Immunization Roundup: FDA Approves FluMist, Updated Novavax COVID-19 Vaccine
Catch up on important immunization news from the month of September.
FDA Approves FluMist as First-Ever Self-, Caregiver-Administered Flu Vaccine
Immunization Roundup: FDA Approves FluMist, Updated Novavax COVID-19 Vaccine / Pixel-Shot - stock.adobe.com
Nasal spray flu vaccine FluMist has been approved by the FDA for self- or caregiver-administration. It is approved for the prevention of the flu caused by influenza virus subtypes A and B and is indicated for use in individuals aged 2 to 49 years. It is the first and only flu vaccine that does not need to be administered by a health care provider. FluMist contains a weakened form of live strains of the influenza virus. The vaccine was first approved by the FDA in 2003 for use in individuals aged 5 to 49 years; in 2007, approval was expanded to include children between 2 and 5 years of age.
FDA Approves Updated Novavax COVID-19 Vaccine
The FDA has granted emergency use authorization (EUA) to an updated COVID-19 vaccine from Novavax to prevent the disease in individuals aged 12 years and older, the company announced in a release.1 Novavax said the vaccine will be available in thousands of pharmacies and grocers across the United States after batches are released by the Center for Biologics Evaluation and Research.
GSK Announces Positive Topline Data for Co-Administration of RSV, Shingles Vaccines
GSK reported positive topline data from a phase 3 study in adults 50 years and older assessing the immunogenicity, reactogenicity, and safety of its respiratory syncytial virus (RSV) vaccine (Arexvy) when co-administered with its recombinant zoster vaccine for shingles (Shingrix). GSK announced that results from its study will be submitted for publication in a peer-reviewed, scientific journal, and will be used to support regulatory submissions to the FDA, European Medicines Agency, and other regulators.
WHO Adds First Mpox Vaccine to Prequalification List
The MVA-BN (Imvanex) vaccine has been added to WHO’s prequalification list. The vaccine, manufactured by Bavarian Nordic, is intended for adults as a 2 dose injection given 4 weeks apart and is the first mpox vaccine to be added to the list. The MVA-BN vaccine is indicated for active immunization against smallpox, mpox, and related orthopoxvirus infections and disease in adults. The WHO additionally added the vaccine can be used off-label in those under 18 years of age and in pregnant and immunocompromised people, indicating use of the vaccine is recommended in outbreak settings where the benefits outweigh the potential risks.
New England Ranks as Most Vaccinated Region in the US
According to a recent report published by consumer-based financial service company WalletHub, New England is the most vaccinated region in the country, with all 6 states that make up the region ranking in the top 10 for most vaccinated states in the US. Indeed, Rhode Island, Massachusetts, and Maine make up the 3 most vaccinated states, with Vermont coming in at 6th, New Hampshire at 8th, and Connecticut at 10th.
Community Pharmacist Education to Combat Vaccine Hesitancy
After performing a pharmacist education intervention prior to pharmacist-patient conversations regarding vaccination opinions, researchers found that better-informed pharmacists were less likely to have their patients refuse a pneumococcal vaccine. Researchers’ key observation was that patients’ reasonings for hesitancy changed from concerns about efficacy to concerns about cost as more well-informed pharmacists were able to curb doubts surrounding the vaccine’s benefits.
Positive Topline Data From 31-Valent Pneumococcal Conjugate Vaccine Clinical Study Announced
Vaxcyte has announced positive topline data from a phase 1/2 clinical study of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) for the prevention of invasive pneumococcal disease.The study evaluated the safety, tolerability, and immunogenicity of VAX-31. VAX-31 demonstrated “robust [opsonophagocytic activity] immune responses” for all 31 pneumococcal serotypes studied. At the high and medium doses, VAX-31 “met or exceeded the regulatory immunogenicity criteria” for all 31 serotypes; at the low dose, the vaccine met or exceeded regulatory immunogenicity criteria for 29 of the 31 serotypes.
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