False claims and conspiracy theories about the research are circulating rapidly online, promoted by several high-profile figures. Debunking messaging may explain that researchers did not create the mutant virus used in the study and that it is not a SARS-CoV-2 variant or any virus that infects humans. Some experts have questioned the validity of the study, and there is no evidence that the research is related to COVID-19 or that it poses any danger to humans.

Fact Checking Source(s): Snopes, TechARP

Clips from the interview are circulating widely online, racking up thousands of engagements per hour. Debunking talking points may continue to underscore the FDA’s response to the official’s false claims, namely that after three and a half years of extensive research and rigorous monitoring and two-thirds of the population receiving COVID-19 vaccines, there is no evidence to support the claim that mRNA vaccines alter or be integrated into a person’s DNA.

Fact-Checking Source(s): WUSF, FactCheck.org

Talking Points and Answers to Tough Questions

Talking Points

• Since January 2020, there have been more than 1 million COVID-19 deaths and 6.5 million COVID-19 hospitalizations in the United States, per the CDC COVID-19 Data Tracker.
• COVID-19 is ranked as one of the top 10 causes of pediatric death in the U.S. Tens of thousands of children and teens have been hospitalized because of this virus. 

Are COVID-19 vaccines safe?
Yes, COVID-19 vaccines are safe. The COVID-19 vaccines have been tested and monitored for safety more than any previous vaccine in U.S. history. All COVID-19 vaccines have been rigorously tested and reviewed for human safety through a three-phase clinical trial process. 

More than 150,000 people participated in U.S. vaccine clinical trials, and almost 700 million vaccine doses have been safely administered in the U.S., with rare instances of adverse reactions. To ensure the continued safety of COVID-19 vaccines, data from clinical trials will continue to be collected for two years after each vaccine is first administered to ensure that they are safe over the long term. As with all vaccines, there will be ongoing monitoring for adverse events among people who are vaccinated in the future.

What is the risk of having a severe adverse reaction to the COVID-19 vaccine?
The risk of having a serious adverse reaction to the COVID-19 vaccine is very low—far lower than the risk of contracting COVID-19. 
Common reactions to COVID-19 vaccination include mild side effects, such as limb soreness, fatigue, low-grade fever, headaches, and chills, which typically resolve within a few days. 

Severe adverse reactions after vaccination are extremely rare, but can cause long-term health issues. Rare adverse events – such as anaphylaxis and other allergic reactions, blood-clotting syndromes, heart inflammation, autoimmune diseases impacting the nervous system, and death – have been identified and investigated for legitimacy through the Vaccine Adverse Event Reporting System (VAERS). 

How were the COVID-19 vaccines developed so quickly?
It’s true that these specific vaccines were developed more quickly than previous vaccines, but their development built upon many decades of work on coronavirus vaccines and mRNA technology.

The process included the same rigorous safety reviews that are required for all new vaccines. Scientists were able to develop the vaccines quickly, safely, and effectively because the urgency of the pandemic created greater access to research funding, reduced bureaucratic obstacles, and encouraged unparalleled levels of government and industry cooperation.

As new variants appear, vaccine researchers will continue to develop updated COVID-19 vaccines, also called “boosters,” to provide the highest level of protection against the virus.

Does the COVID-19 vaccine increase risk of miscarriage?
No, getting a COVID-19 vaccine does not increase the risk of miscarriage. To date, no monitoring system or studies have identified any association between miscarriage and COVID-19 vaccination. 

Studies show that miscarriages are a common outcome of a typical pregnancy, impacting 11% to 22% of all reported pregnancies. However, there is no evidence to show that pregnancy risks or complications, such as miscarriage, preterm delivery, stillbirth, or birth defects, are increased because of the COVID-19 vaccines.

Data do show that experiencing a COVID-19 infection during pregnancy increases the risk of delivering a preterm or stillborn infant. For this reason, vaccination is critical to protect the pregnant person and the infant from negative health outcomes. COVID-19 vaccination provides antibodies to the pregnant person and the baby, protecting them both from the increased risk of serious illness.

Why is it important to continue to collect data about COVID-19 cases? Are case counts accurate?
Accurately tracking the spread of COVID-19 helps federal, state, and local decision-makers allocate critical emergency response funding and develop public health guidance. 

COVID-19 case counts and deaths are key public health indicators, but experts agree that the number of COVID cases are likely undercounted and underreported. Case counts vary because of reporting barriers like the convenience of at-home rapid antigen testing and varied access to COVID-19 testing and diagnosis. COVID-19 death reporting is less burdened by the previous barriers but can be impacted by the timing lags in data entry across many systems of monitoring.

The CDC COVID Data Tracker is a collaborative hub of COVID-19 monitoring information informed by state and county reports from hospitals, healthcare providers, and laboratories. The CDC makes this data publicly available and reports national COVID-19 data to the World Health Organization, as required under international health regulations. The current key indicators – COVID-19 test positivity, emergency department visits, hospitalizations, and deaths – help reveal COVID-19 trends across the nation. 

The National Center for Health Statistics also updates national statistics guidelines to ensure increased specificity and accuracy of COVID-19 death reporting. The cause-of-death determination guidelines distinguish COVID-19 and post-acute COVID-19 syndrome (PACS) as either an immediate or underlying cause of death on death certificates and medical reports. These updates help to clarify if people are dying from COVID-19 illness as an immediate cause of death, or with a COVID-19-related illness or condition as an underlying cause of death.  

The high engagement on posts sharing conspiracy theories increases their risk. Prebunking messaging may emphasize that Disease X is not a real disease; it is a term used in epidemiology to refer to potential future disease threats. Messaging may also explain that epidemic preparedness helps ensure that countries are better equipped to detect, prevent, and respond to these outbreaks and potentially prevent them from spreading beyond their borders. Future pandemics are inevitable and will require global collaboration and preparedness plans.

Fact Checking Source(s): UNMC, USA Today

As the highest-ranking health official in Florida, the surgeon general statement carries weight and may influence the public’s perception of COVID-19 vaccine safety. In a letter to the surgeon general in December 2023, the FDA summarized that over three years of scientific evidence and global safety monitoring have shown mRNA COVID-19 vaccines to be safe and the residual DNA in the vaccines to be harmless. 

Fact-Checking Source(s): Infectious Diseases Society of America, Health Feedback

Talking Points and Answers to Tough Questions

Talking Points

• Since January 2020, there have been more than 1 million COVID-19 deaths and 6.5 million COVID-19 hospitalizations in the United States, per the CDC COVID-19 Data Tracker.
• COVID-19 is ranked as one of the top 10 causes of pediatric death in the U.S. Tens of thousands of children and teens have been hospitalized because of this virus. 

Are COVID-19 vaccines safe?
Yes, COVID-19 vaccines are safe. The COVID-19 vaccines have been tested and monitored for safety more than any previous vaccine in U.S. history. All COVID-19 vaccines have been rigorously tested and reviewed for human safety through a three-phase clinical trial process. 

More than 150,000 people participated in U.S. vaccine clinical trials, and almost 700 million vaccine doses have been safely administered in the U.S., with rare instances of adverse reactions. To ensure the continued safety of COVID-19 vaccines, data from clinical trials will continue to be collected for two years after each vaccine is first administered to ensure that they are safe over the long term. As with all vaccines, there will be ongoing monitoring for adverse events among people who are vaccinated in the future.

What is the risk of having a severe adverse reaction to the COVID-19 vaccine?
The risk of having a serious adverse reaction to the COVID-19 vaccine is very low—far lower than the risk of contracting COVID-19. 
Common reactions to COVID-19 vaccination include mild side effects, such as limb soreness, fatigue, low-grade fever, headaches, and chills, which typically resolve within a few days. 

Severe adverse reactions after vaccination are extremely rare, but can cause long-term health issues. Rare adverse events – such as anaphylaxis and other allergic reactions, blood-clotting syndromes, heart inflammation, autoimmune diseases impacting the nervous system, and death – have been identified and investigated for legitimacy through the Vaccine Adverse Event Reporting System (VAERS). 

How were the COVID-19 vaccines developed so quickly?
It’s true that these specific vaccines were developed more quickly than previous vaccines, but their development built upon many decades of work on coronavirus vaccines and mRNA technology.

The process included the same rigorous safety reviews that are required for all new vaccines. Scientists were able to develop the vaccines quickly, safely, and effectively because the urgency of the pandemic created greater access to research funding, reduced bureaucratic obstacles, and encouraged unparalleled levels of government and industry cooperation.

As new variants appear, vaccine researchers will continue to develop updated COVID-19 vaccines, also called “boosters,” to provide the highest level of protection against the virus.

Does the COVID-19 vaccine increase risk of miscarriage?
No, getting a COVID-19 vaccine does not increase the risk of miscarriage. To date, no monitoring system or studies have identified any association between miscarriage and COVID-19 vaccination. 

Studies show that miscarriages are a common outcome of a typical pregnancy, impacting 11% to 22% of all reported pregnancies. However, there is no evidence to show that pregnancy risks or complications, such as miscarriage, preterm delivery, stillbirth, or birth defects, are increased because of the COVID-19 vaccines.

Data do show that experiencing a COVID-19 infection during pregnancy increases the risk of delivering a preterm or stillborn infant. For this reason, vaccination is critical to protect the pregnant person and the infant from negative health outcomes. COVID-19 vaccination provides antibodies to the pregnant person and the baby, protecting them both from the increased risk of serious illness.

Why is it important to continue to collect data about COVID-19 cases? Are case counts accurate?
Accurately tracking the spread of COVID-19 helps federal, state, and local decision-makers allocate critical emergency response funding and develop public health guidance. 

COVID-19 case counts and deaths are key public health indicators, but experts agree that the number of COVID cases are likely undercounted and underreported. Case counts vary because of reporting barriers like the convenience of at-home rapid antigen testing and varied access to COVID-19 testing and diagnosis. COVID-19 death reporting is less burdened by the previous barriers but can be impacted by the timing lags in data entry across many systems of monitoring.

The CDC COVID Data Tracker is a collaborative hub of COVID-19 monitoring information informed by state and county reports from hospitals, healthcare providers, and laboratories. The CDC makes this data publicly available and reports national COVID-19 data to the World Health Organization, as required under international health regulations. The current key indicators – COVID-19 test positivity, emergency department visits, hospitalizations, and deaths – help reveal COVID-19 trends across the nation. 

The National Center for Health Statistics also updates national statistics guidelines to ensure increased specificity and accuracy of COVID-19 death reporting. The cause-of-death determination guidelines distinguish COVID-19 and post-acute COVID-19 syndrome (PACS) as either an immediate or underlying cause of death on death certificates and medical reports. These updates help to clarify if people are dying from COVID-19 illness as an immediate cause of death, or with a COVID-19-related illness or condition as an underlying cause of death.  

This claim has circulated multiple times since the so-called study was published in September, suggesting that its false conclusion has staying power in anti-vaccine spaces. Prebunking talking points may explain that higher vaccination rates do not correspond to higher excess deaths. Debunking messaging may highlight that the report is not peer-reviewed and uses flawed methods to draw conclusions with insufficient evidence. The analysis concludes that excess deaths after the COVID-19 vaccine rollout were vaccine-related, ignoring that these deaths closely correspond with spikes in COVID-19 infection, not COVID-19 vaccination.

Fact Checking Source(s): Health Feedback, AFP