The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary series with any COVID-19 vaccine ≥6 months previously and are unable or unwilling to receive a booster dose of a bivalent mRNA vaccine. The Novavax vaccine is not authorized for use in persons who have received a booster dose of any other COVID-19 vaccine.

A recombinant quadrivalent human-papillomavirus-like particle vaccine, Gardasil (Merck), has been approved by the FDA for use in girls and women 9-26 years old to prevent diseases associated with infection with human papillomavirus (HPV) types 6, 11, 16, and 18, including genital warts, precancerous cervical, vaginal or vulvar lesions, and cervical cancer.

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).

The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Zilucoplan is the first complement inhibitor to be approved for treatment of myasthenia gravis that can be self-administered. Two IV complement inhibitors, eculizumab (Soliris) and ravulizumab (Ultomiris), were approved earlier.

Eculizumab (Soliris - Alexion) has been approved by the FDA for reduction of hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare form of hemolytic anemia. A recombinant humanized monoclonal antibody, eculizumab is the first drug to be marketed for this indication.

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...

The FDA has approved the complement factor B inhibitor iptacopan (Fabhalta – Novartis) for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. Iptacopan is the first oral drug to be approved in the US for this indication. Three parenterally administered drugs, the complement C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris) and the complement C3 inhibitor pegcetacoplan (Empaveli), are also approved for treatment of PNH.

View the Expanded Table: Some Vaccines for Travelers

With the deployment of hundreds of thousands of troops in Saudi Arabia, health problems endemic to the Arabian Peninsula may be coming to the attention of physicians in the USA and other areas.