Category: Vaccine

In a recent study published in Nature Aging, researchers conducted a randomized clinical trial (RCT) to investigate whether a health education intervention offered to Chinese college students will increase severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) booster vaccinations among their grandparents.

Study:Influence of grandchildren on COVID-19 vaccination uptake among older adults in China: a parallel-group, cluster-randomized controlled trial. Image Credit:fizkes/Shutterstock.com

Coronavirus disease 2019 (COVID-19) has had a significant impact on older individuals, making them the highest risk group for hospitalization, ICU admission, and mortality. Vaccination is successful, although the Omicron variety has decreased, necessitating booster dosage recommendations.

Despite free vaccinations and public health advice, vaccine reluctance is widespread in China, particularly among elders. New measures are required to alleviate hesitation and promote booster vaccination.

Researchers link family members' recommendations to higher vaccination rates, and college-aged grandchildren may encourage vaccination among family members.

In the present study, researchers evaluated the effectiveness of providing SARS-CoV-2 booster vaccinations among grandparents aged 60 years using an educational intervention provided to their 16-year-old grandchildren in China.

The researchers recruited volunteers between September 1 and September 22, 2022. The RCT included college students in mainland China aged 1635, with at least one eligible living grandparent aged 60yearswho completed the first COVID-19 immunization series but did not receive a booster dose and were willing to persuade their grandparents to obtain booster vaccinations.

The researchers eliminated children whose grandparents had received a SARS-CoV-2 vaccine booster between the baseline evaluation and randomization.

The primary endpoint was the SARS-CoV-2 vaccine booster uptake rate among grandparents. Secondary study outcomes were grandparents' attitudes and intentions to receive the booster dosage.

The researchers randomized 202 college attendees in a 1:1 ratio to receive the health educational intervention online with 14 daily SMS reminders (188 grandparents) or the control group comprising 187 grandparents. The students reported their grandparents' vaccine booster status at study initiation and after three weeks.

The health education campaign, built using the knowledge, attitude, and practice (KAP) paradigm, addressed the epidemiology, policy, effectiveness, safety profile, indications, contraindications, and precautions for COVID-19 vaccinations among older individuals in China.

The program was provided to participants via interactive web pages, with questions to gauge their comprehension and interest.

The primary analyses were per-protocol (PP) and intention-to-treat (ITT), with models with robust standard errors.

The team conducted subgroup analyses to evaluate the interventions impacts stratified by the grandparents' age, gender, domicile, education, past cohabitation with grandchildren, and comorbidities, and sensitivity analyses using generalized estimating equations (GEE).

The intervention group grandparents were more likely to receive the vaccine booster than controls [intervention, 31% (45/147); control, 17% (26/154); risk ratio (RR) of 2.0].

In the per-protocol analysis, grandparents' attitudes toward receiving the booster dosage increased significantly among the intervention recipients grandparents (from 4.9 to 5.3, change = 0.4), and a slight rise was detected among those of the control group (from 5.0 to 5.1, change = 0.1).

The intervention group grandparents showed more statistically significant alterations in attitude ratings from baseline to follow-up than those of the controls. Grandparents from the intervention group showed a statistically significant increase in their intention to receive the booster vaccination (from 5.0to 5.4, change = 0.4).

The control group grandparents only showed a minor increase (from 5.1to 5.2, change = 0.1). Intention rating changes were also considerably higher among intervention group grandparents compared to those of controls.

The ITT analysis results were identical to those of the PP analysis, and sensitivity analyses produced results that were compatible with the PP and ITT analyses.

In a subgroup analysis by GEE modeling, the educational intervention program was more effective for grandparents 60 to 69 years old.

The intervention proved more successful for grandparents suffering from chronic conditions when applying GEE modeling to the per-protocol analysis. The effects of chronic diseases were not significant in the ITT analysis, as by robust standard error modeling.

The study findings showed that an educational intervention aimed at college students improved SARS-CoV-2 booster vaccine uptake among grandparents in China, particularly those aged between 60 and 69 years.

The findings indicate that governments may combat vaccine reluctance by mobilizing young individuals, particularly college students with better health literacy, to persuade older family members to receive the COVID-19 vaccine.

College students may use intergenerational connections to convince grandparents to approve vaccination, citing familial duties, similar values, strong personal relationships, and emotional connections.

The social control function of family members discourages risky behaviors. Further research with larger sample sizes and longer follow-ups is needed to validate the study findings.

Future studies could determine the effectiveness of fewer frequent reminders and investigate characteristics that increase or reduce the effectiveness of intergenerational messaging tactics.

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Children can boost vaccination rates by educating their grandparents - News-Medical.Net

LOS ANGELES (KABC) -- The days of school closures and statewide lockdowns may be years behind us, but the threat of COVID-19 still lurks in the shadows. Now, health officials are worried a new variant could ruin what has been a hard-fought respite from the pandemic.

"We do keep seeing new mutations, new subvariants popping up. We call them the FLiRT viruses," said Dr. David Bronstein, an infectious diseases specialist at Kaiser Permanente in the Antelope Valley.

Bronstein said those FLiRT variants at the start of the year made up just 1% of our COVID cases. Today it's 28%. With the summer travel season right around the corner, there are concerns of a possible COVID surge.

Experts are now recommending that anyone who hasn't gotten last fall's vaccine to consider getting it now.

"Not a bad idea to get it now, especially knowing that we're going to be traveling, knowing that we have yet another subvariant that's on the rise that is more transmissible," Bronstein said. "It makes sense to protect yourself."

"The more infections we've had, the more vaccine doses we've gotten, the better our immunity is and subsequent infections should hopefully be less severe for most of us," Bronstein said.

Experts said it'll take several weeks to see if the FLiRT variant will lead to a surge. The good news is there's no reason to believe the new variant will cause more severe illness than other recent strains.

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COVID in Los Angeles: What to know about new FLiRT variants and possible summer surge - KABC-TV

The worst bird flu outbreak in US history continues with strange new developments. Bird flu is now infecting cows, the FDA found viral genetic material in milk, and a second human was recently infected.

H5N1 the strain of highly pathogenic avian influenza circulating currently poses little threat to people as spillover from animals to humans is rare, as is human-to-human transmission. But the recent spillover from birds to cows has triggered new fears that the virus could potentially mutate and cause a deadly human pandemic.

In the past two years, more than 90 million poultry birds from 48 US states have died from the virus or were killed in an attempt to slow the spread of the disease. (Wild birds and some mammals including sea lions and cats have gotten sick, too.)

Historically, farmers and poultry producers have used three main strategies to slow the spread: kill entire flocks of chickens and turkeys at the earliest sign of infection, surveil the movement of the virus, and improve biosecurity measures. This approach, sometimes referred to as stamping out, has thus far failed to curb bird flu and has raised concerns around animal cruelty. But as the virus continues to spread among livestock animals such as cows, relying on mass culling may not be as tenable.

This virus is not going away, said Carol Cardona, a professor at the University of Minnesotas College of Veterinary Medicine. And Im not sure how sustainable this approach that were using is.

Given the record-shattering infection rates among poultry and the unprecedented recent spillover to a wide range of other species, some bird flu experts and wildlife researchers are calling for renewed efforts to develop, test, and deploy a vaccine for poultry and potentially other species. Short of triggering a human pandemic, continued spread of bird flu among livestock could further threaten national and global food security.

The current virus is being spread by wild birds. It is evident that the biosecurity arrangements on some farms, especially chicken layer and turkey farms, are not sufficient to prevent all virus incursions, said Leslie Sims, the director of the Asia Pacific Veterinary Information Services. Vaccination, if used, would add an additional layer of protection.

Effective bird flu vaccines for poultry have existed for years and are even used routinely in other countries. But, in stark contrast to the Covid-19 pandemic when new vaccines were rapidly developed and rolled out, the US has yet to adopt vaccination as a disease control strategy for bird flu. The US Department of Agriculture reported promising results from clinical trials of several vaccine candidates, but despite this breakthrough, a slew of logistical, political, and economic challenges might prohibit their use.

Avian influenza vaccines have long been used around the world with varying degrees of success. In some countries, such as Egypt and China where bird flu is enzootic (meaning it is consistently present in animals), vaccination is routine.

In China, several vaccines have been developed. One study found that vaccinating against H5 and H7 subtypes reduced the number of cases in poultry, but another study pointed out that China continues to suffer recurrent outbreaks while others have suggested that culling would be a more cost-effective strategy. In Egypt, vaccination efforts have largely been unsuccessful, in part because it is the only disease control method used in the country.

Last year, Mexico, Guatemala, and other countries hit hard by the ongoing epidemic also started vaccinating against H5N1. In late 2022, Mexico began vaccinating broiler chickens and other birds in high-risk zones; almost one year later, the government declared the country free of influenza before reporting an outbreak in one flock on a commercial farm about a month later.

Only in the past year did some Western countries begin focusing on vaccination. In March 2023, the Dutch government announced that it had developed two bird flu vaccines and that laboratory trials revealed those vaccines to be effective at preventing infection and disease transmission. Italy and the Netherlands are also testing vaccines. In October, the French government started vaccinating ducks for avian influenza and has since vaccinated more than 21 million. According to a press release from Frances Ministry of Agriculture and Food Sovereignty, there have been only 10 outbreaks since vaccination began compared to 315 outbreaks during the same time in the previous year. (The EU is dividing research among member states.)

Vaccination has played a very important role in the prevention of avian influenza elsewhere, Sims said, adding that widespread preventive vaccination has also been used successfully in Hong Kong since 2003. In both France and Hong Kong, the decision was taken to vaccinate because existing strengthened measures based around biosecurity could not prevent all cases of infection, Sims explained.

The US government has at least considered vaccination before.

During the 2014-2015 bird flu outbreak when more than 50 million chickens and turkeys died or were culled, the USDA stockpiled a bird flu vaccine. However, those vaccines were not deployed; the epidemic was instead brought under control through the stamping-out approach.

Following that outbreak, the USDA developed policies and guidance regarding the use of bird flu vaccines. A 2016 policy brief stated that controlled vaccination for flocks at risk should be included in a multi-prong control strategy alongside enhanced biosecurity, an eradication plan, monitoring, and a repopulation plan.

In a 2016 report, the USDA reported that the stockpiled vaccine wasnt well matched to then-circulating strains. Like influenza in humans, bird flu is a quickly evolving virus. Ensuring that a vaccine is highly effective against H5N1 is the first critical step in a successful vaccination campaign. In 2023, the USDAs Agricultural Research Service began testing five vaccine candidates. According to the USDAs website, studies show the candidates provided near 100 percent clinical protection in chickens. (The USDA has also started to assess the potential to develop an H5N1 vaccine for cows.) The USDA has not released further information about the clinical trials.

However, despite seemingly having an effective vaccine in hand, as of late April, the USDA is still not pursuing bird flu vaccination as a disease control strategy. While USDA is exploring the possibility of developing a poultry H5N1 vaccine to stock and use in an emergency, we are not moving forward with a HPAI vaccination program at this time, a USDA spokesperson told Vox.

Given the scale of the ongoing outbreak, some experts feel that the lack of a vaccine push from the USDA is hamstringing disease control efforts. Im a poultry veterinarian, and as a veterinarian, I dont like the idea that you tell me to go fight the biggest fight of my career and you say, heres your gun; first, lets unload it. Now, go, said Cardona. A vaccine is simply a tool, and how we use it can be very effective.

The USDA and industry stakeholders have cited a slew of various challenges that would hinder vaccination.

The biggest sticking point is around trade. The US exported more than $5 billion in poultry meat and products on average every year for the past three years. The USDA enters into trade agreements with each individual country it trades with, explained Upali Galketi Aratchilage, a senior economist at the Food and Agriculture Organization of the United Nations. Each agreement outlines specific biosafety and production requirements that both countries agree to follow. The USDA said, in an email to Vox, that many of those agreements do not allow bird flu vaccination. For now, biosecurity is the best defense against HPAI, a USDA spokesperson wrote.

One main reason is the potential to import infected poultry. Vaccination does not prevent infection; it prevents severe disease and death by priming the immune system to better squash pathogens upon infection. By preventing overt flu symptoms such as sneezing, coughing, or reduced egg production, infected birds might then inadvertently enter the food chain. Importing an infected bird could set off new outbreaks, threatening the local supply chain.

But, Cardona explained, the industry no longer relies on diagnosing sick poultry based on visible signs and symptoms but on strict protocols that utilize molecular testing.

Take eggs, for example. Before eggs can enter the food chain, the hens that laid the eggs are tested twice for influenza. Farmers collect samples from the hens the day they lay the eggs and then two days later (the virus spreads so fast that it could be detected in that time). The samples that are collected undergo molecular testing, meaning that scientists look for the genetic fingerprints of the virus in the samples which would be found even in asymptomatic chickens. Not every single hen can be tested, but a random and representative selection is tested each time.

Markets have been negotiated based on not using vaccination ... based on, frankly, older data [that] there could be a chance that you would import the virus in an animal or in a product that has vaccine in it, Cardona said.

Another concern is differentiating infected from vaccinated animals, the so-called DIVA problem. Its the challenge of identifying whether a bird is actually sick or just has antibodies after vaccination, as Kenny Torrella has previously explained. Again, this seems like an outdated concern as newer technology is capable of differentiating between animals infected with flu versus those that received the vaccine.

Then theres the logistical challenge that the USDA and other stakeholders cite. The vaccines currently undergoing trials continue to rely on a two-dose regimen, which can be impractical for distribution to flocks, the USDA website states. This hurdle does not seem insurmountable, the experts Vox spoke with said, since poultry already receive several vaccines such as those for Newcastle disease, salmonella, and bronchitis. Some vaccines are given through the poultrys water supply or sprayed in the air. There is even a method where the vaccine is poked through the eggshell and injected into a chicken embryo during development at the hatchery.

Even with biological, technological, and logistical hurdles surpassed, the decision around vaccination seems to be a monetary one. Beyond the cost of vaccination, theres the potential of losing key trade partners. Trade agreements, especially for meat, are notoriously delicate, in part because of the risk of introducing infectious diseases and pests into a countrys food chain but more so because governments need to protect the agricultural industry from foreign competition. The National Chicken Council is opposed to vaccination efforts. The National Turkey Federation says unilateral vaccination would have a severe impact on exports but that it has urged and continues to urge the federal government to move as rapidly as possible to try to develop new agreements with trading partners.

Meat is a highly politically sensitive issue for many countries, and the entire livestock industry is protected in many countries for various reasons, said Aratchilage. Introducing bird flu vaccines is not going to be easy, he added. Its a political decision more than a scientific decision.

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Bird flu 2024: The US can vaccinate birds against avian flu. Why arent we? - Vox.com

A single jab of the double-dose measles vaccine could be up to 2.6 times more likely to be completely ineffective in children born by C-section, compared to those born naturally, new research has found. Researchers said that failure of the vaccine meant that the child's immune system does not produce antibodies to fight against a measles infection, and therefore, remains vulnerable to the disease.

A possible reason behind the vaccine being rendered ineffective could be linked to the development of the infant's gut microbiome, the researchers said.

Previous studies have shown that vaginal or natural birth transfers a greater variety of microbes from mother to baby, thereby boosting the infant's immune system, they said. (Also Read | White bread to aerated drinks: 9 foods that speed up ageing, make you look older than you are)

The study by the University of Cambridge, UK, and Fudan University, China, also found that the second measles dose induced a robust immunity against the viral disease in children born by caesarean or C-section, which involves making a cut in the mother's abdomen and uterus for delivering the baby.

"We've discovered that the way we're born -- either by C-section or natural birth -- has long-term consequences on our immunity to diseases as we grow up," Henrik Salje from the University of Cambridge's Department of Genetics and joint senior author of the study published in the journal Nature Microbiology, said.

Measles is an acute and highly contagious viral disease, occurring primarily in children. Symptoms can include a high fever, cough, runny nose and a rash all over the body. Being vaccinated with two doses is the best way to avoid getting sick and spreading the disease, according to the World Health Organization.

Using data from previous studies of over 1,500 children in Hunan, China, the researchers found that 12 per cent of the children born via C-section had no immune response to their first measles vaccination, compared to 5 per cent of the children born by vaginal delivery.

The researchers said that a lot of children do not end up getting their second measles jab, which can be dangerous for them and for the wider population.

"Infants born by C-section are the ones we really want to be following up to make sure they get their second measles jab because their first jab is much more likely to fail," Salje said.

Increasingly, women around the world are giving birth by C-section because of which children are not exposed to the mother's microbiome in the same way as in a vaginal birth, the researchers said.

"We think this means they take longer to catch up in developing their gut microbiome and with it, the ability of the immune system to be primed by vaccines against diseases including measles," said Salje.

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One jab of measles vaccine more likely to be ineffective in children born by C-section, study finds - Hindustan Times

A large outbreak of pertussis (more commonly known as whooping cough) has been ongoing in the UK since the beginning of 2024. There have been 2,793 confirmed cases so far this year. Sadly, five infant deaths due to whooping cough have been confirmed, with unconfirmed reports that a sixth infant may have died in the last week of the bacterial infection.

This is a stark reminder that whooping cough is a very nasty infection. While the symptoms are usually mild in healthy older children and adults, it can be lethal for babies.

Globally, there are an estimated 24 million cases of whooping cough each year and around 160,000 deaths.

Whooping cough is caused by a bacteria called Bordetella pertussis. Pertussis often begins like most other respiratory infections, with typical symptoms including a runny nose and a fever. The distinctive whoop cough may only appear after a week or so of illness though it does not occur in all cases. As such, confirming cases of whooping cough may require a laboratory test.

Whooping cough is very infectious. On average, a single case of pertussis can transmit infection on to around 15-17 other people. This infection rate is similar to measles and higher than the COVID variants.

The reason whooping cough is so infectious is in part due to pertussis having a very long infectious period of up to five weeks where infected people can pass the bacteria on to others. Prompt treatment can greatly reduce transmission antibiotics shown to reduce contagiousness just five days after starting treatment.

But prior to treatment, there are plenty of opportunities for transmission to occur and for an outbreak to be maintained. Both confirmed and asymptomatic cases can be responsible for onward transmission of whooping cough.

One slightly curious aspect of whooping cough is that there are big outbreaks typically every few years. The last sizeable outbreak in the UK was in 2016 with almost 6000 confirmed cases. The reasons for these cycles are not fully understood, but a key factor is probably waning immunity at the population level.

The immunity from the pertussis vaccine is initially very protective, but it does decline a few years after the initial vaccination. This is why a consistently high vaccine uptake across the population is vital.

The vaccine is very safe and effective. Vaccinating young children and pregnant women some of the most vulnerable groups within the population is particularly crucial for preventing infection and illness.

Children who are fully vaccinated are 84% less likely to get a confirmed whooping cough infection compared to those who werent vaccinated. Vaccines not only prevent young children from becoming unwell vaccines also lower the risk of children transmitting the infection onto young siblings, family members and friends.

Immunisation during pregnancy is also particularly important as the antibodies the mother gets from the vaccine protects the newborn in their first few weeks of life before the baby is themselves old enough to receive their first pertussis vaccine dose. A dose during pregnancy prevents around 78% of pertussis cases in newborn babies.

But vaccine coverage has dropped in recent years. Maternal vaccine uptake was 70% in 2017, but only 58% in 2023.

The percentage of children vaccinated by their first birthday dropped slightly from around 93% just prior to the pandemic to 92% in 2022-2023. A similar drop (from 85% to 83%) is seen with the booster dose children can have prior to their fifth birthday. This drop in coverage may be contributing to the current outbreak.

While one publication has suggested the outbreak is probably a surge fuelled by lockdown, theres no evidence to support this assertion.

This kind of messaging isnt helpful as it doesnt raise awareness or educate the public on the things they can do to prevent the spread of whooping cough. Given that peoples health-related behaviour can be significantly impacted by the news they read, high-profile media sources have a responsibility to report accurate information.

The sheer extent of the pandemic may have affected access to healthcare and vaccination rates, resulting in a drop of the population-wide immunity needed to prevent severe outbreaks. Geographical variations in vaccine uptake might also be a contributing factor though, at the time of writing, there isnt any data available on case numbers by UK region.

To control the current outbreak, widespread use of antibiotics to treat or prevent pertussis infections will probably be used. If anyone suspects they have whooping cough, they should speak to their doctor as soon as possible not only because of the severity of the illness, but because prompt treatment reduces persons infectious period.

While UK guidance does not routinely recommend a pertussis vaccine in adults, an extra dose is known to be safe and effective. This may be advised for people who have come in close contact with someone who has whooping cough. It may also be important for people who could be vulnerable to a severe infection such as the elderly.

Ultimately, whooping cough is an infection that can be prevented by vaccines. The grim news of infant fatalities in the UK reminds us all that there are very good reasons why immunisation is recommended. And, in the longer-term, outbreaks can be minimised in both the number of cases and the severity of cases by maintaining a high vaccine coverage.

Access to vaccination, as well as accurate information about the small risks and significant benefits, is going to be key in bringing the outbreak under control.

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Why is whooping cough surging in the UK? Falling vaccination rates may be the answer - The Conversation Indonesia

The way a newborn is delivered could change the way their immune system later responds to life-saving medicine.

A new study from China suggests the route from womb to world, whether vaginal or surgical, can impact how well the measles vaccine works. Children born via cesarean section need that second jab more than most, researchers found. Without that booster, the vaccine is at a higher risk of failing.

The analysis was conducted by scientists at the University of Cambridge and Fudan University in China and includes data from 1,505 mother-infant pairs in China.

Typically, about 5 percent of children given the first dose of the measles vaccine under the age of 1 do not show an antibody response. Between 2013 and 2018, however, babies born via C-section in China were 2.56 times more likely to experience measles vaccine failure than those born vaginally.

Luckily, the second measles jab made up for that failure, triggering a belated and "robust immune response". But that lag is important to know about, as it can help inform effective vaccine policies.

In 2021, millions of children around the world missed their measles booster - a record number that puts herd immunity in numerous nations at a dangerous tipping point.

"We know that a lot of children don't end up having their second measles jab, which is dangerous for them as individuals and for the wider population," explains geneticist Henrik Salje from the University of Cambridge.

"Infants born by C-section are the ones we really want to be following up to make sure they get their second measles jab, because their first jab is much more likely to fail."

Measles is a viral respiratory disease of imminent threat and one of the most contagious diseases we know of. The vaccine is all we have to reign it in, and it requires at least a 95 percent vaccination rate to achieve herd immunity in a population.

China is close to eliminating measles, but in recent outbreaks, roughly a third of those falling ill with the virus were already vaccinated. These 'breakthrough' infections happen when an individual's immune system either fails to respond to a vaccine, or responds too weakly.

A certain percentage of breakthrough infections are expected, which is why getting as many people vaccinated as possible is so important, but this is a delicate balance, and one that a rise in C-sections could throw out of whack.

Children born via C-section, as opposed to those born vaginally, have a slightly higher likelihood of some immune disorders, and while scientists still cannot work out why that is, there's every reason to dig further.

In 2022, a study linked C-sections to lower antibody responses after meningococcal and pneumococcal vaccines. In the research, babies born vaginally had double the level of protective antibodies after receiving the jabs.

At the time, scientists theorized that babies born via C-section are not 'seeded' with the same important germs from their mother's vagina, and these can have a stimulating effect on a newly formed immune system.

The study in China did not explore why C-sections impacted vaccine responses, but the authors suspect a similar cause.

"With a C-section birth, children aren't exposed to the mother's microbiome in the same way as with a vaginal birth," explains Salje.

"We think this means they take longer to catch up in developing their gut microbiome, and with it, the ability of the immune system to be primed by vaccines against diseases including measles."

For now, however, that is just a theory. While C-section babies do show a different range of bacteria in their guts compared to those born vaginally, other studies suggest the differences disappear after about 9 months.

The newborn immune system is largely a mystery. Researchers can't even agree on whether a baby is born sterile into the world, or already equipped with a microbiome from the womb. It's also unclear whether it is the mother's vaginal microbiome or intestinal microbiome that is seeded in a newborn, and how much breastfeeding plays a role after birth.

Since 2000, the rate of C-sections has doubled worldwide. The surgery now accounts for about 20 percent of births globally, and up to half of all births in some countries like Brazil.

It is crucial for public health that we know how the popular procedure is impacting the immunity of the next generation.

The study was published in Nature Microbiology.

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How You Were Born Could Change Your Response to Life-Saving Medicine - ScienceAlert

Pictured: The front entrance to the FDA headquarters/iStock, Grandbrothers

Dynavax Technologies announced Tuesday that the FDA rejected the company's supplemental Biologics License Application for expanded use of its four-dose hepatitis B vaccine for adults on hemodialysis.

The California biopharma said it received a Complete Response Letter (CRL) from the regulator for its sBLA, which included clinical immunogenicity and safety data from the Phase I HBV-24 study of a four-dose Heplisav-B regimen in 119 adults undergoing hemodialysis. According to the CRL, the application did not provide sufficient data to support the full evaluation of effectiveness or safety.

The CRL stated that the data from HBV-24 were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial, Dynavax said in its announcement.

The company also revealed that the total number of subjects in the single-arm study was found by the FDA to be insufficient to evaluate safety of the four-dose regimen.

Dynavax said in its press release that the FDAs rejection of its sBLA will not impact the approval decision in October 2023 from the European Commission of the four-dose regimen for hemodialysis patients, or the approved indication for Heplisav-B in the U.S., the European Union and U.K. for the prevention of infection caused by all known subtypes of hepatitis B virus in adults.

We are reviewing the agencys feedback and intend to request a meeting with the FDA to evaluate options for providing additional data to support the four-dose regimen for this vulnerable patient population in the U.S., Dynavax CMO Rob Janssen said in a statement.

Janssen added that the company remains confident in the key data collected in HBV-24 which were verified against original source documents during the conduct of the trial.

This isnt the first regulatory bump in the road for Dynavaxs hepatitis B shot. Prior to the vaccines approval in 2017, it was rejected twice by the FDA over unresolved safety concerns.

Dynavax was hoping the expanded use of its hepatitis B vaccine would strengthen its market foothold. Revenues for 2023 showed the shot brought in $213 million, with Heplisav-B securing around 42% of the U.S. market. The company forecast net product revenues of between $265 million to $280 million in 2024. Dynavax did not indicate if Tuesdays FDA rejection will affect its growth estimates.

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

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FDA Rejects Dynavaxs Bid to Expand Use of Hepatitis B Vaccine - BioSpace

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Children born by C-section have less protection from measles if jabbed with only a single dose than babies born by a vaginal birth, scientists have suggested.

Experts from the University of Cambridge and Fudan University in China warned that children must have both doses of themeaslesjab to ensure they are protected against the deadly disease.

A study of 1,505 children born in Hunan, China, found 12 per cent of children born via Caesarean had no immune response to their firstmeaslesvaccination, compared to 5 per cent of children born by vaginal delivery.

The study comes amid growing global concern over rising measles rates and reduced uptake of the measles, mumps and rubella vaccinations.

Researchers who carried out the study suggest the lack of immunity in Caesarean section children is linked to the development of a babys gut microbiome, which is the huge array of microbes that naturally live inside the gut.

Other studies have shown that a vaginal birth transfers a greater variety of microbes from mother to baby, which can boost the immune system.

The study was observational so it is not possible to determine if the childrens immune response was a direct result of the type of birth rather than other factors such as the characteristics of women who have C-sections.

The most recent data covering October to December last year shows just 89.1 per cent of children in the UK have had the first dose of theirmeasles, mumps and rubella (MMR) vaccine by the age of two.

Some 85 per cent of children in the UK have had both doses by age five, which is below the 95 per cent needed for herd immunity to stop the disease spreading.

The Cambridge and Fudan University experts say lower vaccination rates have led to an outbreak ofmeaslesin the UK.

In the new study, researchers examined data for 1,505 children in Hunan, China, which included blood samples taken every few weeks from birth to the age of 12.

This allowed researchers to see how immunity tomeasleschanges over time, including after vaccination.

The researchers said Caesarean section births were linked with 2.56 increased odds of primary vaccine failure, compared to babies born naturally.

However, Caesarean children who had a second dose of themeaslesjab had robust immunity against the disease.

Professor Henrik Salje, from the University of Cambridge and joint senior author of the study, said: With a C-section birth, children arent exposed to the mothers microbiome in the same way as with a vaginal birth.

We think this means they take longer to catch up in developing their gut microbiome, and with it, the ability of the immune system to be primed by vaccines against diseases includingmeasles.

We know that a lot of children dont end up having their secondmeaslesjab, which is dangerous for them as individuals and for the wider population.

Infants born by C-section are the ones we really want to be following up to make sure they get their secondmeaslesjab, because their first jab is much more likely to fail.

In the UK, the first dose of the combined jab is usually given on the NHS between 12 and 13 months of age.

A second dose for full protection is given between the ages of three years and four months, and five.

Adam Finn, professor of paediatrics at the University of Bristol, said the new data was observational and could not prove cause.

But he added: This evidence adds to previous evidence relating to other vaccines which has suggested that babies born by vaginal delivery and/or who are breast fed make stronger or more reliable immune responses.

He said the new research raises important questions that need to be researched further, because many children are born by Caesarean delivery these days and the rates continue to rise.

The authors also correctly emphasise that their findings reinforce the importance of the second MMR dose, he said.

The new study was published in the journal Nature Microbiology.

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C-section babies 'have less protection from measles after only one jab' - The Independent

Babies born naturally are more receptive to measles vaccines compared to those delivered via C-section, according to a new study. ... Read More Babies born naturally are more receptive to measles vaccines compared to those delivered via C-section, according to a new study. This research raises plausible concerns about the vaccine's effectiveness in infants born through C-section. The study found that a single dose of the double-dose measles vaccine could be up to 2.6 times more likely to be completely ineffective in children born by C-section compared to those born naturally. Read Less Babies born naturally are more receptive to measles vaccines than those born through C-section. The findings of a new study might now generate plausible concerns around the effectiveness of the vaccine in infants. A single jab of the double-dose measles vaccine could be up to 2.6 times more likely to be completely ineffective in children born by C-section, compared to those born naturally, new research has found. The reason for this, the researchers from the University of Cambridge UK and Fudan University China have explained, could be due to the development of the infant's gut microbiome as a result of which the child's immune system does not produce antibodies to fight against a measles infection, and therefore, remains vulnerable to the disease. This generates interest around previous studies that say natural birth transfers a greater variety of microbes from mother to baby. "We've discovered that the way we're born -- either by C-section or natural birth -- has long-term consequences on our immunity to diseases as we grow up," Henrik Salje from the University of Cambridge's Department of Genetics and joint senior author of the study published in the journal Nature Microbiology, said. The researchers have, however, found that the second measles dose induced a robust immunity in such kids.

This draws attention to the fact that many women are preferring to undergo c-section for childbirth instead of natural birth. "We think this means they take longer to catch up in developing their gut microbiome and with it, the ability of the immune system to be primed by vaccines against diseases including measles," said Salje.

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First dose of measles vaccine ineffective in kids born via C-section: Study - The Times of India

PETALING JAYA: The Health Ministry will be addressing the concerns regarding the AstraZeneca vaccine by this week.

We will explain the data concerning adverse side effects, as well as the issues and announcements made by AstraZeneca, said Deputy Minister Datuk Lukanisman Awang Sauni, as reported by The Star.

Lukanisman explained that there were reported cases of adverse side effect on vaccinations, however it not specified to only the AstraZeneca vaccine.

The government has the data, and we will announce it as it is important to the public, he was quoted as saying before adding that if side effects from the vaccination surface, the ministrys facilities will be ready to receive them.

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Govt to address AstraZeneca vaccine concerns this week - theSun