Data source and study design
Using an ecological study design, we analyzed publicly available data from the WHO pooled vaccination dataset (n=228 WHO members) merged with the World Banks GNI per capita data (n=215 members). The WHO vaccination data are extracted and compiled from members reports and third parties [24]. The dataset is updated weekly with vaccine introduction and administration by WHO members. We used data as of June 4, 2022. A detailed description of the WHO vaccination dataset and data collection can be found elsewhere [7, 25]. The World Bank GNI per capita data is routinely collected and compiled using reports published by its member countries national statistical authorities, the Organization for Economic Cooperation and Development (OECD), the International Monetary Fund, or directly from countries official data. We selected 2019 GNI per capita data as an indicator of the WHO members economy prior to the pandemic. A detailed description of the World Bank dataset and data collection can be found elsewhere [26, 27]. We excluded WHO members with missing vaccination rates, or GNI per capita; thus, our sample size in the merged dataset was 192 members. All datasets are publicly available and de-identified, therefore, a review from an Institutional Review Board was not required.
The primary outcome of interest was the cumulative number of persons fully vaccinated (i.e., receiving the required number of doses as per the vaccine guideline) per 100 population). Vaccination data were pooled from reports from members and WHO review of publicly available official data or data collected and published by third-party sites [28]. The population estimations for each country were extracted from the United Nations Department of Economic and Social Affairs, Eurostat, National Statistics Office Malta, The Government of the Pitcairn Islands, and Statistics Netherlands. A detailed description of the calculation can be found elsewhere [29, 30].
Cumulative persons vaccinated with at least one dose per 100population was the secondary outcome of interest.
GNI per capita was calculated by the Word bank in U.S. dollars using the Atlas conversion factor. We created a categorical variable to classify members into different income levels based on the World Banks 2019 Gross National Income thresholds. GNI was classified into low income (less than $1,026), lower-middle income ($1,026 to $3,995), upper-middle income ($3,996-$12,375) and high income (more than $12,375). A detailed description of the calculation can be found elsewhere [26, 27]. WHO regions were our secondary exposure. WHO regions are classified into the Africa, Americas, South-East Asia, Europe, Eastern Mediterranean, and Western Pacific regions based on members respective WHO regional offices [4].
The number of vaccine types in WHO members was the covariate. We include the number of vaccine types administered by WHO members as a covariate based on literature [20, 21] and a priori knowledge of possible confounding (availability of various vaccine choices). The number of COVID-19 vaccine types used by each WHO member was categorized into 1 to 3, 4 to 6, 7 to 9, and 10 to 12. We sourced the number of vaccine types data from the WHO data repository [28].
We performed descriptive statistical analyses to determine the cumulative meannumber of persons fully vaccinated per 100 populationstratified by GNI per capita,WHO region, and the number of vaccine types used by WHO members. We performed ANOVA tests to assess significant differences in COVID-19 vaccination by WHO members GNI per capita, region, and the number of vaccine type used. We also performed negative binomial regression to assess the association between the vaccination rates and GNI per capital, WHO region and the number of vaccine types using two models. We used the negative binomial regression model because the COVID-19 vaccination outcomes were rates normalized from count data (i.e., only non-negative integer), and it managed for overdispersion in the dataset.
The first model looked at the crude association between vaccination rates and GNI per capital, WHO region and the number of vaccine types respectively. The second model examined the association between vaccination rates and GNI per capital adjusted for WHO region and the number of vaccine types. To adjust for differential follow-up time in the reporting of vaccination data between countries, we offset in the regression the natural log of the time (in weeks) between April 9th, 2021, and the most recent date each country member reported/updated vaccination data to WHO. April 9th, 2021, was the oldest most recent date a member reported vaccination data to WHO as of June 4th, 2022, therefore, was selected as the baseline follow-up date. We used SAS version 9.4 and STATA 16.1 to perform the analyses.
We present findings on COVID-19 vaccination delays and overdue or missed doses for almost half a million non-EU migrants and resettled refugees compared with the general population in England between 8 December 2020 and 20 April 2022. Refugees and migrants with non-white ethnicity were more likely to have a delayed second or third COVID-19 dose. Refugees and older migrants were more likely to not have received a second or third dose. These data hold immediate relevance to strengthening COVID-19 vaccination for migrants and identify important variability in uptake by age, visa type, and ethnicity.
Our findings highlight more overdue second and third doses (that is, not receiving a subsequent dose) in older migrants compared with their counterparts in England. Slower uptake could have been driven by greater language barriers, limited health literacy, digital exclusion or fear of side effects in older migrants18,19,20. Similar findings were found in a large cross-sectional study in Canada21. Decisions to not receive a second or third dose could also be associated with differences in perceived vulnerability to severe COVID-19 outcomes due to lower levels of underlying health issues in migrants compared with the general population in England22. Patterns in greater overdue second and third doses for older migrants remained even after the follow-up period was shortened to account for potential emigration or embarkations out of England once international travel resumed. In-depth qualitative exploration on the reasons behind older migrants lower uptake is needed especially given the importance of subsequent doses for protection against new variants.
Individuals on work visas were less likely to be overdue for a second or third dose than the England cohort. This may be due to firstly significant proportions of migrants working in health and social care23,24 who were initially prioritized for vaccination and eventually included in the United Kingdom government enforced vaccine mandate, and secondly, more stringent work visa sponsorship requirements may favour the entry of migrants with higher socio-economic status, which has been associated with lower vaccine hesitancy25,26. Conversely, refugees were more likely to be overdue for both second and third doses than the England cohort and were almost two times more likely to be delayed for their second or third dose, which is consistent with studies on low vaccine intent and under-immunization in other forced migrants12,27. Reasons for delays include access barriers, lack of accessible information in appropriate language, fear of vaccine side effects, or lack of familiarity/trust in the health system12,13,28. However, these estimates are probably an underestimation of true inequalities among other forced migrants as the refugee participants in this study are resettled refugees who received government support to facilitate early integration with appropriate health and social care services prior to their arrival.
Migrants with non-white ethnicities were more likely to be delayed for their second dose than migrants with a white ethnicity. This could reflect the unique challenges that being both a migrant and an ethnic minority have on vaccine access as a result of healthcare entitlement, language, literacy and other communication barriers2,29. As some ethnic minority communities experienced higher severe acute respiratory syndrome coronavirus 2 exposure and subsequent COVID-19 infection, second dose delays could have also influenced by following official guidance to wait at least 4weeks after an infection before receiving the next dose30,31. However, those differences disappeared for the third dose, perhaps due to the rapid roll-out of the booster (third dose) programme or more targeted vaccination campaigns. With evidence clearly demonstrating the disproportionate impact of COVID-19 on ethnic minority groups in England, there was a commitment from the United Kingdom government to support bespoke vaccination campaigns targeting ethnic minority communities to increase vaccine and booster uptake32. Still older migrants across all ethnic groups were less likely to return for their third dose than their counterparts within the same ethnic group in the England cohort. Conversely, another study found migrants arriving before 2011 from Black African, South Asian and Other ethnicities had a higher total first dose uptake than their United Kingdom-born counterparts15. Further research is needed in exploring predictors of vaccine uptake such as migration status (for example, migrants and non-migrants), visa type within ethnic groups, and socio-economic status.
Strengths of this study include a large study population with information on migration history linked to vaccination records that cover the primary course of COVID-19 vaccination and the initial booster (third dose) campaign recommended for adults in England. Our comparison dataset OpenSAFELY has been found to be largely representative of the general population in England across age, sex, deprivation level, and region33.
Key limitations of this study include that the Million Migrant-NIMS cohort is not representative of the entire migrant population in England, with a study population consisting of resettled refugees and migrants from non-EU countries who entered on longer-term visas and have an NHS number. Irregular migrants (for example, undocumented migrants, refused asylum seekers, visa overstayers, and children born to irregular migrant couples), migrants on a temporary visa, EU and European Economic Area migrants, non-EU migrants from low-incidence tuberculosis (TB) countries who do not require a pre-entry TB screening as part of visa application and non-EU migrants who emigrated before the start of either health screening programme were not captured. Importantly, some of these groups like irregular migrants could be in more vulnerable situations. Although only half of the Million Migrant cohort with NHS numbers linked to at least one NIMS COVID-19 record, the demographic profile between the two cohorts was broadly similar but the representativeness of our findings as a result could be limited.
There are several potential sources of bias in the linkage methodology that could impact the generalizability of our findings. An individual might not have linked in either the PDS or NIMS COVID-19 vaccination dataset if they never arrived in England, were resident in Scotland, Northern Ireland or Wales, they were never allocated an NHS number, or their linkage variables were recorded incorrectly or inconsistently. Linkage error due to missing or mis-recorded identifiers could result in a selection bias if the missed matches were not missing completely at random. Because the linkage to a NIMS COVID-19 vaccination record relied on having an NHS number, the cohort excluded migrants without any previous contact with health services and who may have been less likely to receive a vaccine. This selection criteria into the cohort probably overestimated vaccine coverage.
Although there is some certainty that individuals who receive an entry visa to the United Kingdom migrate, when and whether they leave after their visa expires is less certain34. Similarly for those with overdue or missed doses, lack of data on emigration during the study period could have led to an over-ascertainment of vaccination overdue. However, for individuals who were most likely to have remained in England for the duration of the study period such as those on refugee, settlement and dependent, and family visas, these estimates are broadly robust and can be helpful indicators of second and third dose uptake35. Importantly, the highest rate of vaccination overdue were found in these subgroups and older migrants, even after the study period was shortened and newly arrived migrants on short-term visas (for example, individuals on student, work, and working holiday visas arriving in the last 5years) were excluded to account for travel out of England.
Several determinants for COVID-19 vaccination coverage were included in this analysis, but no data were available on clinical vulnerability, accommodation (for example, living with someone with a clinical vulnerability or in a care home) or high-risk occupations, all of which were prioritized risk factors for early vaccination in England36. We had no information on death, contraindications, or emigration out of the country; all of which could artificially inflate our denominator for vaccination overdue. Our sensitivity analyses measuring the impact emigration (restricting the follow-up period and excluding shorter-term visa holders) showed minimal effect on our estimates. Lastly, we restricted our analyses to those over the age of 16 for first dose and over 18 for second and third doses, limiting the generalizability of our data to those under the age of 16.
Our findings hold immediate relevance to strengthening COVID-19 vaccination and other routine immunizations for migrants and identify important variability in uptake by age, visa type and ethnicity. Most migrants in our cohort, in particular older migrants and refugees, were more likely to be overdue for their second and third doses than Englands general population. These findings highlight slower vaccination uptake for some migrant groups and reinforce the importance of migrant-inclusive policies and services to ensure equitable access36. Box 1 summarizes key policy and practice areas of relevance to improve COVID-19 vaccination uptake in migrants in the United Kingdom and other European countries.
It remains important to better understand the drivers of low and delayed vaccine uptake in migrant populations and why refugees and older migrants are not returning to receive their second or third dose of the COVID-19 vaccination. The extent to which these are structural or personal barriers, the role of vaccine hesitancy and misinformation, and the impact of policies resulting in the exclusion of some migrant groups from accessing health and vaccination systems need to be further elucidated. As immunity wanes and new COVID-19 boosters are needed for emerging variants, understanding vaccination coverage for high-risk groups such as migrants will be essential for an adequate and equitable response.
Key policy and practice areas requiring action:
Co-design context and culturally appropriate vaccination campaigns and research with international, national, regional and local migrant community organizations to ensure accessibility and culturally appropriate services and to better understand barriers and facilitators to vaccination systems on arrival.
Explore opportunities with stakeholders to strengthen data collection around vaccination uptake and country of birth, visa category and time since arrival in the host country.
Improved consideration of migrant populations in the evaluation and delivery of vaccination programmes for COVID-19 and routine vaccinations.
Further research the causes of uptake variations, including differences between different types of migrants.
Data source
The present study used the TriNetX COVID-19 Network, an international collaboration of health research platforms that compiles de-identified patient data from electronic health records (EHRs). These records encompass a wide variety of patient information, including demographic details, medical diagnoses, procedures, medication records, laboratory results, genomic data, and types of healthcare organization visits. Over 120 healthcare organizations (HCOs) worldwide, predominantly academic health centers, have contributed data from their main hospitals, affiliated institutions, and outpatient clinics to TriNetX. For this specific analysis, we utilized the COVID-19 network, encompassing data from more than 114 million patients from 87 HCOs. TriNetX offers integrated tools for patient-level data analysis and delivers aggregated results to the researchers. Detailed information on the database can be accessed online [24]. Written informed consent was not required because TriNetX contains anonymized data. The Institutional Review Board of the Chi Mei Medical Center approved the study protocol (no. 11202002).
In the patient selection process, the TriNetX database was used, which contains 86 HCOs as of July 4, 2023. The initial patient pool consisted of individuals who had visited these HCOs at least twice between March 1, 2020, and January 1, 2023. Patients who tested positive for SARS-CoV-2 or were diagnosed with COVID-19 between January 1, 2022, and January 1, 2023, and those who were prescribed antiviral agents and were initially hospitalized were identified from this pool. The prescribed antiviral medications included molnupiravir, remdesivir, and nirmatrelvir plus ritonavir. The selection process was identical for all patients diagnosed with influenza within the same timeframe. The analysis was restricted to patients aged18.
Subsequently, several exclusion criteria were used. For the COVID-19 group, patients who were also diagnosed with influenza and those with long-term COVID-related symptoms one year before the index date were excluded. Similarly, for the influenza group, patients who tested positive for SARS-CoV-2 or were diagnosed with COVID-19 and those with long-term COVID-related symptoms one year before the index date were excluded.
Finally, patient selection involved propensity score matching on a 1:1 basis for age at index, race, sex, adverse socioeconomic determinants of health, and comorbid medical conditions. This resulted in two comparable groups for this study: a COVID-19 and an influenza group (Tables S1 and S2).
We considered 47 variables to adjust for imbalances in baseline characteristics between the COVID-19 and influenza groups. The list included both confirmed and suspected risk factors for COVID-19 and more severe cases of the illness, such as demographics (eg, age, sex, and ethnicity), adverse socioeconomic determinants of health (including "problems related to education and literacy," "problems related to employment and unemployment," and "problems related to housing and economic circumstances," as defined by ICD-10), and comorbidities (such as obesity, hyperlipidemia, hypertension, diabetes mellitus, chronic kidney disease, asthma, chronic lower respiratory diseases, ischemic heart disease, neoplasm, chronic liver diseases, stroke, dementia, rheumatoid arthritis, lupus, psoriasis, human immunodeficiency virus infection, mood disorders, and psychotic disorders).
The primary outcome of this study was a composite outcome consisting of 12 clinical features of post-COVID conditions, observed 90180days after the index event. These features include chest/throat pain, abnormal breathing, abdominal symptoms, fatigue/malaise, anxiety/depression, pain, headache, cognitive dysfunction, myalgia, loss of taste or smell, sleep disturbances, coughing, and palpitations [25,26,27].
We investigated the secondary outcomes of all-cause hospitalization, all-cause emergency department (ED) visits, and deaths during the follow-up period. Table S3 provides additional details regarding the diagnostic, visiting, and procedural codes used to define these outcomes [21, 28, 29].
We used the built-in propensity score-matching (PSM) function of the TriNetX platform to ensure a 1:1 match between the participants in the COVID-19 and influenza groups. This was achieved using a nearest-neighbor greedy matching algorithm with a caliper width of 0.1 pooled standard deviation. Standard differences were then computed to assess the balance between groups, with differences in absolute values<0.1, indicating a good match between groups [30].
Subsequently, we performed KaplanMeier analysis, followed by log-rank tests and calculation of hazard ratio (HR) with 95% confidence intervals (CI) to compare the two groups. Statistical significance was set at p<0.05. The HR was used to describe the relative risk of post-COVID conditions based on a comparison of time-to-event rates calculated using a proportional hazard model, which is a built-in function in TriNetX.
For subgroup analysis, we compared the primary and secondary outcomes between the two groups, stratified by age (1864 and65years), sex, vaccine status (unvaccinated, 1 or 2 doses of vaccine, boosted), and race (Caucasian and non-Caucasian). The vaccine type used was Pfizer with CPT code 91,307 (0051A, 0052A, 0071A, 0072A), Janssen 91,303 (0031A), Novavax (0041A, 0042A), and Moderna 91,301 (0011A, 0012A, 0013A, 0111A).
TAMPA, Fla. COVID-19 cases are rising again, but theres still confusion over who should get them.
A lot of people just dont know what they should be doing, said Dr. Jill Roberts, Associate Professor at the USF College of Public Health.
The latest numbers from the CDC show that only about 16% of adults in the United States have received the latest COVID-19 booster.
The vaccination rate is much lower than experts hoped for.
Part of that may be difficulty in actually getting it out there. There's a lot of miscommunication about who should take it, who should not take it, said Roberts.
Health officials believe the initial confusion created a lasting impact.
Officially, the CDC recommends that all people 6 months old and older stay up to date on COVID-19 vaccines.
In our most vulnerable population, thats very, very important. So our elderly patients, our patients with immune-compromised or those caring or living with those individuals, said Dr. Laura Arline, Chief Quality Officer for BayCare.
However, some doctors believe that the reality for everyone else is that its more nuanced for each person, especially when it comes to kids.
In the pediatric population, high-risk kids would have a much more significant benefit to it, but I see really low benefit at this point to children, especially if theyve had COVID or a previous vaccine because they have the immunity, said Dr. David Berger, a certified pediatrician at Wholistic Pediatrics and Family Care.
If a child is healthy and isnt around anyone over 65 or whos immunocompromised, some experts said they may be fine without the shot.
Theres no doubt that the COVID vaccines, at least for the short term, do keep people out of hospitals and worse. But also recognizing that if it isn't an immunologically compromised, a chemo patient, or some other genetic immunodeficiency, most kids are healthy, and overall, the majority of kids dont get hospitalized, said Berger.
Locally, doctors arent currently seeing much of an increase in kids being hospitalized with COVID-19 infections.
In the last few months, it sort of stayed steady, more of a plateau. Maybe a little bit of an increase recently, but nothing significant, said Dr. Sara Kirby, Medical Director for AdventHealth Tampa's Pediatric ER.
However, doctors agree the vaccine does still offer protection and reduces the chance of severe disease.
The COVID shots are now pretty much widely available. Its a good match between the vaccine and the strains that are going around, so I would recommend it, said Roberts.
The vaccines are safe, and they are effective against the current variants. So it is worth getting, said Arline.
Overall, they recommend talking to your doctor to see whats best for your family.
(MASS APPEAL) The COVID-19 pandemic seems like it was both ages ago and yesterday, but here in late 2023 were more than 2 years past the pandemic yet it is still affecting our health and that of our loved ones and workplaces.
Im joined by Dr. Jerome Adams, an anesthesiologist and Former U.S. Surgeon General, to talk about the latest with COVID-19.
Visit modernatx.com for more information.
Sponsored by: Moderna
Cleveland Clinic researchers believe they have found a way to improve COVID-19 vaccines by strengthening and prolonging their effectiveness. Those researchers took a page from the herpes virus to help human cells better learn from messenger RNA COVID-19 vaccines how to recognize and subsequently fight the virus that causes COVID-19, the Clinic announced Monday.
Messenger RNA (mRNA) vaccines, like the original COVID-19 vaccines produced by Pfizer and Moderna in 2020, teach the body's cells how to make copies of the coronavirus' spike protein, according to the American Heart Association. If someone is exposed to the real virus later, their body will recognize it and know how to fight it off, according to the Centers for Disease Control and Prevention.
"mRNA vaccines give our bodies the genetic instructions they need to build pieces of the pathogen that our immune systems can respond to. In this way, mRNA vaccines act a lot like the viruses we fight against," said Dr. Jae Jung, director of Cleveland Clinic's Global Center for Pathogen & Human Health Research.
Viruses have their own genetic makeup, but they don't know how to carry out the instructions written in their genes. As a result, they trick infected host cells into reading the foreign genetic material and making proteins for the virus. Jung's research team took this knowledge and used it to improve how host cells read genetic material in mRNA vaccines.
Viral genes use different DNA and RNA sequences than human genes, making it difficult for host cells to produce the protein the virus is asking for. Jung likened this to saying "Hello" in different languages infected cells can determine what protein the viral genes want them to produce, but the language difference complicates the instructions.
Think of it like using different spellings of the same word when writing out instructions, said Dokyun "Leo" Kim, a graduate student in Jung's lab. Infected cells can figure out what protein the viral genes want them to make, but the spelling differences mean it's a little harder to read the instructions.
Jung used the herpes virus to draw inspiration on how to trick the body's cells into responding better to mRNA COVID-19 vaccines. His previous work determined that the herpes virus had developed a tool called a "trans-inducer" to avoid loss of efficiency.
Jung's lab partnered with Dr. Kun Li to create and test alterations of the COVID-19 mRNA vaccine in mice. According to Cleveland Clinic, they found that adding the "efficiency element" from the herpes virus to the COVID-19 mRNA vaccine greatly improved the immune response and protected against lethal levels of infection in preclinical trials. Jung said this protection was good for up to 20 weeks following vaccination.
"We generated the SARS-CoV-2 spike mRNA with the herpes virus glycoprotein coding usage system. Then there is a translator. Herpes virus has a translator we call that a transducer. We put [them] together, then when you print the human cell, they produce a higher amount of spike protein," Jung said.
Jung noted these modifications to the mRNA COVID-19 vaccine could potentially be applied to other vaccines, like the new Respiratory Syncytial Virus vaccine, but research has a long way to go. His lab is currently applying the same knowledge to other vaccines, like those for Zika virus, so that his research has additional examples before the next stage.
He also said his team isn't sure if these new modifications to the mRNA COVID-19 vaccine would reduce the frequency of booster shots required to keep them updated.
WASHINGTON On Friday, U.S. Sen. Ron Johnson (R-Wis.), ranking member of the Permanent Subcommittee on Investigations, sent a letter to Department of Defense (DOD) Secretary Lloyd Austin regarding the Armysrecent letterto previously discharged service members who were involuntarily separated after refusing to comply with the mandatory COVID-19 vaccination order, allowing them to request a correction of their records and potentially apply to return to service.
Sen. Johnson wrote,Allowing service members torequestto correct their records or potentially apply to return to service falls well short of providing those brave men and women any kind of compensation resulting from their involuntary separation and a profound apology for upending their lives.
If DOD wants to restore its credibility and trust among current and prospective service members, it needs to show that it is willing to be transparent and forthcoming regarding the safety of the COVID-19 vaccines,Sen. Johnson continued.
Sen. Johnson has previously described DODs credibility issues in hismultiple letterson data integrity issues in theDefense Medical Epidemiology Database (DMED). His office continues to receive reports from DOD whistleblowers indicating that adverse medical events are alarmingly persistent in DMED.
For over two years, DOD has stonewalled the senators oversight work that could provide service members and their families much much-needed information about the health consequences of the vaccines.
Last month, DOD admitted to Sen. Johnson that it had identified an increased incidence of very rare conditions myo/pericarditis during COVID-19 vaccine introduction in 2021. However, DOD attempted to downplay the significance of this by stating: It is difficult to report precise numbers of adverse events following immunization since establishing a causal relationship between vaccination and a clinical diagnosis can be challenging. Nonetheless, the military has identified 80-90 cases of myo/pericarditis in Service members following administration of more than 4 million COVID-19 vaccine doses in this population.
Over the last two years I have sent over 60 public letters to federal agencies, including DOD, on various aspects of the pandemic. The overall lack of transparency from you and your colleagues on COVID-19 vaccine safety and efficacy is appalling,Sen. Johnson stated.
The senator is still waiting to receive complete answers to questions his staff sent DOD following the publication of anews articlethat reported on new information from a DOD whistleblower on more increases in medical diagnoses in DMED. The senator also reiteratedrequests for Tricare datathat he made to DOD nearly one year ago. DOD has failed to provide any response to that letter.
Inquiries and requests for information concerning the health and well-being of service members should never be ignored, particularly when those questions are from members of Congress and their staff,the senator concluded.
He is requesting a response to his inquiries by no later than December 15, 2023.
Read more about the senators December 1, 2023 letter to Sec. Austin in theEpoch Times.
Full text of the letter can be foundhere.
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GAITHERSBURG, Md., Nov. 28, 2023 /PRNewswire/ --Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant,today announced that Nuvaxovid XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older. The EUL assists WHO member states in assessing vaccines with the aim of expediting availability and enables the WHO's 194 member states to expedite regulatory approvals to import and administer the vaccine.
"The WHO Emergency Use Listing of our updated protein-based non-mRNA COVID-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies, such as UNICEF, thereby supporting equitable access to our vaccine around the world," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Rural or hard-to-reach areas can benefit from our vaccine's ease of transport and storage profile. As part of a diversified vaccine portfolio, our vaccine can play an important role in helping to protect people around the globe against the latest variants."
Novavax's vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage.1-4
The EUL was based on non-clinical datashowing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.5,6
In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
Novavax's updated COVID-19 vaccine is also authorized in the U.S. and the European Union, and is under review in other markets.
Trade Name in the U.S.The trade name Nuvaxovid has not been approved by the U.S. Food and Drug Administration (FDA).
NOVAVAX COVID-19 VACCINE, ADJUVANTED (2023-2024 FORMULA) AUTHORIZED USESNovavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
IMPORTANT SAFETY INFORMATION What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted? Tell your vaccination provider about all of your or your child's medical conditions, including if you or your child:
Who should not get the Novavax COVID-19 Vaccine, Adjuvanted? A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted? There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine:
Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:
Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:
These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.
What should I do about side effects? If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.
Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 18008227967 or report online to https://vaers.hhs.gov/reportevent.html. Please include "Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA" in the first line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
What about pregnancy or breastfeeding? If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com.
Please see the Fact Sheet for Recipients and Caregiversfor more information. Reporting Adverse Events and Vaccine Administration Errors
About Nuvaxovid XBB.1.5 2023-2024 Formula (NVX-CoV2601) NVX-CoV2601 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M Adjuvant When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.
About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.comand LinkedInfor more information.
Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, availableat www.sec.govand www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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Allison Jones - The Canadian Press
Posted: December 04, 2023 Last Updated: December 04, 2023
There is a lot of COVID-19 circulating in Ontario right now, and levels of both that virus and influenza are on the rise, set to peak over the holiday season, the province's top doctor said Monday.
This is a key week for immunizing against both viruses, Chief Medical Officer of Health Dr. Kieran Moore said, as it takes 10 to 14 days for protection to take effect.
"I want to acknowledge that many people are tired of COVID, but it's not tired of us," Moore said in an interview.
"Certainly we're seeing lots of COVID activity across Ontario. Our metrics for last week were that we had 1,700 people in hospital, around 100 of them requiring intensive care."
That level is lower than at this time last year, but at that time COVID-19 activity was on a downswing, whereas now, it's on the rise, Moore said.
About 1.8 million Ontarians have received the updated COVID-19 vaccine this fall, but that's just 13 per cent of the eligible population and 40 per cent of people over 65.
"Of the hospitalizations both for influenza and COVID, the risk is really associated with age the older that you are, the better protected we need you to be from those two infections through immunizations," he said.
"That leaves 60 per cent of our adults over 65 not protected at present and that's got me anxious as we head into the holiday season."
The rate of people getting COVID-19 vaccinations peaked three weeks ago, he said.
Flu activity is also on the rise, Moore said.
"It's anticipated, unlike last year, that influenza is following a more traditional pattern where it will be most active over the coming holiday and New Year's season, and so it'll be most transmissible in those social settings that are coming up," he said.
Moore does not intend to enact any public health measures.
"I think we'll just continue the risk communication and the measures that people can take in terms of layers of protection, and access to medications," he said.
For COVID-19, there were 6,000 doses of Paxlovid dispensed last week, he said.
When it comes to the triple surge of COVID-19, the flu and respiratory syncytial virus that hit children hard last year and put pressure on children's hospitals, authorities have worked to ensure there won't be any shortages of children's Tylenol, Moore said.
"The system at large, I think, is prepared for this surge," he said.
"I do worry, though, as we head into influenza, that will be an extra burden on those hospitals."
There are also more than 200 people in hospital with RSV, roughly half of them children four years old and under and half people over 65.
Health Canada has approved an RSV vaccine for people aged 60 and older, but it is only available free of charge to people in that age group living in long-term care homes, Elder Care Lodges and retirement homes licensed to provide dementia care services.
The out-of-pocket cost for the medication can be over $250.
The government is looking at expanding public funding for the vaccine to alternative level of care patients in hospital people who can be discharged to a long-term care home, for example, but don't yet have a spot and/or dialysis patients, Moore said.
FILE - A person prepares a COVID-19 vaccine shot in an undated photo. (Associated Press)
WELLINGTON, New Zealand (TND)
A New Zealand IT worker was arrested Sunday over accusations he was involved in "unauthorised disclosure and misuse of data involving the COVID-19 vaccine, 1News reports.
Barry Young, 56, allegedly accessed a computer network within public health agency "Te Whatu Ora" for dishonest purposes and downloaded a terabyte of data. Young then published the information online and used it to bolster claims the agency was covering up vaccine deaths.
Te Whatu Ora CEO Margie Apa said the claims pushed by the employee are misinformation.
New Zealand Health Minister Shane Reti also spoke out on the breach, calling it concerning.
We take the security of our data very seriously and are extremely disappointed at this gross breach of trust by this individual and his alleged involvement in spreading harmful misinformation, Reti said, while referring to the man as a conspiracy theorist.
Young faces up to seven years in prison for the offense. When he arrived in Wellington District Court for an initial hearing, a room of supporters rose and clapped for him, causing the judge to threaten to send them out. Young later yelled freedom before exiting the court.
Young will be released on bail until his trial at a later date.
Te Whatu Ora maintains only four deaths could be possibly linked to the vaccine of the more than 12 million issued throughout New Zealand.
Texas Attorney General Ken Paxton announced last week he would sue pharmaceutical company Pfizer for allegedly misrepresenting the efficacy of its COVID-19 vaccine. He also accusing the pharmaceutical company of "conspiring to censor public discourse."
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