Friday, 28 July 2000
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Post00269 VACCINE RECONSTITUTION + V NEWS 28 July 2000 CONTENTS 1. VACCINE RECONSTITUTION: PROBLEMS AND SOLUTIONS 2. VACCINE NEWS 1. VACCINE RECONSTITUTION: PROBLEMS, APPROACHES AND SOLUTIONS PATH has begun investigating improvements to the reconstitution process of lyophilized vaccines such as measles and BCG. Carrie Tudor, PATH, has kindly posted a note on the problem along with a request: ".... we are trying to better define the problems with reconstitution and the extent of these problems. * We would be grateful for responses to any of the following questions as well as any other ideas people may have about simplifying the reconstitution process." * Replies to: [[email protected]][email protected][/email], [[email protected]][email protected][/email] ___________________________________________________________________________ From: "Tudor, Carrie" To: "'[email protected]'" Subject: Vaccine Reconstitution Date: Wed, 26 Jul 2000 10:50:19 -0700 Dear Allan and TechNet Members: PATH has begun investigating improvements to the reconstitution process of lyophilized vaccines such as measles and BCG. There have been numerous reports of serious problems with improper reconstitution of lyophilized vaccines, primarily the use of the wrong diluent for reconstitution. The current mixing process, requiring separate vials of lyophilized vaccine and diluent, as well as a mixing syringe, is complicated, time-consuming, and prone to error. These problems could potentially be eliminated by integrating the packaging of lyophilized vaccines and their diluents and by presenting the diluent in a dispenser that does not require a syringe and needle. We acknowledge that this approach would not solve the problem of reconstituted vaccines being saved and used for longer than 6 hours; however, we seek to determine whether a simplified and "mixing-syringe-free" reconstitution system would provide a reasonable solution to some of the problems with reconstitution. We are looking for a very simple approach to simplifying reconstitution and several off-the-shelf alternatives have been identified. These include prefilled squeeze containers with a luer fitting to which a "non-sharp" needle could be attached and then injected directly into the vaccine vial. One manufacturer makes a prefilled plastic accordion bottle to which a needle is already attached. These prefills are common in the pharmaceutical industry, but have not been used for vaccine diluents before. We plan to work with vaccine manufacturers to determine what issues would be involved in changing the diluent container. As a first step in the process, we are trying to better define the problems with reconstitution and the extent of these problems. We would be grateful for responses to any of the following questions as well as any other ideas people may have about simplifying the reconstitution process. Questions: 1. What are the main problems or difficulties with the reconstitution process? (in addition to general problems, please provide specific examples of reconstitution problems related to adverse events following immunization (AEFI)). 2. Would programs benefit from a simplified system of reconstitution? How? 3. Do you have suggestions for improving reconstitution practices or equipment? 4. How is diluent transported and distributed? Is it kept in the cold chain? Is it separated from the vaccine? 5. Is the mixing syringe used once? More than once? 6. Is the mixing syringe ever used for injections? 7. How long is measles vaccine typically kept after reconstitution? 8. What vial size do you normally use? 10 dose? Single dose? ** We welcome responses via Technet Forum or directly by phone or e-mail listed below. Thank you, Carrie Tudor, [[email protected]][email protected][/email] Carib Nelson, [[email protected]][email protected][/email] Phone: 206-285-3500 Fax: 206-285-6619 Carrie Tudor, MPH Program Associate PATH (Program for Appropriate Technology in Health) 4 Nickerson St. Seattle, WA 98109 web: http://www.path.org ____________________________________*______________________________________ 2. VACCINE NEWS Selected news items reprinted under the fair use doctrine of international copyright law: http://www4.law.cornell.edu/uscode/17/107.html ___________________________________________________________________________ "Potato Packs Vaccine Punch, Study Finds" Dallas Morning News (www.dallasnews.com) (07/25/00); Beil, Laura The development of edible vaccines has reached a new step as volunteers for the study developed an immune reaction to a virus by eating a potato vaccine. Charles Arntzen of Cornell University believes that it will be possible to create edible vaccines for most diseases. Using potatoes or other foods would be useful for developing nations that do not have refrigerators and sterile storage areas. Nineteen of 20 volunteers in the study developed a reaction against Norwalk virus after eating the potato part. Scientists also are at work on a plant vaccine for hepatitis B, and Robert Rose of the University of Rochester Medical Center in New York is researching a vaccine for human papilloma virus. Arntzen hopes to create a banana vaccine, since they can be eaten uncooked. --- "FDA Tells Congress That Thimerosal in Vaccines Poses Little Risk" Reuters Health Information Services (www.reutershealth.com) (07/24/00) Dr. William Egan of the U.S. Food and Drug Administration (FDA) testified to Congress last week that children should continue to receive childhood vaccines, despite concerns about the use of thimerosal in vaccines. Egan said the risk of diseases like whooping cough, meningitis, and polio outweighs the small risk of exposure to mercury in the preservative. A recent study from the Centers for Disease Control and Prevention stated that the level of thimerosal in vaccines poses little danger, but research will continue. Pharmaceutical companies like Merck are creating thimerosal-free vaccines, after the FDA asked manufacturers to remove the element or to justify why it is used. --- July 21, 2000 [Crossposted from IAC EXPRESS & MMWR] CDC PUBLISHES UPDATE NOTICE ON THE EXPANDED AVAILABILITY OF THIMEROSAL PRESERVATIVE-FREE HEPATITIS B VACCINE The Centers for Disease Control and Prevention (CDC) announced in the July 21, 2000, issue of the MMWR that "an adequate supply of preservative-free hepatitis B vaccine is available for all infant and childhood vaccinations." The complete notice is reprinted below: NOTICE TO READERS: UPDATE: EXPANDED AVAILABILITY OF THIMEROSAL PRESERVATIVE-FREE HEPATITIS B VACCINE Thimerosal, a mercury-based compound, is no longer used as a preservative in any of the pediatric hepatitis B vaccines licensed in the United States. On March 28, 2000, SmithKline Beecham Biologicals (Rixensart, Belgium) received approval from the Food and Drug Administration of a supplement to its hepatitis B license to include the manufacture of single-antigen, preservative-free hepatitis B vaccine (Engerix-B, pediatric/adolescent); distribution of this product has begun. A single-antigen, preservative- free hepatitis B vaccine (Recombivax HB, pediatric) from Merck Vaccine Division (West Point, Pennsylvania) had earlier received similar approval. A preservative-free Haemophilus influenzae type b (Hib)/hepatitis B combination vaccine (Comvax) from Merck Vaccine Division also is available. An adequate supply of preservative-free hepatitis B vaccine is available for all infant and childhood vaccinations. Thimerosal preservative- containing hepatitis B vaccines may continue to be used for vaccination of adolescents and adults as recommended. Some vaccines that do not use thimerosal as a preservative may have trace amounts of thimerosal introduced during the manufacturing process. The amount of thimerosal in the new pediatric/adolescent formulation of Engerix-B (less than 1 mcg of thimerosal/0.5 mL dose of vaccine) has been reduced by more than 96%. Universal vaccination of infants is the central focus of hepatitis B prevention efforts, and initiation of the hepatitis B vaccine series at birth is safe and effective. Many hospitals that had provided routine hepatitis B vaccination to all infants at birth before the July 1999 joint American Academy of Physicians/Public Health Service statement on thimerosal in vaccines discontinued this practice because of concerns about thimerosal. Some of these hospitals did not resume routine vaccination at birth even after hepatitis B vaccines that do not contain thimerosal as a preservative became available (CDC, unpublished data, 2000). Preservative- free hepatitis B vaccines are now widely available, and efforts should be made to reintroduce routine hepatitis B vaccination policies for all newborn infants in hospitals in which these policies and practices have been discontinued. To access the full text of this notice online, go to: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4928a4.htm For a more complete listing of thimerosal-related information, visit CDC's website at: http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/ or Visit the website of the Immunization Action Coalition at: http://www.immunize.org/genr.d/thimer.htm HOW TO OBTAIN A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR: To obtain a free electronic subscription to the "Morbidity and Mortality Weekly Report" (MMWR), visit CDC's MMWR website at: http://www2.cdc.gov/mmwr --- IAC EXPRESS #174 [Crossposted from IAC Express] July 10, 2000 NEW VAERS WEBSITE FEATURES ONLINE REPORTING AND VACCINE SAFETY RESOURCES The Vaccine Adverse Event Reporting System (VAERS) has launched a new website to serve as a nationwide mechanism by which adverse events can be reported, analyzed, and made available to the public. In addition, the site will disseminate vaccine safety information for providers, parents, manufacturers, and others. Of special interest to providers is a Vaccine Safety Bibliography, which is generated monthly from the National Library of Medicine's SDILINE. Sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), VAERS collects information about adverse events that occur after the administration of U.S.-licensed vaccines. Visit VAERS online at: http://www.vaers.org Questions about the VAERS program can be directed to Edward E. Gaunt, PhD, at (800) 822-7967 or [[email protected]][email protected][/email] ____________________________________*______________________________________ Selected news items reprinted under the fair use doctrine of international copyright law: http://www4.law.cornell.edu/uscode/17/107.html
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