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What's new in drug therapy

What's new in drug therapy
Authors:
Diane MF Savarese, MD
Jonathan M Zand, PharmD BCPS
Literature review current through: Mar 2022. | This topic last updated: Apr 29, 2022.

The following material represents a subset of new drugs, drug approvals, drug warnings, and drugs removed from the market from the past six months. This is not a complete list; it includes those topics considered by the authors and editors to be of particular interest or importance. For a complete list of new drug approvals, see http://www.lexi.com/home/newdrugs/.

You can check drug interactions by going to the Lexicomp drug interactions program included with UpToDate.

GENERAL DRUG THERAPY

Switching between levothyroxine preparations (April 2022)

Although clinicians and patients may have concerns about switching between synthetic levothyroxine products, switching is generally not a clinical problem. In a comparative effectiveness study evaluating changes in thyroid-stimulating hormone (TSH) levels after switching or not switching between generic levothyroxine products in 2780 propensity-matched patient pairs, the proportion of individuals with TSH levels within the normal range was similar in nonswitchers and switchers (82.7 and 84.5 percent, respectively) [1]. If a switch from one manufacturer to another is made by the pharmacy and the patient is concerned regarding equivalent efficacy of the preparations, or if maintaining the serum TSH within a narrow range is important (eg, thyroid cancer treatment), we measure a serum TSH six weeks after changing preparations to document that the serum TSH is still within the therapeutic target. (See "Treatment of primary hypothyroidism in adults", section on 'Switching between T4 preparations'.)

New naming convention for therapeutic monoclonal antibodies (January 2022)

The number of therapeutic monoclonal antibodies (mAbs) continues to increase. In order to reduce sound-alikes and specify structural components of the immunoglobulins, the World Health Organization International Nonproprietary Names (INN) Programme has introduced four new suffixes to be used instead of "mab" for antibodies developed from 2022 onward [2]. Unmodified immunoglobulins will end in "tug"; mAbs with an engineered constant region will end in "bart"; bifunctional mAbs will end in "mig"; and variable region fragments will end in "ment." (See "Overview of therapeutic monoclonal antibodies", section on 'Naming convention for therapeutic mAbs'.)

DRUG INTERACTIONS

Antiretroviral therapy and hormone levels in etonogestrel contraceptive implant users (March 2022)

Users of the long-acting etonogestrel contraceptive implant can take most other medications without altering serum etonogestrel levels. However, a study of postpartum implant users with HIV reported those taking the antiretroviral efavirenz experienced reductions in mean serum etonogestrel concentrations that approached the threshold required for ovulation suppression; use of ritonavir-containing regimens did not significantly alter serum etonogestrel levels [3]. We discuss this finding with individuals taking efavirenz as those who strongly desire to avoid pregnancy may prefer an alternative contraceptive method. (See "Etonogestrel contraceptive implant", section on 'Drug interactions'.)

DRUG OR INDICATION WITHDRAWALS

PI3K inhibitor drug withdrawals in relapsed lymphoma (April 2022)

The landscape of phosphoinositide 3'-kinase (PI3K) inhibitors in relapsed lymphoma is changing due to safety concerns and increased risk of death in some randomized trials. For follicular lymphoma (FL), copanlisib is now the only available PI3K inhibitor approved by the US Food and Drug Administration (FDA). While previously approved, the FL indications for duvelisib, idelalisib, and umbralisib were voluntarily withdrawn by manufacturers in December 2021, January 2022, and April 2022, respectively [4-7]. The manufacturers of umbralisib also voluntarily withdrew the indication for marginal zone lymphoma; no other PI3K inhibitor has FDA approval for this indication. Idelalisib and duvelisib maintain approval for chronic lymphocytic leukemia/small lymphocytic lymphoma. (See "Treatment of relapsed or refractory follicular lymphoma", section on 'Copanlisib'.)

Withdrawal of panobinostat from United States market (January 2022)

Panobinostat, an orally available histone deacetylase inhibitor, was granted accelerated approval by the US Food & Drug Administration in 2015 for the treatment of relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone. It is being withdrawn from the US market beginning December 2021; the manufacturer was not able to complete the required postapproval clinical studies as part of the accelerated approval process [8]. (See "Multiple myeloma: Treatment of third or later relapse", section on 'Panobinostat'.)

ADVERSE REACTIONS AND WARNINGS

Safety of intravenous (IV) iron (April 2022)

In two new observational studies evaluating >200,000 iron infusions, the safety of intravenous (IV) iron was evaluated using case definitions of anaphylaxis or infusion reaction based upon billing codes or chart review [9,10]. In one study, administration of antihistamines and other anaphylaxis treatments was used as a surrogate for an infusion reaction. Overall, rates of anaphylaxis were extremely low (from 0.0005 to 0.098 percent). However, these are likely overestimates since antihistamines were sometimes administered as premedication before the IV iron infusion, rather than after the infusion in response to a reaction. Generalizability was hampered by exclusion of certain populations (hemodialysis, inflammatory bowel disease, younger individuals). In general, the availability of IV iron formulations with improved safety profiles has lowered the threshold at which many patients would consider switching from an oral to an IV iron preparation. (See "Treatment of iron deficiency anemia in adults", section on 'Risks/prevention'.)

Cardiometabolic risk factors in breast cancer patients (February 2022)

Treatments for breast cancer can affect an individual's cardiovascular risk factors. In one study including almost 15,000 patients with newly diagnosed breast cancer and 75,000 matched controls, breast cancer patients had a higher incidence of hypertension (10.9 versus 8.9 percent) and diabetes (2.1 versus 1.7 percent) after two years, with higher diabetes incidence persisting after 10 years (9.3 versus 8.8 percent) [11]. These results may have been biased by the fact that breast cancer survivors are seen more frequently in the health care system, as part of routine surveillance. We advise routine screening for cardiometabolic issues in the primary care setting for breast cancer survivors. (See "Approach to the patient following treatment for breast cancer", section on 'Cardiometabolic issues'.)

Dental problems associated with oral dissolving buprenorphine (January 2022)

There are >300 reports of dental problems associated with use of buprenorphine formulations dissolved in the mouth, including the buccal formulation and sublingual tablets [12,13]. Reported problems include dental caries, abscesses, and damaged teeth, many of which have required tooth removal. The incidence of dental problems with buprenorphine is unknown. Patients who use orally dissolving buprenorphine should swish and swallow water after the drug has dissolved, see a dentist soon after starting the drug, and make sure the dentist knows they are taking the drug. The US Food and Drug Administration (FDA) has issued a related safety advisory and will mandate a label change. (See "Use of opioids in the management of chronic non-cancer pain", section on 'Buprenorphine for chronic pain'.)

Routine premedication for PEGylated asparaginase (January 2022)

Asparaginase, a polypeptide of bacterial origin, is an important component of treatment for acute lymphoblastic leukemia, and PEGylated products (eg, pegaspargase, calaspargase) are now preferred for newly diagnosed patients. While they are less immunogenic than nonpegylated E. coli-derived asparaginase, infusion reactions still occur in up to one-third of patients. In 2021, the pegaspargase United States prescribing information was updated to recommend routine premedication with acetaminophen, an H1-receptor blocker, and an H2-receptor blocker administered 30 to 60 minutes prior to each dose [14]. The prescribing information for calaspargase has also been similarly updated [15]. (See "Infusion reactions to systemic chemotherapy", section on 'Asparaginase'.)

Risk of GI bleeding with DOACs (October 2021)

Direct oral anticoagulants (DOACs) are generally preferred over warfarin in individuals with non-valvular atrial fibrillation or venous thromboembolism. A new study evaluated the risk of gastrointestinal (GI) bleeding in over 5000 individuals taking apixaban, rivaroxaban, or dabigatran [16]. Higher rates of GI bleeding were seen in individuals taking rivaroxaban (3.2 per 100 patient-years) than with the other agents (2.5 for apixaban and 1.9 for dabigatran). The once-daily dosing of rivaroxaban and higher peak levels may explain the higher bleeding risk; the other agents are dosed twice daily. These results may be a consideration when choosing among DOACs. (See "Direct oral anticoagulants (DOACs) and parenteral direct-acting anticoagulants: Dosing and adverse effects", section on 'Differences between factor Xa inhibitors'.)

RECENT APPROVALS - DERMATOLOGIC AND ALLERGY THERAPIES

Tralokinumab for atopic dermatitis (February 2022)

Adults with persistent, moderate-to-severe atopic dermatitis (AD) despite optimal topical therapy may require systemic immunomodulatory therapy to achieve adequate disease control. In a recent randomized trial of 380 adults with moderate-to-severe AD, more patients assigned to subcutaneous tralokinumab, a fully human monoclonal anti-interleukin-13 antibody, achieved a 75 percent improvement in the Eczema Area and Severity Index at 16 weeks compared with placebo (56 versus 36 percent, respectively) [17]. All patients were allowed to use a midpotency topical corticosteroid as needed. Treatment was general well tolerated. Conjunctivitis was more common in patients receiving tralokinumab than in those receiving placebo. These findings support the efficacy of tralokinumab for adults with AD; this and other studies were the basis for US Food and Drug Administration approval of tralokinumab for this indication. However, long-term studies are needed before its use becomes routine. (See "Treatment of atopic dermatitis (eczema)", section on 'Tralokinumab'.)

Topical ruxolitinib for atopic dermatitis (October 2021)

Topical ruxolitinib, a Janus kinase (JAK) inhibitor, is a new short-term therapy for atopic dermatitis (AD). In two randomized trials that enrolled over 1200 adolescents and adults with mild to moderate AD (<20 percent of body surface area affected) not controlled by topical prescription medications, more individuals assigned to ruxolitinib cream (0.75% or 1.5%) achieved clear or almost clear skin and reduced pruritis with no increase in adverse effects compared with vehicle [18]. Based on these findings, topical ruxolitinib has been approved by the US Food and Drug Administration for the short-term treatment of mild to moderate AD in immunocompetent individuals with the characteristics of the study participants. Although topical ruxolitinib appears promising, more data are needed regarding its systemic absorption and long-term safety before its use becomes routine. (See "Treatment of atopic dermatitis (eczema)", section on 'Topical ruxolitinib'.)

RECENT APPROVALS - HEMATOLOGIC AND ANTICOAGULANT

Belumosudil for steroid-refractory chronic graft-versus-host disease (GVHD) (December 2021)

More than two-thirds of patients with chronic graft-versus-host disease (cGVHD) require treatment beyond systemic corticosteroids, but there is no consensus treatment for steroid-refractory (SR) cGVHD and current approaches have limited efficacy and/or substantial toxicity. Belumosudil, a novel oral inhibitor of ROCK2, was associated with objective responses and significant symptomatic improvement in more than two-thirds of patients with SR-cGVHD, with mostly modest adverse effects [19]. Belumosudil was recently approved by the US Food and Drug Administration (FDA) for treatment of SR-cGVHD in patients who received two to five prior therapies. We consider belumosudil an acceptable later-line treatment for SR-cGVHD as we await studies that compare it with other available therapies. (See "Treatment of chronic graft-versus-host disease", section on 'Belumosudil'.)

RECENT APPROVALS - NEUROLOGIC AND PSYCHIATRIC

Sublingual dexmedetomidine for agitation in bipolar disorder (April 2022)

The US Food and Drug Administration recently approved a sublingual formulation of dexmedetomidine for agitation in bipolar disorder. Evidence supporting the indication includes a randomized trial in 378 patients with bipolar disorder and mild to moderate agitation, in which dexmedetomidine reduced agitation more than placebo, with improvements beginning 20 minutes after administration and measured at two hours [20]. However, adverse events were twice as common with dexmedetomidine and included somnolence, dry mouth, hypotension, and dizziness. We typically limit use of the drug for mild to moderate agitation in patients who cannot tolerate as needed antipsychotics or benzodiazepines. (See "Bipolar mania and hypomania in adults: Choosing pharmacotherapy", section on 'Agitation'.)

Fenfluramine for seizures associated with Lennox-Gastaut syndrome (April 2022)

Lennox-Gastaut syndrome (LGS) is associated with severe seizures in childhood and a poor neurologic prognosis. Evidence supporting the benefit of fenfluramine comes from a trial of 263 patients with LGS, in which the median reduction in seizure frequency was greater with high-dose fenfluramine compared with placebo (-23.7 versus -8.7 percent) [21,22]. Most patients in the trial were taking one or more concomitant antiseizure medications. Based upon these results, fenfluramine was approved by the by the US Food and Drug Administration for the treatment of seizures associated with LGS in patients two years of age and older [23]. Fenfluramine will likely be used as an adjunct antiseizure mediation in patients with LGS who have refractory seizures. Due to the risk of cardiac valve injury and pulmonary hypertension, fenfluramine is available only through a risk evaluation and mitigation strategy program. (See "Epilepsy syndromes in children", section on 'Treatment of LGS'.)

Efgartigimod alfa for treatment of myasthenia gravis (February 2022)

Efgartigimod alfa, a novel immunoglobulin G1 (IgG1) Fc fragment that inhibits the neonatal Fc receptor and reduces circulating IgG antibody levels, has been under investigation for myasthenia gravis (MG) and other autoimmune disorders associated with IgG autoantibodies. In a trial of 167 patients with generalized MG, weekly infusions of efgartigimod increased the rate of symptomatic improvement at four weeks compared with placebo (68 versus 30 percent) [24]. Adverse effects were mild and similar between groups with short-term follow-up. Based on these results, efgartigimod was approved by the US Food and Drug Administration for treatment of MG in patients with antiacetylcholine receptor antibodies. It will likely find use initially as an alternative steroid-sparing agent for patients unable to tolerate first-line therapies with slower time to effect (table 1). (See "Chronic immunosuppressive therapy for myasthenia gravis", section on 'AChR-positive and seronegative MG'.)

RECENT APPROVALS - ONCOLOGIC

Nivolumab plus relatlimab for advanced melanoma (April 2022)

For patients with metastatic melanoma, there is interest in identifying therapies that enhance efficacy and reduce toxicity. In a double-blind phase III trial of over 700 patients with treatment-naïve advanced melanoma, nivolumab plus relatlimab, a human immunoglobulin G4 lymphocyte activation gene 3-blocking antibody, improved progression-free survival (median 10 versus 5 months) compared to single-agent nivolumab [25,26]. Although differences in three-year overall survival were not statistically significant (56 versus 48 percent, respectively), results were immature at a median follow-up of 19 months. Grade ≥3 treatment-related adverse events occurred in 19 percent in the nivolumab-relatlimab group and 10 percent in the nivolumab group. Based on these data, the US Food and Drug Administration approved nivolumab-relatlimab for patients with unresectable or metastatic melanoma ages 12 years and older, and we consider it as one acceptable option in both BRAF wildtype and mutant disease [27]. (See "Systemic treatment of metastatic melanoma lacking a BRAF mutation", section on 'Nivolumab-relatlimab' and "Systemic treatment of metastatic melanoma with BRAF and other molecular alterations", section on 'Nivolumab-relatlimab'.)

Neoadjuvant nivolumab with chemotherapy in resectable NSCLC (March 2022)

The role of immunotherapy in the neoadjuvant management of resectable non-small cell lung cancer (NSCLC) is being evaluated. In preliminary results of Checkmate 816, among over 350 patients with resectable NSCLC and no known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation, the addition of nivolumab to neoadjuvant platinum-doublet chemotherapy improved pathologic complete response rates (24 versus 2 percent), without impeding the completeness of surgery or increasing complications [28]. Median event-free survival rates with and without nivolumab were 31 versus 21 months. A prespecified interim analysis for overall survival resulted in a hazard ratio of 0.57; although not statistically significant, results were immature [29]. Nivolumab has been approved by the US Food and Drug Administration for use in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable NSCLCs that are ≥4 cm or node positive; we suggest its use in this setting, provided that tumors do not harbor an activating EGFR or ALK mutation [29]. (See "Systemic therapy in resectable non-small cell lung cancer", section on 'Neoadjuvant immunotherapy'.)

Tebentafusp for metastatic uveal melanoma (March 2022)

Metastatic uveal melanoma is a rare, aggressive malignancy with few effective treatment options. Tebentafusp is a bispecific T cell engager targeting glycoprotein 100, a uveal melanoma antigen. In a phase III trial in almost 400 patients with positive human leukocyte antigen (HLA)-A*02:01 and systemic treatment-naïve, advanced uveal melanoma, tebentafusp improved one-year overall survival rates compared with investigator's choice of immunotherapy or chemotherapy (73 versus 59 percent) [30]. Based on these data, the US Food and Drug Administration approved tebentafusp for adults with advanced unresectable or metastatic uveal melanoma who are HLA-1*02:01 positive [31], and we recommend its use as initial therapy in this patient population. (See "Management of metastatic uveal melanoma", section on 'HLA-A*02:01 positive (tebentafusp)'.)

Adjuvant pembrolizumab in localized renal cell carcinoma (December 2021)

In patients with localized renal cell carcinoma (RCC) treated with nephrectomy, adjuvant immunotherapy is being evaluated. In a randomized trial of approximately 1000 patients with clear cell RCC treated with nephrectomy, one year of adjuvant pembrolizumab improved disease-free survival (DFS) compared with placebo (two-year DFS, 77 versus 68 percent), and was well tolerated [32]. Based on these data, the US Food and Drug Administration approved adjuvant pembrolizumab in patients with RCC at intermediate-high or high risk of disease recurrence following nephrectomy [33]. We suggest adjuvant pembrolizumab for those with resected RCC who have an estimated five-year recurrence risk of ≥30 percent. (See "Overview of the treatment of renal cell carcinoma", section on 'Approach to adjuvant therapy'.)

Pembrolizumab as initial therapy for metastatic urothelial carcinoma (November 2021)

The United States (US) Food and Drug Administration (FDA) previously conditionally approved the checkpoint inhibitor pembrolizumab for patients with treatment-naïve metastatic urothelial carcinoma (UC), but long-term follow-up data were limited. In extended follow-up of a phase II trial of almost 400 patients with treatment-naïve, platinum-ineligible metastatic UC, the objective response rate for pembrolizumab was 29 percent at a median follow-up of 56 months, and three-year overall survival was 22 percent [34]. Based on these data, the US FDA granted full regulatory approval to pembrolizumab for patients with locally advanced or metastatic UC who are not eligible for any platinum-containing chemotherapy [35], and it remains one of our preferred options in this patient population. (See "Treatment of metastatic urothelial cancer of the bladder and urinary tract", section on 'Pembrolizumab'.)

Adjuvant abemaciclib in high-risk, hormone receptor-positive, HER2-negative breast cancer (October 2021)

For patients with high-risk, hormone receptor (HR)-positive, HER2-negative breast cancer, previous data have shown benefits with adjuvant abemaciclib. Now, in longer follow-up of 27 months, benefits are maintained, both in regard to invasive disease-free survival (three-year rate of 89 versus 83 percent), and distant recurrence-free survival (90 versus 86 percent) [36]. A higher incidence of Grade ≥3 adverse events (AEs) was observed with versus without abemaciclib (50 versus 16 percent, respectively). These data led to US Food and Drug Administration approval of abemaciclib in patients with HR-positive, HER2-negative, node-positive breast cancer at high risk of recurrence and a Ki-67 score ≥20 percent [37], and we suggest the addition of adjuvant abemaciclib to endocrine therapy in this subset. High risk in this instance is defined as either ≥4 involved axillary lymph nodes; or 1 to 3 involved lymph nodes and either tumor grade 3 or size ≥5.0 cm. However, we note that it is also acceptable not to administer this additional treatment, given the toxicity and only short-term supporting data. (See "Adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer", section on 'Patient selection'.)

Nab-sirolimus for malignant perivascular epithelioid cell differentiation (PEComa) (January 2021)

Mechanistic (mammalian) target of rapamycin (mTOR) inhibitors have shown promise for advanced perivascular epithelioid cell differentiation (PEComa). In an open-label phase II trial in approximately 30 patients with locally advanced unresectable or metastatic malignant PEComa, the mTOR inhibitor nab-sirolimus was associated with an overall response rate of 39 percent [38]. Based on these data, the US Food and Drug Administration (FDA) approved nab-sirolimus in adult patients with locally advanced unresectable or metastatic malignant PEComa. For those without access to nab-sirolimus, other mTOR inhibitors (sirolimus, everolimus, and temsirolimus) are reasonable alternatives. (See "Systemic treatment of metastatic soft tissue sarcoma", section on 'Nab-sirolimus'.)

RECENT APPROVALS - OTHER

Dupilumab for children ≥6 years old with moderate-to-severe asthma (November 2021)

Dupilumab, a monoclonal antibody that blocks interleukin (IL)-4 and IL-13 signaling, is now approved by the US Food and Drug Administration (FDA) for children 6 years of age and older with moderate-to-severe persistent asthma and eosinophilia or dependency on oral glucocorticoids. Approval is based upon trials in adolescents and adults and a single randomized trial in 408 children 6 to 11 years of age with moderate-to-severe asthma that showed a significant reduction in the annual rate of severe exacerbations requiring treatment with systemic glucocorticoids in children treated with dupilumab compared with placebo (rate ratio 0.35, 95% CI 0.22-0.56) [39]. Because dupilumab is also approved for use in selected children with moderate-to-severe atopic dermatitis (AD), it may be particularly useful in children with comorbid refractory asthma and AD. (See "Asthma in children younger than 12 years: Management of persistent asthma with controller therapies", section on 'Add on a biologic agent'.)

COVID-19 MANAGEMENT

Remdesivir approved for treatment of COVID-19 in children age 28 days and older (April 2022)

In April 2022, the US Food and Drug Administration (FDA) expanded approval for remdesivir treatment of COVID-19 to include children ≥28 days of age who weigh ≥3 kg [40,41]. Indications include hospitalization and, for outpatients, mild to moderate COVID-19 with a high risk of progression to severe disease. The FDA based approval on clinical trials in adults and a single-arm, open-label study in 53 hospitalized children ≥28 days of age, in which remdesivir was associated with improvement in clinical status. We make decisions about the use of remdesivir in children with SARS-CoV-2 infection on a case-by-case basis. (See "COVID-19: Management in children", section on 'SARS-CoV-2 antiviral therapy for select patients'.)

Treatment of COVID-19 in outpatients at risk for severe disease (November 2021, Modified February 2022)

Nirmatrelvir-ritonavir, the monoclonal antibody sotrovimab, remdesivir, and high-titer convalescent plasma have all been shown to reduce the risk of hospitalization when given early in the course of COVID-19 [42-45]. For outpatient adults who have mild-to-moderate COVID-19 and are at risk for progression to severe disease (table 2), we recommend treatment with either nirmatrelvir-ritonavir or sotrovimab. When these are not available, we consider remdesivir and convalescent plasma, which may be complicated to administer, as alternatives. If none are feasible options, molnupiravir is an alternative, but it may be less effective and potentially teratogenic [46]. Bebtelovimab is an alternative monoclonal antibody that is active against Omicron, but there are limited data to support its use [47]. When supplies are limited, these treatments should be prioritized for immunocompromised individuals expected to have a suboptimal vaccine response and unvaccinated or incompletely vaccinated individuals at highest risk for severe disease (table 3) [48]. (See "COVID-19: Outpatient evaluation and management of acute illness in adults".)

COVID-19 VACCINATION

Second COVID-19 vaccine booster dose for selected individuals (April 2022)

In the United States, the Food and Drug Administration authorized a second booster dose of an mRNA COVID-19 vaccine for individuals who are >50 years old or are ≥12 years old and have certain immunocompromising conditions (table 1). The Centers for Disease Control and Prevention also indicate that a second booster dose with an mRNA vaccine is an option for any individual who received Ad26.COV2.S (Janssen/Johnson & Johnson) for both the primary and booster doses [49,50]. Vaccine effectiveness following a primary series and single booster dose appears to wane, and observational studies suggest that a second booster dose is associated with increased protection against severe COVID-19 and death [51,52]. However, the absolute benefit may be very small and the duration of effect is uncertain. Among those eligible for a second booster dose, we individualize the decision based on patient preference, risk for severe disease, and risk of exposure; those at the highest risk are most likely to benefit. (See "COVID-19: Vaccines", section on 'Role of booster vaccinations/waning efficacy'.)

COVID-19 vaccination in pregnancy improves infant outcomes (February 2022)

COVID-19 vaccination of pregnant women reduces serious maternal and pregnancy morbidity from infection. In an analysis of data from 20 pediatric hospitals in the United States during a period of Delta and Omicron variant circulation, infants <6 months of age were 61 percent less likely to be hospitalized with COVID-19 if their mothers became fully vaccinated with an mRNA COVID-19 vaccine during pregnancy [53]. Furthermore, 88 percent of the intensive care unit admissions for COVID-19 and the only death occurred among infants of unvaccinated mothers. Thus, maternal vaccination also appears to protect infants in the first six months of life. (See "COVID-19: Overview of pregnancy issues", section on 'Safety and efficacy'.)

COVID-19 vaccination improves outcomes of infected pregnant patients (February 2022, Modified February 2022)

A recent population-based study of over 18,000 pregnant patients in Scotland provides the first evidence of more favorable pregnancy outcomes among those who have received COVID-19 vaccination [54]. In pregnant patients with COVID-19, unvaccinated individuals represented a significantly higher proportion of COVID-19-associated hospital admissions (77 percent), COVID-19-associated critical care admissions (98 percent), and perinatal deaths (100 percent of stillbirths and neonatal deaths). The perinatal death rate in the vaccinated cohort was similar to historical background rates and the rates in pregnant people without COVID-19. These findings further support universal recommendations for pregnant people to be up-to-date with COVID-19 vaccination. (See "COVID-19: Overview of pregnancy issues", section on 'Safety and efficacy'.)

Additional COVID-19 vaccine primary series dose for immunocompromised individuals (August 2021, Modified February 2022)

COVID-19 vaccines are less effective among patients with certain immunocompromising conditions than in the general population; additional vaccine doses have been associated with improved effectiveness in this population. We agree with recommendations from the Advisory Committee on Immunization Practices (ACIP) in the United States that individuals with such conditions (table 4) receive an additional mRNA vaccine dose as part of their primary COVID-19 vaccine series (eg, following two doses of an mRNA vaccine or one dose of Ad26.COV2.S vaccine) (figure 1) [50,55]. This additional primary series dose is distinct from the booster dose, which such patients should additionally receive, although at a shorter interval than recommended for the general population. (See "COVID-19: Vaccines", section on 'Immunocompromised individuals'.)

COVID-19 vaccination does not affect fertility (January 2022)

Possible cross-reactivity between antibodies to the SARS-CoV-2 virus's spike protein and a protein involved in embryo development raised concerns for impaired fertility following either viral infection or vaccination. In the largest retrospective cohort study comparing 222 vaccinated with 983 unvaccinated females undergoing in vitro fertilization (IVF) between February and September 2021, outcomes of ovarian stimulation and embryo transfer were similar for both groups, including similar fertilization and clinical pregnancy rates [56]. These data add to the body of evidence supporting lack of negative effects of vaccination on fertility or IVF cycles. (See "In vitro fertilization: Overview of clinical issues and questions", section on 'No proven effect'.)

Third mRNA COVID-19 vaccine dose and Omicron immunogenicity among cancer patients (January 2022, Modified January 2022)

The Omicron variant of SARS-CoV-2 partially evades vaccine-induced immunity, but for mRNA COVID-19 vaccine recipients in the general population, a third vaccine dose increases neutralizing activity against Omicron; comparable data in cancer patients are lacking. In a prospective cohort study, a third vaccine dose of the mRNA vaccine BNT162b2 was associated with a higher likelihood of detectable neutralizing activity against Omicron in patients with cancer, although the benefit was less in patients with blood cancer compared with those with solid tumors [57]. These data support administering a third dose of mRNA vaccine for patients with active cancer; such patients are also eligible subsequently for a booster dose. (See "COVID-19: Considerations in patients with cancer".)

ITP after COVID-19 vaccination (January 2022)

Exacerbations of immune thrombocytopenia (ITP) as well as new-onset ITP have been reported after COVID-19 vaccination [58,59]. Individuals with ITP who receive any COVID-19 vaccine should be advised about this risk, and platelet counts should be monitored before and after vaccination. The benefits of vaccination outweigh the risks in almost all patients with ITP. Those in the midst of a flare can delay vaccination until the flare is controlled; flares that occur following vaccination tend to be transient and respond well to standard ITP therapy. ITP is distinct from the exceedingly rare syndrome of vaccine-induced immune thrombotic thrombocytopenia (VITT). (See "Initial treatment of immune thrombocytopenia (ITP) in adults", section on 'COVID-19 vaccination'.)

Immunogenicity of available vaccines against SARS-CoV-2 in patients with cancer (January 2022)

Patients with cancer are considered to be at high risk for SARS-CoV-2 infection, but there are limited studies directly comparing available COVID-19 vaccines. In an observational cohort study (CANVAX) of over 700 patients with solid organ or hematologic cancers, two doses of an mRNA vaccine (either BNT162b2/Pfizer-BioNTech or mRNA-1273/Moderna) were associated with higher protective immune responses compared with one dose of the adenoviral vector vaccine Ad26.COV2.S/Janssen [60]. Although clinical outcomes were not measured, other studies in the general population suggest that mRNA vaccines may have greater effectiveness against severe disease. In patients with cancer receiving COVID-19 vaccination, as for the general population, we suggest an mRNA COVID vaccine, rather than an adenoviral vector vaccine. (See "COVID-19: Considerations in patients with cancer", section on 'Safety and efficacy' and "COVID-19: Vaccines", section on 'Indications and vaccine selection'.)

Neutralization of SARS-CoV-2 variants in transplant recipients after three doses of mRNA vaccine (December 2021)

In transplant recipients, administration of a third COVID-19 mRNA vaccine dose has been shown to improve the immune response without causing short-term adverse events; however, data on vaccine immunogenicity against SARS-CoV-2 variants are limited. In a secondary analysis of a recent randomized trial, sera obtained from participants after receipt of the third vaccine dose had greater ability to neutralize wild-type SARS-CoV-2 and Alpha, Beta, and Delta variants when compared with sera obtained after the second dose and sera from participants who received placebo [61]. The third dose was well tolerated; no cases of rejection were reported, and graft function remained stable in all patients for three months after the third dose. These findings support administering a three-dose primary vaccine series among transplant recipients and other immunocompromised patients. (See "COVID-19: Issues related to solid organ transplantation", section on 'Vaccination'.)

COVID-19 vaccination and hematopoietic cell transplant or CAR-T therapy (November 2021)

Immunocompromised individuals who are recipients of hematopoietic cell transplantation (HCT) or chimeric antigen receptor (CAR)-T-cell therapies are at risk for a suboptimal immune response to COVID-19 vaccination. Updated guidance from the United States Centers for Disease Control and Prevention (CDC) now recommends revaccination with a full primary series for patients who were vaccinated prior to receiving HCT or CAR-T-cell therapy and who are at least three months post-HCT or CAR-T-cell therapy. Our recommendations are in agreement with this guidance [62]. (See 'COVID-19: Considerations in patients with cancer', section on 'COVID-19 vaccination' and 'Immunizations in hematopoietic cell transplant candidates and recipients', section on 'COVID-19 vaccine'.)

Evaluation and management of immediate allergic reactions to SARS-CoV-2 vaccines (November 2021)

An international panel of experts in allergy, infectious disease, and emergency medicine released recommendations for the evaluation and management of immediate allergic reactions to SARS-CoV-2 vaccines, based on a systematic review and meta-analysis [63]. These recommendations, which include not performing empiric testing in patients with past anaphylaxis to polyethylene glycol (PEG) or polysorbates, and referring patients who experienced anaphylaxis to the first dose of an mRNA vaccine to an allergist or completing vaccination with a different vaccine, are consistent with our approach. Most patients are able to complete the vaccination process. (See "COVID-19: Allergic reactions to SARS-CoV-2 vaccines", section on 'Immediate reactions to an initial dose'.)

COVID-19 vaccination in children 5 years and older (November 2021)

In October 2021, the US Food and Drug Administration authorized BNT162b2 (Pfizer vaccine) for individuals 5 to 11 years old based on data from randomized trials in over 2000 children in this age group, which demonstrated 91 percent vaccine efficacy against symptomatic COVID-19 and immunogenicity similar to that in adolescents and young adults [64]. There were no cases of vaccine-associated myocarditis in the trials; although the precise risk is uncertain, it is expected to be lower than that seen in older individuals. We agree with recommendations from the Centers for Disease Control and Prevention to give BNT162b2 to children ages 5 to 11 years. Clinicians should be aware that the dose and formulation used for children are different than those for adolescents and adults. (See "COVID-19: Vaccines", section on 'Summary and recommendations'.)

VACCINES - OTHER

Updated recommendations for pneumococcal vaccination in adults (April 2022)

In early 2022, the Advisory Committee on Immunization Practices (ACIP) updated guidance on pneumococcal vaccination to recommend either pneumococcal conjugate vaccinate 20 (PCV20) alone or the combination of PCV15 followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all adults with indications for vaccination [65]. If PCV15 is administered, PPSV23 should be administered at least a year after PCV15. However, in high-risk individuals (eg, immunocompromising conditions, cochlear implant, or cerebrospinal fluid leak), a shorter interval of ≥8 weeks following the PCV15 dose may be used to maximize protection more quickly. (See "Pneumococcal vaccination in adults".)

Expanded indications for hepatitis B virus vaccination in adults (March 2022)

In March 2022, the Advisory Committee on Immunization Practices (ACIP) updated its guidelines to recommend hepatitis B vaccination for all adults <60 years of age, in addition to prior recommendations to vaccinate adults of any age who are at high risk for acquiring hepatitis B virus (HBV) infection (table 5) or who seek protection from HBV [66]. This change stems from the low rate of HBV immunity among adults in the United States, an increase in the incidence of acute HBV infection among adults in their 40s, and the fact that many people may not recognize they are at risk of HBV infection. These recommendations are included in the ACIP recommended immunization schedule for adults aged 19 years or older [67]. (See "Hepatitis B virus immunization in adults", section on 'Indications'.)

2022 ACIP immunization recommendations for adults (February 2022)

The 2022 Advisory Committee on Immunization Practices (ACIP) recommendations for immunizations in adults aged 19 and older have been approved by the United States Centers for Disease Control and Prevention (CDC) (figure 2 and figure 3) [67]. Significant updates include previously released recommendations for use of hepatitis B vaccination (HepB) in healthy adults, recombinant zoster vaccine (RZV) in immunocompromised adults, and pneumococcal conjugate vaccines (PCV15 and PCV20) in different age groups. Recommendations for COVID-19 vaccination are not included in the ACIP immunization tables and are found elsewhere. (See "Standard immunizations for nonpregnant adults", section on 'Immunization schedule for nonpregnant adults' and "COVID-19: Vaccines".)

ACIP recommendations on dengue vaccination (February 2022)

Dengue is endemic to tropical regions of the world, including the US territories of Puerto Rico, American Samoa, the US Virgin Islands, the Federated States of Micronesia, and the Republic of Palau. In December 2021, the CDC Advisory Committee on Immunization Practices (ACIP) recommended the dengue vaccine CYD-TDV (Dengvaxia) for children aged 9 to 16 who live in those US territories and have serologic evidence of prior infection [68]. Serology for dengue must be performed prior to vaccination. In trials, breakthrough infection after vaccination was more likely to be severe in individuals who were seronegative at baseline, and thus such individuals should not receive the vaccine. It is not approved for travelers visiting dengue-endemic areas. (See "Dengue virus infection: Prevention and treatment", section on 'CYD-TDV (Dengvaxia)'.)

Novel trivalent hepatitis B vaccine (January 2022)

Most available hepatitis B virus vaccines are recombinant vaccines using yeast-derived S protein of the surface antigen. In December 2021, the US Food and Drug Administration approved a trivalent mammalian cell-derived recombinant vaccine that contains two pre-S epitopes in addition to the S antigen [69]. Compared with conventional hepatitis B vaccines, this vaccine is more immunogenic in older adults [70]. However, its role remains uncertain since it causes side effects more frequently than conventional hepatitis B vaccines and requires more doses than the adjuvanted recombinant hepatitis B vaccine (HepB-CpG; three versus two doses). (See "Hepatitis B virus immunization in adults", section on 'Mammalian cell-derived'.)

Vaccination against human papillomavirus, especially at an early age, is associated with greater reductions in cervical cancer (December 2021)

Human papillomavirus (HPV) vaccination has been shown to decrease incidence of HPV infection and cervical intraepithelial neoplasia (CIN), but whether vaccinating females at an earlier age is associated with lower incidence of cervical cancer has not been well established. In a registry-based observational study of 13.7 million years of follow-up of females aged 20 to 30 years, females who received the bivalent HPV vaccine at a younger age had a greater relative reduction in the incidence of cervical cancer and CIN3 (34 percent for vaccination at age 16 to 18 years, 62 percent at age 14 to 16 years, and 87 percent at age 12 to 13 years) compared with the unvaccinated cohort [71]. This lends further support to vaccinating against HPV at a younger age. (See "Human papillomavirus vaccination", section on 'Cervical, vaginal, and vulvar disease'.)

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References