COVID-19 Vaccinations: The Next Roll Out and What We May Expect

In March of 2020, ‘pandemic’ – defined by Merriam Webster as – an outbreak of a disease that occurs over a wide geographic area (such as multiple countries or continents) and typically affects a significant proportion of the population, was a word few of us, young or old, had heard outside of a movie or a board game. Now, we are all too familiar with the term and are grappling with COVID-19 as an endemic disease as SARS-CoV-2 becomes a daily reality. Fast forward a year and a half, the US has three recommended and available COVID-19 vaccines that are safe, effective, and reduce the risk of severe illness if infected. A lot has been accomplished, yet there are still questions to be answered.

The vaccines by Moderna and Johnson & Johnson received an Emergency Use Authorization (EUA), while the Pfizer vaccine has progressed from EUA and received full approval on August 23, 2021, for individuals 16 years of age and older. Very recently on October 29, the FDA authorized a EUA for the Pfizer vaccine to include children 5 through 11 years of age.

But why did the FDA authorize different age groups at different times? Since children are not small adults, there are issues that need to be addressed in pediatric vaccine trials, particularly on dosing strength and stages. The 10-microgram dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children 5 to 11 years of age. The vaccine for children 5- 11 years were studied in approximately 3,100 children aged 5 through 11. No serious side effects have been detected in the ongoing study; side effects were similar to those of adults with the most common being pain at the injection site. Additionally, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.

As we look at this EUA and approval mix, it’s important to note that a EUA is different from a full approval yet is based on a thorough and transparent evaluation of data. A EUA does not mean that less data is required. A EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, and during public health emergencies, such as the current COVID-19 pandemic. With this recent age group EUA, the Center for Disease Control (CDC) now expands the COVID-19 vaccine recommendations to about 28 million children in the US. The Pfizer vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

In the US, COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of October 17, 691 deaths from COVID-19 have been reported in the US in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.

This is a big development for school-aged children, not only because it will help prevent the spread of the disease, but also decrease the unvaccinated population gap. COVID-19 is typically less severe in younger age groups and the asymptomatic spread of the disease by children is well documented.  COVID-19 has had a profound social impact, which is especially felt in children’s educational and social development. Most of 2020 and almost the entirety of 2021 was spent at home and interactive classroom settings were replaced with online platforms. However, the prospect of in-classroom settings in the fall of 2021 have contributed to concerns felt by parents on how to keep children safe upon reopening. Likewise, schools have debated how to reopen in-classroom learning while maintaining a high level of safety. But the country isn’t entirely aligned – controversies over-vaccinating school-age children and the concerns over wearing masks all day have erupted in violence since the recent decision.

Before late October 2021, parents had to choose between sending their unvaccinated children to school and risk exposure to the virus or continuing to homeschool, either full-time or in a hybrid model. The limited in-person instruction during the pandemic may have had a negative effect on learning for some children and on the mental and emotional well-being of both parents and children. Now, parents may feel relief knowing their children have access to an authorized vaccine but are faced with a decision whether or not to vaccinate as we enter the fall and winter months.

What will this new EUA for children ages 5-11 do for our country’s overall infection rate? With vaccination rates gradually increasing since the granting of the EUAs and since the FDA’s full authorization of the Pfizer vaccine, infection rates have been dwindling among those choosing to get vaccinated. A majority of the adult population is now vaccinated (or are able to be vaccinated). With the upcoming vaccine rollout as a result of the EUA for children ages 5 – 11, can we hope to see even lower infection-transmission rates over time? Now, as nearly all family members in a household are potentially able to be vaccinated, might we see a decline in COVID-19 cases?

Given this information, do parents feel the relief of the recent EUA and feel like they can drop their shoulders? And are we closer to pre-pandemic normal as we are able to make more strides to shrink the anti-vaccinated gap? These are just a few questions on our minds. Let’s see what develops in the coming weeks and the new year.

Want to learn more? Contact our Halloran team.

References:

1. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html
2. https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html
3. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/transmission_k_12_schools.html
4. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
5. https://www.fda.gov/news-events/press-announcements/fda-will-follow-science-covid-19-vaccines-young-children
6. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
7. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results