Merck Obtains Exclusive Rights to Market and Distribute MassBiologics' Tetanus-Diphtheria (Td) Vaccine in the U.S.
Last update: 4/21/2010 7:30:00 AM
Merck's Adult Vaccine Portfolio Now Includes 9 of the 10 Vaccines on the U.S. CDC's Recommended Adult Immunization Schedule BOSTON & WHITEHOUSE STATION, N.J., Apr 21, 2010 (BUSINESS WIRE) --
MassBiologics (MBL) of the University of Massachusetts Medical School and Merck & Co., Inc. (MRK) announced today that they have entered into an agreement that provides Merck with exclusive rights to market and distribute MBL's tetanus and diphtheria toxoids adsorbed (Td) vaccine in the United States, with the exception of Massachusetts, where MBL will continue distributing the vaccine. Merck plans to begin distributing the Td vaccine in June 2010. Specific financial details of the agreement were not disclosed.
"Adult vaccination is an important element in Merck's commitment to help people be well, and we are delighted to partner with MBL to add tetanus-diphtheria vaccine to our broad U.S. portfolio of adult vaccines," said Soren Bo Christiansen, M.D., senior vice president and general manager, Adolescent & Adult Vaccines, Merck Vaccines.
"This agreement is another example of how Merck engages in partnerships that will enable us to bring the most robust portfolio of products to our customers." MassBiologics' Td vaccine was licensed by the U.S. Food and Drug Administration (FDA) in 1970. The vaccine is indicated for active immunization for the prevention of tetanus and diphtheria and is approved for use in people seven years of age and older.
The U.S. Centers for Disease Control and Prevention (CDC) recommends that adults 19 years of age and older with an uncertain or incomplete history of receiving the primary vaccination series of three doses of Td vaccine should begin or complete the Td primary vaccination series, and that adults who have not had a Td booster shot in 10 years or more should be vaccinated. Adults 19 years of age and older should receive a booster dose of Td vaccine every 10 years.
Tdap (tetanus, diphtheria, and acellular pertussis) vaccine should replace a single dose of Td for adults aged 19--64 years who have not received a dose of Tdap previously, to additionally help protect them against pertussis disease. Tetanus and diphtheria can be serious diseases Cases of tetanus and diphtheria have been drastically reduced in the U.S. since the introduction of vaccines, but people can still be at risk for these diseases.
The bacteria that cause tetanus are found in soil and can enter the body through any cut or wound. Tetanus is not spread from person to person. Because tetanus bacteria are widespread in the environment, vaccination is an important way to protect against tetanus. Almost all cases of tetanus occur in people who have never been vaccinated or who have not had a tetanus booster shot within the preceding 10 years. Tetanus, sometimes called "lockjaw," is a bacterial infection affecting the nervous system. It causes severe muscle spasms that can lead to, among other things, "locking" of the jaw so a person cannot open his/her mouth or swallow. Symptoms include stiffness in the neck, rigidity of abdominal muscles, difficulty with breathing and swallowing, and muscle spasms can cause fractures of the spine and long bones.
According to the CDC, approximately 1 out of 5 cases of tetanus are fatal. Diphtheria is rare in the U.S. due to widespread use of diphtheria-containing vaccines; however, these bacteria are still a concern. Diphtheria continues to occur in other parts of the world. Diphtheria is caused by bacteria that can be passed from an infected person to others by coughing or sneezing. Early symptoms of diphtheria include sore throat, mild fever and chills. Usually the disease causes a thick coating at the back of the throat that makes it difficult to breathe or swallow, and may cause serious breathing problems. The most common complications are inflammation of the heart that can lead to abnormal heart rhythms, and inflammation of the nerves, which can cause temporary paralysis of some muscles.
Diphtheria bacteria not only affects the throat, but can also infect other areas of the body, such as the nose, eye, and skin. Important information about tetanus-diphtheria vaccine The tetanus diphtheria vaccine is contraindicated in patients with hypersensitivity to any component of the vaccine or who have had a severe allergic reaction after a previous dose of this vaccine or any other Td vaccine. Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive the Td vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.
If Guillain-Barre Syndrome occurred within six weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of the Td vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. The most common local adverse reactions associated with Td vaccine may include erythema (redness), tenderness, and swelling at the injection site.
Common systemic reactions may include headache, malaise, and temperature elevations.
DRW