monthly-stats-april-2019.pdf

Data & Statistics The United States has the safest, most effective vaccine supply in history. In the majority of cases, vaccines cause no side effects, however they can occur, as with any medication —but most are mild. Very rarely, people experience more serious side effects, like allergic reactions. In those instances, the National Vaccine Injury Compensation Program (VICP) allows individuals to file a petition for compensation. What does it mean to be awarded compensation? Being awarded compensation for a petition does not necessarily mean that the vaccine caused the alleged injury. In fact: • Approximately 70 percent of all compensation awarded by the VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of t he evidence, that the alleged vaccine(s) caused the alleged injury. • Attorneys are eligible for reasonable attorneys’ fees, whether or not the petitioner is awarded compensation by the Court, if certain minimal requirements are met. In those circumstances, attorneys are paid by the VICP directly. By statute, attorneys may not charge any other fee, including a contingency fee, for his or her services in representing a petitioner in the VICP. What reasons might a petition result in a negotiated settlement? • Consideration of prior U.S. Court of Federal Claims decisions, both parties decide to minimize risk of loss through settlement • A desire to minimize the time and expense of litigating a case • The desire to resolve a petition quickly How many petition s have been awarded compensation? According to the CDC, from 2006 to 201 7 over 3.4 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period , 6, 253 petition s were adjudicated by the Court , and of those 4,291 were compensated. This means for every 1 million doses of vaccine that were distributed, 1 individual was compensated. Since 1988, over 20, 522 petition s have been filed with the VICP. Over that 30-year time period, 1 7,772 petition s have been adjudicated, with 6, 465 of th ose determined to be compensable, while 11,307 were dismissed. Total compensation paid over the life of the program is approximately $ 4.1 billion. This information reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This information is not legal advice and does not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims , which is responsible for resolving petitions for compensation under the VICP.

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 2 VICP Adjudication Categories , by Alleged Vaccine For Petition s Filed Since the Inclusion of Influenza as an Eligible Vaccine for Filings 01/0 1/2006 through 12/31/2017 Name of Vaccine Listed First in a Petition (other vaccines may be alleged or basis for compensation) Number of Doses Distributed in the U.S., 01/01/2006 through 12/31/2017 (Source: CDC) Compensable Concession Compensable Court Decision Compensable Settlement Compensable Total Dismissed/Non - Compensable Total Grand Total DT 794,777 1 0 5 6 4 10 DTaP 101,073,594 19 22 104 145 116 261 DTaP-Hep B-IPV 68,764,777 5 7 28 40 53 93 DTaP-HIB 1,135,474 0 1 2 3 2 5 DTaP-IPV 24,237,580 0 0 3 3 3 6 DTap-IPV-HIB 62,397,611 3 4 9 16 29 45 DTP 0 1 1 3 5 2 7 DTP-HIB 0 1 0 2 3 1 4 Hep A-Hep B 15,826,685 2 0 15 17 4 21 Hep B-HIB 4,787,457 1 1 2 4 1 5 Hepatitis A (Hep A) 176,194,118 8 7 42 57 32 89 Hepatitis B (Hep B) 185,428,393 9 11 64 84 76 160 HIB 119,947,400 3 1 8 12 10 22 HPV 111,677,552 14 14 106 134 175 309 Influenza 1,518,400,000 627 147 2,155 2,929 491 3,420 IPV 72,962,512 0 0 4 4 3 7 Measles 135,660 0 0 1 1 0 1 Meningococcal 94,113,218 1 5 39 45 10 55

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 3 Name of Vaccine Listed First in a Petition (other vaccines may be alleged or basis for compensation) Number of Doses Distributed in the U.S., 01/01/2006 through 12/31/2017 (Source: CDC) Compensable Concession Compensable Court Decision Compensable Settlement Compensable Total Dismissed/Non - Compensable Total Grand Total MMR 101,501,714 23 14 83 120 124 244 MMR-Varicella 24,798,297 9 0 13 22 15 37 Mumps 110,749 0 0 0 0 0 0 Nonqualified 0 0 0 3 3 36 39 OPV 0 1 0 0 1 5 6 Pneumococcal Conjugate 228,588,846 19 3 29 51 33 84 Rotavirus 107,678,219 17 4 20 41 13 54 Rubella 422,548 0 1 1 2 0 2 Td 65,170,306 10 7 61 78 25 103 Tdap 248,258,803 88 17 257 362 72 434 Tetanus 3,836,052 10 1 41 52 20 72 Unspecified 0 1 1 4 6 589 595 Varicella 116,063,014 8 7 30 45 18 63 Grand Total 3,454,269,356 881 276 3,134 4,291 1,962 6,253 Notes on the Adjudication Categories Table The date range of 01/01/2006 through 12/31/2017 was selected to reflect petitions filed since the inclusion of influenza vaccine in July 2005. Influenza vaccine now is named in the majority of all VICP petitions. In addition to the first vaccine alleged by a petitioner, which is the vaccine listed in this table, a VICP petition may allege other vaccines, which may form the basis of compensation. Vaccine doses are self -reported distribution data provided by US -licensed vaccine manufacturers. The data provide an estimate of the annual national distribution and do not represent vaccine administration. In order to maintain confidentiality of an indiv idual manufacturer or brand, the data are presented in an aggregate format by vaccine type. Flu doses are derived from CDC’s FluFinder tracking system, which includes data provided to CDC by US -licensed influenza vaccine manufacturers as well as their firs t line distributors. “Unspecified” means insufficient information was submitted to make an initial determination. The conceded “unspecified” petition was for multiple unidentified vaccines that caused abscess formation at the vaccination site(s), and the “ unspecified” settlements were for multiple vaccines later identified in the Special Masters’ decisions

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 4 Definitions Compensable – The injured person who filed a petition was paid money by the VICP. Compensation can be achieved through a concession by the U .S. Department of Health and Human Services (HHS), a decision on the merits of the petition by a special master or a judge of the U.S. Court of Federal Claims (Court), or a settlement between the parties. • Concession : HHS concludes that a petition should be compensated based on a thorough review and analysis of the evidence, including medical records and the scientific and medical literature. The HHS review concludes that the petitioner is entitled to compensation, including a determination either that it is more likely than not that the vaccine caused the injury or the evidence supports fulfillment of the criteria of the Vaccine Injury Table. The Court also determines that the petition should be compensated. • Court Decision : A special master or the court, within the United States Court of Federal Claims , issues a legal decision after weighing the evidence presented by both sides. HHS abides by the ultimate Court decision even if it maintains its position that the petitioner was not entitled to compensation (e.g., that the injury was not caused by the vaccine). For injury petitions, compensable court decisions are based in part on one of the following determinations by the court: 1. The evidence is legally sufficient to show that the vaccine more likely than not caused (or significantly aggravated) the injury; or 2. The injury is listed on, and meets all of the requirements of, the Vaccine Injury Table, and HHS has not proven that a factor unrelated to the vaccine more likely than not caused or significantly aggravated the injury. An injury listed on the Table and meeting all Table requirements is given the legal presumption of causation. It should be noted that conditions are placed on the Table for both scientific and policy reasons . • Settlement: The petition is resolved via a negotiated settlement between the parties. This settlement is not an admission by the United States or the Secretary of Health and Human Services that the vaccine caused the petitioner’s alleged injuries, and, in settled cases, the Court does not determine that the vaccine caused the injury. A settlement therefore cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury. Petition s may be resolved by settlement for many reasons, including consideration of prior court decisions; a recognition by both parties that there is a risk of loss in proceeding to a decision by the Court making the certainty of settlement more desirable; a desire by both par ties to minimize the time and ex pense associated with litigating a case to conclusion; and a desire by both parties to resolve a case quickly and efficiently . • Non -compensable/Dismissed : The injured person who filed a petition was ultimately not paid money. Non-compensable Court decisions include the following: 1. The Court determines that the person who filed the petition did not demonstrate that the injury was caused (or significantly aggravated) by a covered vaccine or meet the requirements of the Table (for injuries listed on the Table). 2. The petition was dismissed for not meeting other statutory requirements (such as not meeting the filing deadline, not receiving a covered vaccine, and not meeting the statute’s severity requirement). 3. The injured person voluntarily withdrew his or her petit ion.

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 5 Petitions Filed, Compensated and Dismissed, by Alleged Vaccine , Since the Beginning of VICP, 10/01/1988 through 4/01/ 2019 1 Nonqualified petitions are those filed for vaccines not covered under the VICP. 2 Unspecified petitions are those submitted with insufficient information to make a determination. Vaccines Filed Injury Filed Death Filed Grand Total Compensated Dismissed DTaP-IPV 11 0 11 3 3 DT 69 9 78 26 52 DTP 3,286 696 3,982 1,273 2,709 DTP-HIB 20 8 28 7 21 DTaP 454 82 536 225 252 DTaP-Hep B-IPV 85 37 122 41 52 DTaP-HIB 11 1 12 7 4 DTaP-IPV-HIB 43 21 64 14 29 Td 206 3 209 123 75 Tdap 690 6 696 352 72 Tetanus 137 2 139 75 47 Hepatitis A (Hep A) 104 7 111 55 31 Hepatitis B (Hep B) 694 60 754 274 419 Hep A-Hep B 32 0 32 16 5 Hep B-HIB 8 0 8 5 3 HIB 44 3 47 17 20 HPV 388 15 403 130 165 Influenza 5,023 167 5,190 2,869 466 IPV 268 14 282 8 269 OPV 282 28 310 158 152 Measles 143 19 162 55 107 Meningococcal 73 2 75 43 8 MMR 974 61 1,035 402 584 MMR-Varicella 50 2 52 20 13 MR 15 0 15 6 9 Mumps 10 0 10 1 9 Pertussis 4 3 7 2 5 Pneumococcal Conjugate 187 15 202 53 50 Rotavirus 94 5 99 59 23 Rubella 190 4 194 71 123 Varicella 103 9 112 63 30 Nonqualified1 101 9 110 3 101 Unspecified2 5,426 9 5,435 9 5,399 Grand Total 19,225 1,297 20,522 6,465 11,307

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 6 Petitions Filed Fiscal Year Total FY 1988 24 FY 1989 148 FY 1990 1,492 FY 1991 2,718 FY 1992 189 FY 1993 140 FY 1994 107 FY 1995 180 FY 1996 84 FY 1997 104 FY 1998 120 FY 1999 411 FY 2000 164 FY 2001 215 FY 2002 958 FY 2003 2,592 FY 2004 1,214 FY 2005 735 FY 2006 325 FY 2007 410 FY 2008 417 FY 2009 397 FY 2010 448 FY 2011 386 FY 2012 401 FY 2013 504 FY 2014 633 FY 2015 803 FY 2016 1,120 FY 2017 1,243 FY 2018 1,238 FY 2019 602 Total 20,522

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 7 Adjudications Generally, petitions are not adjudicated in the same fiscal year as filed. On average, it takes 2 to 3 years to adjudicate a petition after it is fil ed. Fiscal Year Compensable Dismissed Total FY 1989 9 12 21 FY 1990 100 33 133 FY 1991 141 447 588 FY 1992 166 487 653 FY 1993 125 588 713 FY 1994 162 446 608 FY 1995 160 575 735 FY 1996 162 408 570 FY 1997 189 198 387 FY 1998 144 181 325 FY 1999 98 139 237 FY 2000 125 104 229 FY 2001 86 88 174 FY 2002 104 104 208 FY 2003 56 100 156 FY 2004 62 247 309 FY 2005 60 229 289 FY 2006 69 193 262 FY 2007 82 136 218 FY 2008 147 151 298 FY 2009 134 257 391 FY 2010 180 329 509 FY 2011 266 1,740 2,006 FY 2012 265 2,533 2,798 FY 2013 369 649 1,018 FY 2014 371 192 563 FY 2015 517 137 654 FY 2016 697 179 876 FY 2017 696 185 881 FY 2018 538 189 727 FY 2019 185 51 236 Total 6,465 11,307 17,772

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 8 Awards Paid Fiscal Year Number of Compensated Awards Petitioners' Award Amount Attorneys' Fees/Costs Payments Number of Payments to Attorneys (Dismissed Cases) Attorneys' Fees/Costs Payments (Dismissed Cases) Number of Payments to Interim Attorneys' Interim Attorneys' Fees/Costs Payments Total Outlays FY 1989 6 $1,317,654.78 $54,107.14 0 $0.00 0 $0.00 $1,371,761.92 FY 1990 88 $53,252,510.46 $1,379,005.79 4 $57,699.48 0 $0.00 $54,689,215.73 FY 1991 114 $95,980,493.16 $2,364,758.91 30 $496,809.21 0 $0.00 $98,842,061.28 FY 1992 130 $94,538,071.30 $3,001,927.97 118 $1,212,677.14 0 $0.00 $98,752,676.41 FY 1993 162 $119,693,267.87 $3,262,453.06 272 $2,447,273.05 0 $0.00 $125,402,993.98 FY 1994 158 $98,151,900.08 $3,571,179.67 335 $3,166,527.38 0 $0.00 $104,889,607.13 FY 1995 169 $104,085,265.72 $3,652,770.57 221 $2,276,136.32 0 $0.00 $110,014,172.61 FY 1996 163 $100,425,325.22 $3,096,231.96 216 $2,364,122.71 0 $0.00 $105,885,679.89 FY 1997 179 $113,620,171.68 $3,898,284.77 142 $1,879,418.14 0 $0.00 $119,397,874.59 FY 1998 165 $127,546,009.19 $4,002,278.55 121 $1,936,065.50 0 $0.00 $133,484,353.24 FY 1999 96 $95,917,680.51 $2,799,910.85 117 $2,306,957.40 0 $0.00 $101,024,548.76 FY 2000 136 $125,945,195.64 $4,112,369.02 80 $1,724,451.08 0 $0.00 $131,782,015.74 FY 2001 97 $105,878,632.57 $3,373,865.88 57 $2,066,224.67 0 $0.00 $111,318,723.12 FY 2002 80 $59,799,604.39 $2,653,598.89 50 $656,244.79 0 $0.00 $63,109,448.07 FY 2003 65 $82,816,240.07 $3,147,755.12 69 $1,545,654.87 0 $0.00 $87,509,650.06 FY 2004 57 $61,933,764.20 $3,079,328.55 69 $1,198,615.96 0 $0.00 $66,211,708.71 FY 2005 64 $55,065,797.01 $2,694,664.03 71 $1,790,587.29 0 $0.00 $59,551,048.33 FY 2006 68 $48,746,162.74 $2,441,199.02 54 $1,353,632.61 0 $0.00 $52,540,994.37 FY 2007 82 $91,449,433.89 $4,034,154.37 61 $1,692,020.25 0 $0.00 $97,175,608.51 FY 2008 141 $75,716,552.06 $5,191,770.83 74 $2,531,394.20 2 $117,265.31 $83,556,982.40 FY 2009 131 $74,142,490.58 $5,404,711.98 36 $1,557,139.53 28 $4,241,362.55 $85,345,704.64 FY 2010 173 $179,387,341.30 $5,961,744.40 59 $1,933,550.09 22 $1,978,803.88 $189,261,439.67 FY 2011 251 $216,319,428.47 $9,572,042.87 403 $5,589,417.19 28 $2,001,770.91 $233,482,659.44 FY 2012 249 $163,491,998.82 $9,241,427.33 1,020 $8,649,676.56 37 $5,420,257.99 $186,803,360.70 FY 2013 375 $254,666,326.70 $13,543,099.70 704 $7,012,615.42 50 $1,454,851.74 $276,676,893.56 FY 2014 365 $202,084,196.12 $12,161,422.64 508 $6,824,566.68 38 $2,493,460.73 $223,563,646.17 FY 2015 508 $204,137,880.22 $14,445,776.29 118 $3,546,785.14 50 $3,089,497.68 $225,219,939.33 FY 2016 689 $230,140,251.20 $16,225,881.12 99 $2,741,830.10 59 $3,502,709.91 $252,610,672.33

National Vaccine Injury Compensation Program Monthly Statistics Report Updated 4/01/2019 Page 9 Fiscal Year Number of Compensated Awards Petitioners' Award Amount Attorneys' Fees/Costs Payments Number of Payments to Attorneys (Dismissed Cases) Attorneys' Fees/Costs Payments (Dismissed Cases) Number of Payments to Interim Attorneys' Interim Attorneys' Fees/Costs Payments Total Outlays FY 2017 706 $252,245,932.78 $22,045,785.00 131 $4,441,724.32 52 $3,363,464.24 $282,096,906.34 FY 2018 522 $199,658,492.49 $16,658,440.14 111 $5,091,269.45 58 $5,220,096.78 $226,628,298.86 FY 2019 276 $119,344,851.56 $8,091,796.70 41 $1,985,117.67 30 $2,064,009.07 $131,485,775.00 Total 6,465 $3,807,498,922.78 $195,163,743.12 5,391 $82,076,204.20 454 $34,947,550.79 $4,119,686,42.89 NOTE: Some previous fiscal year data has been updated as a result of the receipt and entry of data from documents issued by the Court and system updates which included petitioners costs reimbursements in outlay totals, "Compensated" are petitions that have been paid as a result of a settlement between parties or a decision made by the U.S. Court of Federal Claims (Court). The # of awards is the number of petitioner awards paid, including the attorneys' fees/costs payments, if made during a fiscal year. However, petitioners' awards and attorneys' fees/costs are not necessarily paid in the same fiscal year as when the petitions/ petitions are determined compensable. "Dismissed" includes the # of payments to attorneys and the total amount of payments for attorneys' fees/costs per fiscal year. The VICP will pay attorneys' fees/costs related to the petition , whether or not the petition/ petition is awarded compensation by the Court, if certain minimal requirements are met. "Total Outlays" are the total amount of funds expended for compensation and attorneys' fees/costs from the Vaccine Injury Compensation Trust Fund by fiscal year. Since influenza vaccines (vaccines administered to large numbers of adults each year) were added to the VICP in 2005, many ad ult petition s related to that vaccine have been filed, thus changing the proportion of children to adults receiving compensation.

https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/monthly-stats-april-2019.pdf