Category: Covid-19

COVID-19 cases have surged throughout the last two winters but as we come out of summer and temps begin to drop, public health conditions not only feel different, they are different, two local public health experts said.

GBH News spoke with Bill Hanage, associate professor of epidemiology and co-director of the Center for Communicable Disease Dynamics at Harvards T.H. Chan School of Public Health, and Dr. Shira Doron, the hospital epidemiologist at Tufts Medical Center, to understand what the pandemic might look like this year as the seasons change.

This fall and winter look better than the last two...at least, as of now.

We are in a totally different place than we were this time last year, Doron said, And a different planet compared to where we were two years ago this time. And a lot of that is our layers of immunity, layers from vaccination and infection.

Hanage agrees things have improved, but does add that he expects fall and winter to bring a rise in COVID infections. And he said even if coming infections result in fewer hospitalizations, hes concerned that the health care system having been strained over the past two years could still be seriously stressed by any potential surge once again.

Get the newly reformulated booster vaccines, if eligible.

The new vaccines should offer enhanced protection against the most current strains of coronavirus, including the BA.5 variant, which accounts for around 90% of infections right now.

Doron said we dont know just how effective the vaccines are at preventing infection, but she and Hanage are confident that the new boosters, like previous versions, will offer long-lasting protection against developing severe disease if someone is infected.

Public schools should not be a big worry, even if theres little-to-no masking.

When asked about back-to-school, Doron said masks are optional and that's OK. The vast majority of children have already had COVID and therefore have immunity, rendering the virus similar in risk to others for which we never considered masking.

Hanage said that dropping masks in schools will result in more infections, but added that's unlikely to be very consequential in terms of the total burden on health care and total numbers of severe disease.

Doron emphasized that, with masking and other precautions creating obstacles to learning, and few other public settings still requiring masks, mandating masks in schools makes little sense.

The virus can always throw a big curveball.

Perhaps the one thing experts can agree on is the degree of unpredictability with the SARS-COV-2 virus as it continues to mutate and put out new variants.

We may see a massive surge [this winter], Doron said. But we may have so much immunity from Omicron and if there isn't a new variant that emerges and out-competes what we have now, which is mostly BA.5, we could also get lucky and not see an uptick in winter.

Hanage said its an open question whether BA.5 will be dominant in a few months, and he has his eye on some newer variants with mutations that raise concern.

We've got a hell of a lot of immunity from people who were infected as well as vaccinated," he said. "That kind of hybrid immunity, we think, produces more durable protection, and is the kind of thing which is going to make surges more manageable going forward, because it's going to be more of a challenge for the virus to be able to infect a lot of us in short order.

Like we said, thoughwatch out for that curveball.

According to Hanage, absent a change, a fast, icepick-style spike of cases like we saw with Omicron last winter is very unlikely but, you know, I've said it to you before, I never bet against natural selection.

"We don't like to make predictions, said Doron, because there's one thing we know about predictions, and that's that they will be wrong. This virus surprises us at every turn."

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5 things to know about COVID-19 as we head into fall - GBH News

Researchers are almost done with the first of three phases and need more volunteers to be part of the trial.

ST. LOUIS Saint Louis University researchers are currently working on a new COVID-19 vaccine trial.

Researchers say the Gritstone COVID-19 vaccine will work with the vaccines many people already have like Pfizer and Moderna and actually help to create multiple layers of protection against the virus.

Director of the SLU Center for Vaccine Development Dr. Daniel Hoft said the Gritstone COVID-19 vaccine is designed to target several coronavirus proteins in addition to spike proteins, which we've heard a lot about with the current vaccines.

We're still worried about the virus mutating to a point where it would escape all of the current immune responses based upon neutralizing antibodies against the spike protein, Dr. Hoft said.

The current vaccines trigger an immune system response that then produces antibodies.

The Gritstone vaccine focuses on what's called the T-cell and T-cell response.

If you can't make antibodies, you're dependent on your T cells to protect the body, Dr. Hoft said.

He said T-cells actually recognize cells infected with the virus and stop it from spreading.

By having all of these other sequences in there, they have the potential to induce these T-cell responses that are different from what the licensed approved COVID vaccines can induce right now, Dr. Hoft said.

Dr. Hoft said the new vaccine can protect a person from several different COVID-19 variants and they hope this study can help fight other illnesses.

What we're learning about vaccines and the ability to induce a strong T-cell response with these vaccines will be important for helping the other fields around us that are developing vaccines for these other major global health problems, Dr. Hoft said.

They're almost done with the first of three phases and actually need more volunteers to be part of the trial.

They're looking for adults 60 years old and up who have had their first Pfizer, Moderna or Johnson and Johnson vaccines and only one booster shot.

The person also needs to be healthy without any significant allergies.

To volunteer, you can email vaccine@slu.edu or call 866-410-6333.

Follow this link:

SLU researchers working on new COVID-19 vaccine trial - KSDK.com

GAITHERSBURG, Md., Sept. 2, 2022 /PRNewswire/ -- Novavax,Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has expanded its temporary authorization ofNuvaxovid (NVX-CoV2373) COVID-19 vaccine in Switzerland for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 and as a heterologous and homologous booster dose for adults aged 18 and older.

"We are pleased to offer the first protein-based COVID-19 vaccine for use both in adolescents and as a booster in adults in Switzerland," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As we continue to explore best practices for managing COVID-19 long term, we have ongoing trials further exploring Nuvaxovid's efficacy and safety as a booster andpreclinical data suggest that our vaccine induces immune response against Omicron variants, including BA.4/5."

Adolescents Aged 12 Through 17The authorization for adolescents aged 12 through 17 is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S. to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary efficacy endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.

Booster in Adults Aged 18 and OlderThe authorization for the booster dose in adults aged 18 and older is supported by data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a meaningful antibody response when used as a heterologous third booster dose.

In the Novavax-sponsored trials, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, often seen with increased immunogenicity. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

In the 12 through 17 year-old population, NVX-CoV2372 has also been granted authorization in the U.S., the European Union, the United Kingdom, Australia, New Zealand, Japan, Thailand,India, andSouth Korea. The vaccine has also been authorized in Japan, Australia,and New Zealandas a booster. Nuvaxovid is actively under review for both indications in other markets.

Swissmedic granted temporary authorization in April 2022 for use of Nuvaxovid in adults aged 18 and older.

Trade Name in the U.S.The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Authorized UseNuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

Important Safety Information: Switzerland

Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.

Events of anaphylaxis have been reported with administration of COVID-19 vaccines including Nuvaxovid. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.

Very rare cases of myocarditis and pericarditis have been reported following the use of Nuvaxovid. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stressrelated reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.

Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.

Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.

Very common (1/10) and common (1/100 to <1/10) adverse reactions observed during clinical studies in individuals 12 years of age and older were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/redness, pyrexia. Fever was observed more frequently in adolescents aged 12 through 17 years compared to adults, with the frequency being very common after the second dose in adolescents.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following website:

About Nuvaxovid (NVX-CoV2373)Nuvaxovid 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 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. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovid 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.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute ofIndia, the world's largest vaccine manufacturer by volume. They are being supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About the NVX-CoV2373 Phase 3 TrialsNVX-CoV2373 continues being evaluated in two pivotal Phase 3 trials.PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations in the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations inthe U.S., compared with placebo. In the pediatric trial, NVX-CoV2373 achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S. Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published inNEJM.

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 NovavaxNovavax, 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. NVX-CoV2373, the company's COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the U.S., European Commission, and the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide and is under review in the U.S. for use in 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 NVX-CoV2373 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, visit http://www.novavax.comand connect with us on LinkedIn.

*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 timing of clinical trial results, the ongoing development of NVX-CoV2373, a COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including with respect to an FDA EUA decision and potential CDC recommendation for NVX-CoV2373, 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 potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, and the efficacy, safety and intended utilization of NVX-CoV2373 and expected administration of NVX-CoV2373 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; 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 Chartan or Giovanna Chandler| 202-709-5563media@novavax.com

Novavax Logo (PRNewsfoto/Novavax)

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Swissmedic Authorizes Novavax Nuvaxovid COVID-19 Vaccine for Adolescents Aged 12 Through 17 and as a Booster in Adults Aged 18 and Older - Yahoo...

Forecasters have used all sorts of tools to gauge where the U.S. and the world are headed with Covid-19, ranging from epidemiologic models to historical ones. Heres another possibility: prediction markets.

Prediction markets use a wisdom of crowds approach to aggregate beliefs and predict future outcomes. They typically function through bets in futures contracts that pay out on expiration of defined yes or no outcomes. The Iowa Electronic Markets, for example, successfully predicted the outcomes of every presidential election from 1988 to 2000 to within 1.5 percentage points.

Prediction markets have their own agnostic efficiency and logic. The investor goal is to make money. The market-maker goal is to accurately predict outcomes without the noise of morality, science, ideology, politics, or culture. The wisdom of crowdsourced betting is harnessed to make accurate predictions in complex scenarios with significant uncertainties.

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In 2008, online prediction market Intrade predicted that Barack Obama would win 364 electoral college votes. He won 365.

The prediction market platform might be used for pandemic forecasting and may be more effective than traditional approaches.

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Morality, science, ideology, politics, and culture are the very forces that have shaped personal and national policy responses to the Covid-19 pandemic. As we approach three years of life with SARS-CoV-2, the virus that causes Covid-19, and deliberations move to the living with the virus phase, decision-making alternatives are needed.

Science offers much legitimate guidance about risk levels and actions to mitigate them whether and when to wear masks, test, quarantine, get vaccinated or boosted, and the like though each of these have been hotly and sometimes acrimoniously debated. This is where prediction markets could earn their stripes.

Applying a detached prediction market lens approach may produce provocative and perhaps more accurate pandemic forecasts than pure evidence-driven approaches. As a thought experiment, let me explore how smart money can be deployed in a virtual Covid-19 prediction marketplace betting on the winners and losers in the next year of Covid. In real life, this tool has been only sporadically applied to Covid-19 and has not fulfilled its potential as input to the Covid zeitgeist.

Investment analysts typically make their forecasts by integrating three factors: the fundamentals (where the pandemic is headed); key societal trends (the external environment); and potential demand for products and services (revenue models).

Fundamentals. In this bettors scenario, 2023 will feature significantly decreased serious illness and deaths, largely as a result of durable steady-state population immunity through both ongoing vaccination and repeated cycles of natural infection and re-infection. Elderly, debilitated, and immune-deficient individuals will continue to bear the brunt of the virus. Neither new variants nor dramatic changes in prevention or treatment will significantly modify this scenario.

Societal trends. These include growing emphasis on protecting vulnerable individuals and populations, growing acceptance of the risk of exposure among non-vulnerable individuals, and more leading from behind relaxation of official regulations and guidelines in response to an increasingly risk-tolerant population. There will be significant ongoing loosening of restrictions like quarantine, isolation, masking, and testing, as well as waning interest in and uptake of vaccination.

Revenue models. Due to congressional resistance, federal funding for Covid-19 relief will dramatically decline. This fall we may see the last round of free vaccines, tests, and treatments. Some of the slack will be taken up by the commercial marketplace. Consumer out-of-pocket costs will increase and the uninsured and indigent will have diminished access to these products. Overall, commercial demand for goods and services in the Covid space will decrease, while some selected areas, like rapid testing, may see an increase, including through direct-to-consumer marketing.

With that background, here are my market-maker predicted Covid-19 trends for 2023:

Long Covid. This is an ongoing American health catastrophe that will draw significant and increasing investment and revenue for basic and clinical research, health care, disability expenses and advocacy.

Protecting the vulnerable. There will be increasing individual and societal focus on safeguards for this group. Even as the rest of society relaxes, vulnerable individuals and populations will require increased vaccines and treatments, non-pharmaceutical interventions, and social support.

Pandemic preparedness. Much remains to be learned and applied in preparation for the spillover of the next animal virus to humans. While federal funding is uncertain, foundation and philanthropic engagement are likely to be high.

In-person activities. Schools, colleges, sports, entertainment, retail, and travel are not only likely to return to normal, but will overshoot. Office-based employment wont get back to what it was, but will increase considerably from pandemic lows.

New point-of-care diagnostics. Consumers have become familiar and comfortable using at-home rapid tests. While the demand for conventional antigen tests will continue to decrease, there will be a need for new diagnostics that can differentiate various causes of cold and flu-like upper repository symptoms. Late-stage development is already occurring in this area.

Oral antivirals. Paxlovid and molnupiravir are both effective in preventing serious Covid-19 among those over age 65, but not in younger age groups. Expect new Medicare coverage but decreased utilization in the under-65 population.

Covid protocols. Most schools, colleges, workplaces, and sports leagues will be abandoning these.

Non-pharmaceutical interventions (masking, ventilation, quarantine, isolation). Going forward, demand will be limited mainly to the vulnerable and the worried-well populations.

Vaccines and testing. The incentives for these fade as the perceived threat diminishes.

U.S. funding for the global pandemic. With decreasing domestic concern about Covid-19 and stretched foreign aid budgets and higher priorities such as supporting Ukraine, this will fall by the wayside.

The CDC. The announced internal reorganization of the Centers for Disease Control and Prevention does not eliminate external issues of independence, interagency and state competition and prerogatives, lack of coordination among key players, and politicization of public health. The recapture of credibility and trust will prove elusive.

A reminder to potential bettors: This is an exercise intended to capture insights into where the pandemic is going, and one I hope will nudge people to put their conceptual money where their mouths are. This illustration of trends is intended to provide fresh insights for policymakers, the public, and the media that are frequently not evident through more conventional forecasting tools.

For those eager to place real-life bets, diligent research and the stock market may offer validation of sagacity. There is a fine line, however, between pandemic prediction and gambling. Caveat emptor.

Steven Phillips is a medical epidemiologist and the vice president for science and strategy for the Covid Collaborative.

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Prediction markets and the future of Covid-19 - STAT

"The Law of COVID-19: Courts, Education, and Civil Rights," the theme of the Elon Law Review's 2022 online symposium, takes place virtually on September 23 with legal scholars and advocates discussing the way the pandemic has affected the judicial system and the balance of public health with protecting individual freedoms.

The 2022 Elon Law Review Symposium takes place virtually on September 23 with legal leaders, scholars, and advocates poised to explore and discuss the impact of the COVID-19 pandemic on the administration of justice

There is no cost to attend and the Elon Law Review has applied to the North Carolina State Bar for the program to count toward 4.0 general CLE credits. You do not need to be a lawyer to participate.

The September 23 program runs from 10 a.m. 3:30 p.m. with a break for lunch. Register here to attend.

The symposium includes Elon Laws annual Jennings Family Lecture in Memoriam to Associate Professor Mike Rich. The Hon. Sam Ervin IV of the Supreme Court of North Carolina will deliver the 2022 address shortly after introductions by the Elon Law Reviews symposium editors.

Questions may be sent to lawreview@elon.edu. Links and additional information will be emailed to registrants prior to the event.

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Symposium to explore impact of COVID-19 on courts & justice - Today at Elon

A USPS logo adorns the back doors of United States Postal Service delivery vehicles as they proceed westbound along 20th Street from Stout Street and the main post office in downtown Denver, Wednesday, June 1, 2022. David Zalubowski/AP hide caption

A USPS logo adorns the back doors of United States Postal Service delivery vehicles as they proceed westbound along 20th Street from Stout Street and the main post office in downtown Denver, Wednesday, June 1, 2022.

The federal government is putting a pause on sending free COVID-19 testing kits to Americans starting in September, due to a lack of funding.

"Ordering through this program will be suspended on Friday, September 2 because Congress hasn't provided additional funding to replenish the nation's stockpile of tests," the ordering website says.

However, the program is still accepting orders before Sep. 2.

The White House first began sending out the kits in January. By last May, the White House said 350 million tests had been given away to 70 million households, more than half of the households in the U.S.

Read more:

The White House is suspending its free COVID-19 testing kit program - NPR

U.S. Army Spc. Eyza Carrasco, left, with 2nd Cavalry Regiment, administers a COVID-19 vaccination at the 7th Army Training Command's (7ATC) Rose Barracks, Vilseck, Germany, May 3, 2021. The U.S. Army Health Clinics at Grafenwoehr and Vilseck conducted a "One Community" COVID-19 vaccine drive May 3-7 to provide thousands of appointments to the 7ATC community of Soldiers, spouses, Department of the Army civilians, veterans and local nationals employed by the U.S. Army. (Photo Credit: U.S. Army photo by Markus Rauchenberger) VIEW ORIGINAL

WASHINGTON A new COVID-19 vaccine will be available to Soldiers as an alternative to the Pfizer-BioNTech, Moderna and Johnson & Johnsons Janssen vaccines, the Army recently announced.

With the availability of the NOVAVAX vaccine, we are pleased to have another tool to help combat the spread of COVID-19, said Lt. Gen. R. Scott Dingle, Army Surgeon General and commanding general of U.S. Army Medical Command.

The U.S. Food and Drug Administration issued an emergency use authorization July 13, 2022 for the Novavax COVID-19 Vaccine, for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

The Novavax vaccine is something called a recombinant protein vaccine. These types of vaccines have been used since the 1980s. Other recombinant protein vaccines include the vaccines for shingles, hepatitis B, and human papillomavirus, Dingle said.

Novavax provides an option for Soldiers who are not fully vaccinated and uses a different technology from the mRNA and viral vector vaccine options. Dr. Steven Cersovsky, Deputy Director of the Army Public Health Center, said Novavax performs like a traditional vaccine.

In a more traditional vaccine, like Novavax, the injection gives your body a part of the virus: in this case, its giving you one protein, the spike protein, Cersovsky said. And it allows your body to generate an immune response to that protein.

Novavax, a two-dose vaccine that does not have a recommended booster, has been widely used in Europe since early 2022 and has been shown to be as effective as other vaccines at preventing severe disease, hospitalization and deaths from the coronavirus infection, Cersovsky said.

Soldiers who voluntarily choose to get Novavax will be considered in compliance with the DOD COVID-19 vaccine mandate.

This vaccine, as one component of all recommended vaccines, supports the Armys goals of sustaining a proficient and ready medical force and healthy Soldiers for Life, Army civilians, and families, Dingle said.

Soldiers have the option and can consult [with] their healthcare providers on the medical aspects, and they have the option to consult [with] their chaplains on the religious aspect, said Lt. Col. William Martin, chaplain and religious accommodations and moral ethics officer at the Armys Office of the Chief of Chaplains. This is a religious matter affecting a medical reality; its really a team advisement here in order to give that Soldier the best information so that, in accordance with their sincerely held religious beliefs, they can make the best decision.

Commanders and medical professionals are being provided with information regarding Novavax; if Soldiers are interested in more information to see if Novavax is right for them, they can contact their commanders, chaplains or medical professionals.

Our number-one priority is protecting the health and welfare of our greatest assets our Soldiers, our family members and Army civilians, Dingle said. We will continue to ensure that our personnel have the most accurate information on protective measures they can take to reduce the spread of COVID-19.

DOWNLOAD [PDF]: COVID-19 Vaccination Options

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Soldiers now have additional COVID-19 vaccine options | Article | The United States Army - United States Army

The FDA recommends to take at least two COVID-19 antigen tests 48 hours apart before ruling out a possible infection. Justin Paget/Getty Images hide caption

The FDA recommends to take at least two COVID-19 antigen tests 48 hours apart before ruling out a possible infection.

We regularly answer frequently asked questions about life during the coronavirus crisis. If you have a question you'd like us to consider for a future post, email us at goatsandsoda@npr.org with the subject line: "Weekly Coronavirus Questions." See an archive of our FAQs here.

Ah, the start of a new school year. Maybe you're one of millions of Americans who have started mingling with peers in the dorms and suddenly find yourself sniffling and wondering if you have COVID-19.

Or you're just getting back from your summer vacation and the back of your throat has a worrisome itch.

You consider taking an at-home rapid test, but you have lots of questions. With new FDA recommendations on testing, how many times should you test for a definitive result? And, how infectious are you if the positive line is faint? And what if the test turns positive but only after an hour?

We posed your questions to the experts: Dr. Abraar Karan, infectious disease researcher at Stanford; Meriem Bekliz, virologist at the University of Geneva; and Dr. Preeti Malani, professor of medicine at the University of Michigan. Here's the scoop:

So I caught COVID-19 and after 10 days I'm still testing positive. But the line on my rapid test is really faint now compared to a week ago. What's the deal? Exactly how contagious am I?

"The faintness or darkness of the line probably has some correlation to degree of infectiousness especially early on [during the infection]," says Karan.

So if the line is faint, that could mean your risk of accidentally passing the virus on to others is low.

"Some people may not be infectious because the tests could be picking up viral debris from a waning infection," says Bekliz.

But don't rip off your mask just yet: There could be other reasons for a faint line.

There is "some room for error" with those rapid tests, Karan says. You're sticking a cotton swab up your nose and hoping to snare some virus. A faint line could mean you've collected less virus this time around. Maybe you swabbed for less time or in only one nostril when your test instructions say to swab both.

"In general, a darker line is a result of more virus [on the swab]," says Malani. "But antigen tests are not especially sensitive, so even with a negative test, you can be contagious."

So the bottom line, say our experts: If you're testing positive even with a faint line you should behave as if you are contagious.

If there's any hint of a positive line, Bekliz recommends you continue to wear a mask, work from home if possible and generally limit contact with other people.

Last week I tested positive for COVID-19 and went through the recommended 5 days of isolation and additional 5 days of masking. How many times do I need to test negative before it's OK to assume I'm virus-free?

Figuring out when it's OK to ease up on your safety measures after catching COVID-19 can be tricky.

If you suspect that you may have COVID but haven't tested positive yet, the FDA now recommends serial testing, which means you should repeat your home test after 48 hours to make sure you aren't accidentally getting a false negative test.

And what should you do if you already tested positive and want to know when you're finally negative?

"The recommendations for serial testing are for people that have been exposed and are trying to diagnose themselves," says Karan. "They're saying to repeat the test after a day or two, but not if your first test is already positive and you're testing to become negative."

Once you have tested positive and your body starts clearing the virus, a negative rapid test should be a pretty good indication you're no longer infectious, so long as you follow the test protocols correctly and wait an appropriate amount of time before testing.

"If it's been like five days [since the onset of symptoms], and the test is negative, then I would feel good about that," says Karan. "If the test is negative one or two days after symptoms start, then I would maybe think you didn't get a good sample and should test again."

While that's reassuring, there wasn't agreement among our experts about exactly what to do. While Karan says one negative test after an appropriate amount of time is good enough, Malani says you should take two just to be sure.

"Usually you want a couple negative tests," says Malani. "If you have two negative antigen tests, that's really helpful."

So that first negative test is likely a good sign, but taking an additional test 24 hours later is a great way to confirm the result and rule out errors in testing.

I was feeling a bit off and took a COVID-19 test. After 15 minutes it looked like the test was negative. But when I came back to check the test an hour later a positive line had appeared! Then I retested three times and they all came back negative. Does this mean I could have COVID-19?

This is a pretty unusual circumstance, our experts say, but one that could potentially indicate bad news.

"The tests aren't really meant to be read an hour later," says Malani. "But it would be a little bit concerning for someone who has symptoms and has their test turn positive later."

Each test kit has its own recommended timeframe for reading the test. BinaxNOW and iHealth kits say you should read the test after 15 minutes, but not after 30 minutes. INDICAID test kits say you should read the test after 20 minutes, but not after 25 minutes. Reading the test after the recommended time frame could lead to a false positive.

However, Karan agrees that "it would be less likely to be a false positive if someone's having symptoms and we're at a time when there's a high amount of virus being spread."

Following the FDA recommendation to test at least twice and waiting 48 hours between tests can help determine your true COVID-19 status as well.

"My advice would be to probably stay put and not expose anyone, and then perhaps repeat the test," Malani says. "Now, if you're feeling great the next day and your test is negative, maybe it was nothing."

Or simply "assume you're positive if you have symptoms," Karan says. "Try to get a PCR test and retest again [at home] in the next few days. If the PCR test is negative, you're probably OK."

No matter the circumstances, if you're worried that you could have COVID-19, our experts think your best bet is to repeat your at-home test over a couple of days. So if you want to ace COVID Testing 101 this school year, just remember that two negative tests are better than one.

See the rest here:

COVID self-test FAQs: Are there false negatives? What does a faint line mean? : Goats and Soda - NPR

The federal government is set to suspend its offer of free at-home COVID-19 tests by Friday, Sept. 2, without congressional authorization for an extension.

The U.S. Postal Services page for ordering the tests states that orders will pause by next Friday or sooner if supplies run out.

Ordering through this program will be suspended on Friday, September 2 because Congress hasnt provided additional funding to replenish the nations stockpile of tests, a message on the federal governments COVID-19 website reads.

The Biden administration originally announced that it would offer 1 billion free at-home COVID-19 tests in January. The federal government used COVID-19 funding from the American Rescue Plan, President Bidens $1.9 trillion economic stimulus and COVID-19 recovery package that he signed into law last year.

Biden has since offered additional rounds of tests for Americans to order, most recently in May. Households could order an additional eight tests in the most recent round.

The seven-day rolling average of COVID-19 cases has declined slightly in recent weeks following an increase fueled by the highly contagious BA.5 omicron subvariant. But a senior administration official told USA Today that the government needs to hold on to tests for a possible rise in the fall.

The official said that the administration will use its existing limited resources to obtain as many tests as it can, but distribution could resume on a large scale if Congress provides the funding for it.

Go here to see the original:

Federal government to halt free COVID-19 at-home tests by early September - The Hill

Programming note: We wont be publishing Prescription Pulse from Monday, Aug. 29, to Monday, Sept. 5. Well be back in your inboxes on Wednesday, Sept. 7.

The CDCs vaccine advisers meet next week to deliberate on recommending Omicron-specific Covid-19 booster shots.

FDA Commissioner Robert Califf wants the health care system to generate more clinical evidence.

A new report from House Democrats on the Select Subcommittee on the Coronavirus Crisis reveals just how much the Trump Administration pressured the FDA over Covid product authorizations.

Its Friday. Welcome to Prescription Pulse. We thought August recess was supposed to be quiet; we apologize for the inconvenience.

Send tips and feedback to David Lim ([emailprotected] or @davidalim), Lauren Gardner ([emailprotected] or @Gardner_LM) or Katherine Ellen Foley ([emailprotected] or @katherineefoley).

Next week, CDC advisers will meet to decide whether to recommend Covid-19 boosters designed to help prevent infections from currently circulating strains. | Spencer Platt/Getty Images

CDC PANEL TO MEET ON OMICRON BOOSTERS The CDCs independent vaccine advisers will meet Thursday and Friday next week to discuss recommending updated Covid-19 boosters to cover the BA.4 and BA.5 Omicron strains that have dominated U.S. infections this summer. The meeting comes after Pfizer and, as of Wednesday, Moderna have applied to the FDA for emergency use authorization for their Omicron-specific products.

That puts the timeline for an FDA decision sometime next week. But the agency wont convene its own independent advisory committee on vaccines, arguing that the panels June 28 discussion covered enough ground for regulators to make their own call.

FDA has no new questions that warrant committee input, Commissioner Robert Califf tweeted Thursday in an extensive thread about the agencys posture as it reviews both companies applications. When available, new boosters are expected to help provide greater protection against the currently circulating strains, he added.

Outside angst: Some medical experts have urged regulators to hold off on green-lighting the shots until the manufacturers have human clinical data on their efficacy. Pfizers and Modernas applications are underpinned partly by early data on their boosters effects in mice since the FDAs request that they focus on the BA.4 and BA.5 strains instead of the first Omicron variant didnt come until the end of June.

Paul Offit, a Childrens Hospital of Philadelphia infectious disease expert on the FDA expert panel, told Lauren he was unpleasantly surprised that the committee wont meet to publicly assess the data for what he considers a new product.

If you hold this vaccine up as being some sort of magic bullet, then people are going to be disappointed when they get mild illness, Offit said.

The administrations take: Ashish Jha, the White House Covid-19 response coordinator, has bullishly promoted the prospect of the reformulated boosters, saying that all the data suggests [they] should be highly effective against the new variants.

The big-picture bottom line is, these are substantial upgrades in our vaccines in terms of their ability to prevent infection, to prevent transmission, certainly to prevent serious illness and death, Jha said of the bivalent boosters during a U.S. Chamber of Commerce event on Aug. 16.

Offit questioned the administrations stance urging a broad fall vaccination campaign to decrease the amount of circulating virus as opposed to tailoring recommendations to those most at risk for severe disease given the mRNA vaccines track record of neutralizing antibodies tapering off after three to six months. I think it is like a leaky sieve, Offit said.

HHS HOLDING COMMERCIALIZATION TRANSITION PLANNING MEETING The federal health department is convening pharmacies, providers, government agencies, consumer groups and industry on Aug. 30 for a virtual meeting to plan the potential transition of Covid-19 vaccines and therapies to the commercial marketplace. Leadership from the CDC, CMS, FDA, NIH, the Health Resources and Services Administration and the Administration for Strategic Preparedness and Response will attend the meeting.

Two breakout sessions will be held: One will focus on commercialization plans for Covid-19 vaccines, while the second will center on therapeutics. Discussion topics include reimbursement and coverage, regulatory issues, and how to make products available to under- and uninsured people, according to an event invite obtained by POLITICO.

Given this process will take months and close coordination with stakeholders across the health care continuum, HHS is engaging closely with these stakeholders to plan and ensure that the transition happens smoothly when the time does come, an HHS spokesperson said.

FDA Commissioner Robert Califf would like to see an increase in useful, reliable clinical evidence. | Andrew Harnik/AP Photo

CALIFF: WE NEED TO GENERATE MORE EVIDENCE Academics, health systems and professional societies should prioritize generating more clinical evidence to help the FDA more rapidly understand the risk-benefit profile of medical products, according to FDA Commissioner Robert Califf.

When the FDAs decisions generate controversy, it is often when the system fails to produce reliable evidence that clarifies an interventions risks and benefits during a relevant time frame, Califf wrote in JAMA earlier this week. The gap between FDA clearance or approval of a medical product (particularly when the accelerated approval pathway is used) and use of the product to treat patients should be filled by an invigorated clinical research system that generates evidence that patients, clinicians and health systems need to make well-informed decisions.

CONGRESSIONAL REPORT SHOWS TRUMP WHITE HOUSE PRESSURED FDA ON COVID THERAPEUTICS Democrats on the House Select Subcommittee on the Coronavirus Crisis published a report on Wednesday, detailing how senior Trump officials pressured the FDA around coronavirus authorizations, Katherine reports.

The findings of the report werent much of a surprise, but it offers new color through emails, texts and official testimony from former FDA Commissioner Stephen Hahn about how persistent some of those efforts inside the White House were throughout the summer and fall of 2020.

On hydroxychloroquine: After the FDA revoked authorization for hydroxychloroquine after data emerged showing its inefficacy and potential harm to Covid patients, Trumps trade adviser Peter Navarro and coronavirus response volunteer Steven Hatfill pushed the FDA to reauthorize the drug. Hatfill characterized the disagreement between White House officials and the FDA as a forthcoming knife fight.

On Fauci: According to the report, Hatfill pushed for Anthony Faucis removal throughout the fall after the director of the National Institute of Allergy and Infectious Diseases dismissed the White Houses push for hydroxychloroquine. In September 2020, Hatfill told Navarro, You really need to consider what is likely to happen over the next 2 months if this little idiot and his Covid treatment panel is not fired.

On vaccines: Hahn testified to the subcommittee that the White House wasnt happy with the FDAs requirement that late-stage Covid-19 vaccine trials included a 60-day safety follow-up which would delay their authorization until after the 2020 election.

And on Navarros emails: This report offers more evidence that Navarro used his personal email for presidential matters. The Department of Justice has sued Navarro to get him to turn over other such emails, first revealed by a separate report from the subcommittee, sent from his personal email account.

WASHINGTON AWAITS BIDEN OIRA NOMINEE With the midterm elections approaching, close watchers of the regulatory apparatus are waiting for Biden to nominate someone to lead the small but powerful Office of Information and Regulatory Affairs, POLITICOs Adam Cancryn reports.

The office, charged with reviewing regulations, could play an outsized role in the final two years of Bidens term as the government implements major elements of Democrats just-passed climate, health and tax law.

OIRA is always at the center of administrative activity the joke is its the most powerful agency nobodys ever heard of, said Sharon Block, who served as its acting chief through Bidens first year. Now, it becomes even more important.

The FDA on Tuesday published final guidance for tobacco manufacturers designing and conducting tobacco product perception and intention studies.

The FDA on Thursday published its annual report on the state of pharmaceutical quality.

The HHS Office of Inspector General posted a memo summarizing its findings that, in the first quarter of 2022, eight drug codes met CMS price-substitution criteria and had an average sales price that exceeded the average manufacturer price by 5 percent or more.

CMS on Thursday finalized its plan to indefinitely delay its radiation oncology payment model.

Read the rest here:

CDC advisers set to weigh updated Covid-19 boosters - POLITICO