February 11, 2021

February 11, 2021

  • National Forum on COVID-19 Vaccine – CDC is facilitating this national forum on February 22–24 to provide information on promising practices and practical tools to inform vaccine implementation in communities across the country. General information and registration details are available online. Registration closes on February 16.

COVID-19 Vaccine Safety Update – Tom Shimabukuro (CDC)

Tom Shimabukuro, Head of CDC’s COVID-19 Vaccine Safety Team, provided an overview of COVID-19 vaccine safety information. He noted that some of this information was previously presented during recent ACIP and NVAC meetings.

V-safe is CDC’s text messaging service offered to all vaccine recipients to follow up on vaccine safety issues and provide reminders when the second dose is due. Participation is voluntary. Tom’s presentation focused on vaccine reactogenicity data collected via v-safe through January 24. At that time, approximately 2 million people had enrolled in the program, and these were almost evenly split between the Pfizer-BioNTech and Moderna vaccines. Approximately 15,000 of the v-safe participants had subsequently reported a pregnancy either during or after vaccine administration.

Early data on dose 1 for either mRNA vaccine showed similar local and systemic reactions, including pain at the injection site, fatigue, headache, and myalgia. Dose 2 results are still being finalized, but reactions appear to be much higher than those observed with dose 1. This is consistent with reactions observed during the clinical trials.

Data from the Vaccine Adverse Events Reporting System (VAERS) is also being closely monitored. Within this spontaneous passive reporting system, headache has been the most frequently reported adverse event for both mRNA vaccines.

Anaphylaxis reports to VAERS have been assessed by CDC physicians and additional follow up has been conducted if necessary. Most reports were after dose 1. The median time to symptom onset post-vaccination was 10 minutes, and 90% of cases of anaphylaxis occurred within 30 minutes.  As more people have been vaccinated, the rate per doses administered has dropped significantly. For the Pfizer-BioNTech vaccine, 50 cases of anaphylaxis have occurred, with a rate of 5.0 per million doses administered from December 14 – January 18. For the Moderna vaccine, 21 cases have been reported, with a rate of 2.8 per million doses administered during the same time period.

Physicians in CDC’s Immunization Safety Office immediately follow up on VAERS reports of deaths and mortality following COVID-19 vaccination. Through January 18, 196 deaths following vaccination had been reported to VAERS. The majority of these were in long-term care facility (LTCF) residents. Tom emphasized that VAERS reports of deaths following vaccination are temporally associated and should not be assumed to be causally related. For example, the background mortality rate in LTCF residents is high due to underlying health status of the population. Available evidence from VAERS monitoring does not suggest a safety problem with respect to older LTCF residents.

In closing, Tom noted that, overall, the safety profiles of COVID-19 vaccines are reassuring and consistent with observations from the pre-authorization clinical trials. Additional population-based monitoring systems will continue to gather safety data as vaccination increases.

In response to questions, Tom stated CDC has not seen any data that would indicate the Moderna vaccine is any more reactogenic than the Pfider-BioNTech vaccine. He also noted that, in spite of one highly publicized case, VAERS does not indicate anything unusual related to idiopathic thrombocytopenia purpura (ITP) following vaccination.

The COVID-19 Pandemic: Impact on US Adolescent and Adult Vaccine Utilization Across Markets – Loren Becker (Avalere Health)

Loren Becker, Associate Principal for Vaccine Policy and Market Access with Avalere Health, provided a presentation on COVID-19’s impact on immunizations in the adolescent and adult populations. In addition, Avalere has issued a white paper and a 2-page infographic on this topic.

Loren noted that, although this topic has been discussed extensively with respect to the pediatric population, less is known about COVID-19’s impact on adolescents and adult vaccination levels. After reviewing claims-based information for the current year compared to the pre-COVID time period, Avalere determined the pandemic has led to a significant and sustained drop in immunization rates among adolescents and adults.

Loren emphasized several key points from the data. Immunization claims declined 41–53% across markets from March–August 2019 compared to the same months in 2020.  There was no direct correlation with COVID-19 cases; however, claims declined and stagnated across all markets. The rise in influenza vaccinations early in the season (up to August) may reflect multi-stakeholder messaging efforts. Even as immunization rates have begun to rebound, the number of missed doses continues to accumulate.

There is an approximate 3-month lag in the data being collected. Loren said Avalere is assessing the appropriate time to conduct an updated review of this data. Carolyn Bridges stated that the guidance to separate COVID vaccination from other vaccines by 14 days may be having an impact and suggested this would be a good topic for future studies. It also will be important for partners to conduct outreach to parents of teens to encourage vaccination catch-up prior to the back-to-school rush. At a future meeting, the Summit may review the best ways to handle outreach in outbreak settings, such as during hepatitis A outbreaks.

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