Category: Covid-19 Vaccine

A COVID-19 antigen rapid test

A new variant of COVID-19, known as FLiRT, is now the most dominant strain in the U.S. This variant, which evolved from the omicron strain, is characterized by changes in its spike protein the part of the virus that binds to host cells. Dr. Matthew Binnicker,director of theClinical Virology Laboratoryat Mayo Clinic, says that these changes could increase the virus' ability to infect cells and evade the immune system, even in people who have previously been infected or vaccinated.

"This variant can evade the immune response more effectively than prior versions of the virus. If you've been infected, or you've been vaccinated, and you've got some antibodies in your system, those antibodies may not recognize the protein on the surface of the virus as well," says Dr. Binnicker.

According to the Centers for Disease Control and Prevention (CDC), this new variant is nowresponsiblefor more than 28% of COVID-19 cases in the U.S. Dr. Binnicker says there is a potential for an increase in cases during the summer months, with a more significant surge expected in the fall and winter.

"I anticipate we'll see an uptick in cases with this more transmissible virus that can evade the immune system. But what I'm really watching are the fall and winter months because that's typically when we see the largest surge in respiratory viral infections," he says.

Watch: Dr. Matthew Binnicker discusses COVID-19 FLiRT strains

Journalists: Broadcast-quality sound bites are available in the downloads at the bottom of the posts. Name super/CG: Matthew Binnicker, Ph.D./Laboratory Medicine and Pathology/Mayo Clinic

For those who are vaccinated, antibodies are present to combat the virus. However, the effectiveness of these antibodies can vary with different virus variants.

"With this latest round of variants, this FLiRT variant, the antibodies that you have from past vaccination may not bind and neutralize the virus as well. If you've been infected or vaccinated in the past three to four months, youre probably going to have antibodies that are going to recognize these newer viruses effectively. And it will help you keep from getting really sick and may even help prevent you from coming down with any symptoms," says Dr. Binnicker.

"If you were infected or vaccinated more than six months ago, you may not have as good of protection, and you may come down with a subsequent infection with the typical symptoms of COVID," he adds.

The symptoms of this variant are consistent with other variants and include:

Receiving an updated vaccine will help protect you from the newer strain.

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A Mayo Clinic virologist explains FLiRT and why you may need a new COVID-19 vaccination - Mayo Clinic

Today in Science, astudy shows that unflagged, factual but misleading Facebook posts reduced the intent to receive the COVID-19 vaccine 46 times more than did false posts flagged by fact-checkers as misinformation, which the authors say points to the need to consider the reach and impact of content rather than just its veracity.

The researchers, from the Massachusetts Institute of Technology (MIT) and the University of Pennsylvania (UPenn), surveyed thousands of participants about the influence of the headlines from 130 vaccine-related news stories on their intent to vaccinate. They also asked a separate group of people to rate the headlines on attributes such as plausibility and political bent.

Then the team extrapolated the survey results to predict the influence of13,206 vaccine-related Facebook links in the first 3 months of the COVID-19 vaccine rollout (January to March 2021) on the vaccination intentions of the platform's roughly 233 million US users.

"We posit that two conditions must be met for content to have widespread impact on people's behavior: People must see it, and, when seen, it must affect their behavior," the researchers wrote. "That is, we define 'impact' as the combination of exposure and persuasive influence."

Posts containing false claims about the COVID-19 vaccine (eg, microchips being placed in vaccines)lowered vaccination intentions by 1.5 percentage points, and content suggesting that the vaccine was harmful to health also reduced vaccination intentions, regardless of any effect of the headline's truthfulness.

Flagged links to misinformation received 8.7 million views, accounting for 0.3% of the 2.7 billion vaccine-related link views. In contrast, stories that fact-checkers didn't flag but that still implied that vaccines were harmfulmany of them from credible mainstream news outletswere viewed hundreds of millions of times. One example of unflagged yet misleading content was a story about a rare case of a young, healthy person who died after receiving the COVID vaccine.

The links that fact-checkers flagged as misinformation were, when viewed, more likely to reduce vaccine intentions than unflagged links. But after weighting each link's persuasive effect by the number of views, the effect of unflagged vaccine-skeptical posts eclipsed that of flagged falsities.

Unflagged vaccine-skeptical content reduced vaccination intention by 2.28 percentage points per Facebook user, compared with 0.05 percentage points for flagged contenta 46-fold difference.

Although flagged posts had more of an impact when viewed, differences in exposure almost entirely determined the ultimate impact.

For example, a single vaccine-skeptical Chicago Tribunearticle, "A healthy doctor died two weeks after getting a COVID vaccine; CDC is investigating why," was viewed by more than 50 million Facebook users (over 20% of Facebook's US users) and garnered more than six times the number of views than all flagged content combined.

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Study: Truthful yet misleading Facebook posts drove COVID vaccine reluctance much more than outright lies did - University of Minnesota Twin Cities

Number of children receiving COVID-19 vaccines

A total of 5,197,925 young people aged 517 years, comprising 1,842,159 children aged 511 years and 3,355,766 adolescents aged 1217 years were included in the study. 4,347,781 young adults aged 1824 years, were included as a comparison. The characteristics of the young people included in the study are detailed in Table1 and Supplementary Table1.

In children aged 511 years, 32% (n=581,545) received at least one dose of COVID-19 vaccine and 16% (n=303,118) received a second dose within the study period. Over 99.9% of 511-year-olds who received at least one COVID-19 vaccine dose received the BNT162b2 vaccine (Table2). 82% (n=1,508,661) of children in this age group had a positive SARS-CoV-2 test recorded between 8th December 2020 and 7th August 2022, 0.4% (n=5665) of whom received their first COVID-19 vaccine dose prior to their first recorded positive SARS-CoV-2 test (Table2).

In adolescents aged 1217 years, 86% (n=2,882,229) received a first dose of COVID-19 vaccine, 67% (n=2,254,214) received a second dose and 14% (n=454,868) received a third dose (Table2).

The characteristics of the population excluded from the self-controlled case series analysis (i.e. those who did not receive any COVID-19 vaccine and did not have a positiveSARS-CoV-2 test recorded during the study period) are presented in Supplementary Table2.

In children aged 511 years, we did not observe an increased risk of any of the pre-specified outcomes in the 142 days following any dose COVID-19 vaccine with BNT162b2, mRNA-1273 or ChAdOX1 (Table3). However, given that less than 0.1% of vaccinated 5-11-year-olds received a ChAdOX1 or mRNA-1273 vaccine, the probability of type II errors was high as the sample size was too small to detect statistically significant associations for these vaccines.

The clinical characteristics of all children hospitalised with a pre-specified safety event are shown in Supplementary Table3. Supplementary Tables47 show the incidence rate ratios (IRR) and 95% confidence intervals (CI) for all outcomes 142 days and in weekly risk periods following each vaccine dose in 511-year-olds in males and females separately, and the effect of ethnicity on the risk of each outcome.

In the 142 days after the first and second doses of BNT162b2, we observed an increased risk of myocarditis in adolescents aged 1217 years (IRR 1.92, 95%CI 1.083.43 and IRR 2.96, 95%CI 1.655.32 for first and second dose, respectively) (Table4). We estimated that an additional 3 (95%CI 05) cases per million exposed would be anticipated after the first dose and 5 (95%CI 36) after the second dose (Fig.1). When we split the risk period into weekly blocks, the increased risk was restricted to 114 days following each dose (Supplementary Table8). There was also an increased risk of hospitalisation with epilepsy (IRR 1.17, 95%CI 1.001.37; excess events per million: 12, 95%CI 023) in the 142 days following the second dose of BNT162b2 (Table4, Fig.1).

Estimated number of excess events per million (95% CI) based on incidence rate ratios of each outcome in the 142 days following vaccination or SARS-CoV-2 positive test compared to baseline period are presented where there were at least five events during the exposure period and when number of excess events is greater than zero. Data available from 8th December 2020 and 7th August 2022. Table4 contains the data presented in this figure. MIS-C Multisystem inflammatory syndrome; ITP Idiopathic or immune thrombocytopenic purpura, ADEM Acute disseminated encephalomyelitis.

In the sex-stratified analysis, the increased risk of myocarditis after the first dose of BNT162b2 was only observed in females (IRR 4.01, 95%CI 1.3312.09; excess events per million: 3, 95%CI 14), while the increased risk following the second dose was observed in males only (IRR 2.87, 95%CI 1.505.51; excess events per million: 9, 95%CI 411) (Supplementary Figs.1 & 2, Supplementary Tables4 & 5). We additionally observed an increased risk of demyelinating disease, restricted to females (IRR 2.41, 95%CI 1.06-5.48; excess events per million: 4, 95%CI 06) following the second dose of BNT162b2. Of the eight female adolescents who experienced demyelinating disease in the 142 days following a second dose of BNT162b2, five were coded as optic neuritis.

In a post hoc analysis investigating differences in risk between children of different ethnic backgrounds, we found that the risk of anaphylaxis following a second dose of BNT162b2 in adolescents with non-white ethnicity was higher relative to the risk in adolescents with white ethnicity (relative IRR 2.55, 95%CI 1.006.46) (Supplementary Table6). However, when the analysis was restricted to the subgroup of adolescents from non-white ethnic backgrounds, the risk of anaphylaxis in the 142 days following a second dose of BNT162b2 was not significantly increased compared to the baseline period (IRR 1.69, 95%CI 0.803.54) (Supplementary Table6). We did not identify any differences in vaccine safety between white and non-white ethnicity for any of the other pre-specified outcomesin under-18s.

We found no evidence for significantly increased risks for any of the pre-specified outcomes in the 142 days following a first, second or third dose of mRNA-1273 vaccine in 1217-year-olds (Table4). However, this analysis lacked power to detect statistically significant associations, except for very large effect sizes, as less than 0.1% of adolescents received a first or second dose of mRNA-1273 vaccine.

There was an increased risk of hospitalisation with epilepsy 142 days after a first dose of ChAdOX1 (IRR 1.93, 95%CI 1.103.39), with an additional 705 (95%CI 1291033) cases expected per million exposed (Table4). This increased risk was restricted to females in the sex-stratified analysis (IRR 2.26, 95%CI 1.034.94) with an additional 813 (95%CI 441164) hospitalisations with epilepsy expected per million female adolescents exposed (Supplementary Table4).

We also observed an increased risk of appendicitis in the 142 days following the second dose of ChAdOX1 (IRR 4.64, 95%CI 1.7712.17; excess events per million: 512, 95%CI 283599) (Table4).

The IRRs and 95% CIs for all outcomes 142 days and in weekly risk periods following each vaccine dose in 1217-year-olds in males and females separately, and the effect of ethnicity on the risk of each outcome, are presented in Supplementary Figs.1 & 2, Supplementary Tables46 & 8.

In children aged 5-11 years who had received at least one dose of COVID-19 vaccine before the date that their positive SARS-CoV-2 test was recorded, we did not observe increased risks of any of the pre-specified outcomes in the 142 days following SARS-CoV-2 infection. In children who had not been vaccinated against COVID-19 prior to infection, there was an increased risk of hospital admission with MIS-C following a SARS-CoV-2 positive test (IRR 11.52, 95%CI 9.2514.36), with an additional 137 (95%CI 134140) cases expected per million exposed (Table3, Fig.2). In the sex-stratified analysis, the risk of MIS-C was slightly greater in male children (IRR 12.00, 95%CI 8.9216.12; excess events per million: 162, 95%CI 157-166) compared to female children (IRR 11.13, 95%CI 7.9615.57; excess events per million: 124, 95%CI 119127) (Supplementary Figs.3 & 4, Supplementary Tables4 & 5). The increased risk was mainly observed in the 2242 days following the date that the positive SARS-CoV-2 test was recorded (Supplementary Table7).

Estimated number of excess events per million (95% CI) based on incidence rate ratios of each outcome in the 142 days following SARS-CoV-2 positive test compared to baseline period are presented where there were at least five events during the exposure period and when number of excess events is greater than zero. Data available from 8th December 2020 and 7th August 2022. Table3 contains the data presented in this figure. MIS-C Multisystem inflammatory syndrome, ITP Idiopathic or immune thrombocytopenic purpura, ADEM Acute disseminated encephalomyelitis.

We also observed increased risks of hospital admission for myositis, myocarditis, acute pancreatitis and ADEM following SARS-CoV-2 infection before vaccination(Table3, Fig.2). In the sex-stratified analyses, we additionally identified increased risks of ITP (in both sexes) and anaphylaxis (in females only) (Supplementary Figs.3 & 4, Supplementary Tables4 & 5).

The IRRs and 95% CIs for all outcomes 142 days following SARS-CoV-2 infection in 511-year-olds in males and females separately, and the effect of ethnicity on the risk of each outcome, are presented in Supplementary Figs.3 & 4, Supplementary Tables4, 5, 6 & 7.

In adolescents aged 1217 years, we observed an increased risk of MIS-C (IRR 12.38, 95%CI 8.8817.28; excess events per million: 84, 95%CI 8186) in the 142 days following a SARS-CoV-2 infection in those who had not been vaccinated prior to SARS-CoV-2 infection (Table4, Fig.1). In the sex-stratified analysis, male adolescents were at higher risk of MIS-C following infection compared to females (IRR 12.33, 95%CI 8.3118.31and IRR 13.11, 95%CI 6.9024.91 in males and females, respectively), with an additional 131 (95%CI 126135) cases expected per million males exposed compared to 48 (95%CI 44-50) in females (Supplementary Figs.1 & 2, Supplementary Tables4 & 5).

We also observed increased risks ofhospitalisation with myocarditis, ITP and epilepsy in the 1-42 days following SARS-CoV-2 infection in adolescents who had not been vaccinated against COVID-19 prior to infection as well as an increased risk of hospitalisation with epilepsy in those who had received at least one vaccine dose prior to infection (Table4, Fig.1). In the sex-stratified analysis, the increased risks ofhospitalisation with myocarditis and epilepsy were restricted to males while the increased risk of ITP following infection was only observed in females (Supplementary Figs.1 & 2, Supplementary Tables4 & 5). We additionally identified increased risks of appendicitis (in females only) and anaphylaxis (in males only) following SARS-CoV-2 infection.

The IRRs and 95% CIs for all outcomes 142 days following SARS-CoV-2 infection in 12-17-year-olds in males and females separately, and the effect of ethnicity on the risk of each outcome, are presented in Supplementary Figs.1 & 2, Supplementary Tables4, 5, 6 & 8.

The results for all analyses in young adults aged 18-24 years are presented in Supplementary Tables6 & 9.

The robustness of the results of the self-controlled case series analyses were assessed by (1) checking that the risk of outcomes during the pre-vaccination period (month prior to vaccination to account for potential bias of people with recent hospitalisation being less likely to get vaccinated) was lower than the baseline period and (2) checking that the risk of the positive control outcome (anaphylaxis) was higherfollowing vaccination or SARS-CoV-2 infection than the baseline period. In the vast majority of analyses the estimates of the pre-vaccination period and the risk of anaphylaxis following vaccination or SARS-CoV-2 agreed with what was expected (SupplementaryTables8 & 9).

Our matched cohort analysis included 1,580,869 children aged 511 years and 1,535,341 adolescents aged 1217 years. Characteristics of the cohort are detailed in Supplementary Table10.

Incidence rates of vaccine safety outcomes in the 142 days following each vaccine dose and following SARS-CoV-2 infection in vaccinated and unvaccinated children are presented in Supplementary Table11. Incidence rates for all outcomes were significantly higher following SARS-CoV-2 infection compared to COVID-19 vaccination.

We matched 160,262 children aged 511 years and 848,186 adolescents aged 1217 years who had received at least one dose of COVID-19 vaccine to a child of the same age and sex who had not received any COVID-19 vaccine doses by the date of the vaccinated childs first vaccine dose (characteristics of matched cohort reported in Supplementary Table12).

As in the self-controlled case series analysis, we identified an increased risk of hospitalisation with epilepsy in the 142 days following a second dose of COVID-19 vaccine with BNT162b2 in 12-17-year-olds (unadjusted IRR 1.77, 95%CI 1.052.99, adjusted IRR 3.88, 95%CI 1.2711.86), but did not find significantly increased risks of appendicitis or myocarditis with BNT162b2 vaccination in adolescents (Supplementary Table13).

We identified additional increased risks of anaphylaxis and appendicitis in 12-17-year-olds following a first dose of BNT162b2 (unadjusted IRR 3.71, 95%CI 1.2311.14 and unadjusted IRR 1.37, 95%CI 1.051.80, respectively) and an increased risk of hospitalisation with epilepsy following a first dose with BNT162b2 in 511-year-olds, although the confidence interval was very wide reflecting the uncertainty of the estimate (unadjusted IRR 16.00, 95%CI 2.12120.65) (Supplementary Table13).

In general, the estimates from the matched cohort study were in agreement with the results from the self-controlled case series analysis in under-18s.

Unadjusted IRRs and IRRs adjusted for self-reported ethnicity (white, non-white, missing), quintile of deprivation (based on Townsend score) and presence of comorbidity (yes/no) for each outcome are reported in Supplementary Table13.

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Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England - Nature.com

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Early in the COVID-19 pandemic, Black Americans were more hesitant to take the COVID-19 vaccine than were white Americans. As the pandemic went on, however, the disparity in vaccination rates between Black and white adults declined.

In a paper titled "What Caused the Narrowing of Black-White COVID-19 Vaccination Disparity in the US? A Test of 5 Hypotheses," published in the current issue of the Journal of Health Communication, researchers at the Annenberg Public Policy Center (APPC) of the University of Pennsylvania assessed explanations for the positive change.

Using April 2021 to July 2022 data from the Annenberg Science and Public Health (ASAPH) survey, a national panel of over 1,800 U.S. adults, the team, led by APPC research director Dan Romer, assessed potential explanations, including increased trust in the Centers for Disease Control and Prevention (CDC), exposure to pro-vaccination messages in the media, awareness of COVID-inflicted deaths among personal contacts, and improved access to vaccines.

None of these factors explained the decline in disparity, however. Only increased knowledge about COVID-19 vaccination made a difference. Knowledge about the COVID vaccine among Black Americans increased over time, and this increase was associated with their receipt of the vaccine.

"Black Americans became less skeptical of the safety and efficacy of the vaccine as time proceeded, which appeared in our data to be an important contributor to increased vaccination rates among them," said Romer.

In the initial wave of the survey, in April 2021, Black respondents were more likely to believe various forms of misinformation about COVID vaccines, such as that the vaccines are responsible for thousands of deaths and that the vaccines can change someone's DNA. By the end of the survey period, knowledge about the vaccine among Black Americans had increased significantly.

It is noteworthy that national efforts by Black members of such organizations as the National Academy of Medicine sought to encourage COVID vaccination in the Black community by endorsing the safety and need for the vaccines. Better information about the vaccines also may have been transmitted within the Black community through religious organizations and local Black newspapers that supported the effort to increase vaccination coverage.

These findings could have important implications for future efforts to encourage vaccination, as they suggest that "exposure to knowledge about vaccine safety and efficacy from trusted sources" can matter.

"Reducing misinformation about vaccination for COVID and vaccines in general is a promising strategy going forward, as the risk of infection from COVID and other diseases will not go away," said Romer.

Along with Romer, the authors of the study include APPC data analyst Shawn Patterson Jr., Adolescent Risk and Health Communication Institute director Patrick E. Jamieson, and APPC director Kathleen Hall Jamieson.

More information: Daniel Romer et al, What Caused the Narrowing of Black-White COVID-19 Vaccination Disparity in the US? A Test of 5 Hypotheses, Journal of Health Communication (2024). DOI: 10.1080/10810730.2024.2354360

Journal information: Journal of Health Communication

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Researchers find knowledge a factor in closing Black-white COVID-19 vaccination gap - Medical Xpress

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Boosters that target the omicron subvariants of SARS-CoV-2 are still providing reasonably durable protection against infection, hospitalization and death from COVID-19, according to new data from a study led by researchers at the UNC Gillings School of Global Public Health.

Published in the New England Journal of Medicine, the study found that COVID-19 boosters targeting the XBB.1.5 subvariants were most effective one month after receiving one. After four weeks, the vaccines were 52.2% effective at preventing infection and 66.8% effective at preventing hospitalization.

The vaccines were also highly effective at preventing death, but exact certainty was hard to quantify given the small number of deaths reported during the study period.

After peaking at four weeks, booster effectiveness waned over time. Effectiveness at preventing infection decreased to 32.6% after 10 weeks and 20.4% after 20 weeks, while effectiveness at preventing hospitalization decreased to 57.1% after 10 weeks.

Danyu Lin, Ph.D., Dennis Gillings Distinguished Professor in the Department of Biostatistics at the Gillings School, is lead author on the study. Using data from the Nebraska Electronic Disease Surveillance System and the Nebraska State Immunization Information System, the research team studied the efficacy of vaccination before and after Oct. 25, 2023, when the JN.1 variant began to emerge.

Vaccine effectiveness was lower in the second group, suggesting that the booster was less protective against the now-dominant JN.1 strain.

"The JN.1 subvariant has been the dominant strain in the United States this year," said Lin. "The relatively low effectiveness of the XBB.1.5 vaccines against the JN.1 subvariant, together with the waning effectiveness over time, underscores the need for new vaccines targeting the JN.1 strain."

Lin says the Food and Drug Administration's general strategy is to deploy new COVID-19 vaccines annually in the fall that target the circulating strains in the spring, and that the findings in this study may contribute to this decision.

"It would be worthwhile to deploy new vaccines this fall that target the JN.1. strain," he said.

More information: Dan-Yu Lin et al, Durability of XBB.1.5 Vaccines against Omicron Subvariants, New England Journal of Medicine (2024). DOI: 10.1056/NEJMc2402779

Journal information: New England Journal of Medicine

Provided by UNC Gillings School of Global Public Health

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Study shows effectiveness of updated COVID-19 vaccines wanes moderately over time, is lower against current variants - Medical Xpress

Vaccination for COVID-19 after an acute coronary syndrome (ACS) event was not associated with better cardiopulmonary outcomes or fewer major adverse cardiovascular events, according to a secondary analysis of the Brazilian VIP-ACS trial.

Censoring the first 90 days post-vaccination in this non-randomized comparison, people with ACS who had received at least one COVID-19 vaccine dose had 4.81 cardiopulmonary events per 100 patient-years as compared with 9.37 among those not vaccinated, Henrique Fonseca, PhD, of the Hospital Israelita Albert Einstein in So Paulo, and colleagues reported in JAMA Network Open.

Despite the numerical difference in cardiopulmonary events between the two groups, the result did not reach statistical significance after adjustment for multiple comparison (P=0.12). Cardiopulmonary events included all-cause death, myocardial infarction (MI), stroke, urgent coronary revascularization, as well as hospitalization for unstable angina, heart failure, or respiratory infection.

Vaccination -- which was mostly with AstraZeneca's COVID shot, a vaccine never authorized in the U.S. -- also did not significantly reduce the secondary endpoint of major adverse cardiovascular events (MACE; P=0.60). There were 4.32 such cardiovascular death, MI, or stroke events per 100 patient-years in the unvaccinated group versus 1.19 events in the vaccinated group.

These prospective findings counter recent retrospective studies demonstrating a short-term reduction in MACE risk after COVID-19 vaccination, Fonseca and colleagues noted.

While an interesting study, it had some important limitations, commented Susan Cheng, MD, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, who was not involved in the study. "It appears they conducted the study relatively early on in the pandemic in a relatively high-CV-risk group of people," she told MedPage Today. "So it may be hard to generalize results to a broader population and to where we are now in the post-pandemic or endemic era."

The study was also relatively underpowered, Cheng pointed out. "This is probably a key issue," she said, noting that there was at least some separation of the 360-day Kaplan-Meier event curves between the vaccinated and unvaccinated individuals, but the total sample size and number of events was quite small in the vaccinated group.

"As a clinician, I would say the results are interesting, although [they] would not change my practice of advising patients who have a high risk for cardiopulmonary events to obtain a COVID vaccination if they have not been recently infected with COVID," she added.

The primary aim of the multicenter VIP-ACS trial was to investigate whether double-dose influenza vaccination during hospitalization for ACS would further reduce the risk of major cardiopulmonary events when compared with guideline-recommended standard-dose influenza vaccination. That randomized comparison -- conducted from July 19, 2019, and Nov. 30, 2020, at 25 centers in Brazil -- concluded that this strategy did not improve cardiopulmonary outcomes compared with standard-dose vaccination.

The prespecified secondary analysis examined COVID-19 vaccination, which was not randomly assigned. During the first 90 days after an ACS event, a total of 1,665 of the 1,801 trial participants did not experience a cardiopulmonary event and were included in the landmark analysis, which was designed to minimize ascertainment immortal bias.

Patients were followed to 360 days. About 30% were female, and the median age was 56.7 years. Approximately 16% had had prior myocardial infarction, and 36% were current smokers.

About half of the secondary analysis patients had received at least one COVID-19 vaccine dose, and at least one dose was the AstraZeneca ChAdOx1 shot for about 64% of these participants. That vaccine first became available in Brazil in early 2021. Other vaccines that were available in Brazil were the Chinese developed-Sinovac vaccine, Pfizer's BNT162b2 mRNA shot (Comirnaty), and Johnson & Johnson's Ad.26.COV2.S vaccine, which is no longer available in the U.S.

"Our results should not be generalized to other COVID-19 vaccines," the researchers cautioned.

Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.

Disclosures

The study was funded by grants from the Brazilian Ministry of Health-Programa de Apoio do Desenvolvimento Institucional do Sistema nico de Sade.

Fonseca reported receiving grants from AstraZeneca, Pfizer, Ach, Colgate, and Essity. Other study authors reported ties to industry.

Cheng reported no relevant financial disclosures.

Primary Source

JAMA Network Open

Source Reference: Fonseca HAR, et al "COVID-19 vaccination and cardiopulmonary events after acute coronary syndromes: A secondary analysis of a randomized clinical trial" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.13946.

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COVID Shot After Acute Coronary Syndrome Might Not Prevent Further Events - Medpage Today

The FDA just approved Modernas second-ever product. Image: Dado Ruvic (Reuters )

The Food and Drug Administration on Friday approved Modernas mRNA-based respiratory syncytial virus (RSV) vaccine for people 60 and older. The approval paves the way for the pharma giant, known for its COVID-19 vaccine, to launch its second-ever product.

Google leak shows it might be lying about its Search algorithm

The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform, Moderna CEO Stphane Bancel said in a statement.

Its also the FDAs first approval for an mRNA vaccine protecting against a disease other than COVID-19.

A phase 3 trial of mRESVIA involving about 37,000 adults aged 60 years or older found that it was almost 84% effective at protecting against RSV lower respiratory tract disease. About 60,000 to 160,000 older adults are hospitalized annually and about about 6,000 to 10,000 die in the U.S. from RSV, according to the Centers for Disease Control and Prevention.

Moderna has been steadily building its pipeline of new medications as its previously only product on the market has dropped in demand.

The company reported this month that its revenue in the first quarter of 2024 plummeted 91% year-over-year to $167 million, down from $1.9 billion in the same quarter last year.

Only 14% U.S. adults have received an updated COVID-19 vaccine, according to the CDC.

Moderna is forecasting that its respiratory franchise, which includes its COVID-19 vaccine and its RSV vaccine, will generate $4 billion in revenue this year.

The company is also developing a combined COVID and flu vaccine. Moderna has more than 40 products in development including a vaccine for the digestive system bug, norovirus.

Modern stock was down about 5% in Friday afternoon trading. But the stock is up 28% so far this year.

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Moderna just got FDA approval for its RSV vaccine only its second product on the market - Quartz

The updated monovalent XBB.1.5 COVID-19 vaccines were effective against Omicron subvariants circulating during the most recent respiratory virus season, but their effectiveness waned over time, according to a brief report.

The three vaccines updated to target the SARS-CoV-2 XBB.1.5 subvariant -- Moderna's and Pfizer-BioNTech's mRNA vaccines and the Novavax vaccine -- were 66.8% effective against hospitalization at 4 weeks, decreasing to 57.1% after 10 weeks, wrote Dan-Yu Lin, PhD, of the UNC Gillings School of Global Public Health in Chapel Hill, North Carolina, and colleagues.

Vaccine effectiveness against infection was about 52% after 4 weeks, decreasing to 33% after 10 weeks, and to 20% after 20 weeks, the New England Journal of Medicine correspondence showed.

"We expected these vaccines to be effective, especially against hospitalization and death. We also expected the effectiveness to decline over time," Lin told MedPage Today. "However, we didn't know beforehand the levels of effectiveness or the duration of protection."

Although the effectiveness against death was higher -- 72% after 4 weeks and 61.4% after 10 weeks -- than against infection or hospitalization, "there remains substantial uncertainty," because there were few deaths in the study population, the authors pointed out.

Data appeared to point to lower effectiveness against infection, hospitalization, and death after the arrival of the JN.1 subvariant, the dominant strain in the U.S. through the end of March of this year.

For those vaccinated before Oct. 26, 2023 -- before the JN.1 variant became predominant -- the vaccines were 64.4% effective against infection after week 4, decreasing to 40.9% after week 10, and 22.4% after week 18. In comparison, for those vaccinated between Oct. 26, 2023 and Feb. 10, 2024 -- when the JN.1 variant was dominant -- vaccine effectiveness against infection was 44.3% after week 4 and decreased to 17.4% after week 10.

Effectiveness against hospitalization in those vaccinated during the period before JN.1 was 73.7% after week 8 and 59.1% after week 10, while effectiveness against death was 86.2% at week 4 and 72.9% at week 8 during this period. Among those vaccinated after the JN.1 variant became dominant, effectiveness against hospitalization was 60.1% after week 4 and effectiveness against death was 59.8% after week 4, and both steadily decreased over time.

"It would be worthwhile to develop and deploy new vaccines targeting JN.1 or future strains," the authors wrote.

The FDA's Vaccines and Related Biological Products Advisory Committee is set to meet on June 5 to discuss and make recommendations on the selection of the formula for the 2024-2025 season. Signs point to the selection of JN.1 or one of its newer descendants such as KP.2, which currently accounts for an estimated 29% of U.S. cases.

Last month, the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition recommended that future formulations of the COVID-19 vaccine use a monovalent JN.1 lineage as the antigen for future formulations. FDA followed WHO's recommendations last year in selecting an XBB.1-based strain, approving the monovalent XBB.1.5-directed mRNA vaccines in September 2023.

Further analyses from Lin's group showed that the XBB.1.5 vaccines were effective across different age groups and among people who had not been previously infected or vaccinated. And Lin commented that the durability of the vaccines "were broadly similar to our previous findings on the durability of bivalent boosters against BQ.1-BQ.1.1 and XBB-XBB.1.5.3."

For their study, the researchers used data on vaccine uptake from the Nebraska Electronic Disease Surveillance System and the Nebraska State Immunization Information System. Researchers examined all discharge data from hospitals of the Nebraska Hospital Association and reviewed all death certificates in Nebraska to identify deaths related to COVID-19.

In the cohort of 1.8 million people, 218,250 received one of the XBB.1.5 vaccines between Sept. 11, 2023 and Feb. 21, 2024. Among the people who received one of the updated vaccines, 61.1% received the Pfizer-BioNTech vaccine and 38.6% received the Moderna vaccine.

The primary outcomes were COVID-19 infection, hospitalization, hospitalization or death (whichever occurred first), and death. There were 21,988 SARS-CoV-2 reported infections during the study period, with 1,364 COVID-related hospitalizations and 237 COVID-related deaths.

The study did not include results of at-home COVID-19 antigen tests.

Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.

Disclosures

The study was funded by the Dennis Gillings Distinguished Professorship and the National Institutes of Health.

Lin and coauthors reported no relevant financial disclosures.

Primary Source

New England Journal of Medicine

Source Reference: Lin DY, et al "Durability of XBB.1.5 vaccines against omicron subvariants" N Engl J Med 2024; DOI: 10.1056/NEJMc2402779.

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COVID Shots Could Use Another Update, Study Suggests - Medpage Today

The state comptroller issued a report Tuesday on the countrys handling of the COVID-19 crisis, criticizing Prime Minister Benjamin Netanyahu for making major decisions without the approval of his coronavirus cabinet that was set up to oversee Israels response to the pandemic.

The report covered the period of 2020 to 2023 when the virus pandemic peaked and then faded away as Israel and other countries embraced mass vaccination programs.

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State Comptroller Matanyahu Englman said that Netanyahu made a key deal with the Pfizer company to give it exclusivity over providing COVID vaccines to Israel through March 2021, and did not update or consult the COVID cabinet. The deal was closed between Netanyahu and Pfizer CEO Albert Bourla over the phone but the cabinet was not informed of the strategic move.

Along with the benefits to the State of Israel, this is a decision that at the time involved risks to public health, even if these were calculated risks, he wrote.

Read more from the original source:

State comptroller slams Netanyahu for sealing Pfizer COVID vaccine deal by himself - The Times of Israel

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Since the rollout of the COVID-19 vaccine in 2021, fake news on social media has been widely blamed for low vaccine uptake in the United Statesbut research by MIT Sloan School of Management Ph.D. candidate Jennifer Allen and Professor David Rand finds that the blame lies elsewhere.

In a new paper published in Science and co-authored by Duncan J. Watts of the University of Pennsylvania, the researchers introduce a new methodology for measuring social media content's causal impact at scale. They show that misleading content from mainstream news sourcesrather than outright misinformation or "fake news"was the primary driver of vaccine hesitancy on Facebook.

"Misinformation has been correlated with many societal challenges, but there's not a lot of research showing that exposure to misinformation actually causes harm," explained Allen.

During the COVID-19 pandemic, for example, the spread of misinformation related to the virus and vaccine received significant public attention. However, existing research has, for the most part, only established correlations between vaccine refusal and factors such as sharing misinformation onlineand largely overlooked the role of "vaccine-skeptical" content, which was potentially misleading but not flagged as misinformation by Facebook fact-checkers.

To address that gap, the researchers first asked a key question: What would be necessary for misinformation or any other type of content to have far-reaching impacts?

"To change behavior at scale, content has to not only be persuasive enough to convince people not to get the vaccine, but also widely seen," Allen said. "Potential harm results from the combination of persuasion and exposure."

To quantify content's persuasive ability, the researchers conducted randomized experiments in which they showed thousands of survey participants the headlines from 130 vaccine-related storiesincluding both mainstream content and known misinformationand tested how those headlines impacted their intentions to get vaccinated against COVID-19.

Researchers also asked a separate group of respondents to rate the headlines across various attributes, including plausibility and political leaning. One factor reliably predicted impacts on vaccination intentions: the extent to which a headline suggested that the vaccine was harmful to a person's health.

Using the "wisdom of crowds" and natural language processing AI tools, Allen and her co-authors extrapolated those survey results to predict the persuasive power of all 13,206 vaccine-related URLs that were widely viewed on Facebook in the first three months of the vaccine rollout.

By combining these predictions with data from Facebook showing the number of users who viewed each URL, the researchers could predict each headline's overall impactthe number of people it might have persuaded not to get the vaccine. The results were surprising.

Contrary to popular perceptions, the researchers estimated that vaccine-skeptical content reduced vaccination intentions 46 times more than misinformation flagged by fact-checkers.

The reason? Even though flagged misinformation was more harmful when seen, it had relatively low reach. In total, the vaccine-related headlines in the Facebook data set received 2.7 billion viewsbut content flagged as misinformation received just 0.3% of those views, and content from domains rated as low-credibility received 5.1%.

"Even though the outright false content reduced vaccination intentions the most when viewed, comparatively few people saw it," explained Rand. "Essentially, that means there's this class of gray-area content that is less harmful per exposure but is seen far more often and thus more impactful overallthat has been largely overlooked by both academics and social media companies."

Notably, several of the most impactful URLs within the data set were articles from mainstream sources that cast doubt on the vaccine's safety. For instance, the most-viewed was an articlefrom a well-regarded mainstream news sourcesuggesting that a medical doctor died two weeks after receiving the COVID-19 vaccine. This single headline received 54.9 million viewsmore than six times the combined views of all flagged misinformation.

While the body of this article did acknowledge the uncertainty of the doctor's cause of death, its "clickbait" headline was highly suggestive and implied that the vaccine was likely responsible. That's significant since the vast majority of viewers on social media likely never click out to read past the headline.

According to Rand, one implication of this work is that media outlets need to take more care with their headlines, even if that means they aren't as attention-grabbing.

"When you are writing a headline, you should not just be asking yourself if it's false or not," he said. "You should be asking yourself if the headline is likely to cause inaccurate perceptions."

For platforms, added Allen, the research also points to the need for more nuanced moderationacross all subjects, not just public health.

"Content moderation focuses on identifying the most egregiously false informationbut that may not be an effective way of identifying the most overall harmful content," she says. "Platforms should also prioritize reviewing content from the people or organizations with the largest numbers of followers while balancing freedom of expression. We need to invest in more research and creative solutions in this spacefor example, crowdsourced moderation tools like X's Community Notes."

"Content moderation decisions can be really difficult because of the inherent tension between wanting to mitigate harm and allowing people to express themselves," Rand said. "Our paper introduces a framework to help balance that trade-off by allowing tech companies to actually quantify potential harm."

And the trade-offs could be large. An exploratory analysis by the authors found that if Facebook users hadn't been exposed to this vaccine-skeptical content, as many as 3 million more Americans could have been vaccinated.

"We can't just ignore this gray area-content," Allen concluded. "Lives could have been saved."

More information: Jennifer Allen, Quantifying the impact of misinformation and vaccine-skeptical content on Facebook, Science (2024). DOI: 10.1126/science.adk3451. http://www.science.org/doi/10.1126/science.adk3451

Journal information: Science

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Misleading COVID-19 headlines from mainstream sources did more harm on Facebook than fake news, study finds - Phys.org