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.
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 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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"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.
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.
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While the U.S. remains focused on the COVID-19 pandemic, we need to also be aware of flu season. Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Every flu season is different, and the substantial health impacts can vary widely from season to season, with some flu seasons being worse than others. Your best defense is vaccination, which provides protection from flu and its potential complications.
The flu vaccines are approved by the U.S. Food and Drug Administration to prevent flu, and they provide important benefits. The Centers for Disease Control and Prevention estimate that during the 2019-20 flu season:
Vaccination prevented more than 7 million flu illnesses, 105,000 hospitalizations, and 6,300 flu-related deaths, according to the CDC.
Its likely that flu viruses and the virus that causes COVID-19 will circulate together in fall and winter. The flu vaccine does not prevent COVID-19. The FDA has approved two vaccines for the prevention of COVID-19 and issued emergency use authorizations (EUAs) for others. For the latest information on COVID-19 vaccines, visit this FDA page.
Meanwhile, the flu vaccines are approved by the FDA for the prevention of influenza disease and to protect against four different virus strains of influenza. Getting vaccinated to prevent this disease can help keep you out of the doctors office for a sick visit and preserve health care resources for patients with other diseases and medical conditions, including COVID-19.
The FDA plays a key role in ensuring that safe and effective flu vaccines are available every flu season. Flu viruses are spread by droplets when people infected with the flu cough, sneeze, or talk. Flu may also be spread when a person touches a surface or object that has flu viruses on it and then touches their own mouth, nose, or eyes.
The CDC recommends that adults and children older than 6 months get a flu vaccine by the end of October. Even if you wait until after October, go get your flu vaccine. Its still beneficial because it can help protect you for the remainder of the flu season. For more information on flu vaccine recommendations, visit this CDC page.
If you have already been sick with the flu this season without getting vaccinated, getting a flu vaccine is still important because it helps prevent disease caused by four different strains of flu viruses. Presumably, you were infected with one type of flu virus strain, so the vaccine would offer protection against the strains that you havent already had.
Flu seasons and their severity are unpredictable. Annual vaccination is the best way to prevent influenza in people ages 6 months and older.
An annual vaccination to prevent flu is the best way to reduce the risk of getting the flu and spreading it to others. When more people get vaccinated, it is less likely that the flu viruses will spread through a community.
The vaccine typically changes each year and contains the four flu virus strains that are expected to circulate in the U.S. during the upcoming flu season. The effectiveness of influenza vaccines varies depending on several factors, such as the age and health of the recipient, the types of circulating influenza viruses, and the degree of similarity between circulating viruses and those included in the vaccine.
The task of producing a new vaccine for the next flu season starts well before the current season ends. For the FDA, its a year-round initiative.
The flu vaccine will trigger your immune system to produce antibodies to protect against influenza disease it will not make you sick with the flu. It can take about two weeks after vaccination for antibodies to develop in the body, which is an important reason to get your flu vaccine early, before flu activity starts.
There are several reasons a new flu vaccine must be made each year.
Flu viruses can change from year to year, so the vaccine is updated to protect against new virus strains that are expected to circulate in the U.S. The vaccine needs to include influenza virus strains that most closely match those in circulation for the influenza season. In addition, the protection provided by the flu vaccine a person received in the previous year will diminish over time and may be too low to prevent influenza disease into next years flu season.
Typically, children and older people are most at risk of getting sick with influenza. The best way to protect babies who are too young to be vaccinated is to make sure people around them are vaccinated. Occasionally, a flu virus will circulate that disproportionately affects young and middle-ageadults.
You also can reduce the spread of the flu and its effects by taking such practical measures as washing your hands, covering coughs and sneezes, and staying home when youre sick.
The FDA has approved numerous vaccines for the prevention of influenza. But if you do get the flu, there are FDA-approved antiviral drugs, available by prescription, to treat your illness. There are several FDA-approved antiviral drugs recommended by the CDC for use against circulating influenza viruses. These drugs work best if started soon after the onset of symptoms (within 48 hours).
Every year, in late February or early March, before that years flu season ends, the FDA, the World Health Organization (WHO), the CDC, and other public health experts collaborate on collecting and reviewing data from around the world to identify the flu viruses likely to cause the most illnesses during the next flu season.
Following that process, the FDA convenes its vaccines advisory committee, consisting of outside experts, to discuss the WHO recommendations and to consider which flu viruses are expected to circulate in the U.S. The committee also reviews data about which flu viruses have caused illnesses in the past year, how the viruses are changing, and disease trends for the U.S. The FDA takes that information into account before it selects the virus strains for FDA-licensed manufacturers to include in their vaccines for use in the U.S.
The closer the match between the virus strains chosen for the vaccine and the circulating strains causing disease during flu season, the better the protection that the flu vaccine provides. Although the vaccine and viruses may not be an exact match in some years, that does not mean the vaccine is not benefiting people. Available data show that the vaccine can reduce the severity of illness in people who get vaccinated but still get sick.
To ensure that the flu vaccine is safe, effective, and of high quality, the FDA prepares and provides reagents (materials to standardize vaccines) to manufacturers that they need to make their vaccine and to verify its identity and potency. The FDA also inspects manufacturing facilities regularly and evaluates each manufacturers vaccine annually before it can be approved.
The FDAs oversight doesnt end there. After manufacturers have distributed their vaccines for use by the public, the FDA and CDC work together to routinely evaluate reports of adverse events following vaccination submitted by vaccine manufacturers, health care providers and vaccine recipients (or their parents/guardians) to the Vaccine Adverse Event Reporting System (VAERS).
Additional efforts are in place to monitor vaccine safety. The FDA partners with private organizations that collect health care data (such as health insurance companies) and other federal agencies (such as Centers for Medicare and Medicaid Services, Veterans Health Administration and CDC) to further evaluate the safety and effectiveness of the influenza vaccines and other vaccines that the FDA has approved or authorized for emergency use.
The Biologics Effectiveness and Safety (BEST) Initiative is one of the programs the FDA utilizes to assess vaccine safety and effectiveness in real-world conditions, reflecting patient care and the real-world use of the influenza vaccine and other vaccines in the U.S. In addition, the CDC maintains the Vaccine Safety Datalink (VSD) program, which evaluates the vaccinessafety similar to the BEST Initiative. VSD receives its data from nine integrated health care organizations in the U.S.
Flu shot: Your best bet for avoiding influenza
Getting a flu shot will often protect you from coming down with the flu. And although the flu shot doesn't always provide total protection, it's worth getting.
This year's annual flu shot will offer protection against four of the influenza viruses expected to be in circulation this flu season. High-dose flu vaccines will be available for adults age 65 and older, but these may not be available at all medical centers.
Influenza is a respiratory infection that can cause serious complications, particularly in young children, older adults and people with certain medical conditions. Getting an influenza vaccine though not 100% effective is the best way to prevent the misery of the flu and its complications. The Centers for Disease Control and Prevention (CDC) recommends annual flu vaccination for everyone age 6 months or older.
Here are the answers to common questions about flu shots:
Private manufacturers make the flu vaccine and take about six months to produce it. The availability of the flu vaccine depends on when production is completed. But generally, shipments begin sometime in August in the United States. Doctors and nurses may begin vaccinating people as soon as the flu vaccine is available in their areas.
It takes up to two weeks to build immunity after a flu shot, but you can benefit from the vaccine even if you don't get it until after the flu season starts. It's usually best for people in the United States to get their flu vaccine in September and October, and aim to get it by the end of October. However, you can still protect yourself against late flu outbreaks if you get the vaccine in February or later.
Because flu viruses evolve so quickly, last year's vaccine may not protect you from this year's viruses. New flu vaccines are released every year to keep up with rapidly adapting flu viruses.
When you get vaccinated, your immune system produces antibodies to protect you from the viruses included in the vaccine. But antibody levels may decline over time another reason to get a flu shot every year.
The CDC recommends annual influenza vaccinations for everyone age 6 months or older. Vaccination is especially important for people at high risk of influenza complications, including:
Children between 6 months and 8 years may need two doses of the flu vaccine, given at least four weeks apart, the first time they are given a flu vaccine. After that, they can receive single annual doses of the flu vaccine. A 2017 study showed that the vaccine significantly reduces a child's risk of dying of the flu. Check with your child's doctor.
Chronic medical conditions also can increase your risk of influenza complications. Examples include:
Anyone with a chronic medical condition should get the flu vaccine. Also, people living in nursing homes or other long-term care facilities should get the flu vaccine.
Check with your doctor before receiving a flu vaccine if:
If you have an egg allergy, you can still receive the flu vaccine.
The flu vaccine will be available as an injection or as a nasal spray.
The nasal spray vaccine is approved for people between 2 and 49 years old.
The nasal flu vaccine isn't recommended for some people, including:
There are other groups advised to be cautious about the use of a nasal spray flu vaccine, such as people with certain chronic medical conditions. Check with your doctor to see if you need to be cautious about getting a nasal spray flu vaccine.
The flu vaccine can also be delivered by an injection that's usually given in a muscle in the arm. If you're an adult under 65, you may also choose an in-the-skin (intradermal) vaccine, or you may prefer to have your vaccine delivered using a jet injector device, which uses a high-pressure, narrow stream of fluid to penetrate the skin instead of a needle.
No. The flu vaccine can't give you the flu. It also does not increase your risk of COVID-19. But you might develop flu-like symptoms despite getting a flu vaccine for a variety of reasons, including:
How well the flu vaccine works to protect you from the flu can vary. The flu vaccine is generally more effective among people under 65 years old. Some older people and people with certain medical conditions may develop less immunity after receiving a flu shot.
Reviews of past studies have found that the flu vaccine is about 50% to 60% effective for healthy adults who are between 18 and 64 years old. The vaccine may sometimes be less effective.
Even when the vaccine doesn't completely prevent the flu, it may lessen the severity of your illness, and reduce the risk of serious complications and serious illness requiring hospitalization.
The flu vaccine does not prevent you from getting COVID-19. However, it's especially important to get the flu vaccine this season because the flu and coronavirus disease 2019 (COVID-19) cause similar symptoms. Flu vaccination could reduce symptoms that might be confused with those caused by COVID-19. Preventing the flu and reducing the severity of flu illness and hospitalizations could also decrease the number of people needing to stay in the hospital.
It also may be possible to get a COVID-19 vaccine at the same time as your flu vaccine.
The flu vaccine is your best defense against the flu, but there are additional steps you can take to help protect yourself from the flu and other viruses, including COVID-19. These steps include the following:
If you become sick with the flu, you can also help prevent the spread of the flu by staying home and away from others. Continue staying home until your fever has been gone for at least 24 hours.
Both COVID-19 and the flu may be spreading at the same time. Your local health department and the CDC may suggest other precautions to reduce your risk of COVID-19 or the flu if you haven't been fully vaccinated. For example, you may need to practice social distancing (physical distancing) and stay at least 6 feet (2 meters) from others outside your household. You may also need to wear a cloth face mask when around people outside your household when indoors and when outdoors in crowded areas. If you're fully vaccinated and are in an area with a high number of new COVID-19 cases in the last week, the CDC also recommends wearing a mask indoors in public and outdoors in crowded areas or when you're in close contact with unvaccinated people.
Getting your flu vaccine can reduce your risk of the flu and its complications, and following these precautions can help protect you from the flu or other respiratory illnesses.
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With the novel coronavirus continuing to circulate and cause severe illness in the United States and worldwide, getting a flu shot is once again more important than ever. The 202122 influenza season will coincide with the continued circulation of SARS-CoV-2, the virus that causes COVID-19, so start planning now.
Common signs and symptoms of COVID-19 (e.g., dyspnea, fever, and cough) can also occur with influenza, which is one of the many reasons why the Centers for Disease Control and Prevention (CDC) recommends that everyone six months and older receive a flu shot. Influenza vaccines provide the best protection against the flu and its potentially serious complications. Furthermore, getting the jab will decrease the prevalence of the flu as well as reduce symptoms that might be confused with those of COVID-19. Make sure your practice is prepared for the flux of injections by updating your billing systems with the 2021 Average Sales Price (ASP) Drug Pricing Files and reading the latest vaccination guidance.
CPT coding for vaccinations involves two codes, one for the vaccine and one for its administration.The table below breaks down the vaccine codes and payment allowances for the 2021-2022 season. These payment allowances are effective Aug. 1, 2021, through July 31, 2022. Download the2021 Average Sales Price (ASP) Drug Pricing Filesfor up-to-date pricing information on all Medicare Part B drugs.
The Medicare Part B payment allowance limits for seasonal influenza vaccines are 95 percent of the Average Wholesale Price (AWP). Payment for the vaccine is based on reasonable cost when the job is furnished in a hospital outpatient department.
Medicare pays for one seasonal influenza virus vaccination perinfluenza season. Annual Part B deductible and coinsurance amounts do not apply for influenza vaccinations. All physicians, non-physician practitioners, and suppliers who administer these vaccines must take assignment on the claim for the vaccine.
When reporting vaccination encounters, use ICD-10-CM diagnosis code Z23 Encounter for immunization. For Medicare, code the administration of the flu shot with G0008 Administration of influenza virus vaccine.
Most vaccines are given as injections and are reported to non-Medicare payers with administration codes
But there are a few oral and intranasal vaccines that are reported using administration codes 90473 and 90474. Only use 90471-90474 when immunization is not accompanied by face-to-face counseling of the patient/family, or for vaccine administration to patients over 18 years of age.
Pediatric vaccine administration with counseling codes are:
Routine annual influenza vaccination is recommended for all persons aged 6 months who do not have contraindications, per the CDC. The American Academy of Pediatrics (AAP) also recommends annual influenza immunization of all children without medical contraindications, starting at 6 months of age.
Influenza vaccination is an important intervention to protect vulnerable populations and reduce the burden of respiratory illnesses during circulation of severe acute respiratory syndrome coronavirus 2, which is expected to continue during the 20212022 influenza season. -AAP
AAP maintains that any licensed, age-appropriate vaccine is acceptable; they do not have a preference for one product or formulation over another. Notably, the AAP clarifies that the flu jab may be administered simultaneously with or any time before or after administration of the currently available novel coronavirus disease 2019 (COVID-19) vaccines.
All seasonal influenza vaccines expected to be available for the 20212022 season are quadrivalent, containing hemagglutinin (HA) derived from one influenza A(H1N1)pdm09 virus, one influenza A(H3N2) virus, one influenza B/Victoria lineage virus, and one influenza B/Yamagata lineage virus.
For the 202122 season, U.S.-licensed influenza vaccines will contain:
Get more information regardingCDC recommendationsfor prevention and control of seasonal influenza and answers to frequently asked questions about the 2021-2022 flu season.
For further clarification, see the recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of seasonal influenza with vaccines.
Stacy Chaplain, MD, CPC, is a development editor at AAPC. She has worked in medicine for more than 20 years, with an emphasis on education, writing, and editing since 2015. Chaplain received her Bachelor of Arts in biology from the University of Texas at Austin and her doctorate in medicine from the University of Texas Medical Branch in Galveston. She is a member of the Beaverton, Ore., local chapter.
The fall 2022 flu season may arrive early. The best way to protect yourself is to get a flu vaccine. Photo: Getty Images.
The fall 2022 flu season may hit early and hard this year, so its best to get your flu vaccine as soon as possible.
To prepare for the upcoming fall and winter flu season, U.S. medical experts keep a close eye on how the flu season played out in the southern hemisphere during their recent fall and winter (from about April through August of this year).
And data from Australia point to a possible rough, early flu season in the northern hemisphere.
Dr. Michelle Barron is one of the top infectious disease experts in Colorado. Shes urging people to get their flu vaccines relatively early this fall.
Every year, we try to guess when the flu is going to hit and when we should get our vaccines. Some people wait to get their flu shot until right before Thanksgiving in case theyll be traveling over the holidays, said Barron, UCHealths senior medical director of infection prevention and control. Based on what were seeing in the southern hemisphere, thats not the best plan this year.
Her advice: Dont wait. Get your flu shot as soon as its available.
Barron reminds people that it takes about two weeks after you get your flu shot for the vaccine to fully go into effect.
Getting your flu shot relatively early this year in September or October is the best way to brace yourself for what could be an early, virulent flu season.
The flu vaccine will protect you for four to six months. If youre a little off on your timing, thats fine. Its best to be early this year. If you get your shot too late, it just means youre more at risk of getting the flu, said Barron, who is also a professorat theUniversity of Colorado School of Medicineon theAnschutz Medical Campus.
We consulted with Barron about how the flu season played out in Australia and what could happen during the fall and winter months in the U.S. She also answered some frequently asked questions about the flu and how COVID-19 may affect the flu season.
We wont really know until it hits us, Barron said. I would love for us to change the course of the flu this year. If we get enough people vaccinated and were smart, maybe we can do that. But we wont know exactly what happens with the flu until it starts to spread.
Its very difficult to predict exactly how this years flu season will play out, Barron said. But, the best indication of what could happen here is to look at what happened with flu cases in the southern hemisphere. So, Barron keeps close tabs on reports from Australian infectious disease experts.
And in the southern hemisphere, the flu hit early and hard this year. Its more typical for flu cases to peak between July and September in Australia. This year, they began climbing in April and peaked at very high levels in May and June. (Please see the chart below from Australian health officials.)
This year, Australian health officials saw a larger spike of flu cases than they had in several years.
If you look at the COVID-19 years, flu cases rarely hit the radar. But if you look at the slope of the curve in Australia and how quickly people got sick, it took off fast, Barron said.
Their peak was early. Thats comparable to November and December here (when cases typically peak in the U.S. in January and February). Thats what Im worried about, Barron said.
The COVID-19 pandemic dramatically reduced cases of the flu around the world. Stay-at-home measures and interventions like masking and social distancing, reduced cases of COVID-19 and also prevented the spread of the flu. So, in both 2020 and 2021, flu cases were much lower than in typical years. Now, as people are resuming their normal activities and few are taking precautions like wearing masks regularly, the flu can spread more easily.
In addition, our bodies immune systems arent used to fighting the flu, so we may be more vulnerable this fall and winter, Barron said.
We havent had exposure for two years, so when it comes to flu, our immune systems arent revved up and ready to go, Barron said.
She uses the analogy of running.
If youre training for a marathon, its time to start running again. You cant rest on your laurels, like your fitness in the past. Its time to log some miles and get your immune system up and ready again because the flu is coming, Barron said.
Yes. Its perfectly safe to get both shots at the same time, Barron said. And thats really convenient. Many people will want to do exactly that in September and October of this year. If everyone who is eligible gets both a new flu and COVID-19 shot this fall, we could dramatically reduce severe cases of both flu and COVID-19 this fall and winter, Barron said.
Getting an annual flu and COVID vaccine could become our new normal, and in future years, the two vaccines could be combined into one vaccine.
Most medical facilities are getting flu shots now. Check with your doctors office or your employer and book an appointment soon.
The new COVID-19 booster shots that specifically fight the newest omicron variants recently have been approved by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. Like flu shots, these new COVID-19 boosters should be available throughout the U.S. within days.
Barron advises people to get their flu shots as soon as possible, and definitely by October.
No vaccine is perfect. And flu vaccines are especially complex, Barron said. Thats because vaccine makers have to guess in advance which flu strains will be circulating later that year. Then they create a vaccine that they hope will fight the prevailing flu strains.
During some years, the flu vaccine works better than in other years.
But even when its not a perfect match, getting the flu vaccine can dramatically reduce hospitalizations and deaths from the flu.
It keeps you out of the hospital and it keeps you from dying, Barron said.
Thats why her advice is quite simple now: Get your flu vaccine.
This is probably going to be a bad flu year. Please protect yourselves, she said. For the past few years, weve been focused on COVID, COVID, COVID. But, we did see a surge of the flu in May of this year. Thats a preview of what could happen this fall and winter. A lot of people could get sick. The flu will be back.
The flu shot does not give you the flu. The shot does not contain live virus. As with any vaccine, there can be side effects, but those are normal, Barron said. If you get the flu after you get the flu shot, you were going to get it anyway. Thats just a case of bad timing and bad luck. The best way to avoid getting the flu is to get your flu shot as early as possible.
Yes. Theres a high dose flu shot for people over age 65. Its meant to give you an extra boost to your immune system, Barron said.
When you schedule your flu shot with your medical provider, if you are older, you should automatically get the specially-formulated shot for older adults. But, of course, its wise to ask about which type of flu shot you are getting.
County health departments across North Georgia will soon be administering drive-thru flu shots.District 2 Public Health announced this week that all 13 county health departments it oversees will offer the drive-thru clinics in the coming weeks (see schedule below).
Habersham Countys drive-thru flu clinic is scheduled from 8:30 a.m.-4:30 p.m. on Monday, October 3. White Countys is Tuesday, Oct. 18 at Cleveland Worship Center. Banks, Rabun, and Stephens are among the counties that have scheduled at least two clinics one each in October and November (see schedule below).
Emergency Preparedness Director, Mark Palen, encourages the public to take advantage of the service.
Not only does this help our citizens get flu shots easily, but it also serves as an important emergency preparedness medical countermeasures exercise for our public health nurses and health department staff, he says.(Source: District 2 Public Health)
According to the CDC, everyone 6 months and older should get a flu shot, it is especially important for those 55 years old and older, and persons with certain medical conditions who may experience more severe illness from the flu virus.
The quadrivalent vaccine (four-in-one) will serve as the regular flu vaccine and will protect against four different strains of flu, both A and B strains of the influenza viruses. The high-dose vaccine, which is also a quadrivalent vaccine, will be available for persons 65 and older.
The flu vaccine will be administered at no cost to those on Medicare, Medicaid, and most commercial insurances.
If an individual chooses to pay out of pocket, the cost is $30 for the regular flu vaccine and $66 for the high-dose.Click to enlarge (Source: District 2 Public Health)
Individuals who would like to receive their flu shot at drive-thru clinics must be 18 years old and older. We encourage residents to wear masks, says District 2 spokesperson Natasha Young.
For more information about your county flu shot drive-thru or to learn more about the different flu vaccine options visit the flu page on the District 2 Public Health website.
To learn more about the influenza virus and how to protect yourself from the flu visit www.cdc.gov/flu.
"Since so many have isolated and quarantined and been wearing masks for the last few seasons, we're expecting now that everybody's dropped their guard and returned to a normal lifestyle, that we might have an increase in the amount of flu cases this year," said Turba. "So vaccination is always important, but I think this year that we might have more exposure than we've had in the previous few years."
