Vaccines

Vaccines are a necessary protective measure in the fight against COVID-19. The CDC recommends practicing A/I specialists have conversations with patients about the importance of getting vaccinated. Take advantage of these resources to learn about vaccination options and stay informed on relevant data.

If you do not have insurance to pay for COVID-19 vaccines you can find COVID-19 vaccine locations near you: Vaccines.gov

Current 2025 Recommendations

FDA fully approved all mRNA vaccines for those 65 and older, and an emergency use authorization for those 12-64 with an underlying condition predisposing to severe disease. However, the approval varies for children less than 12 years old depending on the vaccine. Moderna’s Spikevax is approved for people age 6 months through 64 years with at least one underlying condition, but the newer Moderna formulation, mNEXSPIKE is not approved for 11 and under. The Pfizer/BioNTech’s Comirnaty vaccine was approved for 5 to 64-year-olds with one underlying condition as well, but the FDA revoked the EUA for those 5 and younger, leaving Moderna Spikevax as the only fully approved vaccine for those 5 and under. The Novavax vaccine was approved for ages 65 and older and those ages 12 to 64 with at least one health condition that puts them at increased risk of severe disease. Anyone else who wants the vaccine can discuss it with their health care provider. How vaccines for healthy people less than 65 will be covered by insurance or available at pharmacies remains to be seen. Those less than 65, even with an underlying health condition, may require a prescription from a health care provider to receive the vaccine at a pharmacy. The high cost and storage requirements for these vaccines limit their availability in health care provider offices. The FDA removed the indication for pregnant women. The basis for these recommendations were reportedly the European’s approach to vaccination.

CDC: based on the CDC website accessed today, vaccine is recommended for most adults ages 18 and older. Emphasizes the importance of those over 65, those at high risk of severe illness, or have never received a COVID-19 vaccine. Of note, asthma is considered a high-risk condition. Parents of children 6 months to 17 years should discuss benefits with a healthcare provider, again insurance coverage or ability to receive that vaccine at a pharmacy is questionable for the latter group. It is also not clear if the CDC recommendations will change, since they are counter to the FDA recommendations, and the leadership of the CDC has recently undergone change. If this recommendation remains unchanged, then insurers should pay for the vaccine for the indicated groups, but it is not clear that they will pay for healthy people under age 65 or those with chronic conditions not listed in the CDC material.

ACOG: strongly recommends that all pregnant and lactating women receive the COVID-19 vaccine. The literature supports pregnancy as a high-risk condition for severe illness and adverse pregnancy outcomes due to COVID-19 infection.

AAP: released its own schedule on August 19 which recommended at least one dose of the 2025-2026 vaccine for all children 6 months to 2 years, based on data showing that this age group was the second highest age group for hospitalizations after those 65 and older. For those over age 2, they recommended one dose only for high-risk groups or those who desire protection.

The University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) launched the Vaccine Integrity Project which published the results of a systematic review examining safety, which did not find any concerns. VIP Evidence Review Executive Summary. They have not published their recommendations for a schedule currently.

The states of California, Oregon and Washington have established a public health alliance (West Coast Health Alliance) that will publish their own recommendations, and other states have published their specific recommendations.

Vaccine Data and Approvals

Novavax
Novavax (NVX-CoV2373) is a subunit vaccine made from a stabilized form of the spike protein using recombinant protein nanoparticle technology combined with a proprietary adjuvant. The vaccine is administered as two doses, 21 days apart.  Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is authorized for use as an initial series or as booster doses in individuals 12 years of age and older. It can be considered as an alternative to those who are concerned about mRNA technology, since it is based on prior technology, or in those who had moderate to severe reactions to mRNA vaccines.

Previous studies have shown that earlier doses of mRNA vaccines were associated with an increased risk for myocarditis/pericarditis in adolescent and young adult males. That complication appears to have declined following booster doses. Nonetheless, some people have suggested that vaccination is associated with a large number of cardiac deaths in young athletes. To assess this possibility, investigators searched death certificates for Oregon residents aged 16–30 years who died during June 2021–December 2022 for cardiac or undetermined causes of death. For identified decedents, records in Oregon’s immunization information system were reviewed for documentation of mRNA COVID-19 vaccination received ≤100 days before death. Of 40 deaths that occurred among persons who had received an mRNA COVID-19 vaccine dose, three occurred ≤100 days after vaccination. Two of these deaths were attributed to chronic underlying conditions; the cause was undetermined for one. The authors conclude that the data does not support an association between receipt of mRNA COVID-19 vaccine and sudden cardiac death among previously healthy young persons. mm7314a5-H.pdf (cdc.gov) – April 11, 2024

Efficacy Information

This study (n = 19 899) demonstrated that among individuals with SARS-CoV-2 in pregnancy, COVID-19 vaccination was associated with a lower risk of maternal hospitalization (Delta: relative risk [RR], 0.38; Omicron: RR, 0.38) and critical care unit admission (Delta: RR, 0.10; Omicron: RR, 0.10), as well as preterm birth (Delta: RR, 0.80; Omicron: RR, 0.64) in both the Delta and Omicron variant time periods. The Role of Vaccination in Maternal and Perinatal Outcomes Associated With COVID-19 in Pregnancy | Infectious Diseases | JAMA | JAMA Network - December 15, 2025

Prompted by the latest vaccine advisory process under HHS, these authors conducted a systematic review of immunizations in the US against COVID-19, RSV and influenza. The paper also analyzed the 2023-2024 Advisory Committee on Immunization Practices (ACIP) Evidence-to-Recommendations for each disease. Outcomes included vaccine efficacy and effectiveness against hospitalization, other clinical endpoints and safety.  Vaccine effectiveness against hospitalization from all 3 vaccines varied from 46-68%. Safety profiles were consistent with previous evaluations. Myocarditis associated with COVID-19 vaccines occurred at rates of 1.3 to 3.1 per 100,000 doses in male adolescents, with lower risk associated with longer dosing intervals (other studies have also shown lower risk with booster doses). The RSVpreF vaccine was associated with 18.2 excess cases of Guillain-Barre syndrome per million doses in older adults. Updated Evidence for Covid-19, RSV, and Influenza Vaccines for 2025–2026 | New England Journal of Medicine - October 29, 2025

During August 29, 2024–September 2, 2025, within a multisite network including nine states, vaccine effectiveness of 2024–2025 COVID-19 vaccination was an estimated 76% against COVID-19–associated emergency department or urgent care (ED/UC) visits among immunocompetent children aged 9 months–4 years and an estimated 56% among children and adolescents aged 5–17 years, compared with those who did not receive a 2024–2025 vaccine. Effectiveness of 2024–2025 COVID-19 Vaccines in Children in the United States — VISION, August 29, 2024–September 2, 2025 | MMWR

Using analysis of public literature data, this comparative effectiveness study found that COVID-19 vaccination averted 2.5 million deaths during 2020-2024. The benefit was mostly limited to the population of older individuals. Vaccination rates in the US in those over age 65 remains very low despite this. Global Estimates of Lives and Life-Years Saved by COVID-19 Vaccination During 2020-2024 | Health Policy | JAMA Health Forum | JAMA Network - July 25, 2025

Adverse Reactions

An NIAID clinical trial is underway to study allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines.   A brief synopsis of the study is available here.  A flyer about the study is available here.

MANAGING SEVERE REACTIONS TO MRNA COVID 19 VACCINES 

The CDC has updated their guidance on administration of the SARS-CoV-2 mRNA vaccines with respect to pre-vaccine risks and post-vaccine reactions. The CDC has provided the following differentiation: 

• Contraindication: History of a severe allergic reaction* (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine.
• Precaution: Persons with any immediate allergic reaction to other (non-COVID-19) vaccines or injectable therapies OR a non-severe immediate allergic reaction (onset < 4 hours) after a previous dose of COVID-19 vaccine fall into this category.
  • Risk assessment/counseling with physician prior to second dose
  • 30 minute observation period after vaccination
  • Consider referral to allergist/immunologist
  • Immediate allergic reaction is defined as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration. 
• May proceed with COVID-19 vaccine: Persons with a history of food, pet, insect, venom, environmental, oral medication (including the oral equivalent of an injectable medication) or latex allergies, or a family history of allergies. 
  • 30-minute observation period for anyone with a history of anaphylaxis (due to any cause)
  • 15 minute observation for all others
  • Vial stoppers of mRNA vaccines are not made with natural rubber latex 
  • The mRNA vaccines do not contain egg or gelatin 

Multiple studies have demonstrated that patient with moderate or even severe allergic reactions to a previous mRNA vaccine can receive a second dose safely, with observation. Studies suggest that these reactions may not be IgE-mediated.

Other Reported Reactions

Thrombosis-Thrombocytopenia Syndrom (TTS) 

The Janssen vaccine authorization has been revoked by the FDA. Novavax vaccine is now considered an alternate vaccine of choice.

Thrombosis with Thrombocytopenia Syndrome (TTS) is a rare complication of vaccination with the J&J vaccine which presents with typical and atypical thromboses associated with thrombocytopenia.  Symptoms usually start between 6 and 15 days after vaccination. Most concerning is Cerebral Venous Sinus Thrombosis (CVST) which has been present in 54% of cases. All of the patients have required hospitalization, 66% have been admitted to the ICU, 17% have required post-hospital skilled nursing care and 15% have died (total of 9 patients confirmed as of 12/9/21). This can present with altered mental status, visual disturbances, hemiparesis, and seizures, and can rapidly progress from symptom onset to death. 

Although this is a very serious potential complication, it is also very rare. The overall reporting rate is 3.83 per million doses of J&J vaccine. The reporting rate varies among different age groups and sex.  Two-thirds of the cases have occurred in females. The group with the highest risk is 30-39 year-old females with a reporting rate of 10.60 per 1 million doses, closely followed by the 40-49-year-old female group with a reporting rate of 9.02/million doses. The reporting rate in both females and males over the age of 65 is low. The overall death reporting rate is 0.57/1 million doses but it 30-49-year old females, it is 1.80-1.93/1 million doses. Note: all cases have been reported through VAERS, so these may be underestimates.

Resources: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html

Myocarditis/Pericarditis

Mild episodes of myocarditis have been rarely reported following mRNA vaccination. Recent reports suggest that this complication may be more common with the Moderna vaccine (https://www.bmj.com/content/375/bmj-2021-068665). Most of the patients have been discharged from the hospital within 1-2 days and only treated with steroids or anti-inflammatories. At 3 months FU, 90% are considered fully recovered. There has been one death reported from New Zealand, but details are not currently known. Like the TTS, the reporting rate varies with age and sex with the highest risk group 18-49-year-old males with a rate of 13 cases per 1 million doses. The rate for 18-49-year-old females is 2/million doses, and for 50-64-year-old males and females, 1/million doses. There have not been any cases reported in females over 65 years-old, and 1/million in males over 65.

In the 5-11-year-old age range, out of 7,141,428 doses administered, there have been 8 confirmed cases with another 5 being investigated.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html

Guillain-Barre Syndrome  

The Janssen vaccine authorization has been revoked by the FDA. Novavax vaccine is now considered an alternate vaccine of choice.

This has only occurred at a higher rate following the J&J vaccine. Mortality has been about 1%, 10% have required mechanical ventilation.  Most recover, although some nerve deficits may occur. This typically presents two weeks after vaccination.  Data presented at the July 17th meeting of the ACIP noted the highest rate in males over the age of 50 with 16 cases per 1 million doses. In females over 65, rates are 9/million doses.  Among females 50-64-years-old, and males and females 18-49-years-old, the rates are 5-7 per million doses, slightly over the expected background rate. The risk/benefit ratio favors vaccination for this complication because of the higher risk for hospitalization in those over 50.

Resources: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html

https://www.cdc.gov/vaccines/acip/meetings/slides-2021-12-16.html

Vaccine safety

• In this cohort study  from France including 22.7 million vaccinated individuals and 5.9 million unvaccinated individuals, vaccinated individuals had a 74% lower risk of death from severe COVID-19 and no increased risk of all-cause mortality over a median follow-up of 45 months. COVID-19 mRNA Vaccination and 4-Year All-Cause Mortality Among Adults Aged 18 to 59 Years in France | Public Health | JAMA Network Open | JAMA Network - December 4, 2025

• Effective communication resources

• The latest data show 61% of adults being vaccinated or intending to do so, while only 13% say they definitely will not get the vaccine (the "definitely will not" percent is unchanged since December). A number of statements were tested to see which led participants in the "wait and see" group to most likely say they would get vaccinated. Statements that were most impactful include: 
  • Vaccines are nearly 100% effective at preventing hospitalization and death from COVID-19. 
  • Scientists have been working on the technology used in the new COVID-19 vaccines for 20 years. 
  • More than 100,000 people from diverse backgrounds took part in the vaccine trials. 
  • The vast majority of doctors who have been offered the vaccine have taken it. 
  • There is no cost to get the vaccine. 

Other helpful information/resources

• Cover up personal information and vaccine lot number before taking a selfie with the card,  
• have a backup copy,  
• skip card lamination, if a booster dose becomes necessary it will be hard to add onto a laminated card.  
• replacement can be complicated,  
• There's no easy access to the data,  
• share vaccination status with your doctor. "Things to tell patients about their COVID-19 vaccine card" from the AMA 

The NIH Behavior and Social Sciences Research Coordinating committee has released resources on how to effectively communicate about the COVID-19 vaccine: 
COVID-19 Vaccination Communication 
A Communicator's Tip Sheet for COVID-19 Vaccination 
The CDC has also released training and educational materials for healthcare professionals. This includes information to guide conversations with and answer questions from patients regarding COVID-19 vaccines. 

These sites offers some useful information on counseling vaccine hesitant patients: COVID-19 Vaccine Confidence | CDC  and Communication Resources | CDC Most of these links can be found on the “Stay Up to Date on Vaccines” site: Stay Up to Date with COVID-19 Vaccines | CDC

1/7/2026