The Swine Flu Affair Decision-Making on a Slippery Disease (1978) / Chapter Skim
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Appendix C: Detailed Chronology
Appendix C: Detailed Chronology
Pages 104-125
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From page 104... ...
Theodore Cooper; Dull states that liability problems may drive vaccine manufacturers out of business, and recommends that the Secretary support legislation to indemnify the manufac turers or to compensate all victims of vaccine mid-January – large number of cases of respiratory disease are reported among Army re cruits at Fort Dix, New Jersey; Walter Reed Army Laboratory identifies adenovirus as cause of earlier outbreak of respiratory disease at Fort Meade, Md. 22 – Donald Carmody, a staff officer for Cooper in the Public Health Service, writes memo to his superior in the Office of Policy Development and Planning, emphasiz ing the problems in the Dull proposal and suggesting that it be sent up to Cooper without recommendation 27 – Colonel Joseph Bartley.
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From page 105... ...
Charles Cockburn of the World Health Organization (Geneva) of swine virus finding; Dowdle informs Kilbourne 17 – Kilbourne receives samples of the virus mailed from New Jersey; his lab begins to develop a fast-growing "recombinant" for use in vaccine 18 – CDC notifies state health officials of swine flu finding 19 – CDC calls press conference; Dull announces swine virus has been discovered at Fort Dix; makes no reference to the 1918 pandemic in his prepared remarks, but does in response to questions from reporters 20 – first media coverage of swine flu focuses on CDC's announcement of the previous day; coverage links the Fort Dix virus to the 1918 pandemic 20 – BoB hosts open workshop in Bethesda, Maryland, with representatives from the Armed Forces Epidemiological Board (AFEB)
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From page 106... ...
, Sencer meets Dowdle, Dull, Foege, and other staff from CDC's Epidemiology Bureau for an informal discussion regarding options; stockpiling of vaccine is discussed at some length 10 – at an open meeting in Atlanta, CDC briefs the ACIP on the results of its preliminary investigations; ACIP members concur in need for major action, support production of vaccine and formulation of a plan to administer; stockpiling option is briefly mentioned; afterwards, Sencer telephones Cooper in Washington and summarizes meeting 12 – AFEB holds meeting at Walter Reed Army Institute of Research to determine vac cine formulation for the military; Board recommends that swine component be in corporated into trivalent vaccine, along with A Victoria and B Hong Kong 13 – Sencer finishes action-memorandum which he had prepared in the previous two days; memo calls for mass immunization campaign aimed at vaccinating all Ameri cans, and recommends that Administration ask Congress for $134 million appro priation; proposes plan with Federal Government buying and testing the vaccine and setting dosage levels, the states distributing the vaccine, and public health agen cies and private physicians administering it 13 – Sencer asks Dr. Donald Millar, director of CDC's Bureau of State Services, to form a Program Implementation Group 13 – Cooper leaves for eight-day trip to Egypt, with Acting Assistant Secretary James Dickson tending to affairs in his absence 15 – At Secretary's morning staff meeting, Dickson.
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From page 107... ...
Reuel Stallones, Sencer, and Meyer; following meeting, President goes before television cameras to announce that he is recommending a mass vaccination program for all Americans and urges that Congress immediately pass a special $135 million appropriation; af terwards, Mathews and Cooper conduct press conference 24 – CDC initiates work on a "PERT" chart, plotting out steps and relationships in the swine flu program 25 – Mathews sends memo to Cooper suggesting that he chair a coordinating Task Force for the "National Influenza Immunization Program" 25 – BoB hosts open workshop in Bethesda; conferees include HEW officials, scientists from CDC, NIAID, Department of Defense (DoD) , and Veterans Administration (VA)
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From page 108... ...
Ken nedy, chairman) holds hearings on swine flu program; Kennedy presses hard on lagging immunization rates for childhood diseases 2 – CDC conducts large meeting in Atlanta with state health officers and representa tives of private medicine to explain proposed swine flu program; Sencer outlines desired state participation; state officials question CDC hard on funding of local programs; Goldfield challenges wisdom of decision to mass immunize; TV Evening News broadcasts his dissent 2 – House Appropriations Committee reports out special appropriations bill (HJ Res 890)
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From page 109... ...
holds first meeting with Washington coun sel to the drug manufacturers; antitrust and liability problems are discussed, particu larly the Federal Government's assumption of the duty to warn 15 – President signs the special appropriations bill into law (PL 94-266) 15 – NIAID hosts workshop in Bethesda to discuss plans for flu vaccine trials 20 – Cavanaugh chairs another meeting at the White House on the progress of immuni zation plans 21 – press conference is held at HEW to announce the beginning of vaccine field trials; 3000 volunteers are to be involved 27 – CDC completes its PERT chart 30 – HEW Press Analysis tracks news coverage from 111 newspapers in 60 cities; shows that editorial response to the swine flu program in April has been 88% favorable May 1976 1 – other manufacturers of swine flu vaccine (Merrell, Parke-Davis, Wyeth)
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From page 110... ...
Russell Alexander suggests that the final decision to vaccinate might be postponed pending further swine flu outbreak; con sensus still opposes stockpiling, however; committee also approves risk-benefit statement for use in Vaccinee Consent Form 14 – information packet mailed to Immunization Project directors in states 15 – CDC asks state health officials to contribute to development of informed consent procedures 17 – in an address delivered at the College of Pharmacy at the University of Toledo, Sa bin suggests that the vaccine ought to be stockpiled pending a new outbreak 18 – CDC signs a contract for the purchase of 1400-2000 jet injectors 19 – first technical meeting at BoB with manufacturers regarding production of vaccine 21,24– meeting held between Washington counsel to the manufacturers and OGC nego tiators, including General Counsel William Howard Taft IV; William P Rogers, representing Merrell, informs OGC that Merrell will not participate unless it is as sured of complete indemnity for those functions assumed by the Government 24 – Mathews delegates authority to CDC to award flu grants to states 25 – OGC memo to Mathews through Cooper traces difficulty with manufacturers over liability issue; sets forth contract clause representing maximum Government con cession within existing law; mentions Merrell's refusal to proceed without indemni fication 26 – conference of State and Territorial Health Epidemiologists is held at Cherry Hill, N.J.; immunization program is discussed 27 – CDC issues requests to the four manufacturers for "Vaccine Production Proposals," to be submitted by June 15; cover letter sets goal of initial deliveries in July, with all 40 million bivalent doses delivered by September 1, 120 of the 160 million mo novalent doses delivered by September 1, and the rest of the monovalent by No vember 15 27 – HEW begins to prepare legislation authorizing indemnification of the manufacturers against all claims other than those based on negligence 27 – CDC representatives (Foege, Wendell Bradford)
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From page 111... ...
Burke Giblin, Chairman of the Board of Parke-Davis, sends telegram to the Pres ident, Congress and other Federal officials, detailing the July 1 insurance cut-off and requesting legislative assistance 15 – Cooper announces that Administration will ask Congress to pass indemnification legislation 15-25– manufacurers submit first production proposals, which suggest that only 80 mil lion doses can be delivered by October 1, 146 million by December 1, with first shipments to be made in July 16 – Administration submits proposals to Congress (HR 14409) authorizing HEW to in demnify the manufacturers against damages attributed to swine flu vaccination, ex cept for those claims involving charges of negligent manufacture or breach of con tract 16 – CBS Evening News reports the manufacturers have given the Government notice that they will no longer be insured for production of swine vaccine as of July 1, and that the insurers are reluctant to extend such coverage because "they fear the costs 111
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From page 112... ...
and OGC to discuss possi ble contractual solutions; no progress is made, and Cooper subsequently releases press statement explaining the impasse 112
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From page 113... ...
J.Anthony Morris, a researcher in BoB, charging insubordination and incompetent perform ance; Morris goes public, charging he is being punished for findings that cast doubt on safety of influenza vaccines and immunization 13 – insurance company officials participate in OGC-drug company meetings for the first time; manufacturers indicate willingness to give contract language a try but in surers demur; Mathews holds press conference 13 – Ad Hoc Committee of AFEB meets to discuss immunization program and vaccine composition for armed forces; afterwards, representatives of CDC and AFEB meet, and the latter request whole virus vaccine in 400 CCA doses; CDC defers final de cision 13 – CDC meets with labor organizations and large industries to disseminate information and solicit their support 14 – staff meeting held at CDC with representatives of all PHS Regional Centers to dis cuss progress of state programs 15 – Merrell verbally notifies Cooper it will not purchase eggs after Tuesday, July 20, thus ceasing vaccine production. Cooper also learns that Parke-Davis will decide within weeks on termination of its own production 15 – CDC issues Revised Guidelines on Informed Consent, as well as Information Forms for monovalent and bivalent vaccine 16-19– HEW staffers following liability meet to consider options for solving problem; consideration given to dropping program, but consensus reached that White House should be used to break deadlock 113
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From page 114... ...
the casualty insurance industry lost more than $7 billion worldwide underwriting product liability in 1974 and 1975, and (3) the insurers feel that the Federal Government ought to defend all claims 22-23– ACIP meets in Atlanta and recommends that program continue as planned 23 – Rogers subcommittee continues hearings; insurance executives appear, and are widely assailed for non-support; one of them suggests an insurance pool, but the others are not receptive to the idea 23 – President sends letter to Rogers urging that Congress pass indemnification legisla tion quickly 23, 26– at the urging of Mathews, insurers formulate private insurance plans; insurers' discussions with OGC negotiators produce no solutions 27 – insurers offer three private plans; OGC and the drug companies veto two of the proposals, but ask the insurers to obtain industry commitments for full participation in the third 30 – insurers, manufacturers, and HEW officials meet to make final decision on private insurance program; insurers report failure to fully subscribe excess levels of plan; when pressured, three manufacturers promise to continue production in the immedi ate future, but Merrell, having already discontinued production, does not commit it 114
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From page 115... ...
self to resumption 30 – Mathews tells Rogers about the private insurance impasse and says legislation is needed August 1976 2 – outbreak of mysterious disease reported in Philadelphia; swine flu mentioned as possible cause of so-called Legionnaire's Disease 2 – HEW and subcommittee staff draft new bill, introduced as HR 15050 and S 3785; measure is modeled on Tort Claims Act and stipulates that all claims arising from the program are to be filed with the Federal Government 2 – after telephone calls to drug companies, Dowdle reports that 125 million doses are prepared in bulk 3 – Rogers subcommittee conducts mark-up session of House bill; Mathews then speaks before subcommittee, and says that there is a "possibility" that swine flu is responsible for the Philadelphia deaths; subsequently, the subcommittee reports out HR 15050 by a 6-4 vote 5 – House Commerce Committee considers the Tort Claims bill, but decides not to re port it after receiving word that Legionnaire's Disease is not swine flu; committee postpones further action until August 10 5 – Kennedy Subcommittee conducts hearing on Senate bill, S 3735; Sencer testifies that the mystery disease is almost certainly not swine flu; but members express con cern about possibility of link; subcommittee approves the measure 6 – the President, alarmed by indications that congressional enthusiasm for the bill is waning, urges prompt passage before TV cameras; says he is "dumbfounded" by unwillingness of Congress to act 6 – Senate adopts resolution discharging S 3735 from the Labor and Public Welfare Committee and sending the measure directly to the Senate floor 6 – insurance executives begin to prepare an insurance program for the manufacturers which would extend $220 million coverage, excess of $10 million self-insured 7-8– staffs of interested legislators and government consultants work on the bill, insert ing a number of favorite provisions 9 – at a meeting of insurance company executives and brokers in Washington, the first layer of $20 million is quickly subscribed; 25 of the second layer is also taken; in dustry officials are confident that the balance of the second level will be subscribed 10 – President telephones House Speaker Carl Albert and urges that the Tort Claims bill be reported to the House floor under a no-amendment rule 10 – after reviewing S 3735, the Senate Appropriations Committee clears it for floor consideration, without endorsement 10 – Rogers makes last-minute attempt to muster a quorum in the House Commerce Committee to report out the House version of the bill, but fails 115
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From page 116... ...
final delivery deadline has been set at December 3 15 – contract is signed between CDC and Opinion Research Corporation to conduct monthly surveys of public attitudes toward program 17 – meeting is held in Atlanta between CDC and members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to de termine the adequacy of informed consent forms; commission disapproves CDC's format, offers suggestions 18 – OGC negotiators Taft and Bernard Feiner along with Sencer and David K Rowe, director of CDC's Procurement and Grants office, meet with counsel to the manu facturers in order to arrive at an understanding of the effects of PL 94-380; agree ment reached in all areas except "limitation on contractor profit" 19 – fifth technical meeting is held at BoB with representatives of NIAID and OGC, as well as the drug companies, present 19 – having received notice of the December 3 deadline, Parke-Davis advises CDC that it will cease initiating production of new batches on August 21 unless the delivery deadline is extended; Sencer telegrams back, asking Parke-Davis not to stop pro duction but requesting at the same time that the company aim at the announced De cember 3 deadline 20 – final draft for vaccine labelling is delivered by BoB to the manufacturers 20 – representatives from the four companies meet at CDC to review basis for determin ing "cost" of production 20-24– manufacturers submit revised production estimates, promising 20 million doses by October 1, 193 million by December 3 28 – OGC approves an Introductory Statement Concerning Influenza Vaccination and 116
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From page 117... ...
53% in Survey) September 1976 1 – HEW makes public the production estimates of the manufacturers, as revised in late August 1 – HEW gives CDC authority to sign "letter" contracts with the manufacturers, until such time as cost and pricing methods could be negotiated for use in final contracts 2 – President holds emergency meeting with Mathews, at which the Secretary guaran tees that there will be enough vaccine to permit every American over age 18 who wishes to receive shot to do so by January or February 2 – CDC responds to Parke-Davis telegram of August 31 by stating that the company should try to increase production before December 3, as urged by Mathews 2 – BoB approves first batches of vaccine for release 3 – manufacturers answer charges that they delayed production by claiming that they are operating at full capacity, and have been for months; Merrell says it stopped production of bulk only upon fulfillment of its initial quota 3 – NIAID workshop is held in Bethesda to plan long-term surveillance of vaccine re cipients 3 – brokers for insurance companies write participating companies, detailing proce dures for insuring manufacturers 8 – Committee on Infectious Diseases of the American Academy of Pediatrics meets in Atlanta with officials from BoB, CDC, NIAID, and ACIP to make recommendation on vaccination of the 3-to-18 age group; committee recommends two doses of split virus, bivalent vaccine spaced four weeks apart, for high risk population only; committee declines to make recommendation for healthy youngsters, 3-18, pending further study 8 – CDC sends all manufacturers a letter asking them to ship available vaccine prior to October 1, with assurances that it will not be used until October 1 8 – Cooper instructs CDC to extend delivery date for vaccine to January 15 10 – insurance company representatives inform House Health Subcommittee that the in surance program is fully subscribed 117
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From page 118... ...
reit eration of high risk definition; and (3) a prohibition against giving vaccination be fore October 1 29 – CDC announces that immunization program will officially begin with vaccinations at the state fair in Indianapolis, Indiana October 1976 1 – first swine flu shots given 1 – Taft sends Cooper memo describing how contracts with vaccine manufacturers will include a fund to cover the $2.5 million self-insurance retained by each manufac turer 11 – three elderly Pittsburgh people die shortly after receiving inoculation at same clinic 12 – Pittsburgh health officials decide to close down the immunization program in Alle gheny County pending investigation of the deaths; health officials in nine states fol 118
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From page 119... ...
low suit, and six other program areas suspend use of vaccine drawn from the same batch as used in the Pittsburgh clinic 12 – at a news conference in Atlanta, Sencer says CDC has sent epidemiologists to in vestigate, but that thus far there is no evidence to suggest the deaths were caused by vaccine 12 – preliminary autopsy results are released on two of the three elderly persons whose deaths touched off the scare; results indicate that cause of death in each case was heart attack; however, Allegheny County Coroner Dr. Cyril Wecht sounds skeptical on the TV Evening News; suggests deaths may not have been coincidental 13 – body count begins; Millar issues press release saying that 14 persons in 9 states re portedly died after receiving shot; says numbers are well within range of the ex pected for first two weeks of the program and that no evidence has been found link ing any of the deaths with vaccine 13 – BoB reports completed tests on the batch of vaccine used in the Pittsburgh clinic, with no finding of contamination 14 – 33 persons now reported as having died following vaccination 14 – President and family receive shots before television cameras 14 – Cooper holds news conference to summarize results of the investigation; says both vaccine and immunization program are exonerated, and decries "body count men tality;" all states which suspended either have resumed by now, or will soon; several areas report rapidly falling vaccination rate 14 – on his network radio broadcast, Walter Cronkite chides news media for coverage of Pittsburgh deaths 21 – Sencer writes to manufacturers, asking them to reassess production and delivery capabilities in light of extended deadline 22 – meeting sponsored by NIAID at Bethesda to review latest vaccine trials with the 3 to-18 age group; Seal announces that persons in this group can be safely and effec tively immunized with 2 doses of split virus vaccine administered four weeks apart; says such administration will not begin until formal recommendation is made by ACIP sometime in next few weeks 22 – CDC announces 41 deceased vaccinees to date; still no known connection to vac cine 25 – Leslie Cheek of the AIA writes Rogers, summarizing the insurers' underwriting of program 29 – Sencer sends telegrams to states, explaining that final dosage recommendation for children is still pending November 1976 4-10– CDC develops options for vaccinating children; also considers recommending sec ond dose for the 18-to-24 age group 119
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From page 120... ...
health information and public awareness; it is decided that work groups will be formed to study these is sues and report back at a second conference in March or April 1977 15 – ACIP recommends that healthy persons in the 3-18 age group be given two doses of split virus vaccine four weeks apart; also announces that only 8 million doses of such vaccine remain, and thus only 4 million of the 57 million persons in this cate gory will be able to get shot; in addition, ACIP recommends that a second dose be given to those in 18-to-24 age group 15-19– initial investigation by Minnesota Department of Health into occurrences of Guil lain-Barré syndrome in vaccinees 17 – Taft writes the Internal Revenue Service concerning the tax status of the manufac turers' self-insurance fund 18 – Cooper expresses concern over the low level of participation nationwide; only four project areas over the 50 mark (Wyoming, Hawaii, Puerto Rico, and Trust Territo ries) 19 – report is made of seroconversion to swine virus in 32-year-old man in Concordia, Missouri 21 – New York Times poll shows that over half of those New York City residents who have not received shot feel it is unnecessary 22 – Missouri state health officials confirm the swine flu case in Concordia 22 – Parke-Davis submits official reply to the charge that it had negligently manufac tured millions of doses of vaccine; in answer to HEW charge that it had carelessly used an A Shope strain instead of A swine, Parke-Davis claims total innocence, and suggests that CDC may have given it wrong strain at start 23 – CDC epidemiologists report no evidence of human-to-human transmission of swine 120
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From page 121... ...
virus in Concordia 24 – New York City, New Jersey and Connecticut all report increases in vaccination rate following swine finding in Missouri 24 – Denton Peterson, Immunization Program Representative in the Minnesota Depart ment of Health, calls CDC to discuss case of Guillain-Barré syndrome in vaccinee December 1976 2 – Minnesota reports three additional cases of Guillain-Barré at same time as Alabama reports three cases; CDC begins investigation 3 – isolate taken from a 23-year-old hog farmer in Wisconsin is identified as swine vi rus; subsequent search indicates sick swine the source and some secondary spread spotted 6 – CDC ships Public Awareness materials to project directors, and to radio and televi sion stations 7 – CDC confirms that isolate taken from Wisconsin man is swine virus 9 – Lyle Conrad, assistant director of the Immunization Division at CDC, announces that measles cases are up 64 nationwide from last year; blames the swine flu pro gram, which he claims has diverted resources from more needy programs 11 – investigation of Guillain-Barré is extended to eleven states 13 – Sencer makes a conference call to outside experts; reports preliminary data on the association of Guillain-Barré with the vaccine, and seeks their opinions; consensus is that program should not be halted 14 – CDC issues press release on Guillain-Barré; says that 54 cases in 10 states have thus far been reported, and of the 54, 30 received shot anywhere from one to thirty days before onset of symptoms 14 – Dowdle prepares a reply to Parke-Davis on the matter of the mistaken production of Shope vaccine; refutes the contention of Parke-Davis that CDC was at fault, and re iterates that the company must be held to have been negligent and not paid for the faulty doses 15 – Sencer makes second conference call regarding the Guillain-Barré problem 16 – Sencer conducts morning conference call, his third in four days, with 20 experts from NIAID, BoB and the states, conferees agree on recommendation of a one month suspension to allow for investigation of link; Sencer calls Cooper with the recommendation; Cooper confers with Mathews and Cavanaugh; telephones Salk; President okays suspension 16 – subsequently, Sencer in Atlanta and Cooper in Washington announce suspension of the program 16 – Rogers subcommittee conducts an emergency hearing to get explanation of morato rium from HEW officials 17 – Kennedy subcommittee holds a hearing; chairman says program is dead, and Coo 121
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From page 122... ...
per agrees that it would be difficult to get program started again, if and when such is recommended; Foege estimates incidence of Guillain-Barré in vaccinated group is about four times greater than normal 17 – Millar sends notice from CDC to all project areas explaining moratorium; Dr. Phil Brachman writes state epidemiologists, asking that they survey all Guillain-Barré reported after September 1 20 – swine virus is isolated from 13-year-old boy in Wisconsin; subsequent investigation indicates pigs are source of infection 23 – Cooper submits first of several weekly reports to Congress on the Guillain-Barré evidence 29 – ACIP advises against resuming the program since several more weeks may be needed to investigate; recommends that shot should be available to individual pa tients if both doctor and patient agree that vaccine is needed and if patient is fully informed 30 – HEW announces that the Federal Government has received a total of 31 claims val ued at $1.2 million under the Tort Claims bill 30 – in Vail, Colorado, President tells TV news reporters that he concurred in the De cember decision to suspend, but defends the original March decision to immunize everyone late December – HEW fills out the membership of the six work groups created at the Immunization Conference in November; broad cross-section of interests repre sented; work groups asked to submit reports by March 1 and plan on an early April conference January 1977 5 – CBS Evening News airs a lengthy piece on the issue of declining immunization rates against childhood diseases 6 – Cooper announces resignation, effective Inauguration Day 11 – representatives of HEW and the Department of Justice meet to discuss procedure for handling claims filed under PL 94-380 11 – Minnesota Health Department reports case of swine flu in a 27-year-old man who has had contact with pigs; no human-to-human transmission is discovered 11 – Cooper asks Sencer and CDC for advice on reformulation of informed consent forms 14 – ACIP meets in Atlanta and concludes that the moratorium on all influenza vaccine ought to be lifted; observes that flu shots do appear to entail some slight additional risk of contracting Guillain-Barré (estimated at one case for every 100,000 to 200,000 vaccinations)
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From page 123... ...
estimate the cost of restarting the program, and (3) develop a new informed consent form, and get the concurrence of OGC and the National Commission for the Protection of Human Subjects 18 – CDC formulates new Informed Consent forms, incorporating a warning on the pos sibility of the vaccinee contracting Guillain-Barré 19 – Sencer responds to Cooper, listing the results of CDC's poll of the states; few ex pressed themselves as willing to resume a full-scale public program; Sencer esti mates that the start-up cost would be between $15,000 and $30,000; Sencer also sends Cooper the new Informed Consent forms 19 – Cooper issues news release explaining his decision not to lift the moratorium; says that Informed Consent forms are still a problem, that the states must be consulted individually about scale of resumption, and that a proper scope and target had to be selected for revised program 20 – Califano sworn in as Secretary of HEW 20-21– NIAID workshop on the vaccine test program is held in Bethesda; some criticism leveled on the limited amount of follow-up surveillance that is being done 25 – BoB workshop is held in Bethesda; in attendance are representatives from CDC, NIAID, DoD, and manufacturing firms; conferees discuss alternatives for vaccine composition for 1977-1978 26 – Acting Assistant Secretary for Health Dickson sends memo to Califano, sketching the history of the swine flu program and itemizing the major options for dealing with the current moratorium 28 – OMB approves a Department of Justice supplemental budget of $1.2 million for swine flu litigation in 1977; Justice officials estimate that an equivalent appropria tion will be needed for the same purpose through 1980 28 – World Health Organization announces its 1977-1978 recommendation for influenza vaccine composition February 1977 2 – BoB prepares reply to Parke-Davis on the Shope vaccine matter, claiming that Parke-Davis was negligent and that it ought not to be paid 123
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From page 124... ...
2 – outbreak of Victoria flu is recorded among the patients and staff of a nursing home in Florida 4 – Justice Department reveals that 104 damage claims have been filed against the Fed eral Government under PL 94-380; total value is almost $11 million 4 – Califano announces that a special meeting will be held on Monday the 7th to dis cuss the moratorium and recommend a course of action for the remainder of the 1976-1977 flu season 4 – Califano sends a memo to President Carter, summarizing the history of the morato rium, identifying the problem posed by the recent outbreak of Victoria flu, and stat ing his intention to meet with an ad hoc committee on Monday to discuss the op tions, after which he (Califano) would consult with the White House and make a decision; Califano closes by suggesting that he does not think the President should publicly make the decision 4 – Representatives Henry Waxman and Andrew Maguire of Rogers' subcommittee hold a morning press conference at which they voice their concern over the admini stration and implementation of the program 4 – HEW Undersecretary Hale Champion informs Sencer he will be replaced as head of CDC 7 – Califano convenes an open meeting to discuss resumption of influenza vaccination; ad hoc panel of academic, scientific, political and media experts, chaired by John Knowles, meets at HEW; panel recommends that Califano resume vaccination of the high risk group with bivalent vaccine, but reaches no agreement on general re sumption 7 – During meeting it becomes known that Califano wants Sencer's resignation as di rector of CDC; Sencer confirms 7 – Acting General Counsel Barrett sends memo to Califano, enclosing the revised In formed Consent forms and advising that the Secretary invite comments thereon from Justice and from the National Commission for the Protection of Human Sub jects 8 – at a news conference, Califano announces that he is lifting the ban on bivalent and B Hong Kong vaccines to help combat small outbreaks of Victoria and Hong Kong flu; moratorium is continued on swine monovalent vaccine; mass outreach cam paign is not to be resumed 9 – health officials from a majority of states announce that bivalent vaccine will be made available to physicians and health clinics but that mass immunization pro grams will not be resumed 9 – an AFEB Ad Hoc Subcommittee on Influenza submits recommendations on vacci nation of armed forces for the spring; advises that recruits be given the swine Victoria bivalent vaccine, but that as soon as Victoria monovalent vaccine should become available, recruits be given that only; AFEB accepts the recommendation 14-15– meeting is held at CDC with representatives of NIAID, BoB, and the Department 124
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From page 125... ...
of Agriculture to discuss swine flu in man and pigs and methods of control March 1977 11 – Califano convenes an ad hoc, advisory panel to make suggestions and recommenda tions on flu vaccine policy for the next year; at end of all-day meeting, the group concludes that only high risk group or those with important occupations (70 million in all) should be targets for flu vaccination next winter; vaccine will immunize against Victoria flu; swine flu vaccine is not recommended 125
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