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A summary of presentations from the weekly Summit partner webinars

November 9, 2023 – The latest Summit Summary

Update on Covid-19 and Influenza Safety – Tom T. Shimabukuro (CDC)

Tom T. Shimabukuro, MPH, MD, Director, Immunization Safety Office, Division of Healthcare Quality Promotion, CDC, gave an update on COVID-19 and influenza vaccine safety.

(VIEW SLIDES)

Dr. Shimabukuro stated that the slides he is presenting are the same slides presented at a recent ACIP meeting and can be found at www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-24/COVID-02-Shimabukuro-508.pdf and www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/03-COVID-Shimabukuro-508.pdf.

Key points up front

  • Statistical signal for a schematic stroke after the Pfizer bivalent COVID-19 vaccine was detected in CDC’s Vaccine Safety Data Link in people ages 65 and older (fall 2020)
  • Efforts continue to evaluate the signal, but available data do not provide clear and consistent evidence of a safety problem for ischemic stroke with bivalent mRNA COVID-19 vaccines when given alone or given simultaneously with influenza vaccines, or when influenza vaccine is given alone
  • Variable and inconsistent results obtained in some analysis of the risk of ischemic stroke following bivalent COVID-19 vaccination, simultaneous bivalent with influenza vaccination, and influenza vaccination alone
  • Most study results have not shown an association between vaccination and ischemic stroke, and no clear pattern demonstrating increased risk has emerged
  • Any real or theoretical risks of vaccine adverse events need to be placed in the context of the known benefits of COVID-19 and influenza vaccination in preventing COVID-19 and influenza disease and their potentially serious complications, including stroke
  • Our vaccine safety monitoring systems are designed to be sensitive, and the detection and assessment of potential safety signals and communication of safety information to the public is an example of the vaccine safety monitoring process working

Several analyses using different data sources have been conducted to assess the potential safety signal.   These analyses are summarized below.

First Analysis: Selected analyses of ischemic stroke and bivalent COVID-19 and influenza vaccination

(ACIP meeting: www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/03-COVID-Shimabukuro-508.pdf)

  • Data source: Vaccine Safety Datalink (VSD) COVID-19 Rapid Cycle Analysis (RCA)
  • Primary methodology: vaccinated concurrent comparator that looks at comparing bivalent vaccinated versus other bivalent vaccinated individuals who experience outcome but at different intervals
    • 1–21-day risk interval – biologically plausible related to vaccine risk interval
    • 22–42-day comparison interval – not biologically plausible—probably not related to vaccination
  • Supplemental: Bivalent vaccinated vs. bivalent unvaccinated but eligible for bivalent vaccine in a 1–21-day risk interval
  • Age groups included 18–64 years and ≥65 years
  • Main Findings
    • Statistical signal for ischemic stroke detected in primary analysis after Pfizer-BioNTech in the age group ≥65 years using a 1–21-day risk interval; signal attenuated over time
    • Post-signal assessment detected an elevated risk in the age group ≥65 years receiving same-day Pfizer-BioNTech and high-dose inactivated influenza (HD-IIV4) or adjuvanted inactivated influenza vaccine (aIIV4); finding attenuated over time
    • No elevated risk for ischemic stroke detected in supplemental analysis using secondary comparators.
    • Additional supplemental analyses suggested that comparison interval (22–42 days) rates of ischemic stroke were lower than expected

Second Analysis: Ischemic Stroke after Bivalent COVID-19 Vaccination: A Self-Controlled Case Series Study

(Xu et al., 2023: www.medrxiv.org/content/10.1101/2023.10.12.23296968v1)

  • Data source: Kaiser Permanente Southern California electronic health record
  • Methodology – Modified self-controlled case series using age groups ≥12, 12–64, and ≥65
  • Main findings:
    • No elevated risks detected for either Pfizer-BioNTech or Moderna in any age groups in automated data with a 21-day risk interval
    • No elevated risks detected for either Pfizer-BioNTech or Moderna in the age group ≥65 years in automated data with a 42-day risk interval
    • There were several analyses with statistically significant elevated risks in the age group 12–64 years in automated data with a 42-day risk interval
      • Pfizer-BioNTech and simultaneous influenza vaccination, overall and in those with a history of SARS-CoV-2 infection
      • Moderna in those with a history of SARS-CoV-2 infection
    • After limiting signaling analyses to chart-verified cases, the findings were no longer statistically significant

Third Analysis: Evaluation of Stroke Risk Following COVID-19 mRNA Bivalent Vaccines among U.S. Adults Aged ≥65 Years

(Lu et al., 2023: www.medrxiv.org/content/10.1101/2023.10.10.23296624v1)

  • Data source: Medicare claims data
  • Populations: Community-dwelling Medicare beneficiaries age 65 and older
    • Primary population: recipients of bivalent mRNA COVID-19 vaccine
    • Secondary population: recipients of high-dose or adjuvanted influenza vaccine
  • Methodology – modified self-controlled case series with a Farrington adjustment. The person serves as their own control.
  • Main findings
    • Primary population analysis did not show any consistent stroke risk after mRNA COVID-19 vaccination
    • Increased risk observed with same day administration of influenza vaccination
      • Non-hemorrhagic stroke after Pfizer plus high-dose or adjuvanted flu vaccines using a 22–42-day risk interval
      • Transient ischemic attack after Moderna plus high-dose or adjuvanted flu vaccines with 1–21-day risk interval
    • Secondary population analysis showed a small increased risk of non-hemorrhagic stroke after high-dose or adjuvanted with a 22–42-day risk interval
      • Risk remained for people without concomitant bivalent mRNA COVID-19 vaccinations

Fourth Analysis: Ischemic stroke after COVID-19 bivalent vaccine administration in patients aged 65 years and older: analysis of nation-wide patient electronic health records in the United States

(Gorenflo et al., 2023: www.medrxiv.org/content/10.1101/2023.02.11.23285801v1)

  • Data source: TriNet X, a cloud-based analytics platform that includes electronic health record data for more than 90 million unique patients in the United States
  • Methodology: retrospective cohort study among people age 65 and older
  • Main findings
    • Patients who received bivalent Pfizer COVID-19 vaccination had a similar hazard for ischemic stroke encounters compared to those who received bivalent Moderna COVID-19 vaccination
    • No difference in stroke risk between Pfizer bivalent and Moderna bivalent
    • Lower hazard than those who received monovalent Pfizer or Moderna COVID-19 boosters in the 1–21 or 22–42 days post-vaccination
    • Similar hazards for both bivalent vaccines
    • When they compared the bivalent to the monovalent, they observed lower hazards

Fifth Analysis: Stroke, Myocardial Infarction, and Pulmonary Embolism after Bivalent Booster

(Jabagi et al., 2023: www.nejm.org/doi/full/10.1056/NEJMc2302134)

  • Data source: French National Health Data System linked to the national coronavirus disease vaccination database
  • Methodology
    • Matched cohort study of 1:5 and people age 50 and older
    • Recipient of a monovalent vaccine was matched to recipients of bivalent mRNA COVID-19 vaccine and then followed for 21 days after vaccination
  • Main findings
    • Compared to monovalent Pfizer COVID-19 vaccination, bivalent Pfizer COVID-19 vaccination was not associated with increased risk of systemic stroke, hemorrhagic stroke, myocardial infarction, or pulmonary embolism in people age 50 and older
    • the authors previously found no increase in the incidence of stroke, acute myocardial infarction, or pulmonary embolism after administration of the monovalent Pfizer vaccine (no increased risk for the bivalent compared to monovalent)

Sixth Analysis: BA.1 Bivalent COVID-19 Vaccine Use and Stroke in England

Andrews et al., 2023: jamanetwork.com/journals/jama/fullarticle/2806456)

  • Data source: National Health Service hospital admissions, England, and linked to the National Immunisation Management System
  • Methodology was a self-controlled case series design in people age 50 and older and age 65 and older using a 1–21-day risk window. Further analysis in people age 65 and older given simultaneous bivalent mRNA COVID-19 and influenza vaccination.
  • Main findings
    • No increased risk of stroke in the 21 days after vaccination with either Pfizer or Moderna bivalent COVID-19 vaccines
    • Similar results obtained for ischemic and hemorrhagic stroke for the subset of people age 65 and older given influenza vaccine on the same day as the bivalent mRNA COVID-19 vaccine 

Seventh Analysis: Safety of monovalent and bivalent BNT162b2 mRNA COVID-19 vaccine boosters in at-risk populations in Israel: a large-scale, retrospective, self-controlled case series study

(Yamin et al., 2023: www.sciencedirect.com/science/article/pii/S1473309923002074?via%3Dihub)

  • Data source: Clalit Health Services medical records, largest healthcare organization in Israel with over 3.5 million enrollees, 1.2 million age ≥60 years
  • Methodology: self-controlled case series
  • Main findings
    • No safety signals detected for a schematic stroke after either monovalent or bivalent Pfizer COVID-19 vaccines used in Israel
    • Overall analysis on people age 65 and older

Additional data on ischemic stroke

  • No unusual or unexpected reporting patterns observed, and no evidence of a safety concern detected for ischemic stroke with either of the bivalent mRNA COVID-19 vaccines in Vaccine Adverse Event Reporting System (VAERS) monitoring
  • FDA monitoring in the CMS data and Department of Veterans Affairs monitoring in the VA system did not detect any safety signals for ischemic stroke following bivalent mRNA COVID-19 vaccination using historical comparator designs
  • A separate ad hoc CDC analysis during the bivalent Pfizer-BioNTech ischemic stroke signal assessment did not detect an elevated risk for ischemic stroke after influenza vaccination alone
  • Surveillance conducted by international regulatory and public health partners did not detect a safety concern for ischemic stroke following bivalent mRNA COVID-19 vaccination
  • No evidence of a safety signal for ischemic stroke detected in the manufacturers’ global monitoring of bivalent mRNA COVID-19 vaccination
  • No safety signals were detected for ischemic stroke for primary series or monovalent boosters for Pfizer-BioNTech or Moderna COVID-19 vaccines in U.S. and global monitoring)
  • Data suggest COVID-19 and influenza disease are associated with an increased risk of stroke ACIP Ischemic Stroke, COVID-19 and Influenza in Adults Ages greater than or Equal to 65 years-Feb. 24, 2023 (cdc.gov)
  • Data that suggests COVID-19 and influenza disease are associated with an increased risk of stroke (previously presented at ACIP)

Monthly incidence rates of non-hemorrhagic stroke (NHS) in Medicare claims data suggesting seasonality

(Lu et al., 2023: www.medrxiv.org/content/10.1101/2023.10.10.23296624v1)

  • Seasonal pattern where stroke risk is highest in in the winter months, falls in the summer months, then begins to move up approaching fall and winter months
  • Seasonality of stroke and heart attacks has been observed in many studies

Outpatient visits for respiratory illness in the United States from ILINet

  • Seasonal pattern with higher percentage of visits for ILI in the in the winter months
  • 2022–2023 season is unusual in the sense that the season was early, there was a higher, more narrow, early peak of ILI visits compared to other seasons. Seems to have been more severe.
  • Virus circulation probably aligned closely with COVID-19 and flu vaccination efforts due to the early season.
  • 2023–2024 may be closer to past seasons in terms of timing
  • A lot of vaccination was occurring at a time when there was also a lot of ILI in the population

Interpretation of analyses of ischemic stroke and bivalent COVID-19 and influenza vaccination

  • Variable and inconsistent results obtained in some analysis of the risk of ischemic stroke following bivalent COVID-19 vaccination, simultaneous bivalent COVID-19 vaccination with influenza vaccination, and influenza vaccine alone
    • Lack of consistency in findings from different data systems when using different methods across age groups and across subgroup analysis
    • The most common findings in these studies are findings of no association
    • Multiple comparisons were conducted in these studies without adjusting for multiplicity, and few reached statistical significance
    • These studies were not designed to account for a potential protective effect of vaccination on stroke and later post-vaccination periods. If there’s a protective effect, might expect to see less strokes in a because of protection gained against COVID-19 and flu illnesses, therefore indirectly protecting against strokes.
    • Adjusting for seasonality and restricting analysis to chart-verified cases frequently resulted in attenuated findings or findings that were no longer statistically significant
    • Remaining statistically significant findings tended to be relatively small in magnitude with low relative risk
    • Ischemic stroke cases in the analysis are predominantly occurring in older people and then people in the upper ranges of the age group (12–64 years); there are relatively few cases in younger people
  • Available data do not provide clear and consistent evidence of a safety problem for ischemic stroke with bivalent COVID-19 vaccines when given alone or given simultaneously with influenza vaccines or when influenza vaccine is given alone
  • Most study results have not shown an association between vaccination and ischemic stroke, and no clear pattern demonstrating increased risk emerged
  • Seasonality of stroke risk and an unusual respiratory illness pattern in 2022–2023 could be impacting the results of some of these analyses, and unrecognized SARS-CoV-2 infection could also play a role in the occurrence of stroke after vaccination
  • Any real or theoretical risk needs to be placed in the context of the known benefits of COVID-19 and flu vaccination and preventing COVID-19 and influenza disease. There are potentially serious complications of these infections, including stroke.
  • Simultaneous vaccination provides substantial benefits, keeping patients up to date with recommended vaccines and protected from vaccine-preventable illnesses.
  • The vaccine safety monitoring systems are designed to be sensitive in the detection and assessment of ischemic stroke signal and communication with the public is an example of the safety monitoring process working

Next Steps

  • Conduct additional analysis on the possible relationship between the ischemic stroke and bivalent mRNA COVID-19 vaccination, simultaneous administration of bivalent with flu vaccines, and influenza vaccine alone
  • Continue vigilant safety monitoring of 2023–2024 COVID-19 and influenza vaccines, including for ischemic stroke

Questions

Q: Was the risk different for those age 85 and older in terms of increased risk of administration?

Tom Shimabukuro (CDC): I believe there was one finding in the FDA analysis that’s posted on a preprint which had a statistically significant finding in the 85 and older group. I don’t remember which vaccine it was for, but keep in mind what we’re looking at are statistical signals that don’t necessarily constitute an increased risk. I think our interpretation is when you look at the data, given the inconsistency of findings and the multiplicity of comparisons, the many comparisons of which a small number of those are statistically significant considering when we did adjustments for chart reviews. Many of these findings attenuated or went away. We don’t think that there is strong, clear, or consistent compelling evidence of a safety problem for an ischemic stroke with COVID-19 vaccines, COVID-19 with flu vaccines, or flu vaccine alone.

 

Q: The RSV vaccine is available via shared clinical decision-making for age 60 and older this year for the first time. Is that going to be included in your safety monitoring, as well?

Tom Shimabukuro (CDC): We have monitoring underway for RSV vaccines. Like flu, COVID-19, and other vaccines, we use multiple complementary systems to monitor vaccine safety. For CDC that includes the VAERS, the Vaccine Safety Data Link, V-safe, and our clinical immunization safety assessment project. Our colleagues at FDA jointly manage theirs, and they also have other systems like their BEST system monitoring and CMS. There is monitoring underway for RSV. So far, the update has been limited, so the data are sparse. We’re also doing some focus monitoring on simultaneous administration, so COVID-19, flu, and RSV, or the various combinations of the three. Simultaneous administration is not uncommon, but I would say it’s not really that common. It’s hard to draw conclusions about those data but we are monitoring simultaneous safety of simultaneous administration.

Carolyn Bridges (Immunize.org): I’m wondering if, based on some of these findings that have been talked about and discussed at ACIP, you’ll be able to look back to the Safety Datalink or other systems that you use to look at whether coadministration rates in adults drop or fall this year compared to last given.

Tom Shimabukuro (CDC): Some of the information that’s come out about these studies, we might be able to do that. The availability of vaccines may play a role, but we might be able to look at rates of coadministration of vaccines.

 

Q: We’ve seen very low uptake in this new monovalent COVID-19 vaccine, particularly in younger people, children, and adolescents. I’m wondering if you can say anything about data on myocarditis and pericarditis when people are getting the updated vaccines compared to when they received a dose series? What’s the safety risk of getting myocarditis and pericarditis in the newer vaccines as opposed to the initial vaccine series?

Tom Shimabukuro (CDC): We have sufficient data to conclude that there is a causal association between the COVID-19 mRNA vaccine and myocarditis. The risk appears to be highest in adolescent young adult males. The highest risk is after the second dose in the primary series. It’s theoretically possible. Maybe even likely that there is an increased risk with the new monovalent vaccine. We haven’t seen that. The uptake in those younger age groups has been limited, so the data are sparse. But we’re not seeing anything concerning right now. I think it is important to recognize that it is a known causally-associated adverse event after the mRNA vaccines.

 

Q: Has anyone looked at the safety of switching mRNA vaccine brands versus people staying with a single brand of mRNA vaccine?

Tom Shimabukuro (CDC): In the United States, at the height of the vaccination program, there was very little heterologous vaccination. I think providers are really following the prescribing information, so I don’t think there’s sufficient data to evaluate that practice. I think, based on what we know about other vaccines, there’s no safety issue with heterologous vaccination. I don’t think there are any restrictions on if you’ve had a previous dose of one brand. You need to stick with that for your next subsequent doses (except for children six months through 4 years and previously unvaccinated people who are immunocompromised. See: www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html for details about how can receive heterologous COVID-19 vaccine doses and who should receive homologous COVID-19 vaccine brands).

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General Best Practices on Simultaneous Vaccine Administration – Andrew Kroger (CDC)

Andrew Kroger, MPH, MD, Medical Officer, NCIRD, CDC gave a presentation on general best practices of simultaneous vaccination.

See: General Best Practice Guidelines for Immunization

Immunization Services Division (ISD) perspective – Simultaneously administering all vaccines for which a person is eligible at the time of a visit increases the probability that a child, adolescent, or adult will be vaccinated fully by the appropriate age.

General best practice to vaccinate simultaneously (same clinic day)

Adults

  • Exceptions
    • Pneumococcal vaccination, PCV (conjugate) and PPSV (polysaccharide vaccines) need to be separated from each other
      • Providers need to ensure at least an 8-week interval between these two products if PCV is given first. The interval is one year if PPSV23 is given first.  Details are included in the pneumococcal vaccine recommendations.
      • Both a safety and an effectiveness rationale
        • Safety
          • Separate by at least eight weeks to avoid adverse reactions between the two
          • Those who are high risk and have received PCV generally should wait eight weeks before PPSV23
        • Effectiveness
          • If PPSV23 is given first, need to wait a year before giving PCV
        • Myocarditis is an adverse reaction for the mRNA COVID-19 vaccines and one of the mpox vaccines (ACAM200, Acambis) has a risk of myocarditis as well, so those two would have to be separated by four weeks
        • Jynneos (mpox), which is now going to become a recommended vaccine in the near future, should be separated, particularly in the adolescents for whom myocarditis is the is the highest risk. The Jynneos vaccine has not been found to have a risk of myocarditis.  However, the precaution for ACAM2000 has been extended to include all orthodox vaccines.
        • Oral typhoid vaccine and oral cholera vaccine should not be given simultaneously. Give the oral cholera vaccine first and then begin the oral typhoid series at least 8 hours after the oral cholera vaccine.
        • Don’t give passive immunization products such as whole blood or immunoglobulin (anything that has pre-formed antibody) simultaneously with MMR vaccine and varicella vaccine. This is an effectiveness issue. Only if someone is at high risk of measles or is going to travel soon, give the vaccine even if given a pre-formed antibody.

Children

  • CDC broadly recommends simultaneous vaccination for needed vaccines
  • 2003 National Vaccine Advisory Committee (NVAC) stated that to ensure coverage of vaccines, they should be given simultaneously when indicated
    • MMR coverage is increased if given at the same time as other vaccines
  • 2013 the National Academy of Medicine looked at the child schedule
    • Not feasible to separate out vaccines to get them on time
    • Safe to give vaccines at the recommended ages per schedule

Combination Vaccines for Adults – Studies examined influenza vaccine and pneumococcal polysaccharide vaccines

  • Increased risk of reduced effectiveness
  • Not a safety issue
  • Finding occurred only in those who are at high risk for invasive pneumococcal disease
  • Policy that came as a result is weighing the risks and benefits
  • Important that pneumococcal vaccine be given simultaneously with influenza vaccine when both were indicated to protect the most people and no missed opportunities for vaccination
  • Found reduced immunogenicity of influenza products for age 50 and older in the high-risk group
  • For high-risk individuals, if you try to separate vaccines there may be a missed opportunity
  • Recommendation is to vaccinate simultaneously with influenza and pneumococcal products
  • Data shows some reduced immunogenicity of simultaneous PPSV23 and Zostavax, which maybe should be separated, but there is no policy to do that because antibody results are not sufficient

Vaccines given within a 28-day interval (non-simultaneous)

  • Any injectable or intranasal live vaccine, if not given on the same day as another live vaccine, needs to be separated by 28 days
  • If missed the chance, forces a delay of 28 days for the second live vaccine
    • Has to do with the effectiveness of the replication of the first live vaccine effect and the replication of the second vaccine’s virus such that the second vaccine given has a lower immune response
    • Breakthrough infections possible

Questions

Q: When you looked at the RSV vaccine ACIP recommendations for adults age 60 and older, there was quite a discussion on the ACIP language about the potential decrease in immunogenicity when the vaccine was combined with the flu vaccine, and the ACIP vaccine recommendation discusses the limited safety data on coadministration. I think most of the CDC says it’s okay to give them on the same day. Are you seeing this causing some confusion? Can you help us reconcile the detailed language for some specific  ACIP recommendations versus the overall guidance?

Andrew Kroger (CDC): I’ve heard more about the ischemic and coadministration of influenza and COVID-19 vaccines. There was some discussion at the most recent ACIP meeting about RSV vaccine and influenza. The language in the ACIP recommendations for adults age 60 and older talks about the decreased immunogenicity for flu when flu was coadministered with RSV and then later talks about safety and the lack of data on coadministration, except for flu. Coadministration has some caveats which are not generally reflected in the general language CDC uses. We’re wondering if that’s causing some potential confusion about coadministration.

 

Q: There are questions about the safety of adjuvanted flu and RSV vaccine coadministration. Can you clarify the CDC recommendation for coadministration of RSV with other vaccines?

Andrew Kroger (CDC): To my knowledge, we recommend these vaccines to be coadministered when both are indicated. There’s a difference in the relative strength of the vaccine recommendations. Individually, regarding RSV is shared clinical decision-making for adults 60 years and older. I have not heard a lot of questions come in about this issue. What I have heard are questions about adjuvants. We have an add-on recommendation which I have not talked about at all, and that applied originally to COVID-19 vaccines, so I don’t know how much applies to RSV. COVID-19 is such a reactogenic vaccine that we want that vaccine administered in a different limb from any vaccine that has an adjuvant or any vaccine that may be more reactogenic. The high-dose influenza and adjuvanted influenza vaccine should be administered in separate limbs from COVID-19. We know that one of the RSV vaccines has an adjuvant, so maybe that’s a concern with a lot of people—that issue of the adjuvants interfering with each other. I know that the adjuvant that is in the RSV vaccine is different from the adjuvant that is in the influenza. But, the adjuvant in the RSV vaccine is the same adjuvant that’s in the Shingrix. Those are also recommended simultaneously on the same day if both are indicated.   I have not seen a lot of specific questions on that, but it doesn’t change the general recommendation that the two vaccines if both are indicated, should be given on the same day.

 

Q: Would you suggest people not get multiple adjuvanted vaccines in one day if they can? Do you see anything coming out about reminding providers to let their adult patients know, in advance, that if they get multiple of these adjuvant vaccines on the same day you might not feel well the next day?  Might that help prepare patients in advance?

Andrew Kroger (CDC): It’s different context in adult vaccination versus child vaccination. The policy stands for children going back to 2003. It’s been looked at by the National Academy of Medicine. There are so many vaccines for children that it’s part of our childhood vaccination policy. We will start thinking about if we need to treat adults differently. I think there may be room for more discussion on this. There are a lot of adjuvants in these vaccines and as mentioned, Shingrix and our RSV have the AS01 adjuvant, so, for those two vaccines, there also are programmatic issues that are more relevant with adults that have to do with anatomic space for adult vaccination. With little babies, it’s easy to use. They utilize the anterolateral thigh to get an extra muscle mass to give multiple vaccine doses. With adults, you’ve got two deltoids for your IM vaccines so that programmatic issue is playing a role in terms of how many vaccines you can one get on the same day.

Kelly L. Moore (Immunize.org): This is a whole new issue that requires a serious conversation about reactogenicity in older adults. This isn’t necessarily a safety issue. That’s not a big concern. The big concern is if it’s highly reactogenic and you’re loading up patients with things that then make them feel sick for two days are they going to come back next season and get anything? We have a customer relationship issue, also. That’s why the new RSV guidelines say it is acceptable. It doesn’t say ‘should’ it says ‘acceptable’ in the new RSV guidelines for older adults. It’s acceptable to coadminister, but here are all the caveats why if this patient is reliable and is going to come back then it is reasonable to not give multiple vaccines on the same visit, especially when they’re adjuvanted because of the reactogenicity, not necessarily safety. The issues with loss of immunity lower immunogenicity even though we don’t know what that means clinically yet. That lower immunogenicity for the H3 component of influenza is concerning, so I think there’s more to come here that maybe needs to be incorporated into general best practices. That is simply new territory for all of us regarding adults, so we don’t want to miss an opportunity. If it’s a reliable patient, we also don’t want to make them feel so bad they don’t come back in the future.

Carolyn Bridges (Immunize.org): There’s a statement in the Q&As reminding us all that the Novavax COVID-19 vaccine’s adjuvant is not in any other vaccines.

Another question submitted: are there any efficacy issues with COVID-19 and flu if you don’t wait 30 days between them? Often you hear to wait only two weeks. Is there a recommendation to wait 30 days with COVID-19 and flu if not given simultaneously?

Andrew Kroger (CDC): Not from an effectiveness standpoint. They’re both non-live vaccines so we wouldn’t think one would interfere with the other. So, except for the exceptions mentioned already, there is no needed interval recommended for two inactivated vaccines.   Also, there is no preset interval between an inactivated and live vaccine or a live vaccine followed by an inactivated.  The main issue of concern regarding effectiveness is ensuring an appropriate interval between two live vaccines if they are not given on the same day.

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