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                Health Equity Forum Podcast

Health Equity Forum Podcast

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          Health Equity Forum Podcast
          COVID-19 Vaccine Boosters: Getting the Facts StraightHealth Equity Forum Podcast COVID-19 Vaccine Boosters: Getting the Facts Straight
  
  	
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 In this episode we will be discussing COVID-19 vaccine boosters with FDA Commissioner, Dr. Robert Califf.

Health Equity Forum Podcast: Episode 9 - Transcript

**RADM Richardae Araojo**: Hello, and welcome to the Health Equity Forum Podcast, hosted by the FDA Office of Minority Health and Health Equity. I'm your host, Rear Admiral Richardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at FDA. In this episode, we will be talking about COVID-19 vaccine booster misinformation. In the United States, racial and ethnic minorities and tribal populations have been among those hit hardest by the COVID-19 pandemic. COVID-19 vaccines and booster shots are one of the strongest tools we have to end the COVID-19 pandemic.

Unfortunately, while we have made incredible progress in getting Americans vaccinated, for Blacks and African Americans, Hispanics and Latinos, and Tribal populations, COVID-19 vaccine booster rates are still lower compared to non-Hispanic Whites. One of the most significant barriers impacting these communities' decisions to get vaccinated or boosted is vaccine misinformation and community mistrust about how quickly vaccines were developed.

The FDA is committed to making sure that consumers have the facts they need to ensure that people can make the best and smartest decisions for their health and the health of their families and communities. To help us understand why the vaccines and boosters are safe, and effective, and important to get when eligible, we are thrilled to have with us today, the FDA Commissioner, Dr. Robert Califf. Dr. Califf, it's a pleasure to welcome you to the Health Equity Forum Podcast.

**Dr. Robert Califf**: Thanks for having me. I'm delighted to have this opportunity to speak with you about the importance of vaccines and of booster shots, and the increasing dissemination of misinformation and disinformation about these topics, and about science in general. I can't emphasize enough how dangerous these kinds of distortions and half-truths are to the public health because of the enormous negative influence it has on individual behavior. The COVID-19 vaccines are the best way to protect yourself against the most severe consequences of the disease.

Unvaccinated people are at a higher risk of suffering from complications, hospitalizations, and death from the disease. And the scientific data show that the known and potential benefits of these shots outweigh the known and potential risks. And yet, because there's a great deal of misinformation out there, as well as intentional disinformation that is being distributed, too many people are not getting the simple protection of the shots they need, and as a result, increasing their risk of getting extremely sick.

**RADM Richardae Araojo**: Thank you, Dr. Califf. We're happy to have you here to help us understand what the facts are and why people should feel not only comfortable, but eager to get the protection afforded by the vaccines and booster shots. So, let's get started with discussing a few facts our listeners should know.

Fact Number One: Getting a COVID-19 vaccine and booster is a safer and more dependable way to build immunity to COVID-19 than getting sick with COVID-19.

**Dr. Robert Califf**: Yes. The COVID-19 vaccines and boosters offer people a more dependable and safer way to build immunity and protection against COVID-19 than getting sick with the disease. We have evidence that the broader immune response produced by vaccination following a booster dose provides continued protection against severe disease caused by a broad range of variants.

**RADM Richardae Araojo**: Fact Number Two: A COVID-19 vaccine or booster will not make me sick with COVID-19.

**Dr. Robert Califf**: That is correct. The COVID-19 vaccine or booster will not make you sick with COVID-19. The COVID-19 vaccines and boosters approved or authorized in the United States do not contain live viruses. So it's literally impossible to get the disease from the vaccine.

**RADM Richardae Araojo**: Fact Number Three: COVID-19 vaccines are not responsible for variant versions of COVID.

**Dr. Robert Califf**: That's absolutely correct. A variant is a viral mutation or genetic mutation, a change in the genetic sequence of SARS-CoV-2, the virus that causes COVID-19, when compared to the genetic sequence first identified, for example, Delta and Omicron. The COVID-19 vaccines and boosters do not create nor do they cause variants to emerge.

In fact, vaccines and boosters help prevent new variants from developing by reducing the levels of circulating virus residing in people who are infected. Since mutation always occurs on a random basis, the less virus, the lower the likelihood of new variants emerging.

**RADM Richardae Araojo**: Fact Number Four: Cases of COVID-19 in vaccinated people are generally more mild than in unvaccinated people.

**Dr. Robert Califf**: COVID-19 cases in vaccinated people, known as breakthrough cases, may happen and they are more frequent with the current circulating variants. However, we know from the available information that the symptoms in people with up-to-date vaccinations are generally mild to moderate compared to unvaccinated people. All adults should stay up to date with their COVID-19 vaccinations to reduce their risk of complications in the disease, including hospitalization or death.

**RADM Richardae Araojo**: Fact Number Five: COVID-19 vaccines and boosters do not contain microchips or ingredients that cause cancer or alter your DNA.

**Dr. Robert Califf**: You're remarkably accurate in your facts. This is most certainly true. COVID-19 vaccines and boosters DO NOT cause cancer or alter your DNA or contain microchips. I don't even know where these ideas are coming from, but they're completely unfounded and cause enormous harm by discouraging people from taking these vaccines. The FDA carefully evaluated the safety and effectiveness of the COVID-19 vaccines and boosters and found that the known and potential benefits outweigh the known and potential risks.

**RADM Richardae Araojo**: Thank you, Dr. Califf, for clarifying those facts. And that's a great place to transition to some more detailed questions and answers.

Why should people get a COVID-19 vaccine booster?

**Dr. Robert Califf**: The COVID-19 vaccine booster is a single dose given to people following completion of primary vaccination to help provide continued protection against disease. The FDA has authorized three boosters, Pfizer-BioNTech, Moderna, and Janssen. The booster is available for everyone 12 years of age and older. The Pfizer-BioNTech COVID-19 vaccine and booster is the only one authorized for use in children 12 years and older. The Moderna COVID-19 vaccine and booster and the Janssen COVID-19 vaccine and booster are authorized for people 18 years and older. People can get boosted five months after getting either the Moderna or Pfizer-BioNTech vaccines, or two months after receiving the Janssen vaccine. People should talk with clinicians they trust to determine their eligibility and ask any questions they may have about receiving a booster. Last month, the agency authorized a second booster dose of either Pfizer-BioNTech or the Moderna COVID-19 vaccines for adults 50 years and older and certain immunocompromised individuals.

This action makes a second booster dose of these vaccines available to populations at higher risk for severe disease, hospitalization, and death. I'm 70 years old and I signed up right away to get my additional booster. Emerging evidence suggests that a second booster dose of messenger RNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. People 50 years and older can get a second booster dose at least four months after receiving their first booster dose. Individuals 12 years of age and older with certain kinds of immunocompromise can receive a second booster dose of the Pfizer-BioNTech COVID-19 vaccine four months after their first booster dose. The Moderna COVID-19 vaccine is authorized for a second booster dose in people 18 years of age and older with certain kinds of immunocompromise also four months after the first booster dose. Listeners can visit our website at www.fda.gov/covid19vaccines or COVID.gov to learn more or talk to their trusted clinician.

**RADM Richardae Araojo**: Dr. Califf, did the FDA review the data for the boosters and the vaccines the same way before granting authorization or approval?

**Dr. Robert Califf**: Our scientists and reviewers carefully evaluate the data that the manufacturer submitted for the COVID-19 vaccine boosters. They analyze the safety and immune response data from a subset of participants from the original clinical trial. It's important to note also that consideration was given to real-world data from the US and international authorities from the UK and Israel on the vaccine's effectiveness over time, so we have actual outcome data from people who are getting the various booster shots.

I want to assure listeners that the FDA will continue evaluating the data submitted to us and we will make decisions as appropriate, based on the information we receive. This is what we do with all medical products to help ensure they're safe and effective.

**RADM Richardae Araojo**: And what are the potential side effects for booster shots? Are they the same or different than the vaccine?

**Dr. Robert Califf**: Having minor side effects after getting the booster shot is normal. I certainly had a sore arm after my last booster. Some people may experience inflammation or soreness at the injection site. Fever, headache, and mild to moderate fatigue can also occur. However, it's important to let listeners know that while some serious side effects can occur, they're very rare.

**RADM Richardae Araojo**: And if a person received a COVID-19 vaccine from one manufacturer, do they need to get the booster from the same manufacturer?

**Dr. Robert Califf**: No, you can get a booster shot from a different manufacturer than you received for your initial vaccination. For example, if you receive the Pfizer-BioNTech COVID-19 vaccine, you can get the Moderna vaccine for your booster shot. Or if you had an initial Moderna vaccine, you can get the Pfizer-BioNTech vaccine for your booster shot. We've developed a booster chart titled Do I Qualify for a COVID-19 Vaccine Booster and Which One to help people understand if they're eligible for a booster dose of a COVID-19 vaccine. Listeners can find a link to the chart at the top of the FDA COVID-19 home page.

**RADM Richardae Araojo**: Does the FDA monitor COVID-19 vaccine and booster safety after authorization and approval?

**Dr. Robert Califf**: Yes. The FDA and the CDC have several systems in place to continually monitor the safety of the COVID-19 vaccines. These systems, called passive surveillance and active surveillance systems, are intended to rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System, or VAERS for short, and CDC's text-based V-Safe System, which I certainly participated in, which receive reports of adverse events following vaccination are examples of passive surveillance systems. The FDA's BEST Initiative is an example of an active surveillance system. The system analyzes information occurring in millions of individuals recorded in a large data system to investigate any safety signals that are identified by VAERS or V-Safe.

**RADM Richardae Araojo**: Before we close Dr. Califf, is there anything else you would like our listeners to know?

**Dr. Robert Califf**: I want to take a moment to congratulate the Office of Minority Health and Health Equity and to celebrate the importance of National Minority Health Month. The office has made tremendous advances and contributions to address health disparities and works tirelessly to attempt to close the health equity gap, and we recognize that we have a lot of work yet to do.

This is important as the office and the agency work to gain the trust of diverse populations and increase their confidence in the work we do as an agency. I encourage everyone to visit fda.gov/HealthEquity to access culturally and linguistically tailored health education resources, learn about the health equity focused research, and the research award funding opportunities for creative ideas.

**RADM Richardae Araojo**: Dr. Califf, thank you so much for joining us today and for having such a critically important conversation to help us better understand the importance of COVID-19 vaccine boosters.

**Dr. Robert Califf**: Thank you. It's been great to be with you.

**RADM Richardae Araojo**: As National Minority Health Month ends, I want to encourage our listeners to visit www.fda.gov/covid19vaccines and COVID.gov to find important COVID-19 information provided in multiple languages for you, your family, and your community.

For more information about the Health Equity Forum Podcast series, visit our website at www.fda.gov\HealthEquity. While you are there, check out our library of resources and sign up for our newsletter. Also, don't forget to follow us on Twitter @FDAHealthEquity. Remember, together we can create a world where health equity is a reality for all.

[end of transcript]

                                                                                  Content current as of:
      04/29/2022Health Equity Forum Podcast

          
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          What You Need to Know about FDA’s Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions
 
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