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Immunize.org summarizes ACIP’s February 4 meeting on full licensure of primary series of Moderna COVID-19 Vaccine (Spikevax)
The Advisory Committee on Immunization Practices (ACIP) met on February 4, 2022, to review the January 31 FDA licensure of Moderna COVID-19 Vaccine (Spikevax) for people age 18 years and older. Spikevax joins Comirnaty (Pfizer-BioNTech) as the second COVID-19 vaccine to obtain full FDA approval for its two-dose primary series. Emergency use authorization (EUA) continues to cover administration of a third primary dose for people with moderate to severe immunocompromise and administration of a booster dose following the primary series for all adults. ACIP voted unanimously to approve routine use of the vaccine as licensed by FDA.
Spikevax has the same formulation as the EUA-labeled Moderna COVID-19 Vaccine and can be used interchangeably with the EUA vaccine to provide the two-dose primary series in people age 18 years and older. Now that Spikevax is fully licensed, CDC will also issue emergency use instructions (EUI), as it did for Comirnaty. The CDC’s EUI document will address the use of Comirnaty or Spikevax as additional doses or booster doses for people who received a primary series using a COVID-19 vaccine not authorized in the United States, either in another country or as part of a clinical trial.
ACIP reviewed data from multiple vaccine safety surveillance systems. The Committee extensively discussed the previously identified rare occurrence of myocarditis/pericarditis after receipt of mRNA COVID-19 vaccines, which is somewhat more likely after Moderna than Pfizer-BioNTech vaccination. New data continue to confirm earlier evidence showing the risk to be greatest among younger males following dose 2, with a peak incidence of about 68 cases per million second Moderna doses among males age 18 through 39 years. Long-term follow up studies of people who experienced myocarditis after vaccination are underway; most cases have been clinically mild and most patients have fully recovered within 90 days. Even among younger males, the benefits of vaccination in preventing hospitalization due to COVID-19 greatly outweigh the risks of vaccine-induced myocarditis.
CDC presenters highlighted important proposed changes to its interim clinical considerations for the use of COVID-19 vaccines (key changes noted in bold type). These changes will be in effect once CDC updates its web page entitled "Interim Clinical Considerations for Use of COVID-19 Vaccines Approved or Authorized in the United States":
- For moderately or severely immunocompromised people, the third primary series dose of mRNA vaccine remains recommended 4 weeks after dose 2; however, CDC now recommends that the booster dose (a fourth dose) be given 3 months after dose 3. This replaces the previous recommendation of a 5-month interval.
- For moderately or severely immunocompromised people who have received a single dose of Janssen COVID-19 Vaccine, CDC now recommends an additional dose of Pfizer-BioNTech or Moderna COVID-19 vaccine be given at least 28 days following the Janssen dose. A booster dose (a third dose) of any COVID-19 vaccine product (preferably mRNA vaccine) is recommended at least 2 months after dose 2.
- For recipients of passive antibody products for treatment or post-exposure prophylaxis for COVID-19 infection, there is no longer a recommendation to defer vaccination after receipt of those products
- For immunocompromised people who need pre-exposure prophylaxis with long-acting tixagevimab/cilgavimab (Evusheld, AstraZeneca), defer Evusheld until at least 2 weeks after vaccination
The meeting concluded with presentations on COVID-19 vaccine recommendations in Canada and other countries. Evidence from Canada and other countries indicates extending the interval between doses 1 and 2 of mRNA COVID-19 vaccines to 8 weeks or longer may improve vaccine effectiveness while reducing the risk of myocarditis after the second dose. ACIP will discuss these data and the possibility of altering dosing interval recommendations in future meetings.
Over 212 million people in the United States are fully vaccinated, though coverage varies by age and geography. As of November 2021, when compared to adults who have received a primary series (with or without a booster dose), unvaccinated adults were
4 times more likely to test positive for COVID-19 and
15 times more likely to die. Nonetheless, CDC data from early January 2022 indicate almost 11% of U.S. adults say they probably or definitely will not get vaccinated.
Almost half of unvaccinated adults say that nothing would convince them to get a COVID-19 vaccine. The estimated cost of preventable COVID-19 hospitalizations among unvaccinated adults in the United States over a period of 6 months, from June through November 2021, was almost $14 billion.
The next scheduled ACIP meeting will be held February 23–24, 2022. However, if FDA approves Pfizer-BioNTech’s application for authorization of its vaccine in children age 6 months through 4 years, ACIP may hold an additional meeting before then. Information about past and future
ACIP meetings may be found on the ACIP website.
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CDC issues new pneumococcal conjugate Vaccine Information Statement (VIS) that covers PCV13, PCV15, and PCV20, and issues revised recombinant zoster VIS that covers immunocompromised patients
On February 4, CDC issued two Vaccine Information Statements (VISs) for:
- Pneumococcal conjugate vaccine – The new interim VIS should be provided with any pneumococcal conjugate vaccine (PCV13, PCV15, and PCV20) and outlines new recommendations for adults
- Recombinant zoster (shingles) vaccine – The updated VIS incorporates the expanded indications for this vaccine for adults age 19 years or older who are immunocompromised because of disease or treatment for a disease
CDC encourages providers to begin using these VISs immediately, but printed stocks of the previous editions may be used until exhausted.
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Immunize.org updates "You Must Provide Patients with Vaccine Information Statements (VISs) – It’s Federal Law!" and "Dates of Current Vaccine Information Statements (VISs)" to reflect new VIS version dates
Immunize.org has updated two key documents to help you manage your inventory of VISs.
The revisions reflect changes to the current VIS dates of the pneumococcal conjugate vaccine (PCV) VIS, and the recombinant zoster (shingles) vaccine VIS, as detailed in a separate story.
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CDC issues updates to its "General Best Practice Guidelines for Immunization" for dengue vaccine, influenza vaccine allergies, and storage temperature of MMR vaccine
CDC recently updated their "General Best Practice Guidelines for Immunization" for dengue vaccine, influenza vaccines, and measles-mumps-rubella (MMR) vaccine. The January 24 changes are listed below.
- Dengue – Contraindications and precautions have been added for the newly recommended dengue vaccine. View page 52, table 4–1.
- Influenza – A new footnote for inactivated influenza vaccine and live attenuated influenza vaccine describes the change in allergy-related contraindications and precautions. The classification of a history of severe allergic reaction (e.g., anaphylaxis) is now tied to the history of receiving specific influenza vaccine brands. View page 54, table 4–1.
- MMR – The correct storage temperature range has been applied to MMR vaccine. The vaccine portion (but not the diluent) can be stored at freezer or refrigerator temperature. The storage range of the vaccine is -50° C through 8° C (-58° F through 46° F). View page 119, table 7–1.
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February is Black History Month; Immunize.org celebrates the contribution of Black Americans in vaccinology
February is Black History Month, and Immunize.org would like to recognize the contributions of Black Americans to vaccinology throughout history, including:
- Onesimus, an enslaved man, introduced the idea of smallpox variolation in the United States in the 1700s
- Louis Tompkins Wright, the first Black surgeon on staff at Harlem Hospital in New York City, developed a new way to give the smallpox vaccine in the 1920–1930s
- Loney Clinton Gordon was one of three women to develop the pertussis vaccine in the 1940s
- Henrietta Lacks' cancer cells from the 1950s contributed to the development of the first polio vaccine, the HPV vaccine, and the COVID-19 vaccine
- Mae C. Jemison, the first Black astronaut, worked in vaccine research at CDC in the 1980s–1990s
Early in the COVID-19 pandemic, Kizzmekia S. Corbett, PhD, a viral immunologist, played a key role in developing the Moderna mRNA COVID-19 vaccine while at the National Institutes of Health (NIH). Today, she is an assistant professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, focused on viral immunology research for pandemic preparedness efforts and the development of universal vaccines.
The pandemic has had a disproportionate impact on Black communities, resulting in higher case rates, death rates, and severe illness. Encourage Black Americans to get vaccinated and take advantage of these shareable resources:
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Influenza activity has declined, but continues; encourage vaccination as long as influenza is a threat in your community
Influenza Surveillance
For week 4 ending on January 29, CDC's Weekly U.S. Influenza Surveillance Report, FluView summary reports that activity has decreased in recent weeks, with a decline in outpatient visits and hospitalizations. Activity varies across the country, with four jurisdictions reporting high or very high levels of activity.
Influenza Vaccination Dashboard
CDC's new Weekly Flu Vaccination Dashboard shares preliminary vaccination data. This week’s key fact: As of the week of January 8, overall influenza vaccination coverage for all children age 6 months–17 years is 2.8 percentage points lower than last season. Coverage is 5.2 percentage points lower for non-Hispanic White children this season compared to last season. Compared to non-Hispanic White children, coverage is 11.3 percentage points lower for non-Hispanic Black children (40.1% vs. 51.4%).
CDC recommends everyone age 6 months and older get an annual flu vaccination. Influenza and COVID-19 vaccines may be given at the same visit, if needed. COVID-19 vaccination alone provides no protection from influenza or any other respiratory virus.
Vaccine Finder
If you don’t provide influenza vaccine at your site, please strongly recommend vaccination and refer people to sites that do vaccinate. Use VaccineFinder, a user-friendly website to help people of all ages find influenza, COVID-19, and other vaccines. Participating providers can update their vaccine inventory estimates on VaccineFinder. For questions or more information, contact [email protected].
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Spotlight: Expedite vaccination by using Immunize.org's screening checklists
Immunize.org's Screening Checklist main page links to forms that patients may fill out to simplify and speed up assessment of vaccination needs and contraindications. The back of the screening checklist provides detailed guidance to help healthcare personnel interpret patient answers so they know if a vaccine is contraindicated or can be given with confidence. Several are available in multiple languages.
Screening checklists are especially useful in settings where standing orders or batched orders are used, as well as in settings where the patient’s full medical record is not readily available.
Immunize.org offers nine screening checklists, including:
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Journalists interview Immunize.org experts
Journalists seek out Immunize.org experts to help explain vaccines to the public and policy makers. We help the media understand and communicate the complex work vaccinators do. Here is one of our recent citations.
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These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
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Immunize.org Pages and Handouts
Reminder! Immunize.org introduces new, print-ready patient handout "Not Sure If You Can Get an Influenza Vaccine?"
Do you talk with people who think they should not receive (or give) influenza vaccine because of an egg allergy or pregnancy? Do you feel uncertain about influenza vaccination of those with a history of Guillain-Barré syndrome?
Immunize.org has created a new patient handout Not Sure If You Can Get an Influenza Vaccine? to address these issues. This handout, which can be printed as a two-sided single page, addresses a variety of concerns (e.g., egg allergy, Guillain-Barré syndrome, pregnancy, weakened immune system) with clear guidance reflecting CDC’s most recent recommendations.
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Featured Resources
Immunize Kansas Coalition offers new interactive online education for vaccination during pregnancy
The Immunize Kansas Coalition (IKC) now offers two interactive online modules designed for increasing vaccination during pregnancy.
- Increasing Vaccine Uptake in Pregnant Women is designed for clinical personnel who care for pregnant individuals. It focuses on confidently recommending vaccines during pregnancy, using evidence-based communication techniques, and evaluating workflow changes to increase vaccination rates.
- The Vaccines for My Baby During Pregnancy module is a great resource to share with people who are pregnant now, are trying to get pregnant, or who may want to be pregnant someday. The module focuses on the importance of getting influenza, Tdap, and COVID-19 vaccines, and on answers to common questions about vaccination during pregnancy.
IKC also offers modules for clinicians on HPV vaccines, influenza vaccines (CME available for these two), and for adolescents on adolescent vaccination, infant vaccination, and vaccine information. All modules can be viewed on a smartphone, tablet, or computer. Immunize.org’s Sharon Humiston, MD, MPH, was part of the multi-disciplinary team that developed these innovative modules.
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Newly updated “65+ Flu Defense” website offers resources for healthcare professionals serving older adults
Confident recommendations for influenza vaccine from healthcare providers are powerfully persuasive. To assist you in maximizing protection for your patients, Immunize.org, in collaboration with Seqirus, has updated the "65+ Flu Defense" website at www.influenza-defense.org.
A new fact sheet on the site, The Importance of Preventing Influenza during a Pandemic, offers responses to help guide discussions with patients on the increased importance of flu vaccination during the COVID-19 pandemic. Age increases risks associated with COVID-19 infection, including hospitalization and death. Preliminary studies suggest coinfection with influenza B and SARS-CoV-2 may elevate the risk of poor outcomes.
This helpful site includes information, tools, and tips for communicating with these adults about the scope and severity of influenza, for example:
Check out the updated "65+ Flu Defense" website at www.influenza-defense.org to assist your efforts in protecting this vulnerable population.
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FREE! Immunize.org offers COVID-19 and flu buttons and stickers. Free shipping! Place your order now!
Kids love buttons and stickers! As COVID-19 vaccination programs vaccinate children age 5 and older and offer booster doses to more people, now is the time to stock up on Immunize.org’s FREE “I Got My COVID-19 Vaccine” buttons and stickers, provided at no cost for product or shipping thanks to support from CDC. Stickers are available in English and Spanish. Buttons are available in Spanish. These buttons and stickers are perfect for people of all ages who want to show their confidence in COVID-19 vaccination.
Click the picture to place your order now:
Immunize.org also has a limited supply of our popular “Vacuna Contra LA GRIPE” buttons and stickers, available at no charge for product or shipping, thanks to funding from Seqirus. Now more than ever, it is important to step up our efforts to eliminate disparities in influenza vaccination rates. This bright red Spanish button can help.
Click the picture to place your order now:
“Mass-Vaccination-Resources.org” can help you excel at mass vaccination activities
Immunize.org's website www.Mass-Vaccination-Resources.org assists you in finding ideas for developing your own high-volume clinics. Mass vaccination efforts are useful for influenza and COVID-19 vaccination.
Many of the documents were written in the pre-pandemic era and need modification to ensure that additional protections (e.g., social distancing, personal protective equipment) help safeguard against COVID-19 transmission.
More resources have been added, including:
In addition, Immunize.org's on-demand full-length webinar (1 h. 46 min.) highlighting best practices and offering practical information, Mass Vaccination Clinics: Challenges and Best Practices, can be viewed on www.Mass-Vaccination-Resources.org.
The www.Mass-Vaccination-Resources.org website includes a Related Resources web page linking to three articles by Immunize.org authors that appeared in Becker’s Hospital Review.
If you have a resource to suggest for the website, please send a message to [email protected].
The webinar and the website are supported by a medical education grant from Seqirus.
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Order Immunize.org’s child, adult, and lifetime immunization record cards—wallet-sized, designed to last!
Immunize.org's personal immunization record cards, printed on rip-proof, smudge-proof, water-proof paper are designed to last a lifetime. They’re sized to fit in a wallet when folded. The record cards are for you to give to your patients as a permanent and personal vaccination record and are sold in boxes of 250.
Make bulk purchases and receive quantity discounts. For quotes on larger quantities or customizing, or to request sample cards, call 651-647-9009 or email [email protected].
Visit Shop Immunize.org for additional items, including "Vaccines Save Lives" enamel pins, flu vaccine buttons and stickers, and a vaccine administration training video.
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Notable Publications
“SARS-CoV-2 Infection and Hospitalization among Adults Aged ≥18 Years, by Vaccination Status, before and during SARS-CoV-2 B.1.1.529 (Omicron) Variant Predominance—Los Angeles County, California, November 7, 2021–January 8, 2022” published in MMWR
CDC published SARS-CoV-2 Infection and Hospitalization among Adults Aged ≥18 Years, by Vaccination Status, before and during SARS-CoV-2 B.1.1.529 (Omicron) Variant Predominance—Los Angeles County, California, November 7, 2021–January 8, 2022 on February 4 in MMWR. A summary appears below.
As of January 8, 2022, during Omicron predominance, researchers compared COVID-19 incidence and hospitalization rates in Los Angeles County among people with differing vaccination status.
- Incidence and hospitalization rates were 3.6 and 23.0 times higher, respectively, among unvaccinated people than among people who had received a primary series and a booster dose
- Incidence and hospitalization rates were 2.0 and 5.3 times higher, respectively, among fully vaccinated people without a booster than among people who had received a primary series and a booster dose
During both Delta and Omicron predominance, incidence and hospitalization rates were highest among unvaccinated people and lowest among vaccinated people with a booster. Being up to date with COVID-19 vaccination is critical to protecting against SARS-CoV-2 infection and hospitalization.
Access the MMWR article in HTML or PDF.
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“COVID-19 Vaccination among Persons Living with Diagnosed HIV Infection—New York, October 2021” published in MMWR
CDC published COVID-19 Vaccination among Persons Living with Diagnosed HIV Infection—New York, October 2021 on February 4 in MMWR. A summary appears below.
A study of New York adults from October 2021 found the rate of COVID-19 vaccination among people living with human immunodeficiency virus (HIV) was lower than that of the overall adult population in the state. COVID-19 vaccination coverage was also lower among those with HIV not receiving care and those who were not virally suppressed (having detectable levels of HIV in their blood). Among all people living with HIV, about 1 in 3 had not received any vaccine. CDC recommends people with weakened immune systems, including people with HIV, be up to date on their COVID-19 vaccinations. People with advanced or untreated HIV should [sic] may need an additional primary dose and should get a booster dose, when eligible. Researchers found lower COVID-19 vaccination coverage among New York adults ages 18 years and older with HIV than among the general adult population. Among those with HIV, coverage was lower in women, non-Hispanic Black people, American Indian/Alaska Native people, those who are not virally suppressed (having detectable levels of HIV in their blood), and people not receiving HIV care. Interventions are needed to help people with HIV get vaccinated and stay up to date on COVID-19 vaccines.
Access the MMWR article in HTML or PDF.
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“COVID-19 Vaccination Coverage and Vaccine Confidence by Sexual Orientation and Gender Identity—United States, August 29–October 30, 2021” published in MMWR
CDC published COVID-19 Vaccination Coverage and Vaccine Confidence by Sexual Orientation and Gender Identity—United States, August 29–October 30, 2021 on February 4 in MMWR. A summary appears below.
The National Immunization Survey–Adult COVID Module asked adults about their sexual orientation and gender identity, vaccination status, and the importance of COVID-19 vaccines. They found a higher percentage of gay and lesbian adults received at least one dose of a COVID-19 vaccine than did heterosexual or bisexual adults. Higher percentages of gay, lesbian, and bisexual people thought the vaccine was very or somewhat important for protection from the virus compared with heterosexual people. Higher percentages of people who identified as transgender or nonbinary thought the vaccine was very or somewhat important for protection compared with those who did not identify as transgender or nonbinary. The report also found that non-Hispanic Black women who were gay or lesbian or bisexual had lower vaccination rates than non-Hispanic Black women who were heterosexual. Understanding COVID-19 vaccination coverage and confidence among LGBTQIA+ populations and identifying the conditions under which disparities exist can help tailor local efforts to increase vaccination coverage.
Access the MMWR article in HTML or PDF.
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“Indirect Protection of Children from SARS-CoV-2 Infection through Parental Vaccination” published in Science
In the January 27 issue, Science published Indirect Protection of Children from SARS-CoV-2 Infection through Parental Vaccination. The abstract appears below.
Children unvaccinated against SARS-CoV-2 may still benefit through protection from vaccinated contacts. We estimated the protection provided to children through parental vaccination with the BNT162b2 vaccine. We studied households without prior infection, consisting of two parents and unvaccinated children, estimating the effect of parental vaccination on the risk of infection for unvaccinated children. We studied two periods separately—an early period (January 17, 2021–March 28, 2021, Alpha variant, two doses vs. no vaccination) and a late period (July 11, 2021–September 30, 2021, Delta variant, booster dose vs. two-vaccine doses). We found that having a single vaccinated parent was associated with a 26.0% and 20.8% decreased risk, and having two vaccinated parents was associated with a 71.7% and 58.1% decreased risk, in the early and late periods, respectively. To conclude, parental vaccination confers substantial protection for unvaccinated children in the household.
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“Vaccination with BNT162b2 Reduces Transmission of SARS-CoV-2 to Household Contacts in Israel” published in Science
In the January 27 issue, Science published Vaccination with BNT162b2 Reduces Transmission of SARS-CoV-2 to Household Contacts in Israel. A summary appears below.
The team estimated the effectiveness of vaccination with BNT162b2 (Pfizer-BioNTech mRNA-based vaccine) against household transmission of SARS-CoV-2 in Israel before and after the Delta variant emerged. They found:
- Vaccination reduced susceptibility to infection by 89.4%
- There was a slight, non-significant reduction in the infectiousness of vaccinated individuals who become infected
- The ability of vaccination to prevent transmission was reduced over time because of waning of vaccine-induced immunity and lower effectiveness against the Delta variant
The authors concluded, “It is highly unlikely that population-level transmission of SARS-CoV-2 can be eliminated through vaccination alone.”
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Upcoming Events
Watch February 23–24 ACIP meeting on tick-borne encephalitis, cholera, influenza, MMR, and pneumococcal vaccines
CDC will convene its Advisory Committee on Immunization Practices (ACIP) February 23–24. The meeting will include discussion of tick-borne encephalitis, cholera, influenza, MMR, and pneumococcal vaccines.
No registration is required to watch webcasts of live ACIP meetings or listen via telephone. Opportunities for public comment are described at the website.
View the agenda.
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Virtual: PA-AAP Medical Home Program hosts 3-part webinar series on provider communications with adolescents
The PA-AAP Medical Home Program will host a 3-part webinar series titled "Strategies to Improve Provider Communications with Adolescent Patients: Relationships and Rights." This webinar series will include teen speakers providing perspective on their experiences and recommendations for healthcare professionals. Learning objectives include:
- Describe concerns, preferences, and realities of young people in healthcare settings
- Value diversity among teens and recognize the challenges and opportunities this poses in healthcare settings
- Explain ways to provide high-quality, youth-friendly healthcare services
- Develop confidence and skills to build positive relationships and communicate effectively with teens
The webinar dates are as follows:
Participants may be eligible for CME/CEU.
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