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      Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021–22 Influenza Season

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          Summary

          This report updates the 2020–21 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2020;69[No. RR-8]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For each recipient, a licensed and age-appropriate vaccine should be used. ACIP makes no preferential recommendation for a specific vaccine when more than one licensed, recommended, and age-appropriate vaccine is available. During the 2021–22 influenza season, the following types of vaccines are expected to be available: inactivated influenza vaccines (IIV4s), recombinant influenza vaccine (RIV4), and live attenuated influenza vaccine (LAIV4).

          The 2021–22 influenza season is expected to coincide with continued circulation of SARS-CoV-2, the virus that causes COVID-19. Influenza vaccination of persons aged ≥6 months to reduce prevalence of illness caused by influenza will reduce symptoms that might be confused with those of COVID-19. Prevention of and reduction in the severity of influenza illness and reduction of outpatient visits, hospitalizations, and intensive care unit admissions through influenza vaccination also could alleviate stress on the U.S. health care system. Guidance for vaccine planning during the pandemic is available at https://www.cdc.gov/vaccines/pandemic-guidance/index.html. Recommendations for the use of COVID-19 vaccines are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html, and additional clinical guidance is available at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.

          Updates described in this report reflect discussions during public meetings of ACIP that were held on October 28, 2020; February 25, 2021; and June 24, 2021. Primary updates to this report include the following six items. First, all seasonal influenza vaccines available in the United States for the 2021–22 season are expected to be quadrivalent. Second, the composition of 2021–22 U.S. influenza vaccines includes updates to the influenza A(H1N1)pdm09 and influenza A(H3N2) components. U.S.-licensed influenza vaccines will contain hemagglutinin derived from an influenza A/Victoria/2570/2019 (H1N1)pdm09-like virus (for egg-based vaccines) or an influenza A/Wisconsin/588/2019 (H1N1)pdm09-like virus (for cell culture–based and recombinant vaccines), an influenza A/Cambodia/e0826360/2020 (H3N2)-like virus, an influenza B/Washington/02/2019 (Victoria lineage)-like virus, and an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus. Third, the approved age indication for the cell culture–based inactivated influenza vaccine, Flucelvax Quadrivalent (ccIIV4), has been expanded from ages ≥4 years to ages ≥2 years. Fourth, discussion of administration of influenza vaccines with other vaccines includes considerations for coadministration of influenza vaccines and COVID-19 vaccines. Providers should also consult current ACIP COVID-19 vaccine recommendations and CDC guidance concerning coadministration of these vaccines with influenza vaccines. Vaccines that are given at the same time should be administered in separate anatomic sites. Fifth, guidance concerning timing of influenza vaccination now states that vaccination soon after vaccine becomes available can be considered for pregnant women in the third trimester. As previously recommended, children who need 2 doses (children aged 6 months through 8 years who have never received influenza vaccine or who have not previously received a lifetime total of ≥2 doses) should receive their first dose as soon as possible after vaccine becomes available to allow the second dose (which must be administered ≥4 weeks later) to be received by the end of October. For nonpregnant adults, vaccination in July and August should be avoided unless there is concern that later vaccination might not be possible. Sixth, contraindications and precautions to the use of ccIIV4 and RIV4 have been modified, specifically with regard to persons with a history of severe allergic reaction (e.g., anaphylaxis) to an influenza vaccine. A history of a severe allergic reaction to a previous dose of any egg-based IIV, LAIV, or RIV of any valency is a precaution to use of ccIIV4. A history of a severe allergic reaction to a previous dose of any egg-based IIV, ccIIV, or LAIV of any valency is a precaution to use of RIV4. Use of ccIIV4 and RIV4 in such instances should occur in an inpatient or outpatient medical setting under supervision of a provider who can recognize and manage a severe allergic reaction; providers can also consider consulting with an allergist to help identify the vaccine component responsible for the reaction. For ccIIV4, history of a severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency or any component of ccIIV4 is a contraindication to future use of ccIIV4. For RIV4, history of a severe allergic reaction (e.g., anaphylaxis) to any RIV of any valency or any component of RIV4 is a contraindication to future use of RIV4.

          This report focuses on recommendations for the use of vaccines for the prevention and control of seasonal influenza during the 2021–22 influenza season in the United States. A brief summary of the recommendations and a link to the most recent Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used according to Food and Drug Administration–licensed indications. Updates and other information are available from CDC’s influenza website ( https://www.cdc.gov/flu); vaccination and health care providers should check this site periodically for additional information.

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          Efficacy of high-dose versus standard-dose influenza vaccine in older adults.

          As compared with a standard-dose vaccine, a high-dose, trivalent, inactivated influenza vaccine (IIV3-HD) improves antibody responses to influenza among adults 65 years of age or older. This study evaluated whether IIV3-HD also improves protection against laboratory-confirmed influenza illness.
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            Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak — United States, December 31, 2019–February 4, 2020

            On December 31, 2019, Chinese health officials reported a cluster of cases of acute respiratory illness in persons associated with the Hunan seafood and animal market in the city of Wuhan, Hubei Province, in central China. On January 7, 2020, Chinese health officials confirmed that a novel coronavirus (2019-nCoV) was associated with this initial cluster ( 1 ). As of February 4, 2020, a total of 20,471 confirmed cases, including 2,788 (13.6%) with severe illness,* and 425 deaths (2.1%) had been reported by the National Health Commission of China ( 2 ). Cases have also been reported in 26 locations outside of mainland China, including documentation of some person-to-person transmission and one death ( 2 ). As of February 4, 11 cases had been reported in the United States. On January 30, the World Health Organization (WHO) Director-General declared that the 2019-nCoV outbreak constitutes a Public Health Emergency of International Concern. † On January 31, the U.S. Department of Health and Human Services (HHS) Secretary declared a U.S. public health emergency to respond to 2019-nCoV. § Also on January 31, the president of the United States signed a “Proclamation on Suspension of Entry as Immigrants and Nonimmigrants of Persons who Pose a Risk of Transmitting 2019 Novel Coronavirus,” which limits entry into the United States of persons who traveled to mainland China to U.S. citizens and lawful permanent residents and their families ( 3 ). CDC, multiple other federal agencies, state and local health departments, and other partners are implementing aggressive measures to slow transmission of 2019-nCoV in the United States ( 4 , 5 ). These measures require the identification of cases and their contacts in the United States and the appropriate assessment and care of travelers arriving from mainland China to the United States. These measures are being implemented in anticipation of additional 2019-nCoV cases in the United States. Although these measures might not prevent the eventual establishment of ongoing, widespread transmission of the virus in the United States, they are being implemented to 1) slow the spread of illness; 2) provide time to better prepare health care systems and the general public to be ready if widespread transmission with substantial associated illness occurs; and 3) better characterize 2019-nCoV infection to guide public health recommendations and the development of medical countermeasures including diagnostics, therapeutics, and vaccines. Public health authorities are monitoring the situation closely. As more is learned about this novel virus and this outbreak, CDC will rapidly incorporate new knowledge into guidance for action by CDC and state and local health departments. Some coronaviruses, such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), are the result of human-animal interactions. Preliminary investigation of 2019-nCoV also suggests a zoonotic origin ( 6 ), but the exact origin has not yet been determined. Person-to-person spread is evident ( 7 ); however, how easily the virus is transmitted between persons is currently unclear. 2019-nCoV is similar to coronaviruses that cause MERS and SARS, which are transmitted mainly by respiratory droplets. Signs and symptoms of patients with confirmed 2019-nCoV infection include fever, cough, and shortness of breath ( 8 ). Based on the incubation period of illness from MERS and SARS coronaviruses, CDC believes that symptoms of 2019-nCoV infection occur within 2 to 14 days following infection. Preliminary information suggests that older adults and persons with underlying health conditions or compromised immune systems might be at higher risk for severe illness from this virus ( 9 ); however, many characteristics of this novel coronavirus and how it might affect individual persons and potentially vulnerable population subgroups, such as the elderly or those with chronic health conditions, remain unclear. Epidemiology of First U.S. Cases On January 21, 2020, the first person in the United States with diagnosed 2019-nCoV infection was reported. As of February 4, a total of 293 persons from 36 states, the District of Columbia, and the U.S. Virgin Islands were under investigation based on current patient under investigation (PUI) definitions, ¶ and also included those being evaluated because they are close contacts. Of these PUIs, 11 patients have confirmed 2019-nCoV infection using a real-time reverse transcription–polymerase chain reaction (RT-PCR) assay developed by CDC. These 11 cases were diagnosed in the following states: Arizona (one), California (six), Illinois (two), Massachusetts (one), and Washington (one) (Table). Nine cases were in travelers from Wuhan. Eight of these nine cases were identified as a result of patients seeking clinical care for symptoms and clinicians connecting with the appropriate public health systems. Two cases (one each in California and Illinois) occurred in close contacts of two confirmed cases and were diagnosed as part of routine monitoring of case contacts. All patients are being monitored closely for progressing illness. No deaths have been reported in the United States. TABLE Characteristics of initial 2019 novel coronavirus cases (N = 11) — United States, January 21–February 4, 2020 Case State Approximate age (yrs) Sex Place of exposure Date laboratory confirmation announced 1 Washington 30s M Wuhan 1/21/2020 2 Illinois 60s F Wuhan 1/24/2020 3 Arizona 20s M Wuhan 1/26/2020 4 California 30s M Wuhan 1/27/2020 5 California 50s M Wuhan 1/27/2020 6 Illinois 60s M Household Illinois 1/30/2020 7 California 40s M Wuhan 1/31/2020 8 Massachusetts 20s M Wuhan 2/01/2020 9 California 50s F Wuhan 2/02/2020 10 California 50s M Wuhan 2/02/2020 11 California 50s F Household California 2/02/2020 Abbreviations: F = female; M = male. Public Health Response CDC established a 2019-nCoV Incident Management Structure on January 7, 2020. On January 21, CDC activated its Emergency Operations Center to optimize coordination for domestic and international 2019-nCoV response efforts. To date, CDC has deployed teams to the U.S. jurisdictions with cases to assist with epidemiologic investigation and to work closely with state and local partners to identify and monitor close contacts and better understand the spectrum of illness, transmission, and virulence associated with this novel virus. Information learned from these investigations will help inform response actions. CDC has closely monitored the global impact of this virus with staff members positioned in CDC offices around the world, including mainland China, and in coordination with other countries and WHO. This coordination has included deploying CDC staff members to work with WHO and providing active support to CDC offices in affected countries. In addition, CDC in response to the escalating risks of travel from China has issued a series of Travelers’ Health Notices for both Wuhan and the rest of China regarding the 2019-nCoV outbreak. On January 27, CDC issued a Level 3 travel notice for travelers to avoid all nonessential travel to mainland China.** U.S. quarantine stations, located at 18 major U.S. ports of entry, are part of a comprehensive regulatory system authorized under section 361 of the Public Health Service Act (42 U.S. Code Section 264), that limits the introduction of infectious diseases into the United States to prevent their spread. On January 17, consistent with existing communicable disease response protocols, CDC Quarantine staff members instituted enhanced entry screening of travelers on direct and connecting flights from Wuhan, China, arriving at three major U.S. airports: Los Angeles (LAX), New York City (JFK), and San Francisco (SFO), †† which then expanded to include travelers arriving in Atlanta (ATL) and Chicago (ORD). These five airports together receive approximately 85% of all air travelers from Wuhan, China, to the United States. U.S. Customs and Border Protection officers identified travelers arriving from Wuhan and referred them to CDC for health screening. §§ Any traveler from Wuhan with signs or symptoms of illness (e.g., fever, cough, or difficulty breathing) received a more comprehensive public health assessment performed by CDC public health and medical officers. ¶¶ All travelers from Wuhan were also provided CDC’s Travel Health Alert Notice (T-HAN)*** that advised them to monitor their health for 14 days and described recommended actions to take if relevant symptoms develop. As of February 1, 2020, a total of 3,099 persons on 437 flights were screened; five symptomatic travelers were referred by CDC to local health care providers for further medical evaluation, and one of these persons tested positive for 2019-nCoV. On January 24, 2020, travel bans began to be instituted by the Chinese government, resulting in restricted travel in and out of Hubei Province, including the city of Wuhan, and fewer travelers undergoing entry screening in the United States. In response to the escalating risks associated with travel from mainland China, on January 31, 2020, the Presidential Proclamation further refined the border health strategy to temporarily suspend entry, undergo additional screening, or possible quarantine for individuals that have visited China (excluding Hong Kong, Macau, and Taiwan) in the past 14 days. These enhanced entry screening efforts are taking place at 11 airports at which all air travelers from China are being directed. Laboratory and Diagnostic Support Chinese health officials posted the full 2019-nCoV genome sequence on January 10, 2020, to inform the development of specific diagnostic tests for this emergent coronavirus ( 1 ). Within a week, CDC developed a Clinical Laboratory Improvement Amendments–approved real-time RT-PCR test that can diagnose 2019-nCoV respiratory samples from clinical specimens. On January 24, CDC publicly posted the assay protocol for this test (https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html). On January 4, 2020, the Food and Drug Administration issued an Emergency Use Authorization to enable emergency use of CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories. This authorization allows the use of the test at any CDC-qualified lab across the country. CDC is working closely with FDA and public health partners, including the American Public Health Laboratories, to rapidly share these tests domestically and internationally through CDC’s International Reagent Resource (https://www.internationalreagentresource.org/). In addition, CDC uploaded the genome of the virus from the first reported cases in the United States to GenBank, the National Institutes of Health genetic sequence database of publicly available DNA sequences (https://www.ncbi.nlm.nih.gov/genbank/). CDC also is growing the virus in cell culture, which is necessary for further studies, including for additional genetic characterization. Once isolated, the virus will be made available through BEI Resources (https://www.beiresources.org/) to assist research efforts. Clinical and Infection Control Guidance Additional information about 2019-nCoV is needed to better understand transmission, disease severity, and risk to the general population. Although CDC and partners are actively learning about 2019-nCoV, initial CDC guidance is based on guidance for management and prevention of respiratory illnesses including influenza, MERS, and SARS. No vaccine or specific treatment for 2019-nCoV infection is currently available. At present, medical care for patients with 2019-nCoV is supportive. On January 31, CDC published its third Health Advisory with interim guidance for clinicians and public health practitioners. ††† In addition, CDC issued a Clinical Action Alert through its Clinician Outreach and Communication Activity network on January 31. §§§ Interim guidance for health care professionals is available at https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Health care providers should identify patients who might have been exposed and who have signs or symptoms related to 2019-nCoV infection, isolate these patients, and inform public health departments. This includes obtaining a detailed travel history for patients being evaluated with fever and lower respiratory tract illness. Criteria to guide evaluation and testing of PUIs for 2019-nCoV include 1) fever or signs or symptoms of lower respiratory tract illness (e.g., cough or shortness of breath) in any person, including health care workers, who has had close contact ¶¶¶ with a patient with laboratory-confirmed 2019-nCoV infection within 14 days of symptom onset; 2) fever and signs or symptoms of lower respiratory tract illness (e.g., cough or shortness of breath) in any person with a history of travel from Hubei Province, China, within 14 days of symptom onset; or 3) fever and signs or symptoms of lower respiratory tract illness (e.g., cough or shortness of breath) requiring hospitalization in any person with a history of travel from mainland China within 14 days of symptom onset. Additional nonhospitalized PUIs may be tested based on consultation with state and local public health officials. Clinicians should evaluate PUIs for other possible causes of illness (e.g., influenza and respiratory syncytial virus) as clinically indicated. CDC currently recommends a cautious approach to the examination of PUIs. These patients should be asked to wear a surgical mask as soon as they are identified, and directed to a separate area, if possible, separated by at least 6 ft (2 m) from other persons. Patients should be evaluated in a private room with the door closed, ideally an airborne infection isolation room, if available. Health care personnel entering the room should use standard precautions, contact precautions, airborne precautions, and eye protection (e.g., goggles or a face shield). Clinicians should immediately notify the health care facility’s infection control personnel and local health department. The health department will determine whether the patient needs to be considered a PUI for 2019-nCoV and be tested for infection. If directed by the health department, to increase the likelihood of detecting 2019-nCoV infection, CDC recommends collecting and testing both upper and lower respiratory tract specimens.**** Additional specimen types (e.g., stool or urine) may be collected and stored. Specimens should be collected as soon as possible once a PUI is identified regardless of time since symptom onset. For persons who might have 2019-nCoV infection and their close contacts, information and guidance on how to reduce the risk for transmitting and acquiring infection is available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-prevent-spread.html. Close contacts should immediately call their health care providers if they develop symptoms. In addition, CDC is working closely with state and local health partners to develop and disseminate information to the public on general prevention of respiratory illness, including the 2019-nCoV. This includes everyday preventive actions such as washing your hands, covering your cough, and staying home when you are ill. Additional information and resources for this outbreak are available on the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/index.html). Discussion The 2019-nCoV has impacted multiple countries, caused severe illness, and sustained person-to-person transmission making it a concerning and serious public health threat. It is unclear how this virus will impact the U.S. over time. For the general population, who are unlikely to be exposed to this virus at the current time, the immediate health risk from 2019-nCoV is considered low. CDC, multiple other federal agencies, state and local health departments, and other partners are implementing aggressive measures to slow U.S. transmission of 2019-nCoV ( 4 , 5 ). These measures require the identification of cases and contacts in the United States and the effective management of the estimated 14,000 travelers arriving from mainland China to the United States each day ( 3 ). These measures are being implemented based on the assumption that there will be more U.S. 2019-nCoV cases occurring with potential chains of transmission, with the understanding that these measures might not prevent the eventual establishment of ongoing, widespread transmission of the virus in the United States. It is important for public health agencies, health care providers, and the public to be aware of this new 2019-nCoV so that coordinated, timely, and effective actions can help prevent additional cases or poor health outcomes. The critical role that the U.S. health care system plays in halting or significantly slowing U.S. transmission of 2019-nCoV is already evident: eight of the first 11 U.S. cases were detected by clinicians collaborating with public health to test persons at risk. The early recognition of cases in the United States reduces transmission risk and increases understanding of the virus, including its transmission and severity, to inform national and global response actions. 2019-nCoV symptoms are similar to those of influenza (e.g., fever, cough, or sore throat), and the outbreak is occurring during a time of year when respiratory illnesses from influenza, respiratory syncytial virus, and other respiratory viruses are highly prevalent. To prevent influenza, all persons aged ≥6 months should receive an annual influenza vaccine, and vaccination is still available and effective in helping to prevent influenza ( 10 ). Reducing the number of persons in the United States with seasonal influenza will reduce possible confusion with 2019-nCoV infection and possible additional risk to patients with seasonal influenza. Public health authorities are monitoring the situation closely. As more is learned about this novel virus and this outbreak, CDC will rapidly incorporate new knowledge into guidance for action. Summary What is already known about this topic? In December 2019, an outbreak of acute respiratory illness caused by a novel coronavirus (2019-nCoV) was detected in mainland China. Cases have been reported in 26 additional locations, including the United States. What is added by this report? Nine of the first 11 U.S. 2019-nCoV patients were exposed in Wuhan, China. CDC expects more U.S. cases. What are the implications for public health practice? CDC, multiple other federal agencies, state and local health departments, and other partners are implementing aggressive measures to substantially slow U.S. transmission of 2019-nCoV, including identification of U.S. cases and contacts and managing travelers arriving from mainland China to the United States. Interim guidance is available at https://www.cdc.gov/coronavirus/index.html and will be updated as more information becomes available.
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              2013 IDSA clinical practice guideline for vaccination of the immunocompromised host.

              An international panel of experts prepared an evidenced-based guideline for vaccination of immunocompromised adults and children. These guidelines are intended for use by primary care and subspecialty providers who care for immunocompromised patients. Evidence was often limited. Areas that warrant future investigation are highlighted.
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                Author and article information

                Journal
                MMWR Recomm Rep
                MMWR Recomm Rep
                RR
                MMWR Recommendations and Reports
                Centers for Disease Control and Prevention
                1057-5987
                1545-8601
                27 August 2021
                27 August 2021
                : 70
                : 5
                : 1-28
                Affiliations
                Influenza Division, National Center for Immunization and Respiratory Diseases, CDC; Abt Associates, Atlanta, Georgia; Immunization Safety Office, National Center for Emerging and Zoonotic Infectious Diseases, CDC; Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee
                Author notes
                Corresponding author: Lisa Grohskopf, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC. Telephone: 404-639-2552; Email: lgrohskopf@ 123456cdc.gov .
                Article
                rr7005a1
                10.15585/mmwr.rr7005a1
                8407757
                34448800
                f7971136-e653-4013-a008-27f0c5d6dbf4

                All material in the MMWR Series is in the public domain and may be used and reprinted without permission; citation as to source, however, is appreciated.

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