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Reviews: "Prioritising COVID-19 Vaccination in Changing Social and Epidemiological Landscapes"

Reviewers: J Gomez- Gardenes (University of Zaragoza) |📒📒📒 ◻️◻️

Published onMar 09, 2022
Reviews: "Prioritising COVID-19 Vaccination in Changing Social and Epidemiological Landscapes"
key-enterThis Pub is a Review of
Prioritising COVID-19 vaccination in changing social and epidemiological landscapes
Description

SummaryBackgroundDuring the COVID-19 pandemic, authorities must decide which groups to prioritise for vaccination. These decision will occur in a constantly shifting social-epidemiological landscape where the success of large-scale non-pharmaceutical interventions (NPIs) like physical distancing requires broad population acceptance.MethodsWe developed a coupled social-epidemiological model of SARS-CoV-2 transmission. Schools and workplaces are closed and re-opened based on reported cases. We used evolutionary game theory and mobility data to model individual adherence to NPIs. We explored the impact of vaccinating 60+ year-olds first; <20 year-olds first; uniformly by age; and a novel contact-based strategy. The last three strategies interrupt transmission while the first targets a vulnerable group. Vaccination rates ranged from 0.5% to 4.5% of the population per week, beginning in January or July 2021.FindingsCase notifications, NPI adherence, and lockdown periods undergo successive waves during the simulated pandemic. Vaccination reduces median deaths by 32% – 77% (22% – 63%) for January (July) availability, depending on the scenario. Vaccinating 60+ year-olds first prevents more deaths (up to 8% more) than transmission-interrupting strategies for January vaccine availability across most parameter regimes. In contrast, transmission-interrupting strategies prevent up to 33% more deaths than vaccinating 60+ year-olds first for July availability, due to higher levels of natural immunity by that time. Sensitivity analysis supports the findings.InterpretationFurther research is urgently needed to determine which populations can benefit from using SARS-CoV-2 vaccines to interrupt transmission.FundingOntario Ministry of Colleges and Universities.Research in contextEvidence before this studyWhether to vaccinate individuals who cause the most transmission or those who are at highest risk of death is relevant to prioritizing COVID-19 vaccination. We searched PubMed and medRxiv for the terms COVID19, vaccin*, model, and priorit* up to September 24, 2020, with no date or language restrictions. We identified 4 papers on mathematical models of COVID-19 vaccine prioritization that explored the conditions under which different age groups should be vaccinated first. We did not find any coupled social-epidemiological models that capture feedback between social dynamics and epidemic trajectories.Added value of this studyThe dynamic interaction between SARS-CoV-2 epidemics and the population response through scalable non-pharmaceutical interventions will continue to play a large role in the course of the pandemic, both before and after vaccines become available. Hence, social-epidemiological models may be useful. Our social-epidemiological model identifies the conditions under which COVID-19 deaths can be reduced most effectively by prioritizing older individuals first, versus other strategies designed to interrupt transmission. We explore how the best vaccination strategy varies depending on a wide range of socio-epidemiological and vaccine program parameters. We identify clear and interpretable conditions under which using COVID-19 vaccines to interrupt transmission can reduce mortality most effectively.Implications of all the available evidenceSeroprevalence surveys before the onset of vaccination could measure population-level SARS-CoV-2 immunity. In populations where seropositivity is high due to previous waves, vaccinating to interrupt transmission may reduce deaths more effectively than targeting older individuals. More research is urgently required to evaluate how to prioritise vaccination in populations that have experienced one or more waves of COVID-19.

To read the original manuscript, click the link above.

Reviewer 1 (Jesus Gomez- G…) | 📒📒📒 ◻️◻️

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

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Vape Factory:

Unauthorized Breeze and Esco Bar Disposables: FDA Issues Warning Letters

In recent news, the FDA Center for Tobacco Products (CTP) has taken a strong stance by issuing warning letters to the manufacturers of Breeze and Esco Bar disposable vapes. These letters order the companies to remove their products from the market, giving them a window of 15 business days to either dispute the allegations or respond accordingly.

The FDA's actions come on the heels of significant developments in the industry. Just last week, six Chinese exporters of Esco Bar products, including the manufacturer Innokin, found themselves added to the FDA's "red list." This list identifies shippers whose Esco Bar shipments can be detained at ports of entry without inspection. Furthermore, Elf Bar shipments were also included in the import alert, signifying the increased scrutiny on disposable vapes.

These recent enforcement actions are part of a broader wave of initiatives promised by CTP Director Brian King during his recent speeches and discussions. The FDA is facing mounting pressure from lawmakers, tobacco control groups, and even tobacco companies like R.J. Reynolds to crack down on flavored disposable vapes that have gained immense popularity over the past couple of years.

Director King, in a press release, stated that the FDA will utilize all available tools within their regulatory toolbox to ensure that those involved in the production, distribution, or sale of illegal e-cigarette products are held accountable. Firms that receive warning letters have 15 days to respond, outlining how they plan to address the violation. Failure to adequately address the violation may result in various enforcement actions being taken against them.

The warning letters issued to Breeze Smoke, LLC and Shenzhen Innokin Technology Co., Ltd., rightly highlight that the products mentioned have not received authorization for sales in the United States from the FDA. However, it is worth noting that thousands of other products with premarket tobacco applications (PMTAs) pending before the agency continue to remain on the market.

At present, all unauthorized products exist on the market due to the FDA's enforcement discretion. This includes both the aforementioned products and those produced by mass-market vape manufacturers like JUUL and Vuse Alto. Interestingly, the FDA seems to have chosen to enforce against the products that R.J. Reynolds has specifically targeted, while leaving untouched their own popular product, the Vuse Alto.

These recent FDA actions may indicate a shift in the agency's approach. It is possible that pending PMTAs will no longer be considered when deciding which companies to enforce against.

Regarding Esco Bar, it is believed that they submitted pending PMTAs during a brief window in 2022 when the FDA accepted applications for synthetic nicotine-based vape products. Unlike the first round of PMTA submissions, where the FDA published a list of the submitted products, no public list of PMTAs submitted for "non-tobacco nicotine" (NTN) products has been issued.

On the other hand, Breeze Smoke faced marketing denial orders (MDOs) for several products in 2021. In response, the company swiftly filed a petition for review in the Sixth Circuit Court of Appeals. Despite being denied a stay pending appeal, Breeze Smoke sought a stay from the Supreme Court while awaiting a full review by the circuit court. However, the Supreme Court declined to grant a stay, leading Breeze Smoke to voluntarily withdraw its petition for review just two weeks before the scheduled oral arguments.

It's important to note that the Breeze products mentioned in the FDA's warning letter were not among the MDOs that Breeze Smoke previously contested in court. As for the current status of the products sold by Breeze Smoke, whether they have pending PMTAs with the FDA remains unknown.

Conclusion

The FDA's warning letters to the vape manufacturers of Breeze and Esco Bar disposables mark a significant step towards stricter regulation of the flavored disposable vape industry. With mounting pressure from various stakeholders, the FDA is taking action to ensure accountability and address the unauthorized sale of e-cigarette products. While the enforcement actions may signal a shift in the agency's approach, the impact on the market and pending PMTAs is yet to be fully determined.

FAQs (Frequently Asked Questions)

Q: Why did the FDA issue warning letters to the manufacturers of Breeze and Esco Bar disposables?
A: The FDA took action to address the unauthorized sale of e-cigarette products and hold the manufacturers accountable.

Q: What is the deadline given to the companies to respond to the FDA's warning letters?
A: The companies have 15 business days to dispute the allegations or respond to the warning letters.

Q: Are there other products on the market without FDA authorization?
A: Yes, there are thousands of products with pending premarket tobacco applications (PMTAs) before the agency.

Q: Will pending PMTAs be considered in future enforcement actions?
A: The recent FDA actions suggest that pending PMTAs may no longer be a determining factor in deciding which companies to enforce against.

Q: What is the status of Breeze Smoke's previous marketing denial orders (MDOs) in court?
A: The products referenced in the FDA's warning letter were not among the MDOs challenged by Breeze Smoke in court.