Find out the latest information we are learning from the research and what it means for Montanans

By Madison Hebner

COVID-19 breakthrough cases can be defined as a case that occurs when a person fully vaccinated against the SARS-CoV-2 virus becomes infected with COVID-19. Although infection may still occur after vaccination, individuals who are vaccinated are less likely to become severely ill from infection than those who are unvaccinated. The new SARS-CoV-2 variant, Omicron, appears to cause higher numbers of breakthrough cases in vaccinated people. Let’s dive in to why this is the case. 

Omicron has many mutations in the spike (S) protein. The spike protein is located on the outside of SARS-CoV-2, and the virus uses it to enter human cells. Human immune cells can recognize this protein and build a memory immune response to it, and this is the basis for the Pfizer and Moderna mRNA vaccines. As of the writing of this article in Jan 2022, people who are considered fully vaccinated have either received the initial two-dose series of the mRNA vaccines or one dose of the viral vector vaccine by Johnson & Johnson’s Janssen.

Preliminary studies have shown that vaccine effectiveness is likely to be drastically changed by Omicron. One reason is that the S protein of Omicron is genetically different than the S protein that is a part of the mRNA vaccines, because there are so many changes between the original Alpha variant and the Omicron variant. This results in resistance to some human antibodies, increasing the possibility of infection with Omicron even if a person is fully vaccinated.

Secondly, Omicron appears to multiply rapidly and more efficiently in human nasal passageways when compared to other SARS-CoV-2 variants. This allows Omicron to infect more cells and could likely be more infectious at lower exposure doses, resulting in increased transmission of the virus in the population.

Although the risk of infection with Omicron in fully vaccinated people is higher than seen with other variants of concern, the vaccine still drastically lowers the chance of severe illness, hospitalization, and death. Additionally, the COVID-19 booster promotes an increase of immune memory cells and antibodies, which can help limit infection with Omicron.  

To help reduce the spread of SARS-CoV-2, people should wear a mask, social distance, avoid large crowds, and get their COVID-19 vaccine and booster.  

Peakcock T, Brown J, Zhou J. et al. The SARS-CoV-2 variant, Omicron, shows rapid replication in human primary nasal epithelial cultures and efficiently uses the endosomal route of entry. bioRxiv (2021).  
 
Schmidt F, Weisblum Y, Rutkowska M. et al. High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape. Nature (2021).  

By Madison Hebner

What we know

Omicron, a newly described SARS-CoV-2 variant, was classified as a variant of concern on November 26, 2021 by the World Health Organization (WHO). Omicron has many mutations that may affect how the virus affects our bodies, specifically, this new variant has a notable amount of mutations in the spike (S) protein that is recognized by immune cells. The common COVID-19 PCR detection test will currently detect infection with all COVID-19 variants, including Omicron. 

The Omicron variant has now been detected in all 50 states.  

What we don’t know (and hope to know)

Spread-ability:  Understanding the transmissibility (how likely the virus is to spread from person to person) is important for implementing public health measures. Scientists have now determined that Omicronis more transmissible than the Delta variant.

Disease severity: Researchers have shown that Omicron is less pathogenic than other SARS-CoV-2 variants in hamster models. Additionally, early evidence suggests that infection with Omicron is less severethan observed in infections with the Delta variant. Studies have shown that Omicron does not infect the cells of the lungs as readily, instead causing a localized infection in cells of the upper respiratory airways (such as the nasal passageway).

Vaccine efficacy: Preliminary research suggests that Omicron may be more resistant to the memory antibodies present in individuals who have received the mRNA COVID-19 vaccines (Pfizer and Moderna). This is because the Omicron variant has a notable number of mutations in the spike protein, the part of the virus that binds to antibodies. However, recent studies indicate that full vaccination combined with a booster provides strong protection against Omicron infection. It still holdstrue thatmultiple doses of the COVID-19vaccine will, in most cases, still prevent severe disease, hospitalization, and death, even against Omicron.

What should we do?

To limit the spread of SARS-CoV-2, people should wear a mask, wash hands often, social distance as much as possible, avoid large crowds, and get their COVID-19 vaccine and booster(s). Research has shown that it is safe and effective to receive a COVID-19 and an influenza vaccine simultaneously. Getting both vaccines will help reduce community transmission of COVID-19 and the flu and reduce hospital visits and potential deaths.

This is an evolving situation, and we will continue to update on the Omicron COVID-19 variant as new research and information surfaces. Check back soon! 

>Bibliography

Lazarus R, Baos S, Cappel-Porter H, et al. The safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults: a phase IV, multicentre randomised controlled trial with blinding (ComFluCOV). The Lancet (2021).

“Update on Omicron.” World Health Organization. 28 November, 2021, https://www.who.int/news/item/28-11-2021-update-on-omicron.

Schmidt F, WeisblumY, Rutkowska M, et al. High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape. Nature (2021). 

By Madison Hebner

Vaccinating young adults against COVID-19, especially college-aged people, is critical to reducing COVID illness in our Montana communities. COVID-19 infection and incidence rates are the highest among 18–24-year-olds, so to reduce community transmission of COVID-19, it is necessary for college students and young adults to get vaccinated.

A study completed in November 2020 outlined current COVID-19 vaccine intentions among college students. 91.64% of surveyed students said they intended to get a COVID-19 vaccine once available. However, as of November 28, only 56.8% of U.S. young adults are fully vaccinated, 67.8% reporting at least one dose. In Montana, 55.5% of young adults are fully vaccinated, and 63.5% have at least one dose (according to the Mayo Clinic U.S. COVID-19 vaccine tracker).

Vaccination rates may be low for many of reasons, one reason some college students have stated they are hesitant to get a vaccine if they already had COVID. Experts recommend getting the COVID-19 vaccine even if you have already had COVID.

  • Data has shown that people who have not received a vaccine are more likely to become reinfected with COVID-19 than those who have one or more vaccine doses.
  • Additionally, COVID-19 vaccines produce a stronger memory immune response as compared to a natural infection of COVID and may protect against pre-existing and new variant strains.

Young adults and college-aged students play an important role in keeping Montana healthy. Vaccinations are safe, effective, and widely accessible –schedule your vaccine at Montana State University now and enter the MSU vaccine sweepstakes!

All entries receive an instant $10 credit on your CatCard and will be entered to win prizes such as $5000 financial assistance awards, a season ski pass, and other valuable prizes. Drawings will be held weekly through Dec. 16 and are open to all vaccinated students.

Bibliography

Graupensperger, Scott, et al. “Social Norms and Vaccine Uptake: College Students’ Covid Vaccination Intentions, Attitudes, and Estimated Peer Norms and Comparisons with Influenza Vaccine.” Vaccine, vol. 39, no. 15, 2021, pp. 2060–2067., https://doi.org/10.1016/j.vaccine.2021.03.018.

"U.S. COVID-19 Vaccine Tracker: See Your State's Progress.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 28 Nov. 2021, https://www.mayoclinic.org/coronavirus-covid-19/vaccine-tracker.

“Vaccines for COVID-19.” Centers for Disease Control and Prevention, Health and Human Services, 1 Sept. 2021, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html.

By Michaela Williamson

Vaccine production and approval is a lengthy process. However, in light of novel viruses such as SARS-CoV-2, the process had to move quickly because the benefits of a vaccine outweigh potential associated risks. This has led many to wonder, what exactly is Food and Drug Administration’s (FDA) vaccination approval process and how can this regulatory body expedite production of vaccines?

Prior to clinical trials, vaccine manufacturers must submit an application to the FDA called an Investigational New Drug (IND) application. This application includes data collected from preclinical testing, proposed manufacturing and safety procedures, and a plan for conducting human trials. Once an IND is approved by the FDA, clinical trials may start.

Clinical trials for vaccines then occur in four phases:

1) The first phase of clinical trials involves a small study population of healthy individuals. In this phase, data is collected about adverse reactions, dosage, and the vaccine’s ability to produce an immune response. If the vaccine is proven to be safe and effective in this first phase the clinical trials proceed to the second phase.

2) In the second phase of clinical trials a larger study population is included to further assess safety and immune response. This second phase is essentially an expanded version of the first phase. With success in this phase, the process moves forward to include a third phase.

3) In the third phase of clinical trials for vaccines a much larger study population is included in a randomized and controlled study. This means that a portion of the population included in the study is randomly selected to receive the vaccination as opposed to the rest of the population who receive a placebo (no vaccine). Including a control group into clinical studies allows investigators to collect definitive causal evidence that a vaccination is effective in preventing serious illness in those who receive it. 

It is during or after phase three of a clinical trial, once a predetermined efficacy and safety criteria is met, that the FDA may issue an Emergency Use Authorization (EUA), such as in the case of the SARS-CoV-2 vaccine. In addition to two months' worth of follow-up data collected from participants in clinical trials, manufacturing information is also reviewed before Emergency Use Authorization. During this evaluation, an additional external committee who are investigated for conflicts of interest are consulted. This committee, the Vaccines and Related Biological Products Advisory Committee, makes recommendations on the approval of a vaccination.

4) Following standard approval or EUA, manufacturers must continue to collect information in phase four which includes continued outcome surveillance of those vaccinated for adverse effects and efficacy. This surveillance is overseen by the FDA and Centers for Disease Control and Prevention (CDC) and utilizes reporting systems such as the Vaccine Adverse Effects Reporting System (VAERS) and the Vaccine Safety Datalink. VAERS may be used by doctors, vaccine manufacturers, and recipients to report adverse vaccination effects. The Vaccine Safety Datalink compiles data reported in electronic medical records to track adverse events. These tools help to reveal rare adverse outcomes to vaccination and help steer future recommendations for manufacturers and recipients. An additional component of continued monitoring is the ability of the FDA to remove an approved or authorized vaccination if data reveals that benefits no longer outweigh associated risks.

Expedited production and authorization of vaccination may indicate that there is still limited data to support the safety of a vaccine. It also means that there is a plan to continue collecting data and that preliminary data shows both safety and efficacy of the vaccine. These exhaustive criteria to ensure safety and efficacy from the FDA must still be met prior to granting Emergency Use Authorization. As with every medication, continued monitoring of those receiving vaccination may reveal rare adverse events. This information can help your medical team determine if you might be at high risk for a rare concern. These rare events are also compared to the likelihood that people might experience them to determine if the potential risk outweighs the benefit of reduced infection, severity, and mortality of the disease. In the case of the COVID-19 vaccine, the risks of adverse events are extremely small compared to the much more likely benefit of remaining healthy.

Bibliography

Centers for Disease Control and Prevention. (2021). Selected Adverse Events Reported After Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html

Kesselheim, A. S., Darrow, J. J., Kulldorff, M., Brown, B. L, Mitra-Majumdar, M., Lee, C. C., Moneer, O., & Avorn, J. (2020). An Overview of Vaccine Development, Approval, and Regulation, With Implications for COVID-19. Health Affairs. 40(1), 25-32. https://doi.org/10.1377/hlthaff.2020.01620

U.S. Food and Drug Administration. (2020) Emergency Use Authorization for Vaccines Explained. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

By Madison Hebner

The FDA has granted emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine for children ages 5-11 years old. Additionally, the CDC now recommends that everyone ages 5 and older get a COVID-19 vaccine. Questions? Here’s what you should know.

Are children receiving the same vaccine dose as adults?

The Pfizer vaccine dosage amount for children is 1/3 the amount that adults get for each dose. (5–11-year-olds receive two 10 microgram doses whereas adults receive two 30 microgram doses). The 10 microgram dose was selected for safety, and it still produced an appropriate antibody and T cell memory immune response.

Can children get the COVID-19 vaccine and the influenza vaccine?

Yes! In fact, both vaccines can be administered one after another, which may make it easier for children who are afraid of needles.

Is the vaccine safe for my child?

Results from the clinical trials for children showed a strong safety profile, similar to what was seen in the adult vaccine trials.The side effects observed, such as soreness at the injection site, fatigue, and headache were often even milder than side effects seen in adults.

Why should children get the COVID-19 vaccine?

Children can still get very sick and possibly die from COVID-19, leading to both short-and long-term possible side effects from COVID-19. Recent reporting shows that people who have previously had COVID-19 contracted the disease at more than five times the rate of those who had two doses of a COVID-19 mRNA vaccine. Additionally, children account for approximately 25% of all new COVID-19 cases in the U.S., and K-12 schools are a hot spot for COVID-19 transmission.

Vaccinating children will help limit the spreadof COVID-19. Find out where your child can receive a vaccine today!

Bibliography

“Covid-19 Vaccines for Children and Teens.” Centers for Disease Control and Prevention, U.S. Health and Human Services , 4 Nov. 2021, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Frecommendations%2Fadolescents.html.

LaMotte, Sandee. “Answering Kids' (and Parents') Questions about the COVID-19 Vaccine for Ages 5 to 11.” CNN, Cable News Network, 6 Nov. 2021, https://www.cnn.com/2021/11/06/health/kids-covid-vaccine-questions-and-answers-wellness/index.html.

MacMillan, Carrie. “Covid-19 Vaccine Authorized for Ages 5 to 11: What Parents Need to Know.” Yale Medicine, 3 Nov. 2021, https://www.yalemedicine.org/news/covid-vaccine-for-ages-5-to-11.

“What Does Immunogenicity Mean in the Context of Covid-19 Vaccines?” AstraZeneca, 19 Nov. 2020, https://www.astrazeneca.com/what-science-can-do/topics/disease-understanding/what-does-immunogenicity-mean-in-the-context-of-covid-19-vaccines.html.

 

By Madison Hebner

Do boosters work?

Vaccine boosters increase your body’sproduction of memory cells (someT and B cells). These memory cells help increase the number of antibodies present you have and help the body remember how to fight off an infection of this pathogen (yet again). New research has found that a third dose of the mRNA vaccines developed by Moderna and Pfizer increase these infection-blocking antibodies, when administered several months after the second dose.

So short answer, yes!

Is immunity from vaccines waning?

Background: antibody levels always increase right away after vaccination, but these levels fall as the memory cells decrease. Importantly, these memory B cells continue to produce helpful antibodies for a long time, just at a lowerlevelcompared to right after vaccination. So, we know from research being conducted across the world that these important antibody levels that the SARS-CoV-2 vaccines provide are falling over time. We just don’t know if these decreases in antibodies will mean a decline in protection against the virus. That is what scientists are working to understand now!

Are vaccinations given months ago still preventing infections?

“Are people who were vaccinated earlier on becoming infected with SARS-CoV-2 at higher rates than those who were vaccinated more recently?” Some research data from those already vaccinated suggests yes, but scientists are still working on understanding why. For example: some of those who were vaccinated earlier on were health-care workers, so they might have more exposure to COVID-19 and this could lead to more opportunity for breakthrough cases (vaccinated individuals testing positive for COVID-19). (Note: this is based on data from Israel)

Do vaccines still provide protection from serious illness with COVID-19?

Research continues to show that vaccines are an effective tool that is highly likely to protect you against severe COVID-19 disease, hospitalization, and death. If eligible for a vaccine or booster, talk with your medical team to get protected today! 

Should I get the third COVID-19 booster?

If you received the Pfizer-BioNTech or Moderna COVID-19 vaccine 6 months ago or more and are in one of the following groups, then you are eligible for a booster shot. These groups are: 

  • people who are 65 years and older,
  • 18+ who live in long-term care settings,
  • 18+ with underlying medical conditions (as described by the CDC), or
  • 18+ who work/live in high-risk settings (as described by the CDC).

If you received the Johnson & Johnson COVID-19 vaccine 2 months ago or more and are 18 years of age or older, you are eligible to receive the booster shot. This is only your second shot, but it is considered a booster shot for this vaccine.

You can choose which vaccine brand you would prefer for your booster. Research found that getting a booster of a different vaccine may further reduce risk of symptomatic COVID-19 for some individuals (Atmar, et al. 2021). Talk to your medical provider to see which booster might be most helpful to you. 

Bibliography

Callaway, Ewen. “COVID Vaccine Boosters: The Most Important Questions.”Nature, vol. 596, no. 7871, 2021, pp. 178–180., doi:10.1038/d41586-021-02158-6

Atmar, R. L., Lyke, K. E., Deming, M. E., Jackson, L. A., Branche, A. R., El Sahly, H. M., ... & Beigel, J. H. (2021). Heterologous SARS-CoV-2 Booster Vaccinations–Preliminary Report. Medrxiv. doi: 10.1101/2021.10.10.21264827