The FDA has approved a new Japanese encephalitis vaccine (Ixiaro - Intercell/Novartis). It will replace JEVax (Sanofi Pasteur), which has had tolerability and safety problems and is no longer being manufactured.

No vaccines against tickborne encephalitis (TBE) or dengue are available in the US, but vaccines have been licensed in some other countries.

The heptavalent pneumococcal conjugate vaccine (Prevnar - Wyeth) previously approved by the FDA for prevention of invasive pneumococcal disease in infants and children (Medical Letter 2000; 42:25) has now also been approved for prevention of otitis media. Infants and young children have higher antibody responses to the heptavalent conjugate vaccine (PCV7) than to the older 23-valent pneumococcal polysaccharide vaccine (PPV23) used in adults and older children (D Murray and C Jackson, Mil Med 2002; 167:671).

View the Expanded Table: Some Vaccines for Travelers

The FDA has warned that the antiepileptic and mood-stabilizing drug lamotrigine (Lamictal, and generics) can rarely cause hemophagocytic lymphohistiocytosis (HLH), a serious and potentially fatal immune-related reaction.1HLH, which can be familial, occurs most often in infants, but can occur at any age. Often induced by Epstein-Barr Virus infection (HIV infection and non-Hodgkin's lymphoma are other common triggers), HLH is characterized by an unremitting activation of CD8+ T cells and macrophages.2 If untreated, it causes organ damage, particularly in the liver, bone marrow, and CNS; organ...

The FDA has licensed 4 new monovalent vaccines for prevention of respiratory illness caused by a new influenza A H1N1 virus that appears to be derived from a swine strain. The 5th vaccine should be licensed soon. All of these vaccines are expected to become available in October. An intranasal formulation is expected in the first week of October.

The FDA has licensed Adacel (Aventis Pasteur) and Boostrix (GlaxoSmithKline), two new combination vaccines that include tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap), for use as a booster in adolescents and adults. In the past, older children and adults were not re-immunized against pertussis because of concerns about reactions to the whole-cell vaccine previously used in younger children. The CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) have recommended that either of the new Tdap vaccines replace routine...

immune globulin (human) has been available for many years in an intramuscular (IM) formulation for prevention of Rh isoimmunization in pregnant Rh-negative women (Medical Letter, 16:3, 1974). Recently, the US Food and Drug Administration (FDA) approved the first intravenous (IV) immune globulin preparation (WinRho SD - Univax), not only for preventing Rh isoimmunization, but also for treatment of immune thrombocytopenic purpura (ITP) in Rh-positive patients.

Three products are currently available in the US for treatment of high-risk,1 nonhospitalized adults with mild to moderate COVID-19: oral ritonavir-boosted nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and oral molnupiravir (Lagevrio). Remdesivir is FDA-approved for such use; nirmatrelvir/ritonavir and molnupiravir are available under an FDA Emergency Use Authorization. Because the pivotal clinical trials of these products for outpatient use were conducted in patients who were not vaccinated against COVID-19, some clinicians have questioned whether they can benefit vaccinated...