Attenuvax Measles Virus Vaccine Live/Mosby's

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Measles Virus Vaccine Live (001703)

CATEGORIES:

Indications: Immunization, measles

Pregnancy Category C

WHO Formulary

FDA Pre 1938 Drugs

FDA DRUG CLASS: Vaccines/Antisera

BRAND NAMES: Attenuvax (US); Diplovax (South-Africa); Ervevax (Mexico);

Lirugen (Korea); Lirugen Measles (Philippines); M-VAC (India); Mevilin-L

(Malaysia, Israel); Morbilvax (Thailand, Taiwan); Rimevax (Bahrain, Cyprus,

Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar,

Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Belgium,

Austria, Italy, Switzerland, Bulgaria, Spain, Philippines, Thailand,

Taiwan, South-Africa); Rouvax (Benin, Burkina-Faso, Ethiopia, Gambia,

Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania,

Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone,

South-Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe, France,

Hong-Kong, Taiwan, Thailand, Israel);

(International brand names outside U.S. in italics)

DESCRIPTION:

Attenuvax (Measles Virus Vaccine Live) is a live virus vaccine for

immunization against measles (rubeola).

Attenuvax is a sterile lyophilized preparation of a more attenuated line of

measles virus derived from Enders' attenuated Edmonston strain. The further

modification of the virus in Attenuvax was achieved in the Merck Institute

for Therapeutic Research by multiple passage of Edmonston strain virus in

cell cultures of chick embryo at low temperature.

The reconstituted vaccine is for subcutaneous administration. When

reconstituted as directed, the dose for injection is 0.5 ml and contains

not less than the equivalent of 1,000 TCID50 (tissue culture infectious

doses) of the U.S. Reference Measles Virus. Each dose also contains

approximately 25 mcg of neomycin. The product contains no preservative.

Sorbitol and hydrolized gelatin are added as stabilizers.

CLINICAL PHARMACOLOGY:

Measles virus vaccine produces a modified measles infection in susceptible

persons. Fever and rash may appear. Extensive clinical trials have

demonstrated that measles virus vaccine is highly immunogenic and generally

well tolerated.1-5 A single injection of the vaccine has been shown to

induce measles hemagglutination-inhibiting (HI) antibodies in 97 percent or

more of susceptible persons. Vaccine-induced antibody levels have been

shown to persist for at least 13 years without substantial decline.6

Continued surveillance will be necessary to determine further duration of

antibody persistence.

INDICATIONS AND USAGE:

Measles virus vaccine is indicated for immunization against measles

(rubeola) in persons 15 months of age or older. A second dose of measles

virus vaccine is recommended (see Revaccination ).7,8,9 Infants who are

less than 15 months of age may fail to respond to the vaccine due to

presence in the circulation of residual measles antibody of maternal

origin; the younger the infant, the lower the likelihood of seroconversion.

In geographically isolated or other relatively inaccessible populations for

whom immunization programs are logistically difficult, and in population

groups in which natural measles infection may occur in a significant

proportion of infants before 15 months of age, it may be desirable to give

the vaccine to infants at an earlier age. Infants vaccinated under these

conditions at less than 12 months of age should be revaccinated after

reaching 15 months of age. There is some evidence to suggest that infants

immunized at less than one year of age may not develop sustained antibody

levels when later reimmunized. The advantage of early protection must be

weighed against the chance for failure to respond adequately on

reimmunization.10,11

According to ACIP recommendations, most persons born in 1956 or earlier are

likely to have been infected naturally and generally need not be considered

susceptible. All children, adolescents, and adults born after 1956 are

considered susceptible and should be vaccinated, if there are no

contraindications. This includes persons who may be immune to measles but

who lack adequate documentation of immunity as evidenced by: (1)

physician-diagnosed measles, (2) laboratory evidence of measles immunity,

or (3) adequate immunization with live measles vaccine on or after the

first birthday.12

Measles virus vaccine given immediately after exposure to natural measles

may provide some protection. If, however, the vaccine is given a few days

before exposure, substantial protection may be provided.

Individuals planning travel outside the United States, if not immune, can

acquire measles, mumps or rubella and import these diseases to the United

States. Therefore, prior to International travel, individuals known to be

susceptible to one or more of these diseases can receive either a single

antigen vaccine (measles, mumps or rubella), or a combined antigen vaccine

as appropriate. However, M-M-R* II (Measles, Mumps, and Rubella Virus

Vaccine Live) is preferred for persons likely to be susceptible to mumps

and rubella; and if single-antigen measles vaccine is not readily

available, travelers should receive M-M-R II (Measles, Mumps, and Rubella

Virus Vaccine Live) regardless of their immune status to mumps or

rubella.13,14,15

Revaccination: Children first vaccinated when younger than 12 months of age

should be revaccinated at 15 months of age, particularly if vaccine was

administered with immune serum globulin or measles immune globulin, a

standardized globulin preparation.

The American Academy of Pediatrics (AAP), the Immunization Practices

Advisory Committee (ACIP), and some state and local health agencies have

recommended guidelines for routine measles revaccination and to help

control measles outbreaks.16,17*

Vaccines available for revaccination include monovalent measles vaccine and

polyvalent vaccines containing measles (e.g., M-M-R II (Measles, Mumps, and

Rubella Virus Vaccine Live), M-R-VAX II (Measles and Rubella Virus Vaccine

Live)). If the prevention of sporadic measles outbreaks is the sole

objective, revaccination with a monovalent measles vaccine should be

considered. If concern also exists about immune status regarding mumps or

rubella, revaccination with appropriate monovalent or polyvalent vaccines

should be considered after consulting the appropriate product circulars.

Unnecessary doses of a vaccine are best avoided by ensuring that written

documentation of vaccination is preserved and a copy given to each

vaccinee's parent or guardian.

Despite the risk of reactions (see ADVERSE REACTIONS), persons born since

1956 who have previously been given inactivated vaccine alone or followed

by live vaccine within 3 months should be revaccinated with live vaccine to

reduce the risk of the severe atypical form of natural measles that may

occur.10,12

Use with other Vaccines: Routine administration of DTP (diphtheria,

tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concomitantly with

measles, mumps and rubella vaccines is not recommended because there are

insufficient data relating to the simultaneous administration of these

antigens. However, the American Academy of Pediatrics has noted that in

some circumstances, particularly when the patient may not return, some

practitioners prefer to administer all these antigens on a single day. If

done, separate sites and syringes should be used for DTP and measles virus

vaccine.18

Measles virus vaccine should not be given less than one month before or

after administration of other virus vaccines.

CONTRAINDICATIONS:

Do not give measles virus vaccine to pregnant females; the possible effects

of the vaccine on fetal development are unknown at this time. If

vaccination of postpubertal females is undertaken, pregnancy should be

avoided for three months following vaccination (see PRECAUTIONS, Pregnancy

).

Anaphylactic or anaphylactoid reactions to neomycin (each dose of

reconstituted vaccine contains approximately 25 mcg of neomycin).

History of anaphylactic or anaphylactoid reactions to eggs (see

Hypersensitivity To Eggs).

Any febrile respiratory illness or other active febrile infection.

Active untreated tuberculosis.

Patients receiving immunosuppressive therapy. This contraindication does

not apply to patients who are receiving corticosteroids as replacement

therapy, (e.g., for 's disease).

Individuals with blood dyscrasias, leukemia, lymphomas of any type, or

other malignant neoplasms affecting the bone marrow or lymphatic systems.

Primary and acquired immunodeficiency states, including patients who are

immunosuppressed in association with AIDS or other clinical manifestations

of infection with human immunodeficiency viruses;19,20 cellular immune

deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.

Individuals with a family history of congenital or hereditary

immunodeficiency, until the immune competence of the potential vaccine

recipient is demonstrated.21

*NOTE: A primary difference among these recommendations is the timing of

revaccination: the ACIP recommends routine revaccination at entry into

kindergarten or first grade, whereas the AAP recommends routine

revaccination at entrance to middle school or junior high school. In

addition, some public health jurisdictions mandate the age for

revaccination. The complete text of applicable guidelines should be

consulted.16,17

Hypersensitivity To Eggs

Live measles vaccine is produced in chick embryo cell culture. Persons with

a history of anaphylactic, anaphylactoid or other immediate reactions

(e.g., hives, swelling of the mouth and throat, difficulty breathing,

hypotension and shock) subsequent to egg ingestion should not be

vaccinated. Evidence indicates that persons are not at increased risk if

they have egg allergies that are not anaphylactic or anaphylactoid in

nature. Such persons should be vaccinated in the usual manner. There is no

evidence to indicate that persons with allergies to chickens or feathers

are at increased risk of reaction to the vaccine.12

PRECAUTIONS:

General

Adequate treatment provisions including epinephrine, should be available

for immediate use should an anaphylactic or anaphylactoid reaction occur.

Due caution should be employed in administration of measles vaccine to

persons with a history of cerebral injury, individual or family histories

of convulsions, or of any other condition in which stress due to fever

should be avoided. The physician should be alert to the temperature

elevation which may occur following vaccination. (See ADVERSE REACTIONS.)

Children and young adults who are known to be infected with human

immunodeficiency viruses but without overt clinical manifestations of

immunosuppression may be vaccinated; however, the vaccinees should be

monitored closely for vaccine-preventable diseases because immunization may

be less effective than for uninfected persons.19,20

Vaccination should be deferred for at least 3 months following blood or

plasma transfusions, or administration of human immune serum globulin.

There are no reports of transmission of live attenuated measles virus from

vaccinees to susceptible contacts.

It has been reported that attenuated measles virus vaccine live, may result

in a temporary depression of tuberculin skin sensitivity.10 Therefore, if a

tuberculin test is to be done, it should be administered either before or

simultaneously with measles virus vaccine.

Children under treatment for tuberculosis have not experienced exacerbation

of the disease when immunized with live measles virus vaccine;22 no studies

have been reported to date of the effect of measles virus vaccines on

untreated tuberculous children.

As for any vaccine, vaccination with measles virus vaccine may not result

in seroconversion in 100% of susceptible persons given the vaccine.

Pregnancy Category C

Animal reproduction studies have not been conducted with measles virus

vaccine. It is also not known whether measles virus vaccine can cause fetal

harm when administered to a pregnant woman or can affect reproduction

capacity. Therefore, the vaccine should not be administered to pregnant

females; furthermore, pregnancy should be avoided for three months

following vaccination (see CONTRAINDICATIONS).

Reports have indicated that contracting of natural measles during pregnancy

enhances fetal risk. Increased rates of spontaneous abortion, stillbirth,

congenital defects and prematurity have been observed subsequent to natural

measles during pregnancy. There are no adequate studies of the attenuated

(vaccine) strain of measles virus in pregnancy. However, it would be

prudent to assume that the vaccine strain of virus is also, capable of

inducing adverse fetal effects for up to three months following

vaccination.

Vaccine administration to postpubertal females entails a potential for

inadvertent immunization during pregnancy. Theoretical risks involved

should be weighed against the risks that measles poses to the unimmunized

adolescent or adult. Advisory committees reviewing this matter have

recommended vaccination of postpubertal females who are presumed to be

susceptible to measles and not known to be pregnant. If a measles exposure

occurs during pregnancy, one should consider the possibility of providing

temporary passive immunity through the administration of immune globulin

(human).

Nursing Mothers

It is not known whether measles vaccine virus is secreted in human milk.

Therefore, because many drugs are excreted in human milk, caution should be

exercised when measles virus vaccine is administered to a nursing woman.

ADVERSE REACTIONS:

Burning and/or stinging of short duration at the injection site have been

reported.

Anaphylaxis and anaphylactoid reactions have been reported.

Occasional

Moderate fever (101° - 102.9°F (38.3° - 39.4°C)) may occur during the month

after vaccination. Generally, fever, rash, or both appear between the 5th

and the 12th days. Cough and rhinitis have also been reported. Rash, when

it occurs, is usually minimal, but rarely may be generalized. Erythema

multiforme has also been reported rarely.

Less Common

High fever (over 103°F (39.4°C)).

Mild lymphadenopathy has been reported.

Rare

Reactions at injection site. Allergic reactions such as wheal and flare at

the injection site or urticaria have been reported.

Diarrhea has been reported after vaccination with measles-containing

vaccines.

Children developing fever may, on rare occasions, exhibit febrile

convulsions. Afebrile convulsions or seizures have occurred rarely

following vaccination with live attenuated measles vaccine. Syncope,

particularly at the time of mass vaccination, has been reported.

Thrombocytopenia and purpura have occurred rarely.

Vasculitis has been reported rarely.

Forms of optic neuritis, including retrobulbar neuritis, papillitis, and

retinitis may infrequently follow viral infections, and have been reported

to occur 1 to 3 weeks following inoculation with some live virus vaccines.

Experience from more than 80 million doses of all live measles vaccines

given in the U.S. through 1975 indicates that significant central nervous

system reactions such as encephalitis and encephalopathy occurring within

30 days after vaccination, have been temporally associated with measles

vaccine very rarely.23 In no case has it been shown that reactions were

actually caused by vaccine.24 The Center for Disease Control has pointed

out that " a certain number of cases of encephalitis may be expected to

occur in a large childhood population in a defined period of time even when

no vaccines are administered " .25 However the data suggest the possibility

that some of these cases may have been caused by measles vaccines. The risk

of such serious neurological disorders following live measles virus vaccine

administration remains far less than that for encephalitis and

encephalopathy with natural measles (one per two thousand reported

cases).26

There have been rare reports of ocular palsies, Guillain-Barre syndrome, or

ataxia occurring after immunization with vaccines containing live

attenuated measles virus. The ocular palsies have occurred approximately

3-24 days following vaccination. No definite causal relationship has been

established between these events and vaccination.

There have been reports of subacute sclerosing panencephalitis (SSPE) in

children who did not have a history of natural measles but did receive

measles vaccine. Some of these cases may have resulted from unrecognized

measles in the first year of life or possibly from the measles vaccination.

Based on estimated nationwide measles vaccine distribution, the association

of SSPE cases to measles vaccination is about one case per million vaccine

doses distributed. This is far less than the association with natural

measles, 6-22 cases of SSPE per million cases of measles. The results of a

retrospective case-controlled study conducted by the Center for Disease

Control suggest that the overall effect of measles vaccine has been to

protect against SSPE by preventing measles with its inherent higher risk of

SSPE.27

Local reactions characterized by marked swelling, redness and vesiculation

at the injection site of attenuated live virus measles vaccines, and

systemic reactions including atypical measles, have occurred in persons who

have previously received killed measles vaccine. Rarely, more severe

reactions that require hospitalization, including prolonged high fevers,

panniculitis, and extensive local reactions, have been reported.12,28

DOSAGE AND ADMINISTRATION:

For Subcutaneous Administration

Do not inject intravenously

The dosage of vaccine is the same for all persons. Inject the total volume

of the single dose vial (about 0.5 ml) or 0.5 ml of the multiple dose vial

of reconstituted vaccine subcutaneously, preferably into the outer aspect

of upper arm. Do not give immune globulin (IG) concurrently with measles

virus vaccine.

During shipment, to insure that there is no loss of potency, the vaccine

must be maintained at a temperature of 10°C (50°F) or less.

Before reconstitution, store measles virus vaccine at 2° - 8°C (36° -

46°F). Protect from light.

Caution: A sterile syringe free of preservatives, antiseptics, and

detergents should be used for each injection and/or reconstitution of the

vaccine because these substances may inactivate the live virus vaccine. A

25 gauge, 5/8 " needle is recommended.

To reconstitute, use only the diluent supplied, since it is free of

preservatives or other antiviral substances which might inactivate the

vaccine.

Single Dose Vial: First withdraw the entire volume of diluent into the

syringe to be used for reconstitution. Inject all the diluent in the

syringe into the vial of lyophilized vaccine, and agitate to mix

thoroughly. Withdraw the entire contents into a syringe and inject the

total volume of restored vaccine subcutaneously.

It is important to use a separate sterile syringe and needle for each

individual patient to prevent transmission of hepatitis B and other

infectious agents from one person to another.

10 Dose Vial (available Only To Government Agencies/Institutions)

Withdraw the entire contents (7 ml) of the diluent vial into the sterile

syringe to be used for reconstitution, and introduce into the 10 dose vial

of lyophilized vaccine. Agitate to ensure thorough mixing. The outer

labeling suggests " For Jet Injector or Syringe Use " . Use with separate

sterile syringes is permitted for containers of 10 doses or less. The

vaccine and diluent do not contain preservatives; therefore, the user must

recognize the potential contamination hazards and exercise special

precautions to protect the sterility and potency of the product. The use of

aseptic techniques and proper storage prior to and after restoration of the

vaccine and subsequent withdrawal of the individual doses is essential. Use

0.5 ml of the reconstituted vaccine for subcutaneous injection.

It is important to use a separate sterile syringe and needle for each

individual patient to prevent transmission of hepatitis B and other

infectious agents from one person to another.

50 Dose Vial (Available Only To Government Agencies/Institutions)

Withdraw the entire contents (30 ml) of diluent vial into the sterile

syringe to be used for reconstitution and introduce into the 50 dose vial

of lyophilized vaccine. Agitate to ensure thorough mixing. With full

aseptic precautions, attach the vial to the sterilized multidose jet

injector apparatus. Use 0.5 ml of the reconstituted vaccine for

subcutaneous injection.

Each dose of measles virus vaccine contains not less than 1,000 TCID50

(tissue culture infectious doses) of measles virus vaccine expressed in

terms of the assigned titer of the U.S. Reference Measles Virus.

Parenteral drug products should be inspected visually for particulate

matter and discoloration prior to administration. Measles virus vaccine,

when reconstituted, is clear yellow.

Storage

It is recommended that the vaccine be used as soon as possible after

reconstitution. Protect vaccine from light at all times, since such

exposure may inactivate the virus. Store reconstituted vaccine in the

vaccine vial in a dark place at 2° - 8°C (36° - 46°F) and discard if not

used within 8 hours.

REFERENCES:

1) Hilleman, M. R.; Buynak, E. B.; Weibel, R. E.; Stokes, J., Jr.; Whitman,

J. E., Jr.; Leagus, M. B.: Development and evaluation of the Moraten

measles virus vaccine, J. Amer. Med. Ass. 206: 587-590, Oct. 14, 1968. 2)

Swartz, T.; Klingberg, W.; Nishmi, M.; Goldblum, N.; Gerichter, C.; Yofe,

Y.; Cockburn, W. C.: A comparative study of four live measles vaccines in

Israel, Bull. WHO 39: 285-292, 1968. 3) Krugman, S.; Constantinides, P.;

Medovy, H.; Giles, J. P.: Comparison of two further attenuated live

measles-virus vaccines, Amer. J. Dis. Child.117: 137-138, Feb. 1969. 4)

Studies conducted under the direction of Dr. Conrado Ristori, National

Health Service, Santiago, Chile (Unpublished Data). 5) Studies conducted

under the direction of Dr. Victor Villarejos, Louisiana State University

International Center of Medical Research and Training, San , Costa Rica

(Unpublished Data). 6) Unpublished data: Files of Merck Sharp & Dohme

Research Laboratories. 7) Bottiger, M.; Christenson, B.; Romanus, V.;

Taranger, J.; Strandell, A.: Swedish experience of two dose vaccination

programme aiming at eliminating measles, mumps, and rubella, Brit. Med. J.

295 (14): 1264-1267, November 1987. 8) Markowitz, L. E.; Preblud, S. R.;

Orenstein, W. A.; et al: Patterns of transmission in measles outbreaks in

the United States, 1985-1986, N. Engl. J. Med. 320 (2): 75-81, January 12,

1989. 9) Peltola, H.; Heinonen, O. P.; Valle, M.; et al: Five-year

experience in elimination of indigenous measles, mumps, and rubella in

Finland, Abstracts of the 29th ICAAC, Houston, Texas, Abstract #179, 130,

September 1989. 10) American Academy of Pediatrics: Report of the Committee

on Infectious Disease, ton, III., 1982, p. 136, 137. 11) Wilkins, J.;

Wehrle, P. F.: Additional evidence against measles vaccine administration

to infants less than 12 months of age: Altered immune response following

active/passive immunization, J. Pediatric 94 (6): 865-869, June 1979. 12)

Recommendation of the Immunization Practices Advisory Committee (ACIP),

Measles Prevention, Morbidity and Mortality Weekly Report, 31 (17):

217-224, 229-231, May 7, 1982. 13) Recommendations of the Immunization

Practices Advisory Committee (ACIP), Measles Prevention, MMWR 36 (26):

409-425, July 10, 1987. 14) Jong, E. C., The Travel and Tropical Medicine

Manual, W. B. Saunders Company, p. 12-16, 1987. 15) Committee on

Immunization Council of Medical Societies, American College of Physicians,

Phila. PA, Guide for Adult Immunization, First Edition, 1985. 16) American

Academy of Pediatrics, Committee on Infectious Diseases, Measles:

Reassessment of the Current Immunization Policy, Pediatrics 84 (6):

1110-1113, Dec.1989. 17) Measles Prevention: Recommendations of the

Immunization Practices Advisory Committee (ACIP), Morbidity and Mortality

Weekly Report 38 (S-9): 5-22, December 29, 1989. 18) American Academy of

Pediatrics: Report of the Committee on Infectious Disease, ton,III.,

p. 17, 1982. 19) Center for Disease Control: Immunization of Children

Infected with Human T-Lymphotropic Virus Type

III/Lymphadenopathy-Associated Virus, ls of Internal Medicine, 106:

75-78, 1987. 20) Krasinski, K.; Borkowsky, W.; Krugman, S.: Antibody

following measles immunization in children infected with human T-cell

lymphotropic virus-type III/lymphadenopathy associated virus (HTLV-III/LAV)

(Abstract). In: Program and abstracts of the International Conference on

Acquired Immunodeficiency Syndrome, Paris, France, June 23-25, 1986. 21)

Recommendation of the Immunization Practices Advisory Committee (ACIP),

General Recommendation on Immunization, Morbidity and Mortality Weekly

Report 32 (1): 13, January 14, 1983. 22) Starr, S.; Berkovich, S.: The

effect of measles, gamma globulin modified measles, and attenuated measles

vaccine on the course of treated tuberculosis in children, Pediatrics 35:

97-102, Jan. 1965. 23) CDC. Important Information about Measles, Mumps, and

Rubella, and Measles, Mumps, and Rubella Vaccines. 1980. 1983. 24)

Recommendation of the Public Health Service Advisory Committee on

Immunization Practices, Morbidity and Mortality Weekly Report, 21 (25):

11-13, June 24, 1972. 25) CDC, Measles Surveillance, Report No. 8, p. 23,

December 1971. 26) CDC, Encephalitis Surveillance, p. 16, May 1981. 27)

CDC, Measles Surveillance Report No. 11, p. 14, September 1982. 28) Buck,

B. E.; Yang, L. C.; Caleb, M. H.; Greene, J. M.; South, M. A.: Measles

virus panniculitis subsequent to vaccine administration, J.Pediatrics 101

(3): 366-373, September, 1982.

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