Even though Los Angeles Unified dropped its COVID vaccine mandate for school staff almost a year ago, a lawsuit accusing the district of violating workers rights can still move forward, the U.S. 9th Circuit Court of Appeals ruled on Friday.
The 2-1 ruling by a pair of federal judges appointed by former President Donald Trump revives a case that a lower court had dismissed. It also counters recent rulings by courts including the 9th Circuit that tossed lawsuits challenging expired COVID-19 rules on the grounds that the policies were no longer in effect.
The judges in the majority wrote that this case was different because they found L.A. Unified demonstrated a pattern of withdrawing and reinstating its vaccination policies over the course of the lawsuit.
Accordingly, LAUSD has not carried its heavy burden to show that there is no reasonable possibility that it will again revert to imposing a similar policy, the opinion states.
They also indicated they were open to arguments over the effectiveness of the vaccine, which the U.S. Centers for Disease Control and Prevention describes as a safe way tobuild immunity against COVID-19.
At this stage, we must accept Plaintiffs allegations that the vaccine does not prevent the spread of COVID-19 as true, Judge Ryan Nelson wrote. The opinion characterizes that aspect of the ruling as preliminary and something that would be argued at a lower court.
In a concurring opinion, Judge Daniel Collins invoked Supreme Court precedent that compulsory treatment for the health benefit of the person treated as opposed to compulsory treatment for the health benefit of others implicates the fundamental right to refuse medical treatment.
The plaintiffs alleged that the vaccines do not prevent someone from becoming infected with COVID-19 and characterized it as a treatment rather than a traditional vaccine.
They argued that by requiring employees to get the COVID shot, the school district was interfering with workers rights to refuse medical treatment.
No one with any credibility would tell you that the vaccine prevented COVID or stopped the spread, said John Howard, a San Diego attorney who argued the case on behalf of a handful of Los Angeles Unified employees and an Idaho-based group called the Health Freedom Defense Fund thats filed several other COVID vaccine lawsuits.
But when the hysteria was going on, thats exactly what pharmaceutical companies and others said, Howard said. It was false.
The CDC says: COVID-19 vaccines are effective at protecting people from getting seriously ill, being hospitalized, and dying.
A 2022 study published in the medical journal Lancet found COVID vaccines reduced symptoms in infected people, but did not necessarily slow transmission, although previous research indicated vaccines were effective in slowing the spread of early COVID variants. The Johns Hopkins University Coronavirus Resource Center states that COVID vaccines likely reduce the risk of virus transmission but probably not completely in everyone.
The school district can appeal the ruling to a larger panel of judges on the 9th Circuit, which covers nine states and has been considered the most liberal of the nations appellate circuits. If the new ruling stands, the lawsuit would return to the U.S. District Court for Central California in Los Angeles for further arguments.
We are reviewing the 9th Circuit ruling and assessing the districts options, a spokesperson for the district said late Friday.
Lindsay Wiley, a law professor at UCLA and director of the schools Health Law and Policy Program, said the judges finding against a government intervention is extremely rare.
Judges applying this test are supposed to be highly deferential to the governments rationale and scientific findings, Wiley said. Its also notable that the judges in the majority went out of their way to reach the merits of the plaintiffs claim.
Perhaps most importantly, she said, the judges in the majority said the century-old law that upholds vaccine requirements does not apply unless the vaccine is effective in protecting others, not just the vaccinated person. This analysis is surprising and, I think, misguided.
The ruling could have a chilling effect on government attempts to require vaccines in the future, Wiley said. Governments should be careful to build the evidence base for their vaccination requirements, which are increasingly challenged by well-financed anti-vaccination groups in court.
Courts recently have dismissed similar complaints because Californias COVID public health emergency expired a year ago, ending state measures such as mask mandates and lockdowns.
In 2022, a 9th Circuit panel of 11 judges ruled that a lawsuit against Gov. Gavin Newsom over COVID-related school closures couldnt move forward since schools had reopened and there was no longer a live controversy. Another ruling, last month in a California state appeals court, drew a similar conclusion in a lawsuit against Newsom over COVID safety guidelines.
In a dissenting opinion to the L.A. case, 9th Circuit Judge Michael Hawkins extensively cited the 2022 ruling on California school closures. He was appointed to the court by former President Bill Clinton.
This case is over, he wrote. We cannot grant the sole relief sought by the Plaintiffs, an injunction against enforcement of the school districts now rescinded COVID-19 vaccination policy.
The lawsuit against L.A. Unified stems from the districts initial policy from March 2021 requiring all employees to show proof of having the COVID vaccine or risk losing their jobs. A group of employees sued, and the district tweaked the policy to allow employees to show a negative COVID test if they didnt want to get the vaccine.
A judge dismissed that suit, but, in August 2021, the district re-instated the vaccine mandate as schools re-opened for in-person instruction. The employees filed another suit, this time with the Health Freedom Defense Fund.
L.A. Unified, the nations second largest school district with more than 600,000 students, closed for in-person instruction for more than a year during the pandemic, like most school districts in California. Los Angeles was hit hard by the disease. As of last week, nearly 36,000 people in L.A. County have died of COVID, one of the highest per-capita mortality rates in California and far above the national average, according to public health data.
In August 2021, the United Teachers of Los Angeles union voted to support the districts vaccine mandate. Still, some district employees lost their jobs due to the districts mandate, Howard said.
People lost their homes, their careers. Some people had to leave the state. They had literally gone broke because of what L.A. Unified did to them, he said. It was appalling.
What questions do you have about Southern California?
School holidays are coming up which means some of us may be heading on an interstate trip, a European holiday, or a visit to popular destination Bali.
And you may be wondering whether a COVID-19 booster is necessary as an extra layer of defence.
Although it's not mandatory, experts say travellers should stay up-to-date on COVID-19 boosters given their higher likelihood of exposure to the virus.
Here's how long it takes for a booster to reach maximum protection and who's eligible for one.
Associate professor of public health at the University of Technology Sydney Jane Frawley says you should get a booster two weeks before your holiday.
"The vaccine takes up to 14 days to be effective," Dr Frawley tells the ABC.
"Having a booster will drastically reduce the likelihood of getting COVID-19, and if you do get the virus, your symptoms will be mild in most cases."
Because travel is a high-risk behaviour.
"For some people, they might not perceive themselves to be at high enough risk to receive a booster," University of Queensland infectious disease physician Paul Griffin tells the ABC.
"But we do want people to appreciate the risk of travel and the impact of getting sick when you're trying to enjoy your time elsewhere."
Dr Frawley says you have to remember travelling often involves crowded environments and poor ventilation think airports, planes, cruise ships, trains, buses, and hotels.
This is where exposure is at its greatest.
That's hard to determine.
"It depends on how frequently you've been vaccinated, how long ago your last vaccine was, your own immune system, among some other factors," Dr Griffin says.
"The other thing that affects the performance of the vaccine is when the virus changes it can be hard to know exactly how long protection lasts.
"But what we do know is that while protection declines over time, that doesn't mean it disappears to zero quickly."
This is why the Australian Technical Advisory Group on Immunisation (ATAGI) says most adults (who are not severely immunocompromised) can consider getting a booster every 12 months.
That depends on your age and whether you're at higher risk of severe COVID-19.
Here are the booster dose recommendations according to the Department of Health:
You can also check your eligibility via the COVID-19 booster tool.
But as always, the best advice is to chat with your GP about your vaccine options.
In Australia, we only have one type of vaccine mRNA and there are two different manufacturers:
Dr Griffin says those in need of a booster should be getting the monovalent XBB 1.5 vaccine, which uses mRNA.
"Over the course of the pandemic, we've had multiple vaccines that targeted different variant/s: the original Wuhan strain, bivalent, and monovalent.
"But right now all we have available since the end of last year is the monovalent XBB 1.5 vaccine which targets a subvariant of Omicron."
The ATAGI also says XBB.1.5-containing vaccines are preferred over other COVID-19 vaccines.
An XBB.1.5-containing vaccine is not currently available for children aged six months to five years. However, a formulation has been approved for use and supply of it is anticipated in 2024.
But does one manufacturer have a slight edge over the other? Should people receive the same or the alternate option for their booster?
"In the end, which of those brands you choose doesn't matter," Dr Griffin says.
"Early on, there was some suggestion that if you went from one platform to another, there might be some benefit there.
"But these days we really only have one platform, and there are no significant measurable differences that should make someone pick and choose one over the other."
And as the virus continues to develop, experts say you should keep an eye out for updated vaccines.
There are a few different ways you can do this:
Through your Medicare account, you'll be able to see your COVID-19 vaccine certificates and also see a link to your immunisation history statement.
There are two COVID-19 oral antiviral treatments available:
The antivirals are used to help prevent COVID-19 infections from becoming severe.
They're typically prescribed to individuals who are at higher risk of severe disease if they become infected with COVID-19.
If you are 18 years and older and test positive for COVID-19, you may be eligible for an oral COVID-19 antiviral medicine if you:
You may also be eligible if you test positive for COVID-19 and you are:
It's not mandatory to wear a mask.
But Dr Frawley and Dr Griffin both agree masks are something to consider when travelling, especially if you're at high risk.
"They are still relevant, especially in crowded indoor areas where it's not always possible to avoid viruses like COVID-19 that spread easily through the air," Dr Frawley says.
Keep in mind some countries, airlines and vessel operators may have COVID-19 travel requirements in place.
Here's some other simple advice to take with you:
Here's how case numbers are tracking nationally.
According to the National Notifiable Disease Surveillance System (NNDSS), 45,007 cases were reported in Australia in May.
It was an increase of 24,300 on the previous month.
If we take a look at each state's individual COVID-19 surveillance system, all states (bar the Northern Territory which doesn't record COVID-19 data) have recorded a jump in cases over the past fortnight.
And what about overseas COVID-19 case numbers?
Here's a snapshot of some of the popular international tourist destinations (data from the World Health Organization):
But why are case numbers higher in Australia than the countries listed?
Dr Frawley and Dr Griffin say it is likely due to a few different factors:
Posted19h ago19 hours agoTue 11 Jun 2024 at 6:41pm, updated13h ago13 hours agoWed 12 Jun 2024 at 12:34am
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As of last month, more than twice as many adults in the U.S. had been vaccinated against the seasonal flu than had received the updated COVID-19 vaccine, even though COVID hospitalization rates were higher than those for influenza.
But with Moderna announcing the success of its combined mRNA COVID-19 and flu shot in a late stage trial, company executives said they hope to see an increase in the number of people adhering to vaccination recommendations.
A combination vaccine that could provide dual protection in a single shot has the potential to encourage more widespread vaccination uptake while also reducing the burden of acute respiratory disease on health systems, Francesca Ceddia, Modernas chief medical affairs officer, said in a June 10 blog post.
She said that uptake of the 2023/2024 flu vaccine was 48.4% and 22.4% for the updated COVID-19 vaccine for people over the age of 18. She pointed to CDC statistics that showed the only time in the past seven months hospitalizations for flu were higher than for COVID-19 was a couple of weeks in late December and early January.
The convenience of the two-for-one shot could drive up the percentage of people vaccinated against the coronavirus, says Mansoor Amiji, Northeastern University distinguished professor of pharmaceutical sciences and chemical engineering.
But he says it also has the potential of decreasing flu vaccinations among people who harbor politically tinged fear of the COVID-19 vaccine and the mRNA technology used to create it and the Moderna combination vaccine.
The jury is out to some degree because on one hand there is an advantage because compliance-wise you only have to get one shot instead of two, Amiji says.
That development can appeal to people who are afraid of needles as well as those pressed for time, he says.
People could get one shot and be protected from both of these infections, Amiji says.
But some people may say, I dont want to get a COVID vaccine, so Im not going to get the flu shot either, he says.
The politically charged nature of beliefs about the COVID-19 vaccine, which is based on mRNA technology, means you could deter people from getting either one of the two when you combine them together.
And while Moderna reported that side effects of the combination vaccine were relatively mild, including injection site pain, fatigue, myalgia and headache, those who remember stories of people getting chills and fever after their COVID shot might shy away, Amiji says.
That would be a mistake, he says.
From a safety perspective, the (mRNA) technology is better than anything we have seen in the past.
Some companies are working on developing an mRNA vaccine solely against influenza, but pharmaceutical companies see a great deal of potential with two-in-one vaccines. Moderna competitors Pfizer and BioNTech are currently working on their own versions of the combination shot.
On June 10, Moderna executives announced that a Phase 3 trial of the combination shots, known as mRNA 1083, showed that its efficacy was just as good as or better than single shots in a study of two groups of 4,000 people, one for ages 50 to 64 and the other 65 and up.
Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine, company CEO Stephane Bancel said in a statement.
The company said the next steps are to present the Phase 3 clinical data at an upcoming medical conference and submit it for publication.
Until the data has been peer reviewed, Modernas statements have to be taken with a grain of salt, Amiji says.
Even with FDA approval, the two-in-one vaccine probably would not be available until fall 2025 at the earliest, Amiji says.
But the good news is that its in Phase 3 and has been tested in 8,000 people, he says.
They are taking advantage of this unique attribute of the mRNA platform technology, which is that you can combine mRNA sequences into one package and deliver multiple copies of mRNA that will develop antigens and protect against multiple diseases, Amiji says.
In the near future, he sees a three-in-one vaccine being developed that will potentially immunize people against flu, COVID-19 and RSV.
A combination flu and COVID-19 vaccine developed by Moderna generated a higher immune response in a late-stage trial than standalone vaccines, the company said Monday.
A two-in-one shot could improve vaccination rates and reduce the burden on the health care system.
Modernas phase 3 clinical trial studied two groups of about 4,000 people in each.
In one group, consisting of participants ages 65 and older, researchers compared the combo vaccine, called mRNA-1083, to the influenza vaccine Fluzone HD and Spikevax, Modernas COVID shot.
In the second group, of people 50 to 64, scientists compared mRNA-1083 to the flu vaccine Fluarix and Spikevax.
The study found that not only were immune responses from the combo vaccine not inferior to the other shots, they were statistically significantly higher against three flu strains H1N1, H3N2, and B/Victoria as well as COVID-19.
"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Modern CEO Stphane Bancel said in a statement.
Pfizer and Novavax are also developing combo flu and COVID shots, but Moderna is the first to report positive phase 3 results.
Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health, Bancel said.
Moderna said it will present its data at an upcoming medical conference and submit the study results for publication, when they will be peer reviewed. It will then engage with regulators.
The vaccine will not be available for this years flu season.
Moderna said the combination shot also appears to be safe. The majority of side effects reported were minor, the most common being injection-site pain, fatigue, muscle aches and headache. The side effects were consistent with the other vaccines monitored in the study, the company said.
Francesca Ceddia, chief medical affairs officer for Moderna, noted in a blog post that, as of last month, flu vaccine uptake in the United States was more than double COVID-19 immunization rates (48.4% vs. 22.4%). Meanwhile, COVID-related hospitalizations are higher than with the flu and more than double among older adults.
The convenience that a combination vaccine could offer patients may help fill this gap while simplifying and routinizing vaccination against both diseases, which could help improve compliance with public health recommendations, Ceddia wrote.
Greetings from London, with STAT reporter Andrew Joseph here filling in for Ed. Were dealing with some decidedly June Gloom today, though we suppose that makes it easier to sit in front of a computer instead of longing to escape outside. Whatever you need to power through your day, and your week, we hope you find it. Now to the news tidbits.
Advisers to the U.S. Food and Drug Administration voted unanimously to recommend the approval of a drug for early Alzheimers disease made by Eli Lilly ruling that the treatments ability to slow the cognitive decline in patients outweighed its safety risks, STAT summarizes for us. The outcome of the daylong advisory panel was the best-case scenario for Lilly, making it likely that the FDA will approve the drug, called donanemab, for a broad population of people diagnosed with mild cognitive impairment due to Alzheimers. A decision is expected later this year, and if approved, donanemab would be the second such medicine to reach the market, following a similar antibody called Leqembi that is sold by Eisai and Biogen.
The European Commission on Tuesday announced a contract to secure more than 40 million doses of a preventive avian flu vaccine for 15 countries across the EU and the European Economic Area, the Financial Times reports. The deal procures up to 665,000 vaccine doses which can be adapted to any prevailing bird flu strain from manufacturer CSL Seqirus and includes a provision for a further 40 million vaccines over the next four years. The deal comes as governments monitor an increase in bird flu outbreaks, including among U.S. dairy cows.
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COLORADO SPRINGS, Colo. (KRDO) - A new study shows promising results for a possible combined COVID-19-Flu shot.
The study isn't yet peer-reviewed, but Moderna, the company behind it, reports recipients saw an improved immune response. Other companies have also been testing a combined COVID-Flu vaccine, but Moderna is the first to announce positive trial results.
In the video above, KRDO 13 medical expert, Dr. Neha Sharma provides more information on potential combination vaccines.
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The journey towards a combined flu and Covid-19 vaccine just got one step closer following Modernas announcement of positive data from a Phase III trial of its mRNA vaccine candidate.
Compared to two individual vaccine administrations, a single shot of the combined vaccine elicited a stronger immune response against both diseases.
Named mRNA-1083, Modernas jab comprises a seasonal influenza vaccine candidate, mRNA-1010; and a next-generation Covid-19 vaccine prospect called mRNA-1283, both of which have fared well in their own respective Phase III trials.
Now, in a Phase III trial (NCT06097273) for mRNA-1083, Moderna said the candidate brought about statistically significantly higher immune responses compared to existing vaccines on the market. The trial met its primary endpoints, Moderna said in a 10 June press release.
The study evaluated the safety, reactogenicity and immunogenicity of the vaccine in around 8,000 participants, equally split into two independent age cohorts one with adults aged 65 years and older and the other with adults aged between 50 to 64 years. In the older age group, Modernas candidate was pitted against the companys Covid-19 vaccine Spikevax and Sanofis flu vaccine Fluzone HD. In the younger age group, Fluzone HD was substituted for GSKs Fluarix, whilst Spikevax remained.
Moderna stated that a single dose of mRNA-1083 was non-inferior versus the co-administered comparators. According to Moderna, those who received the combined vaccine showed an improved immune response compared with those who had the flu and Covid vaccines separately. The drugmaker added that the immune response was seen across three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.
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As for safety, mRNA-1083 was in line with licensed vaccines used in the trial. The most common adverse reactions included injection site pain, fatigue, and headache.
The most recent flu season in the UK had a great deal more cases than previous years. Englands National Health Service (NHS) revealed that flu cases in late January were up 75% from the same period last year. At some of the highest levels in winter, data showed an average of 2,226 patients were in hospital each day with flu, three-quarters up from the same week in January 2023.
Modernas CEO Stphane Bancel said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.
While other companies are developing their own combined Covid-flu vaccine, Moderna is ahead of the competition being the only one testing in Phase III trials. Pfizer and BioNTech, for example, announced positive data from a Phase I/II trial in October 2023.
Bancel stated that Moderna is the only company with a positive Phase III flu and Covid combination vaccine.
Although Moderna has not published the full dataset from the Phase III trial, it plans to present the results in more detail at an upcoming medical conference, in addition to a submission for publication. The company said it will engage with regulators on next steps.
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FILE - A patient is given a flu vaccine Friday, Oct. 28, 2022, in Lynwood, Calif. Seasonal flu continues to pick up steam in the U.S. But among respiratory viruses, COVID-19 remains the main cause of hospitalizations and deaths, health officials said Friday, Dec. 1, 2023. (AP Photo/Mark J. Terrill, File)
Dr. Jeffrey Kopin, Chief Medical Officer forNorthwestern Medicine Lake Forest Hospital, joinsJohn Williams to talk about a new study that showed a healthy diet and lifestyle can slow down Alzheimers, the percentage of men who are using weight-loss drugs, the status of Modernas combined COVID-flu vaccine, and when we should be thinking of getting the next COVID shot.
