Drugs Log

Merck & Co., Inc. said it voluntarily recalled 13 lots of its Hib vaccine given to ankle-biters to prevent meningitis and pneumonia as quality control found production equipment may not have been properly sterilised.

Merck recalled 11 lots of Pedvaxhib [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate)]. The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of Pedvaxhib and Comvax were distributed starting in April 2007.

The company said the recall is because it can not assure sterility of these specific vaccine lots. The potential contamination of these specific lots was identified as part of the company’s standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine.

The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because the company cannot assure the sterility of these specific lots of vaccine, it is conducting this recall.

Merck is working closely with the US Food and Drug Administration (FDA) and the US Centres for Disease Control and Prevention (CDC) to inform affected healthcare providers of this recall. The company is also communicating with public health authorities and healthcare providers in the US and in other countries where these lots were distributed, as appropriate.

“We are taking this action because we are committed to ensuring the quality of our vaccines,” said Mark Feinberg, MD, Ph.D., vice president, medical and policy affairs, Merck vaccines and infectious diseases. “We know that our vaccines can play an important role in the nation’s public health system, and we are committed to resolving this issue as quickly as possible to ensure that our vaccines are readily available.”

Physicians are advised not to administer any vaccine from the vaccine lots being recalled. Individuals who received vaccine from these lots should complete their immunization series with a Haemophilus b conjugate-containing vaccine not affected by this recall, but do not need to be revaccinated to replace a dose they received from a recalled lot. The efficacy of the vaccine was not affected, the company officials said in a press statement.

Pedvaxhib is indicated for routine vaccination against invasive disease caused by Haemophilius influenzae type b in infants and children two to 71 months of age. As with any vaccine, the use of Pedvaxhib may not result in a protective antibody response in all vaccines; Pedvaxhib may not induce protective antibody levels immediately following vaccination.

Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age born to HBsAg-negative mothers.

Comvax is contraindicated in patients with hypersensitivity to yeast or any component of the vaccine. Comvax included injection-site reactions, somnolence, irritability, crying, and fever.

As with other vaccines, Comvax may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.

General information about Haemophilus b Conjugate Vaccine

Some commonly used brand names in the U.S. and Canada are:

• Act-Hib
• Hibtiter
• Pedvaxhib
• Prohibit

Category: Immunizing agent, active

Description

Haemophilus b conjugate (hem-OFF-fil-us BEE KON-ja-gat) vaccine is an active immunizing agent used to prevent infection by Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Haemophilus b conjugate vaccine is an haemophilus b vaccine that has been prepared by adding a diphtheria-, meningococcal-, or tetanus-related substance. However, this vaccine does not take the place of the regular diphtheria or tetanus toxoid injections (for example, DTP, DT, or T) that children should receive, the regular tetanus toxoid or diphtheria and tetanus toxoid injections (for example T or Td) that adults should receive, or the meningococcal vaccine injection that some children and adults should receive.

Infection by Haemophilus influenza type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis, which affects the brain; epiglottitis, which can cause death by suffocation; pericarditis, which affects the heart; pneumonia, which affects the lungs; and septic arthritis, which affects the bones and joints. Hib meningitis causes death in 5 to 10% of children who are infected. Also, approximately 30% of children who survive Hib meningitis are left with some type of serious permanent damage, such as mental retardation, deafness, epilepsy, or partial blindness.

Immunization against Hib is recommended for all children 2 months up to 5 years of age (i.e., up to the 5th birthday).

Immunization against Hib may also be recommended for adults and children over 5 years of age with certain medical problems.

This vaccine is to be administered only by or under the supervision of your doctor or other authorized health care professional. It is available in the following dosage form:
Parenteral
Injection (U.S. and Canada)
Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For haemophilus b conjugate vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to haemophilus b conjugate vaccine, haemophilus b polysaccharide vaccine, diphtheria or tetanus toxoid, or meningococcal vaccine. Also tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—This vaccine has not been reported to cause problems in nursing babies.

Children—This vaccine is not recommended for children less than 2 months of age.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of this vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of haemophilus b conjugate vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
Fever or
Serious illness—The symptoms of the condition may be confused with some of the possible side effects of the vaccine
Proper Use of This Vaccine

Dosing—Haemophilus b conjugate vaccine is an haemophilus b vaccine that has been prepared by adding a diphtheria-, meningococcal-, or tetanus-related substance to it. If the vaccine was prepared using a diphtheria-related substance, it is called either HbOC or PRP-D. If the vaccine was prepared using a meningococcal-related substance, it is called PRP-OMP. If the vaccine was prepared using a tetanus-related substance, it is called PRP-T. All of these subtypes of haemophilus b conjugate vaccine work the same way , but may be given at different ages or times.

The dose of haemophilus b conjugate vaccine will be different for different patients. The following information includes only the average doses of haemophilus b conjugate vaccine.
For prevention of Haemophilus influenzae type b infection:
For HbOC or PRP-T injection dosage form:
Adults and children 5 years of age and older—Use and dose must be determined by your doctor.
Infants 2 to 6 months of age at the first dose—Three doses, two months apart, then a booster dose at fifteen months of age. The doses are injected into a muscle.
Children 7 to 11 months of age at the first dose—Two doses, two months apart, then a booster dose at fifteen months of age. The doses are injected into a muscle.
Children 12 to 14 months of age at the first dose—One dose, then a booster dose at fifteen months of age. The doses are injected into a muscle.
Children 15 to 59 months of age at the first dose—One dose injected into a muscle.
For PRP-D injection dosage form:
Adults and children 5 years of age and older—Use and dose must be determined by your doctor.
Infants and children up to 15 months of age—Use is not recommended.
Children 15 to 59 months of age at the first dose—One dose injected into a muscle.
For PRP-OMP injection dosage form:
Adults and children 5 years of age and older—Use and dose must be determined by your doctor.
Infants 2 to 6 months of age at the first dose—Two doses, two months apart, then a booster dose at twelve months of age. The doses are injected into a muscle.
Children 7 to 11 months of age at the first dose—Two doses, two months apart, then a booster dose at fifteen months of age. The doses are injected into a muscle.
Children 12 to 14 months of age at the first dose—One dose, then a booster dose at fifteen months of age. The doses are injected into a muscle.
Children 15 to 59 months of age at the first dose—One dose injected into a muscle.
After Receiving This Vaccine

This vaccine may interfere with laboratory tests that check for Hib disease. Make sure your doctor knows that you have received Hib vaccine if you are treated for a severe infection during the 2 weeks after you receive this vaccine.

Side Effects of This Vaccine

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

Symptoms of allergic reactions

Difficulty in breathing or swallowing; hives; itching (especially of feet or hands); reddening of skin (especially around ears); swelling of eyes, face, or inside of nose; unusual tiredness or weakness (sudden and severe)

Check with your doctor immediately if the following side effect occurs:

Rare

Convulsions (seizures)

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Fever of up to 102 °F (39 °C) (usually lasts less than 48 hours); irritability; loss of appetite; lack of interest; redness at place of injection; reduced physical activity; tenderness at place of injection; tiredness

Less common

Diarrhea; fever over 102 °F (39 °C) (usually lasts less than 48 hours); hard lump, swelling, or warm feeling at place of injection; skin rash; vomiting

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

General information about Comvax Vaccine (Haemophilus B Conjugate/Hepatitis B Vaccine)

Brand Name: Comvax

Comvax Vaccine is used for:

Preventing infection caused by Haemophilus influenzae type B bacteria and hepatitis B virus.

Comvax Vaccine is a vaccine. It works by stimulating the body to produce antibodies against Haemophilus influenzae type B bacteria and hepatitis B virus.

Do NOT use Comvax Vaccine if:

• you are allergic to any ingredient in Comvax Vaccine
• you have a fever

Contact your doctor or health care provider right away if any of these apply to you.

Before using Comvax Vaccine:

Some medical conditions may interact with Comvax Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have an infection, heart or lung problems, multiple sclerosis, a bleeding disorder (eg, hemophilia), low platelet counts, or cancer
if you have a weakened immune system or are taking an immunosuppressive medicine (eg, cyclosporine)

Some MEDICINES MAY INTERACT with Comvax Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:
Immunosuppressive medicines (eg, cyclosporine) because they may decrease Comvax Vaccine’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Comvax Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Comvax Vaccine:

Use Comvax Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Comvax Vaccine is usually administered as an injection at your doctor’i??s office, hospital, or clinic.
If Comvax Vaccine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
If you miss a dose of Comvax Vaccine, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Comvax Vaccine.
Important safety information:
Comvax Vaccine may cause fever, irritability, and redness, tenderness, or a lump at the injection site. These symptoms should go away within 1 to 2 days.
This medicine is not recommended for use in CHILDREN younger than 6 weeks of age or older than 15 years of age. Safety and effectiveness in these age groups have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Comvax Vaccine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Comvax Vaccine is excreted in breast milk. If you are or will be breast-feeding while you are using Comvax Vaccine, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Comvax Vaccine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Crying; irritability; loss of appetite; low-grade fever; redness, tenderness, or a lump at the injection site; sleepiness; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); high fever (above 103 degrees F).