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Confidence in Vaccines Both Steady and Rising in U.S. Adults

Vaccines to protect against respiratory syncytial virus (RSV) in newborns and older adults are being more widely accepted by the American public, while confidence in other vaccines remains unchanged, according to the results of a new Annenberg Public Policy Center survey.

The survey, led by Kathleen Hall Jamieson and other researchers at the University of Pennsylvania, included a nationally representative sample of 1,771 U.S. adults and was conducted from Nov. 14 to 24, 2024.

More than half of U.S. adults (52 percent) think the vaccine given to pregnant individuals to protect infants from RSV is effective, up from 42 percent in October 2023, while 61 percent say the RSV vaccine is effective for adults aged 60 years and older, up from 54 percent in October 2023. In contrast, 86 percent of respondents say the measles, mumps, and rubella vaccine is safe, up from 81 percent in October 2023 and similar to August 2022 (88 percent), and 83 percent say the flu vaccine is safe, unchanged from October 2023. Less than two-thirds of respondents (65 percent) say the COVID-19 vaccine is safe, unchanged from 2023. Respondents view the seasonal flu shot as more effective at reducing the risk for getting a severe illness (75 percent) compared with the COVID-19 booster for reducing the risk for getting a severe case of the disease (55 percent). Despite belief in safety and effectiveness, only 51 percent of respondents either received the seasonal flu shot (40 percent) or say they are very likely to receive it (11 percent) or the COVID-19 booster (38 percent received it and 9 percent are very likely to).

"Despite continuing attacks on the safety and efficacy of certain vaccines by some politicians, nine in 10 respondents say it is important for parents to get their children vaccinated," according to the authors of the report.

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President-Elect Trump Names His Picks to Head the CDC and FDA

President-elect Donald Trump has announced his picks for key health positions in his new cabinet.

To run the U.S. Centers for Disease Control and Prevention, Trump has turned to David Weldon, M.D., a long-time internist who interrupted his medical career to represent a Florida district for seven terms in the U.S. House of Representatives before returning to medical practice.

According to The New York Times, some of Weldon's opinions have been controversial, including endorsing the notion that thimerosal, a preservative used in some vaccines, is a cause of autism in children. That theory has long been discredited by science. In 2007, Weldon also sponsored a failed bill in Congress, which called for vaccine safety research to be conducted by a separate agency within the U.S. Department of Health and Human Services.

Trump has turned to Johns Hopkins School of Medicine pancreatic surgeon Martin Makary, M.D., to run the U.S. Food and Drug Administration. According to The Times, Makary is, on the whole, supportive of childhood vaccines, although he has voiced concern about certain shots, such as the hepatitis B vaccine for newborns and the need for a third COVID-19 booster for healthy children. He has also been a vocal critic of vaccine mandates, claiming instead that doctors underestimate the power of natural immunity in warding off disease.

Trump's pick to be the new surgeon general is Janette Nesheiwat, M.D. She is medical director of CityMD, a chain of urgent care centers, and a frequent Fox News contributor, according to The Times. She is on record as being generally supportive of COVID-19 vaccines, once telling Fox News that they were a "gift from God." But she has also voiced opposition to vaccine mandates.

Nesheiwat also sells her own line of vitamins and is the author of a forthcoming book, Beyond the Stethoscope: Miracles in Medicine, which the publisher notes discusses the "transformative power of prayer." She is also politically well connected: Her sister Julia Nesheiwat was homeland security adviser in the first Trump administration and is the wife of U.S. Rep. Michael Waltz, the Florida Republican who is Trump's pick for national security adviser.

The New York Times Article

CDC Lowers Age for First Pneumococcal Vaccine to 50

The recommended first age at which Americans should get the pneumococcal vaccine has been lowered from 65 to 50, the U.S. Centers for Disease Control and Prevention announced Wednesday.

"Lowering the age for pneumococcal vaccination gives more adults the opportunity to protect themselves from pneumococcal disease at the age when risk of infection substantially increases," CDC director Dr. Mandy Cohen said in an agency statement.

"Pneumococcal bacteria can cause serious illnesses, including pneumonia, meningitis, and bloodstream infections, and older adults are at increased risk for pneumococcal disease," she explained.

Earlier yesterday, the CDC advisory panel had previously voted 14 to 1 to lower the vaccination age, and Cohen approved the move soon after.

Prior recommendations had advised the pneumococcal shot for two vulnerable age groups: children under the age of 5 and seniors age 65 and older. People of other ages with certain health conditions are also advised to get the shot.

Pneumococcal disease is caused by Streptococcus pneumoniae and related forms of pneumococci bacteria.

"Over 150,000 hospitalizations from pneumococcal pneumonia are estimated to occur annually in the United States and it has been demonstrated to complicate influenza infection," according to the CDC.

"Pneumococci is the most common bacterial cause of childhood pneumonia, especially in children younger than age 5 years," the agency noted. "In adults, pneumococci account for 10% to 30% of adult community-acquired pneumonia."

The very first pneumococcal vaccine was licensed in the United States in 1977.

According to the Associated Press, there are four types of pneumococcal vaccine available to Americans, including Capvaxive, made by Merck, which can cost around $300 a dose and protects against 21 types of pneumococci, eight more than other vaccines.

The CDC advisory panel noted that pneumococcal illness tends to appear earlier in Black Americans -- between 55 and 59 years of age -- compared to whites. That was part of the experts' reasoning that the age of first vaccination should be lowered, the AP reported.

It's possible that booster shots of the vaccine may be required about 15 years after the first shot.

More information

Find out more about pneumococcal disease at the National Foundation for Infectious Diseases.

SOURCES: U.S. Centers for Disease Control and Prevention, statement, Oct. 23, 2024; Associated Press

U.S. Whooping Cough Cases Rising, Especially in Teens, CDC Says

Whooping cough cases are climbing at the fastest pace in years as students across America return to school, U.S. health officials reported Thursday.

In figures published by the U.S. Centers for Disease Control and Prevention, a total of 291 cases were reported for the week ending Sept. 14. New York logged the most cases of any state, with 44 infections. Oklahoma followed closely behind with 40 cases, while Ohio has reported 39 illnesses and Pennsylvania has reported 38 infections.

Not since 2015 have numbers that high been reported for Bordatella pertussis infections, when the United States was coming off a resurgence of whooping cough cases that peaked the year before, the data showed.

So far this year, 14,569 cases have been reported, more than four times higher than the number of infections reported by this time last year, the CDC reported.

U.S. health officials have warned for months about a resurgence in breakthrough infections in older children and adults, even though unvaccinated young children and newborns of unvaccinated moms remain the most vulnerable to both infection and severe disease, CBS News reported.

Why are there so many breakthrough infections?

For the past few decades, whooping cough cases have continued to climb because the United States switched to pertussis vaccines that have fewer side effects but aren't as powerful or long-lasting as older shots, CBS News reported.

In Pennsylvania, which has witnessed one of the country's largest pertussis outbreaks this year, health officials noted that high school students have fueled that surge in cases.

"Historically, pertussis was primarily considered a childhood infection; however, there has been an increasing awareness of cases and hospitalizations occurring in older adults," the Pennsylvania Department of Health said in an health alert. "This is likely due to a multitude of factors, including waning vaccine protection and the lack of timely recognition and testing by adult providers leading to more severe infections, co-infections and hospitalizations in older adults."

A similar scenario has unfolded in New York, where 40% of cases outside of New York City have been in teens ages 15 to 19, CBS News reported.

In Oklahoma, which has seen one of the biggest jumps in cases of any state in recent weeks, cases have been seen in people as old as 86, the Oklahoma State Department of Health told CBS News.

The resurgence arrives as the U.S. Food and Drug Administration is weighing speeding up the development of more effective pertussis shots: An FDA advisory panel plans to meet Friday to discuss potential pertussis booster vaccine trials for adults.

The CDC already recommends a number of pertussis shots for children and adults, including boosters of the Tdap vaccine -- which contains antigens designed to protect against pertussis -- for all adults every 10 years.

While whooping cough cases are clearly on the rise, health officials noted that it is not time to panic.

"Despite the resurgence of pertussis, current rates of disease are very low relative to the rates reported during the pre-vaccine era," FDA officials wrote in briefing documents prepared for the advisory panel.

More information

The CDC has more on whooping cough.

SOURCES: U.S. Centers for Disease Control and Prevention, news release, Sept. 19, 2024; CBS News

Most Parents Are Moving Kids Out of Car Booster Seats Too Soon

Most parents are placing their kids in harms’ way by moving them out of their car booster seats too soon, a new study warns.

Four out of five parents moved their kid out of a booster seat before the child was big enough, according to the report, Booster Seat Use in the USA: Breakthroughs and Barriers, published Sept. 16 by Safe Kids Worldwide.

Further, three in four parents didn’t know that children need to ride in boosters until they’re at least 4-foot-9, results show.

“Booster seats save lives and prevent serious injuries, but only if we use them and make sure they are adjusted properly,” said Torine Creppy, president of Safe Kids Worldwide. “Here’s a great first step: once your child is big enough to use a booster seat, keep using it until they can safely ride in a seat belt alone. It’s the best way to keep your child safe.”

For the study, researchers with Ohio State University conducted an online survey of more than 3,000 parents and caregivers with kids ages 4 to 10.

Booster seats can reduce the risk of serious injury by 45% compared to using a seat belt alone, researchers said in background notes.

But survey results showed that many parents aren’t making sure their kid is big enough before getting rid of the booster seat.

The survey also found that carpooling can be a risk for kids:

30% of caregivers said they don’t always follow safety rules when driving a carpool, letting kids ride without the usual restraints.
80% said they’ve noticed other drivers don’t follow safety rules while carpooling kids.
Many also engaged in unsafe practices to make it easier to drop off and pick up kids from school.

“Our goal is for every child to be appropriately restrained for every ride. Achieving that mission requires an understanding of how families make decisions and identifying effective ways to foster growth,” Julie Mansfield, research associate professor at Ohio State University’s Injury Biomechanics Research Center, said in a Safe Kids news release. "Research like this helps us understand the gaps in our current advocacy efforts and helps us to work in a more targeted way to close those gaps.”

Experts recommend a safety belt fit test to determine when a child is ready to lose the booster seat:

A child’s knees should bend at the edge of the seat when their back and bottom are against the seat back, and their feet should touch the floor.
The lap belt must fit snugly across their hips or upper thighs.
The shoulder belt must fit across the shoulder and chest, not the face or neck.

More information

Safe Kids Worldwide has more about the seat belt safety test.

SOURCE: Safe Kids Worldwide, news release, Sept. 16, 2024

Most Patients With MS Have No Risk for Relapse After COVID-19 Vaccination

For most patients with multiple sclerosis (MS), there is no increased risk for relapse after COVID-19 vaccination, according to a study published online Aug. 14 in Neurology.

Xavier Moisset, M.D., Ph.D., from the Universite Clermont Auvergne in Clermont-Ferrand, France, and colleagues conducted a nationwide study using data from the French National Health Data System to estimate the risk for severe relapse after one, two, and three (booster) doses of COVID-19 vaccination in patients with MS. A total of 124,545 patients with MS were identified on Jan. 1, 2021; 82 percent received at least one dose of COVID-19 vaccine until Dec. 31, 2021, with a total of 259,880 doses.

The researchers found that the combined incidence rate ratio was 0.97 (95 percent confidence interval, 0.91 to 1.03; P = 0.30) for MS relapse. In various subgroups, including those aged younger than 50 years, with a duration of MS <10 years, and using disease-modifying treatments (DMTs), the same absence of risk was confirmed. For patients with high MS activity, especially when not treated, a small increase in relapse risk was seen after a booster dose (incidence rate ratio, 1.39; 95 percent confidence interval, 1.08 to 1.80).

"These vaccines can be used without any worry about the risk of relapse to provide booster doses to patients for whom they are warranted," the authors write. "However, particular caution is needed for patients with the highest inflammatory activity in the previous two years, who should first receive DMT."

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text (subscription or payment may be required)

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Many U.S. Adults Lost Trust in Physicians, Hospitals During Pandemic

U.S. adults lost trust in physicians and hospitals during the COVID-19 pandemic, according to a study published online July 31 in JAMA Network Open.

Roy H. Perlis, M.D., from Massachusetts General Hospital in Boston, and colleagues examined how trust in physicians and hospitals changed during the COVID-19 pandemic. The analysis included survey results from 582,634 responses across 24 survey waves (443,455 unique respondents).

The researchers found that overall, the proportion of adults reporting a lot of trust for physicians and hospitals decreased from 71.5 percent in April 2020 to 40.1 percent in January 2024. Factors associated with lower trust in spring and summer 2023 included ages 25 to 64 years, female gender, lower educational level, lower income, Black race, and living in a rural setting. Even when controlling for partisanship, results persisted. Greater trust was associated with greater likelihood of vaccination for SARS-CoV-2 (adjusted odds ratio, 4.94) or influenza (adjusted odds ratio, 5.09) and receiving a SARS-CoV-2 booster (adjusted odds ratio, 3.62).

"As lower levels of trust were associated with lesser likelihood of pursuing vaccination, restoring trust may represent a public health imperative," the authors write.

One author disclosed providing consulting services for pharmaceutical and biotechnology industries.

Abstract/Full Text

FDA Gives Nod to RSV Vaccine for People in Their 50s

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness.

Drugmaker GSK's Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already approved for use in adults 60 and older, since age brings higher risk from RSV disease.

Arexvy is the first to get the nod for people ages 50 to 59 with certain health risk factors.

"A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old," GSK said in a company statement released Friday.

"Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions," the company added. "RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death."

Experts at the U.S. Centers for Disease Control and Prevention are expected to meet in June and October, at which time they might also sign off on the use of Arexvy in people in their 50s. Doing so would give the green light for insurance coverage.

According to CBS News, Pfizer and Moderna are also testing their RSV vaccines for use in younger patients.

Arexvy's safety profile among people in their 50s appears to be similar to that among older people. Less than 10% of people in their 50s who got the shots had any reaction, GSK said, with the most common being injection site pain, fatigue, muscle ache and headache.

According to CBS News, the CDC's advisory panel has been weighing the risk of a neurological condition, Guillain-Barré syndrome (GBS), seen in very rare cases after RSV vaccination. The CDC pegs the rate of GBS at 1.5 cases per million doses.

GSK's latest trial data failed to reveal any "concerning" trends of GBS cases in the 50-to-59 age group, Dr. Phil Dormitzer, senior vice president and global head of vaccines research and development at GSK, told CBS News.

"The risk of GBS tends to go up, it's another one of those risks that tends to go up, with age. But there's nothing to indicate that there's any particular risk of GBS," he said.

New data will be presented to the CDC this month on spacing RSV booster shots for older adults, Dormitzer said.

"This is a really key question," he said. "People originally anticipated it might have to be an every year immunization. But then we found the duration of protection actually lasts for more than one season, clearly."

Trials looking at the use of Arexvy in 18- to 49-year-olds are expected in the later half of the year, GSK said.

More information

Find out more about RSV in older adults at the CDC.

SOURCES: GSK, news release, June 7, 2024; CBS News

CDC Warns Muslim Pilgrims to Saudi Arabia of Meningitis Outbreak

WEDNESDAY, May 22, 2024 (HealthDay News) -- Muslim pilgrims attending the annual Hajj could be at risk for meningitis due to outbreaks occurring in Saudi Arabia, U.S. health officials warned this week.

Twelve cases of meningitis linked to Umrah travel to Saudi Arabia have been reported to national health agencies in three countries, the CDC said in a travel health notice.

Umrah is an Islamic pilgrimage to Mecca in Saudi Arabia that can be performed any time of the year, the CDC said.

The Hajj is an annual pilgrimage, scheduled to occur June 14 to 19 this year, in which between 2 to 3 million Muslims travel to Mecca.

Saudi Arabia requires all Hajj and Umrah pilgrims older than 1 year to be vaccinated for meningitis, the CDC noted.

Nevertheless, nine of the meningitis cases were unvaccinated, the CDC said.

Meningitis is a rare but severe disease that kills 10% to 15% of patients, even if they’re receiving antibiotics, the CDC said.

The infection causes inflammation of the lining of the brain and spinal cord. Symptoms can include fever, headache, stiff neck, nausea, vomiting, light sensitivity and altered mental status, the CDC said.

The infection also can spread into the bloodstream, with additional symptoms including chills, fatigue, cold hands and feet, severe aches and pains, rapid breathing, diarrhea and a dark purple rash.

Symptoms worsen rapidly and can become life-threatening within hours, the CDC noted. Survivors might wind up deaf or require amputation.

There have been five cases reported in the United States, four cases in France and three cases in the United Kingdom, the CDC said.

Ten cases involve patients who traveled to Saudi Arabia, and two were in people who had close contact with recent travelers.

Two cases were in children younger than 18, four in young adults ages 18 to 44, four in middle-aged adults ages 45-64, and two in adults aged 65 or older, the CDC said.

In the United States, meningitis vaccination is routinely recommended for teenagers and for travelers to countries where meningitis outbreaks are occurring. This could include a booster dose for those who had their last vaccination three to five years before.

The CDC is urging doctors to make sure that Muslim patients considering a pilgrimage are fully vaccinated against meningitis.

Doctors also should be on the lookout for symptoms of meningitis among any patients returning to the United States following a pilgrimage to Mecca, the CDC said.

The most recent global outbreak of meningitis associated with travel to Saudi Arabia for Hajj was in 2000-2001, the CDC said.

That outbreak was primarily caused by Neisseria meningitidis serogroup W (NmW), the same bacteria responsible for 10 of the cases in this latest outbreak.

Since 2002, Saudi Arabia has required that international travelers provide documentation of meningitis vaccination, the CDC said.

“Nevertheless, meningococcal vaccination coverage among Umrah travelers is known to be incomplete,” the CDC said.

More information

The U.S. Centers for Disease Control and Prevention has more about meningitis.

SOURCE: U.S. Centers for Disease Control and Prevention, travel health notice, May 20, 2024

CDC Reports Rise in Invasive Serogroup Y Meningococcal Disease

FRIDAY, March 29, 2024 (HealthDay News) -- There has been a rise in invasive meningococcal disease, mainly attributable to Neisseria meningitidis serogroup Y, according to an alert issued by the U.S. Centers for Disease Control and Prevention.

There were 422 cases of invasive meningococcal disease in 2023, the most seen since 2014. So far this year, 143 cases have already been reported, meaning meningitis infections in 2024 will likely surpass 2023 numbers, the CDC added.

Most of the cases last year did not involve meningitis, though at least 17 patients died. The infections were more common in adults ages 30 to 60 years, in Black people, and in people who have HIV, the report revealed.

The CDC alert comes after the Virginia Department of Health warned of a rise in cases linked to the same rare, serious form of meningococcal disease back in 2022.

While antibiotics can quell the infection, quick treatment is critical, the CDC said. An estimated 10 to 15 percent of infected people die, and survivors sometimes suffer deafness or amputations.

Luckily, there are vaccines that shield against meningococcal disease. The CDC recommends that all children get a meningococcal conjugate vaccine, which protects against the rising strain, around the time they enter middle school. Because vaccine protection fades, the CDC also recommends a booster dose at age 16 years. Shots are also recommended for people at higher risk, like those living where an outbreak is occurring or those with HIV infection or other immune-compromising health conditions.

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Maternal Booster COVID-19 Vaccination Protects Infants Through 6 Months

FRIDAY, Feb. 23, 2024 (HealthDay News) -- Maternal booster COVID-19 vaccination protects infants from infection in the first six months of life, according to a study published online Feb. 9 in Pediatrics.

Cristina V. Cardemil, M.D., M.P.H., from the National Institutes of Health in Rockville, Maryland, and colleagues quantified protection against infection from maternally derived vaccine-induced antibodies in the first six months of an infant's life. Full-length spike (Spike) immunoglobulin G (IgG), pseudovirus 614D, and live virus D614G and omicron BA.1 and BA.5 neutralizing antibody (nAb) titers were measured at delivery among infants born to mothers vaccinated during pregnancy with two or three doses of a messenger RNA COVID-19 vaccine.

The researchers found that Spike IgG, pseudovirus, and live nAb titers were significantly higher at delivery for 204 infants of boosted mothers than for 271 infants of nonboosted mothers; infants of boosted mothers were 56 percent less likely to acquire infection in the first six months. The infant's risk for acquiring infection was reduced by 47 percent for each 10-fold increase in Spike IgG titer at delivery, irrespective of boost. Risk reductions of 30, 46, 56, and 60 percent were seen in association with 10-fold increases in pseudovirus titers against Wuhan Spike, live virus nAb titers against D614G, and omicron BA.1 and BA.5 at delivery, respectively.

"We show that a monovalent booster dose during pregnancy leads to higher binding and nAb titers at delivery that are effective against omicron, for an age group that has the highest COVID-19-associated hospitalization rate in pediatrics since the emergence and ubiquitous spread of omicron variants," the authors write.

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

CDC May Recommend COVID Boosters for Some This Spring

FRIDAY, Feb. 16, 2024 (HealthDay News) -- The U.S. Centers for Disease Control and Prevention is weighing whether to recommend another COVID booster shot this spring, most likely for those who are vulnerable to severe illness.

An advisory panel to the CDC is expected to vote on whether to recommend a spring booster during a Feb. 28 meeting, a source close to the panel told NBC News. The panel is expected to focus on the safety of high-risk Americans, including people 65 and older and anyone with a weakened immune system.

"The discussion will be aimed at the people who are most accepting of public health recommendations," Dr. William Schaffner, an infectious diseases expert at Vanderbilt University Medical Center in Nashville, Tenn., told NBC News. "The committee, in its rigorous fashion since the question has come up, will be considering a second dose for people at high risk or for people who wish to get it."

A spring booster would be the same shot approved last fall, which targets the XBB.1.5 subvariant. Luckily, that booster formulation also works well against the JN.1 subvariant, the leading cause of most COVID infections in the United States at the moment.

Experts said a spring booster shot makes sense.

"Waiting till the fall, I think, is a mistake," Michael Osterholm, an infectious disease expert and director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told NBC News. "We have clear evidence that either vaccine or previous infection probably gives four to six months of relative protection against serious illness, hospitalizations and deaths, but wanes substantially after that."

Still, even vulnerable groups like transplant patients, who tend to follow their doctors' advice, are feeling vaccine fatigue, Dr. William Werbel, associate director of epidemiology and quantitative sciences with the Johns Hopkins Transplant Research Center in Baltimore, told NBC News.

"Some people have had seven, eight vaccines," Werbel said. "Transplant recipients would be more receptive and much more likely to follow recommendations, particularly if recommended by the transplant center, but the ceiling is kind of lowered because of this societal fatigue and societal disenchantment with COVID."

Experts generally recommend that even high-risk patients wait at least two months after a COVID vaccination or COVID infection before getting another shot.

Recent research has shown that people who got the latest booster shot were 54% less likely to be infected with COVID this winter.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID vaccines.

SOURCE: NBC News

Canada preparing for fall rollout of new Omicron COVID-19 vaccine

British Columbia is preparing for a fall rollout of an updated COVID-19 vaccine, tailored specifically to the Omicron variant. Provincial health officer Dr. Bonnie Henry emphasized that the new vaccine should be seen as an annual immunization similar to the flu shot, rather than just a booster dose. The recommendation from the National Advisory Committee on Immunization (NACI) suggests that Canadians should receive the updated vaccine if it has been six months since their last dose or COVID-19 infection. The aim is to provide protection against the strains circulating in Canada and globally, building upon the immunity gained from previous vaccinations. The province plans to make the vaccination process easy and convenient, and anyone who wants the vaccine will be offered it. With the anticipation of a potential fall surge of the virus, health officials are urging the public to stay informed and take advantage of this updated vaccine to help combat COVID-19 and ensure community protection...Read More

What are your thoughts?

New COVID-19 mRNA vaccine is safe and highly immunogenic as a heterologous booster

News Medical

The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in more than 600 million confirmed cases and 6.5 million deaths worldwide.mRNA-based vaccines have emerged as a leading platform for COVID-19 protection and are extensively investigated in basic and clinical trials. SYS6006 (CSPC Pharmaceutical Group) is a newly investigational COVID-19 mRNA vaccine encoding a full-length S protein sequence of the prototype SARS-CoV-2 strain and incorporating the key mutations of main epidemic variants.

In March 2023, it has been authorized for emergent use in China by the national medicinal product agency (NMPA) of China. Yet, the data from clinical trials have not been published before. Moreover, the third dose of inactivated vaccine of COVID-19 has been proposed as the initial boosting regimen, and the second heterologous booster (the fourth dose of the vaccine) is worth investigating. By enrolling eligible healthy subjects and convalescent COVID-19 patients, researchers from Shanghai Xuhui Central Hospital have worked and unveiled the first clinical safety and efficacy profile of SYS6006.

These results demonstrated that a modified mRNA vaccine SYS6006 was safe and highly immunogenic as a heterologous booster in healthy Chinese adults. The strong enhancement of antibody titers after heterologous boosting is encouraging, along with the broad-spectrum neutralizing activity of these antibodies against variants of concern, such as Omicron BA.2 and BA.4/5. The titers in the SYS6006 group were higher than those in the convalescent patients. These findings suggest the flexible use of the mRNA vaccine as a booster regimen, which could accelerate the end of the pandemic...Read more

What are your thoughts on this study?

FDA Advisers Say Next Round of COVID-19 Booster Shots Should Target an XBB Variant

THURSDAY, June 15, 2023 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration voted unanimously on Thursday to recommend that COVID-19 booster shots be updated for the fall to protect solely against one of the three XBB variants that have taken hold in the United States.

Those three XBB variants, which are all sublineages of the omicron variant, are XBB.1.5, XBB.1.16, and XBB.2.3, CNN reported. What will be dropped from the updated vaccines will be protection against the original strain of the virus because experts believe it could contribute to lower vaccine efficacy against newer strains.

"Your immune response likes to react to what it's seen before," David Ho, M.D., a professor of microbiology and immunology at Columbia University whose research was cited in FDA briefing documents, told CNN. "That's why we made the recommendation that if you want to broaden out your antibody responses, it's best to remove the ancestral spike in future vaccines."

Although the FDA will make the final decision on the updated vaccines, it typically follows the advice of its advisory panels.

While infections have declined across the United States, the virus could be a concern next winter, the FDA's vaccine chief Peter Marks, M.D., said as the daylong meeting began, the Associated Press reported. "We're concerned that we may have another wave of COVID-19 during a time when the virus has further evolved, immunity of the population has waned further, and we move indoors for wintertime," he told the panel.

A big question will be who should get the updated boosters, Paul Offit, M.D., a vaccine scientist at the Children's Hospital of Philadelphia and a member of the advisory committee, told CNN before Thursday's meeting. "What's the goal of the vaccine?" he asked. "If the goal of the vaccine is the stated goal, which is protection against severe disease, do you really need a yearly vaccine for otherwise healthy people less than 75? I mean, is this the flu model? Because I would argue it shouldn't be."

It is important to have evidence about whether protection from the COVID-19 vaccine against hospitalization and death is waning and, if so, in which groups, Offit added. In a presentation at the advisory panel meeting, the U.S. Centers for Disease Control and Prevention said there is evidence of waning protection from bivalent boosters against hospitalization, CNN reported.

COVID-19 boosters will likely be offered this fall, once they are redesigned by vaccine makers.

CNN Article

Associated Press Article

FDA Advisers Meet to Decide Next COVID-19 Booster Shot

WEDNESDAY, June 14, 2023 (HealthDay News) -- COVID-19 boosters may be offered this fall, but first scientists need to determine what strains to target and who should receive the shots.

Advisers to the U.S. Food and Drug Administration are slated to meet Thursday to discuss plans for fall, a decision with a deadline because drugmakers will need to have the time to manufacture the shots, NBC News reported. The process is similar to deciding on an annual flu vaccine.

FDA scientists said redesigned boosters should target at least one variant of XBB, according to briefing documents published Monday. XBB strains have been spreading since last fall and are related to an omicron subvariant. "These data suggest that an updated strain composition of COVID-19 vaccines to more closely match currently circulating omicron sublineages is warranted for the 2023-2024 vaccination campaign," the scientists write.

As the virus has changed, vaccines have evolved, from a shot in December 2020 that targeted the original virus to FDA-approved shots last fall that targeted the original COVID-19 strain as well as the omicron subvariants BA.4 and BA.5.

The World Health Organization and the European Medicines Agency have both said a booster should target an XBB subvariant. XBB.1.5 is the dominant strain now circulating, with 40 percent of new cases having this strain, according to the U.S. Centers for Disease Control and Prevention. About 18 percent of new cases have XBB.1.16 and 12.5 percent have XBB.1.9.1. Current boosters provide some protection against XBB.1.5, but not as much as for BA.4 and BA.5.

It would make sense if the COVID-19 boosters were offered to everyone in the fall, Ofer Levy, M.D., director of the Precision Vaccines Program at Boston Children's Hospital, told NBC News. "In my mind, it seems like a logical framework," said Levy, a member of the FDA advisory committee who will be involved in Thursday's meeting. "It will boost your antibody response and it probably affects your T cells as well, in a positive way."

NBC News Article

U.S. COVID-19 Hospitalizations Reach Record Low

TUESDAY, May 30, 2023 (HealthDay News) -- COVID-19 hospitalizations in the United States fell below 9,000 in the past week, the first time that milestone has been reached since tracking began in the summer of 2020. The U.S. Centers for Disease Control and Prevention reported that hospitalizations were at 8,256 as of May 25.

Hospitalizations are among the few COVID-19 metrics still being monitored by public health officials, which will continue until April 2024. Still, some infections may no longer be counted because of changes to how hospitals are testing, CBS News reported.

The CDC is still expected to recommend wearing masks when an area's hospitalizations are high. New boosters could be recommended later this year. The U.S. Food and Drug Administration will meet this summer to consider booster recommendations.

World Health Organization advisers have recommended updated COVID-19 boosters targeted to spreading XBB strains. Current boosters target an earlier virus and omicron variants.

Late spring has been a time of record low hospitalizations for each of the past few years. Case numbers previously reached low levels in May and June 2021, for example, but then surged in August of that year because of the delta variant. At that point, hospitalizations were at more than 85,000 in the highest week, CBS News reported. In 2022, something similar happened with record lows in April, following a wintertime omicron surge with 150,000 weekly new hospital admissions.

What will happen this year is not known, but there are again new and shifting variants, from XBB.1.5 strains that are descending in numbers of cases to XBB.1.16 variants that now comprise 19 percent of infections, according to the latest CDC data.

CBS News Article

COVID-19 Vaccines Effective Against Moderate, Severe Disease in Children, Teens

WEDNESDAY, April 19, 2023 (HealthDay News) -- BNT162b2 protects children and adolescents against mild-to-moderate and severe COVID-19, according to a study published online April 7 in Pediatrics.

Nicola P. Klein, M.D., Ph.D., from Kaiser Permanente Northern California in Oakland, and colleagues assessed BNT162b2 vaccine effectiveness against mild-to-moderate and severe COVID-19 in children and adolescents through the omicron BA.4/BA.5 period. The analysis included 9,800 emergency department/urgent care cases with 70,232 controls and 305 hospitalized cases with 2,612 controls.

The researchers found that during the delta variant phase, two-dose vaccine effectiveness against emergency/urgent encounters at 12 to 15 years was initially 93 percent, but waned to 77 percent after ≥150 days. For individuals aged 16 to 17 years, vaccine effectiveness was initially 93 percent but waned to 72 percent after ≥150 days. During the omicron variant phase, vaccine effectiveness for those aged 12 to 15 years was initially 64 percent, waning to 13 percent after ≥150 days, and was 31 percent for those aged 16 to 17 years, waning to 7 percent. A monovalent booster increased vaccine effectiveness to 54 and 46 percent for the two age groups, respectively. For children aged 5 to 11 years, two-dose vaccine effectiveness was initially 49 percent, with waning to 41 percent after 150 days.

"Children and adolescents should receive all recommended COVID-19 vaccinations," the authors write.

Two authors disclosed financial ties to the pharmaceutical industry.

Abstract/Full Text