The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes. Two other pneumococcal vaccines are available in the US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate vaccine licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23; Merck), a 23-valent pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years...

The FDA has licensed MenQuadfi (Sanofi Pasteur), a quadrivalent polysaccharide conjugate vaccine that uses tetanus toxoid as a protein carrier, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y (MenACWY) in persons ≥2 years old.

The FDA has licensed a 13-valent conjugate pneumococcal vaccine (PCV13; Prevnar 13 – Pfizer) for the prevention of invasive pneumococcal disease (IPD) in infants and children <6 years old. It replaces Prevnar (PCV7). An unconjugated 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23 – Merck) is FDA-approved for use in adults.

The U.S. Advisory Committee on Immunization Practices has recommended administration of the quadrivalent conjugated polysaccharide meningococcal vaccine (Menactra – Sanofi Pasteur) to all persons 11 to 18 years old, particularly those entering high school and college freshmen living in dormitories.1,2 The peak incidence of meningococcal disease, after early childhood, occurs in the 15-19 year-old age group. The conjugate vaccine is more immunogenic than the meningococcal capsular polysaccharide vaccine (Menommune – Sanofi Pasteur).ADVERSE EFFECTS — The most common adverse reactions with...

The US Advisory Committee on Immunization Practices (ACIP) has recommended that adults with immunocompromising conditions receive the 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13), even if they have already received the older 23-valent unconjugated vaccine (PPSV23; Pneumovax 23). Prevnar 13, initially approved by the FDA for use in infants and young children, has been licensed since December 2011 for adults ≥50 years old.

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).

Two products combining conjugated estrogens with medroxyprogesterone acetate (Prempro and - Wyeth-Ayerst) were recently approved for marketing by the US Food and Drug Administration. Both combine in one package tablets of Premarin, a conjugated equine estrogen product, with tablets of Cycrin, a medroxyprogesterone acetate brand. With Prempro, both tablets are taken daily continuously; with Premphase, the estrogen is taken daily, but the progestin is taken sequentially on days 15 through 28 of each 28-day cycle.

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.

Efbemalenograstim alfa-vuxw (Ryzneuta – Evive), a nonpegylated granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG2, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia. It is the first nonpegylated, long-acting G-CSF to become available in the US. Two pegylated, long-acting G-CSFs, pegfilgrastim (Neulasta, and biosimilars) and eflapegrastim (Rolvedon), are...

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.