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FILE - A man walks by Pfizer headquarters, Friday, Feb. 5, 2021, in New York. Pfizer reports their earnings on Tuesday, Jan. 30, 2024. (AP Photo/Mark Lennihan, File)
(NewsNation) The state of Kansas has sued the pharmaceutical company Pfizer, accusing it of misleading the public about its COVID-19 vaccine by making false claims about its effectiveness.
Inthe lawsuitfiled Monday, Republican Attorney General Kris Kobach claims Pfizer misled Kansas residents by claiming the vaccine was safe and hid evidence of the shots link to myocarditis and pregnancy issues.
Pfizer made multiple misleading statements to deceive the public about its vaccine at a time when Americans needed the truth, he said in a statement.
Watch Kansas Attorney General Kris Kobach discuss the lawsuit on CUOMO on June 20 at 8p/7C. Find your channel here.Getfactbased,unbiased newscoverage 24/7 with theNewsNation app.
Kobach claims Pfizers alleged false statements violated the Kansas Consumer Protection Act. The state is seeking unspecified monetary damages.
Millions of Kansans heard Pfizers misrepresentations about its COVID-19 vaccine, according to the suit.
The complaint alleges Pfizer earned record company revenue of approximately $75 billion in just two years through its misrepresentations of the vaccine.
For example, Pfizer administered 3,355,518 Pfizer vaccine doses in Kansas as of February 7, 2024.This accounted for more than 60% of all vaccine doses in Kansas, the suit alleges, citing Kansas Department of Health Data.
Additionally, the complaint claims Pfizer gave residents a false impression when it claimed its vaccine was effective, but knew the shot waned over time and did not protect against COVID-19 variants.
The U.S. Food and Drug Administration in 2021added a warningabout myocarditis and pericarditis, both rare heart inflammation conditions, to Pfizer and Modernas COVID-19 vaccines.
COVID-19 vaccine studies conducted last year by the National Institutes of Health found no evidence the shots are linked to an increased risk of miscarriage.
In a statement to The Hill, Pfizer claims the case has no merit and plans to respond to the lawsuit in due course.
We are proud to have developed the COVID-19 vaccine in record time in the midst of a global pandemic and saved countless lives. The representations made by Pfizer about its COVID-19 vaccine have been accurate and science-based, the company said.
Kobachs lawsuit comes as a new study discovered possible links betweenCOVID-19 vaccinesand possible neurological, blood and heart-related conditions.
The new study is the largest of its kind since the pandemic began and could reignite the debate over the risks and benefits of the vaccine.
Additionally, the complaint follows a similar lawsuit filed last year by Texas Attorney General Ken Paxton, which claims Pfizer misled the public when it claimed the shot was 95% effective. The case is pending.
Over the past three years, more than 13.5 billion doses ofCOVID-19 vaccineshave been administered around the world. The World Health Organization recently announced vaccination has saved at least 1.5 million lives in Europe alone.
More than 366 million doses of Pfizers original BioNTech COVID-19 vaccine were administered in the U.S.
NewsNations correspondent Nancy Loo and The Hill contributed to this report.
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Recovery by 90 days was tied to pre-infection vaccination (hazard ratio [HR], 1.30) and infection during the Omicron variant wave (HR, 1.25). These associations were mediated by less severe infection by 33.4% and 17.6%, respectively. Risk factors for long COVID, or post-COVID condition (PCC) were female sex (HR, 0.85) and pre-existing cardiovascular disease (HR, 0.84). The results were similar for reinfections.
"Our study underscores the important role that vaccination against COVID has played, not just in reducing the severity of an infection but also in reducing the risk of long COVID," lead author Elizabeth Oelsner, MD, MPH, said in a Columbia Universitypress release.
"Our study clearly establishes that long COVID posed a substantial personal and societal burden," she added. "By identifying who was likely to have experienced a lengthy recovery, we have a better understanding of who should be involved in ongoing studies of how to lessen or prevent the long-term effects of SARS-CoV-2 infection."
Noting the propensity for American Indian or Alaska Native participants to have prolonged recoveries in models that didn't account for cohort effects, the authors said more research is needed on how much the pandemic may have worsened US social and health disparities, including among Indigenous populations.
"Inclusion of racially and ethnically diverse participants in PCC mechanistic research and clinical trials remains essential to identifying and equitably distributing interventions," they wrote.
Likewise, women had slower recoveries despite a lower rate of severe infection. "Sex differences in risk of PCC, and particularly PCC subphenotypes characterized by neurologic, musculoskeletal, and autoimmune conditions, could be explained by multiple mechanisms, including differences in the immune response and higher risk of autoreactivity and thrombosis in women (vs men),that merit further study," the researchers wrote.
"Further investigation on the longer-term prognosis and mechanisms of PCC, including comparisons of multiorgan structure and function before and after infection, is critical to inform treatment and prevention," they concluded.
Robert Mittendorf / The Bellingham Herald (TNS)
Nearly 20 former Bellingham employees are suing the city and former Mayor Seth Fleetwood over their dismissal for refusing to get vaccinated against COVID-19.
In the lawsuit, filed Thursday with the U.S. Western District Court in Seattle, the employees are seeking unspecified punitive and compensatory damages in a jury trial.
All 18 employees, including former police officers, firefighters, mechanics and Public Works Department employees, are being represented by the Schexnaydre Law Firm of Mandeville, La., and locally by Charice Holtsclaw.
They were fired for not complying with Fleetwood's executive order, issued Sept. 21, 2021, requiring all city employees to have the COVID-19 vaccine by Dec. 6, 2021. By that time, nearly 80% of all city workers had been vaccinated, according to Bellingham spokeswoman Janice Keller.
Neither the plaintiffs' lawyers nor Bellingham officials were immediately available for comment late Tuesday.
Keller, the the city's communications director and deputy city administrator, told The Bellingham Herald in a May 1 email that Fleetwood was acting in good faith to ease the suffering and death caused by the coronavirus pandemic.
"The city's vaccine mandate was enacted as an emergency order to protect the health and safety of employees and the public, during a time when COVID-19 was causing illness, loss of life, and disruption to our community and our workforce. We took this action with great care, and with the support of many employees who were grateful for this additional protection in our workplace. When employees requested accommodations, our team evaluated each request individually and thoughtfully, understanding that their recommendations affected employees' lives and livelihoods. These were difficult decisions made during extraordinary times, with employee and public health and safety at the forefront of our minds," Keller said.
Plaintiffs in the lawsuit filed Thursday include Tawsha Thompson, a former Bellingham police officer with 25 years experience. She ran for the state House as a Republican in 2022, losing to Rep. Alicia Rule, D-Blaine.
Some of the employees who were dismissed say that their requests for medical and religious exemptions under the vaccine mandate were rejected, according to the lawsuit.
As of Dec. 7, 2021, a total of 27 city employees lost their jobs for failing to comply with state and city vaccine requirements, Keller told The Herald in April, when former police officer Joshua D. Wilson sued the city over his COVID-19 firing. Wilson was not named as a plaintiff in Thursday's lawsuit.
Six employees resigned, 17 were dismissed for violating the city's terms of employment, and four were dismissed for violating Gov. Jay Inslee's vaccination order for state employees, teachers and health care workers, such as firefighters, Keller said.
In the lawsuit the plaintiffs say that the COVID-19 vaccines were medical treatments and that they "have a fundamental right and constitutionally protected liberty interest to refuse medical treatments."
The plaintiffs claimed that the vaccines resulted in a "massively anomalous (1,000% higher) number of adverse events and deaths," and that the was no justification for the mandate because the vaccines don't prevent the infection or transmission of COVID.
Fleetwood lifted the vaccine mandate on Feb. 13, 2023.
In addition to the lawsuits, the Bellingham Police Guild, which is the union that represents Bellingham police officers, filed an unfair labor practice complaint against the city with the Public Employment Relations Commission on March 14, 2022, alleging that the city should have first bargained the union over the vaccine mandate, Keller told The Herald.
A PERC hearing examiner ruled April 26 that the city did not commit an unfair labor practice and dismissed the Guild's complaint in the attached decision. The Guild has 20 days to appeal the decision to the full commission.
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Novavax (NVAX Quick QuoteNVAX - Free Report) submitted an application to the FDA, seeking to amend its Emergency Use Authorization (EUA) and update its protein-based COVID-19 vaccine for the upcoming fall season.
While this updated vaccine has been formulated to target the JN.1 variant, management claims that the vaccine has also been shown to be effective against the current circulating strains, including KP.2 and KP.3.
Subject to necessary permissions from the FDA and CDC, Novavax intends to market this updated COVID-19 vaccine in pre-filled syringes by mid-August. If authorized/approved, it will be the only protein-based non-mRNA COVID-19 vaccine in the United States.
Novavaxs filing is based on guidance from the FDA issued last week, which advised COVID-19 vaccine manufacturers Moderna (MRNA Quick QuoteMRNA - Free Report) , Novavax and Pfizer (PFE Quick QuotePFE - Free Report) to update their respective COVID-19 vaccines to target the KP.2 strain if it is feasible. This guidance is an update on the FDAs prior advice issued at the beginning of this month that recommended updating the COVID-19 vaccines to target the JN.1 strain.
The FDAs prior advice was in line with the recommendation issued by a World Health Organization (WHO) advisory committee on Apr 26. However, the FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country since the end of April. The latest CDC data (as of Jun 8) shows that the KP.2 and KP.3 strains were the most prevalent, accounting for nearly half of COVID-19 cases in the country.
The KP.2 strain is a JN.1-derived subvariant that contains two new additional mutations. Per the FDA, this subvariant provides an advantage to the virus either in terms of fitness or escape from immunity.
Management is also working with other regulatory authorities across the globe to secure authorization/approval for updating its protein-based COVID-19 vaccine.
Year to date, the stock has skyrocketed 200.0% against the industrys 6.3% fall.
Image Source: Zacks Investment Research
Currently, Novavaxs COVID-19 vaccine is only authorized by the FDA for use in individuals aged 12 years and older. The FDA is reviewing the companys regulatory filing seeking full approval for the COVID-19 vaccine. A final decision is expected before April 2025.
Earlier this month, Moderna submitted an application to the FDA seeking approval of its mRNA-based COVID-19 vaccine, for the 2024-2025 fall season. Pfizer is yet to provide an update on the FDA filing for its COVID-19 vaccine.
Compared with Pfizer and Moderna, Novavax was not able to reap the benefits of the pandemic due to a delayed launch of its COVID-19 vaccine. During last years vaccination season, sales of Novavax suffered due to delayed approval of its vaccine formulation and product launch. Some investors and analysts believe that Novavaxs early participation in the upcoming vaccination season could capitalize on the opportunity.
Starting next year, Sanofi (SNY Quick QuoteSNY - Free Report) will gain rights to co-market Novavaxs protein-based COVID-19 vaccine globally. The French drugmaker will also have the sole license to develop and market the Novavax vaccine in combination with its influenza vaccine. In return, Novavax will be eligible to receive up to $1.2 billion, including $500 million in upfront payment and the rest in milestone payments. NVAX will also be eligible to receive tiered double-digit percentage royalty payments on product sales under this deal. In addition, Sanofi also agreed to make an equity investment of nearly $70 million in Novavax in exchange for a 4.9% stake.
The deal with Sanofi breathes new life into Novavax, which had been facing uncertainties in its business for a long time. With the backing of a pharma giant, Novavax expects to increase the market share and presence of its COVID-19 vaccine to a larger audience. This deal even allowed management to do away with its previous concerns about its ability to continue as a going concern.
Using the funds from the Sanofi deal, Novavax also started making plans to expand its pipeline. Alongside its first-quarter earnings, management claimed to have been developing a new approach for vaccinating against H5N1 bird flu. It is also advancing core technology for different uses like mucosal vaccination and high-density nanoparticles.
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of todays Zacks #1 Rank (Strong Buy) stocks here.
Earlier this week, Moderna announced positive results for its phase 3 clinical trial of a combined vaccine against COVID and influenza.
So what exactly did the trial find? And what sort of impact would a two-in-one COVID and flu vaccine have on public health? Let's take a look.
Combination vaccines have been successfully used for several decades in Australia and around the world.
For example, the DTP vaccine, a shot that combines protection against diphtheria, tetanus and pertussis (whooping cough), was first administered in 1948.
The DTP vaccine has since been further combined to offer protection against other diseases. A hexavalent vaccine, which protects against six diseases diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b (an infection that can cause brain swelling) is today part of routine childhood immunisation programs in Australia and elsewhere.
Another important combination vaccine is the MMR vaccine, given to children to protect against measles, mumps and rubella.
Moderna's phase 3 trial included roughly 8,000 participants across two age groups. Half were adults aged 50 to 64. The other half were aged 65 and up.
In both age groups, participants were randomised to either receive the combined vaccine (called mRNA-1083) or a control. The control groups received a COVID vaccine and a suitable flu vaccine delivered separately.
The control group in the 50-to-64 age category were given the Fluarix flu vaccine, as well as Moderna's mRNA COVID vaccine, Spikevax. The over-65 control group received Spikevax alongside Fluzone HD, an enhanced flu vaccine designed specifically for older adults.
The study evaluated safety, including any reactions after vaccination, and the protective immune response the vaccines produced.
Moderna reported the combined vaccine elicited a higher immune response in both age groups against COVID and three influenza strains, compared to the co-administered shots.
From a safety perspective, the combined vaccine was well tolerated. Adverse reactions were similar across the experimental and control groups. The most common side effects included muscle aches, fatigue and pain at the injection site.
While the trial results are promising, they are yet to be published in a peer-reviewed journal, which means independent experts haven't yet verified them. And further research may be required to test how the combined vaccine works in younger age groups.
We cannot overstate the importance of vaccines. Each year they prevent up to 5 million deaths around the world from a range of life-threatening infections.
At the same time, we can always do more to boost vaccination uptake, especially in areas with fewer resources and among vulnerable populations.
Combination vaccines have a variety of advantages. For example, the need for fewer injections reduces costs for health systems, decreases storage requirements and reduces the burden on parents. All of these things can be especially valuable in low-income countries.
Notably, research shows combination vaccines make it more likely people will take up routine vaccinations.
Every year, particularly during the winter months, millions of people contract respiratory infections. Indeed, parts of Australia are reported to be facing rapid increases in flu cases at the moment.
According to the World Health Organization, globally, roughly 3 million to 5 million people experience severe influenza annually, and around 650,000 people will die from the disease.
COVID has resulted in more than 7 million deaths around the world to date.
As the COVID pandemic has continued, we've seen pandemic fatigue setting in, as some people appear to have become complacent about their COVID shots. A 2023 study in Australia found 30 percent of the surveyed population were hesitant about and 9 percent were resistant to taking COVID boosters.
Uptake of the flu vaccine, which many people are in the habit of getting annually, may be higher. That said, in Australia the current flu vaccine rates for 2024 are still fairly low: 53 percent for adults over 65 years, 26 percent for those aged 50 to 65, and lower for younger age groups.
A two-in-one COVID and flu vaccine could be an important public health tool to increase vaccine coverage against these two important diseases. Beyond protecting individuals' health, this would have flow-on benefits for the economy and our health system.
Moderna said it will present its trial data at an upcoming medical conference and submit it for publication. The company has also said it will soon apply for regulatory approval, with the possibility of supplying the combined vaccine in 2025.
At the same time, Pfizer and BioNTech also have late-stage trials in progress for a combined COVID and flu vaccine. We will await further developments with interest.
Jaya Dantas, Deputy Chair, Academic Board; Dean International, Faculty of Health Sciences, and Professor of International Health, Curtin University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
AS chairman of the Malaysian Influenza Working Group (MIWG), I noted with interest the recent announcement by Health Minister Datuk Seri Dr Dzulkefly Ahmad regarding the plan to provide free annual influenza vaccinations for older persons under the National Immunisation Programme, beginning in 2025.
This announcement comes almost a year after MIWG, along with partner organisations such as the Malaysian Society of Geriatric Medicine, the Academy of Family Physicians of Malaysia and 30 other organisations, initiated a petition requesting government-funded influenza vaccinations for our senior citizens, who are particularly vulnerable to influenza-related complications.
This is important as older persons experience a decline of immunity as they age and, unlike healthy adults, often do not show regular symptoms when infected by influenza. Instead, they can experience other symptoms such as a decline in overall health, increased risk of injuries due to falls and others.
For those who are unaware, influenza is more serious than a cold it is not just the flu but can be deadly.
While everyone, including young and healthy people, is at risk of contracting influenza, it often takes a heavier toll on older adults. It takes only one infection to increase the risk of heart attack by 10 times and stroke, caused by a blood clot, by eight times.
Older persons are also more likely to experience complications such as pneumonia, inflammation of the heart and sepsis. These illnesses often require hospitalisation and may lead to death.
Up to 70% of influenza-related hospitalisations and 85% of influenza-related deaths occur among those 65 years and above. Furthermore, the risk of influenza-related deaths increases with the presence of more than one non-communicable disease (NCD), which is the case with many of our older adults.
This risk of influenza-related death increases by 20 times for those with heart and pulmonary disease, five times for those with heart diseases, and three times for those with diabetes.
In addition, influenza infection can worsen or complicate NCD symptoms such as exacerbation of diabetic symptoms, causing fluctuations in glucose levels.
These manifold risks are well acknowledged, resulting in many countries, including Thailand, Laos, the Philippines and Singapore, already offering free influenza vaccines to older persons.
Tackling ongoing risks
While we look forward to this on our shores, I urge Malaysians to take action sooner rather than later to protect themselves and their loved ones against influenza as the virus circulates year-round in tropical climates like ours.
The threat, therefore, is always present. Southeast Asia is ranked third highest in influenza-related deaths but only 2-3% of Malaysians are vaccinated against influenza. The influenza vaccine has been around for close to 80 years, since 1945, with extensive research supporting its safety records.
Protecting ourselves and our loved ones with a simple annual shot can help reduce severe illnesses and complications, the cost of treatment and management as well as the corresponding burden on our healthcare practitioners and resources. Most importantly, influenza vaccinations can help save lives.
Heightened awareness needed
Although the influenza vaccine is well-established in many parts of the world, a recent Ipsos survey in Malaysia involving around 600 respondents aged 65 years and older highlighted that more education is needed to dispel common fears and misconceptions.
For example, 52% of respondents still feel that influenza is only a concern in cold climates, and though 70% were aware that it can be prevented through vaccination, 64% were concerned about serious side effects, with 28% believing the misconception that the influenza vaccine is not suitable for people their age. In addition, 69% believe they were already protected through the Covid-19 vaccine.
With such thoughts prevalent, it is hardly surprising that vaccination ranked a lowly eighth place in self-care practices.
Moving towards better vaccine coverage
Malaysia is moving towards becoming one of the aged countries by 2030, with 15.3% of our population being 60 years old and above, and hence, the burden of influenza on our older persons is a public health concern that we can no longer afford to ignore.
To set the foundation for a successful vaccination programme, more intensive educational campaigns are needed, strategically designed to address these misconceptions and alleviate their concerns.
We must acknowledge that awareness is important at all levels, involving government and non-government stakeholders, healthcare professionals and communities, to change perceptions and encourage action.
As frontliners who witness first-hand the effects of heightened risk and complications from influenza among older adults, I call upon the entire community of healthcare professionals to continue acting as advocates and playing an active role in educating and encouraging yearly influenza vaccination, especially among this vulnerable population.
Prof Dr Zamberi Sekawi
Chairman
Malaysian Influenza Working Group
MITCHELL, S.D. (MITCHELLNOW)Twenty-four companies are working to develop an avian flu vaccine for cattle, as the virus spreads among U.S. dairy herds.
Bird flu has infected 90 dairy herds across 12 states since late March, according to the U.S. Department of Agriculture (USDA). Three human cases, all dairy farm workers, have also been reported two in Michigan and one in Texas.
In addition to the two dozen companies working at varying stages of vaccine development, the USDA is conducting its own preliminary research into a vaccine at its laboratory in Ames, Iowa.
The agencys other efforts on bird flu include research into the possibility of respiratory spread of the virus between cows. The main risks to the spreading of bird flu on dairy farms appears to be the movement of people and equipment.
The Department of Health has received the first batch of Mpox treatment just as the number of cases in South Africa increased to 13.
On Thursday evening, the department announced that it has received a batch of Mpox-specific treatment, Tecovirimat (also known as TPOXX or ST-246), for the treatment of patients who experience severe health complications as a result of Mpox disease.
The health department addedthat efforts are being made to secure more treatment, including vaccines, should the need arise.
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However, all mild cases will continue to be managed with supportive treatment used to manage complications like fever, pneumonia, and skin infections, said department spokesperson Foster Mohale.
As the department works to secure more treatment, it said that six more laboratory-confirmed cases of Mpox (previously known as monkey pox) have been detected.
This brings the total number of cases in South Africa from seven to 13. Seven of the cases were confirmed in KwaZulu-Natal, five in Gauteng, and one in the Western Cape.
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ALSO READ: Community Chat: Are you taking extra precautions to avoid getting Mpox?
Two people have died from Mpox since the outbreak.
The department urges all people, regardless of gender, age, or sexual orientation, with suspected Mpox symptoms or who have had physical contact with known cases, to present themselves at a healthcare facility for clinical evaluation because anyone can contract this preventable and treatable disease, Mohale said.
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The health department added that good hand hygiene is one of the best ways to keep people healthy and stop the spread of illness. As a result, people are urged to always wash their hands with soap and water or sanitise their hands with an alcohol-based product, especially before eating or touching their faces and after using the toilet.
Here are some of the common symptoms of Mpox:
The painful rash looks like blisters or sores and can affect the face, palms of the hands, soles of the feet, and groin.
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ALSO READ: Mpox cases rise to seven, all patients have chronic illnesses
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