This will be the last situation report for this event for 2022. Reports will resume on a biweekly basis starting January 5, 2023.
Pediatric units in hospitals remain strained across the US. While some states have seen improvements, pediatric bed utilization is high overall, with 17 states reporting over 80% pediatric beds in use.
RSV has peaked in some areas of the US, and influenza shows signs of plateauing at the national level. However, many jurisdictions continue to experience high hospitalization rates, and clinicians are concerned about additional surge following winter holiday travel and gatherings.
If COVID-19 hospitalizations continues to trend upward, further strain on healthcare infrastructure and workforce may impact patient care. In previous seasonal surges of COVID-19, workforce surge capacity was offset due to lower numbers of pediatric cases (e.g., in 2020). However, with both pediatric and adult clinicians experiencing high case and hospitalization burdens, there is little to no margin for workforce to augment populations they do not typically care for.
As of 12/21, there is no response to AAP and CHA’s 11/15 letter calling for government officials to declare a public health emergency for RSV. Federal officials point to the lack of local and state requests for an emergency declaration through departments of health and mayoral/gubernatorial offices.
Healthcare Ready developed a report explaining how emergency declarations can strengthen public health capabilities and surge capacities in this response. Healthcare Ready recommends that healthcare systems advocate for local declarations to access immediate resources at the state and regional levels.
On 12/22, CDC’s Health Alert Network (HAN) issued a Health Advisory to notify clinicians and public health authorities of a recent increase in pediatric invasive group A streptococcal (iGAS) infections.
Amoxicillin and oseltamivir remain on ASHP and FDA shortage lists.
Oseltamivir Oral Suspension and Capsules of various sizes from 10 different companies remain on the ASHP shortages list, but are not yet on the FDA list. According to ASHP: Ajanta and Alembic have oseltamivir available to contracted customers. Alvogen has oseltamivir suspension and capsules available. Genentech has Tamiflu presentations available and is reviewing orders. Strides has oseltamivir capsules available.
The two largest pharmacy chains, CVS and Walgreens have started implementing limitations on purchasing children’s pain relief and fever reducing over the counter medicines. These measures are meant to protect supply of these products, which are not yet in shortage but are experiencing localized disruptions due to demand. CVS purchases are restricted to two items online and in-store, and Walgreens is limiting buys to 6 items online (in-store purchases are not limited).
Healthcare Ready is regularly updating a map showing HHS data on pediatric hospital bed utilization. The map was last updated with data from 12/21.
Healthcare partners are reporting that many facilities are compared to the number of licensed beds for a facility, instead of staffed and equipped beds. This may be artificially inflating bed availability in many places experiencing staffing and equipment shortages. Healthcare Ready is working to develop a new model for bed availability reporting but will report official data in the meantime. Our mapping tool notes this complication.
Healthcare Ready is ENGAGED for this event. We are monitoring potential concerns for supply chain disruptions and impacts on healthcare services on our Pediatric Surge in Respiratory Illness response page, listing resources and previous situation reports.
Assessment of Healthcare and Logistics Impacts
Background
The confluence of respiratory illnesses is creating a surge in severe clinical presentations and hospitalizations that threaten healthcare delivery systems. Influenza and RSV activities are higher than usual for this time of year, due to relaxed pandemic-related preventative measures.
Healthcare Ready is working to understand these impacts to best support communities with the greatest needs.
Pediatric Hospitalizations
Pediatric units in hospitals remain strained across the US. While some states have seen improvements, pediatric bed utilization is high overall, with 17 states reporting over 80% pediatric beds in use.
As of 12/21, 71.85% of pediatric beds are occupied (+2.11 percentage points from 12/13), with four states reporting bed utilization above 90%. Bed utilization estimates may be underestimated due to low participation from hospitals reporting into HHS TeleTracking. For 12/21 data, 69% of US hospitals were reporting. Local capacity may vary drastically within a given state as not all hospitals report data. As such, hospital capacity is likely more strained than reflected in the available data.
As of 12/21, states with the highest rates of in-patient pediatric bed utilization are: Idaho: 95.31% (-49.43 percentage points), Nevada: 92.45% (-7.55), Arizona: 92.65% (-1.32), Utah: 80.72% (-10.9), Rhode Island: 95.95% (+6.32), District of Colombia: 89.64% (+0.59),Texas: 86.80% (+1.26), Oregon: 82.82% (-5.47), Minnesota: 84.39% (-3.61), Missouri: 88.65%, New Mexico: 87.83%, North Dakota: 81.93%, Connecticut: 81.26%, Virginia: 81.06, Washington state: 80.70%, and Oklahoma: 80.23%.
If the upward trend of COVID-19 hospitalizations continues into the respiratory season, healthcare institutions might end up dealing with compounding crises and surge, putting further strain on healthcare infrastructure and workforce. In previous COVID-19 surges, there was some room for workforce surge – in the 2020 surges of adult patients, pediatric clinicians were available to bolster care because pediatric patients were not severely impacted. However, with both pediatric and adult clinicians experiencing high case and hospitalization burdens, there is little to no margin for workforce to augment populations they do not typically care for.
As of 12/14, vaccination of children for both COVID-19 and influenza remain very low. American Academy of Pediatrics analysis based on CDC data shows only 11% of children aged 6 months to 4 years old have received at least one dose of the COVID-19 vaccine.
On 12/22, CDC issued a Health Advisory to notify clinicians and public health authorities of a recent increase in pediatric invasive group A streptococcal (iGAS) infections. The Health Advisory highlights the recent rise in iGAS infections in children, the increased seasonal risk of iGAS disease for all age groups, and the importance of early recognition, diagnosis, and appropriate treatment of these diseases in children and adults.
If Streptococcus A infections continue to spread globally, the penicillin class of antibiotics, which includes already disrupted amoxicillin formulations, may see greater disruptions in an already strained market.
RSV
Data shows that rates of RSV cases and hospitalizations may have peaked in some areas of the US. However, lack of comprehensive localized (smaller than state-level) data leaves gaps in national picture of when and where cases are peaking. Disclaimer: The following analysis is based on the limited available data for RSV.
CDC National Respiratory and Enteric Virus Surveillance System (NREVSS) RSV laboratory test data show:
RSV cases in HHS Region 8 (Montana, Wyoming, Utah, Colorado, North Dakota, and South Dakota) have likely peaked regionally. Cases in some states in the Region may not have peaked: state level data shows a continuous upward trend in 3-week averages for RSV PCR test positivity in Montana, though this measure may be plateauing. State level data shows a downward trend in 3-week averages for RSV PCR test positivity in Wyoming, though total PCR tests in the state are relatively low (so it is possible some cases have not been captured). PCR test positivity for North Dakota and Colorado indicates cases in those states are trending downward. South Dakota’s PCR test positivity has shown an inconsistent (not continuous) upward trend; it is unclear if this indicates a peak in cases. Data for Utah is not available.
Cases in Region 10 (Washington, Oregon, Idaho, Alaska) may be peaking in some states, while others continue to rise. PCR test positivity for Idaho shows the upward trend in 3-week averages for RSV PCR test positivity may be peaking or plateauing, though the 3-week average positivity for antigen tests have continued to rise. PCR test positivity in Alaska shows PCR test positivity may have peaked. Oregon data shows a downward trend in cases in 3-week averages, though detections remain high. Data from Washington state show a continuous downward trend in 3-week averages for RSV PCR test positivity.
Antigen tests for Region 9 (California, Nevada, Arizona, Hawaii) show RSV cases may be rising in the region again, though positivity is far from the peak that was seen in late October. Three-week averages show a decline in PCR test positivity for the region overall.
WRAP-EM subject matter experts released a 10-minute video "Just-in-time Bronchiolitis Pearls and Pitfalls,” which is intended to be an overview to bronchiolitis care for providers with limited pediatric experience.
For the week ending 12/10, CDC reports that “seasonal influenza remains high but appears to be declining in some areas.”
Influenza-like illnesses (ILI) levels are very high across the United States for the week ending in 12/10. Forty-eight (+2) states, New York City, Puerto Rico and the District of Columbia are experiencing high to very high levels of ILI. Nine (- 3) of the jurisdictions are reporting ILI activity level 13, the highest possible. Those jurisdictions are: Colorado, Idaho, Kentucky, Nebraska, New Mexico, Oklahoma, Tennessee, Washington, and New York City. Connecticut, District of Columbia, New Jersey, and Virginia are no longer at level 13, but continue to have very high activity (level 12).
Very high ILI activity, levels 11-13, indicates that flu activity is 12-20 standard deviations present above the mean, indicating that the area’s infrastructure, workforce, and supply chain capacities might not be able to accommodate local needs without additional assistance.
HHS Region 10 (Alaska, Idaho, Oregon, Washington State) has the highest rate of pediatric mortality (1; rate is calculated as number of deaths reported per 100,000 inhabitants age 17 or younger) followed by Region 4 (0.7).
The number of influenza-related hospital admissions reported to HHS Protect system decreased during week 49 as compared to the previous week, but remain high compared to recent seasons.
CDC estimates that this season, there have been at least 15 million influenza infections, 150,000 hospitalizations and 9,300 influenza-related deaths. For comparison, CDC estimates that there were 9 million influenza infections, 4 million medical visits, 100,000 hospitalizations, and 5,000 during the entire 2021-2022 season.
The test positivity rate increased slightly to 25.4% (+0.6 percentage points) compared to the week ending 12/03 (24.8%).
For the week ending in 12/10, the 0-4 age group experienced the highest rates (15.9%; - 1.2 percentage points compared to the week ending 12/3) of outpatient visits for influenza-like illnesses.
National-level data shows a slight decrease (compared to the prior week) in new hospital admissions of pediatric patients with confirmed COVID-19. New admissions of elderly patients increased since the week ending in 12/10. New admissions of patients with confirmed COVID-19 have shown a continuous upward trend overall that began in late October. As of 12/18, compared to the average admissions for the week ending 12/11:
People ages 0-17: -6.3% new admissions per 100,000
People ages 70+: -5.8% new admissions per 100,000
On 12/09, CDC expanded the eligibility for the updated COVID-19 bivalent vaccines to include children ages 6 months through 5 years.
The COVID-19 public health emergency (PHE) provides federal, state, and local flexibilities in regulation and funding support for the response to RSV and flu. If the COVID-19 PHE is not renewed before its expiration mid-January 2023, between 5.3 and 14.2 million Medicaid enrollees could lose their coverage between January and April 2023.
It is expected that the PHE will be renewed at least one more time, which would move the expiration date to April 2023. Despite this, on 12/19 25 governors sent a letter to President Biden requesting he end the Federal PHE. If the Federal PHE is rescinded, measures relied upon by hospitals to manage ongoing surge, including 1135 waivers, staff redeployment flexibilities, and telemedicine flexibilities, will no longer be available. This would further limit surge capacity of hospitals.
Federal funding for COVID-19 vaccines might run out as early as in January 2023, at which point COVID-19 vaccines and therapeutics will become available only via the commercial market.
According to an analysis from the Kaiser Family Foundation, “private insurers will be required to take on more of the cost of vaccines (including paying for the doses themselves once the federal supply runs out), which could have a small upward effect on premiums.”
Implications for how these changes may affect vaccine availability and out-of-pocket costs to patients will become clearer as the commercial cost of vaccines and mechanisms for distribution and purchasing are defined.
Health Equity Concerns
Some reporting suggests pediatric patient transport, which is already constrained due to staffing, availability of hospital beds that are staffed to receive a patient, and specific supplies needed to transport a child, is especially challenging for rural areas. Ability for rural areas to move patients, especially across state lines, may be limited.
Reporting suggests that the shortage of pediatric beds for patients is related to a “years-long trend among hospitals of eliminating pediatric units” because pediatric units tend to be less profitable than adult counterparts. More than 180 rural hospital closures since 2005 also likely contributes to scarcity of beds and increases strain on existing adult and pediatric units.
Children with underlying conditions, especially obesity and diabetes, are more likely to experience severe COVID-19 and hospitalization. According to data from CDC’s COVID-19 Associated Hospitalization Surveillance Network (COVID-NET), during the 2021-2022 Omicron surge (December 2021 – February 2022): 70% of hospitalized children had an underlying medical condition, 19% were admitted to an intensive care unit, and children with diabetes and obesity were more likely to experience severe COVID-19.
For the limited areas tracked by CDC’s RSV-NET* for the week ending 12/17, hospitalization rates for all races and ethnicities have fallen compared to the previous week.
Source: CDC RSV-NET Interactive Dashboard. Accessed: December 22, 2022.
Healthcare Ready centers building equity into preparedness, response, and recovery resources, including this report. To learn more about Healthcare Ready’s core belief of why it is important to highlight vulnerable populations during disasters, read our Equity Framework.
Government Response
Federal Posture
On 12/22, CDC’s Health Alert Network (HAN) issued a Health Advisory to notify clinicians and public health authorities of a recent increase in pediatric invasive group A streptococcal (iGAS) infections. CDC has also created an advisory page for possible increase in iGAS infections in the US where it outlines what actions parents, healthcare providers, and laboratorians should do if they suspect a child might be infected with Streptococcus A.
On 12/20, CDC’s HAN issued the alert, “Important Updates on COVID-19 Therapeutics for Treatment and Prevention.”
The alert supplements previous advisories that emphasize that the majority of Omicron sublineages circulating in the US have reduced susceptibility to the monoclonal antibody bebtelovimab and the monoclonal antibody combination, cilgavimab and tixagevimab (EvusheldTM). Due to this resistance, as of 11/30, use of bebtelovimab is not FDA authorized for patients with COVID-19.
General recommendations for clinicians and public health practitioners; and,
Guidance for prioritization when antiviral supplies are limited (per medical setting, age, and condition)
On 12/2, Secretary of the Department of Health and Human Services Xavier Becerra sent a letter to state governors providing guidance on how to deal with the pediatric hospitalization crisis. The letter reiterates the resources and tools that are available, including flexibilities under the COVID-19 PHE declaration, as well as funding available from the Centers for Disease Control (CDC).
An emergency declaration would grant waivers for certain Medicare and Medicaid programs and the Children’s Health Insurance Program (CHIP).
PHE waivers for Section 1135 of the Social Security Act waiver would allow for easier movement or transfer of patients, use of new spaces for care, creation of offsite triage to manage capacity challenges, adaptation to workforce shortages, and licensure reciprocity to enable cross-state care, including telehealth.
CDC issued an official Health Advisory on 11/14 about rising rates of RSV and the co-circulation with COVID-19 and influenza and its potential impact on healthcare systems.
State and Local Posture Healthcare Ready developed a report explaining how emergency declarations can strengthen public health capabilities and surge capacities in this response. Healthcare Ready recommends that healthcare systems advocate for local declarations to access immediate resources at the state and regional levels.
The following table summarizes states with active emergency declarations or states of emergency for COVID-19 and/or respiratory surge. Nine states are under a state-level emergency declaration for COVID-19. Two states (Oregon and Colorado) are under a state of emergency specific to respiratory surge.
State
Active state of emergency?
Notes and other emergency measures
California
Yes, for COVID-19
On 11/11, California Health and Human Services Agency issued a Guidance for Response to Surge in Respiratory Viruses among Pediatric Patients. The guidance prescribes space waivers and program flexibilities under Title 22 California Code of Regulations.
Colorado
Yes, for COVID-19 and Other Respiratory Illnesses
On 12/10, Governor Jared Polis extended COVID-19 and Other Respiratory Illnesses Disaster Recovery Order until January 10, 2023. The executive order strikes out the sole mention of "COVID-19" and refocuses state's efforts on recovery to incorporate RSV, influenza, and other respiratory illnesses in the state into the disaster declaration.
Connecticut
Yes, for COVID-19
Connecticut is under a Public Health Emergency for COVID-19. The PHE is set to expire on 12/28/2022.
Delaware
Yes, for COVID-19
On 12/9, Governor John C. Carney extended the COVID-19 public health emergency (PHE) for a month for the tenth time, under which all PHE provision remain in full force. The extension of the PHE assures laboratory testing prior authorization requirement are annulled and, laboratory testing waivers stays in place amongst others.
Illinois
Yes, for COVID-19
On 12/08, Governor J.B. Pritzker issued a new COVID-19 disaster proclamation through an executive order. While neither the new disaster proclamation or executive order mention respiratory illnesses than COVID-19, the documents enable: the extension of mitigation measures; vaccination, testing, and public assistance requirements; financing of licensed medical professional through state funding; waiver of requirements for professionals counselors, clinical professional counselors, social workers, and clinical psychologists; and access to telehealth.
Kansas
Yes, for COVID-19
The Executive Orders and law allowing emergency measures for COVID-19 response in Kansas are in effect until January 2023.
Massachusetts
No
On 11/21, Massachusetts Governor Baker extended a COVID-19 related policy allowing acute care hospitals to use alternative spaces to help facilities manage pediatric medical surge associated with RSV.
New Mexico
Yes, for COVID-19
On 12/1, New Mexico Department of Health (NMDOH) issued a public health order facilitating inter-hospital communication, issuance of waivers from the state's department of health, monitor oxygen supply and any possible shortages and issue public health advisories to New Mexico residents in English, Spanish and other languages.
Nevada
No
On 12/5, Governor Steve Sisolak's Office said that arrangements have been made to ensure pediatric hospitalization surge staffing needs are met by Nevada State Board of Nursing (NSBN) fast-tracking the licensing applications.
Ohio
No
On 11/9, the State of Ohio Board of Pharmacy issued guidance allowing pharmacies to compound amoxicillin by combining it with other drugs or via dilution.
Oklahoma
No
On 11/12, the Oklahoma State Department of Health allowed hospitals to designate adult beds for pediatric use.
Oregon
Yes, for Surge in Pediatric Respiratory Infections
On 12/7, Governor Kate Brown issued executive order No. 22-24 expanding the 11/14 declaration of emergency and calling for Oregon Health Authority (OHA) and other state agencies to deploy emergency volunteer health care workers and designate emergency health centers. On 11/14, Governor Kate Brown issued an executive order No. 22-23 under ORS Chapter 401 to support hospitals during the pediatric RSV response, and Oregon declared a public health emergency.
Rhode Island
Yes, for COVID-19
On 11/10, Governor Dan McKee extended COVID-19 state of emergency declaration executive order 20-2 through January 10, assuring all flexibilities guaranteed under emergency declaration remain in place.
West Virginia
Yes, for COVID-19
West Virginia Department of Health and Human Resources (WVDHHR) will continue to provide the public with the latest COVID-19 data after the State of Emergency declaration is lifted on January 1, as mandated by Governor Jim Justice's proclamation from November 12.
Potential Threats for Pediatric Medical Surge
Several challenges are unique to managing pediatric medical surges, particularly for the healthcare workforce and supply chain. For one, pediatric hospitals require more intensive nursing resources to treat and monitor patients, especially in intensive care and neonatal intensive care units.
Additionally, pediatric supply chains can also be more vulnerable to supply chain disruptions, as some critical products have only one supplier or manufacturer capable of producing the necessary pediatric-specific equipment and supplies.
Product Availability
The repeal of China’s COVID Zero policies have led to a surge in COVID cases. Pharmaceutical companies around the world rely on active pharmaceutical ingredients (APIs) and key starting materials from abroad, including China. Without reliable reporting from China’s economic partners, analysts are keeping a close eye for any warning signs of supply chain disruptions in every sector.
Amoxicillin
Amoxicillin remains in short supply.
The majority of amoxicillin production facilities are located overseas. Domestic amoxicillin capacity is limited by staffing and active pharmaceutical ingredients (API) constraints, as well as reduction of capacity due to low demand in recent years.
The lack of guaranteed demand prior to the respiratory season is driving a lack of surge capacity. Manufacturers of amoxicillin and other antibiotics typically determine production amounts prior to respiratory season based on the amount ordered. Manufacturers typically do not manufacture additional product beyond what is ordered because profit margins for the product are small; it would be a major risk to overproduce and not sell additional product. Contracts that guarantee demand (between manufacturers and government, distributors, and/or providers) may help mitigate shortages for future respiratory seasons.
As of 12/22, multiple forms of amoxicillin remain on the FDA and ASHP drug shortage lists. This includes tablets, capsules, and powder for suspension. Providers and patients continue to experience impacts.
Tamiflu and its generic oseltamivir remain in high demand. As of 12/22, both the oral suspension and capsule formulations of oseltamivir remain on the ASHP shortages list. Oseltamivir is not currently on the FDA shortage list.
Other alternative influenza antivirals include Xofluza, Rimantadine, Zanamivir. There are no reported shortages for these drugs.
FDA notes that while certain variations of Tamiflu are unavailable, there are no reported shortages (as of 12/22) among many companies.
The two largest pharmacy chains, CVS and Walgreens have started implementing limitations on purchasing children’s pain relief and fever reducing over the counter medicines. CVS purchases are restricted to two items online and in-store, and Walgreens is limiting buys to 6 items online (in-store purchases are not limited).
The shortages of pediatric pain relievers as well as influenza and other respiratory illness medications will have compounding impacts on the surge in hospitalizations. If parents and caregivers cannot find medication for their sick children, their condition may worsen, and the parents will have no choice but to bring their children to the pediatric hospital or emergency room where we continue to see long wait times for access to healthcare. It is critical to continue mitigating supply chain disruptions around the pediatric drug shortage before hospitalization rates increase further.
ASHP’s current drug shortages list includes the following drugs that could negatively impact treatment of RSV and other respiratory illnesses:
Reverified 12/22: Oseltamivir Oral Suspension and Capsules of various sizes from 10 different companies have been added. Ajanta and Alembic have oseltamivir available to contracted customers. Alvogen has oseltamivir suspension and capsules available. Genentech has Tamiflu presentations available and is reviewing orders. Strides has oseltamivir capsules available. The sizes/formulations that are in shortage will either release in late December 2022, are on allocation right now, or the company cannot estimate a release date.
Reverified 12/22): 0.9% Sodium Chloride Small Volume Bags (< 150 mL) of various sizes from six different companies have been added. There are a multitude of reasons for the shortage including increased demand, manufacturing delays, and labor shortages. A number of the companies have supplies on allocation as they work through this shortage while Fresenius Kabi expects a release date of mid-to-late December.
Reverified 12/22:0.9% Sodium Chloride Large Volume Bags of various sizes from five different companies have been added. The majority of companies stated that the reason for the shortage was due to an increase in demand. Additionally, a majority of the companies have product on allocation to their customers while Fresenius Kabi estimates a release date of mid-to-late December for the 250, 500, and 1000 mL bags.
Reverified 12/22:Ibuprofen Oral Suspension (Prescription Products Only) from Teva has been added. While no reason for the shortage has been provided, we can assume it is due to or exacerbated by the surge of respiratory illnesses impacting the nation. There has been no estimated resupply date.
Reverified 12/22: 0.9% sodium chloride vials of various sizes from Fresenius Kabi and Pfizer have been added. The shortage is likely caused by increased demand, related to the application of sodium chloride for respiratory therapy. Pfizer has 0.9% sodium chloride 10 mL vials on backorder and the company estimates a release date of May 2023. Fresenius Kabi has 0.9% sodium chloride vials available.
Reverified 12/22: 23.4% Sodium chloride injection of various formulations from Fresenius Kabi and Pfizer have been added. Both Fresenius Kabi and Pfizer have said the shortage is due to an increase in demand. Expected resupply dates are from mid-December 2022 to January 2023.
Reverified 12/22: Ceftazidime Injection (and its generic name Tazicef) from Pfizer, Sagent, and BBraun have been added. The shortage is due to increased demand, likely due to the fact that ceftazidime is used to treat a wide variety of bacterial infections and providers could be prescribing this drug as a remedy to respiratory symptoms.
Reverified 12/22: Rocuronium injection, used during tracheal intubation, is in shortage from several manufacturers due to increased demand and manufacturing delays. Estimated resupply dates vary based on manufacturer.
FDA’s drug shortage database lists the following updates regarding drugs that may be related to treating respiratory illness:
Reverified 12/22: Amoxicillin oral powder for suspension is available for current customers from Hikma pharmaceuticals. As of 12/6 most of the amoxicillin oral powder product for suspension from Sandoz is unavailable while some has limited availability. Additionally, as of 12/6, products from Aurobindo and Teva are on allocation.
Reverified 12/22: albuterol sulfate, a bronchodilator for oral inhalation, manufactured by Akorn Pharmaceuticals, remains unavailable and is estimated to be back in stock by Q2 2023. A 5 mL version from Nephron Pharmaceuticals is available.
FDA’s medical device shortage database lists the following updates regarding medical devices that may be related to treating respiratory illness:
Definitions for product shortage vary by organization. Healthcare Ready sources data from multiple organizations that maintain drug shortage lists, including:
American Society of Health-System Pharmacists (ASHP), which defines a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”
US Food and Drug Administration (FDA), which defines a drug shortage as “a situation where the total supply of all versions of the approved product available at the user level will not meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.”
On 11/22, the FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 and influenza multiplex test for use in a point-of-care (POC) setting. This will expand the testing kit pool as well as reduce the strain on the testing kit supply chain as two tests are combined into one.
Treatments for RSV
A monoclonal antibody therapy called palivizumab is available as a precautionary measure to prevent severe RSV illness in certain infants and children at high risk for severe disease during the normal respiratory season. It cannot cure or treat children who are already suffering from severe cases of RSV; it is a preventative treatment.
On 11/17, AAP updated its guidance: Given the known efficacy of palivizumab along with the unpredictable surge capability of RSV, AAP recommends programmatic consideration of providing more than five consecutive doses of palivizumab depending on the duration of the current RSV surge in a particular region of the country.
Palivizumab is sold under the brand name Synagis, and is marketed by Sobi in the United States. Sobi purchased US rights to Synagis from AstraZeneca in 2018. Before COVID-19, physicians prescribed Palivizumab more frequently as a preventative measure, yet, this treatment strategy slowed during the pandemic.
Workforce Shortages
Workforce shortages continue to impact access to care in hospitals around the country. Resident physicians, doctors, hospitals staff are advocating for increased federal support.
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