Philip Zoellner

Merck Receives New Vaccine Vaxneuvance™ Approval

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Merck Announces U.S. FDA Approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

VAXNEUVANCE, Merck’s approved 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein. VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine. VAXNEUVANCE previously received Breakthrough Therapy designation from the FDA for the prevention of IPD in adults 18 years of age and older. In January 2021, it received Priority Review designation. Read more here.

Pfizer’s Prevnar 20 vaccine wins FDA approval

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The company has now scored FDA approval for its Prevnar 20 vaccine for adults 18 and older.

The vaccine is the first to offer protection against 20 serotypes of pneumococcal disease that cause the majority of pneumonia and invasive pneumococcal disease. In addition to the capsular polysaccharide conjugates already included in Prevnar 13, the new vaccine adds conjugates for seven different serotypes linked with invasive pneumococcal disease, antibiotic resistance and meningitis.

Learn more about Prevnar 20 here.

Ransomware threat targeting health care providers

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On October 28, the FBI, the Cybersecurity and Infrastructure Security Agency (CISA), and the Department of Health and Human Services (HHS) alerted the health care industry to an increased ransomware threat by criminals seeking to capitalize on the COVID-19 pandemic and U.S. elections.

These agencies recommend that providers and their office staff take the following precautions when using email:

  1. Pay close attention to domain names, particularly those that seem suspicious, misleading, or misspelled.

  2. Do not click on links or attachments from senders that they do not recognize and be especially wary of .zip or other compressed or executable file types.

  3. Do not provide sensitive personal information (like usernames and passwords) over email.

  4. Be especially cautious when opening attachments or clicking links if they receive an email containing a warning banner indicating that it originated from an external source.

These agencies do not recommend paying ransoms, as payment does not guarantee files will be recovered. If you or your group becomes a victim of ransomware, CISA recommends that you respond by using the Ransomware Response Checklist, which can be found in the CISA and MS-ISAC's Joint Ransomware Guide. The checklist contains steps for detecting and eradicating ransomware.

ADDITIONAL INFORMATION

Detailed information about ransomware and a copy of the full alert of October 28th can be found on the CISA website.

Sanofi Pasteur’s Latest MenACWY Vaccine

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Sanofi Pasteur announces another advancement in the fight to prevent meningococcal disease. MenQuadfi™ (Meningococcal [Groups A, C, Y, W] Conjugate Vaccine) has been approved by the FDA for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N meningitidis serogroup B disease.

The development of MenQuadfi and the high seroresponse generated in clinical trials illustrates Sanofi Pasteur’s continued commitment and leadership as a longstanding pioneer in meningococcal 

vaccines. ¹⁻⁴

Linked to this webpage are documents with additional information on MenQuadfi:

  • MenQuadfi Flashcard – contains information on studies in which MenQuadfi was compared head-to-head with other licensed quadrivalent meningococcal vaccines

IMPORTANT SAFETY INFORMATION

MenQuadfi should not be administered to anyone who has had a severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MenQuadfi. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi.

Syncope can occur following, or even before, vaccination with MenQuadfi. Procedures should be in place to prevent falling and injury and to manage syncope.

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to give MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.

Immunization with MenQuadfi does not substitute for routine tetanus immunization.

Vaccination with MenQuadfi may not protect all vaccine recipients.

The most common adverse reactions following a primary dose of MenQuadfi in individuals 2 years of age and older include pain at the injection site; myalgia, headache, and malaise. Other common adverse reactions in children 2 through 9 years of age include erythema and swelling at the injection site. In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination. Other adverse reactions may occur.

Please see the full Prescribing Information for MenQuadfi.

Reference:

1. MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

2. Immunization Action Coalition (IAC). Vaccine timeline. https://www.immunize.org/timeline/. Accessed July 17, 2020.

3. Menactra [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. Menactra [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

4. Federal Drug Administration. September 4, 2014 approval letter - Menactra [letter]. September 4, 2014.

http://wayback.archiveit.org/7993/20170723032500/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm413177.htm. Accessed July 17, 2020

If you have any questions, or if PRN’s staff can be of any assistance, please do not hesitate to contact us at 888-PRN-2360 or by email at admin@prngpo.com.

Sanofi Pasteur’s Latest MenACWY Vaccine Has Been Added to Our Purchasing Contract

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MenACWY vaccines, MenQuadfi™ (Meningococcal [Groups A, C, W, Y] Conjugate Vaccine) has been added to our contract. Our members will have the ability to begin reserving doses through VaccineShoppe.com on October 1, 2020 for scheduled shipment in 2021.

MenQuadfi is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N meningitidis serogroup B disease.

MenQuadfi has both a unique National Drug Code (NDC) number and CPT code:

  • National Drug Code (NDC number) 49281-590-05

  • CPT code 90619

CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.

  • MenQuadfi is approved for use in individuals 2 years of age and older, with no upper age limit.1

  • MenQuadfi can be given as a primary dose to persons 2 years of age and older, and a booster dose can be given to persons 15 years and older. 1

  • MenQuadfi is supplied in 0.5 mL single-dose vials as a ready-to-use solution that does not require reconstitution.1

IMPORTANT SAFETY INFORMATION

MenQuadfi should not be administered to anyone who has had a severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MenQuadfi. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi.

Syncope can occur following, or even before, vaccination with MenQuadfi. Procedures should be in place to prevent falling and injury and to manage syncope.

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to give MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.

Immunization with MenQuadfi does not substitute for routine tetanus immunization. Vaccination with MenQuadfi may not protect all vaccine recipients. The most common adverse reactions following a primary dose of MenQuadfi in individuals 2 years of age and older include pain at the injection site; myalgia, headache, and malaise. Other common adverse reactions in children 2 through 9 years of age include erythema and swelling at the injection site. In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination. Other adverse reactions may occur.

Please see the full Prescribing Information for MenQuadfi.

Reference: 1. MenQuadfi vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

Guidebook: Adaptive Vaccinations Solutions

Protecting patients is now more important than ever. The COVID-19 pandemic has brought uncertainty and a “new normal” which requires adaptation and rethinking of how patients receive routine care. The arrival of influenza season this fall will bring additional health risks. Providers and healthcare systems are encouraged to expand efforts to increase influenza vaccination rates to help mitigate the impact of both diseases.

Our partners at Sanofi Pasteur have created the Adaptive Vaccinations Solutions (AVS) guidebook to help providers plan their approach to flu immunizations.

In this interactive guidebook you’ll find:

✔ Considerations to help choose the right alternative vaccine solution for your practice

✔ Guidance on how to host walk-thru clinics and drive-thru clinics

✔ Resources for general flu immunizations planning

✔ Recommendations on incorporating flu immunization discussions into telehealth visits