COVID-19 vaccine dosing impact on maternal and infant antibodies | Image Credit: Ralf - Ralf - stock.adobe.com.
Cord anti-Spike (anti-S) antibody levels are increased 10-fold in patients with 3 or more COVID-19 vaccination doses compared to patients with 2 doses, according to a recent study published in JAMA Network Open.
COVID-19 infection during pregnancy increases the risks of hospitalizations, intensive care unit admission, and mortality. To reduce infection in this population, vaccination is vital.Data has indicated COVID-19 vaccination during pregnancy reduces the risks of maternal morbidity, hospital admission, critical care admission, stillbirth, and neonatal demise.
The COVID-19 vaccine provides anti-S antibodies that are able to cross the placenta through active transplacental antibody transfer, similarly to vaccines against conditions such as influenza. However, there is little data on maternally derived antibodies in infants born preterm.
To determine how the timing of COVID-19 vaccine administration impacts immunity in preterm and full-term infants, investigators conducted an ongoing prospective cohort study. Participants were recruited between February 1, 2021, and January 31, 2023.
Participants included individuals with receipts of at least 2 doses of messenger RNA (mRNA)based COVID-19 vaccines, singleton pregnancy, no previous COVID-19 infection, paired maternal and cord samples, nondetectable antinucleocapsid antibody, no fetal genetic anomaly, and appropriate infant birth weight, Exclusion criteria included 1 dose or less of the COVID-19 vaccine and receiving a non-mRNA-based vaccine.
Data was available for maternal and cord anti-S IgG, number of vaccine doses, timing of doses, gestational age at delivery, and covariates. Electronical medical records were evaluated for clinical data.
Data on race, gender, ethnicity, insurance status, and body mass index (BMI) were also obtained.Preeclampsia and chronic hypertension diagnoses were defined by American College of Obstetricians and Gynecologists criteria and hypertension diagnosis at under 20 weeks gestation, respectively.
Elecsys Anti-SARS-CoV-2 immunoassays (Roche Diagnostics) were used to test paired maternal and infant cord samples. This immunoassay has 99.5% sensitivity and 99.8% specificity.
There were 220 participants included in the final analysis, aged a median 34 years and with a median gravidity of 2 and parity of 0. Of participants, 81.8% were White, 2.3% Black, 11.9% Asian, 0.5% Alaska Native, 6.4% Hispanic, and 92.3% non-Hispanic. Private insurance was reported in 93.2% of participants.
Of deliveries, 36 were preterm and 184 full-term.Median BMI was significantly increased in patients with preterm delivery, as well as rates of pregestational diabetes, preeclampsia, and chronic hypertension. Preterm infants were delivered at a median 35.1 weeks and full-term infants a median 39.5 weeks.
The odds of cesarean delivery and neonatal intensive care unit admission among preterm births were 66.7% and 63.9%, respectively, and the median birth weight was 2437 g. Among full-term infants, these rates were 34.8%, 5.4%, and 3453 g.
Receival of 2 COVID-19 vaccine doses before delivery was reported in 55% of participants and 3 or more in 45%. Of preterm deliveries, 69.4% of patients received 3 or more doses and 30.6% 2 doses. Among full-term deliveries, these rates were 40.2% and 59.8%, respectively.
The unadjusted geometric mean concentration (GMC) for maternal anti-S antibodies was 674 after 2 doses and 8159 after 3 or more doses. For cord anti-S antibodies, these numbers were 1000 and 9992, respectively.
Decreased cord to maternal antibody ratios were observed among preterm births compared to full-term births, at 1.18 and 1.40, respectively. However, a significant difference was not observed based on preterm vs full-term birth status in adjusted models.
These results indicated 2 or less doses of COVID-19 vaccination may not provide adequate protection for infants. Investigators recommended further research to determineoptimal COVID-19 vaccine dosing for maternal and infant protection.
Reference
Kachikis A, Pike M, Eckert LO, et al. Timing of maternal COVID-19 vaccine and antibody concentrations in infants born preterm. JAMA Netw Open. 2024;7(1):e2352387. doi:10.1001/jamanetworkopen.2023.52387
Vaccines save lives, prevent disease and reduce stress on the nations health care system. Because of this, the government has a compelling interest in combatting vaccine misinformation to prevent factually incorrect statements from costing lives.
That is the argument put forth in an amicus brief (PDF) filed with the U.S. Supreme Court in the case Murthy v. Missouri by the AMA, American Academy of Pediatrics, American Academy of Family Physicians, American College of Physicians and American Geriatrics Society.
The brief notes that these organizations represent hundreds of thousands of medical professionals who have witnessed both the lifesaving promise of vaccination in clinical settings and the ability of misinformation to destroy that promise.
Additionally, based on decades of research and professional experience, these organizations believe that vaccines are among the most important public health interventions, and that widespread vaccine uptake has substantial public health benefits that cannot be achieved by any other means.
Meanwhile, the attorneys general of Missouri and Louisiana filed suit after individuals contended social media companies were coerced into censoring them after they posted content criticizing COVID-19 policies and mask and vaccine mandates.
The Biden administration, however, contends that its communication with social media companies was an attempt to mitigate the hazards of online misinformation by highlighting content that violated the companies own policies, according to SCOTUS Blog.
Find out about the cases in which theAMA Litigation Center is providing assistanceand learn about theLitigation Centers case-selection criteria.
Focused argument
The brief focuses on how disinformation diminished uptake of COVID-19 vaccines, which then limited the vaccines ability to save lives by controlling the spread of diseasethereby creating a compelling interest for the government to act.
Combatting vaccine misinformation is, at its simplest, the government trying to prevent factually incorrect statements from costing people their lives, the brief says.
Its argument on this point notes that vaccines approved by the Food and Drug Administration (FDA) are safe and that vaccinations save lives, reduce the prevalence of deadly diseases and lower the burden on the health care system.
It also argues that misinformation about vaccines led to declining immunization uptake, which meaningfully interferes with their lifesaving role in a well-functioning public health system, and that combatting vaccine misinformation diverts time and resources from clinical care.
The brief cites studies that found COVID-19 vaccinations prevented an estimated 235,000 COVID-associated deaths in the U.S. among vaccinated adults between Dec. 1, 2020, and Sept. 30, 2021, and reduced mortality by as much as 40% among hospitalized patients.
It also notes that greater strain on medical resources leads to worse health outcomes, and argues that vaccinations indirectly produced better health outcomes for patients with ailments unrelated to COVID-19 because an increased strain on hospitals and health professionals was avoided.
Incredulous claims go viral
Vaccine safety is subject to FDA scrutiny, which only grants its approval after scientists conduct extensive clinical trials. After vaccines are approved, government agencies continue to monitor their safety, the brief says.
In contrast, disinformation claims that people became magnetized after vaccination or that vaccinated individuals were implanted with a tracking microchip or became infertile were widely circulated without any proof of their validity.
None of these assertions are supported by credible evidence, the brief says, adding that some of these very claims were the subject of communications at issue in this case.
The declining vaccination uptake spurred by disinformation has also resulted in a resurgence of diseasessuch as measlesthat previously verged on eradication, the brief says.
A July 2023 district court ruling to limit administration communication with social media companies was upheld in part by the 5th U.S. Circuit Court of Appeals. In October, the Supreme Court froze the original district court order as modified by the appellate court until it could rule on the case itself, which could happen in June, according to SCOTUS Blog.
In another vaccine-related case, theLitigation Center of the American Medical Association and State Medical Societiesfiled an amicus brief with the 9th U.S. Circuit Court of Appeals urging it to uphold a permanent injunction preventing Montana officials from enforcing a 2021 law barring physicians from knowing the vaccination status of employees or patients who refuse to answer questions about it.
By Chris Wack
Capricor Therapeutics shares were up 7% at $4.42 after the company said its proprietary StealthX exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen.
The stock hit its 52-week low of $2.68 on Nov. 10, and is down 3% in the past 12 months.
Project NextGen is an initiative by the U.S. Health and Human Services Department to advance a pipeline of new, innovative vaccines providing broader and more durable protection for Covid-19.
As part of Project NextGen, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor's StealthX vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases would oversee the study.
The StealthX vaccine is a proprietary vaccine developed internally by Capricor using exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models showed the StealthX vaccine resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 24, 2024 10:48 ET (15:48 GMT)
Theres still time to receive the flu and COVID vaccines. A flu vaccine is the best way to help protect yourself and your loved ones against flu and its potentially serious outcomes. A flu shot can safely help prevent the flu and lessen flu symptoms if you do get sick. A flu shot also can help protect your baby from flu for several months after birth.
Every year flu puts thousands of children in the hospital. Getting your child a flu vaccine can lessen flus more serious symptoms - reducing the risk of serious illness and flu-related hospitalization if they do get sick.
The flu and COVID vaccines continue to be offered each Wednesday afternoon at Veterans Memorial Hospital Community and Home Care/Allamakee Public Health. Flu shots are recommended for all those who have not yet received the vaccine, and they will be effective throughout the rest of the flu season.
According to the Iowa Department of Health and Human Services, flu vaccines are proven to help prevent millions of illnesses and have been shown to reduce the risk of having to go to the doctor by 40-60%. COVID-19 vaccines help protect by creating an antibody response without having to experience potentially severe illness or post-COVID conditions. Although it is still possible to get sick after being vaccinated, flu and COVID immunizations are proven to help prevent severe illness, which can be lifesaving.
Allamakee Public Health offers Comirnaty (Pfizer) COVID vaccine. Anyone can receive Pfizer vaccine, even if Moderna vaccine was given in the past. According to the CDC, it is safe and effective to receive multiple immunizations, such as the flu and COVID-19 vaccines, during the same vaccination appointment. Medicare, Medicaid and most insurances do cover the cost of the flu and COVID vaccine.
The CDC now recommends that everyone age six months of age and older get vaccinated against the flu every year. For those who are at higher risk of developing serious flu complications, flu vaccination is especially important. These groups include: Adults 65 and older Adults with certain chronic health conditions, such as asthma, heart disease, diabetes, and chronic kidney disease Pregnant people Children younger than five years of age, but especially those younger than two years old.
For more information or to make an appointment for a vaccination, call the Veterans Memorial Hospital Community and Home Care Department at 563-568-5660. The Veterans Memorial Hospital Community and Home Care Department is located on the upper level of Veterans Memorial Hospital in Waukon.
Animal vaccines are not a one-size-fits-all, and experts at Elanco Animal Health want to help producers understand what factors to consider when developing a program.
Well, those would really include looking at disease history in the herd. How do you manage these animals, the type of housing, and certainly working with your local herd health veterinarian is going to really facilitate that and get a good plan put together. The type of production system you have. If youre calving, all year round, that would affect some things that you would do versus if you are calving in a specific season, like a 60-day calving season. Those are some things that we consider when were looking at what type of vaccine program were going to put together, said Bret Terhaar.
Terhaar says programs should be tailored to the specific herd, and it is important to store vaccines properly by keeping them cool and out of the sunlight.
January 24, 2024 01:10 PM
January 24, 2024 12:58 PM
January 24, 2024 12:49 PM
AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts inmedicineon COVID-19, medical education, advocacy issues, burnout, vaccines and more.
Featured topic and speakers
A check-in on COVID, flu and RSV cases, and an overview of new COVID and Long COVID studies. AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia, JD, MPH, reports that the tripledemic wave is declining, but vaccination levels for COVID, flu and RSV among adults are still low. Plus, continued supply issues for the RSV vaccine for children, administration errors for the RSV vaccine, and two new studies that could inform future treatments for COVID and Long COVID. AMA Chief Experience Officer Todd Unger hosts.
Unger: Hello and welcome to the AMA Update video and podcast. Today, we have our weekly look at the headlines with the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia. I'm Todd Unger, AMA's chief experience officer. Andrea, welcome back.
Garcia: Thanks, Todd. It's great to be here.
Unger: Well, let's begin by checking in on the tripledemicthe mix of COVID, RSV and the flu. That has been swirling around. Andrea, are things looking any better this week?
Garcia: So far, yes. I mean, overall, respiratory virus season does seem to be easing up just a bit. We've now seen some of those numbers decrease for a second week in a row. If we look at the CDC data, that week ending January 13 showed 24 states and DC experienced high or very high levels of patients seeking care for respiratory illness symptoms. That's down from 37 states and territories the week ending January 6.
In line with those numbers, respiratory viruses seem to be putting less of a strain on our hospitals. COVID, flu and RSV accounted for a combined 6.3% of total emergency room visits in mid-January. That's down from about 7.9% the week prior and 9.9% that last full week of December.
The percentage positive test nationwide for COVID and RSV also decreased about one percentage point if we look at that week ending January 13, and positive tests for flu remained stable. So at least for right now, things generally seem to be turning a corner and trending in the right direction.
Unger: Well, that's good news. Is there anything that we need to keep an eye on?
Garcia: Well, wastewater data for COVID did find viral activity is still very high, with the South reporting an increase in recent weeks. And if we look at ER and outpatient visits, seven states in particular experienced very high levels of respiratory illness in that week ending January 13. Those are Alabama, Georgia, Louisiana, New Mexico, South Carolina, Tennessee and Wyoming.
So we'll need to keep an eye on those areas. And I think I would also just point out that with flu in particular, it's not unheard of for us to have two peaks in a season. So while numbers are heading down, we couldwe could see them go back up again.
Unger: Well then that's a good entree into this next question. Because we've talked about vaccination rates before. Are we still struggling with vaccination numbers?
Garcia: We are. And the CDC updated data last Friday, and vaccination rates for all three illnesses remain low in both children and adults. So for COVID, we're only seeing about 11% of children, 21.5% of adults between 18 and 65, and about 40.9% of adults over 65 receiving that updated vaccine. The numbers are slightly better for flu.
So around 47% of adults and children have received it, 73% of those over age 65. For both COVID and flu, seniors do have the highest uptake of the vaccine. And then, the vaccination rate for RSV, which is recommended under that shared clinical decision-making framework for adults 60 years and up, is hovering at around 21%.
Unger: Andrea, but RSV immunizations for children are another story. Tell us more about that.
Garcia: Yeah, we're still seeing shortages of the RSV immunization for infants. And demand there continues to outpace supply. As a reminder, we're talking about nirsevimab, which is that monoclonal antibody authorized in August for newborns and babies under one who are born during or entering their first RSV season, and then those children up to 24 months who remain at risk of severe RSV disease.
While the manufacturer does continue to make more of those immunizations available, there's currently enough to immunize about 40% of babies who are eligible for the drug. We do know that earlier this month, White House officials met with reps from the manufacturer to discuss ways to meet that patient demand this year as well as next RSV season.
Unger: That's a challenge. What are we hearing from physicians on this front?
Garcia: Well, many pediatricians offices that were lucky enough to receive the antibody, ran out of that drug in December. I think, aside from the shortage, the other complicating factor is that the drug is distributed in both the 50-milligram and 100-milligram doses, with the smaller ones set aside for infants weighing less than 11 pounds. It can be a bit of a guessing game, as you can imagine, for physicians to predict how much of each shot they need to order, because it's hard to know in advance how many babies they're going to see who weigh less than 11 pounds versus those who may require that larger dose.
Many of these immunizations are also being distributed directly through hospitals for newborns rather than through those individual pediatric practices. A smaller rollout is anticipated for next year, but we know RSV is still circulating. So we do still have a ways to go yet this season.
Unger: Well, we're also seeing a few complications in administering the RSV vaccine. Andrea, what's the story there?
Garcia: Well, Todd, vaccine administration errors are generally pretty rare, but they are routinely monitored through the Vaccine Adverse Event Reporting System, or VAERS. Since approval of the RSV vaccine, CDC and FDA have received some reports of the Pfizer and GSK RSV vaccines, which are approved for adults, being administered to young children. The agencies have also received reports of the GSK RSV vaccine being administered in error to pregnant people. That Pfizer RSV vaccine is the only vaccine approved for use during pregnancy. Thankfully, most of the reports had no adverse events, or if they did, they were classified as non-serious.
Unger: That's good. Andrea, all of these vaccines are new. Is that where confusion of this kind is coming from? And what do physicians do if their patients have been given the wrong vaccine?
Garcia: Well, these recommendations do vary. For infants and children, it's recommended they receive a dose of nirsevimab to ensure they're protected. The other option available to protect babies is that maternal vaccine. So the Pfizer RSV vaccine is recommended for use during pregnancy, for people who are at the 32 to 36 weeks of pregnancy during the months of September through January.
It's unclear why these errors happened, but as you said, these are new vaccines this year. It is recommended that facilities do take steps that can help reduce errors like automating prevention alerts in the EHR, ensuring proper education, and training on vaccine recommendations, and paying close attention to labeling following proper storage and administration best practices. If mistakes do occur, it should be reported to us as soon as possible. And if there are questions about vaccine administration errors, physicians can email [emailprotected].
Unger: Excellent. And you can see that on the screen there, [emailprotected]. Andrea, RSV isn't the only virus with breakthroughs. Researchers also continue to study COVID. And we heard about a promising new treatment just last week. Tell us more about it.
Garcia: Yeah, last Thursday, in the New England Journal of Medicine, Chinese researchers published positive trial results of simnotrelvir, which is an oral antiviral that can shorten the duration of mild to moderate COVID symptoms. According to the Center for Infectious Disease Research and Policy, unlike with Paxlovid or other antivirals, that were tested against COVID, this trial was conducted mostly on healthy young adults, none of whom had severe symptoms.
The formulation used in the study included ritonavir, which acted as a booster to the antiviral. And among patients who began that treatment within 72 hours of symptom onset, the length of COVID symptoms was, on average, 36 hours shorter in that treatment group than in the control group. The viral loads were also significantly lower among the treatment group by day five, dropping 30-fold more than the load seen in that control group. So this is good news, something we'll definitely be continuing to follow.
Unger: Absolutely. That sounds very promising. There's also been a new development with long COVID, Andrea. What can you tell us about that?
Garcia: Yeah, so scientists have identified a persistent change in a handful of blood proteins in people with long COVID, which indicates that an important part of the immune system remains on high alert for months after an acute infection. These findings were published last Thursday in the journal Science, and they could help explain what causes that persistent fatigue, brain fog and other debilitating symptoms of long COVID. Experts think this could help pave that way for diagnostic tests and, potentially, a long-waited treatment.
That study followed 113 COVID patients for up to a year after they were first infected along with 39 healthy controls. At the six-month mark, 40 patients had long COVID symptoms. So repeated blood samples in those patients turned up important differences in their blood. A group of proteins indicated that a part of the body's immune system, called the complement system, remained activated long after it should have returned to normal.
Unger: So what is the significance of that particular finding, Andrea?
Garcia: Well, one of the study's investigators explained to NBC News that when you have a viral or bacterial infection, the complement system becomes activated, and it binds to these viruses and bacteria, and then eliminates them. The system then returns to its resting state, where its regular job is to clear the body of dead cells. But if the complement system remains in its microbe-fighting state after the viruses and bacteria are eliminated, it starts damaging healthy cells. And the result is tissue damage and microclots in the blood, which can lead to those symptoms of long COVID. Understanding these mechanisms could help scientists confirm diagnosis and develop effective treatments. The next step here is likely more and larger trials.
Unger: That really sounds like some exciting developments for something that's been debilitating for so many people out there. And we've heard from you and seen your comments on the videos out there on YouTube. And so, we'll continue to track that.
Andrea, as usual, thanks so much for keeping us up to date. That wraps up today's episode. If you enjoyed this discussion, you can support more programming like it by becoming an AMA member at ama-assn.org/join.
We'll be back soon with another AMA Update in the meantime. You can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
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A study of six US cities found a high prevalence of bacterial sexually transmitted infections (STIs) in transgender women (TGW), particularly those with HIV, researchers reported today in the Journal of Infectious Diseases.
Using baseline data from the Leading Innovation for Transgender Women's Health and Empowerment study, which examined HIV incidence and other health outcomes in TGW in six southeastern and eastern US cities (Atlanta, Baltimore, Boston, Miami, New York, and Washington, DC), a team led by researchers from Johns Hopkins Bloomberg School of Public Health analyzed bacterial STI test results from 1,018 participants. The primary outcome was the prevalence of at least one bacterial STI (gonorrhea, chlamydia, or syphilis) at any anatomic site.
The median age of participants was 29 years, 29% were Black, 27% were Hispanic, and 27% had HIV. The overall prevalence of any bacterial STI was 16% but was threefold higher in TGW with HIV (32% vs 11% among those without HIV). After adjustments for age, race and ethnicity, and region, HIV infection remained significantly associated with any bacterial STI (adjusted prevalence ratio, 1.9; 95% confidence interval, 1.39 to 2.62).
Among TGW without HIV, bacterial STI prevalence differed by geographic region, race and ethnicity, and gender identity, and was positively associated with reporting more than 1 sexual partner, hazardous alcohol use, homelessness, having safety concerns regarding transit to healthcare, and no prior receipt of gender-affirming health services. Among TGW with HIV, older age was inversely associated with bacterial STI.
...the variation in bacterial STI prevalence and correlates seen between TGW with and without HIV highlights the differential burden and needs of these two populations
The study authors say the findings underscore the need to develop interventions that are tailored to the unique needs and risks of each population.
"Although participants with and without HIV had a high prevalence of bacterial STIs, the variation in bacterial STI prevalence and correlates seen between TGW with and without HIV highlights the differential burden and needs of these two populations," they wrote. "Elucidating the ways in which situated vulnerabilities are associated with STI risk may help inform more tailored intervention strategies for each population."
A new paper in the journalJAMA Neurology examines whether coronavirus disease 2019 (COVID-19) vaccines cause or exacerbate autoimmune and neurological diseases.
Study:SARS-CoV-2 Vaccination and Neuroimmunological Disease: A Review. Image Credit:Tirachard Kumtanom/ Shutterstock.com
The COVID-19 pandemic was declared in March 2020 and was subsequently accompanied by restrictions on public interactions and travel in an attempt to limit the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Many different vaccine platforms were developed to combat COVID-19, including adenovirus vector- and messenger ribonucleic acid (mRNA)-based vaccines to introduce the viral spike protein, the primary immunogen, into the human body. The novelty of mRNA vaccines led to many concerns about the possibility of unforeseen neurological sequelae, such as Guillain-Barre syndrome (GBS), which is an acute autoimmune disease affecting multiple nerve roots causing sudden paralysis.
Most epidemiological studies have failed to provide evidence of the role of vaccines in neuroimmunological disease. Nevertheless, vaccine-associated immune thrombosis and thrombocytopenia (VITT), characterized by cerebral venous sinus thrombosis, have been identified to be caused specifically by the Oxford-AstraZeneca and Janssen adenovirus vector COVID-19 vaccines. These rare side effects have been reported in up to 15 people for every one million after the first dose of an adenovirus vaccine.
The researchers used data from multiple international studies to examine the potential for a link between COVID-19 vaccines and the incidence of GBS. To this end, adenovirus vector vaccines were associated with an increased risk of GBS.
One United Kingdom study reported a three-times greater risk of admission or death from GBS following Oxford adenovirus vaccine administration. Moreover, the risk of developing GBS within one to 1.5 months of vaccination was increased to about 30 cases for every one million vaccination doses. Most cases occurred after the first dose.
This link was not observable with the Pfizer mRNA vaccine.
The U.K. National Immunoglobulin Database/NHSE IVIG identified a maximum of 140 cases of GBS in excess of the expected number, peaking 24 days from the first dose of the Oxford vaccine. The excess risk was about 0.6 cases for every 100,000 vaccine doses. However, a prospective study covering many centers in the U.K. failed to identify any GBS cases post-vaccination.
German researchers showed a three to four-times rise in GBS cases with adenovirus vector vaccines. In France, there were six additional cases reported for every one million first doses of either adenoviral vaccines, all above 50 years of age, and including only hospitalized cases.
Small studies conducted in the United States suggest an increase in GBS rates by over 30 times. Comparatively, the Vaccine Adverse Event Reporting System (VAERS) identified an increase in incidence by 6.4 cases for every 100,000, with another study indicating an increase in GBS risk by 3.8 times.
Only one study, a large population-based cohort study from Mexico, showed a link between the Pfizer mRNA vaccine and GBS incidence, which was increased two-fold at 1.9 cases for every 100,000 doses as compared to 3.9 cases for the Oxford vaccine.
India reported an increase of up to tenfold between mid-March to mid-April 2021 in three districts of Kerala; however, the study size was small as compared to the overall vaccinated population. Another report suggested a three- to four-fold rise in GBS incidence with adenovirus vaccines as compared to mRNA vaccines after the first dose.
A potential association between mRNA vaccines and Bells palsy has been reported. This potential increased risk was initially reported during phase III clinical trials, during which the risk was found to be equivalent to that following the administration of other vaccines.
Other illnesses affecting the nervous system, such as myasthenia gravis or demyelinating disease of the brain or spinal cord, have not been associated with these vaccines.
It is possible that vaccination may rarely trigger a relapse or worsen symptoms or first presentation in already-diagnosed or susceptible individuals.
Current evidence indicates that there is a small increased risk of GBS following adenovirus vaccination against COVID-19. It is difficult to identify the putative autoimmune trigger; however, the spike protein does not appear to be responsible.
Mouse models have not shown autoimmunity induced by repeated injections of the recombinant SARS-CoV-2 spike protein. Thus, some other component in the adenovirus vaccine may be responsible for this autoimmune response.
Further investigation is essential to understand whether adenovirus vaccines lead to specific T-cell receptor and antibody responses in GBS cases as compared to other individuals who receive the adenovirus vaccine.
Considering the small associations observed between the COVID-19 vaccines, GBS, and Bells palsy, there is no reason to modify current vaccination recommendations or change guidelines for vaccinating those with pre-existing neurological disease due to autoimmune causes.
Journal reference:
Vaccinations are one of the most important public health efforts for preventing serious illness, avoiding hospitalizations and saving lives. During the COVID-19 pandemic, vaccine technology made a huge leap forward with the introduction of messenger RNA (mRNA) vaccines. COVID-19 vaccines developed by BioNTech/Pfizer and Moderna use mRNA instead of weakened viruses or virus fragments to teach the bodys immune system how to respond when presented with an infection.
Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. (See list below.)
In the area of respiratory diseases, the first two vaccines for respiratory syncytial virus (RSV) were approved for older adults and a separate vaccine was approved to prevent RSV infections in infants. RSV is a common respiratory virus that usually causes mild, cold-like symptoms, but it can lead to serious respiratory illness and increased hospitalizations. It results in 14,000 deaths annually among those over the age 65 and about 58,000 hospitalizations of infant younger than 1, according to the National Institute of Allergy and Infectious Disease. GSKs Arexvy, approved for adults in early May 2023, is an adjuvanted vaccine, which means it contains an ingredient to increase immune response. The second adult vaccine was approved a few weeks later. Pfizers Abrysvo is a bivalent RSV prefusion F (preF) vaccine that is composed of two preF proteins selected to optimize protection against RSV A and B strains.The FDA also approved Abrysvo to prevent RSV in infants.
Separately, the FDA approved Sanofi and AstraZenecas Beyfortus (nirsevimab-alip), which prevents RSV in newborns and infants. Beyfortus is the first monoclonal antibody to protect infants through their first RSV season. Although designed to prevent disease like a vaccine, it is not a vaccine because it does not stimulate the immune system.
The FDA also granted accelerated approval in November 2023 to Ixchiq, the first vaccine to prevent the mosquito-borne virus chikungunya. It was approved for use in adults aged 18 years and older. Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions.
It is administered as a single dose injected intramuscularly. The manufacturer, Valneva, has begun a phase 2 trial of the vaccine in children one to seven years of age. Once available, the phase 2 pediatric data are intended to support a phase 3 pivotal study in children to extend the label. A clinical study in adolescents is also ongoing in Brazil.
This year the FDA could approve additional vaccines, including the first self-administered flu vaccine. AstraZenecas has submitted a supplemental biologics license application (sBLA) for a self-administered option for FluMist Quadrivalent, which is a needle-free nasal spray. Researchers said this would provide another option for flu vaccination and potentially increase access and use of flu vaccine,The FDA has set a Prescription Drug User Fee Act (PDUFA) date for a regulatory decision during the first quarter of 2024. If approved, Astra Zeneca has said it to be available for the 2024-2025 flu season.
Regulators are also currently reviewing Mercks BLA for a pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The vaccine was developed using the serotypes responsible for about 80% of pneumococcal disease in those over the age of 65. The PDUFDA action date is June 17, 2024.
Even though advances have been made in the area of vaccines, the question remains whether people in the United States and elsewhere will accept and get these vaccines. Vaccine hesitancy, which ranges from misgiving to outright resistance, took hold during the COVID-19 pandemic because of misinformation about the COVID-19 vaccines, and it has shown staying power. The proportion of U.S. adults who have received COVID-19 vaccines, flu and RSV remains low, according to recent data from the Centers for Disease Control and Prevention. Just 21.4% of adults over the age of 18 have received the COVD-19 vaccine, while 41.5% have gotten a flu vaccine.
Vaccine hesitancy is not just about COVID-19 vaccines. Cases of measles have surged in the Washington, D.C., area, Pennsylvania, New Jersey, Delaware and Washington state, partly because children have not been vaccinated.
In a recent study, researchers from University of Colorado School of Medicine found while the COVID-19 pandemic did not overall impact parent vaccine hesitancy, some misinformation about COVID-19 may be impacting parental trust in childhood vaccines.
In a survey by researchers from University of Michigan School of Public Health found that some parents (12%) believe that childhood vaccines are less important compared with before the pandemic and that some (13%) believe that childhood vaccines are less effective now. They also found that negative beliefs about childhood vaccines were clustered in places with low COVID-19 vaccination rates.
In a another study, researchers from University of Colorado School of Medicine found that misinformation about COVID-19 may be impacting parental trust in childhood vaccines.
Vaccine Approvals in 2023
In Bermuda, the government is celebrating the triumph of its coronavirus (COVID-19) and influenza vaccination campaign as slots for vaccinations were swiftly booked up after their release last week.
The Ministry of Health received a substantial allocation of vaccines, including 5,760 adult doses and 2,880 pediatric doses of the COVID-19 vaccine.
This ample supply has allowed for a robust vaccination drive, ensuring that a large portion of the population can be covered.
Minister of Health, Kim Wilson, expressed her satisfaction with the campaigns success.
She acknowledged the extraordinary demand for vaccinations and extended her gratitude to the dedicated team at the Hamilton Health Clinic for their tireless efforts in accommodating all those who sought vaccination opportunities.
Minister Wilson revealed that the Department of Health is actively working to open up additional appointment slots, further increasing accessibility to the vaccines for the community.
During his recent visit to the Hamilton Health Clinic, Acting Chief Medical Officer, Dr. Shaun Ramroop, praised the clinics operational efficiency.
He shared that the clinic vaccinated over 200 individuals by 1 pm, exceeding the number of scheduled appointments.
He commended the team for their outstanding performance.
The COVID-19 vaccine is available free of charge to residents, with priority given to those at an increased risk of severe illness.
In addition to the COVID-19 vaccine, the influenza vaccine is also being offered. Individuals aged 65 and older can receive it for free, while those aged 12 to 64 may obtain it for a nominal fee of $20.
