Some experts have criticised Pfizer for not informing pregnant women in its trial of maternal respiratory syncytial virus vaccine that trials of a similar vaccine were halted over a potential risk of preterm birth. Others think that notification would have been premature and caused unnecessary anxiety. Hristio Boytchev reports
A debate has broken out over whether Pfizer should have told pregnant women participating in its trial of maternal respiratory syncytial virus (RSV) vaccination that a trial of a similar vaccine was halted over a safety signal around preterm birth, The BMJ can report. Both GSK and Pfizer were developing recombinant RSV F protein vaccines to inoculate pregnant women and protect their babies against RSV, a major cause of infant death globally.
GSK halted its phase 3 vaccine trial on 28 February 2022 after a safety signal emerged: a possible increased risk of preterm births and neonatal deaths. In the vaccine arm, 6.81% of births were preterm (95% confidence interval 5.99% to 7.69%) compared with 4.95% (3.97% to 6.07%) in the placebo arm. For neonatal deaths, the percentage was 0.37% (0.20% to 0.64%) in the vaccine versus 0.17% (0.04% to 0.50%) in the placebo arm.12 No clear explanation has been found for the increase in preterm births, and experts think that it might be unrelated to the vaccine. GSK told The BMJ that the imbalance was observed primarily in low and middle income countries and not consistently after a peak in late 2021,3 and that it was still investigating the cause of the preterm births but was no longer developing its vaccine.
Pfizer was studying preterm births as an adverse event of special interest in its own phase 3 trial, and a numerical (not statistically significant) imbalance in preterm births has recently emerged in phase 3 data: 5.7% (4.9% to 6.5%) in the vaccine versus 4.7% (4.1% to 5.5%) in the placebo arm, although there are not enough data to understand if there is truly an increased risk or what the cause is.45
After GSKs trial was halted, opinion was split among clinical trial ethicists and some vaccine researchers over whether Pfizer should have informed all women participating in its trial about the potential risk or updated its consent forms. Some think that only women who had not yet been vaccinated needed to be informed, whereas others think that because there is currently neither convincing evidence nor an explanation for the increased preterm risk, informing expectant mothers would have only caused unnecessary anxiety.
Charles Weijer, bioethics professor at Western University in London, Canada, told The BMJ that informing pregnant women in Pfizers trial about GSKs results would have allowed women who had not yet received the jab to consider whether they still wanted to get it and women who had already received it to seek additional medical advice and follow-up. Any failure to provide new and potentially important safety information data to trial participants is ethically problematic, Weijer said.
The independent Data and Safety Monitoring Board (DSMB), which reviews and evaluates study data to protect participants safety and monitor the studys progress, should normally have considered GSKs results and decided if they merited attention, said Stephen Evans, emeritus professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine. For Pfizer, the DSMB should have regularly assessed the benefit-harm balance, both on the data in the trial and whether the GSK results affected that balance. They should not base their decision simply on whether a particular result is statistically significant. These are difficult decisions, and it is why DSMBs are independent of the company, he told The BMJ.
The DSMB for the Pfizer trial didnt answer The BMJs questions about whether it had considered the GSK results, and two trial investigators told The BMJ that they hadnt received any communication from the DSMB regarding the results. Pfizer has also been criticised for a passage in some of its trial consent forms, seen by The BMJ, saying that its vaccine candidate was risk-free for the baby; a research ethics expert described this assurance as misleading and irresponsible. Pfizer did not respond to The BMJs questions on the issue of informed consent.
GSK told The BMJ that immediately after making the decision to halt its trials over the safety signal, it informed the health authorities and researchers involved in the trial. It also updated its consent forms. Over a year after GSKs trial was halted, The BMJ reported in May 2023 that experts had called for further analysis of Pfizers phase 3 trial data after the slight numerical increase in preterm births was seen.6 The imbalance was discussed a week later by the US Food and Drug Administrations vaccines and related biological products advisory committee.7 Ahead of the meeting, the FDA published an analysis showing that there was no increase in preterm births in high income countries, but there was a numerical increase in upper middle income countries, driven particularly by South Africa.5
The committee ultimately advised that Pfizers maternal RSV candidate was safe, although four of 14 members voted that the data presented by Pfizer were not adequate to support safety after a detailed discussion on the preterm births. Committee member Paul Offit, professor of paediatrics at the Childrens Hospital of Philadelphia, said in a meeting that Pfizers and GSKs vaccines were almost identical and so was concerned by GSKs results. Hana El Sahly, professor of molecular virology and microbiology at Baylor College of Medicine and committee chairwoman, said that the signal of increased preterm births connected to the Pfizer vaccine was significant in the phase 2, in the phase 3, and in a very similar product, adding that failing to design the Pfizer phase 3 study to deliver clarity was a big missed opportunity.8
Regulators have taken different approaches when approving Pfizers vaccine, which is called Abrysvo. The FDA approved it with conditions, including only giving it to women who are 32-36 weeks pregnant. Available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo, said a warning included in the prescribing information.9 To avoid the potential risk of preterm birth with use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age. The FDA is requiring Pfizer to conduct postmarketing studies to assess the signal of serious risk of preterm birth.
Other regulators and national advisory committees, however, such as the European Medicines Agency and the UKs Joint Committee on Vaccination and Immunisation, did not consider a warning around the possible risk of preterm birth or restricting the use of the vaccine to the later weeks of pregnancy necessary in their regions. The Pfizer vaccine is not yet authorised in the UK, and the details of authorisation are not yet clear.
As Pfizer didnt respond to the questions about whether it had informed expectant mothers in its trial about GSKs results, The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites, as well as more than 80 trial investigators, and none answered saying that it had. Some confirmed that Pfizer continued to enrol and vaccinate women for months after the news of the potential risk of preterm birth in GSKs vaccine trial was made public.
Clinical trial ethicists and some other experts think that Pfizer should have made pregnant women in its trial aware of the potential preterm risk; some trial investigators and health authorities disagree. Once the results of the GSK trial on premature births became public, RSV vaccine studies in pregnant women should be updated to include this possible preterm risk, Klaus berla told The BMJ. berla is director of the Institute of Clinical and Molecular Virology of the University Hospital Erlangen and a member of the RSV working group of the standing committee on vaccination, which develops national recommendations for the use of licensed vaccines in Germany.
The renewal of informed consent is a must, added Rose Bernabe, professor of research ethics and research integrity at the University of Oslo. She pointed to guidelines from the Council for International Organizations of Medical Sciences, which state: Researchers must renew the informed consent . . . if new information becomes available that could affect the willingness of participants to continue.10 The internationally recognised Guideline for Good Clinical Practice contains a similar passage.11 In its trial publication, Pfizer said that it followed these guidelines.12
One trial investigator, speaking to The BMJ on the condition of anonymity because they had signed a confidentiality agreement with the company, said that early in 2022 they questioned Pfizer about the potential risk of preterm birth given the similarity between Pfizers and GSKs products and wanted to know whether Pfizer trial participants could be reassured. All I got from Pfizer was that their data hadnt shown any increase in risk, no answer to my question, the researcher said. Nothing was communicated regarding whether the DSMB had discussed the matter, they said. A trial investigator from South Africa, also speaking on the condition of anonymity, agreed that participants should have been informed.
But other trial investigators disagree. Beate Kampmann, director of the Centre for Global Health at Charite University Hospital Berlin, one of the lead authors of Pfizers phase 3 trial publication, and who was responsible for a trial site in the Gambia, told The BMJ that GSKs results werent relevant to her trial participants as most participants were already in follow-up. She said that the Pfizer vaccine was not the same as the GSK product and that the trials DSMB did not raise any concerns. This was a very location specific and also transient finding, which remains poorly understood, she added. She said that The BMJs questions on informed consent and possible side effects in the trial amounted to getting hung up on issues which are not borne out by the analysis and are distorting the benefits this vaccine can bring.
Kampmann did not clarify whether the DSMB had discussed the GSK results, and the DSMBs chair, Flor Munoz, associate professor of paediatrics at Baylor College of Medicine, refused to tell The BMJ whether the board had reviewed GSKs results, citing confidentiality agreements.
As the risk was uncertain and the cause of the increase in preterm births still not understood, amending the consent forms was not warranted, said Joop van Gerven, chair of the Dutch Central Committee on Research Involving Human Subjects (CCMO), a national ethics body responsible for the trial. This would have caused too much uncertainty (without any clinical consequences) for the large number of patients who had already received the vaccine, he told The BMJ. The Spanish health ministry shared this view.
Pfizer did not disclose in patient consent forms for its phase 3 trial that it was studying preterm birth as an adverse event of special interest, documents from the US, Canada,13 the Netherlands, Finland, and New Zealand, obtained by The BMJ, show. In addition, some Pfizer trial consent forms seen by The BMJ contain contradictory statements, warning of possible life threatening effects of the vaccine on the baby while also carrying a passage saying that only the expectant mother is at risk from adverse effects. The consent forms stated: The risks associated with the study vaccine (RSVpreF or placebo) may be experienced by you, but not your baby, since your baby will not receive the study vaccine or placebo directly.
Knowing what we know now, the statement in question is irresponsible and, given the benefit of hindsight, is actually factually incorrect, said Bernabe of the University of Oslo. The statement gives the false sense of security that the fetus or neonate will not be exposed to any risk or inconvenience. Considering the gravity of the risk that this irresponsible statement veils, this misleading statement should be a ground for questioning the validity of the consent process.
The Dutch national research ethics body, CCMO, admitted that the passage could potentially cause confusion. Following The BMJs queries, the Dutch authority alerted Pfizer to possible reader confusion and recommended the passage be adapted, van Gerven, of the CCMO, told The BMJ. However, as it has since emerged that no new participants will be included in the study, making an adjustment . . . is no longer an issue, he said.
Provenance and peer review: Commissioned; externally peer reviewed.
This feature has been funded by the BMJ Investigations Unit. For details see bmj.com/investigations.
Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med 2023;388:1451-1464.
14 November 2023
A new study by researchers from the International Agency for Research on Cancer (IARC) shows that a new quadrivalent human papillomavirus (HPV) vaccine, which targets HPV types 6, 11, 16, and 18, is safe and effective in provoking an immune response against these HPV types. The study was published in the journal Lancet Oncology.
The researchers compared the efficacy and safety of the new quadrivalent HPV vaccine, given in two doses to girls and boys aged 914 years, with those of a comparable vaccine, given in three doses to women aged 1526 years. The results showed that the new quadrivalent HPV vaccine was as effective and as safe for the younger population as the comparable vaccine.
Access to this new, effective vaccine could help meet the global demand for HPV vaccines and boost coverage for both girls and boys globally.
Sharma H, Parekh S, Pujari P, Shewale S, Desai S, Bhatla N, et al. Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 914 years versus an established quadrivalent HPV vaccine in women aged 1526 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial Lancet Oncol, Published online 7 November 2023; https://doi.org/10.1016/S1470-2045(23)00480-1
Read the article
Launch of online learning resources on cervical cancer screening
To mark three years of the global movement to eliminate cervical cancer, the International Agency...
17.11.2023
IARC-led study finds that 2 million lives are lost to preventable cancers each year across seven countries
Each year 1.9 million lives are lost to cancers caused by four preventable risk factors across th...
16.11.2023
Ultra-processed foods are associated with increased risk of cancer and cardiometabolic multimorbidity
In a ground-breaking multinational study, researchers from the International Agency for Research ...
14.11.2023
Kuehne+Nagel announced that it has executed a unique operation in September 2023, similar to what is called a milk run, to deliver 150 pallets of flu vaccines directly to over 40 Veterans Affairs (VA) hospitals across the United States within less than five days, with the expertise of its road logistics team.
It was an average Monday afternoon in September at our North American headquarters in Jersey City, NJ, when Tomas Salomoni, Ed Penafiel, and Tony Camacho, of Kuehne+Nagels Road Logistics team received a call from a long-time, well-known, pharmaceutical customer that needed special support, reads the release.
For this, the K+N team used a multi-stop lane, according to the geography/distance to optimize equipment utilization and reduce the overall cost.
By early Wednesday morning, within 36 hours of the initial customer call, the Road Logistics team had arranged for three different carriers to pick up over 150 pallets of vaccines from 14 locations across Georgia, Nevada, and Pennsylvania. The vaccines were transported in 14 temperature-controlled trucks to ensure their safekeeping during the journey.
By Friday afternoon, Kuehne+Nagel had made 42 deliveries across 20 states, providing flu shots to over half a million military veterans and their families across the United States.
It reads, Thanks to the extraordinary teamwork and expertise of the Road Logistics team here at Kuehne+Nagel, this seemingly impossible task was accomplished, and many VA hospitals were able to receive the flu vaccines they needed.
As Veterans Day is upon us, we are especially proud of the teamwork and collaboration to achieve this complex and challenging solution for our customer in support of these everyday heroes, said Joachim Goller, regional road logistics manager, Kuehne+Nagel North America. As more than 15 percent of the population in the United States are veterans, and these VA hospitals serve the entire country, we could not be prouder to have stepped up, and supported this important effort, which we know will make a difference in the lives of veterans and their families. This successful delivery proudly coincides with Veterans Day, so a huge shout out to the Road Logistics team for stepping up, taking on this extremely complex operation and making this happen in support of our veterans.
Prince Edward Island
Share on Facebook Share on Twitter Share by Email
Posted: November 17, 2023
Charlottetown-based pharmaceutical company BioVectra isgetting ready to open up new facilities in P.E.I. and Nova Scotia as part of a $90-million expansion.
The new facilities include one of Canada's first mRNA vaccine biomanufacturingcentres in Charlottetown. There is also a new biologicsfermentation suite in Windsor, N.S., and development laboratories in both provinces.
The P.E.I. and federal governments helped fund the expansion.
"It's a day of celebration. It's a day of pride for all of us,"said CEO Oliver Technow.
"Our aim is to be able to supply all Canadians with mRNA therapeutics when they need them."
CBCNews was given an early tour of the vaccine and biomanufacturing centre. It's a large additionwhich is attachedtoexisting buildings near the Charlottetown Airport.
BioVectrasays the facility will be unlike any other in the country.
The new centre includes high-tech equipment. That includes two large robotic "filling isolators" worth $4 million each that fill up vaccine vials and cap themwithout any human hands touching the product until it's sealed.
The machines can fill 100 vials at a time, all within minutes.
Bryan Lowery is vice-presidentof the manufacturing centre. He said the machines willallowmedicationsto stay under sterile conditions.
"It's acomputerized robotic system with two or three motorized arms on the inside of the unit itself," Lowery said. "They actually do all the movements ... that normally a human would be doing."
Lowery said these are the first robotic filling units he's seen after working in the industry for more than a decade.
"It's, I believe, the direction the industry is going," he said.
The centre also has a large production fermenter which helps grow cells that will eventually be used formedicinalingredients in therapies.
There are also extensivepurification suite areasto ensure steriledrug products.
Lowery said it's exciting to have breakthrough technology on-site.
"It's a huge step forward for the company," he said.
Technowsaid a big part of what the company does is to partner with others in the biotech and pharmaceutical industry to help themproduce their products in large quantities.
He said that when the COVID-19 pandemic hit, Canada was caught in a situation where it had to rely on other jurisdictions for vaccines.
"Now, we are the first company in Canada that can actually respond to a future health crisis," he said. "We have the manufacturing domestically to supply these therapies and medicines to Canadians when the time comes."
The CEO said themRNAplatformis a very efficient and safe way to improve people's health.
He said BioVectra is not just looking at vaccines needed for future pandemics, but alsofor products used to treatsevere conditions likecancer, and neurological and cardiovascular diseases.
"We will work on a number of new products and new indications that hopefully will help eradicate certain diseases that we currently have no therapies for," he said.
"There's a lot of research underway to tackle diseases in the oncology space as well as the neuroscience space."
The company said there is a lot of demand for the facility already.Technow said confidentiality agreements prevent BioVectra from mentioning exact names of companies, but that it'salready been working with more than a hundredinternational companies.
He said the new facilities are a "big deal."
"What we do here, nobody else can do in Canada," Technow said.
The company expectsto hire another 125 peoplein Atlantic Canada with the expansions. That's on top of about 650 positions that exist already.
The facility is close to being ready. BioVectrawill hold a grand opening, and then the buildings will essentially be sealed up, off-limits tothe general public.
The industry is heavily regulated. There are a number of steps to validate equipment and processes.
BioVectrawill likely work on some clinical trials at first,but the company expects to start having the products it manufactures at the new centreused on a wider scale by next summer.
BioVectra has seven facilities in Atlantic Canada, five of which are in Charlottetown.
Laura Meader is a video journalist for CBC P.E.I.
Human papillomavirus (HPV) vaccines are unique in the world of routine immunization due to their timing. Many vaccines are given to young children, but HPV vaccination occurs at adolescence, when pediatric visits are no longer routine. As HPV vaccine delivery strategies to reach this population vary by country, so does program cost.
PATH recently worked with immunization program managers on astudy to assess operational context and estimate ongoing costs of HPV vaccine delivery(excluding the cost of vaccines and supplies) beyond the introduction years. The study generated evidence on delivering a two-dose HPV vaccination schedule insix countries: Ethiopia, Guyana, Rwanda, Senegal, Sri Lanka, and Uganda.
The results, described below and recently published in the journalVaccine, shed light on the operational context and costs per HPV vaccine dose delivered. They point to key opportunities that policymakers may wish to consider for greater cost efficiencies, particularly as programs seek to rebuild and accelerate coverage after the acute phase of the COVID-19 pandemic.
HPV vaccine delivery cost per dose varied widely across the study countries based on operational context (frequency and intensity of program implementation activities in each country) and service volume (number of doses delivered).
All immunization programs conduct ongoing activities, such as program planning and management, social mobilization, crisis management, and vaccine distribution and storage. "For HPV vaccination program activities, varying levels of engagement in these activities were apparent within and across countries, depending on context," said Rose Slavkovsky, MPA, health economics program officer at PATH and one of the study authors. "For example, training and crisis management activities were at lower intensities in Rwanda, the longest-running HPV vaccination program in this study sample. Conversely, sustained levels of social mobilization and program planning were apparent in several study countries."
Varied service delivery intensity also contributed to differences in cost estimates across countries. Service volume was important because a lower number of doses delivered per health facility meant a higher cost per dose. The average number of doses delivered per health facility varied by country, as did the frequency of conducting HPV vaccination sessions and other program activities (fixed time points in Ethiopia versus year-round vaccination in Senegal, for example).
Despite the differences among the study countries, there were a couple notable trends. Activities and expenditures at health facilities contributed the largest proportion of the economic cost per dose (see figure below).
Additionally, the largest proportion of costs were opportunity costs. Separate from financial costs that measure direct expenditures, opportunity costs measure the value of existing resources (sometimes shared with other health programs) used by the HPV vaccination program. Of these, health worker and non-health worker time were the largest cost category across study countries, regardless of operational context. Direct expenditures accounted for a smaller share of the delivery costs.
When more doses are delivered, resources are spread over a larger denominator, contributing to a lower cost per dose. A strategy to increase the number of doses delivered could include concurrently vaccinating multiple cohorts. Additionally, adopting asingle-dose vaccination schedule, endorsed in December 2022 by the World Health Organization as an alternative to the current two-dose schedule evaluated in this study, could reduce the delivery cost per fully vaccinated child.
The study team used data from five of the six study countries to model the potential cost implications of implementing this single-dose schedule. This modeling analysis found that, although the estimated financial costs per dose for HPV vaccine delivery could increase because of the smaller number of doses delivered, the financial costper fully vaccinated childcould decrease by nearly half (excluding the cost of vaccine).
Economic cost, which is the sum of both financial and opportunity costs, also decreases significantly per fully vaccinated child on a single-dose schedule.
Studies such as this one demonstrate how improving our understanding of the operational context and costs of vaccine delivery can help improve or reaffirm current strategies in not just the study countries, but other low- and middle-income countries (LMICs) as well. Cervical cancer is still a leading cause of cancer in women in LMICs, but widespread access to HPV vaccines would dramatically reduce the number of cases.
"The potential impact of more widespread HPV vaccine access on the health of women and girls is profound," said Mercy Mvundura, PhD, health economics technical advisor at PATH and study lead. "Our hope is that these study findings will inform planning and decision-making to revitalize cancer-preventing HPV vaccination programs, especially as health systems recover from COVID-related interruptions."
This article was originally published by PATH on 13 November 2023.
The Joint Committee on Vaccination and Immunisation (JCVI) has advised the UK government that meningococcal B (MenB) vaccines should be routinely offered to prevent gonorrhoea by targeting the people at greatest risk.1
Evidence indicates that, even with a modest vaccine effectiveness against gonorrhoea of 32.7-42.0%, rolling out the 4CMenB vaccine to groups with the highest risk could prevent many cases, said the committee. Because infection with the Neisseria gonorrhoeae bacterium does not protect against future infection, many people are commonly reinfected.
Andrew Pollard, JCVI chair, said that
Key Takeaways
The latest KFF COVID-19 Vaccine Monitor survey suggests the lack of public concern about getting sick from COVID-19 may be why many people have not gotten the latest vaccine and why half of the public are not planning on taking precautions to limit the spread of the virus during the coming months.
The November KFF COVID-19 Vaccine Monitor investigates uptake for the new, updated COVID-19 vaccine, which has been recommended by the CDC for people ages 6 months and older. Two months after the vaccine became available, about half of adults say they have gotten or will get the shot, but another half say they wont get the latest shot and a third seem steadfast in that decision.
One in five (20%) adults now say they have received the new, updated COVID-19 vaccine that became available in September. An additional one in four adults say they will definitely get (13%) or probably get (15%) the updated shot. Consistent with demographic differences across other COVID-related behaviors, uptake is highest among those ages 65 and older (34%) and Democrats (32%). This is meaningful given that those ages 65 and older are more vulnerable to COVID-19, as theyre more likely to get seriously sick and experience complications that could result in hospitalization. This is in comparison to smaller shares of younger adults ages 18-29 (18%), Republicans (12%) and independents (16%) who report getting the latest vaccine. Similar shares across racial and ethnic groups report having gotten the updated vaccine, including 26% of Black adults, 20% of Hispanic adults, and 19% of White adults. However, when combining the shares who have gotten the shot and those who intend to get it, Black adults (59%) and Hispanic adults (59%) both outpace White adults (42%).
Uptake of the newest vaccine matches closely to uptake of the updated bivalent booster measured in December 2022, just after the updated bivalent COVID-19 booster had become available for use. About two in ten adults said they had received the booster dose (22%).
One in three (34%) adults say they will definitely not get the new COVID-19 vaccine, and another 17% say they will probably not get the vaccine. The share who say they probably or definitely wont get the new COVID-19 vaccination has remained unchanged from the September COVID-19 Vaccine Monitor, which was fielded immediately prior to when the vaccine became available.
Majorities of those who have never received any COVID-19 vaccine (94%), Republicans (77%), independents (59%), those who live in rural areas (65%), White adults (58%), and those under the age of 65 (55%) continue to say they will not get the updated COVID-19 vaccine.
The survey finds that partisanship is continuing to play an outsized role in vaccine attitudes. While nearly six in ten White adults say they do not plan to get the new vaccine, this increases to eight in ten among White adults who self-identify as Republicans. This is more than twice the share of White adults who are Democrats (29%) who say they will either definitely not or probably not get the vaccine. In fact, three in ten (31%) White adults who are Democrats have already gotten the new vaccine, compared to 11% of their Republican counterparts.
Most adults (79%) say they have heard at least a little about the updated COVID-19 vaccine, with one in five (22%) saying they have heard a lot. A small share (21%) say they have heard nothing at all about the updated vaccine.
Awareness is high across demographic groups, including the vast majority (92%) of adults ages 65 and older who have heard at least a little about the updated vaccine compared to a somewhat smaller share, but still a majority, of younger adults, including six in ten of those ages 18 to 29. Larger shares of Democrats are also more aware of the vaccine, with 86% who have heard at least a little compared to three-quarters (74%) of Republicans.
With most people aware of the latest vaccine, many, including large shares of previously vaccinated adults, have not yet received the updated shot and some dont plan to. About six in ten (58%) adults are previously vaccinated and have yet to get the updated vaccine. This group is roughly divided between people who say they will get the vaccine and those who say they are not planning to get the latest shot. The latest COVID-19 Vaccine Monitor survey explores why this group of previously vaccinated people have not gotten the latest dose.
Around half of adults (47%) have both previously received a COVID-19 vaccine and also say they will get or have already gotten the updated vaccine. On the other hand, one in five (20%) adults are previously unvaccinated and say they will not get the updated vaccine. That leaves three in ten (31%) who have previously been vaccinated but now say they will not get the updated shot.
More than four in ten Republicans (43%) and one in three independents (35%) say they are previously vaccinated but wont get the updated shot, compared to 19% of Democrats. A larger share of White adults (34%) also report being previously vaccinated but not planning on getting the latest shot compared to Black adults (20%). Around a quarter of Hispanic adults (26%) are previously vaccinated but now do not plan to get the latest vaccine.
In 2021, KFF surveys examining initial vaccine rollout found that concerns about vaccine safety were the driving reason why people didnt get vaccine. Even as those concerns dissipated among most of the public, a small share of the public remained steadfast and never received a COVID-19 vaccine. Yet, subsequent booster never reached the same uptake levels as seen in the initial vaccine rollout. And as the country enters its fourth year of COVID-19 concerns, it appears this trend continues.
When asked about a series of reasons that could explain why people are not getting the latest vaccine, not being worried about getting COVID-19 tops the list. About half (52%) of those who were previously vaccinated say lack of worry about COVID-19 is at least a minor reason why they havent gotten the vaccine, including a quarter who say it is a major reason. Getting vaccinated may also not be a priority for some with around four in ten (37%) saying being too busy is at least a minor reason why they have not gotten it yet, and another third saying they are waiting to get it a later date. Experiences from previous doses may also be keeping people from getting the new vaccine with about a quarter saying that bad side effects from a previous COVID-19 vaccine dose is a reason why they have not gotten the new vaccine.
Small shares say there are other barriers to getting the vaccine including 16% who say they cannot take the time off work and 13% who say they havent been able to get an appointment. One in ten (11%) say their doctor told them to wait or to not to get the updated vaccine.
Among Hispanic adults who were previously vaccinated but have not gotten the new shot, about half (55%) say they arent worried about getting COVID-19, they are too busy (51%), or they are waiting to get it at a later date (48%). In addition, a third (35%) of Hispanic adults as well as a quarter (22%) of Black adults cite not being able to take time off work, compared to just one in ten (9%) White adults.
Democrats top reasons for not getting the updated COVID-19 vaccine suggests there will likely still be additional uptake in this group, while Republicans top reasons may indicate more resistance to the latest vaccine. Among those who were previously vaccinated but havent gotten the new shot, half of Democrats (49%) say being too busy is a major or minor reason they havent gotten the updated vaccine yet, compared to 22% of Republicans and 35% of independents. On the other hand, two-thirds of Republicans (66%) and more than half of independents (57%) say not being worried about getting COVID is at least a minor reason why they have not gotten the updated vaccine, compared to a third of Democrats (35%).
With fall and winter holidays coming up, the possibility of a further wave of COVID-19 infections is looming with increased indoor gatherings and time with friends and family. Yet, most of the public is not worried about spreading or catching COVID-19 over the coming months. About three in ten adults are worried they will spread COVID-19 to people close to them (31%) or they will get seriously sick from COVID-19 (28%), and about a quarter (26%) are worried they will get COVID-19 over the holidays. A larger share of the public is worried about increased hospitalizations, with almost half (46%) saying they are very or somewhat worried that there will be an increase in hospitalizations in the U.S. this winter.
Older adults are not more worried than younger adults about the spread of COVID-19 this holiday season except for concerns about increases in cases and hospitalizations. Around half (53%) of adults ages 65 and older say they are worried that there will be an increase in COVID-19 cases and hospitalizations this winter, compared to smaller shares (44%) of those under the age of 65.
Around the same share say they are very or somewhat worried about an increase in COVID-19 cases and hospitalizations this winter as were in December of last year when there was a similar uptick in COVID-19 cases.
In addition to not being worried about COVID-19 during the upcoming holidays, the public is divided on precautions, with half of adults saying they arent planning to take any of the precautions asked about in the survey, while the other half report they plan to take at least one precaution this fall and winter. The most common precautions people said they planned to take were avoiding large gatherings (35%) or wearing a mask in crowded places (30%). Smaller shares say they are avoiding travel this fall and winter as a precaution against COVID-19 (25%), avoiding dining indoors at restaurants (19%), or taking a COVID-19 test before visiting with friends or family (18%).
The share who say they plan to take precautions to limit the spread of COVID is similar to the share of the public who said they were taking precautions because of the tripledemic back in January of this year. Back then, about half (46%) of adults said the news of COVID-19, RSV, and the flu spreading that winter had made them more likely to take a precaution, including three in ten (31%) who said they were more likely to wear a mask in public and a quarter (26%) who were more likely to avoid large gatherings.
While four in ten (39%) White adults say they will take at least one precaution, majorities of Black adults (72%) and Hispanic adults (68%) report they are planning to take any of the precautions mentioned.
Similarly, partisanship and previous vaccine uptake continue to be strong predictors of whether people plan to take precautions to limit the spread of the virus. Two thirds (66%) of Democrats and half (48%) of independents say they plan to take at least one precaution, compared to three in ten (29%) Republicans who say the same. Just over half (53%) of vaccinated adults say they are taking any of the precautions, compared to four in ten (39%) unvaccinated adults.
Similar shares of younger and older adults report that they will be taking at least one precaution during the fall and winter. However, four in ten (41%) adults ages 65 and older say they plan to avoid large gatherings, compared to a third (33%) of those under the age of 65. While younger adults are less likely to say they will avoid large gatherings, larger shares of younger adults say they will take a test for COVID-19 before spending time with friends of family, with 21% who say so (including 25% of those ages 18-29), compared to one in ten (10%) of those ages 65 and older.
The Covid-19 vaccines were hailed as a miracle upon their arrival. They were delivered earlier than anyone thought possible and proved exceptionally effective in preventing hospitalizations and deaths. More than 80 percent of all Americans, and more than 90 percent of adults, received at least one dose of the vaccines, remarkable penetration in a country where less than half of people get their flu shot every year.
But so far this year, just 14 percent of adults have received a dose of the new vaccine formulation that became available in September compared to 28 percent who have gotten a flu shot.
This raises a question that would have seemed unthinkable three years ago: What if we make a miraculous vaccine and nobody wants it?
Ever since that first shot, the publics interest in subsequent Covid-19 vaccines has been steadily dropping. Less than 70 percent of the US finished their initial two-dose vaccine series. Less than 20 percent of the country received last years bivalent booster shot.
Experts say the publics disinterest in the latest Covid shots is likely a combination of poor messaging from authorities, a diminishing fear about a virus that three years ago was wholly unknown, and the political polarization of the pandemic itself. But whatever the reasons, that vaccine ambivalence still poses a health threat.
Elderly people and very young infants continue to have a higher chance than the rest of the population that they will be hospitalized with Covid-19. Vaccination rates have fallen off for the former group, who are also most likely to die from an infection, and they were never strong to begin with for the latter; 95 percent of children under 4 are unvaccinated. About half of seniors being hospitalized for Covid-19 these days have never gotten a vaccine, experts say, affirming that the unvaccinated continue to be hit much harder by the virus.
Infectious disease experts saw 2023 as a pivotal year for the countrys transition out of the pandemic. It would test whether the US health system could marshal a strong response to the winter Covid-cold-and-flu season, specifically through a successful vaccination campaign. The dismal start to that campaign may force a difficult question upon the public health community: If Americans dont care about getting vaccinated against Covid-19 anymore, what do we do now?
Part of the story is simply human nature. Covid-19 arrived in 2020 behaving strangely (with so much asymptomatic transmission) and incurring a deadly toll (the first iteration of the virus was notably more virulent than the flu). Much of the economy shut down and people were confined to their homes. It was a scary time and vaccines offered hope for a future in which not only would you be less likely to get seriously ill but that life could get back to normal. When shots went out to hospitals, pharmacies, and vaccination clinics in December of 2020, Americans were eager to get them.
But three years and multiple new vaccine formulations later, the novelty is gone.
Americans arent as worried about Covid-19 now. More than 70 percent of US adults said they were not concerned about getting seriously ill from Covid-19 in a November survey from the KFF health policy think tank. That figure has been about the same for the flu and RSV, suggesting Americans have come to view the novel coronavirus as a similar health risk to other cold-weather illnesses that have been circulating for a long time. Half of the people who were previously vaccinated but do not plan to get the updated Covid-19 vaccine cited a lack of concern about the virus as a reason for skipping the latest shot, per KFF.
People arent scared of this virus anymore, Paul Offit, director of the Vaccine Education Center at the Childrens Hospital of Philadelphia, told me.
As evidence, he recounted that he had ridden the subway with 100 screaming, maskless football fans heading to the Eagles-Cowboys game. No one on that subway car had a mask on, he said. We are close to winter, and this is in theory a winter virus.
Familiarity is one part of that change in attitudes. Another is political polarization: Republicans, both the rank-and-file and their political leaders, have grown more and more hostile toward the Covid-19 vaccines, with a general skepticism toward government mandates spilling into conspiracy theories and disinformation. (Offit marveled at that turn of events: These vaccines are the most amazing medical and scientific accomplishment of his lifetime and the greatest accomplishment of the Trump administration. And yet.)
Only 23 percent of Republicans said in KFFs November poll that they had or would get the latest version of the Covid-19 vaccine this fall or winter. Another 43 percent of the party said they received an earlier dose but will not get the new shot and 34 percent said they have never been vaccinated at all. To compare, 40 percent of independents said they had or would get the new shot and 72 percent of Democrats said the same. While reality does not exactly match up to those responses, the gap between Republicans and the rest shows partisanship is driving vaccine attitudes.
Its become part of somebodys identity that theyre not somebody who gets Covid shots in particular, said Dr. Cline Gounder, a senior fellow at KFF and editor-at-large for Public Health at KFF Health News. That may spill over to vaccines, but it starts with Covid.
There are worrying signs of a more general resurgence in vaccine skepticism: 3 percent of US schoolchildren reported a vaccine exemption for the coming school year, the highest share on record according to the CDC. Ten states have an exemption rate above 5 percent; only two did three years ago.
But while that uptick is worrying, it is clear, as Gounder noted, that Covid is a special case for Americans. Flu vaccination rates last season were in line with rates from before the pandemic: Lower than youd like (57 percent for kids, 46 percent for adults) but historically unremarkable. Flu vaccinations this year are on track with last years pace, according to the CDC.
People were already accustomed to the annual flu vaccination campaign before the pandemic and they seem to be mostly sticking to old habits. So why do so many seem so immune to the public health communitys plea that they get a Covid-19 shot at the same time?
The other factor may be that Americans have become inured to such public health messaging after years of living through a public health emergency.
Partly, the vaccines are a victim of their own success. The initial clinical trials reported incredible results not only in stopping severe disease (the primary public health goal) but in stopping any illness at all. The gobsmacked headlines may have led the public to expect to never get sick at all, and public health messages failed to break through with the reality check that while you may still feel sick, it is much less likely youll end up in the hospital and that should count as a win. When reality didnt meet expectations, seeds of doubt and distrust were sown.
For the later shots, Gounder said the public health messaging itself, which generally encourages everyone to get another Covid-19 shot, may be part of the problem. People are more familiar with the virus now and that means many have a general idea of how it works. They may know, for example, that age and chronic health conditions are the best indicators of ones risk of serious illness or death from an infection.
Other countries, such as the United Kingdom, have targeted their recommendations to people over 65 and people at a heightened risk because of their health, as well as the people who live with and care for those at-risk folks.
The United States has to date instead erred toward simplicity with its vaccine messaging and recommendations: Everyone older than 6 months is recommended for yet another shot. Experts acknowledge there is an argument for that strategy. But as Covid-19 has become a more familiar illness and people have a better understanding of it, there may be a better argument for a more nuanced approach.
At this point, people have likely lived through an infection of their own and have firsthand experience with Covid-19. The initial vaccination campaign was crucial because people had no immunity to Covid-19 at all; the population was naive. But the public health reality has changed three years later: Most people have either been vaccinated or infected or both.
So when the official vaccine guidance remains largely unchanged, and the messages public health authorities are sending fail to acknowledge the varying risks or that people do possess some immunity, they may end up being ignored.
I understand some of the skepticism, Gounder said. When you tell everyone youre all at risk, get your shot, it doesnt correspond with your lived reality.
There are short-term steps the US could be taking to bolster Covid-19 vaccine uptake, particularly for the most vulnerable. Additional funding for nursing homes to hold vaccination campaigns, for example: Only 17 percent of nursing home residents are up to date on their shots. Experts also stressed the importance of communicating to people that the very young can get seriously ill with Covid-19; even if they dont die, the health complications can be serious. Gounder said shed like to see that messaging start with more of a focus on pregnant women, who can pass some immunity to their unborn child.
But there is a larger question brewing when only 10 percent of the US population is showing much urgency about getting a Covid-19 vaccine: How are we going to keep doing this?
Pfizer said in September that it expected about one in four Americans to get the latest shot. Though there is still time, current vaccination rates are well short of that goal. It is an open question how the for-profit pharmaceutical manufacturers who produce these vaccines will respond to what the market is telling them.
Gounder said it is difficult to imagine a cessation of Covid-19 vaccinations entirely. The public health case for immunizing the elderly in particular is strong. But drug makers may scale back their production, especially if the governments recommendations become more targeted.
The federal government is putting a lot of money behind pharmas pursuit of a universal Covid vaccine, but until those efforts bear fruit (if they ever do), there may also be less interest in producing new formulations of the vaccine after uptake for this seasons new shot was so paltry.
The known unknowns for the future, which could spur another round of investment and interest in updated Covid-19 vaccines, are biological. The virus has been evolving and will continue to evolve and could, in theory, reach a point where the current vaccines are ineffectual.
The other question mark is inside of us. The reason many people still enjoy protection from serious illness is because our bodys T-cells are familiar with the virus and can activate when they detect it. They may not be able to stop an infection entirely (that is the role of antibodies, which are quicker to fade) but they can stamp out the virus before a person becomes too sick.
What we dont know today is how long our T cells memory will last, and how durable that immunity really is. The only way to find out is for more time to pass.
Will you support Voxs explanatory journalism?
Most news outlets make their money through advertising or subscriptions. But when it comes to what were trying to do at Vox, there are a couple reasons that we can't rely only on ads and subscriptions to keep the lights on.
First, advertising dollars go up and down with the economy. We often only know a few months out what our advertising revenue will be, which makes it hard to plan ahead.
Second, were not in the subscriptions business. Vox is here to help everyone understand the complex issues shaping the world not just the people who can afford to pay for a subscription. We believe thats an important part of building a more equal society. We cant do that if we have a paywall.
Thats why we also turn to you, our readers, to help us keep Vox free. If you also believe that everyone deserves access to trusted high-quality information, will you make a gift to Vox today?
Yes, I'll give $5/month
Yes, I'll give $5/month
We accept credit card, Apple Pay, and Google Pay. You can also contribute via
years and older, and 31.7% of adults 65 years and older have gotten the latest set of Covid-19 vaccines, according to Centers for Disease Control and Prevention (CDC) numbers as of November 17. (Francine Orr / Los Angeles Times via Getty Images) Los Angeles Times via Getty Images
Remember Covid-19? You know that thing that has led to over 1.15 million American dying since early 2020? And that thing that may have left well over 8 million Americans to continue suffering with long Covid? Well, fewer and fewer people in the U.S. these days seem to be viewing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a real threat based on the low uptake of the latest updated Covid-19 vaccine and the results from a recently conducted KFF survey.
As you probably know from seeing all those noses out there, many people have completely dropped the use of face masks as if the masks were soiled underwear. Fewer and fewer businesses seem to be maintaining any type of Covid-19 precautions such as running air purifiers or even keeping hand sanitizer dispensers filled. And just 5.4% for children, 14.8% of all adults 18 years and older, and 31.7% of adults 65 years and older have gotten the latest set of Covid-19 vaccines, according to Centers for Disease Control and Prevention (CDC) numbers as of November 17.
Why have these updated vaccine numbers been so low? Well, the KFF survey revealed that over half of those adults who had gotten vaccinated against Covid-19 previously but did not get the latest updated Covid-19 vaccine pointed to, guess what, not being worried about Covid-19 as being the main reason for not getting the latest shot that became available over past couple months.
No matter how any may try to spin it, the roll-out of the updated vaccine this Fall has been far from a rousing success. The updated vaccine targets the XBB.1.5, Omicron subvariant of the SARS-CoV-2, which sounds like a mouthful and is the subvariant that was the dominant circulating one through early 2023. Thus, this updated vaccine should offer significantly better protection against the alphabet soup of subvariants that have been circulating of recent such as the EG.5 and the BA.2.86. Plus, the protection offered by Covid-19 vaccine begins to wane four to six months after vaccination. Thus, you can view getting the updated vaccine a bit like updating the software in your smartphone. If you last got vaccinated sometime in early 2023 or earlier, its not clear how well protected against Covid-19 you currently may be.
Nevertheless, interest in getting vaccinated against Covid-19 has certainly dropped like a rock in a hot tub since 2020 and 2021. The percentages of American who have gotten the updated vaccine are way lower than the 69.5% of all Americans and 79.1% of American adults whove been fully vaccinated, meaning that they received their primary series of the Covid-19 vaccines. Heck the updated vaccine rates are even lower than current influenza vaccination rates with 35.1% of children, 36.3% of all adults, and 59.5% of adults age 65 and older already having gotten their flu shots this season. So, the low uptake of the updated Covid-19 vaccine may be due specifically to a Covid-19 perception thing rather a general vaccine perception thing.
Indeed, this latest KFF Covid-19 survey, which queried a nationally representative sample of 1,301 U.S. adults via telephone or the Internet from October 31 through November 7, 2023, has given a Covid-in-the-air-but-I-dont-care picture of how many Americans may be thinking. Even though the past three Holiday seasons have experienced Covid-19 surges, only 31% of the survey respondents were worried about spreading Covid-19 to others and only 28% were worried about getting seriously sick from Covid-19. About half of respondents indicated that were not going to take any of the Covid-19 precautions indicated in the survey questions. Only 35% planned on avoiding large gatherings, only 30% planned on wearing face masks in crowded locations, and only 18% planned on taking a Covid-19 tests prior to visiting with friends or family. Think about that when you share some fruitcake with extended family and friends at your next Holiday gathering.
Are all of these low numbers really that surprising given that so many politicians and business leaders have been seemingly trying to sweep SARS-CoV-2 under the rug since 2021? People have politicized the heck out of Covid-19 and Covid-19 precautions, which may have made politicians a bit wary about taking a harder Covid-19 prevention stand. Theres been no real clear messaging from the White House and federal government about what specific Covid-19 precautions should be taken this Fall and coming Winter. That lack of clarity can leave a lot of people guessing and relying more on whatever bleep may be spreading on social media, which can be like relying on whats written on bathroom stalls to make career, romantic, and life decisions. Moreover, without a more comprehensive national surveillance system, its become increasingly difficult to track SARS-CoV-2 activity and know where and when people may be at greater risk for catching the virus. Thus, the U.S. seems to be flying a bit blind about what to do about Covid-19 going forward.
As the hashtag #Covidisnotover has continued to emphasize on social media, Covid is not over. Sure, its not the same threat that it was in 2020. But getting Covid-19 now is still no joke. Even if youve been vaccinated, you can still get long Covid and more severe Covid-19, albeit its a less and less likely possibility the more updated you are on vaccination. All indications are that the SARS-CoV-2 will continue to circulate. Viruses dont respond to that life coaching mumbo jumbo that says if you believe it, it will happen or mind over matter or fake it until you make it. This doesnt mean that you should live in fear of the virus and not do what you want to do in life. It does mean that there needs to be more of a clear national plan on how to deal with the SARS-CoV-2 now and into the future.
I am a writer, journalist, professor, systems modeler, computational, AI, and digital health expert, medical doctor, avocado-eater, and entrepreneur, not always in that order. Currently, I am a Professor of Health Policy and Management at the City University of New York (CUNY) School of Public Health, Executive Director of PHICOR (@PHICORteam) and Center for Advanced Technology and Communication in Health (CATCH), and founder and CEO of Symsilico. My previous positions include serving as Professor By Courtesy at the Johns Hopkins Carey Business School, Executive Director of the Global Obesity Prevention Center (GOPC) at Johns Hopkins University, Associate Professor of International Health at the Johns Hopkins Bloomberg School of Public Health, Associate Professor of Medicine and Biomedical Informatics at the University of Pittsburgh, and Senior Manager at Quintiles Transnational, working in biotechnology equity research at Montgomery Securities, and co-founding a biotechnology/bioinformatics company. My work has included developing computer approaches, models, and tools to help health and healthcare decision makers in all continents (except for Antarctica). This has included serving as the Principal Investigator of over $60 million in research grants from a wide variety of sponsors such as the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), National Science Foundation (NSF), the Centers for Disease Control and Prevention (CDC), UNICEF, USAID, the Bill and Melinda Gates Foundation, and the Global Fund. I have authored over 250 scientific publications and three books. In addition to covering health, healthcare, and science for Forbes, I maintain a blog "A Funny Bone to Pick" for Psychology Today, a Substack entitled "Minded by Science"and have written articles forThe New York Times, Time, The Guardian, The HuffPost, STAT, the MIT Technology Review and others. My work and expertise have appeared in leading media outlets such as The New York Times, ABC, USA Today, Good Morning America, Tamron Hall Show, BBC, The Los Angeles Times, Newsweek, CBS News, Businessweek, U.S. News and World Report, Bloomberg News, Reuters, National Public Radio (NPR), National Geographic, MSN, and PBS. Follow me on Twitter (@bruce_y_lee) but dont ask me if I know martial arts.
In the United States, there's an 8.6 percent increase in cases, with 16,239 new hospital admissions in the week ending November 11. Fourteen states have a big increase in coronavirus hospitalizations, according to the latest CDC maps . The spike in cases is higher in the upper Midwest, parts of the South Atlantic, and southern Mountain regions. Health officials expected this because colder weather makes the virus spread more easily. People are concerned, especially with the rise in cases in the United States. "Colder weather tends to lead to an increased spread in viruses and other infections," notes the CSC. A study from 2020 suggests that the Covid virus can last longer in cold and dry conditions, making it harder during certain seasons. Since late June, the number of people going to hospitals has been going up. It was highest in early September but stayed around 15,000 in October and November. It's much lower than the peak in January 2021, which was over 150,600 people. But now, there are worrying trends in some states. Vermont is at the top with a 70 percent increase, and Iowa and Alaska follow with 60 percent. Montana, Minnesota, and Hawaii have increased over 30 percent. Virginia, Tennessee, Wisconsin, Nebraska, North Dakota, New Mexico, Arizona, and Washington DC report increases over 20 percent. "While the magnitude of the rises in some states might be startling, this may be because they represent a relatively low number of hospital admissions'', says the report. Vermont with a 70 percent increase had just 43 hospitalizations in a week. As spikes in specific areas led institutions to reintroduce mask mandates over the summer, the changing circumstances highlight the crucial need to stay watchful and alert amid fluctuating inflation rates.
