COVID-19 Vaccine Commercialization

Tuesday, September 12, 2023, marked the beginning of COVID-19 commercialization. Here are some important changes to be aware of in this new period of COVID-19 vaccination:  

1. The Department of Public Health’s COVID-19 program has formally ended.  

2. Bivalent COVID-19 vaccines are no longer authorized for use.  

3. The Advisory Committee on Immunization Practices (ACIP) approved the use of updated (monovalent) COVID-19 vaccines. 

4. Providers can order the updated COVID-19 vaccine for privately insured patients by directly contacting the manufacturers for each product (see below for more information). 

5. With the exception of certain specialty providers, all Vaccines for Children (VFC) providers are required to stock COVID-19 vaccine inventory for both privately/CHIP insured patients and VFC eligible patients.  

6. Philadelphia vaccine providers are encouraged to enroll in the Bridge Access Program to provide updated COVID-19 vaccines for uninsured or underinsured adults 18 years and older. 

The new COVID-19 vaccine products are monovalent (single), Omicron variant XBB.1.5. Under the new recommendation, everyone over 6 months is eligible for an updated COVID-19 vaccine this fall.   

Providers can place COVID-19 vaccine orders for VFC eligible patients and/or the Bridge Access Program eligible patients through the PhilaVax immunization information systems (IIS). A step-by-step ordering guide is available to assist with this. 

Recommendations for COVID-19 Vaccine 

• Everyone ages 5 years and older is recommended to receive 1 dose of a 2023-24 mRNA COVID-19 vaccine. 
• Children ages 6 months – 4 years should complete a multi-dose initial series (2 doses of Modera or 3 doses of Pfizer mRNA COVID-19 vaccine) with at least one dose of the 2023-24 COVID-19 vaccine. 
• People who are moderately or severely immunocompromised should complete a 3 dose initial series with at least one dose of the 2023-24 COVID-19 vaccine and may receive 1 or more additional 2023-24 COVID-19 vaccine doses. 
• Bivalent mRNA COVID-19 vaccines are no longer recommended. 

Available Products 

Pfizer 2023-24 COVID-19 Vaccine 

Comirnaty 12+ 

• FDA website 
• Package insert 

2023-24 COVID Vaccine 5 yrs – 11 yrs 

• FDA website 
• EUA 

2023-24 COVID Vaccine 6 mo – 4 yrs 

• FDA website 

• EUA 

Moderna 2023-24 COVID-19 Vaccine 

Spikevax 12+ 

• FDA website 
• Package insert 

2023-24 COVID Vaccine 6 mo – 11 yrs 

• FDA website 
• EUA 

Additional Resources 

• Immunize.org’s Ask the Experts 

If your office needs assistance placing an order or has questions, please reach out to dphproviderhelp@phila.gov. 

Purchase Vaccine for Privately Insured Patients 

To procure vaccine on the private market, please contact your local sales representative: 

• Pfizer: Brian Bengston, Brian.Bengston@pfizer.com 
• Moderna: Lynne Timby, Lynne.Timby@modernatx.com  
• Novavax: Rich Aceto, RAceto@novavax.com 

Guidance for Patients Regarding Vaccine Availability 

Patients are having some initial difficulty finding updated COVID-19 vaccine, especially pediatric doses. This is due to delays in shipping from manufacturers. The Health Department published recommendations for Philadelphians seeking updated COVID-19 vaccine doses. Read the recommendations here and consider sharing them with your patients. 

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.  

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. 

Notes From the Immunization Program:
Current Recommendations for Hepatitis B Vaccination

The Advisory Committee on Immunization Practices (ACIP) has modified its recommendations for hepatitis B (HBV) vaccination. The ACIP now recommends that all adults aged 19-59 years and adults aged 60 and older with risk factors receive hepatitis B vaccines. 

Ensure these groups are up to date on hepatitis B vaccination:  

• Infants  
• Children aged <19  
• Adults aged 19-59  
• Adults aged 60 and older with risk factors for hepatitis B  
• Risk factors include sexual exposures, people at risk by percutaneous or mucosal exposure, and others. A complete list can be found here. 

Adults aged 60 and older without known risk factors may also be vaccinated.

Why hepatitis B and why now?

In 2019, the United States saw a rise in acute hepatitis B cases. Opioid use, which remains a growing public health concern in Philadelphia, has contributed to this increase in cases nationally.  
 
To counter the rising incidence of acute hepatitis B in the U.S., ACIP expanded its recommendations for hepatitis B vaccination in November 2021. 

However, a national survey conducted in February 2022 revealed that 55% of family physicians were unaware of the updated hepatitis B vaccine recommendations, and only 8% had fully implemented the new recommendations. 

In Philadelphia, we have seen a small rise in the numbers of adults receiving hepatitis B vaccination following the new recommendations. However, the urge to vaccinate Philadelphians remains high. Pennsylvania has the fourth highest number of newly reported chronic HBV cases in the nation and Philadelphia accounts for most of these cases. Syringe exchange programs help decrease risky injection among drug users in Philadelphia, yet obstacles to safe injection persist.  

Healthcare professionals can continue to decrease morbidity by promoting hepatitis B vaccination. A vaccine recommendation from patients’ provider is the strongest predictor of whether patients get vaccinated. 

Strategies for increasing hepatitis B vaccination rates:

1. Do not assume that hepatitis B vaccination has been completed. ACIP guidelines state that only written documentation should be accepted as evidence of previous vaccination. 
2. Use Philadelphia’s immunization information system (IIS) to verify whether patients have received hepatitis B vaccination. Providers can register with PhilaVax IIS by completing this form. 
   • A PhilaVax login enables providers to use the ‘Patient Search’ module to quickly search for a patient and access prior vaccinations received in the city of Philadelphia or surrounding jurisdictions. PhilaVax also hosts a vaccine recommender tool which highlights patients’ overdue vaccinations. 
3. Use every opportunity to offer hepatitis B vaccine to unvaccinated patients, even sick visits. If you don’t stock hepatitis B vaccine, refer patients to another local hospital, health center, pharmacy, or organization that can vaccinate.  
   • Patients who are uninsured or underinsured can visit a local Federally Qualified Health Center (FQHC), Vaccines for Children (VFC) provider, or Vaccines for Adults at Risk (VFAAR) provider to receive vaccine at no or low cost.  
4. Document hepatitis B immunizations and maintain updated records. 
   • Participate in Philadelphia’s immunization information system (IIS) to report immunizations given.