Hepatitis vaccines

A full-term neonate was accidentally given carboprost 250 pg intramuscularly in an error for hepatitis vaccine. Within 15 minutes, he became tachypneic and hypertensive and then developed bronchospasm and dys-tonic movements and/or seizure activity in the arms. He was hyperthermic and had diarrhea. He recovered within 18 hours. 

Following intramuscular (IM) administration, drugs must cross one or more biological membranes in order to enter the systemic circulation. Intramuscular injection is used mainly for drugs and vaccines that are not absorbed orally, for example, aminoglycosides, insulin, and hepatitis vaccine. The IM route is often used for sustained medication and specialized vehicles, such as aqueous suspensions, oily vehicles, complexes and microencapsulation, which has been developed for slow delivery of drugs by this route. ... 

In a paper dealing mainly with indications for the use of hepatitis vaccine, the data on the hepatitis A vaccines most widely used, HAVRIX (manufactured by Glaxo SmithKline) and VAQTA (manufactured by Merck), have been summarized (1). The data are based on prelicensure clinical trials and worldwide follow-up reports. No serious adverse effects have been attributed to hepatitis A vaccines. In children who received HAVRIX, soreness (15%) and induration (4%) at the injection site, feeding problems (8%), and headaches (4%) have been the most frequently observed adverse effects. In children who received VAQTA, the most common adverse effects were pain (19%), tenderness (17%), and warmth (9%) at the injection site. The reported frequencies were similar to the frequencies reported with hepatitis B vaccines. 

By 1988 it was possible to summarize the adverse effects reported after the distribution of over 1.8 million doses of plasma-derived hepatitis B vaccine (Table 1) (2). From 1982 onwards, the Centers for Disease Control, the Food and Drug Administration, and the manufacturers, Merck Sharp Dohme, had supported a special surveillance system to monitor spontaneous reports of reactions to plasma-derived hepatitis vaccine. During the first 3 years, about 850 000 persons were immunized. In all, 41 reports were received for one of the following neurological adverse events convulsion (n = 5), Bell s palsy (n — 10), Guillain-Barre syndrome (n = 9), lumbar radiculopathy (n — 5), brachial plexus neuropathy (n = 3), optic neuritis (n — 5), and transverse myelitis (n = 4). Half of these events occurred after the first vaccine dose. However, no conclusive causal association could be made between any neurological adverse event and the vaccine (3). 

Reports of studies of the efficacy and safety of recombinant hepatitis vaccines have been published (SED-12, 805) (SEDA-14, 282) (SEDA-15, 351) (SEDA-16, 385) (SEDA-17, 373) (SEDA-18, 334). Table 1 shows the adverse effects reported after the distribution of 205 000 doses of recombinant vaccine. 

Guillain-Barre syndrome occurred in a 7-year-old girl after the administration of recombinant hepatitis vaccine (20). The author noted that several other such incidents had been reported after the use of recombinant vaccines, two involving optic neuritis and one Guillain-Barre syndrome. 

Associated Press. Press release, 15 April 1999. Hepatitis vaccine safety questioned in the United States. http //www. who.int/vaccines-diseases/safety/hottop/HBV Press.html (accessed 2 August 2000). 

Genetic manipulation (GM) also offers the prospect of healthier animals with improved resistance to diseases such as mastitis or to the ticks that can infest cattle, thus reducing the need for antibiotics and pesticides. Medicines may be produced in the milk of cows. For example, GM cows could produce milk with a clotting factor for hemophiliacs, milk containing human serum albumin for blood transfusions, or milk with a hepatitis vaccine. Several of these medicines could be produced much more efficiently than with the technologies currently used. Some of the potential changes that can be brought about in milk are listed in Table 1. 

Stiefelhagen P. [Oral vaccines — a future prospect Hepatitis vaccination in the vegetable market ]. MMW Fortschr. Med., 2003 ... 

Ambirix (contains recombinant hepatitis Vaccination against Glaxo SmithKiine... 

However, infections from other viruses present significant risks. The hepatitis viruses (A, B, C, and D) became recognized as very real hazards for laboratory workers who handled human specimens, particularly blood. The risk of hepatitis infections from exposure to materials containing these viruses is much greater than the risk from HIV. Remarkably, a recent report indicated dramatic reductions in acute hepatitis infections, principally due to strong vaccination programs for children for hepatitis A and B—a clear illustration of the need for hepatitis vaccination for laboratory workers exposed to human specimens. See Special Topic 43.3.1 Chemical Analysis of Human Specimens. 

The antimicrobial thimerosal is used as a preservative in hepatitis vaccines. Two degradation compounds (dithiosalicylic acid, thiosalicylic acid) were separated h om their parent on a C g column (A = 226 nm) using a 65/35/0.9 methanol/water/ H3PO4 mobile phase [559]. Elution was complete in 12 min. A calibration curve from 20 to 80 g/mL was used and a 5 g/mL detection limit (S/N = 3) was rqiorted. 

The schedule and method of implementation, method of compliance, hepatitis vaccination, post-exposure evaluation and follow-up, communication of hazards and record keeping required by 29 CFR 1910.1904 and 1030. 

Following the medical evaluation, the healthcare professional will provide a written opinion to our company. The information in the opinion is limited to whether the employee requires the hepatitis vaccine, and if the vaccine was administered. The opinion letter further acknowledges that the employee has been informed of the medical evaluation results relating to the exposure and whether additional treatment is recommended. We give the employee a copy of the written opinion within 15 days after the evaluation. 

---