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Author: Rishi Sharma

Developments in RSV Biologics

Developments in RSV Biologics

Respiratory syncytial virus, or RSV, is a negative-sense, single-stranded RNA virus. It is a common respiratory virus that usually causes mild, cold-like symptoms. In most regions of the United States, RSV season starts in the fall and peaks in the winter.  

Although most people who develop RSV infection have mild illness, certain individuals are at risk for severe disease and death. It is estimated that between 60,000 and 160,000 older adults are hospitalized due to RSV, and between 6,000 and 10,000 older adults die due to RSV each year.  
 
Among children younger than 5 years, 58,000 to 80,000 are hospitalized each year due to RSV; and 100 to 300 die from it.  

Those at high risk for severe illness from RSV include: 

  • Premature infants 
  • Infants, especially those 6 months and younger 
  • Children younger than 2 years old with chronic lung disease or congenital heart disease 
  • Children with suppressed immune systems 
  • Children who have neuromuscular disorders, including those who have difficulty swallowing or clearing mucus secretions 
  • Older adults, especially those 65 years and older 
  • Adults with chronic lung or heart disease 
  • Adults with weakened immune systems 

Vaccine Developments 

In 2004, the U.S. Food and Drug Administration (FDA) approved Synagis (manufactured by Sobi) the first monoclonal antibody used to prevent severe disease caused by RSV in high-risk infants. It must be given monthly throughout the RSV season. 

In May 2023, FDA voted in support of approval for RSVpreF, Pfizer’s vaccine candidate to prevent severe disease caused by RSV in infants through vaccination of pregnant people. RSVpreF is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV. The FDA’s decision on the potential approval of RSVpreF is expected in August 2023. 

Also in May, the FDA approved two RSV vaccines, Arexvy and Abrysvo, manufactured by GSK and Pfizer, respectively. FDA approved both vaccines for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.  

In June 2023, the ACIP voted to recommend Pfizer and GSK’s adult RSV vaccines for adults 60 and older using shared clinical decision making.  

In July 2023, FDA approved nirsevimab (AstraZeneca and Sanofi), a monoclonal antibody that will be used to protect newborns and infants born during or entering their first RSV season. In contrast to Synagis, it will only have to be given once in a season. Nirsevimab is the first passive immunization product to be considered for inclusion by the ACIP in the CDC immunization schedule as a vaccine-like seasonal immunization. The ACIP will meet to discuss recommendations for implementation and inclusion in the VFC program on August 3. 

Vaccine/Antibody Availability and Insurance Coverage 

RSV vaccines for older adults are expected to be available this fall.  
 
These vaccines will be covered by Medicare Part D, Medicaid, and Affordable Care Act-compliant insurance plans. It is not yet known whether Arexvy and Abryvo will be included in the Vaccines for Adults at Risk (VFAAR) program. 

CDC is assessing whether nirsevimab will be included in the Vaccines for Children (VFC) program, so its cost and availability is unknown at this time.  

Developments in RSV vaccines are ongoing. Updates to vaccine product availability and insurance coverage of available vaccines are expected in the coming months.  

Interested in the COVID-19 Bridge Program?

Interested in the COVID-19 Bridge Program?

The Immunization Program will soon be launching a new vaccine program called the Bridge Program. Read on for more information, and complete the interest form below by July 14th!

The Bridge Program is a COVID-19 vaccine program for uninsured and underinsured adults 19 years of age and older in Philadelphia county.

The program will only offer COVID-19 vaccines for uninsured and underinsured adults, 19 and older.

Sites that wish to enroll in the Bridge Program will need to complete an enrollment form. This includes sites that are already enrolled in the COVID-19 program.

Provider Eligibility

  • Providers already seeing or are willing to see uninsured or underinsured adults, 19 years of age and older.
  • Providers who want to offer COVID-19 vaccine to their eligible patients.
  • Providers that can estimate the number of uninsured or underinsured adults their site currently sees or will see. Note: This information will be required on the Bridge Program enrollment form. Sites will not be able to enroll without this information.

Who counts as uninsured or underinsured?

  • Adults not covered by any health insurance plan.   
  • Adults who have health insurance, but coverage does not include any vaccines.
  • Adults who have health insurance, but coverage does not include all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP).
  • Adults who have health insurance, but there is a fixed dollar limit or cap for vaccines.

The Immunization Program expects to launch the Bridge Program in early fall, with an exact launch date still forthcoming, but in alignment with commercialization of COVID-19 vaccine.

To gain a better understanding of the numbers of sites interested in participating in the Bridge Program, we ask you to complete the above survey by Friday, July 14, 2023.

Commercialization of COVID-19 Vaccine

Commercialization of COVID-19 Vaccine

COVID-19 vaccine will soon be available for purchase on the commercial market and will be available to order through the Vaccines for Children (VFC) Program. We do not have an exact date or timeline for commercialization, but we want to provide as much lead time as we can for our VFC providers about this upcoming change.

Commercialization of COVID-19 vaccines will transition vaccines previously purchased by the U.S. government to established pathways of procurement, distribution, and payment by both public and private payers.

What does this mean?

There will not be a separate COVID-19 Provider Program as currently exists.

  • All VFC providers will be required to maintain a supply of COVID-19 vaccine for the entire patient population they serve. As with other ACIP recommended vaccines, your practice will need to stock COVID-19 vaccine for both VFC eligible children and privately insured patients once commercialization occurs.

Why is this important?

  • COVID-19 vaccine is an ACIP-recommended vaccine and has been added to the CDC Child and Adolescent Immunization Schedule.
  • Your patients may not have access to COVID-19 vaccine elsewhere. Pharmacies are not authorized to vaccinate kids under 3 years of age, so your practice may be the only place your patients can get vaccinated.
  • A very low percentage (<20%) of kids 6 months – 4 years have been vaccinated against COVID-19 in Philadelphia, which means they may not be protected against severe disease and death from COVID-19.

Did you know?

  • You don’t need an ultra-low freezer to store COVID-19 vaccine! You can store COVID-19 vaccines in your regular storage units.
  • Providers should never turn down an opportunity to vaccinate for COVID-19 due to fears of vaccine wastage! We expect smaller packaging sizes of vaccine to be available this fall with commercialization.

Please be on the lookout for updated messages from the Immunization Program about commercialization throughout the summer. Have questions or concerns? Direct them to vaccines@phila.gov.

Updated COVID-19 Delivery Schedule

Updated COVID-19 Delivery Schedule

With commercialization of COVID-19 nearing, PDPH will be reducing our capacity to deliver partial orders of COVID-19, placed through the Monday.com order form below. In June, we will deliver orders the week of the 12th and the week of the 19th. Any orders placed later in June will not be delivered until July. In July and August, we will deliver partial orders during the 3rd full week of the month. Please see the below ordering schedule for reference.

As we move forward with this new delivery schedule, sites will need to order slightly more vaccine to have enough supply to last them up to a month between orders.

If you have questions regarding COVID-19 deliveries, please email covidproviders@phila.gov.

Potential Risk for Resurgence in Mpox Cases

Potential Risk for Resurgence in Mpox Cases

Mpox cases in Philadelphia peaked in July 2022, and have since decreased significantly.

Around the country, there have been sporadic mpox cases in 2023. Chicago, however, has experienced a resurgence of mpox cases between April and May 2023.  
 
In May 2023, one mpox case was identified in Philadelphia after several months with no cases. More cases are expected to be identified in Philadelphia in the coming days and weeks.  
 
“Since there was one reported case in May, [I suspect] that there were others that were subclinical or went undiagnosed,” says Dr. Lenore Asbel, infectious disease expert at the Division of Disease Control.  
 
“As providers [and] the community were aware of the cases in Chicago, there [has been] a slight uptick in both providers offering and patients seeking vaccine. We are trying to be proactive as last year the increase coincided with Pride activities, travel, etc.” 

Mpox Cases in Chicago 

Of the mpox cases reported in Chicago, all were among men who were symptomatic, and none of these patients were hospitalized.  
 
9 out of the 13 patients who are known to have had mpox in Chicago between April 17 and May 5 had received 2 JYNNEOS vaccine doses.  

While patients who tested positive in Chicago were largely vaccinated, those who have been fully vaccinated are likely to develop milder symptoms than those who aren’t vaccinated. They are also less likely to transmit the virus to others.  
 
There have been 20 additional mpox cases reported in Chicago since May 5. Track reported mpox cases in Chicago here

What You Need to Know 

The CDC offers communication resources for providers to educate patients about mpox vaccination. Learn about how to reduce stigma when educating patients about mpox. 
 
Prepare your patients for the summer with resources for sexual health testing and mpox vaccination.  

VFC/VFAAR Re-enrollment Begins Today!

VFC/VFAAR Re-enrollment Begins Today!

The Philadelphia Vaccines for Children (VFC)/ Vaccines for Adults at Risk (VFAAR) annual re-enrollment period is now open!  

Sites enrolled in VFC and/or VFAAR must submit a re-enrollment form by June 30th  in order to continue to participate in these programs.
Follow these 3 easy steps, for a smooth re-enrollment!

1. Complete this survey
Your answers will help us better support you throughout the next year. A submission is required to complete re-enrollment for your site.

2. Update Clinic Tools
Update the information indicated for your site in the Clinic Tools, Clinic Information module. Use these job aids to guide you through making needed changes to the clinic tools page:

3. Use these job aids to guide you through the enrollment form step by step:

Do you have the access to PhilaVax that you need?

The vaccine coordinator and medical director must log into the PhilaVax IIS to access, complete and sign the electronic re-enrollment form. If you have not completed the 2023 User Confidentiality Agreement to renew your account or do not have a PhilaVax user account, use the link below to complete it now.

PhilaVax User Confidentiality Agreement 

If you have trouble accessing the above link or you have a PhilaVax account and need to update your password, you can email PhilaVax@phila.gov for assistance. 

We’re here to help! Having trouble, email DPHProviderHelp@phila.gov to connect with our team.

Vaccine Temperature Monitoring: New Paper Temperature Logs Available

Vaccine Temperature Monitoring: New Paper Temperature Logs Available

To ensure that the vaccine at your site is viable when administered to patients, consistent temperature monitoring is an important part of participating in the program. Our program requires sites to maintain active and passive monitoring. The passive monitoring is recorded by the Digital Date Logger (DDL) and reported to our program regularly. The active monitoring is recorded on the paper temperature logs.

Please download and review the updated documents below:
Fridge Temperature Log (Celsius)
Fridge Temperature Log (Fahrenheit)
Freezer Temperature Log (Celsius)
Freezer Temperature Log (Fahrenheit)

Please use the new logs and review the instructions to make sure you are documenting temperatures correctly.

Paper temperature logs are a requirement for the VFC, VFAAR, and COVID-19 programs and must be kept on file for at least 3 years.

Protecting Infants from Vaccine Preventable Diseases

Protecting Infants from Vaccine Preventable Diseases

National Infant Immunizations Week is April 24 to April 30 this year, serving as a reminder to protect infants in Philadelphia from vaccine preventable diseases.  
 
Over the years, immunization providers in the United States have reached major milestones in protecting infants through vaccines. Through immunization, we can now protect infants and children from 15 vaccine-preventable diseases before age 2.

Schedule and Updates 

View the CDC immunization schedule for children and adolescents.  
 
There are important updates to COVID-19 immunization recommendations for infants: 

Previously unvaccinated: Children 6 months through 5 years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of age). 

Previously vaccinated: Children 6 months through 4 years who previously completed their full two- or three-dose monovalent Moderna/Pfizer COVID-19 primary vaccination series are now recommended to receive a dose of Moderna/Pfizer’s updated (bivalent) COVID-19 vaccine.  

Children 6 months through 5 years of age who have received one, two, or three doses of a monovalent COVID-19 vaccine should receive a bivalent vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history. 

Healthy People 2030 

Philadelphia immunization providers have made measurable progress in infant immunization coverage. However, immunization rates fell during the COVID-19 pandemic, and have not yet returned to pre-pandemic levels. 

In Philadelphia, vaccination coverage with 4 doses of the DTaP vaccine in children between 0 and 2 years old was around 84% in 2021.  
 
Healthy People 2030 objective IID-06 is: Increase the coverage level of 4 doses of the DTaP vaccine in children by age 2 years. The target for this objective is 90%. 
 
Philadelphia providers have an opportunity to increase immunization coverage for this metric to reach or exceed the target by 2030. 

Local Data 

In addition to increasing DTaP vaccine coverage, Philadelphia providers can improve infant immunization coverage by focusing on addressing disparities
 
Local data shows that influenza vaccination coverage among infants was lowest at 55.8% among the lowest income group in the data set, as compared with 84.3% among the highest income group in the set. In addition, influenza vaccination coverage was 61.2% among Black infants and 61.9% among Hispanic infants, as compared with 73.8% among white infants. 

Rotavirus coverage was 65.7% among the lowest income group, as compared with 87.1% among the highest income group. Rotavirus coverage was 70.3% among Black infants and 69.8% among Hispanic infants, as compared with 84.1% among white infants. 

Preexisting social determinants of health such as economic burden, lack of transportation, and lower rate of insurance coverage contribute to these disparities. However, immunization providers can use multiple strategies to close the gaps in vaccination coverage.  
 
Strategies to increase vaccination rates among Black, Hispanic, and American Indian/Alaska Native communities include strongly recommending flu vaccination and making culturally appropriate vaccine recommendations (e.g. using materials with images representative of those in the community, addressing community-specific concerns and misinformation, and using the predominant language spoken in the community, such as Spanish). 

Providers can also work toward increasing vaccination coverage among low-income populations by using evidence-based strategies such as immunization reminders, standing orders to provide vaccination whenever appropriate, and immunization information systems. Additionally, review immunization schedules with parents at the child’s first visit to show vaccines that are upcoming.  

Resources 

Improving communication between providers and patients is crucial to increasing immunization coverage among infants in your office.  
 
Download and print coloring sheets for National Infant Immunizations Week. 
 
Talk with parents and caregivers about their infant’s missing immunizations. Continue the conversation and offer educational resources for caregivers who are hesitant. 

Increasing HPV Vaccine Uptake for All Ages 

Increasing HPV Vaccine Uptake for All Ages 

Increasing human papillomavirus (HPV) vaccination rates can be tricky, particularly due to the stigma associated with sexual behavior among adolescents. International HPV awareness day was March 4, and served as a reminder to continue local HPV vaccine promotion efforts.  
 
Nationally, HPV is estimated to cause 36,000 new cases of cancer each year. We have an opportunity to eradicate HPV-associated cancers, and yet too many people are not getting a safe and effective vaccine that prevents six different cancers associated with HPV including oral pharyngeal and cervical cancer.  
 
The HPV vaccine is approved for ages 9 years through 45 years. The American Cancer Society and American Academy of Pediatrics (AAP) recommend vaccination at age 9. 

Are We Making Progress? 
 
Healthy People 2030 vaccination objective IID-08 aims to increase the proportion of adolescents who receive recommended doses of the HPV vaccine. This objective is measured by tracking the proportion of adolescents aged 13–15 years receiving 2 or 3 doses of HPV vaccine.  
 
The objective’s target is 80%, and the latest national data indicate that 54.5% of adolescents have received the recommended doses. This is a slight improvement from previous years, but there is still progress to be made to achieve the desired target. 

Strategies for Increasing Vaccination Uptake 
 
Receiving a health provider recommendation for the HPV vaccine is the most effective strategy for improving vaccination rates. However, barriers such as parental hesitancy (for adolescents), insufficient provider recommendation, and time constraints can inhibit HPV vaccine uptake.  
 
Here are some tools and resources to boost HPV vaccine uptake in your practice:  

Administrative processes: 

  • Set your electronic health record and pharmacy notifications for patients aged 9 years through 45 years. Starting at age 9 has been shown to increase vaccine completion by 22 times
  • Review your patients who have not completed their 2 or 3 dose series and proactively recall patients to complete the series. Check adult patients through age 45 to ensure they have started and completed their HPV series.  
  • If you are not able to stock vaccine at your facility, leverage your local pharmacy to administer vaccinations to patients. 
  • Implement standing orders for immunization in your practice. 
  • Identify an immunization champion at your facility – the person who will take the lead of your standing orders program. 

Clinical encounters:

  • Make a strong recommendation for HPV vaccines for all patients aged 9 years through 45 years. Data shows that your recommendation may improve vaccination rates by up to 5 times. 
  • For adults aged 26 years through 45 years, engage in shared decision making to help determine whether the patient will benefit from vaccination. A vaccination recommendation should be made in all healthcare settings to include acute, non-acute, GYN, dental, and pharmacy locations. 
  • Encourage same day vaccination in your facility. 

This toolkit from the American Academy of Pediatrics (AAP) has patient-focused materials (social media graphics, videos, and articles) which can promote awareness of the HPV vaccine. Additionally, this AAP resource contains professional resources and printable PDFs to promote HPV vaccine education. 

What’s New With Pediatric Vaccines?

What’s New With Pediatric Vaccines?

This month, the Advisory Committee on Immunization Practices published updated immunization schedules for 2023. COVID-19 vaccine has been added to the routine pediatric immunization schedule for ages 6 months and up, among other important additions. There have been several recent changes to vaccine products for pediatric patients as well.  

ACIP Immunization Schedule Changes 

The changes in the Advisory Committee on Immunization Practices’ pediatric immunizations schedule  from 2022 to 2023 are:  

  • COVID-19 row: COVID-19 vaccination now recommended from age 6 months–18 years. 
  • Pneumococcal conjugate row: PCV15 has been added. It is interchangeable with PCV13. 
  • IPV row: A “See Notes” section has been added to the column for people aged 17–18 years. 

The changes in the catch-up immunization schedule for 2023 are:  

  • Pneumococcal conjugate row: Language has been revised. The text now reads “This dose is only necessary for children aged 12–59 months regardless of risk, or aged 60–71 months with any risk, who received 3 doses before age 12 months.” 

The changes in the immunization by medical indication schedule for 2023 are: 

  • COVID-19 row: A new row was added to summarize COVID-19 vaccination recommendations by medical conditions or other indications.  

View the full MMWR here

Product Changes

The changes in routine pediatric vaccine products from 2020-2021 to 2022-2023 are:  

  • MMR: Priorix added. 
  • Meningococcal conjugate (MCV4): Menactra discontinued, and MenQuadfi added. 
  • Pneumococcal conjugate (PCV15): Vaxneuvance added. 
  • Flu (IIV4):  
    • Flucelvax (multi-dose vial): now available at 6 mo+ instead of 2 yrs+.  
    • Flucelvax (single dose syringe): now available at 6 mo+ instead of 2 yrs+. 
    • Fluzone (multi-dose vial): now available at 6 mo+ instead of 3 yrs+.  
    • Afluria (pre-filled syringe): 0.25 mL pre-filled syringe for 6 – 36 months no longer available. 0.5 mL pre-filled syringe available at 3 yrs+.
    • Afluria (multi-dose vial): available at 6 months – 3 yrs for 0.25 mL dose and at 3 yrs+ for 0.5mL dose.

The American Academy of Pediatrics offers customizable reminder and recall resources for your practice to help ensure children are caught up on routine vaccinations. 
 
If you are not already a Vaccines for Children (VFC) provider, enroll your practice in the VFC program using this guide.