Category: Covid-19 Vaccine

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.

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MS and COVID-19: No Evidence of Increased Relapse Activity After Vaccination - Multiple Sclerosis Peer-to-Peer - Medpage Today

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.

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Kent COVID-19 Vaccination Clinic to Close March 30, Urges Shots Before Federal Funding Ends - Hoodline

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.

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After steep cost cuts, Novavax's fourth-quarter performance falls short of expectations - FiercePharma

The main covid-19 vaccines seem to have a net positive effect on our heart health

Fly View Productions/Getty Images

Many covid-19 vaccines appear to reduce the risk of heart attacks, strokes and other blood clot conditions for at least six months, according to a study of the health of about 46 million people amid the coronavirus pandemic. This is despite them causing rare side effects that affect the heart and blood clotting system.

The net benefit to heart conditions most probably happens because the vaccines protect against severe covid-19, which itself can cause heart attacks,

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Covid-19 vaccines seem to cut the risk of heart attacks and strokes - New Scientist

The watchdog also saw a signal for the heart problems myocarditis and pericarditis in February 2021, but did not include the conditions in safety updates until June 2021, MPs said.

In effect, the MHRA licences medical products as safe knowing it lacks the processes to properly monitor adverse events, the APPG wrote.

In the case of Covid-19 vaccines, given the comparatively novel technology and record manufacturing speed, could the MHRA have even properly scrutinised the licensing data or known the short term safety?

Historically trust and confidence in vaccines and vaccine safety has been high in the UK, but it seems that the experience of the Covid-19 vaccines has undermined this and by association trust in the regulator and the pharmaceutical industry.

Now more than ever a wide-reaching and in-depth review is needed.

The group also warned that the MHRA Yellow Card reporting system which encourages patients and doctors to flag-up medicine side effects grossly underestimates complexities, and in some instances picks up just one in 180 cases of harm.

An analysis by Stockport NHS Foundation Trust found that in the North West of England, 1,058 people had been admitted to hospital with stomach bleeds caused by anticoagulant medication over five years, yet just six Yellow Card reports were made during the period.

Side effects from drugs account for one in every 16 hospital admissions in Britain, and cost the NHS more than 2 billion each year.

But trials are often too small to pick up adverse reactions, particularly when they are driven by rare genetic mutations, meaning it is vital to continue monitoring drugs in the community.

The MHRA recently said it would investigate why blood thinners were causing dangerous side effects in between two and five per cent of patients.

The APPG said it was also concerned that MHRA regulation of medicine was funded by the pharmaceutical industry and said the body had shifted from focusing on scrutiny to trying to help drugs get approved.

Dame June Raine, the chief executive of the MHRA, who announced she would be stepping down last week, has previously said the agency was transitioning from watchdog to the enabler, a phrase which MPs said warranted its own investigation.

Graham Stringer MP, co-chair of the APPG on pandemic response and recovery, said:

The MHRA oversees a failing system that is slow to act, causing harm to patients and beset with conflicts of interest.

We cannot allow it to continue. Thats why we have written to the health select committee calling for an urgent investigation into the MHRA.

The APPG said that concerns raised directly with the MHRA had been met with an habitually dismissive and evasive response.

Dame June said: We have made significant steps to put patients at the heart of all our work.

These include incorporating patient views and lived experience into our safety reviews; involving patients in the early stages of planning medicines development and building a new responsive reporting system for patients to tell us about any adverse incidents. We have also led on legislative changes to strengthen surveillance for medical devices and medicines, meaning patient safety is embedded firmly into law.

Our progress so far in making changes based on meaningful patient involvement gives us a solid base to build upon as we continue on this important journey.

We are committed to enabling innovation that brings transformative medical products safely to patients.

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Medicines regulator failed to flag Covid vaccine side effects and must be investigated, say MPs - The Telegraph

The culture of public health and medicine rests on open discussions in which different points of view are considered for the betterment of patient care and health. This process depends on psychological safety so individuals feel free and safe to speak and openly disagree. These factors collectively create a just culture, which improves systems and organizations and is being widely implemented in healthcare nationwide.

However, in the face of politicized anti-science and anti-expert sentiment and attacks, we need to ask if just culture is being restricted in public health. Following a series of legislative policy changes in Florida affecting academic institutions, health care, and public health, we see a regression in the open dialog of medical and public health experts about infectious disease control practices related to COVID-19 and now measles.

On January 3, 2024, in marked opposition to the CDC, FDA, and medical and public health experts, State Surgeon General Dr. Joseph Ladapo recommended that everyone avoid COVID-19 mRNA vaccines over concerns that they contain DNA. This notion starkly contrasts ample scientific data showing that these vaccines do not alter a persons genes, even if they contain minuscule amounts of DNA related to vaccine production. This announcement came on the heels of an earlier announcement on September 13, 2023, recommending that individuals younger than 65 not receive the updated COVID-19 vaccine, even though 25% of COVID-19 deaths have occurred in those younger than 65. Previously, he recommended that young adult men avoid the vaccine because of concerns about myocarditis. However, this risk of myocarditis is very rare, and the risk of myocarditis following COVID-19 is far greater than after vaccination.

Following these announcements, there was broad national criticism of these Florida-only policies. In contrast, the response by the Florida medical and public health community to these controversial recommendations, either in support or opposition, was modest. This tepid response contrasts the first years of the pandemic, when Florida medical organizations, medical schools, and public health experts often commented publicly about the state's COVID-19 mitigation and vaccination policies.

Currently, there is ameasles outbreakin a South Florida elementary school. Dr. Ladapo, not the county health officer, has stated that children at high risk for getting measles can attend school while potentially being contagious,leaving the decision to the parents. Although we are early in this outbreak, we are observing a similar situation where there is considerablenationaloutcry against his recommendation, while the response from the Floridamedical communityislimitedto afew practitioners.

Measles is a very contagious virus, 5 to 10 times more contagious than COVID-19, as it travels long distances and lingers in the air for hours. If an unvaccinated individual is exposed, there is a very high chance that the person will get the virus, which can result in encephalitis, pneumonia, and hearing loss.

Reflecting anti-vaccine and anti-science activity that has become part of the political agenda, rates of measles vaccination among young children have fallen below critical levels in many parts of the US. Not surprisingly, there has been a recent rise in measles cases in the US. The medical community overwhelmingly supports childhood vaccinations but is drowned out by policies that weaken vaccination requirements and misinformation that erodes confidence in vaccines.

Measles outbreaks can be controlled through early post-exposure vaccination measures and quarantining unvaccinated and exposed individuals for 21 days, spanning the incubation period. This recommendation is based on the fact that individuals with measles can be contagious for several days before they show symptoms. Even though more than 90% of the population may be vaccinated against measles in some parts of the U.S., those who are unvaccinated or medically compromised are at high risk if exposed, irrespective of community vaccination rates.

Having a child out of school for three weeks is a long time. Yet, coming out of the pandemic, we have widely available tools to facilitate remote learning, which the school has implemented. When parents do not feel comfortable that an outbreak can be controlled, it is natural for them to keep their children out of school. It was reported that almost 20% of the student body was absent several days after this outbreak, even in this school, which had previously reported high vaccination rates. Was it considered that emphasizing standard measles control policies are being followed, rather than allowing children with potential measles to go to school, could boost attendance?

We need to ask what has happened over the past year to discourage the airing of views contrary to state policies. Is there self-censorship or external censorship? Was there opposition to these recent recommendations by Dr. Ladapo from inside the Florida Department of Health? The answer may lie in reviewing recent legislative and state actions that may give medical experts and those at academic institutions pause in speaking out.

First, a law was passed allowing faculty tenure to be revoked at state universities, meaning faculty with secure positions can now be fired. Florida University faculty members have stated that this policy limits the freedom of experts to speak openly over fears of retribution.

Second, the Medical Freedom bills signed into law in Florida on May 11, 2023, now allow physicians to make public, unsubstantiated, and false claims without consequence. Medicine has regulated itself to keep the public safe. Without these guardrails, inaccurate information can increase without the proper checks of hospital credentialing boards and medical societies. Does this new law make physicians powerless to challenge false and potentially harmful medical information?

Third, the state regulateshospital fundingandMedicaidpatient care reimbursement rates. University, medical school, and hospital leadership administrators may thus be concerned when faculty members speak publicly and run afoul of political leaders.

Fourth, we see the state dictating what can and cannot be taught at K-12 schools and public universities, something unheard for college and universities in the past. Recently, the Florida Board of Governors banned sociology from the core curriculum of the university system. Considering that the most popular majors at the University of Florida, for example, are psychology and biological sciences, for which sociology is foundational, one needs to ask if the state policy is in the students best interest.

Fifth, healthcare providers are now being drawn into culture wars. Medical organizations are also being investigated for health-related issues at the state and national levels.

We now see what happens when policies threaten the perceived ability of medical experts, university experts, medical societies, and public health employees to speak openly. Public discussion about crucial public health state policies fades.

Florida once took its place among the states with the highest COVID-19 vaccination rates for those older than 65 in the US and was among those with the lowest COVID-19 death rates per capita, ranking 29th in the spring of 2021. In contrast, Florida currently has one of the lowest booster COVID-19 vaccination rates in the U.S. and ranks 8th in COVID-19 deaths per capita. Now, Florida has a serious measles outbreak and is not following standard measures of infection control by allowing potentially contagious children to return to school.

Consideringthe high vaccination rateof 97% at the outbreak site, this outbreak will be contained. But what will happen when measles lands in a school or community with lower vaccination rates and standard public health measures need to be followed?

Do we really want to limit discussions about infectious disease control policies? We have learned the clear advantages of a culture that considers different viewpoints in medicine and public health.

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Florida's War on Public Health | TIME - TIME

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Louisiana public health officer who championed COVID vaccines resigns - Shreveport Times

Senate Bill 295, filed by Smithfield Senator Lindsey Tichenor, is being billed as a medical freedom measure.

In a statement, Tichenor argues Kentucky citizens were "forced to make compromising health decisions in order to retain their employment, gain access to medical treatment, or to enroll in schools during the response to the pandemic." The bill would block compulsory COVID or mRNA-based vaccinations in those instances.

The lawmaker goes on to call the vaccines "ineffective" and "dangerous."

SB 295 represents a pivotal step in addressing the complexities surrounding vaccination mandates and underscores the importance of preserving individual liberties in the face of public health challenges, Tichenor wrote.

The largest study to date of COVID vaccine safety looked at nearly 100 million vaccinated people across eight countries. The World Health Organization's Global Vaccine Data Network examined 13 medical conditions, including myocarditis, convulsion, and Guillain-Barr syndrome and found elevated risks associated with the vaccines.

Even with the findings, however, researchers concluded the risks from COVID-19 itself remain much higher than the risks of adverse events.

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Kentucky bill bars COVID vaccination mandates in certain situations, citing risk of adverse events - WUKY

(Precision Vaccinations News)

The US Food and Drug Administration (FDA) announced in a post on X that on May 16, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public discussion to recommend the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.

On February 26, 2024, the FDA confirmed that changes to the vaccine composition may be necessary based on the currently circulating strains of the virus that causes COVID-19.

After receiving any recommendations from the VRBPAC regarding the 2024-2025 formula update, the FDA plans to take appropriate regulatory actions on updated COVID-19 vaccines so that manufacturers can make them available by September 2024.

The FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for seasonal influenza vaccines.

Background material and the link to the online teleconference and/or video conference meeting will be available on theAdvisory Committee calendar no later than twobusiness days before the VRBPAC meeting.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time.

Contact Information:Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, FDA, 202-657-8533 or[emailprotected].

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US FDA to Review COVID-19 Vaccine Formulas on May 16, 2024 - Precision Vaccinations

As the world navigates through the lingering mist of the COVID-19 pandemic, a groundbreaking study has emerged, casting a new light on the voyage we've embarked upon with mass vaccination. This exploration, encompassing the health data of approximately 46 million souls, reveals a compelling narrative about the vaccines designed to shield us from the virus's wrath. It's a tale of protection against severe illness and an unexpected champion of heart health, despite unveiling a slight uptick in certain medical conditions.

The study in question unfurls a tapestry of data illustrating that vaccines not only arm us against COVID-19 but also fortify our defenses against heart attacks, strokes, and other menacing blood clot-related conditions for a span extending at least six months post-administration. This revelation is particularly poignant, considering the virus itself can set the stage for serious cardiovascular complications. The essence of this discovery lies not merely in the numbers but in the lives potentially saved by this dual protection.

Yet, no journey is without its perils. The study acknowledges a slight increase in the risk of certain conditions, including Guillain-Barr syndrome, Bell's palsy, convulsions, myocarditis, and pericarditis, attributed to the vaccines from Moderna, Pfizer-BioNTech, and AstraZeneca. Myocarditis cases, for instance, showed a notable increase following the second dose of Moderna's vaccine. However, the narrative takes a turn when considering these adverse effects remain significantly rarer compared to the risks posed by the virus itself. The dialogue surrounding vaccine safety is nuanced, emphasizing that while the journey is not devoid of risk, the path of vaccination leads to a greater safeguard against the tempestuous seas of COVID-19.

In the wake of these findings, the medical community and public health officials remain steadfast in their support for vaccination. The Global COVID Vaccine Safety project, backed by esteemed institutions, steers this ship with a clear message: the benefits of COVID-19 vaccination far outweigh the potential risks. This stance is not born out of complacency but from a rigorous examination of the data at hand. As we venture further into this uncharted territory, the potential for refining vaccine formulations and administration strategies illuminates the horizon, promising smoother seas ahead for global health.

In essence, the study underscores the critical importance of vaccination in our collective battle against COVID-19. It serves as a reminder of the vaccines' role not just as a shield against the virus but as a beacon of hope for preventing the heart-related storms that the virus can provoke. As we continue to sail through these turbulent times, the key to navigating safely lies in heeding the science, understanding the risks, and embracing the protective embrace of vaccination.

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Navigating the Waters of COVID-19 Vaccination: A Heartfelt Perspective on Risks and Rewards - Medriva