The U.S. Centers for Disease Control and Prevention says an extra dose can boost protection that may have diminished, especially for people who are at high risk.
Author: newscentermaine.com
Published: 7:05 PM EST February 29, 2024
Updated: 7:05 PM EST February 29, 2024
The role of COVID-19 vaccination in protecting hypertensive patients from severe outcomes advocates prioritization alongside blood pressure management. Research indicates that patients with poorly controlled hypertension face a higher risk of severe COVID-19 outcomes, such as increased hospitalizations, intensive care unit admissions, and ventilator support requirements. This situation underscores the importance of vaccination and maintaining up-to-date vaccinations for individuals with poorly controlled hypertension to prevent infection and its severe consequences.
Robert Walker MD, senior vice president and chief medical officer at Novavax, assesses the effectiveness of COVID-19 vaccines in preventing serious illness in individuals with high blood pressure and determines their impact on reducing the risk of adverse cardiac events, including myocardial infarctions and strokes.
120 million people have hypertension, and only a quarter of them, said Walker. You know, there are other cardiovascular diseases and other comorbidities that put people at increased risk of all these things that we've been talking about, not just hypertension. So, the public health effect, the impact would be huge just based on the sheer numbers of people that we're talking about here.
The effectiveness of COVID-19 vaccines was evaluated through pivotal efficacy trials leading to their licensure and further supported by 2 large database studies conducted aimed at understanding the vaccines' role in preventing major adverse cardiac events among individuals with high blood pressure.
We know that COVID vaccines are highly effective at preventing infection, Walker states. We know that from many studies that have been done as pivotal efficacy trials that lead to the licensure of these vaccines. We also know from 2 very large database studies, 1 conducted in the US, and 1 conducted in Korea, that COVID-19 vaccines can prevent major adverse cardiac events. And by major adverse cardiac events, we're talking about acute myocardial infarctions and strokes. And their relative risk reductions have been shown in these studies range from 20 to 40%.
Currently, in the United States, there are primarily 2 categories of vaccines: mRNA vaccines and protein-based vaccines, NovaVax, specializes in protein-based vaccines. The goal of both vaccine types is to elicit an immune response against the SARS-CoV-2 virus, thereby safeguarding individuals from infection, illness, and the severe outcomes that can arise, particularly in adults.
I think it's important to have those conversations to understand the 2 different types of vaccines that are available, and also make sure that you're staying up to date, you want to make sure that the vaccine you receive is intended to protect against the viruses that are the strains of viruses that are currently circulating in the community. So, the vaccine that we received a year ago, is probably not going to be the best protection for what circulating now. General good hygiene and good advice is to stay in touch with your physician, and make sure your underlying illnesses, if you have them are being well managed and appropriately controlled. All those efforts together, I think will do their part to keep people healthy.
All in all, insights from Novavax and Dr. Robert Walker emphasize vaccines' role in mitigating severe health outcomes. Ensuring vaccinations are current and managing underlying health conditions are paramount in protecting this vulnerable group. Through collective adherence to these strategies, we can significantly reduce COVID-19 impact on those with hypertension and the wider community.
WASHINGTON, D.C. Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio) is investigating possible undue interference on the accelerated approval of Pfizers COVID-19 vaccine by the U.S. Food and Drug Administration (FDA).
During the Select Subcommittees hearing titled Assessing Americas Vaccine Safety Systems, Part 1, FDA Director Dr. Peter Marks testified that the FDAs approval of the COVID-19 vaccine may have been rushed in order to meet arbitrary mandate policies set forth by the Biden Administration.
Previous documents uncovered by the Select Subcommittee revealed that scientists warned Dr. Marks and other FDA officials on numerous occasions about the dangers of rushing the COVID-19 vaccine approval process.
The FDA seemingly disregarded the warnings, dismissed the scientists who brought forward the concerns, and went forward with the accelerated approval process. The day after approval, the Biden Administration announced its first COVID-19 vaccine mandate.
Chairman Wenstrup is reiterating requests for transcribed interviews with Dr. Peter Marks and former FDA Commissioner Dr. Janet Woodcock.
The chairman is also asking current FDA Commissioner Dr. Robert Califf to provide documents and information related to the COVID-19 vaccine approval process.
Dr. Peter Markss Feb. 15, 2024 testimony:
Notably, on August 9, 2021, U.S. Defense Secretary Lloyd Austin stated that he would, make the COVID-19 vaccines mandatory no later than mid-September, or immediately upon the U.S. Food and Drug Administration (FDA) licensure, whichever comes first.
This assertion could have increased pressure on Biden Administration officials to expedite approval of the COVID-19 vaccine. Less than a month later, on August 23, the FDA approved the COVID-19 vaccine for public use.
One day after the FDAs approval, Secretary Austin issued a memorandum mandating the COVID-19 vaccine for all U.S. military service members.
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The Centers for Disease Control and Prevention recommended Wednesday that people 65 and older get a second dose of a coronavirus vaccine made available in the fall because they are at higher risk for severe disease from the virus.
Most covid-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk, CDC Director Mandy Cohen said in a statement after endorsing the recommendation from the agencys vaccine advisory panel.
The 11-1 vote, with one abstention, by the Advisory Committee on Immunization Practices appeared to take some members by surprise.
A subgroup of advisers had suggested softer language that would have said older adults may get a second dose instead of should. That language, members said, would have given clinicians more flexibility and also takes into account growing vaccine hesitancy four years into the pandemic.
But Camille Kotton, clinical director for transplant and immunocompromised host infectious diseases at Massachusetts General Hospital in Boston, pushed for the stronger language so clinicians can make clearer recommendations to patients. Too many Americans are still unaware they should be getting a coronavirus vaccine, she said. Using the word may is too soft, especially for the most vulnerable, she said.
Demetre Daskalakis, who directs the CDC center overseeing respiratory infectious-disease threats, warned the panel that more absolute statements around vaccines will create a chilling effect for folks who have not been vaccinated.
A CDC recommendation means that those who are eligible for a second shot will have that additional dose covered by insurance. Eligible consumers should be able to get the additional dose within a day or two from pharmacies or health-care providers stocking the vaccines. There are no supply shortages, CDC officials said.
The recommendation applies only to those 65 and older. The additional dose should be given at least four months after a previous dose for healthy older adults, or at least three months after a coronavirus infection. Its unclear whether those getting a second shot now will also need another shot for the 2024-2025 fall and winter season.
David Kaslow, a representative of the Food and Drug Administration who was sworn in as a temporary voting member for the meeting, said there may be a new vaccine approved for the 2024-2025 winter season. In that case, he said, it would not be optimal for people to get a second dose of a current vaccine later than June.
The CDC already recommended in the fall that people age 5 and older get an updated vaccine to protect against serious illness. Uptake among adults has been low only about 22 percent of those 18 and older have received a dose of an updated vaccine. And only about 42 percent of those 65 and older have received a dose. People who are moderately or severely immunocompromised are already allowed to get additional doses of an updated coronavirus vaccine.
The recommendation Wednesday acknowledges that risk of severe illness continues throughout the year for older adults, not only during the winter months. Unlike flu and RSV, which usually occur in the fall and winter, coronavirus surges have occurred in the spring and summer.
This will be the third year in a row that spring boosters will be offered. Things with covid are unpredictable, CDC expert Megan Wallace told the panel. Officials are hoping the coronavirus is moving in a direction that is more like flu, with a clear season, but I dont think we are there yet, she said.
To be sure, the impact of the coronavirus has changed dramatically since the start of the pandemic in 2020, with new infections causing far fewer hospitalizations or deaths. By the end of last year, 98 percent of people in the United States had disease-fighting antibodies from vaccination or prior infection or both, for the strongest immunity.
But panel members said coronavirus infections are still at levels similar to those in years past. Another vaccine dose would restore some degree of vaccine effectiveness that may have waned since the fall.
While hospitalization rates have fallen across all age groups, certain groups continue to be hospitalized at higher rates, including older adults, infants and people with underlying medical conditions or certain disabilities. Data presented at the vaccine advisers meeting show that 67 percent of covid-19 hospitalizations from October 2023 to January 2024 were in those 65 and older. During the first seven months of 2023, adults 65 years and older accounted for 63 percent of hospitalizations and 88 percent of in-hospital deaths from covid-19, according to the CDC. There are still roughly 20,000 people a week hospitalized for covid-19 and about 2,000 deaths a week caused by the disease.
But there are drawbacks to allowing a second dose, according to data presented at the meeting. Given broad immunity in the population, there is an incremental benefit from a second dose of the updated vaccines targeting one of the omicron subvariants, XBB.1.5, that was widely circulating in the fall when the vaccines were approved by the FDA.
Allowing a second dose may decrease public confidence in the benefits of a single dose of an updated vaccine, the CDC said. Recommendations for an additional dose may also increase vaccine fatigue, potentially reducing uptake of the vaccine in the fall.
Even though the virus has continued to evolve, the CDC says the updated coronavirus vaccines continue to be effective against different circulating variants, such as JN.1, which started to dominate in January.
WASHINGTON, D.C. Today, America First Legal (AFL) filed a lawsuit against the U.S. Department of Health and Human Services (HHS) on behalf of John Solomon, CEO and Editor in Chief of Just The News. The lawsuit seeks to compel the Biden Administration to comply with a January 2, 2024, Freedom of Information Act (FOIA) investigation seeking all records of updates and corrections relating to COVID-19 Vaccinationssuch as formal diagnoses, recovery, or deaththat are collected after the initial reports to the Vaccine Adverse Event Reporting System (VAERS), but that are not published in the public VAERS database.
According to HHS, VAERS is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. The system analyzes reports of adverse events following the administration of a vaccine. Narayan Nair, the FDA division director who oversees VAERS, acknowledged that there are two parts to VAERS, the front-end system and the back end.
The public-facing database contains only initial reports, while the private, back-end system contains all updates and correctionssuch as a formal diagnosis, recovery, or death. For example, the public VAERS database reportedly did not include an autopsy examiners conclusion that the death of a 15-year-old boy was caused by stress cardiomyopathy following [his] second dose of the Pfizer-BioNTech covid-19 vaccine.
For years, the Biden Administration pressured Americans to take the COVID-19 vaccine. Citizens and scientists were lied to about vaccine efficacy and safety; they were fired from jobs, expelled from colleges, and even discharged from the military. Studies now prove that these mRNA COVID-19 vaccines lead to potentially deadly adverse effects like myocarditis and pericarditis, among other things. Yet, the Biden Administration continues to hide the truth.
The FIOAs essential purpose is to ensure an informed citizenry; this checks corruption and holds the government accountable. America First Legal will keep fighting to uncover the truth about the VAERS system and make public the vital information Mr. Solomon has requested.
Statement from John Solomon, CEO and Editor in Chief of Just the News:
The governments vaccine safety data has always been a record of public import. Unfortunately, in the era of COVID, there is evidence and suggestions that a second set of safety books were being kept. There is no reason for the agencies to keep this vital safety data from the American public. As journalists, we at Just the News are grateful for the extraordinary help of America First Legal in trying to formally identify this data, free it from its current bureaucratic obfuscation and release it for the publics benefit. said John Solomon.
Statement from Reed D. Rubinstein, America First Legal Senior Vice President:
The bureaucrats refusal to come clean about their botched COVID-19 response erodes trust in our government and thus damages public health. Without transparency, trust cannot be restored, and without accountability, mistakes cannot be corrected. The stonewalled information must be produced. said Reed Rubinstein.
Read the lawsuit here.
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L.L. Bean has just added a third shift at its factory in Brunswick, Maine, in an attempt to keep up with demand for its iconic boot.
Orders have quadrupled in the past few years as the boots have become more popular among a younger, more urban crowd.
The company says it saw the trend coming and tried to prepare, but orders outpaced projections. They expect to sell 450,000 pairs of boots in 2014.
People hoping to have the boots in time for Christmas are likely going to be disappointed. The bootsare back ordered through February and even March.
"I've been told it's a good problem to have but I"m disappointed that customers not getting what they want as quickly as they want," said Senior Manufacturing Manager Royce Haines.
Customers like, Mary Clifford, tried to order boots on line, but they were back ordered until January.
"I was very surprised this is what they are known for and at Christmas time you can't get them when you need them," said Clifford.
People who do have boots are trying to capitalize on the shortage and are selling them on Ebay at a much higher cost.
L.L. Bean says it has hired dozens of new boot makers, but it takes up to six months to train someone to make a boot.
The company has also spent a million dollars on new equipment to try and keep pace with demand.
Some customers are having luck at the retail stores. They have a separate inventory, and while sizes are limited, those stores have boots on the shelves.
A federal immunization committee on Wednesday voted in favor of recommending an additional COVID-19 vaccine dose for seniors aged 65 and up.
The Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC) met Wednesday to discuss numerous agenda items including vaccine data and recommendations for COVID-19; tetanus and diphtheria; flu; polio; and chikungunya.
ACIP members voted 11-1 in favor of recommending an additional dose of the 2023-24 COVID-19 vaccines for those 65 and older.
Current CDC guidance recommends an additional COVID-19 vaccine dose for people who are moderately or severely immunocompromised, with people in this group having the option of getting one more dose two months after their initial shot.
According to the most recent CDC estimates, about 23 percent of adults are believed to have gotten the updated, monovalent COVID-19 vaccines. Among Medicare fee-for-service beneficiaries 65 and older, this figures stays the same at 23 percent, though the most recent update from the CDC for this demographic is from November.
COVID-19 vaccines are highly effective at preventing severe illness, hospitalization and death, but their effectiveness has been observed to wane over time, just as the protection from natural infection does. Among older adults, the immune response triggered by vaccines has consistently been observed to be weaker.
In a statement to The Hill, vaccine makers Pfizer and Novavax welcomed the ACIP’s vote.
“Pfizer supports the CDCs adoption of ACIPs recommendation that eligible adults 65 years of age and older should receive an additional dose of a 2023-2024 formula COVID-19 vaccine,” Pfizer said.
“We believe this will help offer additional protection against COVID-19 for this age group. We look forward to having ongoing discussions with regulatory bodies about the potential need of updating COVID-19 vaccines for this upcoming 2024-2025 season.”
“Todays recommendation acknowledges the need to protect vulnerable older adults from COVID-19 this spring with an additional dose of XBB.1.5 vaccine,” Novavax said in a statement.
“Data from our clinical trials indicate Novavaxs COVID-19 vaccine maintains a favorable side effect profile while inducing neutralizing antibody responses to JN.1, which is currently causing the majority of symptomatic illness, and also JN.4 which is a further future-drift strain.
Moderna did not immediately respond when reached for comment.
Many multiple sclerosis (MS) patients remain hesitant to get vaccinated against COVID-19 for fear of relapse, especially those on disease-modifying treatments (DMTs), which could potentially affect response to the vaccine. With this in mind, the research team behind a new nationwide study sought answersand by extension a measure of comfort, perhapsfor patients who are concerned that this prophylactic measure may exacerbate their MS.1
For patients and physicians, the results are reassuring
This registry-based study of patients with MS, which was published in the European Journal of Neurology, assessed the risk of a clinically relevant relapse associated with the COVID-19 vaccine in a large cohort (n=8169) of Danish patients.1 Among the study population, which included patients with relapsing forms of MS, there was no notable change in the percentage of patients who relapsed in the 90days (1.3% versus 1.4% of patients; P=.627) and 180days (2.7% versus 2.6%; P=.918) both before and after receiving the COVID vaccine. (The observational period post-vaccination, notably, was also longer in this study than in prior ones.)
Similarly, in terms of annualized relapse rates (ARR), there was no statistically significant difference between the 3 periods studied:
Given these findings, the authors reported that their results overall can be relied upon to moderate vaccine hesitancy in patients with MS.
Physicians can glean considerable confidence from this extensive study, which includes more than 8000 patients, regarding the safety profile of vaccines in patients with multiple sclerosis, lead author Dominika Stastna, MD, PhD, a neurologist and neuroscientist at Charles University and General University Hospital in Prague, told MedPage Today.
Vaccine compliance rates are found to be high
The study draws some of its strength from its country of origin. Care of Danish patients with MS is centralized at 13 MS treatment centers across Denmark, where, for almost 30 years, it has been mandatory to document demographic and clinical information during regular visits. Danish patients with MS also showed a high rate of compliance with the national COVID vaccination program: Among the total study population, 87.3% agreed to receive the initial dose of the vaccine; of these patients, 99.7% completed the second dose, and more than 90% followed up with a third dose.
This also indirectly indicates trust in the health system and good tolerance, says Dr. Stastna.
Data were pulled from the Danish Multiple Sclerosis Registry, which Dr. Stastna praised. Our paper shows the importance of real-world data collection and the usefulness of patient registries, she explains. Indeed, in times of global pandemic, these have helped to confirm the safety of a key weapon against infectionvaccinationin specific populations that are generally not represented in clinical trials.
Considering the effects of DMTs
Patients with higher Expanded Disability Status Scale scores in this study faced an increased risk of relapse, as did younger patients (the latter finding consistent with those of prior studies). Considering that the authors only studied individuals with clinically isolated syndrome and relapsing-remitting MS, this heightened risk may stem from the fact that these patients have more-active disease in general.
In that vein, the strongest predictor of future relapse post-vaccination was the occurrence of a relapse in the year pre-vaccination. Given that DMTs are one of the most relevant factors affecting relapse, the authors performed subgroup analyses including only patients who did not initiate, switch, or discontinue DMTs during the observational period. Even in this population, however, there was no evidence of higher risk of relapse in connection with the COVID-19 vaccine.
Therefore, for patients with MS who worry that protecting themselves against COVID might mean exacerbating their disease activity, the results of this robust study are heartening.
This substantial body of evidence can be a valuable tool for physicians in reassuring patients who might be hesitant about vaccination, demonstrating a well-documented safety record in this specific population, concluded Dr. Stastna.
Published: February 28, 2024
Caitlan Rossi is a scientific and medical writer.
As Novavax emerges from its transition year in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024.
The company's loss per share of $1.44 exceeded analyst expectations of 45 cents per share, CNBC reports, while its fourth-quarter revenues of $291.3 million came short of the analysts'estimate of $322 million.Novavax's stock was trading down by about 23% just before 9 a.m. ET on Wednesday.
Amid plummeting COVID vaccine demand, Novavaxlast year initiated cost cuts, manufacturing modifications and laid off 30% of its workforce.
In all, the vaccine makerreducedits full-year 2023 operating expenses by $1.1 billion, or 41%, versus 2022, the company saidin an earnings release Wednesday. Through aggressive cost-cutting, Novavax exceeded the goal for its previously stated savings plan by $150 million across R&D and selling, general and administrative (SG&A) expenses.
On the revenue side, Novavax generated $984 million last year, down from the $2 billion it scored over the same period in 2022. Last year's total net loss came to $545 million, showcasing why the company has been so focused on cutting costs.
Looking ahead, Novavax aims to generate sales between $800 million and $1 billion in 2024. The company expects total first-quarter revenue to clock in at approximately $100 million.
Novavaxs restructuring scheme comprises one of three priorities the company set out to complete in 2023.
Elsewhere, the company also angled to deliver an updated COVID-19 vaccine for the 2023 fall vaccination season. It also seeks to leverage its technology platform and portfolio to create a future beyond its pandemic shot Nuvaxovid.
To the first point, the U.S. FDA expanded its emergency use authorization (EUA) to include Novavaxs updated protein-based shot in early October. Novavax says it subsequently gained commercial experience in the U.S. and has made efforts to recalibrate its U.S. field teams for the commercial COVID shot market.
In the company's pipeline, Novavaxis working on a COVID and flu combo shot.
Time's ticking for folks in Kent to get their COVID-19 shots for free. The Kent COVID-19 Vaccination Clinic is set to shut down on March 30 due to federal funding cuts, as has been announced by Public Health. Those in need of an updated vaccine, particularly individuals aged 65 and over, are encouraged to take advantage of the remaining days, considering the CDC's recent recommendation for an additional dose for this age group.
The clinic is operating at full tilt to offer vaccines at no cost to the uninsured and will bill insurance for those covered, though Kaiser plans won't cut the mustard here since it's out of network. According to the Public Health Insider, in a commendable two-birds-one-stone approach, a flu shot is also on the house when you roll up for your COVID jab. To quickly get in and out, people have to swing by between 9:30 am and 6:00 pm, Tuesday through Saturday, and take note that they do take lunch from 12:30 pm to 1:30 pm.
For those who can't or prefer to not get out of their vehicles, the Park and Vax program is there to accommodate, by dialing 206-477-6950 to book a spot in advance. Or else, just drop by the location at Kent Public Health Center, 25742 104th Ave SE, Kent, WA 98030. Although registration is available in a swath of languages online or by phone, they're urging appointments to ease the process.
Post-March, vaccine seekers won't have to fret. Vaccinations will be available at community health centers, most pharmacies, and other healthcare providers. To find one near you, head to vaccines.gov. In addition, Public Health hasn't turned a blind eye to youngsters under three, directing parents to pediatricians or Childhood Vaccine Program providers, all easy to locate on a given map. And for those stuck at home, a helping hand comes in the form of in-home vaccination without cost at least until June. To grab this offer, just hit up the In-Home COVID-19 Vaccine Program at 206-848-0243 or drop a line to [emailprotected].
As the days wind down for the clinic, there's a palpable sense of appreciation for the staff who've pulled all stops to immunize over 3,340 people since October. "We are enormously proud and grateful to our staff who have made it possible to vaccinate over 3,340 people since October," echoes the thank you note stretching across Public Health Insider. So, while the clinic prepares to close its doors, the gratitude for its contribution to the health of King County doesn't look to be taking any breaks.
