NCCN Update on COVID-19 Vaccines and MAb Prophylaxis – Medscape

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The National Comprehensive Cancer Network (NCCN) has issued updated recommendations for vaccination and preventive treatment of COVID-19 for people with cancer.

The guidance is based on the latest approvals from the US Food and Drug Administration (FDA) and the rising rates of COVID-19.

It includes new information on the preventive use of human monoclonal antibodies (MAbs), which have recently been approved by the FDA.

In early December 2021, the FDA granted emergency use authorization (EUA) to AstraZeneca for its combination of the long-acting monoclonal antibodies tixagevimab/cilgavimab (Evusheld) to prevent COVID-19 in people with moderately to severely compromised immune systems. As previously reported by Medscape Medical News, the EUA was authorized on the basis of a phase 3 trial that showed that a one-time dose of the two agents reduced the risk of developing symptomatic COVID by 77% in comparison with placebo (P < .001).

Even though vaccines currently provide the best defense against COVID-19, certain immune-compromised individuals or those who have a history of severe adverse reactions to a vaccine need an alternative prevention option, Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, commented at the time of the EUA.

Preexposure prophylaxis is indicated for adults and children starting at age 12 (weighing at least 40 kg) and who have moderate to severe immune compromise and may not be responsive to vaccination.

The NCCN notes that patients with blood cancers and those receiving stem cell transplants or engineered cellular therapy (CAR T-cells) are more likely to have inadequate responses to COVID-19 vaccination and are at highest risk of major COVID-19 complications. Therefore, the committee states that it is reasonable to prioritize this population for preexposure therapy over patients with solid tumor cancers in the event of limited supply.

"We have new agents to prevent and treat COVID-19 that will benefit patients with cancer," said Brahm Segal, MD, Roswell Park Comprehensive Cancer Center, co-leader of the NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis, in a statement. "An important challenge on a national level is to ensure drug availability to patients with cancer and others at high risk for COVID-19."

The committee also supports recommendations from the Centers for Disease Control (CDC), American Society of Transplantation and Cellular Therapy, and the American Society of Hematology that previously vaccinated patients completing stem cell transplantation or engineered cellular therapy should receive a repeat vaccination series starting 3 months post treatment.

The new updated guidance is as follows:

The NCCN committee endorses vaccination for all eligible persons, based on FDA-approved indications or EUA. With the widespread availability of highly effective and safe vaccines, the committee reiterates the need for patients with cancer to be fully immunized, including receiving third doses and boosters.

Vaccination is also recommended for caregivers, household/close contacts, and the general public.

Vaccination should be delayed for at least 3 months following hematopoietic cell transplantation or engineered cellular therapy in order to improve vaccine efficacy. Vaccine delays in patients with cancer should also include those recommended for the general public (eg, recent exposure to COVID-19, recent monoclonal antibody therapy).

The committee supports use of any of the available FDA-approved or EUA vaccines but with strong preference for mRNA vaccines (Pfizer/BioNTech [BNT162b2/Comirnaty] or Moderna [mRNA1273]) over the Janssen/Johnson & Johnson (Ad26.COV2.S adenovirus vector) vaccine, as recommended by the CDC-ACIP Vaccine Advisory Committee.

The committee strongly supports mandates for healthcare worker vaccination.

The NCCN also outlined specific vaccine recommendations for cancer patients, based on their tumor type and treatment.

"The medical and scientific community's response to the COVID-19 crisis continues to be extremely encouraging, even in the face of setbacks like new variants and surging infection rates," said Robert W. Carlson, MD, chief executive officer, NCCN, in a statement.

"Rapid research, thoughtful analyses, and tireless care delivery is allowing us to save so many more people than we could have a year ago. We hope by sharing this simplified guidance highlighting the latest research and approvals, we can help make sure the very latest in evidence-based care reaches as many patients and providers as possible."

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NCCN Update on COVID-19 Vaccines and MAb Prophylaxis - Medscape