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Review 2: "Demographic Differences in US Adult Intentions to Receive a Potential Coronavirus Vaccine and Implications for Ongoing Study"

This study presents a reliable analysis of polling data, and draws attention to the population "unsure" of whether or not they will accept a coronavirus vaccine. Nevertheless, it leaves many questions unanswered that would be useful for policymakers going forward.

Published onOct 08, 2020
Review 2: "Demographic Differences in US Adult Intentions to Receive a Potential Coronavirus Vaccine and Implications for Ongoing Study"
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key-enterThis Pub is a Review of
Demographic Differences in US Adult Intentions to Receive a Potential Coronavirus Vaccine and Implications for Ongoing Study
Description

Abstract Background: The coronavirus pandemic9s public health and economic impacts have led to much hope in the US regarding the prospect of a safe, effective vaccine to either prevent infection or minimize symptoms and reduce mortality risk. However, recent US polls indicate a concerning level of hesitancy that will likely lead to suboptimal uptake if such a vaccine becomes available. This study investigated demographic differences regarding US adults9 intent, uncertainty, and refusal to receive a potential coronavirus vaccine and specific reasons for intention to receive it. Methods and findings: Multivariable analysis of Associated Press (AP)-NORC Center for Public Affairs Research cross-sectional survey data collected in May 2020 from a US nationally representative panel of adults (n=1000). Respondents were asked if they would receive a coronavirus vaccine (yes, unsure, no). Among those answering yes, the specific reasons were: to protect self, family, and community; chronic health condition; and having a doctor who recommends vaccines. Multinomial logistic regression models indicated numerous subgroup differences between participants who indicating (1) uncertainty versus refusal, (2) intent versus refusal, and (3) intent versus uncertainty, with the highest number of significant differences observed in the third comparison. Overall, higher likelihood of intention to receive the vaccine versus uncertainty and refusal were mostly observed among respondents with a college education or greater, White, non-Hispanic racial-ethnic identity, ages 60 or older, and more liberal (versus conservative) ideology. Despite variation in endorsement across the five reasons for wanting to receive the vaccine, subgroup differences were fairly consistent across these specific reasons when comparing respondents endorsing such intentions versus, respectively, refusal and uncertainty in separate analyses. Conclusions: These findings suggest that the approval of a vaccine will potentially face problems with overall uptake due to uncertainty or refusal and contribute to creating significant demographic disparities in COVID-19 morbidity and mortality risk. Ongoing assessment of such attitudes are needed as Phase III trials proceed, but the findings highlight need for measuring uncertainty and its underlying reasons, as well as multiple types of education and outreach efforts for those who are uncertain as well as avoidant.

RR:C19 Evidence Scale rating by reviewer:

  • Reliable. The main study claims are generally justified by its methods and data. The results and conclusions are likely to be similar to the hypothetical ideal study. There are some minor caveats or limitations, but they would/do not change the major claims of the study. The study provides sufficient strength of evidence on its own that its main claims should be considered actionable, with some room for future revision.

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Review:

This preprint describes a study aiming “to contribute to current understanding about potential hesitancy towards a COVID-19 vaccine by evaluating demographic differences in US adults’ intentions to receive a potential coronavirus vaccine.” One good justification for exploring demographic differences is that “hesitancy could risk exacerbating existing disparities in COVID-19 cases and mortality—especially among African Americans, Latinos, and other racial-ethnic groups as well as lower SES groups” (p.4) – if it is differentially distributed. Likewise, as the author notes, other demographic variables such as age, cohabitation/conjugal status, employment status, and where one lives could make a difference, as may one’s political identity. Overall, in the population surveyed, only half intended to get vaccinated; 20% said no; 30% were not certain. If the demographic variables identified were predictive or more or of less ‘vaccine hesitance’, then targeted, tailored outreach would be justified. The investigator acknowledged, insightfully, that the ‘unsure’ group has too often been overlooked and merits the most scrutiny.

Beyond asking how demographics linked up to whether a person thought they would accept a COVID-19 vaccination, the author explored ‘motivations’ to do so. These included, for instance, ‘to protect my family’. As such, the options were too coarse-grained to be of much use in really understanding hesitancy. In addition, motivations for avoiding vaccination were not queried. This particular oversight was an artifact of the nature of the investigation, which drew on data already being collected for the Associated Press (AP)-NORC Center for Public Affairs Research poll - data which were likely not collected under the same mindset as would be data collected for an IRB-approved research study. This was not noted in the limitations section, nor were the poll’s methods elsewhere defended. There is no reason to assume on the face of it that the data were ‘bad.’ But given the options included in the present project, we can deem the ‘motivations’ options lacking in the kind of nuance that would give them utility.

The key findings of the paper were regarding demographic differences in intent to receive a SARS-C0V-2 vaccine. The RR:C19 project solicits reviews that ask “whether the overall conclusions and main claims should be taken seriously or not.” In this case, unless a statistician invited to review the paper identifies an error, they can – although linking demographic differences in yes/no/unsure answers to the motivations surveyed was somewhat of a leap. Unsure persons were not asked the reason-specific items. Recoding those items as if they were, and then answered ‘unsure’ seemed an unjustified stretch. The uncertainty could have had nothing to do with one of those five factors.

Notably, the kind of knowledge about target populations necessary for fruitful outreach is not the focus of this research, which asks only if targeted outreach may be needed. Nonetheless, the author did, in the end, ask how such outreach might be focused and some of the ideas, although speculative, could be useful, including the implicit suggestion at the end that early adoption may hinge on factors that can be leveraged, and the observation that context matters.

This preprint describes a study aiming “to contribute to current understanding about potential hesitancy towards a COVID-19 vaccine by evaluating demographic differences in US adults’ intentions to receive a potential coronavirus vaccine.” One good justification for exploring demographic differences is that “hesitancy could risk exacerbating existing disparities in COVID-19 cases and mortality—especially among African Americans, Latinos, and other racial-ethnic groups as well as lower SES groups” (p.4) – if it is differentially distributed. Likewise, as the author notes, other demographic variables such as age, cohabitation/conjugal status, employment status, and where one lives could make a difference, as may one’s political identity. Overall, in the population surveyed, only half intended to get vaccinated; 20% said no; 30% were not certain. If the demographic variables identified were predictive or more or of less ‘vaccine hesitance’, then targeted, tailored outreach would be justified. The investigator acknowledged, insightfully, that the ‘unsure’ group has too often been overlooked and merits the most scrutiny.

Beyond asking how demographics linked up to whether a person thought they would accept a COVID-19 vaccination, the author explored ‘motivations’ to do so. These included, for instance, ‘to protect my family’. As such, the options were too coarse grained to be of much use in really understanding hesitancy. In addition, motivations for avoiding vaccination were not queried. This particular oversight was an artifact of the nature of the investigation, which drew on data already being collected for the Associated Press (AP)-NORC Center for Public Affairs Research poll - data which were likely not collected under the same mindset as would be data collected for an IRB-approved research study. This was not noted in the limitations section, nor were the poll’s methods elsewhere defended. There is no reason to assume on the face of it that the data were ‘bad.’ But given the options included in the present project, we can deem the ‘motivations’ options lacking in the kind of nuance that would give them utility.

The key findings of the paper were regarding demographic differences in intent to receive a SARS-C0V-2 vaccine. The RR:C19 project solicits reviews that ask “whether the overall conclusions and main claims should be taken seriously or not.” In this case, unless a statistician invited to review the paper identifies an error, they can – although linking demographic differences in yes/no/unsure answers to the motivations surveyed was somewhat of a leap. Unsure persons were not asked the reason-specific items. Recoding those items as if they were, and then answered ‘unsure’ seemed an unjustified stretch. The uncertainty could have had nothing to do with one of those five factors.

Notably, the kind of knowledge about target populations necessary for fruitful outreach is not the focus of this research, which asks only if targeted outreach may be needed. Nonetheless, the author did, in the end, ask how such outreach might be focused and some of the ideas, although speculative, could be useful, including the implicit suggestion at the end that early adoption may hinge on factors that can be leveraged, and the observation that context matters.

Regardless, in terms of the question as to whether the demographic factors identified made a difference, the evidence to support the conclusion (yes) was, as per RR:C19 standards, “Reliable: The ‘main study claims are generally justified by its methods and data” and the findings are “actionable with limitations.” Again, barring objections from a statistician (which I am not), the paper could be published with revisions.
While one might argue ‘of course demographic factors make a difference; anyone who keeps up with the nightly news knows this: why investigate?’ it always is necessary to explore the evidence for our assumptions. If common sense were enough, we might all agree that the world is flat.

Regardless, in terms of the question as to whether the demographic factors identified made a difference, the evidence to support the conclusion (yes) was, as per RR:C19 standards, “Reliable: The ‘main study claims are generally justified by its methods and data” and the findings are “actionable with limitations.” Again, barring objections from a statistician (which I am not), the paper could be published with revisions.

While one might argue ‘of course demographic factors make a difference; anyone who keeps up with the nightly news knows this: why investigate?’ it always is necessary to explore the evidence for our assumptions. If common sense were enough, we might all agree that the world is flat.

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Vape Factory:

FDA regulation on vape manufacturers and retailers

For Manufacturer of E-Cigarettes, Vapes

As a manufacturer of electronic cigarettes (e-cigarettes), vapes, or other Electronic Nicotine Delivery Systems (ENDS), it is crucial to be aware of the regulatory framework imposed by the U.S. Food and Drug Administration (FDA). The FDA oversees various aspects of ENDS, including manufacturing, importation, packaging, labeling, advertising, promotion, sale, and distribution. However, it's important to note that FDA regulations apply to ENDS components and parts, excluding accessories.

Regulated Components and Parts of ENDS

The following are examples of components and parts of ENDS that fall under FDA regulations:

  • E-liquids: These are the fluids used in ENDS devices, typically containing nicotine and other ingredients.

  • Glass or plastic vial containers: Used to store and dispense e-liquids.

  • Cartridges: These are pre-filled containers that hold e-liquids and are attached to ENDS devices.

  • Atomizers: The atomizer is the part of an ENDS device responsible for heating the e-liquid and converting it into vapor for inhalation.

  • Cartomizers and clearomizers: Similar to atomizers, these components deliver e-liquid in vapor form.

  • Certain batteries: FDA regulations cover specific types of batteries used in ENDS devices.

  • Digital display or lights: Components that enable users to adjust settings and view information on the device.

  • Tank systems: Reservoirs that hold e-liquids.

  • Drip tips or mouthpieces: The part of an ENDS device that users inhale vapor from.

  • Flavorings: Various flavors added to e-liquids.

  • Programmable software: ENDS devices that contain programmable software are subject to FDA regulations.

  • Products marketed for therapeutic purposes: ENDS products advertised as aids for smoking cessation fall under the regulation of FDA's Center for Drug Evaluation and Research (CDER). The FDA has clarified the criteria for determining when tobacco-derived products are classified as tobacco products, drugs, and/or devices.

Compliance Requirements for ENDS Manufacturers

If you engage in any of the following activities related to ENDS, you must comply with the FDA's requirements for manufacturers:

  • Making or modifying ENDS products

  • Mixing or preparing e-liquids containing nicotine

  • Manufacturing, fabricating, or assembling ENDS devices

  • Processing, labeling, repacking, or relabeling ENDS products

  • Importing ENDS products

To ensure compliance, it is essential to familiarize yourself with the specific regulations governing ENDS manufacturing. For guidance and assistance with understanding FDA requirements, you can reach out to the Office of Small Business Assistance within the FDA's Center for Tobacco Products (CTP). This office provides valuable resources, including online educational materials, to help regulated industries navigate FDA regulations and policies effectively.

Are You a Retailer of ENDS Products?

If you operate as a retailer of ENDS products, it is crucial to understand your role in safeguarding the well-being of consumers, particularly youth, and adhering to FDA regulations. The following resources can assist you in complying with FDA tobacco regulations:

"This is Our Watch" Program

"This is Our Watch" is a voluntary education program designed to provide resources to tobacco retailers, enabling them to better understand and comply with FDA regulations. By actively participating in this program, retailers play a direct role in protecting young individuals from nicotine addiction and the harmful effects of tobacco use. To safeguard the future generation from tobacco-related diseases, it is essential for tobacco retailers to be well-informed about the rules and regulations.

Retail Sales of Tobacco Products

For comprehensive information regarding federal rules that retailers must follow, the Retail Sales of Tobacco Products offers valuable insights. This resource provides guidance, regulations, and access to webinars specifically curated for retailers in the tobacco industry. By staying updated with these resources, retailers can ensure compliance and contribute to the health and well-being of their communities.

Vape Shops with Mixing or Modification Services

If you operate a vape shop that offers services such as mixing or preparing e-liquids containing nicotine or modifying ENDS products, it is important to note that you may be classified as both a manufacturer and a retailer of tobacco products. Consequently, you are required to comply with the regulations outlined for both roles, as mentioned above.

Conclusion

In conclusion, understanding and complying with FDA regulations is crucial for vape manufacturers and retailers involved in the production, distribution, and sale of E-Cigarettes, Vapes, or other ENDS. By adhering to these regulations, you contribute to the safety and well-being of consumers, particularly young individuals. Stay informed, seek guidance when needed, and ensure compliance to navigate the regulatory landscape effectively.

FAQs

1. Are accessories for ENDS devices regulated by the FDA?
No, FDA regulations for ENDS cover components and parts but exclude accessories.

2. What are some examples of regulated components of ENDS?
Regulated components include e-liquids, cartridges, atomizers, batteries, tank systems, flavorings, and more.

3. What should I do if I have specific questions about FDA requirements for small businesses?
You can contact the Office of Small Business Assistance within the FDA's Center for Tobacco Products (CTP) for guidance and answers to your queries.

4. How can vape shops comply with FDA regulations?
Vape shops must adhere to the requirements for both manufacturers and retailers, as they may have legal responsibilities in both capacities.

5. What resources are available for tobacco retailers to understand and comply with FDA regulations?
The "This is Our Watch" program and the Retail Sales of Tobacco Products provide valuable resources, guidance, and webinars for tobacco retailers to ensure compliance with FDA regulations.

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ENDS Manufacturers: Understanding FDA Regulations and Compliance Requirements

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Learn about FDA regulations and compliance requirements for ENDS manufacturers. Understand the guidelines for retailers of ENDS products and vape shops. Discover how to comply and ensure consumer safety.