Brace for Flu Season as COVID-19 Pandemic Persists

August 11, 2020

Keep up-to-date on flu vaccine options and counseling considerations, especially as coronavirus disease 2019 continues to strike.

With influenza season approaching, it is critical to be prepared, because coronavirus disease 2019 (COVID-19) will likely still be circulating throughout the United States. Pharmacists serving on the front lines amid the pandemic also will play an important role in flu vaccine administration and education.

The CDC estimates that from October 1, 2019, to April 4, 2020, there have been 410,000 to 740,000 hospitalizations and 24,000 to 62,000 deaths related to influenza in the United States.1 Influenza vaccine efficacy varies and was 39% effective overall during the 2019-2020 season.2 A total of 185 influenza-associated pediatric deaths were reported to the CDC; generally, approximately 80% occur in those who were not fully vaccinated.3

Promoting flu vaccines is critical to easing the influenza hospital burden, especially because COVID-19 will likely coincide with the upcoming season.4 Everyone 6 months and older should receive the current influenza vaccine, which offers the best way to prevent flu and serious complications, including hospitalization and death.4 Even though the influenza vaccine does not protect against COVID-19, it can help keep patients healthy and prevent hospitalizations during the pandemic.4

Both influenza and COVID-19 are infectious respiratory illnesses, but there are differences between the viruses (Table 1)5. Flu symptoms typically include fever, cough, body aches, and fatigue, and patients may also experience vomiting and diarrhea.5

Influenza Vaccines Available for Upcoming Season

Vaccine options are similar to the 2019-2020 flu season and include standard-dose quadrivalent, quadrivalent cell-based, and recombinant quadrivalent shots (Table 2,2,4,6). The live attenuated influenza vaccine nasal spray is also an option.4,6 For adults 65 years and older, 2 new vaccines are available for the 2020-2021 flu season. These include a quadrivalent high-dose vaccine (Fluzone High-Dose Quadrivalent), replacing the trivalent high-dose vaccine, and a quadrivalent adjuvanted vaccine (Fluad Quadrivalent), which is similar to the previous trivalent, with 1 additional influenza B component.7,8 Pharmacists should educate patients to get vaccinated before the end of October to ensure optimal protection and remind them that it takes about 2 weeks after administration for the flu vaccine to become fully effective.4

Additionally, universal influenza vaccines are being investigated to provide long-lasting protection against most or all flu strains. There are currently 2 universal flu vaccines in the pipeline: FLU-v and M-001 (Table 39,10,11).

Immunization Counseling Pearls

Families should be counseled that children 6 months to 8 years of age require 2 doses of the flu vaccine separated by at least 4 weeks if they are receiving it for the first time or previously received just 1 dose.12 Families should ensure that they begin the vaccine process early for their children, especially those being vaccinated for the first time, because full efficacy occurs 2 weeks after administration of the second shot.12

The World Health Organization named vaccine hesitancy as one of the 10 threats to global health in 2019.13 According to a recent survey, approximately 25.8% of parents are hesitant for their children to receive the influenza vaccine.14 These results further emphasize the important role that pharmacists can play in countering vaccine hesitancy and the antivaccination movement. As schools begin to reopen, it is critical to ensure that children are vaccinated against influenza, because pediatric patients are at a high risk of serious complications.3,14

The CDC’s Advisory Committee on Immunization Practices met June 24, 2020, and recommends any approved influenza vaccine for the upcoming flu season, listing certain conditions as contraindications for the live vaccine FluMist nasal spray and providing more information about antiviral drug interactions (Table 2).2 Individuals at high risk of serious complications from the flu include adults 65 years and older, pregnant women, young children, and individuals with chronic health conditions including asthma, cardiovascular disease, diabetes, HIV/AIDs, and cancer.15 Most of these are also risk factors for severe COVID-19 complications, making flu vaccination especially critical this season. Pregnant women are at a higher risk of complications from influenza because changes in the immune system, heart, and lungs occur during pregnancy.15 One recent CDC study revealed that pregnant women may also be at an increased risk of COVID-19 complications including hospitalization, intensive care unit admission, and mechanical ventilation compared with nonpregnant women.16 Therefore, it is extremely important to get the influenza vaccine during pregnancy for maternal protection and to pass on protective antibodies to the developing baby as the COVID-19 pandemic continues during flu season.17

Flu Vaccine Health and Safety Guidance During COVID-19

Pharmacists can serve as vaccine champions and promote a safe immunization administration environment. Experts including Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and Robert R. Redfield, MD, director of the CDC, provided testimony on June 23, 2020, on COVID-19 and the impending flu season.18 One of the hot topics centered on a new laboratory test, developed by the CDC, that checks for 3 viruses simultaneously: influenza viruses A and B and severe acute respiratory syndrome coronavirus 2, which causes COVID-19. This would enhance public health surveillance and provide an important diagnostic tool for detecting and treating coinfection with influenza and COVID-19, and on June 18, 2020, the CDC requested emergency use authorization (EUA).19 On July 2, the FDA issued the EUA for the test on July 2, making it the third diagnostic test for detection and differentiation of viruses causing influenza and COVID-19.19

Other discussion points included goals for greater influenza vaccine coverage through education and increasing flu vaccines for uninsured, high-risk adults. The CDC awarded $140 million to 64 jurisdictions to enable state health departments to launch an initial scale-up for influenza season, and the funds will also support staffing and preparedness during summer.18 In an email with Drug Topics®, Natalie E. Azar, MD, assistant professor of rheumatology at NYU Langone and NBC News medical contributor, discussed the concern of flu predisposing patients to COVID-19 complications, such as COVID pneumonia. “Thus, rather than having a direct protective effect from vaccination against influenza, getting the flu shot could indirectly protect folks from a bad outcome from COVID-19,” Azar said.

Although there are no vaccines currently available to directly protect against COVID-19, there are several investigational candidates currently going through clinical trials (Table 3).20-28

Considerations for In-Pharmacy Vaccinations During Pandemic

The CDC recommends that pharmacies and other facilities resume administering routine vaccinations to ensure that communities are protected from vaccine-preventable diseases, and influenza vaccination is emphasized to reduce the overall burden of respiratory illness especially during COVID-19.32 Specific guidance is provided to protect pharmacists, staff, and patients during vaccine administration.33 Pharmacies should implement strategies to screen patients for fever and COVID-19 symptoms prior to providing influenza vaccines, and face masks should be worn by pharmacists, staff, and patients.33 Eye protection should also be considered when administering immunizations.33 Gloves should be worn and changed between patients, and hands should be washed before and after vaccine administration. There should also be a dedicated space ensuring at least 6 feet between patients in line or waiting areas.33

Walgreens recently announced that they resumed immunization services ahead of flu season with additional health and safety measures that follow the updated CDC guidelines.34 Key measures include requiring all pharmacy team members to wear disposable face masks while administering immunizations. Patients are encouraged to wear a face covering when entering the pharmacy and will be provided with a face mask if they do not have one prior to receiving vaccines. All pharmacy team members administering vaccines will be given plastic face shields for additional protection. At least 6 feet of distance will be maintained between pharmacy areas for completing paperwork and waiting for immunizations.34

References:

  1. 2019-2020 U.S. flu season: preliminary burden estimates. CDC. Accessed June 24, 2020. Updated April 17, 2020. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm
  2. Jenco M. CDC committee addresses COVID-19, flu, MenACWY vaccines. American Academy of Pediatrics. June 25, 2020. Accessed June 27, 2020. https://www.aappublications.org/news/2020/06/25/acip062520
  3. Weekly U.S. influenza surveillance report. CDC. Accessed June 22, 2020. Updated July 17, 2020. https://www.cdc.gov/flu/weekly/index.htm
  4. Frequently asked influenza (flu) questions: 2020-2021 season. CDC. Accessed June 22, 2020. Updated July 2, 2020. https://www.cdc.gov/flu/season/faq-flu-season-2020-2021.htm 
  5. Maragakis LL. Coronavirus disease 2019 vs. the flu. Johns Hopkins Medicine. Accessed June 30, 2020. Updated July 20, 2020. https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-disease-2019-vs-the-flu
  6. Influenza vaccine for the 2019-2020 season. FDA. Accessed June 28, 2020. Updated December 5, 2019. https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2019-2020-season
  7. FDA approves Fluzone High-Dose Quadrivalent (influenza vaccine) for adults 65 years of age and older. News release. Sanofi. November 4, 2019. Accessed June 27, 2020. http://www.news.sanofi.us/2019-11-04-FDA-approves-Fluzone-R-High-Dose-Quadrivalent-Influenza-Vaccine-for-adults-65-years-of-age-and-older
  8. Fluad Quadrivalent. FDA. Accessed June 27, 2020. Updated July 6, 2020. https://www.fda.gov/vaccines-blood-biologics/fluad-quadrivalent
  9. Promising Results in Trial of Universal Flu Vaccine Candidate. News Release. National Institute of Allergy and Infectious Diseases; March 16, 2020. Accessed July 21, 2020. https://www.niaid.nih.gov/news-events/promising-results-trial-universal-flu-vaccine-candidate
  10. Pleguezuelos O, James E, Fernandez A, et al. Efficacy of FLU-v, a broad spectrum influenza vaccine, in a randomized phase IIb human influenza challenge study. NPJ Vaccines. 2020; 5:22. doi: 10.1038/s41541-020-0174-9. 
  11. NIH Report on Phase 2 Clinical Trial of BiondVax’s M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved. News Release. BiondVax Pharmaceuticals Ltd.; June 10, 2020. Accessed July 21, 2020. https://www.biondvax.com/2020/06/nih-report-on-phase-2-clinical-trial-of-biondvaxs-m-001-universal-influenza-vaccine-candidate-concludes-both-primary-endpoints-achieved/
  12. Children & influenza (flu). CDC. Accessed June 27, 2020Updated October 23, 2019.. https://www.cdc.gov/flu/highrisk/children.htm
  13. Ten threats to global health in 2019. World Health Organization. Accessed June 29, 2020.https://www.who.int/news-room/feature-stories/ten-threats-to-global-health-in-2019
  14. Kempe A, Saville AW, Albertin C, et al. Parental hesitancy about routine childhood and influenza vaccinations: a national survey. Pediatrics. 2020;146(1):e20193852. doi: 10.1542/peds.2019-3852
  15. People at high risk for flu complications. CDC. Accessed June 28, 2020. Updated August 27, 2018.. https://www.cdc.gov/flu/highrisk/index.htm
  16. Flu vaccine safety and pregnancy. CDC. Accessed June 28, 2020. Updated October 16, 2019.. https://www.cdc.gov/flu/highrisk/qa_vacpregnant.htm
  17. Ellington S, Strid P, Tong VT, et al. Characteristics of women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status - United States, January 22-June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(25):769-775. doi:10.15585/mmwr.mm6925a1
  18. Redfield RR, Fauci AS, Giroir BP, Hahn SM. Witnesses appearing before the House Energy and Commerce Committee hearing on oversight of the Trump Administration’s response to the COVID-19 pandemic. U.S. House of Representatives Document Repository. June 23, 2020. Accessed June 29, 2020. https://docs.house.gov/meetings/IF/IF00/20200623/110829/HHRG-116-IF00-20200623-SD003.pdf
  19. Coronavirus (COVID-19) update: FDA authorizes additional COVID-19 combination diagnostic test ahead of flu season. News Release. FDA. July 2, 2020. Accessed July 6, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-covid-19-combination-diagnostic-test-ahead-flu
  20. Experimental COVID-19 Vaccine Safe, Generates Immune Response. News Release. National Institutes of Health; July 14, 2020. Accessed July 21, 2020. https://www.nih.gov/news-events/news-releases/experimental-covid-19-vaccine-safe-generates-immune-response
  21. Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2-Preliminary report. N Engl J Med. Published online July 14, 2020. doi: 10.1056/NEJMoa2022483. 
  22. COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial. News Release. AstraZeneca; July 20, 2020. Accessed July 21, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/covid-19-vaccine-azd1222-showed-robust-immune-responses-in-all-participants-in-phase-i-ii-trial.html
  23. Folegatti PM, Ewer KJ, Aley PK, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. Published online July 20, 2020. doi:https://doi.org/10.1016/S0140-6736(20)31604-4. 
  24. Merck to Announce Multiple Scientific Efforts to Combat COVID-19. News Release. Merck; May 26, 2020. Accessed July 21, 2020. https://investors.merck.com/news/press-release-details/2020/Merck-to-Announce-Multiple-Scientific-Efforts-to-Combat-COVID-19/default.aspx
  25. Merck Completes Acquisition of Themis: Milestone Reflects Merck’s Commitment to Accelerate SARS-CoV-2 Vaccine Program. News Release. Business Wire; June 19, 2020. Accessed July 21, 2020. https://www.businesswire.com/news/home/20200619005217/en/Merck-Completes-Acquisition-Themis
  26. Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data. News Release. Pfizer; July 20, 2020. Accessed July 21, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-update-german
  27. Zhu FC, Guan XH, Li YH, et al. Immunogenicity and safety of a recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. Published online July 20, 2020. doi: https://doi.org/10.1016/S0140-6736(20)31605-6
  28. Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July. News Release. Johnson & Johnson; June 10, 2020. Accessed July 22, 2020. https://www.jnj.com/johnson-johnson-announces-acceleration-of-its-covid-19-vaccine-candidate-phase-1-2a-clinical-trial-to-begin-in-second-half-of-july
  29. Associated Press. New rule requires Tennessee students to get flu vaccines. U.S. News & World Report. June 26, 2020. Accessed June 30, 2020. https://www.usnews.com/news/best-states/tennessee/articles/2020-06-26/new-rule-requires-tennessee-students-to-get-flu-vaccines
  30. Flu vaccination coverage, United States, 2018–19 influenza season. CDC. Accessed July 1, 2020. Updated September 26, 2019. https://www.cdc.gov/flu/fluvaxview/coverage-1819estimates.htm
  31. 60% of U.S. adults plan to get seasonal flu vaccine: Reuters/Ipsos poll. May 26, 2020. Accessed July 1, 2020. https://www.reuters.com/article/us-health-coronavirus-flu-poll/60-of-u-s-adults-plan-to-get-seasonal-flu-vaccine-reuters-ipsos-poll-idUSKBN23220X
  32. Vaccination guidance during a pandemic. CDC. Accessed July 1, 2020. Updated June 9, 2020.. https://www.cdc.gov/vaccines/pandemic-guidance/index.html
  33. Guidance for pharmacies. CDC. Accessed July 1, 2020. Updated June 28, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/pharmacies.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhealthcare-resources%2Fpharmacies.html
  34. Walgreens resumes immunization services with new safety measures. News release. Walgreens. June 22, 2020. Accessed July 1, 2020. https://news.walgreens.com/press-releases/general-news/walgreens-resumes-immunization-services-with-new-safety-measures.htm

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