Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

PERTUSSIS VACCINE DEVELOPMENT ALLOCATED $4.5 MIL

Executive Summary

PERTUSSIS VACCINE DEVELOPMENT ALLOCATED $4.5 MIL. in the House/Senate fiscal 1990 budget agreement for the National Vaccine Program. The program's budget is part of the HHS appropriations bill, HR 2990. The conference agreed on appropriations of $6 mil. for the program, $4.5 mil. of which is to be used exclusively for "basic and applied research and clinical trials of pertussis vaccines," according to the report accompanying the bill. The remaining $1.5 mil. is to be applied to support the program office. The agreement was reached Oct. 5. "Development, testing and approval of new acellular petussis vaccines are the highest priority of the vaccines program," the report notes. The report adds: "neither limited fiscal resources nor limited opportunities for appropriate field testing sites should be wasted in a diffuse approach. Therefore, the conferees expect that the National Vaccine Program Interagency Group will coordinate all pertussis trials funded through the National Vaccine Program or other funding sources in the department [HHS]." The full House approved the conference agreement Oct. 11; the Senate, Oct. 19. The interagency task force recommended assigning acellular pertussis vaccines a top priority at a National Vaccine Advisory Committee meeting in March ("The Pink Sheet" March 13, T&G-4). The recommendation followed the rejection by Swedish regulators of a Biken acellular vaccine license application due to concerns with the vacine's efficacy. The vaccine was the furthest along of the acellular products in clinical development. By funding other trials, the conferees said they "do not wish to impede possible approval of any acellular pertussis vaccines currently under review by the Food and Drug Administration." No product licensing applications for acellular pertussis vaccines have cleared the agency. In addition to Connaught/Biken, acellular pertussis vaccines are also under development by Lederle/Takeda, Institut Merieux and the National Institute of Child Health and Human Diseases. The interagency group acts as the implementing arm of the National Vaccine Program, which was established by the National Childhood Compensation Injury Act of 1986. The National Vaccine Advisory Committee was created to advise the program's director -- the NIH assistant secretary for health. With regard to the vaccine injury compensation program, the report states that the House conferees have agreed to a Senate amendment permitting HHS to use injury trust fund monies for the program's administrative costs. Extra funding for administrative expenses was one of several recommendations for improving the program made by Childhood Vaccine Advisory Commission Chairman Stephen Lawton in a Sept. 20 letter to HHS Secretary Sullivan. Lawton expressed substantial concern with the program's ability to function as intended by Congress due to a lack of support by HHS and the Justice Department. At a recent commission meeting on the status of the program, he said: "The commission determined that, at present, the program is in serious jeopardy. Neither HHS nor Justice is participating fully in the program, despite legal responsibilities to do so. Yet, the U.S. Claims Court continues to process petitions for compensation without formal participation by these departments."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1135544

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel