FOR IMMEDIATE RELEASE: April 22, 2005
Schumer Warns: Pediatric Vaccine Stockpile Nearly Empty – Millions Of New York Kids’ Health At Risk
Stockpile of Vaccines for Common Sicknesses like Diphtheria, Whooping Cough, Mumps, Measles, and Chicken Pox Dangerously Low Because of Federal Bookkeeping Rule
Schumer: A Stand-off Between Government and Drug Companies Shouldn’t put our Children’s Health at Risk
With news that the Federal government’s stockpile of vaccines for common children’s sicknesses is dwindling to an all time low, with drug makers unwilling to make more to fill the stockpile because of a grudge match over federal bookkeeping rule, today Senator Charles E. Schumer called on the Securities Exchange Commission and the Department of Health and Human Services to come up with an exemption for vaccine makers when it comes to counting revenue. The stockpile, which is supposed to contain over 40 million vaccinations for common childhood sicknesses ranging from Chicken Pox to Diphtheria, has around 13 million doses at the ready, with no vaccines for some of the most common childhood ailments.
“A stand off between government and drug companies shouldn’t endanger our children,” Schumer said. “Doctors should not have to hold off on immunizing kids because they don’t have the tools they need. Research shows that a vaccine delayed is a vaccine denied, and when kids are young we should never take that gamble”
Last summer the CDC asked four companies to make new sales to the stockpile and three said no. The companies can’t treat the money they get as revenue when they sell millions of doses of vaccine to the stockpile – the shots are not considered “sold” until they are delivered when the government calls for them in emergencies. Instead, the vials are held in the manufacturers' warehouses and considered unsold in the eyes of investors and auditors until they are actually used.
The problem lies in a rule that was put forth by the SEC in December 1999 seeking to clear up confusion about revenue recognition because booking phony, theoretical or incomplete sales is the most common way companies make themselves look more profitable than they are. As a result the vaccines aren’t “sold” until they are actually delivered – after they are sold, which wreaks havoc on accounting.
The stockpile currently has 13.2 million doses with a goal of 41 millions doses.
“Without a fix, the stockpile is only going to get smaller and the gaping hole in our public health system, even bigger,” Schumer said.
According to the CDC, of the 8 vaccines they stockpile for 11 diseases, the quantities of what they need versus what they follows:
Vaccine Target Quantities Doses Purchased & Delivered
Diptheria Tetanus, Pertussis (DTaP) 10,000,000 0
Polio (EIPV ) 8,000,000 3,655,000
Hepatitis A (HEPA) 4,000,000 1,000,000
Hepatitis B (HEPB) 6,000,000 2,000,000
Haemophilus Influenza B (Hib) 8,000,000 1,000,000
Measles, Mumps, Rubella (MMR) 4,000,000 4,000,000
Pneumococcal (PCV) 8,000,000 0
Varicella (VAR) 2,000,000 2,000,000
In addition, this January, the CDC approved a vaccine against Neisseria Meningitidis which causes nearly 3000 infections per year in the United States. 10% of those infected die and 20% are permanently disabled. Next month it will be added to the list of shots all American children should get, meaning that it should also be stockpiled. But, with the current situation, it is unlikely that it will happen.
In its near-depleted state, the stockpile could potentially put New York children at risk. Just 3 years ago, the country didn’t have adequate supply of five vaccines that protect against eight diseases, physicians and clinics were required to ration vaccines and change the schedule of routine shots. The halving of last year’s flu vaccine supply also served as a wake up call.
“Last year’s flu vaccine debacle should serve as lesson to the Feds. The entire country was nearly hysterical when the supply was cut in half,” said Schumer. “The reality is there are very few remaining vaccine makers in the US, and we need to make it easier for them to add to the supply, this SEC rule is making it much, much harder.”
If there were to be an outbreak of Whooping Cough or Pertussis, New York children could potentially face a major disaster. Between July 2003 and December 2004 in Westchester, just north of New York City, health officials recorded 151 cases of whooping cough. In a normal year there are only 6 or 8 cases. What started in effect as a single infection made its way into 40 cities and towns.
Statewide the story is worse. New York was the state with the third highest number of Whooping Cough outbreaks in 2003. If there were to be a serious, uncontrollable outbreak of disease, New York could have to turn to the Pediatric Vaccine Stockpile for back up, there might not be any to go around and the outbreak would be impossible to stop.
In an effort to combat this looming and potentially deadly problem, today Senator Schumer called on the SEC to create an exemption for vaccine makers that would allow for companies to “recognize revenue” for sales to the stockpile or work with HHS to quickly come up with another solution..
He also wrote to HHS Secretary Michael Leavitt urging him to work with the SEC to resolve this. Schumer noted that, in the Omnibus spending bill passed by Congress last year, the Secretary was requested to work with the SEC and report back with a solution or a suggestion for a legislative remedy by March 21st of this year. However, the report has yet to be issued, and although there are reports that at least one company notified HHS of this problem over two years ago, action has yet to be taken to ensure adequate stockpiles.
"Our history with vaccine shortages has seriously undermined the public's confidence in immunization programs – a confidence that public health officials have worked long and hard to earn. For every day the government stands idle on this issue, we risk losing not inches or feet, but miles of the ground we have gained in recent years,"
The pediatric vaccine stockpile was created in 1983 and is supposed to hold enough vaccine to supply the nation for six months. The 11 diseases that it holds vaccines for are Diphtheria, Haemophilus influenzae type B (Hib) Hepatitis A, Hepatitis B, Measles, Mumps, Whooping Cough, Pneumococcal disease, Polio, Rubella (German measles) Tetanus (lockjaw) and Chicken Pox.
The stockpile has been dipped into nine times for either a vaccine supply disruption or disease outbreak. The first withdrawal of vaccine from the pediatric vaccine stockpile was made in 1984. The most recent instance of a withdrawal of vaccine from the stockpile was in August and September 2003 when CDC withdrew 46,000 doses of MMR vaccine to be used to control a measles outbreak in the Marshall Islands. The most recent instance of a withdrawal of vaccine from the stockpile before that was a withdrawal of 700,000 doses of MMR vaccine from the stockpile in January 2002 to address a manufacturing disruption at Merck.
In New York City, only 80% of children ages 19-35 months receive an adequate schedule of vaccines, though only 69% receive the full coverage recommended by the CDC. If there were to be an outbreak of disease, a supply disruption and no Pediatric Vaccine Stockpile, those numbers could drop and New York City could be facing an epidemic. In fact the last major measles epidemic was in the early 1990s.
The nation last faced a measles outbreak in the 1990s. Over 55,000 were infected and 166 died. The outbreak began in Houston, which has a low immunization rate. That’s why these gaping holes in the nation’s public health system are so dangerous. Disease spreads very quickly, which is why every child needs to be immunized.
By 18 months of age, it is recommended that each of the 11,000 babies born each day in the United States receive up to 20 doses of vaccine to protect against 11 diseases.
To date, 49 state immunization programs reported rationing one or more vaccines. Shortages have also prompted the majority of states to waive or change immunization requirements for school and day care programs so that children who had received fewer than the mandatory immunizations could enroll. States reported that vaccine shortages and missed make-up vaccinations may reduce coverage and increase the potential for disease to spread; however, data are not currently available to measure these effects.
Today, Schumer was joined by Dr. Arthur Fierman, MD, Associate Professor of Pediatrics of the NYU School of Medicine and Co-Chair of the NYC Coalition of Immunization Initiatives. Standing with them were Stephanie Zinn, her 7 month old son, Cody and Anel Soriano and her 3 year old daughter “Muffin” Massanet.