Unmet Needs: Better Vaccines, Treatments, and Guidelines
There are still many areas of need in COVID-19 prevention and treatment, according to experts.
“The biggest needs are in vaccine research, drug development, and education targeting vaccine hesitancy,” Dr Hochman said. Researchers should aim to “develop vaccines that target areas other than the SARS-CoV-2 spike protein, which has mutated over time and resulted in reduced protection from prior SARS-CoV-2 infection,” she added.
Continue Reading
Dr Banerjee pointed to the need to develop mAbs like Evusheld that could protect against new variants and to create a faster pipeline to get these mAbs to vulnerable patients.
“Many of our patients aren’t able to mount adequate responses to COVID-19 vaccines because of their underlying malignancies or the treatments they’re on, so the ability to confer passive immunity is critical,” he said.
Dr Hijano hopes to see changes in the regulatory process to allow the identification of a prophylactic mAb for younger children.
“The fast pace at which SARS-CoV-2 changes has left children under 12 years to almost never have a monoclonal option available, because every time companies were opening trials in children, the monoclonals were ineffective against the newest variants and the study could not continue,” he explained. He also noted the need for antivirals that can be used in all age groups.
Another unmet need is COVID-19 management guidelines relevant to specific patient groups.
“Most of the current guidelines are for immunocompromised patients in general, which lumps together people with hematologic malignancies, solid organ transplantation, and those receiving immunomodulatory therapy for inflammatory or rheumatologic conditions,” Dr Sherman said. “We urgently need more specific guidelines for each of these groups of patients, since the underlying disease and treatments received impact the immune system differently.”
“Clinicians need to be able to provide evidence-based recommendations to protect all patients with cancer and be able to address the vast amount of misinformation propagated on social media and through other avenues,” Dr Gralow said. “That means staying up to date and understanding the evidence and rationale for recommendations.”
Disclosures: Dr Mossad, Dr Gralow, Dr Hochman, Dr Tam, and Dr Hijano reported having no relevant disclosures. Dr Banerjee disclosed relationships with SparkCures, Sanofi Pasteur, Genentech/Roche, Janssen Oncology, Bristol-Myers Squibb/Celgene, and Pack Health. Dr Sherman is involved in COVID-19, HIV, and other vaccine trials conducted in collaboration with the National Institutes of Health, HIV Vaccine Trials Network, COVID Vaccine Prevention Network. Dr Boonyaratanakornkit disclosed research funding from Vir Biotechnology and GlaxoSmithKline.
References
1. Patel P, Twentyman E, Koumans E, et al. Information for persons who are immunocompromised regarding prevention and treatment of SARS-CoV-2 infection in the context of currently circulating omicron sublineages — United States, January 2023. MMWR Morb Mortal Wkly Rep. 2023;72(5):128–131. doi:10.15585.mmwr.mm7205e3
2. Forster V. Responses to COVID-19 vaccines vary in patients with hematologic malignancies. Cancer Therapy Advisor. Published August 20, 2021. Accessed February 28, 2023.
3. Storrs C. Responses to COVID-19 vaccines in cancer patients: Impact of tumor and treatment type. Cancer Therapy Advisor. Published August 31, 2021. Accessed February 28, 2023.
4. Storrs C. Cancer patients may have double the risk of breakthrough infection after COVID-19 vaccination. Cancer Therapy Advisor. Published December 7, 2021. Accessed February 28, 2023.
5. Goodman J. Risk of death from COVID-19 “remains high” in vaccinated cancer patients. Cancer Therapy Advisor. Published February 16, 2022. Accessed February 28, 2023.
6. Schieszer J. Risk of breakthrough COVID-19 higher for patients with cancer. Cancer Therapy Advisor. Published April 7, 2022. Accessed February 28, 2023.
7. Schieszer J. Breakthrough COVID-19 in cancer patients more common during omicron wave. Cancer Therapy Advisor. Published April 21, 2022. Accessed February 28, 2023.
8. Blevins Primeau AS. Cancer patients have higher risk of breakthrough COVID-19, poor outcomes. Cancer Therapy Advisor. Published January 9, 2023. Accessed February 28, 2023.
9. Link-Gelles R, Ciesla AA, Fleming-Dutra KE, et al. Effectiveness of bivalent mRNA vaccines in preventing symptomatic SARS-CoV-2 infection — Increasing community access to testing program, United States, September–November 2022. MMWR Morb Mortal Wkly Rep. 2022;71(48):1526–1530. doi:10.15585/mmwr.mm7148e1
10. Link-Gelles R, Ciesla AA, Roper LE, et al. Early estimates of bivalent mRNA booster dose vaccine effectiveness in preventing symptomatic SARS-CoV-2 infection attributable to omicron BA.5- and XBB/XBB.1.5-related sublineages among immunocompetent adults – Increasing community access to testing program, United States, December 2022-January 2023. MMWR Morb Mortal Wkly Rep. 2023;72(5):119-124. doi:10.15585/mmwr.mm7205e1
11. Lin D-Y, Xu Y, Gu Y, et al. Effectiveness of bivalent boosters against severe omicron infection. N Engl J Med. 2023; 388:764-766. doi:10.1056/NEJMc2215471
12. Chalkias S, Harper C, Vrbicky K, et al. A bivalent omicron-containing booster vaccine against Covid-19. N Engl J Med. 2022 Oct 6;387(14):1279-1291. doi:10.1056/NEJMoa2208343
13. Wang, Q, Bowen A, Valdez R, et al. Antibody response to omicron BA.4–BA.5 bivalent booster. N Engl J Med. 2023; 388:567-569. doi:10.1056/NEJMc2213907
14. Miller J, Hachmann NP, Collier AY, et al. Substantial neutralization escape by sars-cov-2 omicron variants BQ.1.1 and XBB.1. N Engl J Med. 2023; 388:662-664. doi:10.1056/NEJMc2214314
15. Collier AY, Miller J, Hachmann NP, et al. Immunogenicity of BA.5 bivalent mRNA vaccine boosters. N Engl J Med. 2023;388:565-567. doi:10.1056/NEJMc2213948
16. Healy LM. Bivalent COVID-19 vaccine may not protect cancer patients from current variants. Cancer Therapy Advisor. Published February 15, 2023. Accessed February 28, 2023.
17. Forster V. Lack of mask mandates leaves cancer patients feeling unprotected. Cancer Therapy Advisor. Published July 6, 2022. Accessed February 28, 2023.
18. Markowitz A. State-by-state guide to face mask requirements. AARP. Updated February 13, 2023. Accessed February 28, 2023.
19. Lee BY. New York state drops face mask requirements for hospitals, health care facilities. Forbes. Published February 12, 2023. Accessed February 28, 2023.
20. Oregon, Washington will lift mask requirements in health care settings on April 3. KATU. Published March 3, 2023. Accessed March 3, 2023.
21. Money L. California to alter COVID rules in healthcare settings: Masks and vaccinations not required. Los Angeles Times. Published March 3, 2023. Accessed March 3, 2023.
22. Biden to lift COVID-19 emergency measures in May. HealthDay via Cancer Therapy Advisor. Published February 2, 2023. Accessed February 28, 2023.
23. Moderna will not be charging for COVID-19 vaccination after public health emergency ends. HealthDay via Cancer Therapy Advisor. Published February 21, 2023. Accessed February 28, 2023.
24. Cox C, Kates J, Cubanski J, Tolbert J. The end of the COVID-19 public health emergency: Details on health coverage and access. Kaiser Family Foundation. Published Feb 03, 2023. Accessed February 28, 2023.
25. Lawrence L. COVID-19 vaccine booster, Evusheld improve protection for patients with blood cancers. Cancer Therapy Advisor. Published July 13, 2022. Accessed February 28, 2023.
26. Goodman J. Evusheld appears less effective against omicron for patients with blood cancer. Cancer Therapy Advisor. Published May 31, 2022. Accessed February 28, 2023.
27. FDA announces Evusheld is not currently authorized for emergency use in the U.S. US Food and Drug Administration. Updated January 26, 2023. Accessed February 28, 2023.
28. Coronavirus (COVID-19) update: FDA revokes emergency use authorization for monoclonal antibody bamlanivimab. US Food and Drug Administration. Published April 16, 2021. Accessed February 28, 2023.
29. Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the omicron variant. US Food and Drug Administration. Published January 24, 2022. Accessed February 28, 2023.
30. REGEN-COV usage revisions. Regeneron. Published January 24, 2022. Accessed February 28, 2023.
31. Emergency use authorization (EUA) for the treatment or post-exposure prophylaxis of COVID-19. Lilly. Accessed February 28, 2023.
32. FDA updates sotrovimab emergency use authorization. US Food and Drug Administration. Updated April 5, 2022. Accessed February 28, 2023.
33. FDA announces bebtelovimab is not currently authorized in any US region. US Food and Drug Administration. Updated November 30, 2022. Accessed February 28, 2023.
34. Interim clinical considerations for COVID-19 treatment in outpatients. Centers for Disease Control and Prevention. Updated February 10, 2023. Accessed February 28, 2023.
35. Therapeutic management of nonhospitalized adults with COVID-19. National Institutes of Health. Updated December 28, 2022. Accessed February 28, 2023.
36. Waters MD, Warren S, Hughes C, Lewis P, Zhang F. Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: The special case of molnupiravir. Environ Mol Mutagen. 2022;63(1):37-63. doi:10.1002/em.22471
37. Wang L, Berger NA, Davis PB, Kaelber DC, Volkow ND, Xu R. COVID-19 rebound after Paxlovid and molnupiravir during January-June 2022. medRxiv [Preprint]. 2022:2022.06.21.22276724. doi:10.1101/2022.06.21.22276724
38. Wong GL, Yip TC, Lai MS, Wong VW, Hui DS, Lui GC. Incidence of viral rebound after treatment with nirmatrelvir-ritonavir and molnupiravir. JAMA Netw Open. 2022;5(12):e2245086. doi:10.1001/jamanetworkopen.2022.45086
39. Therapeutic management of hospitalized adults with COVID-19. National Institutes of Health. Updated August 8, 2022. Accessed February 28, 2023.
40. COVID-19 convalescent plasma. COVID-19 treatment guidelines. National Institutes of Health. Updated December 1, 2022. Accessed February 28, 2023.
41. Therapeutic management of nonhospitalized children with COVID-19. COVID-19 treatment guidelines. National Institutes of Health. Updated December 28, 2022. Accessed February 28, 2023.
42. Therapeutic management of hospitalized children with COVID-19. COVID-19 treatment guidelines. National Institutes of Health. Updated August 8, 2022. Accessed February 28, 2023.
This article originally appeared on Cancer Therapy Advisor
