COVID-19 Vaccine Information

Flu season is upon us once again, and for a second time in as many years it’s occurring during the COVID-19 pandemic. But the 2021 flu season is different from last year’s, in several significant ways.

For one thing, the COVID-19 pandemic is now being driven by the delta variant, which is much more transmissible than previous variants. In-person schooling is also back in session for millions of students. And, perhaps most importantly, COVID-19 vaccines are now available for those ages 12 and up, immunocompromised patients are now eligible for a third dose of the two mRNA vaccines — and soon (fall 2021), many more fully vaccinated people may be eligible for a booster shot, based on updated recommendations from the Centers for Disease Control and Prevention (CDC).

So, how does this affect when and whether you should get a flu shot? We asked Elizabeth Frenzel, M.D., who manages MD Anderson’s employee flu vaccination program. Here is her advice.

If you haven’t gotten a COVID-19 vaccine, don’t wait

Vaccinations are all about reducing risk: both the risk of contracting a particular disease, and the risk of becoming severely ill or dying from it, should you develop a breakthrough infection. All three COVID-19 vaccines have proven highly effective at reducing those risks — even against the delta variant. That’s why it’s more critical than ever to protect yourself and your loved ones by getting vaccinated against COVID-19.

“People are out and about more now than they were at this time last year,” Frenzel notes. “And masking and social distancing may not be as universally practiced as before. We’ve already seen a spike in RSV (respiratory syncytial virus) cases. And we’re expecting a robust flu season this year, too. So, don’t wait any longer. The best time to get vaccinated against COVID-19 is now. And get your flu shot as soon as it becomes available.”

There’s no need to stagger your vaccinations

The CDC says it’s OK for everyone age 12 and older to receive a COVID-19 vaccine alongside other vaccines. So, there’s no need to space them out.

That means whether you’re getting your first, second or third dose of the COVID-19 vaccine (if eligible) or a booster shot (once they’re available), you can get it on the same day as other vaccines, such as flu shots. Some places are even offering both appointments at the same time.

Why reducing your risk is more important than ever

With so many hospitals filling up with unvaccinated COVID-19 patients, that can mean long waits for urgent care of any kind.

“It’s not just about COVID-19 anymore,” says Frenzel. “Right now, it’s about reducing the risk of needing urgent care for any other reason as well, whether that’s a broken arm, a heart attack or stroke, a kidney stone, or pneumonia. And vaccination works. That’s why we strongly encourage anyone who can get vaccinated against the flu and COVID-19 to do so as quickly as possible. And when it’s your turn to get a third dose or booster of the COVID-19 vaccines, don’t put it off. Vaccination can protect you from severe illness and keep you out of the hospital, but it also protects those around you. It benefits everyone.”

Schedule a COVID-19 vaccine appointment at MD Anderson. Current patients who are eligible for a third COVID-19 vaccine dose can self-schedule a vaccination appointment through MyChart; immunocompromised members of the general public can schedule a third COVID-19 dose at MD Anderson through our scheduling portal.

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Last updated Aug. 23, 2021

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, certain immunocompromised individuals, including certain cancer patients and survivors, can 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.

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.

By contrast, a booster dose is a supplemental dose given to groups whose immune response has waned over time.

Is the vaccine you receive for the third dose different than the vaccine people will receive for the booster?

The FDA has fully authorized Pfizer-BioNTech’s COVID-19 vaccine, now called Comirnaty, for individuals age 16 and older. In addition, the Pfizer vaccine continues to be available under its emergency use authorization for individuals age 12 through 15 and for the administration of an additional third dose in immunocompromised individuals.

According to the FDA, the same formulation is used for these vaccines.

The Delta variant is highly transmissible and immunocompromised individuals may not have built up a strong immune response after the first two doses, it’s important to go ahead and get the third dose if you’re eligible. The hope is that will help strengthen your body’s immune response against COVID-19.

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. Examples include:

• Active or recent cancer treatment. Recent includes within one year of completing immunosuppressive therapy.
• Solid-organ transplant
• CAR T cell therapy 
• Autologous or allogeneic hematopoietic stem cell transplant within the last two years, or beyond two years for patients with chronic graft vs. host disease (GVHD), and/or ongoing immunosuppression
• History of primary immunodeficiency
• Advanced or untreated HIV infection
• People on active immunosuppressive therapy, such as chemotherapy, radiation therapy, high-dose corticosteroids, alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, tumor-necrosis factor (TNF) blockers, certain biologic agents (e.g., rituximab) and other biologic agents that are immunosuppressive or immunomodulatory.

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.

Will we need additional doses or boosters after this third dose?

This is something researchers are still looking at. They hope to gain a better understanding of whether future doses or boosters will be needed and, if so, how frequently.

Is MD Anderson offering the third dose of COVID-19 vaccines?

Yes. Eligible MD Anderson patients can sign into MyChart to schedule an appointment; 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.

Appointments for community members who are eligible for a third dose of the vaccine will be available at MD Anderson soon.

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.

What is your advice to immunocompromised individuals who don’t want to get a third dose, either because they’ve already had COVID-19 or don’t want to get another shot?

Talk to your doctor about these concerns, but it’s really important to get the third dose if you are immunocompromised. The latest research indicates the COVID-19 vaccines are safe and effective, but their effectiveness may wane over time and/or they may become less effective with new variants. In addition, an immunocompromised individual may not have had a sufficient immune response to their initial vaccine series or infection; a third dose has been shown to improve immunity in those who have received a complete vaccine series, and it is expected to improve immunity in those who had a COVID-19 infection.

 

Whether it’s a cancer drug, vaccine or other medication, medical treatments in the U.S. have to go through a specific process to make sure they’re safe and effective before being released to the public.

The Food and Drug Administration (FDA) oversees the process from start to finish – and even after approval.

To better understand the FDA approval process, we spoke to Vivek Subbiah, M.D. Here’s what he shared.

The FDA carefully reviews all drugs and vaccines

Cancer drugs and vaccines, like the COVID-19 vaccine, follow a similar process for approval.

The first step is called discovery. This is when researchers learn about the disease they’re targeting and make a plan to treat it. With vaccines, they’re trying to mimic a virus’ effects on the body to train the immune system to recognize and defend against it. Cancer drugs may target a specific type of cancer, genetic mutation or protein within the cells.

After discovery, the new treatment goes through three phases of clinical trials before it can be approved. Each phase is designed with different variables to make sure the treatment is effective and safe.

Phase I is the first time the treatment will be given to humans to determine the best dose and preliminary safety data. Phase II clinical trials test for safety and efficacy. Phase III studies test for efficacy and collect more safety data in a larger group of people. If a Phase III clinical trial is successful, the drug or vaccine can be submitted for FDA approval.  

“With cancer drugs, the approval process can take anywhere from six to 12 years,” Subbiah says. Each phase can take around two years, but the timeline depends on how rare the disease being treated is.

For less common conditions, each phase may take longer because there simply aren’t enough patients to work with. This is one of the reasons it is so important for people to enroll in clinical trials, especially if you’re diagnosed with a rare disease or condition. 

The process for vaccine approval is similar, but there’s not a definite timeline, as we’re seeing with COVID-19 vaccine development. In most cases, the better the understanding of a virus and the disease it causes, the more efficient a vaccine will be.

Emergency use authorizations (EUA) may be granted in certain cases if vaccines are effective

Just because a drug or vaccine is developed quickly doesn’t mean researchers are taking shortcuts. “The FDA vaccine development program is one of the most robust in the world,” Subbiah says.

In some cases, if a drug or vaccine is successful in a Phase II or early Phase III study, they may be authorized or approved more quickly. For vaccines, this is called an emergency use authorization (EUA). If a vaccine receives emergency use authorization, that means the results of the clinical trial show the vaccine is working, and side effects are tolerable and the benefits outweigh the risks.

EUAs are only valid for a certain amount of time – for example, throughout a public health crisis like the COVID-19 pandemic. After receiving an EUA, a vaccine or drug still needs to go through the full FDA approval process like the COVID-19 vaccines are. This process can take some time. That’s why clinical trials for many COVID-19 vaccines are continuing, even though they’ve already received EUA.  

Accelerated approval is often used for cancer drugs

The FDA may also approve cancer drugs before a Phase III clinical trial is done. This process is called accelerated approval.

“We’ve seen accelerated approvals with several cancer drugs recently,” Subbiah says.  Sotorasib , selpercatinib and pralsetinib are three drugs that have seen such encouraging results in clinical trials that they’re now available for patients with non-small cell lung cancer with specific mutations through accelerated approval.

"The studies are showing these drugs offer so much benefit to patients that it’s critical we offer them as soon as possible to save as many lives as possible,” Subbiah adds.  

This fast-track to approval is exactly how the FDA process is designed to work, Subbiah says. “In the case of a public health emergency like the COVID-19 pandemic, the FDA pulls all its resources together to quickly and safely find a way to protect as many people as possible,” he explains.

That teamwork gives him hope for the future of drug development. “If we applied the COVID-19 vaccine model to cancer drugs, we could have safe and effective treatments created more quickly,” Subbiah says. 

The FDA continues monitoring after approval to ensure safety

No drug is 100% effective or completely without side effects. So, those side effects and the long-term effectiveness of the drug or vaccine will be monitored by the FDA – even after the drug or vaccine has been approved.

“When you think of the FDA, it’s not just one group that makes the decisions,” Subbiah says. “There are dozens of government agencies involved making sure these treatments are safe.”

These include the Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services and others. The FDA also seeks the input of Vaccine and Related Biological Products Advisory Committee.

Before a drug or vaccine can be approved for a different population, like children, those groups would need to be included in a Phase I clinical trial and start the whole process over.

FDA-approved drugs and vaccines are safe and effective

Science has come such a long way in recent years that drug development can happen more quickly now than ever before. “If something’s been approved by the FDA, you can trust that it’s safe,” Subbiah says.

He stresses that this is especially true for COVID-19 vaccines, even though they are new. The technology used for these mRNA vaccines has been around for decades, which is why researchers were able to develop these COVID-19 vaccines so quickly, Subbiah explains.

“Thanks to science and vaccines, we’ve been able to eradicate so many diseases,” he adds. “You should have confidence in the FDA and how it oversees development of these treatments.”

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