Mike Stucka USA TODAY NETWORK| The Gaston Gazette
North Carolina reported 31,230 new cases of coronavirus in the week ending Sunday, down 6.1% from the previous week. The previous week had 33,265 new cases of the virus that causes COVID-19.
North Carolina ranked sixth among the states where coronavirus was spreading the fastest on a per-person basis, a USA TODAY Network analysis of Johns Hopkins University data shows. In the latest week coronavirus cases in the United States increased 2.3% from the week before, with 795,621 cases reported. With 3.15% of the country's population, North Carolina had 3.93% of the country's cases in the last week. Across the country, seven states had more cases in the latest week than they did in the week before.
Gaston County reported 611 cases and five deaths in the latest week. A week earlier, it had reported 689 cases and five deaths. Throughout the pandemic it has reported 72,809 cases and 888 deaths.
Across North Carolina, cases fell in 62 counties, with the best declines in Mecklenburg County, with 3,489 cases from 3,891 a week earlier; in Cumberland County, with 1,015 cases from 1,330; and in Wake County, with 3,191 cases from 3,427.
>> See how your community has fared with recent coronavirus cases
Within North Carolina, the worst weekly outbreaks on a per-person basis were in Swain County with 540 cases per 100,000 per week; Surry County with 507; and Wayne County with 504. The Centers for Disease Control says high levels of community transmission begin at 100 cases per 100,000 per week.
Adding the most new cases overall were Mecklenburg County, with 3,489 cases; Wake County, with 3,191 cases; and Guilford County, with 1,420. Weekly case counts rose in 38 counties from the previous week. The worst increases from the prior week's pace were in Carteret, Robeson and Wayne counties.
In North Carolina, 37 people were reported dead of COVID-19 in the week ending Sunday. In the week before that, 204 people were reported dead.
A total of 3,047,625 people in North Carolina have tested positive for the coronavirus since the pandemic began, and 25,724 people have died from the disease, Johns Hopkins University data shows. In the United States 92,927,104 people have tested positive and 1,037,021 people have died.
>> Track coronavirus cases across the United States
USA TODAY analyzed federal hospital data as of Sunday, Aug. 14. Likely COVID patients admitted in the state:
Likely COVID patients admitted in the nation:
Hospitals in 13 states reported more COVID-19 patients than a week earlier, while hospitals in 18 states had more COVID-19 patients in intensive-care beds. Hospitals in 27 states admitted more COVID-19 patients in the latest week than a week prior, the USA TODAY analysis of U.S. Health and Human Services data shows.
The USA TODAY Network is publishing localized versions of this story on its news sites across the country, generated with data from Johns Hopkins University and the Centers for Disease Control. If you have questions about the data or the story, contact Mike Stucka at mstucka@gannett.com.
Mike Stucka USA TODAY NETWORK| Telegram & Gazette
Massachusetts reported 9,882 new cases of coronavirus in the week ending Sunday, down 6.6% from the previous week. The previous week had 10,584 new cases of the virus that causes COVID-19.
Massachusetts ranked 41st among the states where coronavirus was spreading the fastest on a per-person basis, a USA TODAY Network analysis of Johns Hopkins University data shows. In the latest week coronavirus cases in the United States increased 2.3% from the week before, with 795,621 cases reported. With 2.07% of the country's population, Massachusetts had 1.24% of the country's cases in the last week. Across the country, seven states had more cases in the latest week than they did in the week before.
Worcester County reported 1,012 cases and eight deaths in the latest week. A week earlier, it had reported 1,007 cases and four deaths. Throughout the pandemic it has reported 217,432 cases and 2,697 deaths.
Across Massachusetts, cases fell in 10 counties, with the best declines in Middlesex County, with 1,928 cases from 2,231 a week earlier; in Essex County, with 1,091 cases from 1,178; and in Suffolk County, with 1,110 cases from 1,178.
>> See how your community has fared with recent coronavirus cases
Within Massachusetts, the worst weekly outbreaks on a per-person basis were in Berkshire County with 185 cases per 100,000 per week; Hampden County with 174; and Essex County with 138. The Centers for Disease Control says high levels of community transmission begin at 100 cases per 100,000 per week.
Adding the most new cases overall were Middlesex County, with 1,928 cases; Suffolk County, with 1,110 cases; and Essex County, with 1,091.
In Massachusetts, 61 people were reported dead of COVID-19 in the week ending Sunday. In the week before that, 48 people were reported dead.
A total of 1,987,385 people in Massachusetts have tested positive for the coronavirus since the pandemic began, and 21,285 people have died from the disease, Johns Hopkins University data shows. In the United States 92,927,104 people have tested positive and 1,037,021 people have died.
Note: For Massachusetts, Johns Hopkins University reports data in a combined health department for Dukes and Nantucket counties. Those two counties may appear without any cases, and this will skew rankings of counties.
>> Track coronavirus cases across the United States
USA TODAY analyzed federal hospital data as of Sunday, Aug. 14. Likely COVID patients admitted in the state:
Likely COVID patients admitted in the nation:
Hospitals in 13 states reported more COVID-19 patients than a week earlier, while hospitals in 18 states had more COVID-19 patients in intensive-care beds. Hospitals in 27 states admitted more COVID-19 patients in the latest week than a week prior, the USA TODAY analysis of U.S. Health and Human Services data shows.
The USA TODAY Network is publishing localized versions of this story on its news sites across the country, generated with data from Johns Hopkins University and the Centers for Disease Control. If you have questions about the data or the story, contact Mike Stucka at mstucka@gannett.com.
Ministers should urgently classify Covid-19 as an occupational disease to prompt employers to reduce the risk of exposure and help workers access key benefits, the TUC has said.
The UK is out of step with other major countries that have recognised Covid as a disease that people can get in the course of their work, especially in certain sectors, it says.
The umbrella body for British trade unions is urging the Department for Work and Pensions (DWP) to use its powers to prescribe Covid. If the DWP agrees, Covid would be treated the same as, for example, a disease related to workplace exposure such as asbestos-related cancer, which is a known risk for people who have worked in construction or firefighting.
Frances OGrady, the TUCs general secretary, accused ministers of shocking negligence for not having already prescribed Covid, given the considerable evidence of people getting it at work.
If you become sick due to your work, with life-changing consequences, you should get proper support. But ministers have still not added Covid to the list of occupational diseases, she said. Two years into this pandemic that is shocking negligence. And it leaves workers unfairly exposed.
In a report, the TUC states: At least 20,000 people die prematurely every year because of occupational disease as a result of occupational disease. There are more than 70 prescribed occupational diseases known to be a risk from certain jobs. These diseases arise as a result of employment requiring close contact with a hazardous substance or circumstance.
Someone whose diagnosis has been linked to their job is able to claim financial support.
Research by the International Labour Organization has shown that many other nations, including Australia, Canada and China, already recognise Covid as an occupational disease, subject to evidence of infection through a job role. In France it is automatically treated as such for healthcare workers, although the latter must have been affected by a severe form of coronavirus.
At least 20 of the 50 states in the US presume that many first responders and key workers who get Covid including paramedics and firefighters have done so while at work.
In Britain, ministers can designate an illness as an occupational disease subject to guidance from the Industrial Injuries Advisory Council, an independent body, which assesses the evidence. However, in March last year it published a review which showed that some people were at double the risk of catching Covid if they worked in areas such as nursing, social care, bus or taxi driving, food processing, retail or security work.
Employers are obliged to report cases of any prescribed disease to the Health and Safety Executive and their local council. Employees can then access benefits and compensation through the industrial injuries scheme to help them cope with their illness and disability.
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The British Medical Association and the all-party parliamentary group (APPG) on coronavirus, which is made up of MPs and peers, already supports designation of Covid as a work-related hazard. Layla Moran, the Liberal Democrat MP who chairs the APPG, urged rapid progress. Ministers cannot continue to bury their heads in the sand, she said.
A government spokesperson stressed the benefits already available to people whose ability to work is hampered by having Covid or long Covid.
For anyone with a disability or long-term health condition, including long Covid, there is a strong financial safety net, including statutory sick pay, Esa and universal credit, they said.
Pip is also available for those who have daily living and/or mobility needs for three months, and are expected to have these for at least another nine months. Pip assessments are carried out by trained healthcare professionals, who carefully consider how an individuals disability or long-term health condition impacts their day-to-day life.
Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older
GAITHERSBURG, Md., Aug. 15, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.
"It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants."
This application for EUA issupported by data from Novavax'Phase 3 PREVENT-19 trialconducted in the United States and Mexico, and from the UK-sponsored COV-BOOST Phase 2 trial. As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted. The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose.
In the PREVENT-19 trial, following the booster, local and systemic reactions had a median duration of approximately two days. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose.
In the U.S., the FDA granted EUA, followed by a positive recommendationfrom the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), and endorsement from the CDC for a two-dose primary series in adults aged 18 and older in July.Doses of the Novavax COVID-19 Vaccine, Adjuvanted have been available for use in the U.S. since July.
This project has been supported in part with federal funds from the Department of Health and Human Services (HHS); the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number MCDC2011-001.
Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 18 years of age and older to prevent Coronavirus Disease 2019 (COVID-19).
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Authorized UseThe Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
IMPORTANT SAFETY INFORMATION
ContraindicationsDo not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and PrecautionsManagement of Acute Allergic Reactions:Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according tothe Centers for Disease Control (CDC) and Prevention guidelines.
Myocarditis and Pericarditis:Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted(see Full EUA Prescribing Information).
Syncope (fainting):May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence:Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
Limitations of Vaccine Effectiveness:The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
Adverse ReactionsAdverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis.
Myocarditis, pericarditis, and anaphylaxis have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.
Reporting Adverse Events and Vaccine Administration ErrorsThe vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
Complete and submit reports to VAERS online: https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.
To the extent feasible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website:www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
Please click to see theNovavax COVID-19 Vaccine, Adjuvanted Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and EUA Full Prescribing Information.
About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373)The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
The PREVENT-19 trial is being conducted with support from the U.S. government, including the Department of Defense, BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the HHS, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS. BARDA is providing up to$1.75 billionunder a Department of Defense agreement (number MCDC2011-001). JPEO-CBRNDis also providing funding of up to$45.7 millionunder a separate agreement. To date, the U.S. government has agreed to order 3.2 million doses of the Novavax COVID-19 Vaccine, Adjuvanted. Novavax and the U.S. government will determine the timing, pricing, and amounts for delivery of any additional doses. Novavax intends to pursue additional U.S. procurement of both the Novavax COVID-19 Vaccine, Adjuvanted doses and other potential formulations.
Novavax has established partnerships for the manufacture, commercialization, and distribution of the Novavax COVID-19 Vaccine, Adjuvanted worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute ofIndia, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.
About Matrix-M AdjuvantNovavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visitwww.novavax.comand connect with us onLinkedIn.
*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.
Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the potential for subsequent orders from the U.S. government for additional doses of NVX-CoV2373 and other potential formulations, the timing of clinical trial results, the ongoing development of NVX-CoV2373, NVX-CoV2515, a bivalent vaccine candidate and a COVID-seasonal influenza investigational combination vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including potential recommendations and authorizations from the CDC, Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID-19 pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety, intended utilization, and expected administration of NVX-CoV2373 and Novavax' other vaccine candidates are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; unanticipated challenges or delays in conducting clinical trials; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year endedDecember 31, 2021and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available atwww.sec.govandwww.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
InvestorsErika Schultz | 240-268-2022ir@novavax.com
MediaAli ChartanorGiovanna Chandler| 202-709-5563media@novavax.com
SOURCE Novavax, Inc.
SALT LAKE CITY--(BUSINESS WIRE)--Xlear has filed an Amended Answer in response to the U.S. Governments lawsuit against the company. According to Nathan Jones, Xlears CEO, the Amended Answer serves three main purposes: First, it provides the Court with still more data that supports the statements Xlear made that nasal hygiene is an additional layer of protection in fighting COVID-19, that our public health officials are ignoring; Second, it lays out in greater detail how the U.S. Governments lawsuit is an effort to censor science that doesnt comport with the Governments vaccine-myopic, failing strategy to combat the disease; Third, it documents how experts, including Dr. Fauci, are increasingly saying the nose is the critical place to fight the virus.
Xlears Amended Answer provides two new studies that support the statements Xlear made about the use of its nasal spray as a potential additional layer of protection against COVID-19:
Jones continued: These arent the Random Clinical Trials the Government is so focused onbut you cant deny the mounting wall of evidence that nasal hygiene should be used as an additional layer of protection against COVID-19. Moreover, the Government recently announced that it wont require Random Clinical Trials for the new variant vaccinesthat requirement seems to only apply when it is convenient for the Government.
Jones also noted that the SARS-CoV-2 variants are all strains of coronavirus, and experts have long recommended nasal hygiene to combat coronaviruses. As a rule, prevention methods and symptom-reduction modalities (e.g., over the counter drugs, handwashing) are not variant specific; they are used against colds and flus on the whole, many caused by coronaviruses. One countermeasure that experts, including the US Government, recommend to fight the common cold, including coronavirus-infections, is nasal hygiene. DeGeorge KC, Ring DJ, Dalrymple SN. Treatment of the Common Cold. Am Fam Physician. 2019 Sep 1;100(5):281-289. PMID: 31478634, reprinted by NIH as authority at https://pubmed.ncbi.nlm.nih.gov/31478634/ (Treatments with proven effectiveness for cold symptoms [coronavirus infections] in adults include over-the-counter analgesics, zinc, nasal decongestants . . . The only established safe and effective treatments for children are . . . nasal saline irrigation . . .). Its commonsense, something our Governments response to COVID seems to be lacking, Jones added.
As part of its efforts to silence Xlear, the Government asked the Utah Federal Court to preclude Xlear from filing the Amended Answer. The Federal Court ruled in Xlears favor. The Courts ruling specifically noted: The court shares some concern here, as expressed by Defendants, that the underlying purpose [in the Governments motion to prevent Xlears Amended Answer] is to prevent discovery into disputed facts that may lend support to Defendants proposed amendments. In other words, the Government is doing everything they can stonewall us from shining a light on their failed COVID-19 response, Jones added.
A new more infectious and more dangerous variant is sweeping the nation. Infections are up. Hospitalizations are up. Deaths are up. At the same time, fewer and fewer people are willing to get vaccinated for the third, fourth, who knows how many times, Jones noted. Its obvious we need a new, broader'vaccine-plusapproach. But rather than educate people, the Government is suing us in retaliation for talking about the science. Im deeply afraid even telling the Court about these new studies will bring more Government retaliation, however in the face of the Governments failure what choice is there. When science gives way to dogma, people suffer, Jones concluded.
In a recent study posted to the medRxiv* preprint server, researchers evaluated the impact of removing mask mandates in schools on the incidence of coronavirus disease 2019 (COVID-19) cases.
Mounting evidence suggests that universal masking effectively minimizes severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission in school and community settings. Following the updated guidelines from the Centers for Disease Control and Prevention (CDC) in February 2022, many state-wide restrictions mandating masks in schools and community settings were lifted.
While the Massachusetts (MA) Department of Elementary and Secondary Education (DESE) removed state-wide masking requirements in schools on February 28, 2022, only two school districts, Boston and Chelsea, sustained masking requirements until June 2022. This represents a unique opportunity to assess the impact of masking in schools.
In the present study, researchers examined the impact of the staggered lifting of masking requirements in schools on COVID-19 incidence in students and staff in MA school districts. They used district-level data from DESE on COVID-19 cases, enrolment, and staffing for the 2021-22 school year. Additional data on COVID-19 indicators from the surrounding communities were obtained from the MA Department of Public Health (DPH).
School districts reported COVID-19 case data every Thursday for the past seven days (Thursday to Wednesday). The studys primary outcome was weekly COVID-19 rates among students and staff. Seventy-two school districts with 294,084 students and 46,530 staff were included in the study. The authors implemented a difference-in-differences approach with staggered implementation and compared the weekly incidence of COVID-19 between school districts with and without mask requirements.
Of the 72 school districts, 70 lifted masking requirements after the state-wide mandate was lifted, and only Boston and Chelsea public schools continued masking requirements throughout the period. Before mask mandates were removed, the COVID-19 case rates in Boston/Chelsea were similar to other regional districts, which later discontinued mask mandates. After removing the mask mandates, case rates diverged substantially between schools that sustained masking and those that removed the masking.
The difference-in-differences analysis showed no meaningful differences in the case rates before the removal of state-wide masking. Contrastingly, once mask mandates were removed, COVID-19 case rates were consistently higher in districts that removed masking requirements than those that did not. Lifting mask mandates was associated with substantial increases in the case rates among staff and students in 12 of the 15 weeks.
COVID-19 cases increased with the time since a district removed masking requirements. In the first week post-removal of masking, the authors estimated 1.44 excess cases per 1000 students and staff relative to those that sustained masking. Notably, the strength of association between COVID-19 case rates and masking requirements varied with the background COVID-19 case rates in the surrounding community.
The strongest association was noted in the weeks when community case rates were the highest for a given district. After 15 weeks (post-removal), removing mask requirements was associated with 44.9 additional COVID-19 cases per 1000 students and staff. The excess rate corresponded to 11,901 cases (> 9000 in students and nearly 3000 in staff). Intriguingly, this effect was more prominent among staff, with 81.7 excess cases per 1000 staff in schools without masking requirements.
The team noted that schools that maintained masking requirements had a higher proportion of low-income students, English-learning students, students with disabilities, and Black and Latinx students and staff. These schools had older buildings with poor physical conditions and crowded classrooms. In contrast, schools that removed masking were newer in a better condition, with fewer low-income, English-learning students and Black/Latinx students/staff.
Conclusions
The study found a significantly higher incidence of COVID-19 in schools that lifted mask requirements in February/March 2022. Specifically, removing mandates might have contributed 45 excess cases per 1000 students and staff. The MA DESE requires positive cases to isolate for five days at least or until symptoms subside. This translates to a minimum of over 17,000 days of school absence for students or > 6500 days of teacher absence in the best-case scenario.
In summary, the results underscored the importance of masking policies in schools to reduce the risk of COVID-19 among those made vulnerable by racism and other forms of oppression. The authors suggested that school districts should proactively develop mitigation policies in anticipation of a surge in the Winter during the 2022-23 school year. Specifically, enforcing mask requirements in December/January and lifting them in March or later could effectively curb the impact of COVID-19 in schools.
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
BOSTON -- The state will not be recommending mask requirements or COVID surveillance testing of asymptomatic individuals in schools this year. The Massachusetts Department of Elementary and Secondary Education released its updated coronavirus guidelines for schools on Monday.
"This upcoming school year, districts and schools should focus their COVID mitigation strategies towards vulnerable and symptomatic individuals," a memorandum said.
Contract tracing and test-to-stay programs will no longer be provided by the state. Districts and schools can still implement their own COVID testing systems but must handle staffing and supply logistics on their own.
"DESE and DPH strongly recommend that schools and districts interested in implementing their own testing program during the 2022-23 school year limit that program to symptomatic rapid testing."
New exposure guidelines also said students who were exposed but are asymptomatic can remain in school.
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Students return to school with relaxed COVID guidelines in place for first time in nearly three year - CBS Los Angeles
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Kara Finnstrom and Tina Patel provide team coverage as more than 500,000 students across Los Angeles County return to school for the first time without coronavirus guidelines in place for the first time in nearly three years.
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Monkeypox in Erie: Denise Johnson, M.D., PA secretary of health
Denise Johnson, M.D., Pennsylvania's physician general and acting secretary of health, talks about monkeypox during a visit to Erie on July 14.
David Bruce, Erie Times-News
Two more cases of monkeypox have been found in Erie County, increasing the total to three during this worldwide outbreak.
Erie County Department of Health officials said Monday that the cases were reported last week. No other details were immediately available.
The latest news comes as the county's response to the monkeypox outbreak has evolved, as both free vaccine and testing are now available though there are restrictions.
Monkeypox vaccine continues to be limited primarily to those who have been in close contact with others diagnosed with the viral illness.
Testing is also available but can be done only on people with lesions, said Dalen Michael, director of the Central Outreach Wellness Center, 3104 State St., which offers free vaccine and free testing. The Erie County Department of Health, 606 W. Second St., also offers free vaccine.
"You must have lesions because we have to swab (the discharge) for the test," Michael said. "We've seen people who want the test and we can't do it because they don't have lesions."
More than 10,400 monkeypox cases had been found in the United States as of Wednesday, the highest number of any country in the world, according to the Centers for Disease Control & Prevention.
Only three cases of the viral illness have been confirmed in Erie County, well below the 147 cases in Philadelphia County and 38 cases in Allegheny County. But Michael said he expects to see more cases as the disease spreads.
"It hasn't really hit here yet," Michael said. "But I think it will. It's a concern for every city."
More: Monkeypox arrives in Erie, public health threat less because spread is slower
Monkeypox spreads through prolonged and close skin-to-skin contact, which can include hugging, cuddling and kissing, as well as through the sharing of bedding, towels and clothing. Most cases involve men who have sex with other men, but others have been diagnosed as well.
The primary symptom of monkeypox is a rash that can look like pimples or blisters that appear on the face, inside the mouth, and on other parts of the body, like the hands, feet, chest, genitals or anus,according to CDC. A person can also develop flu-like symptoms like a fever, headache and chills.
The mortality rate for monkeypox is 1% to 3%, according to the CDC.
More monkeypox vaccine is headed to Erie County, as both the county health department and Central Outreach Wellness Center expect additional doses by next week.
The Food and Drug Administration also issued an emergency use authorization for the Jynneos smallpox vaccine that allows shots to be administered in a way that allows five doses to be obtained from a current single dose.
More: FDA allows new delivery of monkeypox vaccine to make more doses available
"We would love to see this result in an expansion of who can get vaccinated, but we aren't there yet," said Charlotte Berringer, R.N., director of community health services for the county health department.
Not vaccinating high-risk people who haven't yet been exposed to someone with monkeypox frustrates Michael, who said vaccinating more people will prevent future cases.
"I would love to be able to vaccinate everyone who I feel is at risk," Michael said.
If you feel that you have been exposed to someone with monkeypox and need information, you can talk with a county health department nurse at 814-451-6700, option 2. To schedule testing or a vaccination at the Central Outreach Wellness Center, call 814-619-4009.
Monkeypox testing can also be ordered by many local primary care physicians, though the cost depends on a person's health insurance coverage.
Contact David Bruce atdbruce@timesnews.com. Follow him on Twitter@ETNBruce.
Since June, there have been over 10,000 confirmed monkeypox cases in the U.S. In early August, the Biden administration declared monkeypox a public health emergency with several states such as California and Illinois, and cities like New York and San Francisco following suit.
On August 10, a panel of Johns Hopkins experts including Amesh Adalja, MD, Noreen Hynes, MD, and William Moss, MD, PhD from the School of Public Health, and Jason Farley from the School of Nursing, gathered to discuss the monkeypox emergency. Lainie Rutkow moderated the conversation.
The panel covered topics such as the prevention, testing, and treatment of monkeypox; ways of reducing stigma around the outbreaks; and the limited availability and distribution of monkeypox vaccines. The following is an overview of the conversation with key takeaways.
Watch the full recording of the event here, and read The Hubs recap here.
What does monkeypox testing look like right now in terms of availability?
AA: Testing has gotten better in the last several weeks than it was early on, where it was really restricted to CDC-affiliated laboratories, which is not adequate in an infectious disease emergency. We have to think about making testing much more distributed, even more so than it is right now. This should be something at clinics, where individuals presenting for care can be tested quickly.
We are limited because this is a test that requires you to swab skin specimens, and lesions may not be the first symptoms individuals get. We need to think about whether we can do saliva testing, or can we do other ways of testing so that people can know their status earlier.
There are some technological hurdles there. Just as it was with COVID-19, testing has become a major barrier to getting a handle on the outbreak.
How are antivirals like Tecovirimat or Tpoxx helpful?
NH: Even if someone has monkeypox, they don't necessarily need to receive an antiviral because the particular strain that's circulating in the U.S., and worldwide outside of the endemic area, is something that is usually mild and has a very low case fatality rate.
Until we have enough antivirals, were probably not going to administer [them] to someone who can stay quarantined. But we might be more likely to use one of the three antivirals that we have on someone who needs to be in a congregate living space.
How concerned should people be about potential exposure of monkeypox during domestic or international travel?
JF: What we know right now is that your personal risk of coming in contact with an individual who might have monkeypox is still relatively low. We have limited data on how long monkeypox lives on surfaces, and whether or not its replicating or a transmissible virus is still an area of debate. I would say you should feel free to travel.
I do have patients using pre-exposure prophylaxis for HIV that are planning travel to endemic areas where currently there are a lot of cases among men who have sex with men, and I caution them about harm reduction strategies while they are traveling.
How do we know that monkeypox can be controlled?
AA: Contagiousness during the incubation period is a key factor. That's why SARS-CoV-2 is so hard to control and why the 2009 H1N1 pandemic spread throughout the world in a matter of months.
If something is contagious during its incubation period, it's very hard to intervene. We don't seem to see that with monkeypoxjust like we didn't see that with smallpoxand that's actually one of the key reasons why smallpox could be eradicated.
What do we know about the sexual spread?
AA: Around 2017 in Nigeria, there was person-to-person spread in individuals who had multiple sex partners and a lot of the lesions were in the genital area. Theres an understanding that this virus could get into sexual networks and spread through that close contact.
It's important to use the words sexual network or close contact because it's not clear at this point if monkeypox is behaving as a strictly sexually transmitted infection, meaning the virus being is conveyed from one person to another through bodily fluids.
Whats the fastest route to containment at this point?
AA: When we think about how smallpox was eradicated, they didnt vaccinate everybody. They just vaccinated close contacts of [infected] individuals using contact tracing.
This did not work for monkeypox because many people did not know who they were in contact with and who might have been exposed. The containment [strategy] here will be getting the vaccine to at-risk individuals, [such as] a man who has sex with multiple partners, or goes to those types of events where [monkeypox has been] spread.
We [also] have to think about harm reduction. Having a new sexual partner right now is a risk factor for monkeypox. Think about decreasing the number of partners you have until you're vaccinated or immune, or exchanging information with people so that contact tracing is possible.
What does isolation look like for suspected or confirmed monkeypox patients?
JF: Individuals should isolate at home until the lesions have completely healed, without contact with other individuals. Try to avoid sharing as much common area as possible. Individuals should also be wiping down surfaces in shared spaces, and avoid sharing bathroom facilities. Do not share anything that would have contact with the skin, including soap.
Obviously, individuals who are experiencing homelessness and others have a different set of recommendations within congregate settings.
Can someone who has had monkeypox be reinfected?
JF: We don't have a lot of data on this, but we can extrapolate what we know about other orthopox infections, namely smallpox.
Individuals who were infected with smallpox were protected from reinfection. Theres likely a similar phenomenon that occurs with monkeypox, where people are not going to get reinfectedand definitely not immediately.
There may be some time over several years that somebody could get reinfected, or that their immunity wanes, or if they [become] immunosuppressed. In general, we expect most people to not be susceptible to reinfection in the near term, which I think will be useful when it comes to thinking about the trajectory of this outbreak in non-endemic countries.
How has stigma played a role in this outbreak?
JF: The vast majority of cases in the monkeypox outbreak have been among men who have sex with men, but we know that transmission is certainly not limited to that group. Many public health experts are concerned about the dangers of stigma and discrimination in relation to the outbreak.
The impact of the diagnosis of monkeypox and living with this infection can have a very overwhelming effect on the individuals being diagnosed and experiencing considerable symptoms.
With this particular illness, stigma has presented itself in a variety of different ways:
For example, a patient in his mid-thirties is a gay man, [and] he is not out to his employer or many of his family members. A diagnosis of monkeypox means notifying friends, family, and sexual partners within his network. Contact investigations include his place of employment.
His fear really intensified when we began to discuss the recommendations around how long to remain in isolation and telling his employer about his monkeypox, potentially leading to his outing as a gay man. He feared losing his employment when he was told he needed to isolate until all lesions had crusted and healed, and new skin had formed. For an individual not taking [antiviral] therapy, this could be three to four weeks, and for someone with therapy about two weeks.
There have been comparisons of monkeypox stigma to stigma faced by this community of people during the early days of the HIV/AIDS epidemic. What are some parallels?
JF: Too many people currently at risk of monkeypox infection continue to face limited access to prevention treatment, and sex-positive harm reduction strategies. This fuels the dehumanization of a community who are fundamentally pro-science, pro-harm reduction, pro-vaccine, and are pleading for access to prevention and care services.
This harkens back 40 years to the beginning of the AIDS epidemic when the media and the world jumped on the gay community and the intersex community as pariahs of people causing AIDS.
Now, we know that HIV was circulating among heterosexual individuals for decades before we identified it in the gay population. Historically, monkeypox outbreaks are not centered within the gay community.
What vaccines do we have?
WM: There are two vaccines, the MVA-Bavarian Nordic, which is a live but nonreplicating vaccine, also called by its brand name JYNNEOS, and a live replicating smallpox vaccine called ACAM2000.
MVA-BN was originally created by the Department of Health and Human Services as an alternative vaccine against smallpox in the event of a smallpox bioterrorism event to be given to individuals who should not receive the live replicating vaccine, particularly people who are immunocompromised, or the many people who have things like eczema, which can be problematic.
There are not enough of the non-replicating JYNNEOS vaccine. On August 9, the FDA announced that they were going to permit fractional dosing, getting five doses out of one usual dose. There will still be two doses that people get [in the series].
The ACAM2000 is a much more reactogenic vaccine with a lot more side effects.
Why is the availability of these vaccines such an issue?
WM: The U.S. government is currently distributing about 1.1 million doses, but some experts estimate that we need at least 3.5 million doses, and that need may expand as transmission increases.
There have been missteps along the way. At one point, the U.S. government had about 20 million doses of the JYNNEOS vaccines stored in the national stockpile, but those expired.
There were delays in getting the 1.1 million doses that are currently being allocated by the U.S. government, delays in requesting these from the manufacturer Bavarian Nordic in Denmark, and then also delays in additional orders of the 5.5 million.
The U.S. government has invested more than $1 billion in this vaccine and reportedly owns about 16.5 million doses, but those doses were stored in bulk, not in the vaccine vials that we need in order to distribute these to the points of administration.
How can availability be fixed?
WM: The U.S. government is looking to contract another firm that can actually do what's called the fill and finishtaking the bulk vaccine and bottling, capping, and labeling it. That will expedite the availability of additional vaccines.
In some jurisdictions, there have been proposals or actual implementation of a delayed second dose. There is some concern about this because although we don't have great data, it's that second dose that really boosts the neutralizing antibody levels.
The biggest news lately has been fractionated intradermal dosing. On August 8, the FDA issued an emergency use authorization for the use of intradermal injection, which is one-fifth of those of the standard subcutaneous dose for people 18 years or older. There is a biological rationale for a lower dose of a vaccine administered intradermally because of the high abundance of immune reactive cells or antigen-presenting cells in the dermis. There are also long historical examples of using fractionated intradermal dosing for yellow fever, inactivated polio vaccine, rabies vaccine, and meningococcal vaccine. We have a fair amount of experience with this.
What does the distribution of monkeypox vaccines look like?
Using a similar framework for COVID-19 vaccines, there are four Ds essential to a successful and effective vaccine rollout: doses, delivery, demand, and data.
Once doses are available, we need mechanismsdeliveryto get them into eligible populations. Given the vaccine supply shortage, the JYNNEOS vaccine is recommended for post-exposure prophylaxis, or what's called expanded post-exposure prophylaxis for individuals with known or presumed exposure to someone with monkeypox or with behaviors or experiences that put them at risk.
Currently, it's not widely recommended that these vaccines be used or the JYNNEOS vaccine be used as what's called pre-exposure prophylaxis, although the CDC guidelines say that this can be considered, as vaccine supply shortages are remedied.
We have a very high demand right now, but we do need to ensure that going forwardparticularly among those most vulnerable groups and groups with suspicions of either vaccines or the governmentthat demand remains high as vaccine supplies improve.
[In terms of] data, we need to be able to know how many individuals have been vaccinated with one or two doses. This is our opportunity to learn about the effectiveness of these vaccines against monkeypox. We have very limited data, both with the subcutaneous administration and particularly with the intradermal administration.
The goal of our vaccination program is quite different from the one for COVID 19, where the primary goal was preventing severe disease, hospitalization, and death. We're not seeing that with the current monkeypox outbreak. We just want to prevent infection.
If someone received a smallpox vaccination, what does that mean relative to monkeypox?
WM: Despite the fact that we're using vaccines designed for smallpox, there's not actually a whole lot of evidence around the protective efficacy of smallpox vaccines against monkeypox, although we know that there's a lot of cross-immunity with the different orthopoxviruses. One of the studies is from the early 1980s in the DRC, where they showed that individuals who had been previously vaccinated against smallpox had protection against monkeypox.
That said, smallpox vaccination ceased 50 years ago here in the U.S., and the duration of protection following smallpox vaccination is not lifelong. It's a function of how many doses an individual received and whether they had any boosting due to exposure to natural smallpox.
My sense would be that there's probably little to no protection conferred by prior smallpox vaccination 50 years ago or longer. There may be some protection against more severe disease. But again, we're not really seeing a lot of severe disease with this current monkeypox outbreak.
Amesh Adalja, MD, is a senior scholar at the Center for Health Security and an adjunct professor in Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health. He is also an affiliate of the Johns Hopkins Center for Global Health.
Noreen Hynes, MD, is an associate professor in International Health; Population, Family and Reproductive Health; and Environmental Health and Engineering. She has a primary appointment with the Johns Hopkins School of Medicine.
William J. Moss, MD, MPH, is the executive director of the International Vaccine Access Center, deputy director of the Malaria Research Institute, and a professor in the departments of Epidemiology, International Health, and Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health.
