Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test – FDA.gov

For Immediate Release:
Statement From:

Statement Author

Leadership Role

Director – CDRH Offices: Office of the Center Director

Dr. Jeffrey E. Shuren MD, JD

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”

In addition to this new prescription home test, Quidel also was issued an EUA in December 2020 for their QuickVue SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine – FDA.gov

For Immediate Release:

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

FDA Evaluation of Available Safety Data

The Janssen COVID-19 Vaccine is administered as a single dose. The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death. 

It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

FDA Evaluation of Available Effectiveness Data 

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. 

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

There were 116 cases of COVID-19 in the vaccine group that occurred at least 14 days after vaccination, and 348 cases of COVID-19 in the placebo group during this time period. There were 66 cases of COVID-19 in the vaccine group that occurred at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time period. Starting 14 days after vaccination, there were 14 severe/critical cases in the vaccinated group versus 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe/critical in the vaccine group versus 34 cases in the placebo group. 

At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. 

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives. 

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner. 

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

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‘We’re not there yet’: Biden officials issue somber warning about uptick in Covid-19 cases – STAT

WASHINGTON — Biden administration officials on Friday warned of a “very concerning” uptick in Covid-19 cases this week, urging Americans not to let down their guard despite an ongoing vaccination campaign and case rates that are substantially lower than their peak last month.

“We may be done with the virus, but clearly the virus is not done with us,” Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said during a White House press briefing. “I know people are tired and they want to get back to life, to normal, but we’re not there yet.”

Walensky’s shift in tone comes after a slight but noteworthy uptick in reported Covid-19 cases. Health officials have reported over 70,000 cases each of the past three days, the first increase after roughly seven weeks of plummeting case counts.

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The current totals are dramatically lower than mid-January’s, when the country recorded over 250,000 each day. But they are still high — more than double the initial 2020 outbreak, which saw roughly 30,000 daily cases in April, and a surge in July, which saw roughly 65,000.

“We at CDC consider this a very concerning shift in the trajectory,” Walensky said. “The most recent seven-day average of cases, approximately 66,350, is higher than the average I shared with you on Wednesday. In fact, cases have been increasing for the past three days compared to the prior week.”

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Walensky sounded the alarm even as the U.S. continues to administer roughly 1.3 million vaccine doses each day, according to CDC data. The country has distributed over 68 million vaccine doses already, and roughly 14% of Americans have received at least one dose of the two-dose vaccine regimen.

Most Americans, however, likely won’t be vaccinated for months, leaving huge swaths of the population susceptible to the virus, which has already resulted in over 500,000 U.S. deaths.

The officials also warned that new variants of the SARS-CoV-2 virus, which causes Covid-19, could set back the U.S. pandemic response if Americans let down their guard. Anthony Fauci, the government researcher and chief medical adviser to Biden’s pandemic response, warned that February’s encouraging news could be erased if case counts hover at their current level instead of dropping further.

“If we plateaued at 70,000, we are at that very precarious position that we were at right before the fall surge,” he said. “We don’t want to be people always looking at the dark side of things, but you want to be realistic.”

The White House briefing occurred as a Food and Drug Administration committee considered whether to recommend the authorization of a new, one-dose vaccine developed by Johnson & Johnson.

“More vaccine is on our way,” Walensky said. “We are at the precipice of having another vaccine in our toolbox.”

That hearing, however, also featured its own warning, particularly concerning the presence of new and potentially more transmissible variants of the virus, particularly three first discovered in Brazil, South Africa, and the United Kingdom.

“We have to assume, in the absence of other information, that these variants probably could exist throughout the entire U.S.,” said Adam MacNeil, a CDC epidemiologist.

The U.S., he added, is currently “nowhere close” to having herd immunity.

Despite the concern over the new variants, Fauci urged Americans to become vaccinated as quickly as possible, even as he highlighted ongoing trials from the drug manufacturer Moderna to determine whether a potential “booster” shot could help protect against the South African variant specifically.

“Get vaccinated,” Fauci said. “The vaccine that is available to you — get that vaccine.”

Matthew Herper contributed reporting.

COVID-19 Daily Update 2-26-2021 – West Virginia Department of Health and Human Resources

​The West Virginia Department of Health and Human Resources (DHHR) reports as of February 26, 2021, there have been 2,157,910 total confirmatory laboratory results received for COVID-19, with 131,234 total cases and 2,291 total deaths.

DHHR has confirmed the death of a 68-year old female from Webster County.

“As we solemnly observe this tragic loss of life, we must continue to fight this virus,” said Bill J. Crouch, DHHR Cabinet Secretary. “It is our duty to protect our family members and neighbors. We extend our condolences to this family.”

CASES PER COUNTY: Barbour (1,192), Berkeley (9,649), Boone (1,567), Braxton (772), Brooke (2,009), Cabell (7,769), Calhoun (229), Clay (376), Doddridge (466), Fayette (2,644), Gilmer (710), Grant (1,062), Greenbrier (2,419), Hampshire (1,522), Hancock (2,588), Hardy (1,264), Harrison (4,817), Jackson (1,664), Jefferson (3,607), Kanawha (12,029), Lewis (1,032), Lincoln (1,219), Logan (2,686), Marion (3,655), Marshall (2,997), Mason (1,766), McDowell (1,348), Mercer (4,205), Mineral (2,575), Mingo (2,115), Monongalia (7,949), Monroe (945), Morgan (928), Nicholas (1,170), Ohio (3,619), Pendleton (619), Pleasants (800), Pocahontas (589), Preston (2,528), Putnam (4,194), Raleigh (4,663), Randolph (2,383), Ritchie (621), Roane (602), Summers (701), Taylor (1,082), Tucker (499), Tyler (613), Upshur (1,678), Wayne (2,604), Webster (311), Wetzel (1,078), Wirt (353), Wood (7,014), Wyoming (1,738).

Delays may be experienced with the reporting of information from the local health department to DHHR. As case surveillance continues at the local health department level, it may reveal that those tested in a certain county may not be a resident of that county, or even the state as an individual in question may have crossed the state border to be tested. Such is the case of Mingo and Ritchie counties in this report.

West Virginians may now pre-register for their COVID-19 vaccination at vaccinate.wv.gov. The COVID-19 dashboard located at www.coronavirus.wv.gov shows the total number of vaccines administered. Please see the vaccine summary tab for more detailed information. 

COVID-19 Vaccines May Need Updates For Viral Variants : Shots – Health News – NPR

Vaccine makers are moving to test booster shots, prompted by new coronavirus variants that have sprung up in South Africa, the U.K. and elsewhere. Mark Felix/AFP via Getty Images hide caption

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Mark Felix/AFP via Getty Images

Vaccine makers are moving to test booster shots, prompted by new coronavirus variants that have sprung up in South Africa, the U.K. and elsewhere.

Mark Felix/AFP via Getty Images

The U.S. is still ramping up its vaccination program, hoping to finally clamp down on the COVID-19 pandemic. But even as vaccine doses are being rolled out, their makers are exploring several strategies to bolster them, hoping to protect people against worrying new variants that have sprung up in recent months, from South Africa to the U.K.

The companies that have FDA-authorized vaccines are currently working on the problem, out of concern that mutations in SARS-CoV-2 could make the virus more difficult to control. Several strains seem to spread more easily than older forms of the coronavirus. There are also concerns that some mutated versions could elude antibody responses that would normally protect people who have been immunized or previously infected.

Here’s an overview of the approaches being pursued by Pfizer and its partner BioNTech and Moderna – the drugmakers with U.S.-authorized vaccines – along with Johnson & Johnson, whose vaccine is now poised for FDA authorization:

Booster shots of the existing vaccine: This approach relies on giving people who have already been vaccinated a follow-up dose of the same vaccine.

Pfizer and BioNTech calls for people who have already completed the normal two-dose regimen to get a third 30-microgram dose, 6-12 months later. Moderna’s plan calls for a 50-microgram dose, after people have gone through its two-dose regimen.

Variant-specific booster shot: Much like how specific vaccines are tailored to fight influenza, drugmakers can craft a version of their vaccine to combat individual coronavirus variants. Moderna says its new vaccine candidate, based on the strain first identified in South Africa, is now ready for clinical testing. The company says it has shipped doses of that potential vaccine to the National Institutes of Health to get started.

Last month, Paul Stoffels, the chief scientific officer at Johnson & Johnson, said his company is also preparing a special version of its vaccine to target the spike protein found in the B.1.351 seen in South Africa.

A ‘multivalent’ booster: In this approach, drug companies essentially blend two versions of their vaccines into a single booster shot. One would target original or “ancestral” versions of SARS-CoV-2, while the other would go after new variants. Moderna says it will look at combining its original vaccine – known as mRNA-1273 – with the newer version it created to fight the B.1.351 coronavirus variant first identified in South Africa.

Putting the boosters front-and-center: As drugmakers tweak their original vaccines to respond more acutely to variants, they will also consider whether new versions of their vaccines might effectively replace the initial recipes. Moderna says it will explore whether its variant-specific booster and its multivalent booster should become the primary vaccination series of shots for people who haven’t been exposed to the coronavirus.

In the future, different circumstances will likely determine which vaccine or booster a person receives.

Someone who has antibodies from a previous infection or immunization would probably only get a booster shot, for instance, while someone whose system hasn’t been exposed to the coronavirus would receive “an updated vaccine that aims to provide immunity to both the ancestral strains and variants of concern,” Moderna said on Thursday, during a call with investors.

It’s also possible people could receive a vaccine that’s tailored to variants that have been detected in their country.

Johnson & Johnson’s new vaccine was found to be 66% effective at preventing moderate to severe cases of COVID-19 – a result that reflects testing in numerous countries, including South Africa and Brazil, where troubling new variants have emerged.

Current versions of their vaccines work against the new COVID-19 strains, Pfizer, Moderna and Johnson & Johnson say. Health experts also stress that all three of the vaccines are overwhelmingly effective in preventing the worst outcomes, such as hospitalizations and deaths. Still, newly tailored versions of the vaccines may be needed, as strains of SARS-CoV-2 continue to mutate and combine.

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine,” Pfizer CEO and Chairman Albert Bourla said in a statement about his company’s plans to study boosters’ effect on variants.

Pharmaceutical companies are studying boosters out of caution, Bourla added, to make sure they have an answer in the pipeline for an evolving coronavirus — and to ensure they have a path for emergency authorization if an updated vaccine or booster becomes necessary.

“This regulatory pathway is already established for other infectious diseases like influenza,” said Ugur Sahin, CEO and co-founder of BioNTech.

Both Moderna and Pfizer/BioNTech created their vaccines using relatively new messenger RNA technology, which has been hailed for its ability to produce vaccine candidates quickly. That swift process, the drug makers say, can also help them produce new versions of their vaccines in response to coronavirus mutations.

Citing the speed and flexibility of mRNA, Moderna CEO Stéphane Bancel said on Thursday that his company “is committed to making as many updates to our vaccine as necessary until the pandemic is under control.”

In contrast, Johnson & Johnson used a viral vector technique to make its vaccine, using the same strategy as the AstraZeneca / University of Oxford team. The approach is known to take longer than mRNA, but the resulting vaccine can also give patients immunity after a single dose.

Along with providing protection against new coronavirus variants, another potential benefit of booster shots, drug makers say, is that they can prolong or enhance protection even at smaller doses than the original regimen, easing some of the pressure on strained production and distribution networks.

FDA.gov Coronavirus (COVID-19) Update: February 23, 2021 – FDA.gov

For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Yesterday, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19
  • The FDA issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. The Pulse Oximeter Accuracy and Limitations: FDA Safety Communication provides:
    • Important recommendations for patients and their caregivers on how to use pulse oximeters at home.
    • Recommendations for health care providers on how to use pulse oximeters for better accuracy.
    • Background on pulse oximeters and the FDA’s actions to evaluate factors that may affect pulse oximeter accuracy and performance.
    • Instructions for reporting problems with pulse oximeters to the FDA.
  • Testing updates:
    • As of today, 331 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 37 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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DCDHHS’ COVID-19 Update #83 | Tuesday, February 23, 2020 | News List – darenc.com

Dare County Department of Health & Human Services, COVID-19 Update

DCDHHS COVID-19 Update #83
Tuesday, February 23, 2021
12:00 p.m.

Dare County COVID-19 Case Update

We are pleased to report Dare County’s COVID-19 data continues to trend in the right direction. Specifically, there were only 37 new positive cases last week. This is the lowest it has been since the beginning of October. Additionally, the percent of positive tests to total tests for this past week decreased from 10.9% to 8.2%. While these numbers are looking much better, we still need to remain vigilant. Please continue to do what we know works to control the spread by following the 3Ws: Wear a face covering, wait 6 ft apart and wash your hands frequently or use hand sanitizer. 

Since our last report on 2/16, there have been 41 new COVID-19 cases. Of these 41 new cases:

The total COVID-19 positive case count in Dare County is 2756, of which there are 46 active cases among residents of Dare County. Currently, 8 residents are hospitalized due to complications from COVID-19. Sadly, 1 resident death was reported last week. Our thoughts are with the family and friends who have lost their loved one.

COVID-19 Vaccine

We were speechless last Thursday when we were informed that the state was going to provide us with 100 of the 3,000 doses requested for our Mega Vaccine Event. We will continue to advocate for more doses as we stand prepared to vaccinate approximately 3,000 individuals per week when the vaccine allotment increases. For the next 3 weeks, we will receive a standard allocation from the state of 500 first doses per week. This week we will provide 600 first doses since we received the extra 100 doses from our event request.

We continue to ask for everyone’s patience with the vaccine roll out. Our ability to vaccinate everyone who wishes to be vaccinated is completely dependent on our vaccine allocation from the state.  Over the past 7 weeks we have administered 7,798 first doses of the COVID-19 vaccine in Dare County and 4,521 second doses.

The limited vaccine allotment is only related to first doses. We have not been informed that there are any issues with second dose allotments. All second dose appointments remain as scheduled.

There are currently 2,206 individuals aged 65 and over on our vaccine waiting list. Starting on February 24th, in accordance with the state’s vaccination prioritization phases, we will begin accepting registrations for school and day care personnel. All eligible individuals who register for the vaccine are placed on the waiting list in order of when they registered. For anyone who has completed a registration form online and no longer needs an appointment, please email us at covid19@darenc.com to remove your name from the waiting list. This will help us be as efficient as possible when calling people to schedule appointments. 

Information on COVID-19 vaccinations in Dare County can be found at www.darenc.com/covidvaccine.  General information on the COVID-19 vaccines can be found on the state’s website www.covid19.ncdhhs.gov/vaccines.

We have been informed by the state that the Walgreens locations in Dare County are participating in the federal COVID-19 vaccination program and have started receiving a limited number of doses weekly. The vaccines provided to Walgreens are not part of the state’s allocations. Please go to www.walgreens.com for more information on their COVID-19 vaccine program.

Key Metrics

Each week we review the 4 key metrics associated with disease investigation and surveillance. The metrics are:

This past week there were 451 COVID-19 diagnostic tests reported in Dare County. This brings the total number of tests performed since early March to 33,237.  There were 37 positive cases between February 15 and February 21. The percent of positive tests to overall tests in Dare County since we started testing in early March decreased to 8.27%. The percent of positive tests to total tests for the past week decreased to 8.20%. Syndromic surveillance of individuals presenting with COVID like symptoms to the emergency department and urgent care centers, showed low levels of activity. These graphs can be found on the dare county website at www.darenc.com/covid19.

Communications and Information Sharing

Dare County DHHS has an established schedule of communication to share information regarding COVID-19. Every Tuesday, a written update and a video update which includes an overview of the previous week’s COVID-19 key metrics is issued. Additional updates will be released as needed. All released videos and written updates can be found on our website, DHHS facebook page, Dare County Twitter page, and Dare Emergency Management Twitter page. If you would like to receive these updates directly to your email, please sign up to receive our enotifications.

New positive cases are updated on the dashboard on our website and shared on the DHHS facebook page when we receive them. To find the most up-to-date information on COVID-19 cases in Dare County visit www.darenc.com/covid19. State COVID-19 data is available at https://covid19.ncdhhs.gov/dashboard.

Contact Us

We encourage you to stay informed by visiting www.darenc.com/covid19 or by visiting the CDC or NC DHHS websites. If you have specific needs or questions you may also call the Dare County COVID-19 call center open Monday-Friday from 8:30 to 5:00 at 252-475-5008.

This release is available in:

English | Spanish

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants – FDA.gov

For Immediate Release:

Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. 

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

The FDA has anticipated the possible emergence of SARS-CoV-2 variants and has already been prepared to address changes in the virus, informed by the agency’s experience with evolving infectious diseases, such as influenza and HIV. While the FDA has already been communicating with individual medical product sponsors to provide information and scientific advice as they evaluate the impact of SARS-CoV-2 variants on their products, in the spirit of transparency and to continue to encourage public input on this important topic, the agency published this suite of guidances.

As with any evolving situation, the FDA will be continuously monitoring the situation and updating its plans as more information becomes available. The agency is committed to communicating with the public as the FDA determines the best paths forward. The FDA urges Americans to continue to get tested, get their vaccines to prevent COVID-19 and follow important health measures—wash your hands, wear a mask and maintain social distance.

Vaccines

The FDA updated its October 2020 guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to provide recommendations to vaccine developers, including those who have already received emergency use authorization (EUA) for their COVID-19 vaccines and are seeking to amend their EUA to address new variants. At this time, available information suggests that the FDA-authorized vaccines remain effective in protecting the American public against currently circulating strains of SARS-CoV-2. However, if there is an emergence of SARS-CoV-2 variant(s) in the U.S. that are moderately or fully resistant to the antibody response elicited by the current generation of COVID-19 vaccines, it may be necessary to tailor the vaccines to the variant(s).

The updated guidance outlines the FDA’s scientific recommendations for modifications to authorized vaccines. For example, the FDA expects that manufacturing information will remain generally the same for an authorized vaccine and a modified vaccine candidate from the same manufacturer. For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. Manufacturers are also encouraged to study the modified vaccine in both naïve (non-vaccinated) individuals and in individuals previously vaccinated with the authorized vaccine. Additionally, the guidance outlines the FDA’s recommendations for assessments of safety to support an EUA for a modified vaccine. Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may 
be authorized without the need for clinical studies. 

COVID-19 Tests

The FDA issued a new guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests. The guidance provides information on evaluating the potential impact of emerging and future viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests, including design considerations and ongoing monitoring. The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test. The FDA identified a few tests that are known to be impacted by emerging viral mutations, though at this time the impact does not appear to be significant. 

The clinical impact of viral genetic mutations on a test’s performance is influenced by various factors, such as the sequence of the variant, the design of test (for example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target), and the prevalence of the variant in the patient population. The guidance describes the FDA’s activities to better understand the public health impact of new virus variants and the impact on test performance, such as monitoring publicly available genomic databases for emerging SARS-CoV-2 genetic mutations and monitoring the potential effects of genetic variation on molecular tests that have been issued an EUA. The guidance also provides recommendations to test developers, such as considering the potential for future viral genetic mutations when designing their test, and conducting their own routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations, which may be the basis of viral variants, on the performance for molecular, antigen and serology SARS-CoV-2 tests.

Therapeutics

To address the impact of emerging variants of SARS-CoV-2 on the development of monoclonal antibody products targeting the virus, the FDA has issued a new guidance, Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency. FDA has also revised a second guidance covering drugs and biological products more broadly for COVID-19, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.

The new guidance provides recommendations for developers of SARS-CoV-2-targeting monoclonal antibodies during the COVID-19 public health emergency. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged. This guidance provides recommendations on efficient approaches to the generation of non-clinical, clinical, and chemistry, manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.

The revised guidance covering drugs and biological products more broadly, originally published in May 2020, describes the FDA’s current recommendations regarding phase 2 and phase 3 clinical trials for drugs and biological products under development to treat or prevent COVID-19, including the patient population, trial design, efficacy endpoints, safety considerations and the statistical considerations for such trials and more. Today, this guidance was updated to address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants and the availability of authorized COVID-19 vaccines. 

With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Governor Cuomo Announces Single-Day COVID-19 Positivity Rate Drops Below 3 Percent for First Time Since November 23 – ny.gov

Governor Andrew M. Cuomo today updated New Yorkers on the state’s progress during the ongoing COVID-19 pandemic. The statewide positivity rate, now at 2.99 percent, dropped below 3 percent for the first time since November 23.

 

The Governor also said the first case of the South African variant has been identified in a resident of New York State. The sequencing, involving a Nassau County resident, was conducted at Opentrons Labworks Inc’s Pandemic Response Lab, a New York City based commercial lab, and verified at the Wadsworth Center in Albany. Last week, a Connecticut resident who had been hospitalized in New York City was found to have the South African variant.  

 

“We continue to see a reduction in positivity and hospitalizations throughout the state, which is good news, and this progress is allowing us to reopen the valve on our economy even further,” Governor Cuomo said. “But with the discovery of a case of the South African variant in the state, it’s more important than ever for New Yorkers to stay vigilant, wear masks, wash hands and stay socially distanced. We are in a race right now — between our ability to vaccinate and these variants which are actively trying to proliferate — and we will only win that race if we stay smart and disciplined.”

   

Today’s data is summarized briefly below:

  • Test Results Reported – 221,157
  • Total Positive – 6,610
  • Percent Positive – 2.99%
  • 7-Day Average Percent Positive – 3.44%
  • Patient Hospitalization – 5,764 (-213)
  • Net Change Patient Hospitalization Past Week – -829
  • Patients Newly Admitted – 602
  • Hospital Counties – 55
  • Number ICU – 1,162 (+0)
  • Number ICU with Intubation – 794 (-7)
  • Total Discharges – 142,307 (+715)
  • Deaths – 75
  • Total Deaths – 37,851

 

The regional hospital bed capacity and occupancy numbers, including the number of hospitalizations as a percent of the region’s population, is as follows:

 

Region

COVID Patients Currently in Hospital in Region

COVID Patients as Percent of Region Population

Percent of Hospital Beds Available Within 7 Days Under Surge Plan

Capital Region

168

0.02%

35%

Central New York

95

0.01%

32%

Finger Lakes

213

0.02%

40%

Long Island

983

0.03%

34%

Mid-Hudson

606

0.03%

43%

Mohawk Valley

109

0.02%

36%

New York City

3,130

0.04%

31%

North Country

74

0.02%

57%

Southern Tier

134

0.02%

47%

Western New York

252

0.02%

38%

Statewide

5,764

0.03%

35%

 

The regional ICU bed capacity and occupancy numbers are as follows:

 

Region

Total ICU Beds in Region

Total Occupied ICU Beds in Region

Percent of ICU Beds Available in Region (7-day Avg)

Capital Region

236

174 

27%

Central New York

262

170 

32%

Finger Lakes

397

246 

37%

Long Island

857

662 

22%

Mid-Hudson

678

394 

40%

Mohawk Valley

127

93 

29%

New York City

2,609

2,032 

21%

North Country

60

29 

45%

Southern Tier

126

74 

44%

Western New York

545

344 

38%

Statewide

5,897

4,218 

28%

     

Each region’s 7-day average percentage of positive test results reported over the last three days is as follows:

 

REGION

THURSDAY

FRIDAY

SATURDAY

Capital Region

2.09%

2.00%

1.90%

Central New York

1.41%

1.33%

1.24%

Finger Lakes

2.33%

2.37%

2.32%

Long Island

4.36%

4.31%

4.27%

Mid-Hudson

4.43%

4.14%

4.18%

Mohawk Valley

2.11%

2.11%

2.02%

New York City

4.40%

4.40%

4.41%

North Country

3.91%

3.95%

3.82%

Southern Tier

0.78%

0.76%

0.76%

Western New York

3.01%

2.87%

2.28%

Statewide

3.60%

3.53%

3.44%

 

Each New York City borough’s 7-day average percentage of positive test results reported over the last three days is as follows:

 

BOROUGH

THURSDAY

FRIDAY

SATURDAY

Bronx

6.20%

6.00%

5.67%

Brooklyn

4.57%

4.56%

4.48%

Manhattan

3.01%

2.98%

2.91%

Queens

4.96%

4.95%

4.88%

Staten Island

4.57%

4.47%

4.23%

 

Of the 1,578,785 total individuals who tested positive for the virus, the geographic breakdown is as follows:

 

County

Total Positive

New Positive

Albany

20,392

56

Allegany

2,839

7

Broome

14,228

83

Cattaraugus

4,281

12

Cayuga

5,289

47

Chautauqua

7,185

33

Chemung

6,362

12

Chenango

2,376

17

Clinton

3,390

21

Columbia

3,318

6

Cortland

3,078

4

Delaware

1,448

10

Dutchess

21,565

113

Erie

63,468

220

Essex

1,298

7

Franklin

1,954

19

Fulton

3,202

32

Genesee

4,293

21

Greene

2,582

9

Hamilton

276

0

Herkimer

4,505

6

Jefferson

4,622

40

Lewis

2,005

9

Livingston

3,452

18

Madison

3,765

10

Monroe

51,564

141

Montgomery

3,095

16

Nassau

143,615

546

Niagara

14,984

27

NYC

684,185

3,384

Oneida

19,393

42

Onondaga

31,909

61

Ontario

5,646

20

Orange

35,648

152

Orleans

2,398

4

Oswego

5,894

19

Otsego

2,247

9

Putnam

8,116

31

Rensselaer

8,788

28

Rockland

37,579

101

Saratoga

11,604

44

Schenectady

10,624

31

Schoharie

1,168

8

Schuyler

850

3

Seneca

1,544

12

St. Lawrence

5,233

39

Steuben

5,426

11

Suffolk

158,029

513

Sullivan

4,616

22

Tioga

2,752

12

Tompkins

3,389

13

Ulster

9,754

56

Warren

2,769

6

Washington

2,248

16

Wayne

4,382

12

Westchester

104,400

410

Wyoming

2,756

8

Yates

1,007

1

 

Yesterday, 75 New Yorkers died due to COVID-19 in New York State, bringing the total to 37,851. A geographic breakdown is as follows, by county of residence:

 

Deaths by County of Residence

County

New Deaths

Albany

1

Bronx

5

Broome

1

Delaware

1

Dutchess

1

Erie

1

Kings

13

Lewis

1

Manhattan

6

Monroe

3

Nassau

4

Niagara

1

Oneida

1

Onondaga

1

Orange

2

Queens

14

Rensselaer

1

Rockland

2

Saratoga

2

Schenectady

1

Suffolk

9

Sullivan

1

Westchester

3

FDA.gov Coronavirus (COVID-19) Update: February 19, 2021 – FDA.gov

For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • On Feb. 16, the FDA approved two abbreviated new drug applications (ANDAs) for piperacillin and tazobactam for injection (ANDAs 208674 and 208675), indicated to treat intra-abdominal infections in adult and pediatric patients 2 months of age and older, nosocomial pneumonia in adult and pediatric patients 2 months of age and older, skin and skin structure infections in adults, female pelvic infections in adults and community-acquired pneumonia in adults. The most common side effects of piperacillin and tazobactam for injection are diarrhea, constipation, nausea, headache and insomnia. 
  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Dr. Paul’s Lab for selling an unapproved product with fraudulent COVID-19 claims. The company sells “COVID-Aid Tincture,” and misleadingly represents the product can treat or prevent COVID-19 in people. The FDA requested that Dr. Paul’s Lab take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
    • As of today, 331 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 37 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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