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FDA Authorizes Additional COVID-19 Vaccine Dose for Cancer Patients

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FDA Authorizes Additional COVID-19 Vaccine Dose for Cancer Patients

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Soon, additional COVID-19 vaccine doses will be available for everyone in the U.S. to provide added protection against the coronavirus. For now, the focus is on those with weakened immune systems. Research studies show that immunocompromised people who have low or no protection following two doses of mRNA COVID-19 vaccines may have an improved response after an additional dose of the same vaccine.

Based on this research, the Food and Drug Administration (FDA) has amended the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines. This allows for certain immunocompromised individuals, including certain cancer patients and survivors, to receive a third vaccine dose in order to strengthen their immune system’s response against COVID-19. But who is actually eligible for a third dose? And what can you expect if you or a loved one needs one?

To answer common questions about third COVID-19 vaccine doses, we spoke with infectious diseases specialist and head of Internal Medicine David Tweardy, M.D.

What is the difference between a third dose and a booster shot of COVID-19 vaccine?


An additional dose – also called a third dose – follows the initial two-dose vaccine series for people who may not have mounted a strong enough immune response after receiving the initial vaccine series. In other words, these individuals may not have had the same level of protection against COVID-19 as other individuals due to their weakened immune systems, so they need additional protection that can be provided by a third dose.

By contrast, a booster dose is a supplemental dose given to groups whose immune response has waned over time. Booster COVID-19 vaccine doses will likely be available for everyone in the U.S. in September. But for now, the FDA and Centers for Disease Control and Prevention (CDC) have authorized additional doses of Pfizer and Moderna’s COVID-19 vaccines for severely immunocompromised individuals, and these are the only people who should get an additional dose of COVID-19 vaccine at this time.

Who is eligible for a third dose of the COVID-19 vaccines?


People eligible for an additional COVID-19 vaccine dose include those who received the two-dose Moderna or Pfizer COVID-19 vaccine series and are moderately or severely immunocompromised, such as those with certain conditions identified by the CDC.

Do I need to get the same type of vaccine for my third dose as I got for the first two? For instance, if I got the Pfizer vaccine before, do I need to get the Pfizer vaccine again?

The CDC recommends that a third dose of the same mRNA vaccine be used, whenever available, for people who received either the Pfizer or Moderna COVID-19 vaccine series. If you’re not sure which mRNA vaccine you got or aren’t able to get the same vaccine, it’s OK to get either the Pfizer or Moderna mRNA COVID-19 vaccine.

What if I got the one-dose Johnson & Johnson vaccine? Do I need to another dose, or can I get the Pfizer or Moderna two-dose series?


There is not yet enough data on to determine whether an additional dose of the Johnson & Johnson’s Janssen COVID-19 vaccine provides improved antibody response in immunocompromised people. The FDA’s authorization for additional doses only applies to the two mRNA COVID-19 vaccines. The FDA and CDC are working to provide guidance on this issue.

When should eligible cancer patients get a third dose?


People with moderately to severely compromised immune systems can receive an additional dose at least 28 days after their second dose of the Pfizer or Moderna COVID-19 vaccine.

However, patients currently receiving chemotherapy, immunotherapy, CAR T cells, stem cell transplants or participating in clinical trials may need to coordinate timing of their additional vaccine dose with their treatment schedule to optimize their vaccine response. Talk to your primary health care provider to determine the appropriate timing for your additional vaccination dose if you are immunocompromised or taking immunosuppressive therapies.

Can childhood cancer patients get a third dose?


Yes. Adolescents ages 12-17 years are eligible to receive the Pfizer COVID-19 vaccine. Those younger than age 18 are not authorized to receive the Moderna vaccine, and children younger than age 12 years are not authorized to receive any COVID-19 vaccine at this time.

What are the most common side effects of the third dose?


Reactions reported after the third mRNA dose are similar to what people experienced after receiving the two-dose series. The most commonly reported side effects are fatigue and pain at injection site. Most post-vaccination symptoms are mild to moderate and resolve within 1-2 days.

Do I need antibody testing to receive an additional vaccine dose?


No. Outside the context of research studies, the CDC does not recommend antibody testing to determine an immune response to vaccination. In many cases, you may have a negative antibody test result even if you are fully vaccinated.

What precautions do cancer patients need to take after receiving a third dose?


People who are immunocompromised may continue to experience a reduced immune response to COVID-19 vaccines, even after receiving the third dose. It is important to continue following COVID-19 safety precautions, including wearing a mask in indoor public settings, staying apart from others who are not from your household, and avoiding crowds and poorly ventilated indoor spaces. Because the Delta variant is highly contagious, social distancing and wearing high-quality KF-94 or KN-95 mask may offer better protection.

It is also important to encourage your family, friends and anyone you spend time with to get vaccinated.

Is MD Anderson offering the third dose?


Yes. This week, eligible patients will be able to start self-scheduling third dose appointments through MyChart; you will need to bring your proof of prior vaccination and attest that you meet criteria for immunocompromised conditions. We are unable to accept walk-ins.

Can I get the third dose somewhere else if it’s more convenient?


Yes. People who meet the eligibility criteria for additional COVID-19 doses should consider getting vaccinated wherever they can. Use the National Vaccine Finder to see appointments available in your community. Again, talk to your primary health care provider to determine the appropriate timing for your additional vaccination dose if you are immunocompromised or taking immunosuppressive therapies.

Reference: Commissioner O of the. Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals. FDA. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised Published August 16, 2021. Accessed August 19, 2021. 


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