Category Archives: Covid-19

Published on July 09, 2021

The City of Fort Worth continues to host community vaccine clinics at convenient locations across the city. Most sites are available for adults 18 years and older only. Parents of youth ages 12-17 should call 817-392-8478 to learn about additional options.

Register onlineor use a smartphone to scan the QR code. The clinic dates for the week of July 12 are below:

Tuesday, July 13

Wednesday, July 14

Thursday, July 15

Friday, July 16

Bob Bolen Public Safety Complex, 505 W. Felix St., is also available 9 a.m. to 4 p.m. Monday and Friday.

A pop-up clinic is available at First Street Methodist Mission, 801 W. First St., from 9 a.m. to 3 p.m. Wednesday, July 14.

Register for the pop-up sites.

To learn more, call 817-392-8478 or email the hotline.

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COVID-19 vaccination clinic schedule for the week of July 12 - City of Fort Worth

The West Virginia Department of Health and Human Resources (DHHR) reports as of July 7, 2021, there have been 3,030,600 total confirmatory laboratory results received for COVID-19, with 164,346 total cases and 2,901 deaths.

There were no deaths reported to DHHR over the last 24 hours.

CASES PER COUNTY: Barbour (1,515), Berkeley (12,864), Boone (2,180), Braxton (1,020), Brooke (2,249), Cabell (8,894), Calhoun (396), Clay (543), Doddridge (646), Fayette (3,560), Gilmer (888), Grant (1,317), Greenbrier (2,903), Hampshire (1,928), Hancock (2,845), Hardy (1,587), Harrison (6,211), Jackson (2,265), Jefferson (4,806), Kanawha (15,507), Lewis (1,301), Lincoln (1,607), Logan (3,305), Marion (4,660), Marshall (3,540), Mason (2,064), McDowell (1,616), Mercer (5,201), Mineral (2,993), Mingo (2,774), Monongalia (9,400), Monroe (1,226), Morgan (1,231), Nicholas (1,908), Ohio (4,319), Pendleton (725), Pleasants (959), Pocahontas (683), Preston (2,965), Putnam (5,336), Raleigh (7,103), Randolph (2,863), Ritchie (762), Roane (665), Summers (865), Taylor (1,285), Tucker (547), Tyler (749), Upshur (1,975), Wayne (3,183), Webster (547), Wetzel (1,394), Wirt (457), Wood (7,954), Wyoming (2,060).

Free pop-up COVID-19 testing is available today in Barbour, Berkeley, Doddridge, Jefferson, Lincoln, Mingo, Putnam, Ritchie, Tyler/Wetzel, and Wayne counties.

Barbour County

9:00 AM 11:00 AM, Barbour County Health Department, 109 Wabash Avenue, Philippi, WV

Berkeley County

10:00 AM 5:00 PM, 891 Auto Parts Place, Martinsburg, WV

Doddridge County

Jefferson County

10:00 AM 6:00 PM, Hollywood Casino, 750 Hollywood Drive, Charles Town, WV

Lincoln County

Mingo County

10:00 AM 2:00 PM, Seven Eleven, 11 West Second Avenue, Williamson, WV

Putnam County

Ritchie County

1:00 PM 4:00 PM, Ritchie Regional, 138 S Penn Avenue, Harrisville, WV

Tyler/Wetzel Counties

Wayne County

10:00 AM 2:00 PM, Wayne Community Center, 11580 Rt. 152, Wayne, WV

More:

WV DHHR: COVID-19 Daily Update 7-7-2021 - West Virginia Department of Health and Human Resources

The World Health Organization (WHO) has updated its patient care guidelines to include interleukin-6 receptor blockers, a class of medicines that are lifesaving in patients who are severely or critically ill with COVID-19, especially when administered alongside corticosteroids.

These were the findings from a prospective and a living network meta-analysis initiated by WHO, the largest such analysis on the drugs to date. Data from over 10000 patients enrolled in 27 clinical trials were considered.

These are the first drugs found to be effective against COVID-19 since corticosteroids wererecommended by WHOin September 2020.

Patients severely or critically ill with COVID-19 often suffer from an overreaction of the immune system, which can be very harmful to the patients health. Interleukin-6 blocking drugs tocilizumab and sarilumab act to suppress this overreaction.

The prospective and living network meta-analyses showed that in severely or critically ill patients, administering these drugs reduce the odds of death by 13%, compared to standard care. This means that there will be 15 fewer deaths per thousand patients, and as many as 28 fewer deaths for every thousand critically ill patients. The odds of mechanical ventilation among severe and critical patients are reduced by 28%, compared with standard care. This translates to 23 fewer patients out of a thousand needing mechanical ventilation.

Clinical trial investigators in 28 countries shared data with WHO, including pre-publication data. Researchers worldwide compiled and analyzed the data. With the support of these critical partnerships, WHO has been able to issue a rapid and trustworthy recommendation for the use of interleukin-6 receptor blockers in severe and critical COVID-19 patients.

These drugs offer hope for patients and families who are suffering from the devastating impact of severe and critical COVID-19. But IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world, said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19. So, the greatest need for these drugs is in countries that currently have the least access. We must urgently change this.

To increase access and affordability of these life-saving products, WHO calls on manufacturers to reduce prices and make supplies available to low- and middle-income countries, especially where COVID-19 is surging.

WHO also encourages companies to agree to transparent, non-exclusive voluntary licensing agreements using the C-TAP platform and the Medicines Patent Pool, or to waive exclusivity rights.

In addition, WHO has launched anexpression of interestfor prequalification of manufacturers of interleukin-6 receptor blockers. Prequalification of innovator and biosimilar products aims to expand the availability of quality-assured products and to increase access through market competition and reduce prices to meet urgent public health needs.

The rest is here:

WHO recommends life-saving interleukin-6 receptor blockers for COVID-19 and urges producers to join efforts to rapidly increase access - World Health...

Wednesday, June 30, 2021

In mid-March 2020, a team of researchers led by a Virginia Commonwealth University professor conducted a survey of 500 U.S. adults to investigate how likely they would be to adhere to preventive behaviors that were recommended at the time, such as not touching your face, social distancing, avoiding large gatherings and staying away from people who were sick.

The results of the study, Stay Socially Distant and Wash Your Hands: Using the Health Belief Model to Determine Intent for COVID-19 Preventive Behaviors at the Beginning of the Pandemic, publishedin the journal Health Education & Behavior, provide insights into how public health officials can encourage people to take difficult but potentially lifesaving preventive measures in future outbreaks.

COVID-19 is not the last time were going to be confronted with infectious diseases. Theres a fairly good likelihood its not the last time were going to be confronted with a pandemic, said lead author Jeanine Guidry, Ph.D., an assistant professor in the Richard T. Robertson School of Media and Culture in the College of Humanities and Sciences and director of the Media+Health Lab at VCU. Understanding how these things work in the beginning even though it wont be exactly the same because we have now had the experience of COVID I think is going to be really helpful.

When the survey was conducted March 16-18, 2020, COVID-19 was still emerging in the U.S. On the first day, there were 4,500 diagnosed cases and 88 deaths, and on the final day of the survey there were 7,100 cases and 141 deaths in the U.S. By the end of May 2021, there had been more than 33 million cases and nearly 600,000 deaths in the U.S.

The researchers asked the respondents: How likely are you to adhere to the following recommended COVID-19 preventive behaviors: social distancing, wash your hands with soap and water for at least 20 seconds, avoid touching your face, avoid close contact with anyone who is sick, stay home when you are sick, cover your cough or sneeze with your elbow or a tissue, avoid large gatherings?

A majority of respondents said they were extremely likely to abide by the recommendations, ranging from 56.8% saying they were extremely likely to not touch their face to 74.2% saying they were extremely likely to follow hand-washing guidelines.

The results also found that women were significantly more likely than men to say they would follow the recommended COVID-19 preventive behaviors of social distancing, washing hands, avoiding touching their face, respiratory hygiene, staying home when sick, and staying away from sick people.

Additionally, non-Hispanic Black respondents reported significantly lower intentions to follow the recommended COVID-19 preventive behavior of avoiding large gatherings, as compared to non-Hispanic white respondents.

That is concerning, particularly because at this point we had just started to learn that COVID-19 was actually affecting people of color in a more severe manner and more frequently than their white counterparts, Guidry said. Not just that we know now that they were more likely to be infected and get really sick, but they were actually less likely to carry out those behaviors in the early stages.

Paul Perrin, Ph.D., a professor in the Department of Psychology in the College of Humanities and Sciences, was a co-author on the paper. The studys findings, he said, are critical for illuminating various influences on people's adherence to COVID-19 preventive behaviors.

Across all types of preventive behaviors, if people believed that a specific behavior could help prevent contracting and spreading COVID-19, they were much more likely to engage in that behavior, he said. As a result, public health campaigns that spread awareness of the health benefits of particular preventive behaviors may be the most likely to achieve their goal of increasing those preventive behaviors.

The researchers investigated whether a widely used model guiding health communications in a crisis, known as the Health Belief Model, could predict whether different groups would adhere to COVID-19 preventive behaviors. The model is based on the hypothesis that as people fear diseases, health actions depend on the degree of fear (i.e., perceived threat) and the expected fear-reduction potential of those health actions. Its key constructs include perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy (or a persons confidence in their ability to perform an action).

In the case of COVID-19 preventive behaviors, we operationalize perceived severity as how serious one perceives COVID-19 to be, perceived susceptibility as how vulnerable one perceived oneself to be to COVID-19, perceived benefits as the perceived advantages of the recommended preventive behaviors for COVID-19, perceived barriers as perceived obstacles to these preventive behaviors, and self-efficacy as ones ability to carry out the preventive behaviors which are the focus of this study, the researchers wrote.

The researchers used the Health Belief Model to test likely adherence to each of the recommended preventive behaviors. The model worked to predict at least some of the behavioral intentions, suggesting that the model would be useful for public health officials in crafting messages amid a crisis like COVID-19.

The results are a reminder, Guidry said, that health communication works best when public health specialists and communication specialists work in collaboration and incorporate tested theories like the Health Belief Model.

You have to convince people that if you do this [action], youre actually going to protect yourself and those you love against getting this disease, she said. And I think that just makes sense and it helps if you put messages together. Dont just talk about, for example, Weve now lost X number of hundreds of thousands of people whove died of COVID. Also mention that we have effective ways to prevent it. Thats the lesson that we should learn in all cases.

The study was supported by a grant from the Arthur W. Page Society. The grant originally was to fund a study on messaging around the flu vaccine, but the researchers asked to shift its focus to COVID-19 once the outbreak occurred.

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Originally posted here:

A VCU-led study conducted early in COVID-19 could help confront the next health crisis - VCU News

Even before there was a coronavirus state of emergency, there was a daily Department of Public Health coronavirus data report or dashboard. Now, with the state of emergency weeks in the past and COVID-19 metrics at record low levels, DPH plans to stop publishing new data seven days a week.

The daily interactive dashboard that tallies cases, deaths, hospitalizations and more, and the daily vaccination report that DPH publishes will be published only Monday through Friday beginning July 1, DPH announced Wednesday. Weekend data will be included in each Monday report.

DPH said the change is being made "to reflect the improving trends in COVID-19 activity in the Commonwealth."

As of Thursday, DPH is also getting rid of the green, yellow and red color-coding system it used to denote the relative risk of COVID-19 transmission in cities and towns, though it will continue to report municipal-level data weekly.

Higher education metrics will be updated weekly instead of daily and most sections of the interactive dashboard will display the last four weeks of information with complete data available in archives.

DPH began sharing COVID-19 case information on a daily basis and in a consistent format beginning March 9, 2020, when there was one confirmed case and 40 presumptive cases in the Bay State.

As the pandemic worsened and the demand for a greater level of understanding grew, DPH reformatted its daily report a handful of times. With the exception of holidays and during a data system upgrade, DPH published a new report every day throughout the state of emergency and since it ended.

DPH said it will post its data dashboard at 5 p.m. each weekday and will post its weekly vaccination dashboard and municipality data on Thursdays at 5 p.m. There will be no daily dashboard update on Monday, July 5 -- DPH said the update it will post Tuesday will include data from July 3, 4 and 5.

Continued here:

Mass. Making a Series of Changes to Its COVID-19 Reporting Dashboard - NBC10 Boston

The West Virginia Department of Health and Human Resources (DHHR) reports as of June 30, 2021, there have been 3,008,327 total confirmatory laboratory results received for COVID-19, with 164,041 total cases and 2,891 deaths.

DHHR has confirmed the deaths of a 79-year old female from Gilmer County, an 88-year old female from Wayne County, a 76-year old male from Berkeley County, an 84-year old female from Jefferson County, a 90-year old female from Wayne County, an 81-year old female from Mineral County, a 79-year old male from Wetzel County, a 65-year old female from Braxton County, a 54-year old male from Fayette County, a 94-year old female from Marshall County, a 76-year old female from Mercer County, and an 83-year old male from Kanawha County.

Eleven of the 12 deaths reported in todays dashboard report are a result of the Bureau for Public Healths continuing data reconciliation with the official death certificate. Seven of the eleven deaths were from April and May 2021, while four of the deaths occurred in September 2020 (1), October 2020 (2), and January 2021 (1).

We are saddened by the loss of more West Virginians and extend deepest condolences to these grieving families, said Bill J. Crouch, DHHR Cabinet Secretary. Lets continue taking every precaution we can to stop the spread of this disease, including scheduling a COVID-19 vaccination for yourself and all eligible family members.

CASES PER COUNTY: Barbour (1,514), Berkeley (12,838), Boone (2,178), Braxton (1,015), Brooke (2,247), Cabell (8,885), Calhoun (389), Clay (543), Doddridge (644), Fayette (3,554), Gilmer (886), Grant (1,315), Greenbrier (2,894), Hampshire (1,925), Hancock (2,844), Hardy (1,581), Harrison (6,193), Jackson (2,255), Jefferson (4,799), Kanawha (15,496), Lewis (1,287), Lincoln (1,606), Logan (3,294), Marion (4,653), Marshall (3,537), Mason (2,062), McDowell (1,614), Mercer (5,181), Mineral (2,980), Mingo (2,761), Monongalia (9,398), Monroe (1,223), Morgan (1,226), Nicholas (1,905), Ohio (4,314), Pendleton (725), Pleasants (958), Pocahontas (681), Preston (2,959), Putnam (5,330), Raleigh (7,091), Randolph (2,854), Ritchie (760), Roane (665), Summers (865), Taylor (1,280), Tucker (547), Tyler (746), Upshur (1,968), Wayne (3,179), Webster (544), Wetzel (1,390), Wirt (457), Wood (7,948), Wyoming (2,058).

Free pop-up COVID-19 testing is available today in Barbour, Berkeley, Doddridge, Jefferson, Lincoln, Morgan, Ritchie, Tyler/Wetzel, and Wayne counties.

Barbour County

9:00 AM 11:00 AM, Barbour County Health Department, 109 Wabash Avenue, Philippi, WV

1:00 PM 5:00 PM, Junior Volunteer Fire Department, 331 Row Avenue, Junior, WV

Berkeley County

10:00 AM 5:00 PM, 891 Auto Parts Place, Martinsburg, WV

Doddridge County

Jefferson County

10:00 AM 6:00 PM, Hollywood Casino, 750 Hollywood Drive, Charles Town, WV

Lincoln County

Morgan County

11:00 AM 4:00 PM, Valley Health War Memorial Hospital, 1 Health Way, Berkeley Springs, WV

Ritchie County

1:00 PM 4:00 PM, Ritchie Regional, 138 S Penn Avenue, Harrisville, WV

Tyler/Wetzel Counties

Wayne County

10:00 AM 2:00 PM, Wayne Community Center, 11580 Rt. 152, Wayne, WV

See the original post here:

COVID-19 Daily Update 6-30-2021 - West Virginia Department of Health and Human Resources

A natural gas flare on an oil well pad burns as the sun sets outside Watford City, North Dakota January 21, 2016. REUTERS/Andrew Cullen

June 30 (Reuters) - Who of the traditional bulls predicted a rally that saw oil prices doubling in the last eight months? The short answer is no one.

Of more than 50 analysts polled by Reuters last October when Brent was hovering near $35 per barrel amid a second large wave of global lockdowns to slow the coronavirus pandemic, almost none dared to predict prices would approach $60.

U.S. bank Goldman Sachs saw second-quarter average prices hitting $57.50 a barrel and much smaller Houston-based consultancy Stratas Advisors had the boldest bet at $60.

As prices have exceeded $75 per barrel this June, the most accurate forecasters predict a further rally fuelled by recovering demand and tight OPEC supply albeit at a more modest pace.

Overall, the 44 analysts polled by Reuters this month forecast benchmark Brent prices to average about $67.48 a barrel this year, up from the $64.79 consensus in May.

Oil demand was seen growing by 5-7 million barrels per day (bpd) this year.

"The upward range of oil will be limited by the ability of OPEC to bring back supply to address unexpected upward movements in demand and prices," John Paisie, Stratas Advisors president, told Reuters.

Paisie predicts Brent will average around $75 a barrel in the third quarter and $78.50 in 2022, adding: "One reason that we think that increase in oil prices will be more moderate is the strength of the U.S. dollar."

A firmer greenback makes oil priced in dollars more expensive in other currencies, potentially weighing on demand.

Goldman Sachs was more bullish, seeing Brent averaging $80 a barrel in the third quarter "with potential spikes well above", with the global market facing "its deepest deficits since last summer." read more

Most analysts expect the Organization of the Petroleum Exporting Countries and its allies, or OPEC+, to gradually unwind record output cuts this year, with discussions over easing likely to start in August. read more

Oil's rally could also face headwinds from a potential U.S-Iran deal that could boost global supplies and a spike in COVID-19 cases, which could undermine demand recovery, participants said.

Analysts saw Iran potentially adding about 1-2 million bpd of output into the global market over the next six months or so.

"The main question is whether Saudi Arabia and other Gulf producers are ready to accommodate Iranian volumes while maintaining a tight control on their cumulative supply under the OPEC+ deal," said Intesa Sanpaolo analyst Daniela Corsini.

Reporting by Nakul Iyer in Bengaluru; Editing by Arpan Varghese, Noah Browning and Louise Heavens

Our Standards: The Thomson Reuters Trust Principles.

Read more:

Oil to sustain surprise rally despite Iran, third COVID-19 wave threat: Reuters poll - Reuters

Protecting health and care workers means decent working conditions, occupational health and safety, promoting IPC practices and so much more.

Episode 1 showcased experts from governments, labour unions, academia, CSOs and international organizations who shared lessons learnt on fair and safe working conditions, mental health, work organization, gender transformative action and other key issues.

COVID-19 has underscored the urgent need to invest in health and care workers readiness, education and employment. A critical objective of the International Year of Health and Care Workers is to mobilize commitments from Member States, Internationalrn Financing Institutions, bilateral and philanthropic partners to protect and invest in health and care workers to accelerate the attainment of the SDGs and COVID-19 recovery.

Episode 2 showcased experts from governments, international financing institutions, academia, and international organizations who shared lessons learnt and strategies on capitalizing on health workforce investments for shared dividends in health, jobs,rn economic opportunity and equity.

Read this article:

Health Workforce in COVID-19 Action Series: Time to Protect. Invest. Together. - World Health Organization

Confirmed cases of COVID-19 have passed 181.8 million globally, according to Johns Hopkins University. The number of confirmed deaths stands at more than 3.93 million. More than 3 billion vaccination doses have been administered globally, according to Our World in Data.

Officials in Australia have extended COVID-19 restrictions - including lockdowns and social distancing. Four major cities are already under a hard lockdown.

Moderna's COVID-19 vaccine has shown a promising response to the Delta variant in a lab study, with a modest decrease in response compared to the original strain.

Romania has agreed to sell 1.17 million excess doses of the Pfizer/BioNTech vaccine to Denmark, the Danish health ministry said on Tuesday.

Ireland has lifted restrictions on giving the Oxford/AstraZeneca COVID-19 vaccine to adults aged under 50 and also closed the recommended gap between doses from 8 to 4 weeks.

Greece will allow people who are fully vaccinated against COVID-19 inside restaurants without masks, the government announced yesterday.

India has reported 45,951 new daily COVID-19 cases, according to health ministry data.

Members of the US military who were vaccinated against COVID-19 showed higher-than-expected rates of heart inflammation - although the condition was still very rare - a study released yesterday showed.

Oxygen prices in Jakarta have more than doubled, with warnings of shortages, as Indonesia's capital fights a surge in COVID-19 cases.

International tourism arrivals are set to stagnate this year, except in some Western markets, a new report from UNCTAD and the UN's World Tourism Organization has said.

The decline, caused by COVID-19, is set to cause between $1.7 and $2.4 trillion in losses this year, with the report also warning that the sector is not expected to rebound fully until 2023.

International arrivals fell more than 70% from pre-pandemic levels last year, causing $2.4 trillion in losses in 2020.

Numbers of international tourists plunged last year.

Image: UNCTAD

"In international tourism we are at levels of 30 years ago, so basically we are in the '80s... Many livelihoods are really at threat," said Zoritsa Urosevic, Geneva representative of the Madrid-based UNWTO.

The Biden Administration has announced plans to donate 2 million doses of the Pfizer/BioNTech COVID-19 vaccine to Peru.

"The United States is donating 2 million Pfizer vaccine doses to Peru as a part of our ongoing solidarity with the people of Peru as they recover from this devastating pandemic," State Department spokeswoman Jalina Porter said.

The US will also ship 2.5 million doses of the Moderna COVID-19 vaccine to Pakistan, White House Press secretary Jen Psaki said.

Meanwhile, 2.5 million doses of the Moderna jab will also be shipped to Bangladesh.

As part of work identifying promising technology use cases to combat COVID, The Boston Consulting Group recently used contextual AI to analyze more than 150 million English language media articles from 30 countries published between December 2019 to May 2020.

The result is a compendium of hundreds of technology use cases. It more than triples the number of solutions, providing better visibility into the diverse uses of technology for the COVID-19 response.

To see a full list of 200+ exciting technology use cases during COVID please follow this link.

Written by

Joe Myers, Writer, Formative Content

The views expressed in this article are those of the author alone and not the World Economic Forum.

Excerpt from:

COVID-19: What you need to know about the coronavirus pandemic on 30 June - World Economic Forum

Christine Lentz, a Morrison & Foerster summer associate in our San Diego office,contributed to the writing of this article.

The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration (FDA) process, approval for these products could take months, if not yearstime many Americans did not have. Fortunately, the FDA had a secret weapon in the fight against COVID-19: emergency use authorizations (EUAs). In April 2020, we reported on the FDAs use of EUAs in the early months of the pandemic. Now, over one year later, we revisit the topic of EUAs to highlight the role they have played in pandemic responsiveness and explain what to expect going forward.

Congress first established the FDAs power to issue EUAs through the Project Bioshield Act of 2004. Generally speaking, EUAs enable the FDA to authorize unapproved products (or unapproved uses of approved products) for temporary use as emergency medical countermeasures against threats to public health and safety. From 2004 until recently, the FDA seldom issued EUAs; across the Zika, Ebola, MERS Coronavirus, H1N1/Swine flu, and Anthrax crises, the FDA issued EUAs for only a few dozen products combined.

The COVID-19 pandemic, however, led to the issuance of over 600 EUAs, including authorizations for three vaccines and ten drug and biological therapeutic products, as well as a wide range of personal protective equipment, in vitro diagnostics, ventilators, and more. Among these authorizations, the FDA responded to the testing and supply shortages prevalent at the start of the pandemic by issuing several umbrella EUAs for larger categories of devicese.g., Surgical Masks and Independently Validated Serology Tests for SARS-CoV-2which allowed those products on the market without individual review.

Several treatments for mild-to-moderate COVID-19 were authorized for emergency use, such as Gileads remdesivir, GlaxoSmithKlines Sotrovimab, Eli Lillys Bamlanivimab and Etesevimab, and Regenerons REGEN-COV (Casirivimab and Imdevimab). In addition, Fresenius Kabi received an EUA for its Propoven 2% Emulsion IV, which maintains sedation in patients requiring mechanical ventilation in an intensive care setting. Baxter Healthcare received authorization for its REGIOCIT replacement solutionfor adults treated with continuous renal replacement therapy in a critical care setting during the COVID-19 pandemic.

EUAs remain in effect until the circumstances justifying the authorization of emergency use during the pandemic end, the FDA revokes the EUA to protect public health or safety, or the FDA approves a marketing application for the product/use. To determine whether products temporarily authorized under EUAs remain necessary, the FDA periodically reviews the circumstances and appropriateness of existing authorizations, particularly the status of product approval. If the sponsor is not actively working toward approval, licensure, or clearance, the FDA may consider terminating the EUA. If an EUA remains in effect for more than one year, the FDA must provide the sponsor with a written explanation of obstacles to approval and specific actions to overcome them.[1]

During the current pandemic, the FDA has revoked, for a variety of reasons, three of its umbrella EUAs and several individual EUAs. One typical explanation for revocation is that when the FDA approves a product, it renders any prior EUA redundant. For example, the FDA revoked the corresponding EUA upon approving Gileads Veklury (remdesivir) for use in adults and certain pediatric patients.

Other times, however, the FDA revokes EUAs after learning that products are not completely effective or safe for use. Recent EUA revocations include reported adverse effects (Chloroquine phosphate and hydroxychloroquine sulfate); poor clinical performance (Chembios DPP COVID-19 IgM/IgG System); decreased effectiveness (Autobios Anti-SARS-CoV-2 Rapid Test; NovaSteriliss Nova2200 for Decontaminating Compatible N95 Respirators); increased viral variant resistance (Eli Lillys Bamlanivimab); and/or excessive risk-benefit ratio.

As the pandemic has evolved, so have public health needs and FDA priorities, which in turn have resulted in the discontinuation and de-prioritization of EUA application review for certain COVID-19 products.

For example, according to recent guidance (May 2021), the FDA may decline to review or process new EUA requests for COVID-19 vaccines, unless those developers have previously engaged with the Agency on the development of their manufacturing process and clinical trials program. If a developer has already received feedback from the FDA, its EUA request is more likely to contain comprehensive data and information that meet authorization issuance requirements, whereas quality and data in new applications may prove difficult to verify.

In addition to de-prioritizing new COVID-19 vaccine EUA submissions, the FDA no longer reviews requests nor adds new respirator models to the umbrella emergency use authorizations for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (as of Oct. 15, 2020) orImported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (as of Mar. 24, 2021). Respirator manufacturers who are not listed under the existing EUAs may submit a separate EUA request; however, the FDA does not encourage such submissions, as there is decreased demand for those devices.

Given the countrys continued recovery from the COVID-19 pandemic, we can likely expect additional classes of products to become deprioritized or ineligible for EUA. For example, as the proportion of vaccinated citizens increases and hospitalization rates decrease, many of the medical devices the country had scrambled to make available over a year ago will become less critical.

Companies with current EUAs or those considering applying for emergency use of their products should consult legal counsel to ensure continuity of product marketing and commercialization when the COVID-19 public health emergency is ended and/or EUAs are no longer effective.

Unless FDA announces a transitional policy for EUAs, manufacturers should assume they will need to receive full approval or clearance from the FDA to continue marketing their products after the public health emergency ends. For example, several Zika- and Ebola-related tests with emergency use authorizations received market clearance before the declared end of their respective emergencies. In October 2020, the FDA approved Inmazeb, the first treatment for Ebola Virus in the United States. To date, Pfizer-BioNTech and Moderna have submitted BLAs for their mRNA vaccines, along with requests for Priority Review to accelerate the approval process, while simultaneously expanding their EUAs.

The FDA encourages sponsors of EUA products to follow up EUA issuance with an appropriate approval, biologics license application (BLA), or device premarket submissionsuch as 510(k), De Novo Classification Request, or Premarket Approvalso that authorized products can remain on the market with minimal interruption once the EUA is no longer in effect. The FDA further expects sponsors to include a plan for safety follow-up in their EUA requests, which will inform benefit-risk determinations in support of EUA continuation.

The FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval. Once enough data is available, EUA holders should consider submitting applications for FDA approval, as the process can take several months. Legal counsel can assist sponsors in navigating applications to accelerate the approval process, e.g., for Fast Track, Priority Review, or Material Threat Medical Countermeasure Priority Review Vouchers. Although the Secretary of Health and Human Services (HHS) must provide sufficient advance notice to allow for the disposition of an unapproved product, and of any other provided information/labeling related to an unapproved use before an EUA declaration terminates, this can unnecessarily disrupt the commercialization of your COVID-19 products.

[1] 21 U.S.C. 360bbb-3.

[View source.]

Read more:

EUAs And The FDAS Fight Against COVID-19: An Evolving Landscape - JD Supra