Vaccines licensed

Public Health Agency of Canada licensed vaccines www.phac-aspc.gc.ca/dpg-eng. php vaccines Licensed vaccines used in Canada... 

Oral vaccines that are licensed for human administration are limited. Presently, there are few oral vaccines licensed for human use (Table 11.2), although many orally administered vaccine candidates are in development. Live attenuated oral polio (OPV) is the vaccine of choice for the prevention of poliomyelitis... 

Reports on adverse events after the administration of the two hepatitis B vaccines licensed in the US (Engerix-B and Recombivax HB) have been compared in two different surveillance systems VAERS and Vaccine Safety Datalink (VSD) (8). VSD is a computerized record linkage system designed to allow more rigorous evaluation of... 

The remaining vaccinia vaccine licensed in the United States (Dryvax, manufactured by Wyeth, Philadelphia, Pa.) is a live, infectious virus prepared from calf lymph. Like all smallpox vaccines that were marketed in the United States, it derived from the NYCBOH strain and contains 108 plaque-forming units per milliliter. Current vaccinia vaccine stocks (> 12 million doses) are held by the CDC. It must be noted that the potency of several lots of this lyophilized vaccine has fallen. Pharmaceutical companies in the United States lack interest in manufacturing new lots of vaccine, owing to the absence of a profitable retail market, antiquation of calf-lymph production techniques and facilities, and the manufacturer s legal liability for vaccination complications. 

Samples and control materials were from lots of vaccines licensed in the U.S.A. by the FDA. 

Biologicals. Figure 4 Licensed human vaccines. From Immunity Immune Response in Inflammatory Disease by DeFranco, Locksley and Robertson [2]. 

A large and rapidly growing number of clinical trials (phase I and phase II) evaluating the potential of DNA vaccines to treat and prevent a variety of human diseases are currently being performed ( http // clinicaltrials.gov) however, there is yet no licensed DNA vaccine product available for use in humans. The clinical trials include the treatment of various types of cancers (e.g., melanoma, breast, renal, lymphoma, prostate, and pancreas) and also the prevention and therapy of infectious diseases (e.g., HIV/ABDS, malaria, Hepatitis B vims, Influenza vims, and Dengue vims). So far, no principally adverse effects have been reported from these trials. The main challenge for the development of DNA vaccines for use in humans is to improve the rather weak potency. DNA vaccines are already commercially available for veterinary medicine for prevention of West Nile Vims infections in horses and Infectious Hematopoetic Necrosis Vims in Salmon. 

Haemophilus influenzae type b (Hib) conjugate vaccine. Three Hib conjugate vaccines are licensed for infant use. If PRP-OMP (PedvaxHIB or ComVax) is administered at ages 2 and 4 months, a dose at age 6 months is not required. DTaP/Hib combination products should not be used for primary immunization in infants at ages 2, 4 or 6 months, but can be used as boosters following any Hib vaccine. 

Viruses are the most common cause of diarrheal illness in the world. A live, oral vaccine is licensed and recommended for use in infants for the prevention of rotavirus infection. 

Rifaximin is likely to be effective in the treatment of milder forms of shigellosis and has been shown to be effective at preventing infection owing to S. flexneri.10 Antimotility agents are not recommended because they can worsen dysentery and may be related to the development of toxic megacolon. No vaccines are licensed currently for the prevention of shigellosis. 

Hepatitis A vaccine was licensed in the United States in 1995. It is an inactivated whole virus vaccine that is administered in a... 

Prior to measles vaccine availability the number of cases of measles approached the birth rate of approximately 3 to 4 million annually. The first measles vaccine was licensed in 1963. Since that time there has been a 99% reduction in reported measles cases. Currently, there is a goal to eliminate measles transmission in the United States through aggressive immunization programs. 

Streptococcus pneumoniae is the most common bacterial cause of community-acquired respiratory tract infections. S. pneumoniae causes approximately 3000 cases of meningitis, 50,000 cases of bacteremia, 500,000 cases of pneumonia, and over 1 million cases of otitis media each year. The increasing prevalence of drug-resistant S. pneumoniae has highlighted the need to prevent infection through vaccination. Both licensed pneumococcal vaccines are highly effective in preventing disease from the common S. pneumoniae serotypes that cause human disease. 

The first rotavirus vaccine was a tetravalent rhesus rotavirus strain. It was licensed in the United States in 1998 and subsequently withdrawn from the market due to an association with intussusception. A pentavalent human-bovine reassortant rotavirus vaccine was approved by the FDA in February 2006. The exact mechanism by which the vaccine produces an immune response is unknown however, this live virus vaccine replicates in the small intestines and induces immunity. 

Many factors have to be considered when developing combination vaccines. First the selected components need to be given on a similar schedule and all components should already be licensed in the United States. The excipients contained in the individual vaccines may interfere with another component when combined, altering a component s immunogenicity. Finally, the immunogenicity of the combination must be similar (within 10%) to the immune response when the components are administered separately. This has been problematic with combinations containing Haemophilus influenza type b vaccine, for which the immune response has been significantly blunted in some combinations.13... 

Most vaccines are administered in two- to four-shot series in order to elicit the best protection. Childhood and adult immunization schedules are revised frequently and published annually by the CDC Advisory Committee on Immunization Practices. Current immunization schedules can be found at www.cdc.gov/nip/. The childhood schedule is published in January and the adult schedule in October of each year. Recommendations will be published throughout the year in the Morbidity and Mortality Weekly Report (MMWR) as new vaccines are licensed or new information necessitates a change in previous recommendations. 

In 1902 Congress passed the Biologies Control Act, which licensed and regulated the interstate sale of serums and vaccines used to prevent and treat diseases in humans. The effect of this would seem obvious because, after much discussion before the Committee on Interstate and Foreign Commerce, the final result was passage of the Federal Food, Drug, and Cosmetic Act of 1906 [2]. This bill was signed into law by President Theodore Roosevelt on June 30, 1906 [3]. The Meat... 

ISCOMs are stable (non-covalent) complexes composed of a mixture of Quil A, cholesterol and (an amphipathic) antigen. ISCOMs stimulate both humoral and cellular immune responses and have been used in the production of some veterinary vaccines. Their use in humans, however, has not been licensed so far, mainly due to safety concerns relating to the Quil A component. 

Two inactivated virus vaccines are currently licensed in the United States, Havrix and Vaqta. Approved dosing recommendations are shown in Table 25-3. Seroconversion rates >94% are achieved with the first dose. 

This schedule indicates the recommended ages for routine administration of currently licensed childhood vaccines, as of December 1,2006, for children aged 0-6 years. Additional information is available at http //www.cdc.gov/nip/recs/child-schedule.htm. Any dose not administered at the recommended age should be administered at any subsequent visit, when indicated and feasible. Additional vaccines may be licensed and recommended during the year. Licensed combination vaccines may be used whenever any components of the combination are indicated and other components of the vaodne are... 

These schedules indicate the recommended age groups and medical indications for which administration of currently licensed vaccines is commonly indicated for adults ages 19 years and older, as of October 1,2007, Licensed combination vaccines maybe used whenever any components of toe combination are indicated and when the vaccine s other components are not contraindicated. For detailed recommendations on all vaccines, including those used primarily for travelers or that are issued during toe year, consult the manufacturers package inserts and the complete statements from toe Advisory Committee on Immunization Practices (wmcdc.gov/vaccines/pubs/acip-list.htm). ... 

The quadrivalent human papillomavirus vaccine is recommended as a three-dose series (0, 2, and 6 months) for all females 11 to 12 years old. The vaccine is licensed for females 9 to 26 years of age. 

Two types of trivalent poliovirus vaccines are currently licensed for distribution in the United States an enhanced inactivated vaccine (IPV) and a live attenuated, oral vaccine (OPV). IPV is the recommended vaccine for the primary series and booster dose for children in the United States, whereas OPV is recommended in areas of the world that have circulating poliovirus. 

Drugs There is an antitoxin stored at the CDC. To arrange to use this antitoxin, call your state health department (or CDC at 404-639-2206 or 404-639-3753 workdays, or call weekends or evenings at 404-639-2888). This chemotherapy (antitoxin) available from CDC is a licensed trivalent equine antitoxin for serotypes A, B, and E. There is no reversal of botulism disease with this drug, but the antitoxin does usually prevent further nerve damage. The U.S. Department of Defense (DOD) has a heptavalent equine despeciated antitoxin for serotypes A - G (IND). DOD also has pentavalent toxoid (vaccine) for serotypes A - E (IND). The currently recommended schedule is for use at zero, two, and twelve weeks with a one year booster. This vaccine is supposed to induce solidly protective antitoxin levels in greater that 90 percent of those vaccinated after one year. Contact USAMRIID, (U.S. Army Medical Research Institute of Infectious Diseases), Fort Detrick, Maryland. Tel. 301-619-2833. 

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