In EE. UU. se, they are implementing updated COVID-19 vaccines, targeting the most recent and most prevalent variants of the disease.
The updated vaccines, from Pfizer/BioNTech and Moderna, are available for people 6 months and older. The Food and Drug Administration approved mRNA vaccines on Sept. 11 for ages 12 and older, and the FDA issued an emergency use authorization for children ages 6 months to 11 years. The next day, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13 to 1 to propose that everyone 6 months of age and older get vaccinated, and the CDC approved that it went ahead.
The 2023-2024 vaccines, as the FDA and CDC have called them, come a year after vaccine makers rolled out bivalent booster vaccines, the first edition of COVID-19 vaccines updated to target circulating variants. With the FDA’s most recent action, bivalent booster vaccines are no longer FDA-approved and will no longer be available. Novavax, which makes a protein-based COVID-19 vaccine, has also submitted an updated vaccine for FDA review, but the company has not yet developed an updated vaccine. Resolution on the matter.
The updated vaccines target the omicron variant that ruled the new cases this year. The launch comes as the United States has noticed an increase in new hospitalizations due to COVID-19 in recent weeks, even though the numbers so far are only around 19,000. new hospital admissions for the week of Sept. 2: These are part of the cumulative COVID-19. 19 peak numbers delayed last year, according to the CDC.
Here we answer common questions about newer vaccines.
All Pfizer/BioNTech and Moderna COVID-19 vaccines (original, bivalent booster and newer updates) use the same generation of mRNA to trigger an immune reaction to the spike protein of SARS-CoV-2, the virus that causes COVID-19. . The Spike protein is what the virus uses to enter cells. The mRNA from those vaccines provides commands for cells to produce their own spike proteins, which then generate protective antibodies and T cells in the body.
The difference between versions of vaccines is the type of spike protein they produce in the frame. The mRNA in the 2023-2024 vaccines instructs cells to produce the spike protein of the micron variant XBB. 1. 5. The variant is a past fear at the end of the year, when the CDC estimated it accounted for 40. 5% of new COVID-19 cases in the U. S. In the U. S. , a figure that rose to nearly 90% in early March.
In mid-June, the FDA asked vaccine brands to focus on the XBB line for updated vaccines.
While the prevalence of XBB. 1. 5 in particular has fallen precipitously since then, XBB derivatives account for an estimated majority of new instances combined in early September. Another variant, EG. 5, which accounts for one-fifth of the new instances, is descended from an XBB variant and similar to XBB. 1. 5.
The vaccine updated last year was bivalent, with one part of the mRNA targeting the original virus and the other part targeting certain omicron variants. The 2023-2024 vaccine, monovalent, targets only the XBB. 1. 5 variant.
Anyone 6 months of age or older is eligible to receive those vaccines.
The FDA has said that people five years and older can receive a single dose of any of the mRNA vaccines if it has been at least two months since the last dose of the COVID-19 vaccine. Unvaccinated people may also receive a single dose.
Children between 6 months and four years old who have already been vaccinated would likely receive one or two doses, depending on the vaccines they got and when they were vaccinated.
Children in this age group who have been vaccinated against COVID-19 can receive three doses of the latest Pfizer vaccine or two doses of the Moderna vaccine.
Those who are immunocompromised may also receive more doses.
As for waiting time after a recent COVID-19 infection, the CDC advised 3 months before getting vaccinated. But some experts say other people who, if at increased risk of becoming seriously ill, would likely wait longer. “There is also evidence to support that it takes up to six months after a COVID infection to get an updated COVID vaccine,” Andy Pekosz, a professor of microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, said in a question-and-answer consultation on the vaccine update. In fact, a recent infection deserves to offer coverage instead of a new COVID-19 infection or severe illness due to variants of the XBB line.
The FDA said it approved and legalized newer vaccine formulations based on its evaluation of production data and knowledge showing that the immune reaction to vaccines against the prevalent variants is that of older versions of the vaccines against the older variants.
As we explained when the FDA legalized bivalent boosters, the firm uses a technique similar to annual flu shots, which are changed each year to combat flu strains predicted for that season. Flu vaccines are approved annually without clinical studies because adjustments from previous vaccines are minimal and because it would be unimaginable to monitor Americans’ vaccines every year before flu season.
In a Moderna trial, the updated vaccine bolstered neutralizing antibodies against the XBB. 1. 5 and XBB. 1. 16 variants, as well as the new EG. 5. 1 and BA. 2. 86 variants, according to blood tests done 29 days after other people won. the vaccine. In the randomized clinical trial, another 50 people won the monovalent vaccine targeting XBB. 1. 5 and 51 gained a bivalent edition versus XBB. 1. 5 and BA. 4/5, the latter being the variants targeted by last year’s bivalent vaccine.
The BA. 2. 86 variant, another descendant of the ommicron, worries experts because of its high number of mutations. But so far only a small number of cases have been known worldwide. According to the CDC’s assessment, the updated vaccines “will be effective in reducing severe illness and hospitalizations” against the variant, and so far there is no evidence that BA. 2. 86 causes more severe illness than other circulating variants.
In the Moderna trial, those who won the bivalent XBB. 1. 5 vaccine also showed an accumulation of neutralizing antibodies opposed to the XBB variants, but not as significant an accumulation as with the vaccine targeting XBB. 1. 5 alone. The effects of the study has not yet been published in a peer-reviewed journal, but is still available as a preprint.
A subset of participants who received the XBB. 1. 5 vaccine, 20 people, also experienced improved antibodies opposed to the FL. 1. 5. 1 variant, which accounted for about 14. 5 of the cases in the two-week period ending Sept. 2, according to the CENTERS FOR DISEASE CONTROL AND PREVENTION.
All participants in the randomized trial had already received the number one vaccine series plus a booster, as well as the 2022-2023 bivalent booster. The median time since receipt of the bivalent recall was approximately 8 months. Anyone who had a COVID-19 test Infection was excluded within three months of study evaluation, but those who had ever had a COVID-19 infection beyond this period had higher antibody levels before and after receiving an updated vaccine than those who had not.
The Pfizer/BioNTech clinical trial for the current vaccine is being conducted in two hundred people aged 12 to 55 and another two hundred people over 55, and is ongoing. The company presented data from studies in mice, in which 10 mice have so far won the XBB. 1. 5 vaccine and 10 have won last year’s bivalent vaccine. All the mice had already won series number one and a booster dose of the bivalent. Blood tests showed that the updated vaccine produced higher levels of neutralizing antibodies than the newer one. variants (XBB. 1. 5, EG. 5 and BA. 2. 86) compared to last year’s bivalent vaccine.
In addition to the most recent and smaller studies, experts drew on several years of knowledge about the Moderna and Pfizer/BioNTech vaccines to make vaccine approval or submission decisions. The FDA said it was thinking about “the totality of the evidence” and that “the benefit-risk profile of legal and previously approved COVID-19 mRNA vaccines is well understood to the extent that those vaccines have been administered to many millions of people in the United States. “
At the Sept. 12 ACIP meeting, the CDC’s advisory committee, Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, and the only member to vote against general advice that anyone 6 months of age or older get the vaccine. — expressed fear about the “limited amount of data,” especially on children. Sanchez favored more limited advice for older adults and certain higher-risk groups, adding the immunocompromised and pregnant women.
But other committee members pointed to the wealth of knowledge from previous versions of those vaccines. “I think it’s a complex and sophisticated point, but I think we have a little bit of knowledge, adding a little bit of knowledge about the use of those vaccines in young people, but that knowledge builds on previous monovalent and bivalent vaccines,” Dr. Matthew F. said. Daley, a pediatrician and senior scientist at the Kaiser Permanente Health Research Institute in Colorado. “It’s not a total absence of knowledge. We communicate about limited knowledge, we communicate about limited knowledge about XBB. 1. 5 as a strain.
Dr. Beth P. Bell, a clinical professor at the University of Washington School of Public Health, agrees, saying that “there’s all kinds of falsified information” about the benefits and protective profile of COVID-19 vaccines: “Well, not exactly with that “vaccine,” but the 2023-2024 edition is “a very, very vaccinated. “
We have no knowledge about the effectiveness of specifically updated vaccines, however, knowledge about previous similar vaccines shows that they were effective in preventing serious disease. And the studies we explained above via Moderna and Pfizer/BioNTech show that the updated vaccine edition increases neutralizing antibodies opposed to new and emerging variants.
At the ACIP meeting, CDC presented updated knowledge on the efficacy of the COVID-19 vaccine.
For adults, data collected between September 2022 and August 2023 through a network of medical services showed a large improvement in coverage against hospitalization and severe illness from COVID-19 after receiving the bivalent booster. People over the age of 18 who gained only doses of the original monovalent mRNA vaccines showed 22% efficacy against hospitalization and 32% against severe disease, compared with unvaccinated people. Bivalent retirement increases those figures to 65% and 69%, respectively, if you earn about two months or less. before being in poor health or hospitalized.
Bivalent efficacy decreased to 48% and 50% after approximately two months and decreased after approximately six months to 22% and 46%, respectively, for coverage against hospitalization and major illness. Data across the age organization showed that vaccines were more effective at preventing hospitalization. in adults aged 65 years and older than in the cohort aged 18 to 64 years.
The CDC also presented figures found in a study published in August in children aged 6 months to 5 years, comparing the effectiveness of the vaccine in preventing emergency room visits or emergency care for COVID-19 disease. It found that getting the first series and at least one dose of the bivalent vaccine — from Moderna or Pfizer — has a protective efficacy of 61% against these types of medical visits, compared with unvaccinated children, 14 days or more after the bivalent dose.
But the CDC said the estimate was vague because of the small number of young people involved. For example, there were 8 young people positive for COVID-19 in the vaccinated group.
Bivalent booster use is low overall (17% of the population) and only 0. 6% of children aged four and older had received the vaccine as of May 10, according to the latest available CDC data. Almost 70% of the EE. UU. La population has won the number one vaccine.
In a column published in The New York Times on September 13, CDC Director Dr. Anna S. Mandy K. Cohen, said: “Since Covid-19 vaccines have become widely available in 2021, more than 270 million Americans have received injections, avoiding countless deaths and hospitalizations. It connected to a report by the Under Secretary for Planning and Evaluation at the U. S. Department of Health and Human Services. The U. S. Department of Health and Drug Administration estimated that vaccines “were linked to 670,000 to 680,000 fewer hospitalizations and 330,000 to 370,000 fewer deaths among Medicare beneficiaries in 2021. “
Moderna’s clinical trial for the newest vaccine showed that the percentage of participants who reported mild side effects, such as pain, swelling, headache, fatigue and muscle aches, similar or in many cases, decrease than rates of previous COVID-19 reports. Vaccines. .
But the protection assessment of this formula is based on hundreds of millions of doses of COVID-19 vaccines administered in recent years. “These vaccines underwent extensive clinical trials before widespread distribution in 2021, and since then their protection has been heavily monitored, with more than 670 million doses administered in the United States for more than two years,” Cohen wrote in his Times op-ed. “Our understanding of those vaccines means that, as with the annual flu vaccine, brands can now continue to advance the most productive solution for circulating strains. “
Safety monitoring has shown that vaccines are remarkably safe, with mild side effects and very rare serious events. mRNA vaccines have been linked to myocarditis and consistent with carditis, inflammation of the central muscle or surrounding mucosa, especially in young men after the second dose. The CDC says cases are temporarily limited with medication and rest. Late last year, the company knew the greatest risk was among 16- to 17-year-olds, with a rate of 106 cases per million instant doses.
A COVID-19 infection can also cause myocarditis, and the CDC says the dangers of COVID-19 “far outweigh the dangers of a rare adverse reaction to vaccination. “
However, myocarditis is known to be a possible side effect of bivalent boosters. At CDC’s ACIP meeting, CDC also presented knowledge on protection from the bivalent vaccine launched last year.
Dr. Nicola Klein, director of Kaiser’s Center for Ongoing Vaccine Studies, presented surveillance data from Vaccine Safety Datalink, a CDC program that relies on electronic medical records from several fitness organizations across the country. There were no signs of protection for other older people aged 5 to 64 years within 21 days of receiving the bivalent booster, in addition to myocarditis. As of March 11, only two cases of myocarditis were known among about 650,000 bivalent doses given to older people aged 12 to 39. within seven days of receiving the dose. The vaccination rate is low, he said.
Anaphylaxis, a rare but serious allergic reaction, was also detected at a rate of about five cases compared to millions of doses of the first series and booster shots. These reactions, expected with any vaccine, occur immediately after receiving the vaccine and can be treated.
Some experts have said modern vaccines target those most at risk for severe COVID-19 headaches, such as the elderly, while others favor a broader proposition. The CDC advisory committee, which voted 13 to 1 to recommend the updated vaccine to anyone 6 months of age or older.
In the debate leading up to the vote, Bell said, “It is clear that vaccination will prevent serious illness and death in all age groups. It is a disease that can be saved with a vaccine. And for this reason, I am in favor of the universal recommendation. . . Because I think it’s vital that other people have access to the vaccine. (Without a CDC recommendation, insurers may not have covered the cost of the vaccine. )
However, he noted that “there is not the same risk in all ages or in all populations. And it’s clear that some other people, like older people like me, other people with underlying health problems, are at a much higher risk of dying. So I think the kind of message wants to explain that and make it clear that there is this differential risk and that many other people with underlying health problems who are older are dying and need reinforcement. “
Dr. Sarah S. Long, a pediatrician and professor at Drexel University School of Medicine, said that, first of all, she wanted to “want to keep track of a threat-based [presentation], because basically I’m involved in that if it’s just presented universally, it’s like business as usual” and other people might not get the vaccine. adding those who are most at risk of dying. “I still don’t know exactly what is the most productive way to realize our most productive intentions and vaccinate other people,” Long said, adding that he was “moving towards” universality, even if it wasn’t “a smart thing to do. “Because I think we will present it and nobody will get it for the other people who want it (in the end she voted for the universal proposal).
CDC data presented at the meeting shows that people age 75 and older have the same hospitalization rates due to COVID-19; The next groups are babies 6 months and older and 65 to 74 years. Of the older children 17 and older who died in hospital from COVID-19 between January 2022 and June 2023, some had no underlying health problems.
Dr. Sandra Adamson Fryhofer, the American Medical Association’s liaison to the CPIA and a nonvoting member of the committee, highlighted the trend toward young people and encouraged others to adopt the universal recommendation.
“There is no organization that obviously does not pose a threat from COVID and even young people and adults without an underlying pathology can suffer serious illness due to COVID,” Fryhofer said. “And now we’re at a point where immunity and vaccine-induced infections are starting to decline. We have these new emerging variants. We are all more susceptible. . . This new vaccine will help protect us from COVID.
Sanchez, the only one who voted against the universal recommendation, said after the vote that he was “very much in favor of vaccination and in fact [of] high-risk groups” and that knowledge showed that the updated vaccines had contrary neutralizing activity. to circulating variants. But he worries about “extremely limited knowledge about children, infants and other individuals” and possible side effects such as myocarditis. “That’s why I think you have to weigh all that,” Sanchez said. “That’s why I’m hesitant to make it a universal recommendation, even if I get vaccinated with the COVID vaccine. “
In a phone interview, Dr. Paul A. Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia, told us that targeting the vaccine to the highest-risk groups “will have the greatest effect on this virus. “Four groups for whom vaccination can save serious diseases: those over 75 years of age; those with physical fitness disorders such as obesity, diabetes, and chronic lung and central diseases; immunocompromised persons; and other pregnant people.
He said he wasn’t saying other people get vaccinated, but that targeting high-risk equipment is “where we do the most good. “
Offit, who is 72, fit and has hybrid immunity from being vaccinated and having had COVID-19, said he has no plans to get the updated vaccine himself. We asked if there was a post-vaccination or a post-vaccination. It was from infection during which he would receive another dose. “This is where the CDC can help other people like me,” offering them more data on other people hospitalized with COVID-19, he said, such as their age, fitness status, time since the last vaccine or infection and whether they’ve taken an antiviral when they became infected.
“If other people like me are hospitalized” — other healthy people who have received 3 doses of vaccine and a previous infection — “it’s okay, I’m satisfied to get vaccinated,” he said. “I just don’t think I want it right. “
He added that it’s reasonable for young, healthy people in close proximity to high-risk people to receive the updated vaccine, saying it would grant three months of coverage instead of mild illness, a “low-risk, low-reward” option. decision.
Dr. Sairam Parthasarathy, a professor of medicine at the University of Arizona whose studies include results on fitness disparities similar to COVID-19, told us he supports the CDC’s advice that anyone 6 months of age or older deserves to get the updated information. vaccine. ” COVID is rising again and spreading in schools, in other places and in other places, while the heat forces Americans to congregate in air-conditioned confined spaces,” he said.
Vaccines are no longer loose through the federal government, but private insurance companies, Medicare and Medicaid, as well as some CDC systems, will cover them.
CDC’s Bridge Access program provides loose vaccines to adults without fitness insurance and those whose insurance does not cover full costs, through local gyms, physical care providers and some retail pharmacies. The Childhood Vaccines Program provides vaccines free of charge to children who are Medicaid eligible, uninsured, underinsured, or American Indian or Alaska Native. Visit CDC for more information on where to get vaccines through HRV.
Vaccines. gov provides data on where vaccines can be obtained, adding locations that participate in the Bridge Access program. In addition to pharmacies, up-to-date vaccines could possibly be obtained at doctors’ offices.
It is still clear, but it is possible.
In an interview published in July via NY1’s Spectrum News, Cohen, the director of the CDC, predicted that her company will most likely propose annual COVID-19 injections “within the next two weeks. “
“[Yes] we anticipate that COVID will be similar to the flu vaccine, in which you get the annual flu shot and the annual COVID vaccine,” Cohen said.
The FDA “also expects that the composition of COVID-19 vaccines will need to be updated annually, as is the case with the seasonal flu vaccine,” unless a more virulent variant emerges, as discussed in the FDA’s news release on the seasonal vaccine. Flu vaccine update. 19 vaccines.
But a CDC spokesperson told us that an annual COVID-19 injection to the regimen’s vaccination program is still being considered.
“CDC and the Advisory Committee on Immunization Practices (ACIP) will continue to monitor disease levels, variants, and vaccine effectiveness over the coming months to determine long-term policy recommendations for COVID-19 vaccines, and will add how COVID-19 vaccines deserve to be administered. for example through the organization by age or for others with severe COVID-19 risk points,” spokeswoman Candice Hoffmann told us in an email.
Yes, getting any of the vaccines at the same time is imaginable and safe, according to the CDC. Co-administering vaccines, or giving them at the same time, is a practice recommended by CDC to ensure that others receive all of their vaccines, and is convenient for others who do not need to return for a second visit. But getting more than one vaccine at the same time is optional.
Several studies and surveillance data have not identified any aspects of severe protection in patients who received COVID-19 and influenza vaccines. A CDC study based on self-reported data suggests that other people who received either injection experienced a slight accumulation of mild side effects. , such as pain at the injection site, fatigue, headaches, and muscle aches. But the reactions were usually mild and didn’t last long. And other people may choose to receive each vaccine in separate arms to decrease pain at the injection site.
In May, the FDA approved the Pfizer and GSK vaccines to prevent illness caused by breathing the syncytial virus, or RSV, and severe illness in adults 60 and older. The CDC said those adults can simply get vaccinated, after discussing it with their physical care provider.
The CDC says more studies are needed to show that other people receive COVID-19, flu, and RSV vaccines simultaneously, but the CDC spokesperson told us it’s “acceptable” for others 60 and older to do so.
Some studies recommend that the injections would possibly produce a weaker immune reaction if given on the same day, but it’s unclear whether that relief is clinically significant, the firm says.
“When deciding to co-administer other vaccines with RSV vaccine at the same visit, providers should determine whether the patient is current with recommendations regarding recently recommended vaccines, the feasibility of returning to receive more doses of the vaccine, and the threat of receiving the vaccine. “preventable diseases, vaccine reactogenicity profiles and patient preferences,” Hoffmann said.
Some experts propose that people over 60 get vaccinated first instead of RSV because it provides longer protection, and leave flu and COVID-19 vaccines for the rest, as MedPage Today reported.
“We can start giving this [RSV vaccine] right now because the knowledge suggests that it provides really extensive long-term coverage for at least one RSV season, and most likely longer,” said Dr. William Schaffner, a professor at Vanderbilt University. Medical school, he told MedPage Today.
Editor’s note: SciCheck articles that provide accurate fitness data and correct erroneous fitness data are made possible by a grant from the Robert Wood Johnson Foundation. The Foundation has no control over the editorial decisions of FactCheck. org and the views expressed in our articles do not necessarily reflect those of the Foundation.
Q: Is the installation of offshore wind farms in the United States killing whales?
A: Whales have been dying at an uncommon rate along the Atlantic coast since 2016, due to shipping movements or entanglements in fishing gear. Federal agencies and experts say there is no link to offshore wind operations, though they continue to examine potential risks. .