BNUMBER:  B-274490; B-274490.2
DATE:  December 13, 1996
TITLE:  Wyeth-Lederle Vaccines and Pediatrics

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 Matter of:Wyeth-Lederle Vaccines and Pediatrics 

File:     B-274490; B-274490.2

Date:December 13, 1996

Andrew N. Goldfarb, Esq., Elizabeth Goss, Esq., Albert F. Cacozza, 
Jr., Esq., and Samuel D. Turner, Esq., Fox, Bennett & Turner, for the 
protester.
Barbara Robbins, Esq., Department of Health and Human Services, for 
the agency.
Tania L. Calhoun, Esq., and Christine S. Melody, Esq., Office of the 
General Counsel, GAO, participated in the preparation of the decision.

DIGEST

1.  Under pediatric vaccine procurement conducted pursuant to statute 
which states that the agency "shall, as appropriate" award multiple 
contracts, protest that contracting agency improperly provided for a 
single award instead of multiple awards is denied where the record 
shows that the agency reasonably determined that the circumstances 
were not appropriate for multiple awards.

2.  Under pediatric vaccine procurement, protest that contracting 
agency improperly failed to follow a "statutorily required" procedure 
with respect to use of the list of vaccines established by the 
Advisory Committee on Immunization Practices (ACIP) is denied where 
statute does not require any particular procedure, and ACIP clearly 
intended rapid incorporation of vaccine into the immunization program 
and the conditions ACIP established for such incorporation have been 
met.

DECISION

Wyeth-Lederle Vaccines and Pediatrics protests the terms of request 
for proposals (RFP) No. 96-170(N), issued by the Department of Health 
and Human Services, Centers for Disease Control and Prevention (CDC), 
to obtain diphtheria and tetanus toxoid with acellular pertussis 
(DTaP) vaccine pursuant to the Vaccines For Children (VFC) Program.[1]  
Wyeth-Lederle also protests the award of a contract to Connaught 
Laboratories, Inc. under this solicitation.

We deny the protests.

BACKGROUND

The pediatric vaccination schedule to provide optimal protection 
against diphtheria, tetanus, and pertussis calls for five doses of 
vaccine--three doses given at ages 2, 4, and 6 months as the primary 
infant series, and two booster doses given between the ages of 12 and 
18 months and between the ages of 4 and 6 years.  

Since 1948, whole-cell pertussis vaccines (DTP), which contain 
inactivated whole bacterial cells of the pathogen that causes the 
disease, have been recommended to fulfill the five-dose regimen.  In 
recent years, DTP has been associated with a number of adverse 
reactions and side effects.  Concerns about its safety led to the 
development of the DTaP vaccine, which contains acellular pertussis, a 
more purified vaccine which contains only components of the bacterium, 
rather than the whole cell.  DTaP causes fewer adverse reactions in 
children and is considered to be a safer alternative than DTP.  In 
1991, both Wyeth-Lederle and Connaught received Federal Drug 
Administration (FDA) licenses to manufacture DTaP for use only as the 
fourth and fifth booster doses in the vaccination schedule.  The 
requirements for the infant series in the schedule were still to be 
filled by DTP, as no manufacturer was licensed to provide DTaP for 
this purpose.[2]

The CDC's contracts for the booster doses of DTaP were scheduled to 
expire at the end of August 1996.  In a draft document dated July 25, 
1996, the CDC outlined its options for meeting its DTaP requirements 
under the VFC Program.[3]  Among other things, the agency considered 
whether it should award a single contract or different varieties of 
multiple contracts.  In this regard, as discussed below, OBRA states 
that the agency shall, as appropriate, enter into contracts with each 
qualified manufacturer.  The agency was aware that five manufacturers 
were currently seeking or planning to seek licensure to provide DTaP 
in the infant series, and expected that such licenses would be issued 
within 1 to 12 months.  The CDC opted to negotiate a contract with 
"all vaccine companies that are licensed to provide DTaP for use in 
infants beginning at 2 months of age."  

On July 31, approximately 1 month before the CDC's current contracts 
for DTaP  were to expire, the FDA licensed Connaught to distribute 
DTaP for the infant series.  Hence, Connaught was now the only 
manufacturer licensed to provide DTaP for all five doses. 

On August 13, the contracting officer telephoned the manufacturers 
known or believed to be seeking licensure for the required vaccine.  
Her contemporaneous accounts of these conversations show that she 
generally advised them that a procurement would be synopsized in the 
Commerce Business Daily that week; that a solicitation would be issued 
shortly; and that a contract would have to be put in place "very 
quickly" to "get the vaccine out to the children."  She stated that 
the solicitation would contemplate a single award since only one 
manufacturer was appropriately licensed, but that a new solicitation 
for multiple awards would be issued when additional manufacturers were 
licensed.  She also asked the manufacturers for the status of their 
license applications.  One manufacturer, not Wyeth-Lederle, indicated 
that its licensure was imminent, but an FDA representative would not 
verify this claim.  The representative stated that there were 
"complicating things" about DTaP, with so many details involved that 
she would not want to "hazard a guess" as to when this license would 
be approved.

The agency elected to proceed with the procurement as planned, given 
the pending expiration of its current contracts, its view that there 
was an urgent need to "get the vaccine to the children," and the 
uncertainties about licensure of other manufacturers.  The 
solicitation, issued August 30, anticipated the award of an indefinite 
quantity contract to provide DTaP licensed for use in children 2 
months of age and older--the entire regimen.  The solicitation 
provided for a minimum of 4 million doses of vaccine with an estimated 
maximum of 16 million doses over a period of 12 months.

Under the heading "Evaluation and Award," the solicitation stated:

     "c.The [g]overnment intends to make only one award under this 
        solicitation, to the offeror that submits the lowest price per 
        dose.

     "d.In order to be considered for award, the offeror must . . . 
        provide evidence of a current FDA license prior to award for 
        the proposed product.  Product licensure is a matter of 
        responsibility that may be demonstrated up to the time of 
        award."

The only substantive submission required of offerors was a vial size, 
unit price, and  total estimated price.  Initial proposals were due on 
September 5, 5 days after issuance of the solicitation.  

Wyeth-Lederle filed its initial protest just prior to closing.  The 
firm also submitted a proposal, along with Connaught and a third 
manufacturer.  While Wyeth-Lederle submitted the lowest price per 
dose, the firm was not licensed and was thus ineligible for award.  
Connaught was awarded the contract on September 19, in the amount of 
$224,960,000, and Wyeth-Lederle's supplemental protest followed.  To 
date, there is no evidence that any manufacturer aside from Connaught 
has been licensed to provide DTaP for the infant series.

Wyeth-Lederle principally argues that the CDC improperly decided to 
make only one award; provided for an unduly short response period; and 
improperly failed to follow a "statutorily required" procedure with 
respect to this vaccine.  

DISCUSSION

The primary OBRA provision at issue, codified at 42 U.S.C.  sec.  1396s, 
states:

     "(d)  Negotiation of Contracts with Manufacturers

        "(7)  Multiple Suppliers

        "In the case of the pediatric vaccine involved, the Secretary 
        shall, as appropriate, enter into a contract . . . with each 
        manufacturer of the vaccine that meets the terms and 
        conditions of the Secretary for an award of such a contract 
        (including terms and conditions regarding safety and quality). 
        . . ."

Wyeth-Lederle does not dispute that this provision does not require 
the CDC to award multiple contracts in every acquisition of pediatric 
vaccine, but to do so "as appropriate."  See SmithKline Beechman 
Pharmaceuticals, B-271845, Aug. 23, 1996, 96-2 CPD  para.  82.  The 
protester contends, however, that the CDC had no reasonable basis to 
conclude that award to multiple suppliers under this acquisition was 
"not appropriate," and, thus, that the CDC improperly failed to allow 
for multiple awards. 
Strictly speaking, the protester has suffered no prejudice as a result 
of the agency's inclusion of the "single award" clause in this 
solicitation.  That is, even if the "single award" clause were removed 
and substituted with a "multiple award" clause, the protester would 
still be ineligible for award because it does not possess the required 
license.  Prejudice is an essential element of a viable protest.  See 
Lithos Restoration, Ltd., 71 Comp. Gen. 367 (1992), 92-1 CPD  para.  379.

It appears, however, that Wyeth-Lederle's real complaint is that the 
agency should not have issued any solicitation at all unless it could 
have made award to multiple manufacturers--in other words, that the 
CDC should have waited until other manufacturers were licensed before 
issuing a solicitation.  

The record shows that the agency recognized the benefits of making 
multiple awards.  The options paper reflects that the agency opted to 
negotiate contracts with all vaccine companies licensed to provide 
DTaP for use in infants beginning at 2 months of age.  However, as the 
expiration dates of the CDC's current DTaP contracts approached, the 
plain fact was that only one manufacturer was so licensed, and all the 
evidence showed that the chances of other manufacturers receiving 
licenses in the near future were slim.  The CDC also believed that it 
was vital that a contract be established for the "new" DTaP--that 
which could be used for all doses--as soon as possible, as it was much 
safer than DTP.  As the contracting officer states, the combination of 
these factors presented technical considerations which made it 
desirable to consider different award strategies.  CDC chose to make a 
single award rather than delay the procurement for development of a 
multiple award scheme.  However, CDC made it clear to all 
manufacturers that it intends to issue a multiple award solicitation 
for the "new" DTaP as soon as another manufacturer has been licensed 
to sell the product, and utilized only a 4-month supply as the 
guaranteed minimum so that the present contract could be easily 
replaced by a new one.

Wyeth-Lederle's arguments, which boil down to a contention that the 
justifications for multiple awards outweigh the agency's concern that 
this requirement was urgent, are unpersuasive.  

Wyeth-Lederle principally asserts that a single award will pose 
problems for the other manufacturers in subsequent purchases of the 
vaccine.  These manufacturers may be discouraged from continued 
production of DTaP; they may be unable to obtain a fair market share 
for the vaccine; and there may be difficulties with interchangeability 
from one brand of the vaccine to another.  The CDC's options paper 
shows that the agency considered each of these potential problems and 
addressed each in view of the circumstances.  To alleviate the 
negative commercial impact on the manufacturers, the agency planned to 
issue a new solicitation for multiple awards as soon as additional 
manufacturers were licensed, as discussed above.  The CDC also 
considered the issue of interchangeability and concluded that the 
Advisory Committee on Immunization Practices (ACIP), discussed further 
below, would likely allow interchangeability if necessary.  
Wyeth-Lederle's implicit argument that additional manufacturers will 
soon be licensed is unsupported.  The only evidence suggests that 
issuance of additional licenses will come later rather than sooner.  
In sum, the record compels a conclusion that the CDC considered the 
potential problems of a single award and reasonably concluded that the 
urgency of the procurement warranted proceeding in this manner.  

Wyeth-Lederle contends that the CDC has "substantially overstated" the 
public health significance of DTaP for use in infants in determining 
that there was an urgent need for this procurement.[4] 

The record is abundantly clear that the agency considered this 
acquisition to be urgent because it wanted to provide what is 
universally acknowledged to be a safer vaccine to children covered by 
this program.  The CDC's recent statement in this regard, see 61 Fed. 
Reg. 48596, 48597 (Sept. 13, 1996), is consistent with those made by 
others in the scientific community.  According to the CDC, DTP is an 
acceptable alternative to DTaP, but the latter is the preferred 
alternative.  DTaP is less likely to cause the mild and moderate 
problems seen after DTP is received.  Mild problems are soreness, 
redness, or swelling where the shot was given; fever; fussiness; 
drowsiness; and diminished appetite.  Moderate problems are ongoing 
crying for 3 hours or more; fever of 105 degrees Fahrenheit or higher; 
unusual, high-pitched cries; seizures; and shock-collapse.  Severe 
problems--decreased consciousness, coma, or long seizure--also occur 
after receipt of DTP.  These problems cause some children lasting 
brain damage, but there is disagreement about whether DTP is the 
cause.  The risk of serious problems after receipt of DTaP is not yet 
known, but experts believe it is even less likely to occur than after 
receipt of DTP.  

Wyeth-Lederle contends that the fact that DTP is still an acceptable 
alternative, and the fact that only the mild and moderate problems are 
proven to occur less frequently when DTaP is used, preclude the agency 
from determining that its needs for DTaP are urgent.  Given the 
statements above, and others in the record which confirm those 
statements, we cannot agree.  The contracting officer states that 
"[i]t would be unconscionable to withhold this product from the 
[n]ation's children for any reason, including waiting some 
indeterminable period for other manufacturers to have licenses 
approved by the FDA."  Wyeth-Lederle has not shown that the 
contracting officer's concern, or her decision based upon that 
concern, is unreasonable.  Under the circumstances, we have no basis 
to question any aspect of the agency's determination that appropriate 
circumstances existed here to warrant a single award.

Wyeth-Lederle also argues that the CDC improperly "ignored 
requirements for identification of vaccines" to be purchased under the 
VFC Program.  In this regard, OBRA provides that "[t]he Secretary 
shall use, for the purpose of the purchase, delivery, and 
administration of pediatric vaccines under this section, the list 
established (and periodically reviewed and as appropriate revised) by 
the 
[ACIP]. . . ."  42 U.S.C.  sec.  1396s(e).

In 1994, the ACIP adopted VFC Resolution No. 2/94-3 to initially 
provide for use of DTaP in the VFC Program.  This resolution limited 
use of DTaP to the fourth and fifth doses.  However, on June 20, 1996, 
"to assure the most rapid incorporation of DTaP vaccines into the 
routine immunization program," the ACIP approved VFC Resolution No. 
6/96-2, which broadened use of DTaP in the VFC Program to include 
administration to infants as young as 2 months of age, subject to 
three conditions:  that the DTaP vaccine(s) is (are) approved for this 
use by the FDA; that the ACIP has published a notice in the Morbidity 
and Mortality Weekly Report (MMWR) recommending the use of DTaP 
vaccines for all five doses; and that a federal contract for purchase 
of DTaP vaccine for all five doses has been established. 

All of these conditions have been met.  The FDA has approved 
Connaught's DTaP vaccine for use in the infant series.  On August 9, 
the ACIP published a notice in the MMWR recommending the use of 
Connaught's DTaP vaccine for the first three doses, and had previously 
approved DTaP vaccines for the last two doses.  A federal 
contract--this one--for purchase of DTaP for all five doses has been 
established.  The agency considers that it has fully met its statutory 
obligations.

Wyeth-Lederle argues that this resolution has not been published in 
the Federal Register and subjected to notice and comment--as were the 
initial ACIP list and at least one subsequent revision--and that it 
cannot therefore be used by the agency for the purpose of this 
acquisition.  However, the statute does not require that any 
particular procedure be followed to make ACIP's revisions to the list 
effective.  The recommendation is clear that the ACIP wanted rapid 
incorporation of DTaP into the immunization program, and that the 
conditions it established for such incorporation have been met.  While 
Wyeth-Lederle correctly asserts that the ACIP plans to do further work 
in this area, the protester has not shown that this work must be done 
before the CDC can consider this recommendation effective for purposes 
of OBRA.  Under the circumstances, we have no basis to conclude that 
the agency's actions here were improper.[5]   

The protests are denied.

Comptroller General
of the United States

1. The VFC Program is provided for by the Omnibus Budget 
Reconciliation Act of 1993 (OBRA), 42 U.S.C.  sec.  1396s (1994).  This is 
a federally funded program for the acquisition and distribution of 
pediatric vaccine for the immunization of eligible children.  

2. Both of these firms are licensed to manufacture DTP for use 
throughout the regimen.

3. The CDC had issued a solicitation to procure DTaP for only the 
fourth and fifth booster doses in the spring.  That solicitation was 
canceled in view of the CDC's expectation that licenses would soon be 
awarded to manufacturers of DTaP for the infant series as well.  The 
record shows that the CDC did not want to award a separate contract 
for the booster doses due to inherent logistical problems and safety 
issues that could arise with two vaccines on the shelf with different 
indications.  

4. The protester makes this argument in the context of its challenge 
to the agency's use of a 5-day response time instead of the "standard" 
30-day response time.  See Federal Acquisition Regulation  sec.  5.203(b); 
12.205(c).  A review of its pleadings, however, shows that the 
argument applies equally here, and that the issues are intertwined.  
In any event, Wyeth-Lederle was not prejudiced by the agency's use of 
the shorter period since even if the agency had used the longer 
period, the firm would not have been eligible for award because it is 
not properly licensed.  Further, the shorter period did not prevent 
the firm from submitting the lowest-price per dose. 

5. As for Wyeth-Lederle's argument that the CDC gave Connaught an 
unfair competitive advantage by telling the firm that there would be a 
5-day response period, the protester has not shown that any advantage 
was gained since the protester itself offered the lowest price per 
dose.  In a related argument, the protester's assertion that the 
agency engaged in an improper de facto sole source award to Connaught 
is belied by the fact that multiple proposals were submitted and 
considered, and the agency's statement that the protester would have 
received award if it had been licensed.