Category: Corona Virus

As the Centers for Disease Control and Prevention shifts its guidelines around COVID, the Federal Drug Association also revised its guidance around the amount of at-home tests one should take if potentially exposed to the virus.

Here's what you need to know about the coronavirus pandemic across Illinois today:

Under revised guidance from the Food and Drug Administration, individuals who have been exposed to COVID-19 may need to take as many as three at-home tests to ensure that they are not experiencing asymptomatic infections.

The new guidance was issued last week after the Centers for Disease Control and Prevention changed its own recommendations for those exposed to COVID, saying that quarantine is no longer recommended for those exposed to the virus and who are not showing symptoms.

According tothe new guidance from the FDA, individuals who are exposed to COVID are recommended to take a series of at-home tests to ensure that they are not experiencing an asymptomatic infection.

In total, the FDA recommends that patients who are not experiencing symptoms after an exposure to take three tests within a 96-hour span.

Read more here.

Fueled by the fast-spreading BA.5 subvariant, COVID-19 infections continue to occur across Illinois, with some communities in the southern portion of the state especially hard hit.

As of Friday, dozens of Illinois counties were listed at "high" community level status, according to the latest metrics from the Centers for Disease Control and Prevention, which did improve from a week earlier.

Read more here.

When many school districts across Illinois welcome back students next week, classrooms will look significantly different than last year - at least in terms of COVID precautions.

Following the lead of federal health officials, the state of Illinois announced it is adopting relaxed COVID guidance for K-12 public schools, which includes dropping the quarantine requirement and easing physical distancing.

Read more here.

Anyone who contracts COVID-19 is advised to isolate for at least five days, but could you be contagious even after that?

It's a possibility, according to Chicago's top doctor.

Read more here.

The Centers for Disease Control and Prevention released a new set of COVID guidelines Thursday, clarifying whether recovering individuals need to test out of isolation.

In its updated guidelines, the CDC recommended different approaches for patients based on their symptoms.

Read more here.

The Centers for Disease Control and Prevention unveiled a series of new COVID guidelines on Thursday afternoon, marking the organizations continued efforts to loosen restrictions as new treatments and vaccine formulations continue to be released.

The new guidelines, which focused primarily on changing quarantine and isolation recommendations, had been discussed for several weeks, but now the agency says it has streamlined its tips on what to do if individuals are infected with, or exposed to, the virus.

Read more here.

The Centers for Disease Control and Prevention released its new COVID guidelines Thursday, shifting several recommendations just days after Chicago Public Schools issued its own set of policies for the 2022-2023 school year.

Both guidelines are reflective of continued efforts to loosen restrictions as new treatments and vaccine formulations continue to be released.

Read more here.

Two of Illinois most populous counties have seen reductions in several key COVID metrics in recent weeks, with Cook and McHenry counties both dropping to a medium community level of the virus, according to the Centers for Disease Control and Prevention.

In the Chicago area, Grundy County also dropped to the medium level according to the updated metrics. Kankakee County has continued its recent declines in COVID metrics, falling to a low community level of the virus.

Read more here.

After more than a week of waiting, the Centers for Disease Control and Prevention finally unveiled its new guidelines for isolation, quarantine and social distancing, but one of the biggest changes involves those who experience more severe symptoms of the virus.

The new guidelines propose different approaches for patients who experience traditional mild symptoms, including fever, cough and other cold-like issues, and those who experience more severe illness, including those who suffer from difficulty breathing or shortness of breath.

Read more here.

The Centers for Disease Control and Prevention has issued changes to its guidelines for COVID isolation and quarantine, changing the recommendations for unvaccinated individuals who were exposed to the virus and offering new advice on how to end isolation and what to do if symptoms return.

Read more here.

With new COVID variants and subvariants behindrising cases in Illinoisand other parts of the country, many are wondering if symptoms are changing as more begin to experience them.

Currently, the BA.5 omicron subvariant accounts for nearly 90% of COVID cases in the United States, according to estimates provided by the Centers for Disease Control and Prevention.

Read more here.

As the Centers for Disease Control and Prevention weighs potential changes to a host of COVID protocols, Chicago Public Schools has announced the tweaks it will make to the districts handling of the virus this fall.

According to Dr. Allison Arwady, commissioner of the Chicago Department of Public Health, and CPS CEO Pedro Martinez, CPS will not require students and faculty to be vaccinated against the virus when they return to buildings this fall.

Read more here.

According to the latest estimates from the Centers for Disease Control and Prevention, the BA.5 subvariant of COVID is still continuing to make up a greater share of coronavirus cases, but another variant is slowly gaining steam as well.

Those estimates,released every Tuesday, show that the BA.5 subvariant currently makes up 87.1% of cases in the United States, up from 84.5% a week ago.

See more metrics here.

Health experts have noted that the BA.5 omicron subvariant has led to more symptomatic infections, but could some people still have the virus and not know it?

Chicago's top doctor said the answer to that question is still yes, though she notes that even those with symptoms may mistake them for other illnesses.

Read more here.

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Illinois Coronavirus Updates: FDA Recommends 3 At-Home Tests, COVID Alert Levels Shift - NBC Chicago

Britain on Monday became the first country to authorize a coronavirus vaccine that targets two variants, the original virus and Omicron, the variant that became dominant over the winter.

Half of each dose of the Moderna-made vaccine will target the original variant, and the other half will target Omicron. In clinical trials, the vaccine, an updated version of Modernas original Covid vaccine, generated a good immune response to these two variants, as well as the BA.4 and BA.5 subvariants in adults, researchers found.

Dr. June Raine, the chief executive of Britains Medicines and Healthcare Products Regulatory Agency, said she was pleased that the new booster vaccine met the regulators standards of safety, quality and effectiveness. The decision was endorsed by Britains independent expert scientific advisory body, the Commission on Human Medicines.

The first generation of Covid-19 vaccines being used in the U.K. continue to provide important protection against the disease and save lives, Dr. Raine said. What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve.

In the United States, Moderna said in late July that the government had secured 66 million doses of a vaccine it was developing that targets the virus that circulated in 2020 and the Omicron BA.4 and BA.5 subvariants. The Biden administration expects to begin a Covid-19 booster campaign next month with updated vaccines from Pfizer and Moderna targeting new variants, according to people familiar with the deliberations. Officials decided to delay expanded eligibility for second boosters of existing vaccines this summer because the new formulations were close to being ready. Currently, only Americans over 50 and those over 12 with certain immune deficiencies are eligible for second booster doses.

Moderna said in a statement that it was working with British health officials to distribute the new vaccine, but it was unclear when the shots would be available to the public. A British government official said the health service would provide more details in due course about how and when eligible people could access the booster vaccine. Moderna said it had completed regulatory submissions for the vaccine in Australia, Canada, and the European Union and expected further authorization decisions in the coming weeks.

Stphane Bancel, Modernas chief executive, said in a statement on Monday that Britains authorization highlighted the dedication and leadership of the U.K. public health authorities in helping to end the Covid-19 pandemic. He added that the vaccine had an important role to play in protecting people in the U.K. from Covid-19 as we enter the winter months.

The emergence of highly contagious Omicron subvariants this spring appeared to reduce the protection offered by the Pfizer-BioNTech and Moderna vaccines against Covid hospitalizations, with more vaccinated people admitted to the hospital with Covid than they had been during the winter Omicron wave. But booster shots have raised peoples levels of protection, scientists from the U.S. Centers for Disease Control and Prevention said last month. The C.D.C. recommends that people receive booster shots as soon as they are eligible.

Britain has high vaccination rates overall, with 76 percent of the population fully vaccinated and 60 percent having received an additional dose. By comparison, in the United States, 67 percent of the population is fully vaccinated, but the booster program has stalled, with just 32 percent having received an additional dose. Globally, 64 percent of the population is fully vaccinated, according to The New York Timess Covid vaccine tracker.

Britain accelerated its booster program in December to counter the highly contagious Omicron variant. Currently, anyone 16 years and older is eligible for a booster shot, in addition to some children aged 12 to 15.

Anyone aged 50 and over will be eligible for a further dose in the fall, as well as those 5 years and over who are in a clinical risk group, including pregnant women, the British government said last month. Household contacts of those who are immunocompromised, frontline workers and caregivers will also be eligible. Side effects of the new vaccine were the same as those seen for the original Moderna booster dose and were typically mild, with no serious safety concerns, British regulators said.

Modernas updated vaccine is licensed only as a booster shot, so people who missed the first two vaccines need to receive those first, a British government spokesman said.

Rupali Limaye, the deputy director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said that Britains approval of the updated vaccine targeting Omicron was great news, especially for people in high-risk groups, now that mask requirements and other safety measures had been dropped.

The more we can be specific about really protecting people against this specific variant, the better off were going to be, she said. A challenge for health authorities, especially in the United States, will be increasing trust around the vaccines, amid high levels of misinformation and mistrust. This isnt something that were going to say, Go get it, and we have tons of people waiting in line. Its going to require some persuasion.

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U.K. Approves Covid Booster Vaccine That Targets Two Variants - The New York Times

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.

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Gaston County reported 611 additional COVID-19 cases this week - Gaston Gazette

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.

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Worcester County reported 1,012 additional COVID-19 cases this week - Worcester Telegram

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.

Archie Bland and Nimo Omer take you through the top stories and what they mean, free every weekday morning

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.

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Government urged to classify Covid as an occupational disease - The Guardian

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.

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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...

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.

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Xlear Files Amended Answer to the Government's Lawsuit on COVID-19 Statements; Provides Still More Data In Support of Xlear's Use as Additional Layer...

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.

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What is the impact of removing masking on COVID-19 case rates among students and staff in the public-school setting? - News-Medical.Net

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.

The CBS Boston team is a group of experienced journalists who bring you the content on CBSBoston.com.

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DESE will not recommend universal mask requirements, COVID surveillance testing in schools this fall - CBS Boston

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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Students return to school with relaxed COVID guidelines in place for first time in nearly three year - CBS Los Angeles