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The new COVID vaccine is out. Why you might not want to rush to get it - ABC News
(SACRAMENTO)
A new, updated coronavirus vaccine is on the way.
This week, the U.S. Food and Drug Administration (FDA) approved and granted emergency use authorization for updated mRNA COVID-19 vaccines. The vaccines come from makers such as Pfizer and Moderna. The new 2024-25 formula includes a monovalent (single) component designed to prevent severe illness from the recent Omicron variant KP.2 strain of SARS-CoV-2.
We talked to two experts at UC Davis Health: Stuart Cohen, the chief of the Division of Infectious Diseases, and Dean Blumberg, the chief of Pediatric Infectious Diseases. They answered common questions about the new COVID-19 vaccine, including when it will be available, who should get the vaccine and why.
Cohen: The FDA just approved the new formula and is debating when exactly to allow the release of the vaccines. The expectation is that they will be available within the next several weeks. This includes both the mRNA vaccines, like Pfizer and Moderna, and a bit later the more traditional protein vaccine (Novavax).
Cohen: SARS-CoV-2, the virus that causes COVID, continues to mutate. According to the Centers for Disease Control and Prevention (CDC), the variant called KP.3.1.1 is the predominant strain of virus circulating now. Its a strain related those known as the FLiRT variants.
So, the new vaccines will be targeting a different strain of the virus than last years vaccine. The mRNA vaccines will target the KP.2 strain, which was dominant in the spring. The protein vaccine (Novavax) will target the JN.1 strain. All three vaccines will be active against the current variants.
Blumberg: These new strains are as different from [the original] Omicron as Omicron was from the ancestral strain. Theyre pretty far apart evolutionarily. The updated vaccine is a much better match for the currently circulating variant. That match is about 80 percent. We expect it to be much more effective.
Cohen: The CDC recommends that everyone ages 6 months and older receive an updated 2024-25 COVID-19 vaccine. The new vaccine will help protect against the potentially serious outcomes of COVID-19 this fall and winter. This is regardless of whether they have ever previously been vaccinated with a COVID-19 vaccine.
It is important to understand that even though the disease has become less severe, people who receive vaccines have a milder illness and a lower risk for long COVID than those who have not been vaccinated.
Cohen: Yes, immunity wanes over time and the virus mutates. That is the reason the CDC made its recent recommendation.
Blumberg: If youve had COVID in the past three months, youre likely protected. But the immunity seems to wear off after about three months. I do recommend waiting those three months before getting the vaccine, because that will prolong your time that youre protected. For example, if you got COVID in August, then why not wait until November to get your updated vaccine? Then youre protected for another four to six months through the winter.
Cohen: There are several reasons to get the vaccines. Both COVID and influenza can be serious diseases, leading to hospitalization, long term symptoms and even death. Even though these vaccines do not fully prevent people from getting infected, they do decrease the risk that those infections will cause severe outcomes.
Data from the CDC continue to show the importance of vaccination to protect against severe outcomes of COVID-19 and flu, including hospitalization and death. In 2023, more than 916,300 people were hospitalized due to COVID-19 and more than 75,500 people died from COVID-19. During the 2023-24 flu season, more than 44,900 people are estimated to have died from flu complications.
Blumberg: You can get the influenza vaccine and COVID vaccine at the same time. You can get them simultaneously.
You can also get your COVID vaccine at the same time as youre getting your vaccine for RSV (respiratory syncytial virus). Remember that RSV vaccines are recommended for those who are older and certain younger groups who are at more risk of severe disease.
Blumberg: The U.S. has a robust vaccine safety system. There is no question the benefits of vaccination far outweigh any adverse effects.
Cohen: While illness is usually mild in children, it can be more severe on occasion. Children are also a chain in the transmission of SARs-CoV-2. The risk of the vaccine is less than the risk of the disease.
Cohen: There is no clear preference. Most people have taken the mRNA vaccines, and they will be available sooner. But for the people who do not want an mRNA vaccine, waiting for Novavax is an option.
Cohen: People continue to be hospitalized from COVID, and there were approximately 75,000 deaths last year. Everyone has COVID fatigue, but being smart about taking the right precautions will help determine whether someone will get severe disease. The vaccines have been proven safe and effective. When case numbers are high, use of a mask could be protective. The vaccine just furthers the protection by decreasing disease severity, if one does get infected.
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What you need to know about the 2024-25 COVID-19 vaccine recommendations - UC Davis Health
Every medical intervention comes with both benefits and risks. For vaccinations, the benefits greatly outweigh any potential hazards in most people.
The new COVID-19 vaccines based on mRNA technology are no exception. But one risk associated with themmyocarditis, especially for young menhas raised concerns among the public.
A new study published in JAMA has found that the risk associated with getting myocarditiswhich is inflammation of the heart muscle, often triggered by the immune system as it responds to an infectionshortly after getting the COVID-19 vaccine is lower than the risk that can come from getting the disease.
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Researchers led by Dr. Mahmoud Zureik, professor of epidemiology and public health at the University of Versailles, studied people ages 12 to 49 who had been hospitalized with myocarditis in France from Dec. 2020 to June 2022, when mass vaccination campaigns were taking place. They sorted people into three groups: people who developed myocarditis and were hospitalized within seven days of receiving an mRNA shot, those who were admitted to the hospital within 30 days of getting COVID-19 but had not had an mRNA vaccine in the prior seven days, or people who had myocarditis that was due to other causes. Everyone was followed for 18 months.
In that time period, people with vaccine-related myocarditis were half as likely to be readmitted to the hospital for myocarditis or heart-related events compared to those with infection-related myocarditis or people with myocarditis due to other causes.
The findings indicate that the risk of myocarditis linked to the mRNA vaccines is very, very low, says Zureik. And it's important to remember that the risk of COVID-19 to the heart "is not limited to myocarditis. There are other cardiovascular risks as well."
Read More: Long COVID Looks Different in Kids
The results are timely, as COVID-19 cases and emergency room visits continue to climb in the U.S.. The increases are due in part to new variants and waning immunity people have from their last vaccines, which targeted different versions of SARS-CoV-2. That's why the U.S. Food and Drug Administration recently approved an updated version of the vaccine to recognize the currently circulating variants. But uptake of recent shots has been low.
The study did not delve into the reason why the vaccines are linkedhowever slightlyto myocarditis, or why the immune system's response to the vaccine seems to be different than that generated by a COVID-19 infection. Its possible that because people are aware of the potential myocarditis risk associated with the vaccine, people hospitalized for the condition after getting vaccinated could have milder cases, Zureik says.
More research is needed to better understand how the mRNA vaccines are interacting with the bodys immune system, but the findings provide some confidence that the shots do not seem to be associated with any substantially greater risk of heart inflammation, even months after immunization.
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Youre More Likely to Get Heart Issues From COVID-19 Than the Vaccine - TIME
New COVID-19 vaccines are expected to be available as soon as this week, a promising development amid California's potent and enduring summer wave of the disease.
The U.S. Food and Drug Administration authorized the distribution of the updated Moderna and Pfizer COVID-19 vaccines for the 2024-25 season on Thursday. And in preparation for winter, when COVID typically surges again, federal officials said Americans will soon be able to register to receive four free tests in the mail.
Major retailers including CVS, Walgreens, Rite Aid, Ralphs, Vons, Pavilions, Albertsons and Safeway are already accepting appointments for the new COVID-19 vaccines, or soon will. Kaiser Permanente expects to begin administering the shots by mid-September, and possibly earlier in some locations.
The new vaccines have been reformulated in hopes of providing optimal protection against the most commonly circulating coronavirus strains, a process that can be comparable to development of the annual flu shot.
Read more: FDA approves updated COVID-19 vaccines; shots should be available in days
The arrival of the latest vaccines comes amid a surprisingly powerful summer COVID wave the strongest in terms of infections since 2022. Increased circulation of new hyperinfectious subvariants has sickened many Americans, ruined vacations and weddings and forced people to miss work.
Coronavirus levels in wastewater are considered "high" or "very high" in 45 states, including California, as well as in the District of Columbia. Coronavirus sewage levels were considered "moderate" in Michigan, New Jersey, Vermont and West Virginia; no data was available for North Dakota.
Earlier this year, some of the coronavirus subvariants that succeeded last winter's dominant strain were collectively nicknamed FLiRT a play on some of the technical terms for their mutations. That group included a strain officially known as KP.2.
A successor subvariant, KP.3, had a different mutation and so was nicknamed FLuQE pronounced "fluke." An even more contagious subvariant, KP.3.1.1, had a mutation that was deleted, giving it the unofficial moniker deFLuQE, or "de-fluke."
For most people, September and October are the best months to get vaccinated against both COVID-19 and flu, according to the U.S. Centers for Disease Control and Prevention. Everyone age 6 months and older should receive updated COVID-19 and flu vaccines, and can get both during the same visit, the CDC said.
"The important part is getting it done," CDC Director Mandy Cohen said at a briefing. "If September, from a calendar perspective, works better for folks, great. October gets you closer to the to the winter season. But the important part is getting it done."
Read more: Rising COVID clashes with carefree California summer as cases jump, precautions fade
Dr. Cohen said Friday that peak winter hospitalizations for COVID-19, flu and respiratory syncytial virus, or RSV a triple-header that has strained hospitals in the past are expected to be similar to last year's, or even slightly improved. But that forecast could prove overly optimistic, she said, if some assumptions end up being wrong for example, if fewer people get vaccinated than expected.
COVID-19 continues to circulate at a very high level nationally and in California.
The rate at which coronavirus tests are coming back positive continues to rise. For the week that ended Aug. 14, 14.4% of reported coronavirus tests were positive in California. That's higher than the peaks seen last summer and winter, and up from about 11% a month ago.
But depending on the region, "I think we are potentially seeing some indication of a plateauing of the summer increase in COVID-19," said Dr. DemetreDaskalakis, who heads the CDC's National Center for Immunization and Respiratory Diseases. Still, "we're not out of the woods yet," he added.
Read more: 'The virus wants to live.' California's big COVID spike isn't expected to ease anytime soon
There are now 26 states, including California, where COVID-19 is projected to be "growing" or "likely growing." That's down from 44 states in those categories about six weeks ago, according to the CDC.
There are initial signs that the summer surge may be starting to peak in some areas, including Los Angeles County, although trends won't be clear until there are a few weeks of sustained declines.
For the week that ended Aug. 18, there were an average of 421 coronavirus cases a day in L.A. County. The week prior, there were 484.
Out of all emergency department encounters countywide for the week that ended Aug. 18, 3.9% were related to the coronavirus, down from the previous week's 4.3%. Last summer's peak was 5.1%.
COVID hospitalizations are essentially flat. For the week that ended Aug. 17, a daily average of 478 coronavirus-infected people were in hospitals in L.A. County. The week before, there were 481. Last summer's peak was 620.
"Given that this is just one weeks data, its too soon to know if these declines will continue or indicate if transmission has plateaued or peaked," the L.A. County Department of Public Health said in a statement to The Times.
Coronavirus levels in the county's wastewater are up, but that metric has a longer lag time than other indicators. For the 10-day period that ended Aug. 10, coronavirus levels in L.A. County sewage were measured at 87% of last winter's peak. That's up from the 10-day period that ended Aug. 3, when coronavirus levels were at 76% of the winter peak.
Overall, coronavirus levels in California's wastewater have been largely flat in recent weeks.
In general this summer, emergency room visits, hospitalizations and deaths from COVID have been rising, but, fortunately not as sharply as during earlier waves of the pandemic.
"While the COVID virus continues to mutate and change faster than the flu virus, our underlying immunity from prior vaccines and prior infections provides some protection," Cohen said. "But we know that protection decreases over time, and certain groups continue to be at higher risk from COVID and other viruses, and we need to continue to protect ourselves and our loved ones."
COVID remains more of a threat than the flu.
"In terms of what is hospitalizing more folks and what is killing more folks, COVID continues to be a more dangerous virus than flu," Cohen said.
Nationally, at least 50,000 COVID-19 deaths have been reported since October, compared with at least 25,000 flu deaths. CDC estimates on flu deaths will be updated later this year.
That's why it's so important that people get freshly vaccinated heading into fall, doctors say. Those at highest risk include seniors and immunocompromised people who haven't been vaccinated against COVID-19 in more than a year.
Read more: California COVID surge is surprisingly stronger, longer-lasting than experts had expected
As of the end of last winter, just 29% of seniors nationally had received the previous COVID-19 vaccination, according to data on a subset of Medicare beneficiaries. As of July 31, 37% of California seniors had received at least one dose of that vaccine, which first became available last September.
It's not just seniors who can be at risk. "Remember ... 80% of the adults in the country have some sort of underlying condition that could put them at some sort of increased risk," Cohen said.
And the very young can be vulnerable, too.
"When we look at who went to the emergency room for COVID, we actually saw that it was highest for those under the age of 5," Cohen said of this summer's wave. "We can't forget that at every age group, there are risks, including our young children."
Each new infection also carries the risk of long COVID in which symptoms, sometimes severe enough to be debilitating, can emerge, persist, resolve and reemerge over a period of weeks, months or years.
"I have a tremendous empathy, having seen people struggle with long COVID in their 30s and 40s, people who you might think were otherwise low-risk," Dr. Peter Marks, the FDA's vaccine chief, said Friday. There are estimates that getting vaccinated can reduce the risk of developing long COVID by 50%, Marks said.
Read more: Long COVID risk has decreased but remains significant, study finds
People who might want to consider getting the updated COVID-19 vaccine as soon as possible include those who are older or immunocompromised and haven't been vaccinated in more than a year. Those groups are at highest risk for being hospitalized with COVID-19 now, said Dr. Peter Chin-Hong, a UC San Francisco infectious diseases expert.
"I would love them to get protected, if they would want to go and get the vaccine now," Chin-Hong said.
Another consideration is whether you are about to go on a trip, or planning an unmissable event or experience.
"Right now, if they want to prevent infection, it's a good time to get something, because it's so closely matched to what's going around," Chin-Hong said of the new vaccine.
Getting the COVID-19 vaccine now will offer good protection against severe disease through the winter, he said.
Read more: COVID surging in California. Is it time to bring back masks, hand sanitizer? What experts say
Chin-Hong said the best protection against infection is within roughly six to eight weeks after getting vaccinated though that window can be wider if the vaccine is a close match to circulating subvariants.
Marks said timing is a matter of personal choice, but he already has his own vaccine appointment scheduled.
"Getting vaccinated now probably gives you the maximum amount of protection that you can get against what's currently circulating, and that will last for several months at least," he said.
The many people who have recently had COVID-19 may wait for as long as three months to get vaccinated, according to the CDC, as an infection in many cases imparts strong, if fleeting, protection against the virus at least for a few weeks or months. But there are some reasons to get the vaccine soon after an illness, such as if you, a family member or household member are at high risk of severe COVID illness, or if transmission is elevated where you live.
And for people who just got vaccinated against COVID over the summer with the older formula, they can wait two months before getting the updated one, Chin-Hong said, "so October would be fine for them."
"To me, the sweet spot is always October," he said, as it's closer to the peak of the late fall and winter respiratory virus season, as well as major holidays like Thanksgiving, Christmas and the New Year.
Read more: COVID and bird flu are rising. Here's how to keep yourself safe
Another measure health officials recommend, particularly when transmission is elevated, is testing when you feel sick, or before events especially if medically vulnerable people are going to attend.
Starting in late September, free COVID tests from the federal government will be available for order at covidtests.gov.
The CDC has also simplified recommendations on who should get vaccinated for respiratory syncytial virus, or RSV. The agency now recommends that all adults age 75 and up, as well as those 60 to 74 at increased risk for severe RSV disease, get vaccinated. Those risk factors include having chronic heart or lung disease, a weakened immune system, certain medical conditions like severe obesity and severe diabetes, and living in a nursing home.
The RSV vaccine is not annual, meaning people who got one last year don't need to get another one at this time, the CDC said. Those who didn't can get it on the same visit as their flu and COVID shots.
An RSV vaccine is also available for expectant mothers at weeks 32 to 36 of pregnancy to pass protection on to their fetuses. An RSV antibody is available for babies and some young children, too.
"All of these vaccines prevent the worst of these infections," Cohen said. "That means fewer visits to the doctor, fewer hospitalizations, and more time to enjoy the fall and winter with family and loved ones."
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This story originally appeared in Los Angeles Times.
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Labor Day is here and, for many Colorado students, school is already well underway. That means its time for annual vaccine shots.
Newly updated COVID-19 vaccines won recent approval from the federal government. Updated flu vaccines are available as well.
We interviewed a pair of experts: Dr. Rachel Herlihy, Colorados state epidemiologist and Dr. Amy Duckro, an infectious diseases physician and the executive director of Population Health for Kaiser Permanente Colorado.
Editors note: Answers have been edited for length and clarity.
Herlihy: It typically takes a couple of weeks for them to start arriving. I would say that probably two to three weeks is a good bet for timing for when the COVID vaccine should start arriving in the state.
Duckro: Most healthcare systems are just starting to receive their flu shots and the COVID vaccines are expected to be coming in within the coming few weeks. At Kaiser Permanente, we expect to have the COVID-19 vaccines by mid-September.
Duckro: We recommend that all eligible persons get both the flu and the COVID vaccine, and the CDC has recently updated their recommendation that regardless of previous vaccination history, everyone is expected or everyone is recommended to receive an updated COVID-19 vaccine. So, that is a little bit new, because before we used to have all of the different recommendations based on your previous vaccine history. Now it's becoming much more simple.
Herlihy: The COVID vaccine is recommended for everyone six months of age and older. So really just about everybody is recommended to receive the new COVID vaccine.
Herlihy: The vaccines are safe and effective, and we now have multiple years of data demonstrating the safety and effectiveness of these vaccines. Of course, we don't have data yet for this year's vaccine, but the data from last year's vaccine showed strong effectiveness and decreased your risk of developing COVID and severe complications of COVID. So certainly recommend that folks take advantage of this updated vaccine that should provide added protection.
Duckro: It's important to think about getting vaccinated not only to protect yourself, but also to protect the community regarding safety. These are some of the most well-studied vaccines in our history of immunizations, especially with the COVID vaccine. We have had such robust and intensive monitoring of vaccine side effects, and the release of that information has been very public and transparent because of the concerns about really being honest with people about what to expect. But because we have gathered so much information nationally about side effects, we really understand that these vaccines are safe and effective.
Duckro: Generally speaking, earlier in the respiratory virus season is better because you want to have protection when these viruses begin circulating, and it can take a couple of weeks after you get vaccinated to have sufficient levels of immunity to protect yourself from infection. So really when these vaccines become available, it's recommended to get them as soon as possible.
Herlihy: We typically recommend September and October as the ideal time to receive those fall respiratory virus vaccines. So that's going to include COVID, of course, but also influenza. And, for those individuals that might be eligible, they should think about the RSV vaccine. That's not a vaccine you need to get every year. It's a one-time vaccine, at least for now, but certainly that's a third vaccine to consider.
Herlihy: You certainly should still get a shot, but there might be some considerations around timing. National experts say that it's probably okay to wait up to three months or so after you've had COVID to get that next vaccine. So that certainly could be a consideration, but its also really important to talk to your healthcare provider about that. Certain people who are at higher risk for severe disease, or people who might be immunocompromised might not want to wait that long. So, it's really going to be an individual decision.
Duckro: Yes, absolutely. If you had COVID recently, you would want to get your flu shot now, but you might consider waiting a couple of months to get the new COVID vaccine because you will have some immunity after having had infection to the virus. But with illness or with vaccination over time that immunity lessens or wanes. And so that then getting a vaccine a couple of months after that infection is reasonable to help bring your antibody levels back up and continue to offer you protection.
Herlihy: They do, and that is absolutely a reason to consider getting the COVID-19 vaccine there is demonstrated effectiveness data showing that the vaccine prevents long COVID as well.
Duckro: Certainly the biggest protection around that is if you don't get infected, you aren't at risk for long COVID.
Herlihy: There's not a preference between those three. So certainly all of them can be considered. We know that the Pfizer vaccine and the Moderna vaccine are built on the mRNA technology. The novavax vaccine is a little bit more of the traditional vaccine technology. So some people who may have had a symptom or side effect from having one of those vaccines may want to consider the other one. But in general, all of the vaccines are equally recommended.
Duckro: There really is no preference among them. As long as we have the updated recommendations from CDC, then that's what we will follow and recommend.
Duckro: There is a possibility that a vaccine that is produced may not have as optimal protection as desired. However, what is consistently seen is that even when the vaccines are not a perfect match, there is still some protection offered in reducing the risk of severe disease or death from infection following the COVID pandemic.
Herlihy: National experts are saying they expect these vaccines to provide strong protection to the variants that are circulating now. Theyre much more closely related to what's circulating now than what was circulating a year ago, or the vaccine you would've received a year ago.
Herlihy: We would absolutely love to see higher vaccination rates than we are seeing right now. So certainly encourage individuals to get the vaccine, especially people that might be at increased risks. So older adults, people with underlying medical conditions, that would be a group of folks where the vaccine is going to be particularly important. And we do tend to see slightly better numbers here for uptake in Colorado compared to nationally, but absolutely not what we would like them to be.
Duckro: The more conversations we can have on an individual level as doctors and nurses and pharmacists with our patients to help encourage them to be vaccinated and consider the safety implications both for themselves and for the people they love. That is meaningful. And then on a larger scale, thinking about how we remind people of the benefit of vaccination and the avoidance of disease and that whatever virus we're talking about or infection, whether it's polio or the flu or COVID or RSV, that all of these illnesses really can do significant damage. And there's nothing worse than imagining a family member, a child, a grandparent suffering or dying from an infection that was preventable or could have been lessened in severity by a vaccine.
Duckro: You can get both the flu, the COVID and the RSV vaccine, if you're eligible, at the same time. And there are some people who say, well, I like to spread them out because I don't want to deal with side effects. That may be worse. It's true that you might have a little bit more of a reaction if you get them on the same day, but my personal perspective is why suffer more than once? So if you're going to get these vaccines, which we do recommend getting them on the same day, then that avoids the impact you're going to have by having them at different times. And it's more efficient. People are busy, so getting in the office and getting the vaccines all at once is a time saver and makes sense.
Herlihy: Yes, you can absolutely get them at the same time. And again, I would consider that third vaccine, the RSV vaccine for older individuals.
Herlihy: The vaccine is absolutely recommended for children starting at the age of six months, and that would include both influenza vaccination and COVID vaccination. But keep in mind that extra doses, additional doses might be needed for a child that has never been vaccinated before.
Duckro: I think both in terms of protecting the child from infection, serious illness, and also the possibilities of long COVID, there's also the impact to the community, which is to reduce the likelihood of children being a vector or a means of spread to a more vulnerable person, someone, one of their teachers, a grandparent, a family member who's immune suppressed. Those are all important reasons for children to be vaccinated.
Duckro: It's always important to check in with your doctor and your healthcare team to make sure you're up to date on routine vaccinations. These vaccines are tried and true, and they have been protecting us from infections, various infections for decades. It's important to stay up to date with recommendations and make sure that your child is up to date with their own vaccine recommendations, especially as they return to school.
Herlihy: Now is the right time to make sure your child is up to date on required vaccines. So certainly recommend that parents check their immunization records, and you can do that online now with our immunization registry or check with your healthcare provider to see if your child is up to date to have all of those completed forms and requirements in place.
Herlihy: That new RSV vaccine that just came around last year is now recommended for everyone 75 years of age and older. And then, for individuals in the 60 year to 74 year age group, they may consider receiving that vaccine based on underlying medical conditions, conversations with your healthcare provider.
Duckro: The RSV vaccine is not expected to be an annual vaccine, and with all vaccines, immunity likely wanes or is reduced over time. So making sure you get the vaccine at the time it's recommended is ideal. There is also a vaccine product for pregnant women, an antibody product against RSV for babies as children have a higher risk for severe disease and death from RSV. So pregnant women should be making sure to be in touch with their doctors to either get that vaccine for themselves or plan for that for the antibody product for their children.
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People with postvaccine myocarditis did not share the typical mid-term complications associated with conventional myocarditis, based on a population-based study from France.
With 18-month follow-up of people who had been hospitalized for myocarditis during the COVID-19 pandemic, it appeared that composite clinical outcomes were more favorable if people had developed myocarditis soon after COVID-19 mRNA vaccination rather than conventional myocarditis (weighted HR 0.55, 95% CI 0.36-0.86).
Meanwhile, the risk of poor composite outcomes -- counting hospital readmission for myopericarditis, other cardiovascular events, and all-cause death -- was comparable between post-COVID-19 myocarditis and conventional myocarditis groups (weighted HR 1.04, 95% CI 0.70-1.52), according to Laura Semenzato, MSc, a statistician at Saint-Denis Cedex France in Paris, and colleagues.
These findings applied to young people and older myocarditis patients alike. "However, affected patients, mainly healthy young men, may require medical management up to several months after hospital discharge," Semenzato's group maintained in JAMA.
The authors added that their results, based on the French National Health Data System, are consistent with past data associating postvaccine myocarditis with a lower short-term risk of heart failure compared with other types of myocarditis.
"These data do confirm the largely favorable prognosis of patients with post-vaccine myocarditis. The extended follow-up provides additional reassuring evidence that while this is a real entity, very few patients suffer long term clinical consequences from this," commented James de Lemos, MD, cardiologist at UT Southwestern Medical Center in Dallas.
The results support the notion that "vaccine associated myocarditis is fundamentally different, and much lower risk, than COVID myocarditis and non-COVID, non-vaccine myocarditis," he told MedPage Today.
Indeed, although the preponderance of evidence points to a causal relationship between the first mRNA COVID-19 vaccines and myocarditis -- occurring more often in young men and adolescent boys -- postvaccine myocarditis has been rare and fairly mild. Reports show a few days of hospitalization being typical for recovery, and the fear of excess sudden cardiac deaths among affected people has yet to become reality.
"Given the effectiveness of vaccines, these facts point to the unmistakable conclusion that [coronavirus] vaccines remain a safe and crucial part of dealing with this now-endemic virus," according to cardiologist James Januzzi Jr., MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston.
Indeed, mainstream public health officials continue to endorse COVID vaccines for prevention among children and adults.
Last week, the FDA approved and granted emergency use authorization to the updated vaccines from Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty) for people ages 6 months and older. These new vaccines target the KP.2 strain of SARS-CoV-2 to better target currently circulating variants.
CDC Director Mandy Cohen, MD, MPH, quickly endorsed giving these vaccines to every individual ages 6 months and older.
"I tell my patients on a routine basis they should be vaccinated when appropriate. Since a new variant is out there, rates of COVID are rising quite substantially. The good news is that a new version of the vaccine is now available, which is tailored for the current variant that is circulating," Januzzi wrote in an email.
For their French cohort study, Semenzato's group used a database that covered all individuals, ages 12-49 years, who were hospitalized for myocarditis between Dec. 27, 2020 and June 30, 2022.
These were 4,635 people included in total: 12% with postvaccine myocarditis (within 7 days after COVID-19 mRNA vaccine), 6% post-COVID-19 myocarditis (within 30 days of SARS-CoV-2 infection), and 82% conventional myocarditis (remainder of cases).
Patients with postvaccine myocarditis were younger and more frequently men compared with the other groups. Two-thirds of postvaccine myocarditis cases occurred after a second vaccine dose.
Trends in medical management of people after hospitalization were similar across the three myocarditis groups.
The authors noted that one patient with postvaccine myocarditis had required extracorporeal membrane oxygenation. After hospital discharge, the person died, and myocarditis was judged the most likely cause of death.
Semenzato and colleagues said 18-month follow-up was complete for 99% of the population.
Despite the large sample, they nevertheless cautioned that they were unable to capture cases of myocarditis that did not require hospitalization, and results may vary depending on how postvaccine myocarditis is defined.
One important question that remains unanswered in this field is why some people develop myocarditis after getting a COVID-19 mRNA vaccine and not others.
"The mechanisms producing myocardial injury after administration of a COVID-19 mRNA vaccine are not well understood, with various hypotheses such as an altered gene expression, direct immune activation by mRNA, molecular mimicry, immune dysregulation, or aberrant cytokine expression," Semenzato and colleagues wrote.
Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
Disclosures
Semenzato de Lemos, and Januzzi had no relevant disclosures.
A co-author disclosed nonfinancial support from the French Society of Cardiology.
Primary Source
JAMA
Source Reference: Semenzato L, et al "Long-term prognosis of patients with myocarditis attributed to COVID-19 mRNA vaccination, SARS-CoV-2 infection, or conventional etiologies" JAMA 2024; DOI: 10.1001/jama.2024.16380.
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COVID Vax Myocarditis Stays Mild With Good Prognosis Over a Year Later - Medpage Today
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Get ready for another COVID-19 vaccine dose. The Food and Drug Administration just approved new versions of COVID-19 boosters that are designed to better protect against the highly transmissible coronavirus strains that are circulating now.
With COVID-19 wastewater levels high and hospitalizations increasing right as kids head back to school, the new shot will help provide more protection at a crucial time, experts tell TODAY.com. And because another surge is likely this winter, it's a good idea to get your updated shot before then, they say.
Pharmacies are expected to start offering the shots in the coming days, NBC News reports.
"We continue to see a lot of COVID-19 activity across the country right now," CDC Director Dr. Mandy Cohen said on a call with reporters.
Were in a were in a significant summer surge right now, Dr. Natalie Azar, NBC medical contributor, said during a Aug. 22 segment on the TODAY show. More than 40 states are reporting high or very levels of COVID-19 in wastewater, according to data from the U.S. Centers for Disease Control and Prevention.
"This is a not an unsurprising summer wave," Dr. Megan Ranney, dean of the Yale School of Public Health, tells TODAY.com "Once again, the virus has mutated, people's immunity has waned and we are using fewer precautions. So we're seeing a lot of cases."
However, current data suggests that those higher levels of COVID-19 are not translating into similar increases in emergency visits and hospitalizations or deaths, Cohen said. This is a similar trend that we saw last summer as well.
That said, hospitals are still seeing people with serious COVID-related complications, Dr. Stuart Ray, professor of medicine and oncology in the division of infectious diseases at Johns Hopkins University School of Medicine, tells TODAY.com.
In the hospital, in just the last couple of weeks, (I) saw people with pretty severe complications of COVID, like blood clots in their lungs, he says, including among relatively young and healthy people. While our situation is different from what it was in March 2020, COVID "is not just a cold," he says.
The surge is largely fueled by the emergence of new highly transmissible variants, particularly FLiRT strains like KP.3 and its relative, KP.3.1.1.
While the last updated vaccines did provide some protection against strains like those, the new variants are different enough that an updated booster is warranted, Dr. Bernard Camins, medical director for infection prevention at the Mount Sinai Health System, tells TODAY.com.
Vaccination continues to be the cornerstone of COVID-19 prevention, Dr. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, said in a press release announcing the approvals.
"Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants," the statement continued.
As we head into the fall, "it's important to stay vigilant and to use the tools we have to keep ourselves safe and healthy," Cohen said on the call, including vaccines, tests and treatments for COVID-19.
"Make a plan now to get your updated vaccine in September or October, ahead of the expected increases in (COVID-19 and flu) this winter," Cohen added.
The new vaccines are designed to provide better protection against more recent strains, particularly the JN.1 strain that was responsible for the massive surge earlier this year. If possible, the FDA advised drugmakers to target the KP.2 variant, which is a descendent of JN.1, for the fall shots.
The updated doses one from Pfizer and the other from Moderna will target just one strain: KP.2, the FDA release explains.
"This updated (vaccine) should give us the most current immunity that's available," Ray explains.
KP.2 is one of the FLiRT variants that took over during the summer, as TODAY.com explained previously. The most recent estimates show that variant KP.3.1.1 is now lead, causing about 37% of cases in the U.S. Meanwhile, KP.3 is responsible for about 17% and KP.2.3 is causing a little more than 14% of cases.
Another variant, LB.1, is also responsibly for about 14% of COVID-19 cases right now. This is another descendent of JN.1.
However, JN.1 itself has dropped off considerably and is now responsible for just 0.2% of cases, according to estimates from the CDC.
Back in June, the CDC recommended that anyone 6 months and older receive an updated COVID-19 shot as well as a flu vaccine this year, Azar said. Older adults should also consider getting the new RSV vaccine this fall, Camins says, which was approved just last year.
People who are in more vulnerable groups "definitely want to be getting in line to get the (new COVID booster)," Azar added. That includes people ages 65 and older, those with weakened immune systems and those with certain underlying health conditions that put them at a higher risk for severe COVID-19 complications.
For those who cant get the vaccine yet but remain at a higher risk for COVID-related complications amid the current surge, Camins recommends falling back on the strategies weve used previously. That includes wearing a high-quality mask when in crowded, indoor settings and avoiding those settings when possible.
"Even though the virus is mutating, which allows it to keep causing all these waves, the way it spreads has not changed," Ranney says. In addition to wearing a mask in crowded space and on public transit, she recommends holding events outside and testing before getting together with high-risk folks to reduce the spread.
Ray also recommends wearing high-quality masks or respirators, especially when in a crowded indoor area, on a plane or taking public transit.
People in this group should also keep Paxlovid in mind in the event of a COVID-19 infection, Camins says.
Immunocompromised folks, for whom a vaccine dose may not provide as much protection, can also ask their doctor about a monoclonal antibody treatment, Camins says. The FDA gave the drug, Pemgarda, emergency use authorization in March of this year. It may help protect against COVID-19 infections in this population, Camins says.
This vaccine was approved earlier in the season than others in the past. Last year's fall booster was approved in mid-September 2023 and protected against XBB coronavirus strains, for example.
But experts are predicting yet another wave to occur later in the year, as we've seen every winter with COVID-19. And it's important to get the updated vaccine before that surge, Ranney advises, but
It takes a couple weeks for the protection from the vaccine to reach its peak effect, Ranney says, and that protection then gradually wanes over the next two to three months. So getting it as soon as it's available may mean you're not as protected from a later winter surge.
That makes it challenging to perfectly time your updated dose. Here are some things to consider to help guide your decision.
High-risk folks, including older adults, should consider getting the new dose as soon as it's available because the virus is still circulating at high levels in many areas of the country, the experts say.
If you can't get it now, make sure you get it before the winter surge, Ranney says. "Whether you get it today or in mid-October, just get the darn booster. ... Just getting the booster is the most important part for those high risk people," she says. "And we had dismally low rates of vaccination for those highest risk groups last year."
Keep in mind that people in those categories may be eligible for another vaccine dose later in the winter season when the protection from this one wanes, Camins says. That's what happened this past February when the CDC recommended another dose for older adults amid a major post-holiday surge. But, Camins adds, we don't know for sure if that will happen this year too.
People who are at a lower risk for COVID-19 may have a particularly tricky time deciding when to get the updated shot, Azar said.
Those folks likely won't be eligible for a dose later in the winter, but protection from the vaccines begins to wane after about 90 to 120 days, Camins explains. That's why, "if you're low to moderate risk, you might actually want to wait a couple of months so that you're protected when the inevitable winter surge happens," Azar said.
Children going to school should also get the vaccine as soon as its available, especially high-risk children, to reduce their risk of being infected in the classroom and bringing it home, Dr. William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine, previously told TODAY.com.
For kids who aren't as high risk, "I don't think it is as essential for them to get the booster as it was a couple of years ago," Ranney says. "Its not a bad idea to get the booster, (but) it's a bit more of a choice of what degree of protection you want against infection."
Keep high-risk situations in mind to help plan your dose, says Camins, who is planning to get the vaccine before traveling next month. Think about timing your vaccination so you're protected during any major trips you have planned, for example, or high-risk events, like large indoor weddings.
The vaccine's "greatest effect on reducing transmission is going to be in those first couple months after you get it," Ranney says. "So if you do have big events, plan (getting your shot) around that."
Those who've gotten a COVID-19 infection during this summer wave may want to consider delaying their next dose.
"The vaccine isn't going to do as much if you've been recently infected because your body's already revved up with antibodies," Ranney explains. "It's not going to hurt you to get it now, but it's just not going to have as much of an effect. So you might as well wait a couple months."
People who've had a recent COVID-19 infection should aim to stay up-to-date with vaccines, the CDC says, but they "may consider delaying" their shot by three months.
"We know that a lot of people got infected over the summer," Azar said. "In that case, you might actually want to wait about three to four months before getting (the updated booster)."
A COVID-19 infection will leave you with some protection from currently circulating strains, as TODAY.com explained previously. But protection after an infection is typically not as persistent as that from a vaccine, so you should still get the updated dose at some point.
As with people who were recently infected, those who recently got another dose of a COVID vaccine should wait a few months before getting the new one, Ray says.
"They might have received an additional dose of the vaccine recently because of susceptibility, travel or major events," he explains. "I know people who were traveling in the past couple of weeks who got the older XBB booster simply because they wanted to be as immune as they could and the new one wasn't available."
In that case, Ray recommends waiting at least three months between doses. It's not dangerous to get another dose earlier than that "you just won't get as big of a boost" as you would if you let your immune system "reset" in between doses, he explains.
If you don't have insurance, you should try to get the new booster soon after it becomes available.
The funding for the CDC's Bridge Access Program, which helps uninsured adults get vaccines, is running out at the end of August, Ranney says. Although the CDC has found another $62 million that can help cover vaccines for the uninsured, Ranney explains, "that's not going to go real far when you think about the number of uninsured people in the U.S."
So, if you are uninsured, "please go get the booster as soon as you possibly can," she says.
As with any vaccine, there is a potential for side effects.
The exact side effects of a COVID-19 vaccine or booster will vary from person to person. But the FDA notes that the side effects you experience may similar to those you had with previous doses of a COVID-19 vaccine.
Keep in mind that side effects are a sign that your immune system is building a response and that the vaccine's working, Ray explains. If you don't get side effects, that doesn't mean the vaccine isn't doing its job. But if you do, "you're just having a nice, vigorous response," he says, "and that's not a bad thing."
It is safe to get your COVID-19 vaccine and flu shot at the same appointment to help you save time. And, as TODAY.com explained previously, research indicates people who get both at once don't necessarily have more or more intense side effects.
However, Ray notes, the shots will likely need to be administered into different arms which means you might end up with two sore shoulders instead of just one. Whether you do it in one appointment or two, "you'll want to get both of those vaccines anyway," he says.
In general, the CDC says people may experience:
These side effects are typically temporary and mild, but may still interfere with your ability to go about your usual tasks for a day or two.
For more severe arm pain, you can try taking an over-the-counter pain reliever after your vaccination, gently stretching and using your arm or using a cool or warm compress, the CDC says.
Do not take a pain reliever before getting the shot, as this can affect the immune response, according to the National Foundation for Infectious Diseases. And, of course, its important to get rest and stay hydrated as your body deals with the side effects.
If you can, plan to take it easy the day after your vaccine.
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New Fall COVID-19 Booster Vaccine: Side Effects, When To Get It - TODAY
WASHINGTON U.S. regulators approvedupdated Covid-19 vaccineson Thursday, shots designed to more closely target recent virus strains and hopefully whatever variants cause trouble this winter, too.
With the Food and Drug Administrations clearance, Pfizer and Moderna are set to begin shipping millions of doses. A third U.S. manufacturer, Novavax, expects its updated vaccine version to be available a little later.
We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants, said the FDAs vaccine chief, Peter Marks.
The agencys decision came a bit earlier than last years rollout of updated Covid-19 vaccines, as asummer wave of the viruscontinues in most of the country. The Centers for Disease Control and Prevention already has recommended this falls shot for everyone age 6 months and older. Vaccinations could be available within days.
While most Americans have some degree of immunity from prior infections or vaccinations or both, that protection wanes.Last falls shotstargeted a different part of the coronavirus family tree, a strain thats no longer circulating and CDC data shows only about 22.5% of adults and 14% of children received it.
Skipping the new shot is a hazardous way to go, because even if your last infection was mild, your next might be worse or leave you with long Covid symptoms, said Robert Hopkins Jr. of the National Foundation for Infectious Diseases.
This falls vaccine recipe is tailored toa newer branch of omicron descendants. The Pfizer and Moderna shots target a subtype called KP.2 that was common earlier this year. While additional offshoots, particularly KP.3.1.1, now are spreading, theyre closely enough related that the vaccines promise cross-protection. A Pfizer spokesman said the company submitted data to FDA showing its updated vaccine generates a substantially improved response against multiple virus subtypes compared to last falls vaccine.
The big question: How soon to get vaccinated? This summers wave of Covid-19 isnt over but the inevitable winter surges tend to be worse. And while Covid-19 vaccines do a good job preventing severe disease, hospitalization, and death, protection against mild infection lasts only a few months.
People who are at high risk from the virus shouldnt wait but instead schedule vaccinations once shots are available in their area, Hopkins advised.
That includes older adults, people with weak immune systems or other serious medical problems, nursing home residents and pregnant people.
Healthy younger adults and children can get vaccinated anytime. I dont think theres a real reason to wait, Hopkins said although its OK to seek the shots in the fall, when plenty of doses will have arrived at pharmacies and doctors offices.
The exception: The CDC says anyone who recently had Covid-19 can wait three months after they recover before getting vaccinated, until immunity from that infection begins to wane.
Hopkins, who sees patients at the University of Arkansas for Medical Sciences, calls it vital for more youngsters to get vaccinated this year especially with schools starting as coronavirus levels are high around the country.
Covid does not kill many children, thank goodness, but it kills far more children than influenza does, Hopkins said, adding that teachers, too, should quickly get up to date with the vaccine.
Health authorities say its fine to get a Covid-19 and flu vaccination at the same time, a convenience so people dont have to make two trips. But while many drugstores already are advertising flu shots, the prime time for that vaccination tends to be late September through October, just before flu typically starts its cold weather climb.
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FDA approves updated Covid-19 vaccines, shots should be available in days - STAT
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FDA approves updated COVID-19 vaccines for upcoming fall and winter season - ABC News
