Three Things Thursday highlights three things I am paying attention to as an epidemiologist each week.
It has been a busy week.
In my little corner of the world, it is the week before fall break on campus. This means there are exams to write (and grade), lessons to wrap up, and senior thesis proposals are due. It is also birthday week in our house — both of our kids celebrate their birthdays this week. And we are all still riding high from my sweet husband’s amazing marathon run this past week. Rehearsals for The Nutcracker are also in full swing (mark your calendars for performances on November 24-26 at The Academy Theatre).
Outside my little corner of the world, the Nobel Prize for Physiology or Medicine was awarded to Drew Weissman and Katalin Karikó, who are the masterminds behind mRNA vaccine technology. Can we all pause for just a second and acknowledge that the COVID-19 mRNA vaccines won the Nobel Prize?!?!
Following the Nobel Prize announcement, the Director of CDC’s Center for Forecasting and Outbreak Analytics, Dr. Dylan George, announced that we should expect a “moderate” COVID-19 season and typical influenza and RSV seasons this year with a similar number of hospitalizations as last year.
Given the excitement of the week — vaccine technology won the Nobel Prize!! — the three things I am ACTUALLY paying attention to (and need a little bit of explanation so that we can all put information into action to create healthier communities) are the approval of the Novavax COVID-19 vaccine, the successful completion of a Phase 1/2 clinical trial for a combined flu-COVID vaccine, and data that illustrate the serious risks posed by RSV for older adults and very young children.
Hoping this post helps to educate and empower you
to be healthy and create healthy communities.
The NOVAVAX COVID-19 Vaccine Is Approved
On Tuesday, the FDA authorized the use of the Novavax COVID-19 vaccine. The vaccine — a protein-based (old school) vaccine — is produced and Gaithersburg, MD, and provides individuals with a non-mRNA vaccine option. Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, celebrated the approval by noting —
“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The vaccine is available to anyone who is 12 years of age and older. It is a single, monovalent booster shot (containing the protein of an Omicron subvariant).
CDC approved the Novavax vaccine at its meeting on September 12th.
Following Novavax’s approval in the US, a study was published in JAMA Network Open yesterday that concluded —
“…that vaccination with NVX-CoV2373 (aka Novavax) was associated with protection against Omicron infection and symptomatic COVID-19 up to 4 months after completion of the primary cycle.”
The Novavax booster will be distributed this week. It should be widely available in the coming days.
Personally, I have been holding out for Novavax. I am planning to get my COVID and flu vaccines the week of October 16. If Novavax is available locally, I plan to get it. In addition to the results shared this week, there is evidence that immunity from the mRNA vaccine + the protein vaccine (Novavax) is a little bit stronger. Plus, I’m a sucker for wanting to see the underdog win — and Novavax, a small US-based company — is swimming with the sharks (Pfizer and Moderna). I want Novavax to succeed.
Also — if you are wondering why I am waiting to get vaccinated, the answer is simple. My youngest turns 12 on the 13th and he will be eligible for the adult COVID booster then. I’d like him to get a full (non-child’s) dose. Plus the kids’ vaccine is wicked hard to come by right now. So we are waiting until he is 12 and will get vaccinated after his birthday weekend. Pictures and stories to come!
Combination Flu-COVID Vaccine
Yesterday Moderna announced the positive results of a Phase 1/2 clinical trial of its combination (one shot) influenza-COVID vaccine. Phase 1 and 2 clinical trials are designed to evaluate both the safety and immunogenicity of the combined vaccine (compared to two individual vaccinations) in human participants.
Combination vaccines are desired in order to improve the consumer experience (one shot vs. two) and increase compliance with vaccine recommendations. Stéphane Bancel, Chief Executive Officer of Moderna noted that —
"Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies. Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems. We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses."
Moderna plans to begin a Phase 3 clinical trial this year in adults over 50 years old. Their goal is to seek regulatory approval (assuming the clinical trial shows the vaccine to be safe and effective) in 2025.
RSV Hospitalizations Are Severe
Yesterday a study published in the Morbidity and Mortality Weekly Review (aka the MMWR) showed that the total number of hospitalizations for RSV in 2022-23 was lower than either flu or COVID hospitalizations. However, RSV hospitalizations were more severe and were more likely among individuals over 75 years old. According to the study’s authors —
"Clinical outcomes in patients hospitalized with RSV were worse than those among patients hospitalized with COVID-19 or influenza. Because RSV disease is less common than COVID-19 or influenza disease among hospitalized patients, clinicians might be less aware of RSV as a serious respiratory pathogen in older adults."
This news comes on the heels of a study also published yesterday in JAMA Network Open where Canadian health researchers found —
“…that the burden of RSV-associated hospitalizations in Canadian pediatric hospitals was substantial, particularly among infants aged less than 6 months, and RSV hospitalizations increased in 2021-2022 compared with the prepandemic period, while the severity of illness remained similar.”
Given the severe risks of RSV to both the elderly and the very young, getting vaccinated is of the utmost importance An RSV vaccine is available for adults aged 60 and older. Additionally, a vaccine is available to pregnant people to provide protection for the fetus and newborn. Monoclonal antibodies are also available to young children to prevent infection.
It has been quite a week (both personally and in public health/preventive medicine). If you have questions, please ask me —
Please share this post with your friends and family. Doing so will provide them with reliable information to help them create healthy communities. And it will disrupt the cycle of misinformation.