 251M doses, expected to receive 40M by this point actually has yield only 11.3 M doses. 1000 have died and 20K hospitalized so far due to H1N1 (and presumably lack of vaccine).
Study shows vaccine will be too late to have impact on H1N1
Lieberman holds hearing on Vaccine shortage, but only Fox News reports MSM ignores (WH Embargo?)
> 1000 people in US have died due to H1N1
