Governor Cuomo Updates New Yorkers on State’s Progress During COVID-19 Pandemic – ny.gov

Governor Andrew M. Cuomo today updated New Yorkers on the state’s progress during the ongoing COVID-19 pandemic. COVID-19 hospitalizations dropped below 5,000 for the first time since December 8. There were 4,954 COVID-19 hospitalizations yesterday, the lowest number since December 7. The single-day positivity rate dropped to 2.80 percent, the lowest number since November 21. 

 

“Protecting New Yorkers and saving lives has always been our top priority, and we’re seeing significant progress in reducing the spread of COVID while vaccinating residents as quickly as possible,” Governor Cuomo said. “As the COVID numbers decrease, we’ve been able to slowly open the valve and let economic activity increase, but we still have a lot of work to do to defeat this beast once and for all. Our vaccine distribution network is equipped to handle far more vaccines than the state currently receives, and there’s no doubt we’ll be able to kick vaccinations into overdrive once the supply increases. It’s also critical that we continue making the vaccine accessible to all New Yorkers. We’re going to get through this pandemic together, but we need everyone to continue taking it seriously and staying vigilant.”

 

Today’s data is summarized briefly below: 

 

  • Test Results Reported – 273,132
  • Total Positive – 7,647
  • Percent Positive – 2.80%
  • 7-Day Average Percent Positive – 3.15%
  • Patient Hospitalization – 4,954 (-80)
  • Net Change Patient Hospitalization Past Week – -491 
  • Patients Newly Admitted – 601 
  • Hospital Counties – 52
  • Number ICU – 1,012 (-18)
  • Number ICU with Intubation – 694 (-6)
  • Total Discharges – 149,481 (+558)
  • Deaths – 78
  • Total Deaths – 38,970

 

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

106

0.01%

35%

Central New York

48

0.01%

33%

Finger Lakes

174

0.01%

40%

Long Island

834

0.03%

34%

Mid-Hudson

497

0.02%

43%

Mohawk Valley

76

0.02%

39%

New York City

2,926

0.03%

31%

North Country

51

0.01%

58%

Southern Tier

83

0.01%

50%

Western New York

159

0.01%

36%

Statewide

4,954

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

234

192 

18%

Central New York

262

178 

34%

Finger Lakes

397

252 

36%

Long Island

855

666 

24%

Mid-Hudson

683

419 

40%

Mohawk Valley

97

61 

29%

New York City

2,607

2,059 

23%

North Country

55

22 

57%

Southern Tier

126

63 

50%

Western New York

545

327 

40%

Statewide

5,861

4,239 

29%

 

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

 

REGION

WEDNESDAY

THURSDAY

FRIDAY

Capital Region

1.88%

1.92%

1.96%

Central New York

0.87%

0.92%

0.91%

Finger Lakes

1.75%

1.83%

1.80%

Long Island

4.18%

4.21%

4.19%

Mid-Hudson

4.12%

4.15%

4.19%

Mohawk Valley

1.54%

1.65%

1.60%

New York City

3.98%

3.94%

3.94%

North Country

2.61%

2.61%

2.62%

Southern Tier

0.72%

0.73%

0.75%

Western New York

1.85%

1.98%

1.94%

Statewide

3.12%

3.16%

3.15%

 

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

 

BOROUGH

WEDNESDAY

THURSDAY

FRIDAY

Bronx

5.14%

5.27%

5.11%

Brooklyn

4.32%

4.46%

4.25%

Manhattan

2.59%

2.71%

2.73%

Queens

4.39%

4.46%

4.23%

Staten Island

4.43%

4.72%

4.62%

 

Of the 1,674,380 total individuals who tested positive for the virus, the geographic breakdown is as follows:

 

County

Total Positive

New Positive

Albany

21,180

66

Allegany

2,924

5

Broome

15,384

108

Cattaraugus

4,489

15

Cayuga

5,428

7

Chautauqua

7,425

23

Chemung

6,480

12

Chenango

2,487

13

Clinton

3,761

20

Columbia

3,443

9

Cortland

3,231

24

Delaware

1,573

13

Dutchess

22,900

106

Erie

66,604

260

Essex

1,363

3

Franklin

2,160

18

Fulton

3,424

6

Genesee

4,473

14

Greene

2,700

7

Hamilton

285

0

Herkimer

4,601

13

Jefferson

4,891

19

Lewis

2,096

11

Livingston

3,599

10

Madison

3,893

11

Monroe

53,274

107

Montgomery

3,244

12

Nassau

151,970

643

Niagara

15,508

46

NYC

735,394

4,079

Oneida

19,896

30

Onondaga

32,733

52

Ontario

5,898

22

Orange

38,029

182

Orleans

2,472

5

Oswego

6,106

19

Otsego

2,470

39

Putnam

8,539

36

Rensselaer

9,205

45

Rockland

39,546

222

Saratoga

12,190

44

Schenectady

11,010

32

Schoharie

1,243

2

Schuyler

872

1

Seneca

1,648

8

St. Lawrence

5,689

45

Steuben

5,581

19

Suffolk

165,879

590

Sullivan

4,863

18

Tioga

2,854

18

Tompkins

3,509

9

Ulster

10,279

41

Warren

2,907

17

Washington

2,397

17

Wayne

4,528

6

Westchester

109,951

435

Wyoming

2,879

12

Yates

1,023

1

 

Yesterday, 78 New Yorkers died due to COVID-19 in New York State, bringing the total to 38,970. A geographic breakdown is as follows, by county of residence:

 

Deaths by County of Residence

County

New Deaths

Bronx

9

Broome

1

Clinton

1

Erie

3

Fulton

1

Kings

11

Manhattan

11

Monroe

3

Nassau

8

Niagara

1

Onondaga

1

Orleans

1

Queens

12

Rockland

1

Saratoga

2

Suffolk

6

Tompkins

1

Ulster

1

Westchester

4

Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test – FDA.gov

For Immediate Release:

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.

“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.”

Cue COVID-19 Test for Home and Over The Counter (OTC) Use test is authorized for non-prescription home use for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. This test is intended for use in adults (self-swabbing) or children two years of age or older (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.

The authorized test includes: the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader (used by the Cue Health Monitoring System, provided separately), and the Cue Health Mobile Application (App) that is downloaded onto compatible mobile smart devices, like a smart cell phone. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes. The mobile application requires individuals to create an account, and in the future will be updated to include capability to report test results as appropriate to public health authorities to monitor disease prevalence.

Cue COVID-19 Test for Home and Over The Counter (OTC) Use correctly identified 96% of positive samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms. Cue Health expects to produce more than 100,000 tests per day by summer 2021.

“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. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public.”

The FDA has authorized more than 330 tests and collection kits for a variety of uses, users and locations to provide a wide array of test options. FDA has also prioritized review and authorization of EUA requests taking into account a variety of factors, as discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product, with the goal of expanding overall US testing capacity and patient access to tests. The FDA has, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point-of-care (POC) tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput, widely distributed tests). Tests with EUA authorization can be found on our website at In Vitro Diagnostic EUAs.

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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Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19 – FDA.gov

Image

Illustration / vector image with a light blue background that depicts a respirator mask on the right, and the words "ELASTOMERIC RESPIRATOR INNOVATIONS" on the left.

By: Suzanne Schwartz, M.D., M.B.A., Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health

Since the COVID-19 public health emergency was declared over a year ago, access to personal protective equipment (PPE), for health care personnel has been a significant challenge. In particular, the supply chain for respirators, which are regulated by the U.S. Food and Drug Administration when they meet the definition of a device, has been heavily stressed as health care personnel and health systems have fought to secure these critical devices. The respirator type most commonly used in a health care setting is the disposable, N95 filtering facepiece respirator (FFR), which is designed to achieve a very close facial fit and provide efficient filtration of airborne particles. 

Elastomeric respirators, which provide similar protection to other FFRs and are also approved by U.S. Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH), may also be used in health care settings. Given that elastomeric respirators are designed to be reusable, they can help to protect health care personnel in our hospitals and doctor’s offices in times of reduced disposable N95 supply. In particular, this type of respirator can play a critical role in the nation’s response to COVID-19 and bolster future readiness for similar outbreaks and public health emergencies.

Suzanne B. Schwartz, M.D., M.B.A.
Suzanne B. Schwartz, M.D., M.B.A.

A major obstacle limiting the wider use of reusable respirators in health care settings has been the inclusion of exhalation valves as a design feature, which means the respirator cannot provide source control. Source control helps to prevent the transmission of infection through a person’s respiratory secretions, which are produced when speaking, coughing, or sneezing. This limits their practical use with viral agents like SARS-CoV-2, and because the exhaled air from such respirators potentially compromises the sterile field, these devices cannot be used in an operating room. Solving these challenges has not been easy, but, working together, health care personnel, device manufacturers, and scientists have created a new path forward.

Specifically, CDC NIOSH has worked interactively with industry to recently approve first-of-its-kind elastomeric respirators without an exhalation valve by Mine Safety Appliances (MSA) Safety incorporated and elastomeric respirator configurations with an exhalation valve cover from the company 3M. NIOSH also just approved the Dentec Safety Specialists half mask respirator without an exhalation valve. By addressing respiratory protection and source control needs, elastomeric respirators can provide the solutions our health care personnel need to stay safe while saving lives. Though they require higher costs up front because they are reusable, they can provide a cost-effective approach in the long-term to disposable N95 FFRs. 

These innovative designs for reusable respirators intended for use in health care settings address current design needs, are authorized for use during the public health emergency through the FDA’s umbrella emergency use authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency once they are approved by NIOSH and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection, and may have far-reaching benefits as we refine the nation’s responses to public health crises in the future. 

The FDA, in conjunction with CDC NIOSH, will continue to encourage innovation that helps make available critical respiratory protective technologies to address the needs of our health care personnel.

For regular updates on CDRH’s efforts and the FDA’s COVID-19 response, please visit: www.fda.gov/medical-devices.

COVID-19 vaccine FAQs – University of Dayton – News Home

How effective are the vaccines at preventing laboratory-confirmed COVID-19 illness? 

In phase 3 clinical trials, the Pfizer-BioNTech vaccine was 95% effective against contracting symptomatic COVID-19. The Moderna vaccine was 94% effective against contracting symptomatic COVID-19. The Johnson & Johnson Janssen vaccine was 85% effective against contracting symptomatic COVID-19. All vaccines have proven to be close to 100% effective in preventing severe illness and death attributable to COVID-19. Learn more about how COVID-19 vaccines work. 

How and when can I get a vaccine? 

Visit https://vaccine.coronavirus.ohio.gov to search for providers vaccinating in the current phase by county and ZIP code, and also for the State of Ohio’s current criteria regarding who is eligible for the vaccine. 

What does the Catholic Church say about getting a COVID-19 vaccine? 

In speaking about the Moderna and Pfizer COVID-19 vaccines, Pope Francis said: “I believe that ethically everyone must take the vaccine. It is not an option; it is an ethical action, because you are playing with your health, you are playing with your life, but you are also playing with the lives of others.” The Vatican’s doctrinal office also has said it is morally acceptable for Catholics to take the vaccines. Additional guidance comes from the U.S. Conference of Catholic Bishops, which has stated that receiving the COVID-19 vaccine “ought to be understood as an act of charity toward the other members of our community. In this way, being vaccinated safely against COVID-19 should be considered an act of love of our neighbor and part of our moral responsibility for the common good.” 

Can a COVID-19 vaccine make me sick with COVID-19? 

None of the emergency use authorized and recommended COVID-19 vaccines or COVID-19 vaccines in development in the United States contains the live virus that causes COVID-19, so a COVID-19 vaccine cannot make you sick with COVID-19. However, some vaccinations may result in symptoms similar to COVID-19. These symptoms are a result of the vaccine teaching the immune system how to recognize and fight the virus, and are a sign the body is building protection against the virus that causes COVID-19. It also is possible to be exposed and develop COVID-19 illness shortly after vaccination and before your body develops protective antibodies. Learn more about how COVID-19 vaccines work.  

What are side effects of the vaccine?

You may have mild side effects, including soreness or redness at the injection site. Other common short-term side effects are fever, chills, headache, tiredness and muscle or joint pain. These side effects are normal as your body creates an immune response to protect you from COVID-19, and may increase with the second dose. Individuals who were infected with COVID-19 may experience some of these symptoms after the first vaccine dose. Learn more about what to expect in this video from the CDC. 

How long will it take for the vaccination to take effect? 

It typically takes a few weeks for the body to build protection against the virus that causes COVID-19 after vaccination. So it is possible someone could be infected with COVID-19 just before or just after vaccination and still get sick with the virus before you are fully immune.  

Will the vaccine protect against the new COVID-19 variants now confirmed in the U.S.? 

According to the CDC, scientists are working to learn more about how easily variants might spread. Researchers and public health officials are studying whether variants spread more easily person-to-person, cause milder or more severe disease in people, are detected by viral tests, respond to medicines used to treat people for COVID-19, and/or change the effectiveness of COVID-19 vaccines.

The CDC’s recommendations for slowing the spread of COVID-19 — wearing masks, staying at least 6 feet apart from others, avoiding crowds, ventilating indoor spaces, and washing hands often — also will also help prevent the spread of variants.

After getting a COVID-19 vaccine, will I test positive for COVID-19 on a viral test? 

Neither the authorized and recommended vaccines nor the other COVID-19 vaccines in clinical trials in the United States should cause you to test positive on viral tests, which assess whether you have a current infection.​ However, you may test positive on some antibody tests, which indicate you had a previous infection and may have some level of protection against the virus. Experts are looking at how COVID-19 vaccination may affect antibody testing results. 

If I had COVID-19 and recovered, do I still need to get vaccinated with a COVID-19 vaccine? 

Yes, because of the severe health risks associated with COVID-19 and because reinfection with COVID-19 is possible. Plus, experts are unsure about how long someone who had COVID-19 will have natural immunity. The CDC is providing recommendations to federal, state and local governments about who should be vaccinated first. 

Will a COVID-19 vaccine alter my DNA? 

COVID-19 mRNA vaccines do not change or interact with your DNA in any way. Learn more about how COVID-19 mRNA vaccines work. 

Is it safe for me to get a COVID-19 vaccine if I am planning to be pregnant, already pregnant, breastfeeding or planning to get a screening mammogram?  

According to the CDC, based on current knowledge, experts believe COVID-19 vaccines are unlikely to pose a risk to a person trying to become pregnant in the short or long term. Furthermore, the CDC adds there is no evidence antibodies formed from COVID-19 vaccination cause any problems with pregnancy, including the development of the placenta. In addition, there is no evidence suggesting fertility problems are a side effect of ANY vaccine. People who are trying to become pregnant now or who plan to try in the future may receive the COVID-19 vaccine when it becomes available to them. Pregnant women have a higher risk of complications from COVID-19, so they are advised to discuss vaccination with their obstetrician.

The CDC also states mRNA vaccines are not thought to be a risk to the breastfeeding infant. People who are breastfeeding and are part of a group recommended to receive a COVID-19 vaccine, such as healthcare personnel, may choose to be vaccinated.

If you are planning to get a screening mammogram soon, you may wish to schedule that with the timing of the second dose of your vaccine in mind. Some experts recommend waiting until six weeks after the second vaccine dose. Consider consulting with your physician for more insight.  

Additional information can be found at the bottom of the CDC’s “Myths and Facts about COVID-19 Vaccines” page and the CDC’s “Vaccination Considerations for People who are Pregnant or Breastfeeding,” plus by consulting with your primary care physician or specialist.

What are the ingredients in the COVID-19 vaccine?

The COVID-19 vaccines available in the United States do not contain eggs, preservatives or latex. For a full list of ingredients, please see each vaccine’s fact sheet for recipients and caregivers: 

How are UD employees being compensated for time off to receive the vaccine?

Employees should use sick time to get the vaccine, as well as for time taken because of an adverse reaction to the vaccine. Similar to reporting for a COVID-19 illness, report your sick time as you normally would and then contact Beth Schwartz, director of UD’s benefits and wellness program, to replenish your charged sick time. UD employees should use this form to report they’ve received their full COVID-19 vaccination and upload their vaccination record; this form needs to be completed to replenish your sick time.

Were minorities or people with high-risk health conditions included in the clinical studies?

Yes. Approximately 42% of participants in Pfizer BioNTech’s worldwide clinical trials, 37% of the Moderna study population, and 26% of the participants in Johnson & Johnson’s study were from minority communities, which is similar to the diversity of the U.S. at large. In addition, clinical studies included participants age 65 and older (21% of Pfizer-BioNTech participants; 23% of Moderna participants) or 60 and older (34% of Johnson & Johnson participants); and those with high-risk chronic diseases, such as diabetes, severe obesity and cardiac disease (46% of Pfizer-BioNTech participants; 42% of Moderna participants; 41% of Johnson & Johnson participants).

If I received the vaccine, do I still need to quarantine after a COVID-19 exposure? 

Vaccinated persons who have been exposed to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria:

  • Are fully vaccinated (i.e., more than 2 weeks following your final dose of a one- or two-dose series).
  • Are within 3 months following receipt of the last dose in the series.
  • Have remained asymptomatic since the current COVID-19 exposure.

Persons who do not meet the above criteria should continue to follow UD quarantine guidance after exposure to someone with suspected or confirmed COVID-19 and must report their close contacts on the University’s COVID-19 health reporting page.

For more info, please visit the “Public health recommendations for vaccinated persons” section on this page.

Do I need to wear a mask if I have received the vaccine?  

Yes, to protect yourself and others, it will remain necessary after receiving the vaccine to continue following CDC and public health guidelines, which include wearing a face covering over your nose and mouth, staying at least six feet away from others, avoiding large gatherings and poorly ventilated spaces, and washing your hands often. 

It’s important for everyone to continue using all the protective tools available as we learn more about how COVID-19 vaccines work in real-world conditions. Experts are looking at how many people get vaccinated and how the virus is spreading in communities. Experts also do not yet know whether getting a COVID-19 vaccine will prevent you from spreading the virus that causes COVID-19 to other people, even if you do not get sick yourself. The CDC will continue to update this page as it learns more.

How can I report my vaccine record to the University? 

UD students and employees should use this form to report they’ve received their full COVID-19 vaccination and upload their vaccination record.

When will the University provide the vaccine to students, faculty and staff?

The University is an enrolled provider and will provide the vaccine when it becomes available to the University from the State of Ohio. Visit Ohio’s COVID-19 Vaccine Distribution page for more information.

I am a UD student and have received the COVID-19 vaccine. Do I still need to participate in the University’s surveillance testing? 

Yes. We will continue conducting surveillance testing in accordance with guidance from the Ohio Department of Health on surveillance testing for higher education.  

Will the University require students, faculty and staff to have the COVID-19 vaccine?  

The University highly recommends students, faculty and staff receive the vaccine.

Where can I find more information about COVID-19 vaccines?

Please consult the Centers for Disease Control and Prevention “Myths and Facts about COVID-19 Vaccines” page and the CDC “Frequently Asked Questions about COVID-19 Vaccination” page.

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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