Recent advancements in Alzheimer's disease treatments targeting the removal of toxic proteins (white matter) from the brain have sparked a renewed interest in developing vaccines to combat thismemory-robbing disease.
Clinical trials for at least seven Alzheimer's disease vaccines, aiming to leverage the immune system to eliminate disease-related proteins such asbeta-amyloid or tau, are underway or completed.
This resurgence in vaccine development followeda setback over two decades ago when an initial vaccine attempt was abandoned due to 6% of volunteers developing life-threatening brain inflammation known as meningoencephalitis.
Researchers subsequently shifted focus towards a safer approach, utilizing precisely targeted manufactured antibodies that bypass the body's immune system.
Recent successes such asEisai Co LtdESAIY andBiogen Inc.'sBIIBLeqembiandEli Lilly And Co.'sLLYdonanemabhave reinforced the idea that removing amyloid is crucial for combating early-stage Alzheimer's, marking a turning point after years of failed attempts that cast doubt on the amyloid theory.
The current wave of Alzheimer's disease vaccine development involves efforts by companies such asVaxxinity IncVAXX,AC Immune SAACIU, andProthena Corporation PlcPRTA, aiming to rectify past vaccine failures by designing shots that stimulate an immune response without triggering excessive inflammation.
Citing Dr. Reisa Sperling from Mass General Brigham in Boston, Reuters noted the potential of vaccines in Alzheimer's disease prevention, leading trials targeting individuals with Alzheimer's disease proteins in their brain and considering expanding studies to asymptomatic individuals with these proteins in their blood.
While these vaccines are still in the early stages, their potential as a more accessible alternative to existing treatments like Leqembi, which require frequent infusions, offers hope for the global Alzheimer's disease population, estimated at 39 million.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
image:
Work in Tartu University`s virology lab. Author Kaspar Koolmeister
Credit: Photographer Kaspar Koolmeister
The chikungunya virus is widespread in tropical regions, where it is spread to humans by mosquitoes of the genus Aedes. Chikungunya is characterised by high fever, headache, muscle and joint pain, rash and sometimes diarrhoea. This viral disease has become a global health threat. At least five million cases of chikungunya virus infection have been reported in the last 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas where mosquitoes carrying the virus are endemic. However, chikungunya virus has also spread to new geographical areas, causing a rise in global prevalence of the disease. So far, there is no specific medicine for the disease.
According to Professor Andres Merits, head of the working group that prepared the vaccine candidate at the University of Tartu, the vaccine was assembled on a desk in room 435 of the Institute of Technology. Merits made a synthetic copy of the chikungunya virus genome, which was attenuated by introducing mutations into it by then UT virologists Aleksei and Valeria Lulla. The virus was first made in January 2011, then it was analysed and subjected to pre-clinical trials in collaboration with researchers from Sweden, the UK, France and other countries. "This is a major achievement probably the first in Estonian research where a vaccine designed and made by us becomes available for human use," said Merits.
Obtaining FDA approval is the most important step in the drug development process, which opens up the possibility of using the vaccine in the US. In other regions, it will need to be approved by other regulatory authorities, such as the European Medicines Agency in Europe. Usually, the FDA is the first to give approval, with others following suit some time later.
The application to the FDA was submitted in February 2023, so the approval was issued quite quickly. The approval will be followed by a rigorous follow-up to further assess the effectiveness of the vaccine and the adverse effects of its use. According to Merits, the biggest market for the vaccine is likely to be Brazil and other South American countries, as well as Southeast Asia, where the virus is a major problem. In the US, the vaccine is primarily intended for people wishing to travel to high-risk areas.
Press contact: Margit Meiesaar Faculty of Science and Technology Institute of Technology Project Manager Nooruse 1-426C margit.meiesaar@ut.ee +372 737 4840
Randomized controlled/clinical trial
Not applicable
Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.
Wednesday November 22, 2023
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A new wave of COVID-19 cases is hitting the country, as experts warn people to remain vigilant and stay up to date with their vaccines as holidays approach.
Associate Professor James Trauer, head of the epidemiological modelling unit at Monash University, says there has been a surge of COVID-19 infections passing through the community.
Vaccination remains our most important defence against COVID, even though the virus shouldnt ruin Christmas this year, he said.
COVID-19 is now an endemic virus, which means it cannot be eliminated and is continuously transmitted.
Surges in coronavirus cases were generally caused by new variants, which meant it was more difficult than ever to predict when these waves would peak, Prof Trauer said.
Scientists view of community transmission is further muddied by a lack of data.
With a marked decline in testing, the daily number of cases does not paint a clear picture of the spread of the virus, though researchers can still use hospital admission numbers and wastewater surveillance to monitor COVID-19 waves.
The severity of coronavirus cases has decreased and fewer Australians are being admitted to the intensive care unit because of high levels of population immunity garnered through vaccinations and natural protection from past infections.
But Prof Trauer says Australians should still exercise caution by wearing a mask and testing before interacting with vulnerable populations, such as those older than 65 years and especially Australians more than 75.
They should also seek booster vaccines as they provide longer-term immunity than reinfection.
New COVID-19 vaccines, which target common variants of the virus, will be made available to the public from December.
Pfizers monovalent XBB.1.5 vaccine will be available for use in eligible Australians five years and older, while the Moderna monovalent XBB.1.5 vaccine can be used for those aged 12 and older.
Those who had their 2023 vaccinations do not need to get jabbed again, but authorities say only one quarter of vulnerable Australians have had their booster shots.
Our most important protection against the effects of COVID is immunity, which can be enhanced through vaccination, Prof Trauer said.
Getting the COVID and flu vaccines simultaneously could be safe and even beneficial, according to study findings presented at the Vaccines Summit Boston this week.
In a study, researchers found that people who got both shots at the same time showed higher levels of antibodies against COVID than those who got the two vaccines on different occasions.
Among 42 health care workers in Massachusetts, 12 of them received a bivalent COVID booster and a seasonal influenza shot on the same day last fall.
COVID AND FLU VACCINE RATES ARE DECLINING FOR US HEALTH CARE WORKERS, CDC REPORTS: DISTURBING TREND
Another group of 30 got the two shots on two separate days within that same month.
Three to four weeks later, those who had gotten both vaccinations simultaneously were found to have higher levels of COVID-fighting antibodies than those who received the shots separately.
Researchers found that people who got both the COVID and flu shots at the same time showed higher levels of antibodies against COVID than those who got the two vaccines on different occasions. (iStock)
That higher level of protection was detected for as long as six months, the researchers found.
"We showed that the COVID antibody responses were higher and more durable if the COVID and flu vaccines were given on the same day," said Susanna Barouch, the studys lead author and an intern at the Ragon Institute's Systems Serology Lab in Cambridge, Massachusetts, at the conference.
COVID VACCINE POLL FINDS MORE THAN HALF OF ADULTS ARE LIKELY TO SAY 'NO THANKS' TO THE VAX
The study findings have been published to the preprint server BioRxiv, but they're currently in the peer review process and have not yet been published in a scientific journal.
The new study 'sfindings have been published to the preprint server BioRxiv, but they're currently in the peer review process and have not yet been published in a scientific journal. (iStock)
"We thought that these findings were very important for immediate public health decision-making," said Ryan McNamara, the lab's director and senior author on the study, in explaining the early release of the data.
"I would have to see more data before I would say that combining them is a better strategy."
As far as why the human body produces a higher immunity response after a double vaccination, McNamara hypothesized that the simultaneous doses could stimulate the immune system more than a single shot.
The Centers for Disease Control and Prevention (CDC) states on its website that "getting a flu vaccine and COVID-19 vaccine at the same visit is recommended if you are eligible and the timing for each vaccine is right."
A general view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia. The CDC states on its website that "getting a flu vaccine and COVID-19 vaccine at the same visit is recommended if you are eligible and the timing for each vaccine is right." (REUTERS/Tami Chappell/File Photo)
Some studies have shown, however, that getting both vaccines together could increase the intensity of side effects.
In a 2022 study published in JAMA Network Open, participants who got both shots at the same time experienced up to 11% more side effects, including headache, muscle pain and fatigue.
COLD, FLU, COVID-19 AND RSV: HOW TO IDENTIFY THE DIFFERING SYMPTOMS AND STAY SAFE
Other research has suggested that receiving dual shots could slightly increase the risk of stroke among the elderly.
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, commented to Fox News Digital that the size of the study was very small, consisting of only 42 health workers.
Fox News medical contributor Dr. Marc Siegel said the new study's results do not warrant "changing clinical practice." (Fox News)
"I wouldn't change clinical practice as a result," said Siegel, who was not involved in the research.
"It makes some sense that priming the immune system with exposure to two antigens (flu and SARS COV-2) at the same time could cause a more robust overall immune response," the doctor went on.
"But the downside is that if you experience side effects, you won't know which vaccine caused them, since the most common side effects are somewhat similar such as muscle aches, headaches and sore arm."
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Dr. Shana Johnson, a physical medicine and rehabilitation physician in Scottsdale, Arizona, was not involved in the study but reviewed the findings.
"These are interesting preliminary findings, but they need to be replicated in a larger, higher-quality study to see if the results hold true," she told Fox News Digital.
"For the elderly, I would be more hesitant to take the two vaccines together given the October 2023 report of a safety signal finding an elevated stroke risk in those 85 years and older," one doctor noted. (iStock)
"Also, we dont want to make health care recommendations based solely on lab data."
The downside of taking the two vaccines together, according to Johnson, is the increased risk of side effects.
"For the elderly, I would be more hesitant to take the two vaccines together given the October 2023 report of a safety signal finding an elevated stroke risk in those 85 years and older," she added.
CLICK HERE TO GET THE FOX NEWS APP
Siegel said that in his own practice, he tends to space out vaccinations unless the patient wants the shots to be given at the same time.
Added the doctor, "I would have to see more data before I would say that combining them is a better strategy."
For more Health articles, visit www.foxnews.com/health.
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By Kelly Laco, Executive Editor Of Politics For Dailymail.Com 19:27 21 Nov 2023, updated 16:00 22 Nov 2023
The U.S. Army is catching heat for attempting to win back favor with soldiers fired for refusing the COVID-19 vaccine as the military struggles with severe recruitment challenges.
Last week, the Army sent out a mass letter to soldiers who were fired after decliningthe COVID-19 vaccine for religious or medical reasons, offering a 'correction of military records.'
'As a result of the rescission of all current COVID-19 vaccination requirements, former Soldiers who were involuntarily separated for refusal to receive the COVID-19 vaccination may request a correction of their military records from either or both the Army Discharge Review Board (ADRB) or the Army Board for Correction of Military Records (ABCMR),' the letter reviewed by DailyMail.com states.
The letter sparked an outcry of fury at the Defense Department by lawmakers and current and former service members.
John Frankman, a former U.S. Army Captain who voluntarily left the Army on July 1 due to negative career repercussions for refusing the vaccine, told DailyMail.com that the letter will 'not have any effect on bringing service members back' because it doesn't offer a policy change.
'There has always existed the ability to apply to upgrade ones discharge status and apply to return to the military,' he explained.
Frankman added that until there is accountability for the 'failed' vaccine policy and for other disasters such as the botched Afghanistan withdrawal, 'no one will trust the current leaders at the top.'
'[Secretary of Defense] Lloyd Austin needs to be fired, and service members need to automatically have their discharges upgraded, receive back pay, be given the ability to return if they choose, and there needs to be a very serious and thorough introspection on how such terrible policy decisions were ever able to occur,' he told DailyMail.com.
Frankman also said the 'crazy recruiting crisis' is crushing military readiness.
The Army faced a huge shortage of recruits in fiscal year 2022 at 55,000 - which was 10,000 short of its target for the year.
Secretary of the ArmyChristine Wormuth downplayed the shortage, saying the aim for 65,000 new recruits was a 'stretch goal.'
'The recruiting enterprise in the Army very much understands how important that role is they don't need us to signal to them to put the pedal to the metal,' she said at the Pentagon in October.
'We've got a lot of work to do to implement all of these changes, so I would imagine we'll settle on something lower than 65,000 for 2024.'
'Our dedicated troops should never have been discharged for putting their personal health and safety ahead of an experimental COVID shot,' Rep. Bob Good, R-Va., wrote on X in reaction.
'They should be unconditionally reinstated and restored with full pay and benefits,' he continued.
Former Army officer Brad Miller said the letter does not go far enough to remedy the harm he experienced.
'Why doesn't the Army ask me if I want my resignation converted into a retirement dated with the release date of this new policy, and along with it offer compensation for the command I was wrongly relieved of, compensation for the remainder of whatever my career might have been, and then offer me my adjusted pension from this month forward? Then offer the same to all others similarly wronged,' he stated.
He went on to say the Pentagon can't 'fix itself' and claimed Biden administration officials' loyalty is 'assuredly un-American.'
Retired Air Force veteran Patrick Fox said the Army has entered 'panic mode' by sending the letter.
'Given how politically radioactive this decision by the DoD was, how much resentment it generated internally, and how much bad press it generated when it as made - mollifying policy like this indicates Army leadership are feeling the pressure on recruitment numbers,' he wrote on X.
'To a degree they're willing to eat a little crow on this to alleviate it. If it gets bad enough, and senior leadership are backed into a corner, promises to restore rank & pay are not unthinkable in the future.'
A current Army officer told DailyMail.com that the Army has 'continued to miss the mark on taking care of its service members and veterans.'
'For the veterans separated due to the mandate, it seems unnecessary that they should need to submit for a Discharge Characterization Upgrade after being unlawfully discharged,' he continued.
'I believe the Army needs to make amends with the American People and take the first step in making things right for these former service members: the branch should automatically upgrade the discharge characterizations to Honorable as that was the true reflection of these individuals service to the Nation. This would also allow for veterans to make forward progression in the new chapter of their lives by being able to utilize their earned GI Bill,' the officer explained.
DailyMail.com reached out to the Army for a response.
Over 8,000 service members - many who sought religious exemptions - were fired for refusing to comply with the Pentagon's COVID-19 vaccine mandate enacted in August 2021.
Following outrage over the mandate, the Fiscal Year (FY) 2023 National Defense Authorization Act (NDAA) passed in December 2022 terminated the mandate, but it did not reinstate service members who were fired for not receiving the shot nor provide any other compensation.
Amendments by Rep. Jim Banks, R-Ind., that passed out of the House Armed Services Committee over the summer were included to 'offer redress' to service members who were 'unjustly discharged' by requiring the Pentagon to set up a reinstatement process and ensuring no negative retaliation.
But some current and former troops are saying that the amendments that would go into the FY 2024 NDAA are not strong enough to undo the 'serious harassment' they endured over the last two years.
Frankman, who was in the Special Forces as part of the Green Berets, said that the 'missed career opportunities' he endured over the last two years could never be undone by any action of Congress.
An active-duty Army officer told DailyMail.com that the fired troops have had 'their lives turned upside down and were betrayed by those charged with protecting them.'
And a formal apology from their service branches would be key to be able to have trust restored, he added.
Our scientific efforts played an important role during a global health crisis. Learn more about SARS-CoV-2, the coronavirus that causes COVID-19 disease, and Pfizers work throughout the pandemic.
Coronaviruses comprise a large family of viruses, some of which cause respiratory illnesses in humans, ranging from common colds to more severe conditions.1 The coronavirus involved in the outbreak that began in 2019 was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).2 The disease it causes was named coronavirus disease 2019 or COVID-19.2
From the beginning of the pandemic, we understood that fighting COVID-19 would require the power of science and unprecedented collaboration among scientists, companies, governments, and other stakeholders around the world.
Since 2020, we have been working on a multi-pronged approach to address COVID-19 and today we are focused on prevention through vaccinations, detection, and treatment for appropriate adult patients through medication. While there have been advancements in the fight against COVID, there is still more work to be done. At Pfizer, we remain unwavering in our commitment to combatting COVID-19.
COVID-19 Vaccine: Prevention through getting eligible people vaccinated is critical in helping the fight against COVID-19. Thats why, in 2020, we set out to make the impossible possible. In collaboration with BioNTech, we delivered a breakthrough COVID-19 vaccine to the world using messenger RNA (mRNA) technology, which is a molecule that contains the instructions or recipe that directs the cells to make a protein using its natural machinery.
We worked with tremendous urgency, without compromising quality, coordinating closely with trial participants and investigators, regulatory bodies, other companies, and governments to bring this vaccine forward. Our success was made possible in part due to Pfizers longstanding history in vaccine research, development, and delivery, which dates back more than a century.
COVID-19 Treatment: In early 2020, recognizing the urgency of the COVID-19 pandemic around the world, Pfizer initiated a drug discovery program in an effort to develop a treatment for SARS-CoV-2 virus, complementing our vaccination efforts. We assembled a committed, multidisciplinary team to support the development of treatment intended for those with COVID-19 that might be high risk for progression to severe COVID-19.
Pfizer researchers identified an oral protease inhibitor to progress into clinical studies. On December 22, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the treatment of eligible patients diagnosed with COVID-19 at high risk of progressing to severe illness. On May 25, 2023, the FDA approved for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Since 2020, we have continued to scale up our at-risk manufacturing efforts to expand vaccine and treatment access to different countries, based on local authorization or approval. Billions of Pfizer-BioNTech COVID-19 vaccines and tens of millions of oral COVID-19 treatment courses have been distributed to countries around the world.
We remain committed to working toward broad, equitable, and affordable access to Pfizer and BioNTechs COVID-19 vaccine and Pfizers COVID-19 oral antiviral treatment for eligible patients around the world and are working with governments and other appropriate partners on a tailored approach.
In May 2023, three years after COVID-19 was designated as a pandemic, the World Health Organization (WHO) and the U.S. Department of Health and Human Services (HHS) declared the end of the Public Health Emergency (PHE) for COVID-19.3,4 While clinical and real-world data still show that existing COVID-19 vaccine options can help protect against the virus, we are continuing to follow the science by exploring new vaccine approaches that may be needed as the virus evolves. We also continue to run a COVID-19 clinical development program, consisting of completed and ongoing clinical trials, to evaluate our oral therapy for potential use in additional patient populations.
Our goal is to stay ahead of the virus by continuing to progress cutting-edge science that we believe may help serve patients in need. We are proactively advancing a multi-pronged strategy to evaluate additional treatment candidates as well as the potential for combination therapy.
In the meantime, we believe that one of the best safeguards against the spread of COVID-19 is getting all eligible people up to date with their vaccination schedule, and for those who do get COVID-19, educating and encouraging them to speak with their healthcare professional about available treatment options.
We remain committed to working toward broad, equitable, and affordable access to Pfizers COVID-19 vaccine and oral COVID-19 treatment for eligible patients around the world. To that end, we continue to work with governments and other appropriate partners on a tailored approach. While developing groundbreaking treatments and vaccines for COVID-19 are crucial, we do not feel we are fulfilling our broader commitment to patients if we dont work to make our vaccines and treatments accessible to every eligible person who needs them.
Albert Bourla announces an important agreement with the U.S. government that will make it easier for patients to access Pfizers oral antiviral treatment for COVID-19. This will help ensure that the United States will have a robust stockpile for future use and helps provide more clarity on the commercial market for COVID related products. This is the next logical step in Pfizers unrelenting effort to help ensure every eligible patient continues to have access to this potentially life-saving medicine.
This video includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Please refer to Pfizer press release for more information. We also encourage you to read our reports filed with the U.S. Securities and Exchange Commission (SEC), including the sections captioned Risk Factors and Forward Looking Information and Factors that May Affect Future Results, for a description of such substantial risks and uncertainties. These reports are available at pfizer.com and the SECs website.
Frequently Asked Questions About Pfizer and COVID-19
Like the flu, the virus that causes COVID-19 mutates often, which means it can escape the defenses your immune system built up against earlier strains. As of September 2023, about 85% of COVID-19 cases in the U.S. are caused by Omicron XBB strains5 and people who were vaccinated in past seasons may no longer be adequately protected because their body may not recognize the new strains. This season's vaccine is matched to the Omicron XBB.1.5 subvariant, while the previous bivalent vaccine was matched to the Omicron BA.4 and BA.5 sublineages.
The vaccine should be administered at least 2 months after the last dose of any COVID-19 vaccine.6 Talk to your healthcare provider or pharmacist if you are unsure if you need an additional dose.
If you recently had COVID-19, you still need to stay up to date with your vaccines, but you may consider delaying your next vaccine dose by 3 months from when your symptoms started or, if you had no symptoms, when you first received a positive test.
Talk to your healthcare provider about taking over-the-counter (OTC) medicine, such as ibuprofen, acetaminophen, aspirin (only for people ages 18 years or older), or antihistamines.7
While vaccines are one of the best ways individuals can help reduce the risk of infection, COVID-19 cases are still possible, and some people are at high risk for severe illness. Therefore, it is important that we have access to testing and treatment options for individuals that are diagnosed with COVID-19. This is why both vaccines and treatment options are necessary to help reduce the larger burden of COVID-19 disease in the world.
COVID-19 oral treatments may be right for you, even if you are vaccinated, if you are at high risk of progressing to severe illness. Talk to your doctor for individual medical advice.
Clinical and real-world data show that COVID-19 vaccines can help protect against COVID-19, particularly against the risk for severe disease and hospitalization. However, if you do get sick, have symptoms of COVID-19, and have a high risk factor for progression to severe illness, you should speak with your doctor about treatment options as soon as possible.
Side effects may vary depending on the individual and which vaccine is administered. Be sure to consult a healthcare provider to make decisions that are right for your medical history.
Safety is a top concern for all of us and Pfizer takes reports of side effects that are potentially associated with our COVID-19 vaccines very seriously. While hundreds of millions of people have taken the vaccine safely, it is important to note that every medicineand vaccinehas side effects.8 These side effects are rigorously monitored in clinical trials to ensure the benefits outweigh the risks.9
More detailed information is available on the CDCs Possible Side Effects After Getting a COVID-19 Vaccine page. Please visit our Coronavirus Resources page for more information about Pfizers work on COVID-19.
Emergency Use Authorization
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 6 months through 11 years of age. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com
U.S. FDA Emergency Use Authorization Statement
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk for progression to severe COVID-19, including hospitalization or death.
PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.
These vaccines are really well tolerated by children. Compared to other vaccines, they don't seem to be particularly likely to cause fever or lots of other uncomfortable symptoms.
[Music] Welcome to the Australian Prescriber Podcast. Australian Prescriber, independent, peer-reviewed and free.
We've heard a lot about COVID-19 vaccination early in the pandemic and, in fact, that is what has given us a pathway to resuming the function of our society. COVID-19 is an ongoing issue, however, a constantly evolving one, and vaccines are on the front line of managing it. So here in 2023, what do we do about COVID-19 vaccines in our everyday lives, and what does the future look like? Ketaki Sharma is a staff specialist at the NCIRS, the National Centre for Immunisation Research and Surveillance, and she's co-authored an article in Australian Prescriber about COVID-19 vaccines in 2023, and she joins us on the podcast today. Ket, welcome to the program.
Thanks, David. Thank you for having me.
So tell me a little bit about how COVID-19 evolving has affected vaccination and, potentially, does it affect at all the rationale for vaccination?
Yeah, it absolutely does. So COVID-19 has evolved starting from quite early in the pandemic with the emergence of different variants. I'm sure the listeners would be familiar with the nomenclature used for those variants. We started off with Alpha, Beta, then we had a very big wave of Delta. That one was particularly virulent and certainly had an impact on the push for vaccination because we were seeing much more severe disease. More recently, all of those older variants have been replaced by Omicron. So since the emergence and global domination of Omicron during 2022, we no longer detect any of those older variants.
As we all know, the original vaccines were based on what we call the ancestral or the original version of SARS-CoV-2, sometimes also called the Wuhan strain because that's where it emerged. We are now facing a virus that's adapted with several different rounds of mutations. There is evidence that when you look at the neutralising antibody or the immune responses to that original vaccine compared to some of the newer vaccines based on variants, there is a benefit to having a vaccine that is based on a more recent variant of SARS-CoV-2. So it has, and it probably will continue to influence COVID-19 vaccine development just like we see with the annual flu vaccine, which is tailored every year to target the most recent strain.
So perhaps I can ask you: COVID-19 vaccination now, what's the primary aim of what we're trying to do in terms for our patients and for society? It sounds like things have probably shifted from that time at the very beginning.
Yeah, absolutely. So the initial stated aim of the Australian COVID-19 vaccine program was to reduce infection and even potentially reduce transmission of the virus. But now we are well past that, and the main goal is to reduce the risk of severe illness specifically. That's why in the most recent rounds of booster advice, the people that are targeted are really those who still are at risk of severe illness, namely older adults and people with risk factors like medical conditions that increase their risk of severe COVID.
Right. So perhaps maybe we can run through the booster recommendation first. Obviously, the vast majority of Australians have had primary vaccination. Talk me through the booster recommendations now.
The two key groups that should be vaccinated now would be people aged 75 years or older if they haven't had a dose in the last 6 months. You can consider vaccination for people aged 65 to 74, that includes healthy 65- to 74-year-olds. You can also consider vaccination for people aged 18 to 64 with severe immunocompromise. There was also an earlier statement issued by ATAGI [Australian Technical Advisory Group on Immunisation] in February of 2023 that was a little bit broader. So that advised to consider vaccination for adults aged 18 to 64 even if they have no risk factors and for 5- to 17-year-olds who do have medical risk factors. So if people hadn't even had that first dose and so they're still well over 6 months since their last dose, you could also consider catching them up as well. I know all of this is extremely complicated and hard to take in when you're listening, so I would encourage listeners to have a look at the COVID-19 chapter of the Australian Immunisation Handbook, which has recently been published and which summarises all of this information in a more digestible way.
For that considered category, what would make individuals decide to have that vaccine or not?
So obviously the most important thing, I think, is the individual's preferences. So some people are quite concerned and they want regular booster doses of COVID-19 vaccines even if they're not in one of those risk groups. So sometimes we find ourselves having to reassure people the other way that in fact, actually, if you are a young healthy person you don't need another dose right now. So personal preference is one of the most important ones.
Other things to consider are if they have had previous COVID-19 infections, which we think the vast majority of Australians have had. So recent serosurveys have showed over two-thirds of adults have evidence of past infection, but if they don't think they've ever had COVID, then they wouldn't have hybrid immunity. So that's another reason you might want to give a relatively younger adult a booster. The other thing is life circumstances. So for example, if somebody's about to go on a holiday and they really don't want to get COVID, impending overseas travel or a new job working in a health facility where they anticipate they might have increased risk, that just might influence the specific timing of giving someone a booster dose.
As someone who's had COVID overseas, it wasn't a lot of fun, so I can certainly understand the rationale behind that. Can we just talk a little bit through hybrid immunity, because I think people wonder about that a lot?
So hybrid immunity is clearly better than having protection from just vaccination alone or from just infection alone. In Australia, we think the majority of the population probably already has this hybrid immunity, but both of those types of protection wane over time. On top of that, we will potentially keep facing new variants of SARS-CoV-2. So one of the more recent ones called BA.2.86 has some mutations that may make the vaccines or past infections a little bit less protective. That doesn't necessarily mean it'll cause severe diseaseit just means that hybrid immunity will not necessarily provide very long-term protection against severe disease for all members of the population. So we have to keep on monitoring the evidence to see which groups are emerging as being at continued risk.
Now in terms of which vaccine to go with. You've put a link in there to a beautiful A3 poster. How would we go about approaching what type of vaccine to give people in this booster setting?
I think now we're sort of entering a situation where it almost shouldn't matter. Just like the annual flu vaccine, the vast majority of people don't turn up to their GP or pharmacist asking for a specific brand of flu vaccine. They just ask for that year's flu vaccine. So that's been the case with the variant-based vaccines we've had so far. So we've had two different BA.1-based vaccines. We've had two different BA.4-5-based vaccines, and all of those are based on subvariants of Omicron. ATAGI's advice has been to consider them all basically equivalent, even if BA.4-5 was a little bit later than BA.1, they appear to be equally immunogenic against the circulating variants at the time that they were used. We now also have from the TGA [Therapeutic Goods Administration] the approval of two newer vaccines based on XBB.1.5, which is another Omicron subvariant that's even more recent.
So we currently know that those vaccines are very immunogenic against the newer Omicron subvariants, including BA.2.86. We don't yet have clinical data to show if they're very superior in their protection against severe disease. So the possibilities are if they turn out to be very superior, then potentially there could be a preferential recommendation. But it seems equally likely that people would be recommended to just have the latest vaccine that's available, not consider which brand, not consider the specific doses, just get your COVID-19 vaccine.
That simplicity in a sea of choice is definitely something that's appreciated for us as frontline clinicians. I think the other little bit of complexity is about what to do about primary vaccination. There might be some adults who haven't been vaccinated who might be still keen to get vaccinated, but there's obviously a large number of children who have never been vaccinated. What are our current primary vaccination recommendations?
So ATAGI's current recommendations are that all children aged 5 and older should have a primary course of 2 doses of COVID-19 vaccine. For children under the age of 5, so 6 months up to 5 years old, you're only recommended to have a primary course if you have risk conditions for severe COVID-19. So it's quite a limited vaccination program for those very young children, but recommended for all children 5 and older. But I will mention that other countries around the world, some of them have stopped vaccinating healthy young children or reduced down to a single dose. So that's potentially something that we could see around the world becoming more common. I think part of the reason for that is widespread exposure to past infections of SARS-CoV-2. Even at the very beginning before anyone was exposed, the risk of severe COVID-19 was always extremely low in young children.
So let's get the flip side of this, and I think some of the concerns that maybe some people had about vaccinating in younger children and adolescents was about vaccine safety. If the accusation before was that we hadn't had enough experience, certainly we've had a lot of experience with vaccine safety now.
Yeah, absolutely. Over 13 billion doses of COVID-19 vaccines have been administered globally. So we definitely have a lot of safety data, probably more safety data on these vaccines than any other product in history. In Australia specifically, there is data available on COVID-19 vaccine safety in children, which you can link to from the NCIRS website through a program called AusVaxSafety. It looks at the reactions reported by children in the days following vaccination, and what you'll find is that these vaccines are really well tolerated by children. Compared to other vaccines, they don't seem to be particularly likely to cause fever or lots of other uncomfortable symptoms. The other safety concern that has been raised in relation to young people is myocarditis, so inflammation of the heart muscle, and also pericarditis, which is the heart lining, but that tends to be more common in older adults.
Myocarditis, the highest risk is in young adolescents or young adults 16, 17 would be the peak age, and seems to be most common after the second dose, but still overall rare. And it's important to recognise that the risk of myocarditis is much higher with the virus itself. So based on that riskbenefit analysis, vaccination was still recommended. As I've mentioned, it doesn't seem to be something that young children seem to be at risk of.
So I know I'm getting really into the minutiae here, but if someone does have an adverse event, what should their clinicians do then? Should they be reporting that adverse event, and what about revaccination after that?
Yeah, so we would encourage clinicians to report any adverse events that you think are either severe or unusual. So you don't need to report somebody coming forward with a fever or a local injection-site reaction that you think is within the expected norm following vaccination. But certainly severe adverse events, we would request all immunisation providers to report those to the TGA. Then in terms of assessment and management of the adverse event, as with all other vaccines, it depends on the severity.
So the only absolute contraindications to future doses of COVID-19 vaccines would be anaphylaxis or a very severe adverse event that has been attributed to a previous dose of that vaccine. The only other contraindication is the very unique one, which is a previous history of capillary leak syndrome, which is specifically a contraindication to the Moderna vaccine. But that's so rare, it almost feels strange to mention. The main thing to recall is anaphylaxis doesn't seem to be any more common with COVID-19 vaccines compared to any other type of vaccine, and the vast majority of people tolerate these vaccines really well.
So let's look forward a little bit in terms of what the future might hold, always a slightly dangerous thing within COVID-19. So how might the future variant landscape evolve? How do you think we'll work with vaccines to try and combat those evolutions?
So there's actually already a committee established whose entire remit is this question, and it's a technical advisory group to the WHO specifically on COVID-19 vaccine composition. So what that committee is doing is monitoring the virus and variants as they evolve and issues guidance. So in May of 2023, that committee recommended development of vaccines based on the XBB.1.5 subvariant, which is exactly what we've seen. So I think in future we can see similar coordinated efforts to recommend which variants appear to be either particularly virulent or particularly dominant, and that can inform future vaccine development.
There are also vaccine developers looking at broader vaccines, so using components from different types of coronaviruses and not just focused on one particular variant. So theoretically, those could provide broader protection. There's also vaccines being looked at and even registered in a couple of countries overseas with a different platform like intranasal vaccines. That again, could theoretically broaden your immune response because it engages the innate immune system and different parts of your immune system. So there is a potential that we may see better vaccines come out in the future but, at the very least, I think we can expect to see periodically updated vaccines to match what the most dominant variants are.
Finally, I think a question which often gets asked: what about timing with the influenza vaccine? That's obviously another vaccine that we give seasonally and may well be nice to align with the COVID-19 vaccination program. Do you think that's something that we're likely to see in the future?
Yeah, absolutely. In fact, that's another product that is being developed by multiple manufacturers. So combined COVID-19 and influenza vaccines. We are not yet sure what the exact seasonality of SARS-CoV-2 is. In Australia, we have had peaks over summer months as well, but we certainly have also seen severe illness rise over winter months. The last ATAGI guidance for booster doses was issued in September, so it does make sense that, 6 months later if you have patients that are still at high risk, it may well be very convenient. By that time, I expect we may have updated advice in the Handbook, but it may well make sense to combine those two vaccines. One of the biggest benefits of that is the logistics for providers not having to bring people back multiple times and also being able to be opportunistic. Because if someone's coming in for the flu vaccine and they haven't been thinking about COVID, you can look at their risk factors and you can get them vaccinated while they're there.
Great. Well, we thank you and everyone at the NCIRS for all their hard work in trying to make sure that we keep up with this evolving landscape. Thank you for your work on this article in Australian Prescriber. Please do go and check it out, and thank you very much for joining us on the podcast today.
Thanks for having me, David. Before I go, can I just plug the NCIRS website where we're soon going to have an updated decision aid for COVID-19 vaccines. So that's something that your patients will be able to click through themselves and think about all of those factors that we've discussed and think about whether they might be ready to have another booster dose.
Brilliant, that sounds incredibly useful, and thank you very much for joining us.
[Music]
Ketaki Sharma is a member of the Australian Regional Immunisation Alliance. Ketaki contributed to the authorship of the Australian Immunisation Handbook and statements from the Australian Technical Advisory Group for Immunisation. I'm a member of the Drug Utilisation Subcommittee of the PBAC. The views of the guests and the host on this podcast may not represent Therapeutic Guidelines or Australian Prescriber. I'm David Liew and once again, thank you for joining us on this Australian Prescriber Podcast. [This interview was conducted on 21 October 2023.]
Receiving at least one dose of a covid-19 vaccine before the first infection is strongly associated with a reduced risk of developing post-covid-19 condition, commonly known as long covid, finds a study published by The BMJ today.
The findings, based on data for more than half a million Swedish adults, show that unvaccinated individuals were almost four times as likely to be diagnosed with long covid than those who were vaccinated before first infection.
The researchers stress that causality cannot be directly inferred from this observational evidence, but say their results "highlight the importance of primary vaccination against covid-19 to reduce the burden of post-covid-19 condition in the population."
The effectiveness of covid-19 vaccines against SARS-CoV-2 infection and severe complications of acute covid-19 are already known, but their effectiveness against long covid is less clear because most previous studies have relied on self-reported symptoms.
To address this, researchers investigated the effectiveness of primary covid-19 vaccination (the first two doses and the first booster dose within the recommended schedule) against post-covid-19 condition using data from the SCIFI-PEARL project, a register based study of the covid-19 pandemic in Sweden.
Their findings are based on 589,722 adults (aged 18 and over) from the two largest regions of Sweden with a first covid-19 infection registered between 27 December 2020 and 9 February 2022.
Individuals were followed from a first covid-19 infection until a diagnosis of post-covid-19 condition, vaccination, reinfection, death, emigration or end of follow-up (30 November 2022), whichever came first. Average follow-up was 129 days in the total study population (vaccinated: 197 days, not vaccinated: 112 days).
Individuals who had received at least one covid-19 vaccine dose before infection were considered vaccinated.
A range of factors including age, sex, existing conditions, number of healthcare contacts during 2019, education level, employment status, and dominant virus variant at time of infection were also accounted for in the analysis.
Of 299,692 vaccinated individuals with covid-19, 1,201 (0.4%) were diagnosed with post-covid-19 condition during follow-up, compared with 4,118 (1.4%) of 290,030 unvaccinated individuals.
Those who received one or more covid-19 vaccines before the first infection were 58% less likely to receive a diagnosis of post-covid-19 condition than unvaccinated individuals.
And vaccine effectiveness increased with each successive dose before infection (a dose-response effect). For example, the first dose reduced the risk of post-covid-19 condition by 21%, two doses by 59%, and three or more doses by 73%.
This is an observational study, which provides less conclusive evidence of causality, and the researchers point to several limitations such as limited data on post-covid-19 condition symptoms and that the diagnosis code is not yet validated, the potential impact of reinfections on vaccine effectiveness, and expectations about the protective effect of vaccination.
However, this was a large, well designed study based on high quality, individual level registry data with a low risk of self-reporting bias, suggesting that the results are robust.
As such, the authors conclude: "The results from this study highlight the importance of complete primary vaccination coverage against covid-19, not only to reduce the risk of severe acute covid-19 infection but also the burden of post-covid-19 condition in the population."
These findings, combined with evidence from other studies, highlight the association between the immune system and the development of post-viral conditions, and underline the importance of timely vaccination during pandemics, say researchers in a linked editorial.
They call for continued investigation into the evolution of long term residual symptoms of covid-19 and other viral illnesses as well as steps to "improve the accuracy of recording both recovery and continued illness after infection, and in quantifying key family, social, financial, and economic outcomes."
"Such estimates are fundamental to unlocking the funding required for future research and increased investment in specialist clinical services offering treatment and rehabilitation to support patients with post-viral conditions," they conclude.
Source:
Journal reference:
Lundberg-Morris, L., et al. (2023) Covid-19 vaccine effectiveness against post-covid-19 condition among 589722 individuals in Sweden: population based cohort study. BMJ. doi.org/10.1136/bmj-2023-076990.
By: Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research (CBER), FDA andDaniel Jernigan, M.D., MPH, director of the National Center for Emerging and Zoonotic Infectious Diseases, CDC
Monitoring vaccine safety is an important responsibility shared by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
And there's no part of America's vaccine safety system more talked about than the Vaccine Adverse Event Reporting System (VAERS).
VAERS is an early-warning monitoring system for vaccine safety. It allows patients, pharmaceutical companies, medical personnel and other users to report concerns about medical events that occurred after someone received a vaccination. CDC and FDA experts partner to review reports and, when appropriate, to make changes to clinical recommendations. In some cases, these changes can include pausing or stopping the administration of a vaccine.
What VAERS doesnt do, though, is tell us whether a vaccine caused a medical issue. That requires investigation.
VAERS has a proven track record of successfully helping to identify safety issues.
What follows below explains how VAERS works, how successful it's been and addresses some of the common myths about the system.
VAERS: A Critical Part of the National Vaccine Safety System Vaccines are a cornerstone of modern medicine, preventing debilitating diseases and saving countless lives. As we evaluate new vaccines, safety is one of the most important areas we monitor, because vaccines, like any medical intervention, are not without risks.
To protect the public, the United States has built a multilayered system that monitors vaccine safety, including the Vaccine Adverse Event Reporting System (VAERS). VAERS, established in 1990, is a collaborative effort between the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). When a potential issue is detected, the system raises the flag for scientific experts to investigate further.
While arguably the most visible piece of Americas vaccine safety surveillance system, VAERS isnt always well understood. Some critics expect it to do things it isnt designed to do, while others use the publicly available, unverified information to inaccurately claim that VAERS reports show that vaccines definitively caused certain adverse - or harmful health outcomes.
How Does VAERS Work?
Both the CDC and the FDA take every adverse event seriously. We investigate all events that potentially indicate a safety concern.
VAERS relies on individuals, including healthcare providers, vaccine manufacturers, and the public, to submit reports of adverse events following vaccination. Some of these reported events may be true adverse reactions to a vaccine, while others may not be related. These reports, which range from mild reactions, like soreness and fatigue, to more severe complications, are reviewed by VAERS staff within days to identify potential patterns of concern.
The fundamental question in vaccine safety is if an event is directly caused by a vaccine. To understand whether an adverse event is related to the administration of a vaccine most often requires careful examination of the facts underlying multiple reports to VAERS. Further studies are often conducted involving comparisons of the rate of an event to rates of the same event in populations that have not been vaccinated, or who have been vaccinated at a different point in time. Since most events that occur after vaccination also occur in people who are not vaccinated, these comparisons are critical to sorting out whether vaccines may have caused a particular event.
Our experts also look carefully to see if there are differences in reported adverse events between what men and women, or between different ethnic groups to determine whether particular populations may be at risk.
After an adverse event is reported, the information is processed and sent to the CDC and the FDA. Physicians and scientists there collaborate on evaluating the reports. In the case of reports related to the COVID-19 vaccines, for example, FDA and CDC experts assessed relevant data from serious reports and shared important findings with each other. (Serious reports are defined by the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or extension of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.)
Scientists perform further analysis using other safety systems such as the CDC's Vaccine Safety Datalink and Clinical Immunization Safety Assessment Project, or in the FDAs Biologics Effectiveness and Safety system and data obtained in collaboration with the Centers for Medicare & Medicaid Services. In addition to information obtained by VAERS investigators, these systems are better able to assess health risks and shed light on whether the vaccine caused the adverse event. During the height of the COVID-19 pandemic, the CDC and the FDA had hundreds of people working on vaccine safety, and serious reports were followed up within five days. This includes reports of serious events that were in the original list identified during clinical trials or new potential safety concerns that warrant further review. The five-day timeline for follow-up remains true to this day.
Not long after COVID-19 vaccines were authorized in late 2020, there was a backlog of reports, due in part to requirements under FDAs emergency use authorizations that require manufacturers and vaccination providers to report any serious adverse event, regardless of whether it was believed the vaccine caused the event. During that initial time, a backlog of serious reports was cleared within a month and reports of non-serious events were cleared within three months.
What are the limitations of VAERS?
Reports sent to VAERS may include incomplete, inaccurate, coincidental, and unverified information. Only after experts have reviewed all the facts and looked at all available data will they make a determination about the cause of the event.
Investigators may or may not reach out to the individual who submits a report to VAERS. VAERS experts may contact health systems or facilities for information related to a report to ensure they have all available information. This has sometimes led to confusion for individuals who have reported serious events, as they assume the ball was dropped. Even though the person who submitted a report may never hear from VAERS, without fail, work is happening to obtain more information about reported life-threatening events.
How has VAERS performed?
VAERS has worked again and again.
It has helped identify notable COVID-19 vaccine safety concerns. After VAERS detected an increase in rare, life-threatening allergic reactions just weeks after the first vaccines were administered, for example, the CDC and the FDA provided information and guidance to help prevent and manage them. Just days after VAERS detected that six out of the more than 6 million patients who received the Janssen vaccine had developed blood clots, the CDC and the FDA paused the use of the vaccine to better understand this adverse event. And after detecting myocarditis following the mRNA COVID-19 vaccines, the CDC provided advice to healthcare providers about the potential risk and recommended that some people, primarily teen and young adult males, space out their vaccines. Additionally, the FDA announced revisions to the patient and provider fact sheets to reflect updated information about adverse events, including, for example, information about the suggested increased risks of myocarditis and pericarditis following vaccination.
VAERS is constantly evolving, with ongoing efforts to enhance its data quality and analysis capabilities. While not without limitations, VAERS has proven to be vital in detecting both potential and actual safety issues and informing vaccine policy decisions that protect the health of the American public. Thats a job the CDC and the FDA take seriously. We know that failure to detect and communicate a serious health issue related to a vaccine could impact confidence not only in COVID-19 vaccines but in all vaccines.
Bottom line: VAERS works and has a track record that proves it.
