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According to Nationwide Childrens Hospital, RSV is one of the leading causes of infant hospitalization.
Author: 10tv.com
Published: 6:17 PM EDT November 3, 2023
Updated: 6:17 PM EDT November 3, 2023
Vaxart, Inc.
Trial evaluating the ability of oral vaccine tablets to induce breast milk antibodies and transfer of antibodies to young infants
SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced it has dosed the first subject in its Phase 1 clinical trial evaluating Vaxarts oral pill bivalent norovirus vaccine candidate focused on lactating mothers.
Initiating this study is an important step toward Vaxarts goal of developing a vaccine that may reduce the significant global health threat norovirus poses to children under 5 years of age, said Dr. James F. Cummings, Vaxarts Chief Medical Officer. We believe an oral norovirus vaccine pill may make it possible for mothers to protect their infants against this highly contagious virus for which there currently is no approved vaccine.
Norovirus sickens approximately 21 million people in the United States each year, and 15% of children under age 5 contract norovirus annually. This would translate into about 3 million sets of parents needing to take time from work (approximately 2.2 days on average) to care for their children.
Globally, in countries that have adopted a rotavirus vaccine program, norovirus has become the leading cause of pediatric gastroenteritis in health care settings.1 Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world.
About the VXA-NVV-108 Clinical Trial
The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age and their breast-feeding infants (aged 30 days to 11 months). The study is expected to enroll approximately 76 subjects at seven sites in South Africa. Subjects will be randomized into high- or low-dose vaccine (N=30 for each arm) or placebo (N=16). The primary endpoints are:
Story continues
Frequency, duration and severity of solicited symptoms of reactogenicity (local and systemic) for one week following study drug dose;
Frequency, duration and severity of unsolicited treatment-emergent adverse events (TEAEs), serious AEs (SAEs), adverse events of special interest (AESIs) and new onset of chronic illness (NOCIs) through the active period (four weeks post dose);
Serum VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose);
Breastmilk VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose).
1 Shah and Hall, Infect Dis Clin North Am. 2018 Mar; 32(1): 103-118.
About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxarts development programs currently include pill vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxarts first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from preclinical and clinical trials and the timing of such results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," anticipate, "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Contacts
VaxartMedia Relations:
Investor Relations:
Mark Herr
Andrew Blazier
Vaxart, Inc.
FINN Partners
mherr@vaxart.com
IR@vaxart.com
(203) 517-8957
(646) 871-8486
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When the first vaccines for COVID-19 rolled out in December 2020, some people hoped they would be a silver bullet against the novel virus the way that polio and smallpox shots are nearly 100% effective against those diseases.
Instead, the updated COVID vaccine is being compared to the flu vaccine in the sense that its goal is to prevent severe disease, hospitalization and death rather than to eliminate infection entirely.
That doesn't mean the COVID and flu vaccines are failures, health experts at Northeastern say.
Mansoor Amiji, university distinguished professor of pharmaceutical sciences and chemical engineering, and Neil Maniar, professor of the practice in public health, say vaccines differ according to whether the viruses they've been designed to quell are mutating or stable.
The measles and polio viruses are stable and don't mutate over time, Amiji says. The same is true for the virus for smallpox, which has been eradicated globally and only exists in the lab.
Making a vaccine with an antigen from a stable virus means a vaccinated person's immune system is primed to recognize and destroy the virus every time it appears, Amiji says.
"If you start to see an outbreak of polio, in any part of the world, these vaccines are still incredibly effective. If the virus crops up, it won't evade the immune system or evade the vaccine's response," he says.
Such is not the case with influenza, the virus that causes flu, and SARS-CoV-2, the virus that causes COVID-19.
COVID-19 has gone through an alphabet soup of strains, from the alpha to beta, delta, omicron, Pirola and Erisand is still evolving.
"Even though we have so many people either having natural infection or who have been vaccinated, these viruses continue to mutate," Amiji says.
"We're making vaccines that are looking for the spike proteins in the virus and are basically teaching our immune cells to look for the spike protein. But if the spike protein is mutating, then the vaccine efficacy starts to wane," he says.
Influenza mutates even faster, which is why there are new flu vaccine formulas every year and why 50% is considered a good efficacy rate, he says.
The combinations of antigenic proteins on the influenza surface, known as hemagglutinin and neuraminidasethe H and N in virus nomenclaturevary year to year and even within the flu season, Amiji says.
The flu vaccine is "made up of a cocktail of these peptides," he says. "It's really a guessing game. There is no way of knowing which strain will be prevalent and which vaccines will work," he says.
That rate is making the flu vaccine a harder sell among the public.
The Centers for Disease Control and Prevention says during a year with a good match, vaccination reduces the risk of flu illness by between 40% and 60% among the overall population.
Consumer research shows "that many people believe flu vaccination doesn't work because of first- or second-hand experience where vaccination may not have prevented illness," the CDC says.
Concerned about drops in flu vaccination among high-risk groups such as pregnant women and children during the COVID-19 pandemic, the CDC this fall came up with a new campaignone that spotlights how the flu vaccine can reduce not only the risk of influenza but of potentially serious outcomes.
Called "Wild to Mild," the campaign pairs images of powerful and dangerous animals with innocuous counterpartsa raging bear with a teddy bear or a lion with a kitten, for instance.
"It's definitely a change in messaging," Maniar says.
"It's a clarification in what is being messaged," he says. "There has been sort of this prevailing idea that, "If I get the vaccine, I'm not going to get the flu." And we know that's not the case."
"There's a lot of empirical evidence to show what the vaccine really does is it reduces severity. It reduces the likelihood that someone is going to be hospitalized or even die from getting the flu," Maniar says.
The same is true with vaccination for COVID-19, he says.
"There are some individuals who after getting vaccinated will not get the flu or get COVID, because their immune systems have a more robust protection against the virus," Maniar says.
"But that's not the case for everyone. I think that's where managing expectations comes into play," he says.
The updated COVID vaccineno longer called a booster by the FDAtargets the XBB.1.5 omicron strain prevalent this spring. Pfizer says the monovalent vaccine also addresses currently circulating offshoots of omicron, known as eris or EG.5, andpirola, BA.2.86.
"Vaccination remains right now our best strategy to not just ideally prevent but to have a benign type of infection, just basically a few chills and a sore throat," Amiji says.
"It would be great if you don't get infected. But even if you do get the infection it will be very mild, and you won't be hospitalized."
The flu virus undergoes both antigenic shifts and drifts, Amiji says.
The former is when hemagglutinin and neuraminidase undergo such huge changes the influenza vaccine is not effective at all. Drift is when slight modification occurs, he says.
There are glimmers of hope that both flu and COVID vaccines will become more effective in the future, Amiji says.
Using AI in pharmaceutical technology has led to preclinical studies showing the effectiveness of a universal mRNA flu vaccine that covers more than dozen flu strains in a season, he says.
"The same concept is being applied to a universal COVID vaccine," Amiji says.
"They're not in the clinic yet," he says, but adds he wouldn't be surprised if they were on the market by next fall.
In the meantime, Amiji says he plans to get the updated COVID vaccine and a flu shot this weekend.
"I would absolutely recommend that people get their flu and COVID vaccines as soon as possible," he says.
"As we get toward the winter season, and people start congregating with Thanksgiving holidays and Christmas holidays, the propensity for infection just increases."
"Nearly all pediatricians encounter parents who want to do what is best for their child -- even though it may mean they have questions about vaccines," the American Academy of Pediatrics (AAP) notes in its advice to physicians on how to talk to vaccine-hesitant parents.
Addressing hesitancy can be complex, but communication is key, experts told MedPage Today.
"The factors that influence it are so broad," infectious disease physician Lori Handy, MD, MSCE, of the Vaccine Education Center at Children's Hospital of Philadelphia, told MedPage Today, and these factors can range from a lack of confidence or trust in the medical system or pharmaceutical companies to convenience issues.
Accordingly, it's important to "make sure providers are very knowledgeable about the vaccine they're providing," she said, and that they "encourage questions from anyone who has some level of hesitancy."
The Message Is Benefit
As the season for respiratory pathogens heats up, Ashlesha Kaushik, MD, a pediatrician, infectious disease specialist, and national spokesperson for the AAP, reiterated that viruses like influenza and respiratory syncytial virus (RSV) can lead to plenty of sickness and hospitalizations among kids.
Though parents are familiar with annual recommendations for the flu shot, there are now new options designed to protect infants against severe disease from RSV. CDC advisors recently recommended the monoclonal antibody nirsevimab (Beyfortus) for infants and a maternal RSV vaccine (Abrysvo) designed to pass on protection from mother to infant at birth. In most cases, just one or the other is recommended.
It will be important for providers to discuss both new options with parents, Kaushik said.
Aside from flu and RSV, Kaushik said it's also essential to address the benefits of COVID vaccination in children. Kids, especially those who are immunocompromised, can develop severe complications from COVID, she noted.
Yet, parental hesitancy persists.
Recent polling from KFF found that while nearly half of U.S. adults expect to get the new COVID vaccine this fall, most parents don't expect to get it for their children.
The poll also indicated that there are partisan gaps related to the issue of vaccine hesitancy, but partisans agree their personal doctors, including their children's pediatricians, are "their most trusted sources of vaccine information," KFF noted.
Several suggestions aimed at helping pediatricians have these conversations include listening to parents' concerns and acknowledging them in a non-confrontational way, promoting partnerships in decision-making, and being open regarding what is known about vaccination and what is not known, according to the AAP. Other tips include personalizing information for parents based on cultural beliefs, specific concerns, and literacy level, as well as explaining what clinical trials are and how they work.
'Victims of Our Own Success?'
And it's not just newer vaccines parents are hesitant about.
A little more than 20 years ago, measles was eliminated in the U.S. following the success of the measles, mumps, and rubella (MMR) vaccine. More recently though, there have been a number of measles outbreaks, largely affecting unvaccinated kids.
"It is highly concerning to see outbreaks of measles in the U.S.," Handy said. "We had decades of measles eradication in the country."
Ultimately, she said, "We may be victims of our own success," as these days, parents may not even know what measles is.
But the risks are very real.
MMR is such an effective and safe vaccine that offers lifetime protection, Kaushik said, and measles "can be very devastating."
"It's not a simple rash," Kaushik explained. It can affect the brain and can lead to a condition called subacute sclerosing panencephalitis (SSPE). Advanced stages of the progressive neurological condition are characterized by patient deterioration to a comatose state, and then to a persistent vegetative state. "I've seen children get very, very sick," she added. "We should not take these outbreaks lightly."
Measles is just one example of the risks posed by vaccine hesitancy. Kaushik also pointed to another vaccine-preventable disease: polio.
History has shown how detrimental polio can be long-term if a child contracts it, she said. And, "for decades now, so many millions of children have been protected" through vaccination. She worries about the outcome for an unvaccinated child should we see a large outbreak in the future.
"We need to pick what's best for our children," Kaushik said. Contracting a disease that could have been prevented by a vaccine "might not be a passing event."
She added that children in other parts of the world continue to lose their lives from vaccine-preventable diseases due to a lack of access. In the U.S., "we have had the privilege," of having vaccines available. "My heart really goes out to those children," who cannot get the vaccines they need, she said.
In reiterating the importance of vaccines, new and old, to parents, Handy said it's critical to explain why they have been developed in the first place: "Vaccines are only designed for those infectious diseases that are really consequential pathogens."
Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.
Disclosures
Neither Handy nor Kaushik reported any relevant conflicts of interest.
CLAIM
The more COVID-19 vaccines doses people receive, the higher the risk of getting COVID-19; vaccines contain DNA fragments that modify the genome and cause cancer
DETAILS
Inadequate support: The claim that vaccinated people are more likely to get COVID-19 or aggressive cancers isnt supported by evidence. In fact, epidemiological studies show that additional doses of vaccines reduce the risk of getting COVID-19. Moreover, there is no data indicating that residual DNA contained in COVID-19 vaccines can modify the human genome. Factually inaccurate: Contrary to the claim, regulatory authorities were aware that vaccines could contain residual amounts of DNA. In fact, the amount of residual DNA is among the criteria assessed to ensure quality in the vaccine manufacturing process.
KEY TAKE AWAY
Epidemiological data show that additional doses of COVID-19 vaccines (boosters) reduce the risk of getting the disease. Residual DNA in mRNA vaccines, small fragments broken down by enzymes, are leftovers from the vaccine manufacturing process. The quantity of residual DNA in the COVID-19 mRNA vaccines is within the acceptable range established by regulators, who were aware of residual DNA in the vaccines prior to authorization. Theres no scientific evidence suggesting that residual DNA poses a risk to health in the quantities present in COVID-19 mRNA vaccines.
Once again, Malone made several unsubstantiated claims about COVID-19 vaccine safety. This review will explain what those claims are and why they are unsubstantiated.
The data that is coming from all over the world is that the multiply vaccinated or inoculated are the ones at highest risks of becoming diseased with SARS-CoV-2. Its called negative effectiveness.
Malone claimed that COVID-19 vaccines showed negative effectiveness. It means that getting the vaccine would increase the risk of getting the disease, whereas the goal of a vaccine is supposed to be the opposite.
Malone didnt provide any evidence to support his claim. However, his mention of the multiply vaccinated, strongly hinted at a study by Cleveland Clinic researchers, which assessed the effectiveness of bivalent COVID-19 vaccines in healthcare zorkers[1]. One of the key observations of their study was that the number of vaccine doses received showed a positive association with the risk of COVID-19. This means that people who received more doses also had a great risk of COVID-19.
Because of this observation, the study formed the basis for misinformation, specifically the claim that getting vaccinated against COVID-19 actually increased a persons risk of COVID-19. Health Feedback explained in a previous review that this claim is unsupported by scientific evidence.
The studys lead author, infectious disease physician Nabin Shrestha, clarified in an email to Health Feedback that association is not causation, and that Any claim that our study shows a causal relationship between getting more doses of the COVID-19 vaccine and higher risk of infection is false.
Interpreting the studys results requires taking into account a few of its limitations, as these could bias the results. Its important to keep in mind that there are several variables that can modify ones risk of infection; the number of vaccine doses a person received is only one of them.
One such variable is whether a person was previously infected. This is because a previous infection with SARS-CoV-2 provides some degree of immunity against reinfection, although this protection wanes over time. Therefore, whether participants had had a previous infection by SARS-CoV-2, and how long ago the infection took place, can influence the results of the study. In fact, this was discussed as one of the studys potential limitations by the studys authors in the Discussion section.
Another variable influencing a persons risk of infection is their level of exposure to the virus. For example, frontline healthcare workers, such as physicians and nurses, are more likely to be exposed to the virus compared to those who dont have patient-facing jobs, such as clerical staff. If people who receive more doses of the vaccine are also more likely to have patient-facing jobsand therefore more often exposed to COVID-19then the greater risk of COVID-19 seen in this group could be due to their greater exposure to the virus.
Consequently, the observed association between COVID-19 risk and the number of COVID-19 vaccine doses may simply reflect the fact that people at higher risk of COVID-19 due to their work are more likely to receive more vaccine doses. However, the study didnt report whether those who received more doses were also more likely to hold patient-facing jobs. As such, this is one potential caveat in the study that we cannot rule out.
Contrary to Malones claim, real-world data actually confirm that getting more doses of a COVID-19 vaccine doesnt increase the risk of getting the disease. Several studies reported a reduced risk of infection after a third dose compared to only two doses[2-4]. Additional doses were also associated with a reduced risk of severe disease and hospitalization[5,6].
These [vaccines] are delivering short fragments of DNA into your body and they will cause genetic changes and this may be one of the drivers behind the quote turbo cancers that were seeing arise.
This is simply a repetition of a claim that circulated on the internet in 2023 after the release of two preprints reporting the presence of DNA in the Pfizer and Moderna COVID-19 mRNA vaccines.
Much has been made of these findings, with individuals like entrepreneur Steve Kirsch and outlets like The Epoch Times claiming that this DNA could alter peoples DNA and cause cancer. Health Feedback already discussed this claim in two previous reviews and concluded that it was unsubstantiated.
As we explained before, the vaccine manufacturing process involves the use of DNA. Briefly, a circular of DNA molecule called a plasmid carrying the genetic material to produce the SARS-CoV-2 spike protein, as well as other DNA sequences to improve efficiency, is introduced into the bacterium Escherichia coli. This plasmid is then replicated on a mass scale in the bacterium E. coli.
Next, the plasmid DNA is harvested from the bacteria and cut so that the segment containing the genetic material encoding the spike protein is isolated. This segment is then transcribed into mRNA and incorporated into the vaccine nanoparticles. The remaining DNA from the plasmid is digested by enzymes and broken into pieces. Thus, some amounts of DNA from the manufacturing process can remain in the final product, in the form of small fragments.
While there is residual DNA in the COVID-19 mRNA vaccines, Malone didnt mention that the amount of DNA detected in the vaccine vials is well below the World Health Organization and U.S. Food and Drug Administrations recommended limit of 10 ng DNA/dose . In fact, as a previous Health Feedback review noted, this was acknowledged by the authors of one of the preprints that Malones claim relies on.
Furthermore, there is no scientific evidence or plausible mechanism suggesting that these DNA fragments would alter our genome.
Among the DNA sequences identified, the authors reported the presence of DNA derived from the simian virus 40 (SV40) in the Pfizer vaccine (but not Moderna). The SV40 virus has been found to cause cancer in some animals like hamsters[7,8] and had been the cause of a health scare when it was found to contaminate polio vaccine used in the fifties and sixties.
However, there is no evidence that SV40 increases the risk of cancer in humans, as we explained in one previous review. Furthermore, vaccine vials only contain fragments of one segment of the SV40 DNA, not the virus itself nor its full genetic sequence, which makes the risk of an interaction with our genome even less plausible.
As Health Canada, the Canadian health agency, said in a statement to Health Feedback:
The SV40 promoter enhancer sequence was found to be a residual DNA fragment in Pfizer-BioNTech COVID-19 vaccine. The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators.
Health Canada also told to The Epoch Times that:
The DNA plasmid used for the Pfizer vaccine production is linearised, degraded, and reduced in quantity through additional steps. There is no peer-reviewed evidence that linearised or fragmented DNA is capable of translocating to the nucleus of cells.
Furthermore, even if residual DNA were to make it into our cells, theres also no evidence indicating this would lead to its integration into our DNA, causing mutations. Indeed, cells have mechanisms to recognize and target DNA entering the cells, as the presence of foreign DNA is interpreted as a signal of infection.
In fact, there are already a number of vaccines in use that contain DNA, such as the COVID-19 adenovirus vector vaccines, as well as the chickenpox vaccine (the virus for chickenpox is a DNA virus). Yet they arent associated with genome modification or cancer.
It is also inaccurate to claim that regulators were unaware of residual DNA in the vaccines. Monitoring the presence of residual DNA in biological products and assessing its potential health concerns isnt new to regulatory agencies[9].
A document submitted by BioNTech to the European Medicines Agency, dated 19 February 2021, indicated that residual DNA was among the impurities that were quantified during the process of developing and validating the vaccine manufacturing process(Process- and product-related impurities including host cell genomic DNA, RNA, proteins, endotoxins, bioburden and plasmid isoforms, for the plasmid DNA, are routinely quantified).
Emails released by The Epoch Times also show that Health Canada was aware of the presence of residual plasmid DNA as a process-related impurity during review and prior to the authorisation of the mRNA COVID-19 vaccines.
Finally, Malone also mentioned turbo cancers, that we are allegedly seeing arise. While there is no official definition of what turbo cancer is, the name implies that this is a rapidly progressing, aggressive form of cancer.
Yet, the National Cancer Institute explained that There is no evidence that COVID-19 vaccines cause cancer, lead to recurrence, or lead to disease progression. In fact, cases of alleged turbo cancers are merely a narrative built on anecdotal accounts and have no basis in fact.
A review of global childhood vaccination coverage published today in Morbidity and Mortality Weekly Report shows that routine childhood immunization rates increased in 2022 compared to 2020, but they have yet to reach prepandemic levels in many countries.
The new review is an assessment of the World Health Assembly's Immunization Agenda 2030 (IA2030), the 2021 to 2030 global strategy. A central target of IA2030 is reducing the number of children who have not received the first dose of a diphtheria-tetanus-pertussiscontaining vaccine (DTP) (zero-dose children) 50% by 2030, the authors said.
The initial IA2030 implementation was halted during the COVID-19 pandemic, and estimates show a 40% increase in the number of zero-dose children during 20192021, with fewer vaccinations administered in 2021 compared with 2020. In the current study, the authors used the World Health Organization (WHO) and UNICEF's Estimates of National Immunization Coverage (WUENIC) at the national, regional, and global level to show immediate pre- and post-pandemic changes.
Estimates of global DTP vaccine coverage increased from 86% in 2021 to 89% in 2022, but it remained below 2019 coverage (90%). Among the 194 WHO countries, 73 (38%) experienced at least a 5% decline in DTP coverage from 2019 to 2021, and only 15 (21%) achieved DTP coverage in 2022 that equaled or exceeded that in 2019.
The number of zero-dose children (14.3 million) decreased 21%, from 18.1 million in 2021, but was still 11% higher than the 12.9 million in 2019.
For measles-containing vaccines, coverage increased from 81% to 83% in 2021 and 2022, but it remained below the 2019 coverage level (86%). Currently only the Eastern Mediterranean region has returned to prepandemic levels of coverage.
"Global distribution of zero-dose and incompletely vaccinated children in 2022 highlights equity issues in immunization coverage and ongoing challenges faced by many low- and lower-middleincome countries," the authors wrote.
Zero-dose and undervaccinated children tend to live predominantly in low- and lower-middleincome countries.
"Zero-dose and undervaccinated children tend to live predominantly in low- and lower-middleincome countries and underserved communities; this includes the urban poor and those living in remote rural or conflict-affected settings. WHO and UNICEF recommend that countries enhance their immunization programs to bolster resiliency against public health events such as the COVID-19 pandemic."
Pfizers plunging COVID-19 product demand has spurred a companywide cost-cutting campaign, with nearly 200 jobs now on the chopping block in Michigan.
The New York drug giant is cutting roughly 200 positions at its Kalamazoo, Michigan, site following a review of demand for its COVID-19 vaccine Comirnaty and antiviral Paxlovid, a spokesperson saidFriday.
Pfizer blamed the job cuts on lower-than-expected utilization for COVID-19 products." The companydoes not take these changes lightly," the Pfizer representative added.
All decisions that impact people, processes and initiatives will be made with transparency, compassion and respect, Pfizers spokesperson said over email. We also remain committed to our patients and will continue to produce the COVID-19 vaccine to meet demand."
The move comes after the Big Pharma unveiled a COVID cost-cutting campaign designed to achieve $3.5 billion in savings by the end of 2024.
Earlier this month, Pfizer slashed its 2023 revenue projection by $9 million, which the company blamed on a $7 billion decrease in its projection for sales of oral antiviral Paxlovid plus a $2 billion cut for its BioNTech-partnered COVID vaccine Comirnaty.
Meanwhile, Pfizer recently confirmed plans to shutter its Peapack, New Jersey, facility in early 2024. Of the roughly 791 positions affected, the "vast majority" of workers will be reassigned to Pfizer's New York headquarters, a company spokesperson said earlier this week.
The latest move in Kalamazoo comes after Pfizer threw down $750 million to upgrade that site late in 2022.
Aside from coronavirus vaccines, Pfizer also uses its Kalamazoo plant to make its oral COVID antiviral Paxlovid. As part of a production push for the med, Pfizer last summersaidit would create hundreds of highly skilled jobs at the site, which is among the companys largest.
In June 2022, the company formally unveiled a $120 million investment at the Kalamazoo campus alongside plans to create 250 new jobs, with the aim tobolsterproduction of Paxlovid.
AstraZeneca in partnership with the University of Oxford developed one of the first vaccines against Covid-19. The vaccine, which used an adenovirus to smuggle instructions into human cells to make antibodies against the novel coronavirus, saved countless lives. But a problem soon emerged. A tiny proportion about one in 50,000 of those vaccinated developed blood clots.
This blood clot syndrome is known as vaccine-induced immune thrombotic thrombocytopenia, or VITT. In people with this condition, something goes wrong with the immune response and people make antibodies that can stick to one of the bodys own proteins.
The protein is called platelet factor 4 (PF4). We know that in the course of infection, many people make antibodies that stick to PF4 as part of the immune response, but these antibodies usually stick weakly. In VITT, antibodies form that can stick to PF4 like superglue.
The antibodies in VITT glue PF4 molecules together, forming large structures known as immune complexes. These complexes bind to and activate small cells called platelets that are vital for blood clotting. Normally, platelets float around in the blood in an inactive state, but once activated they spread out, get very sticky, and spew out hundreds of different chemicals.
In VITT, platelets are strongly activated and this causes blood clots. The blood clots commonly affect the veins surrounding the brain, which is a very unusual and rare site for clots. Many people with VITT reported excruciating headaches, which continue to affect survivors.
Billions of platelets get used up in these clots, leading to low numbers of platelets in the blood. In some patients, this led to serious bleeding and nearly one in four died. Many survivors are also have life-long, disabling symptoms.
In just two and a half years, doctors and scientists around the world have begun to unravel the secrets of VITT. How VITT causes clots and why some people get it is a main area of work. Through understanding this, potential treatments are also being discovered.
So far, there is only one genetic clue as to why some people get VITT. A variation of a gene that makes parts of antibodies is linked to VITT and this is more common in people of European descent Europeans seem to be at higher risk of VITT. There must be other genes involved, but they are tricky to find. In the UK, scientists have done DNA sequencing on over 200 patients with VITT and results are expected soon.
In our lab, we work on how platelets get activated in VITT. In 2021, our team showed the main mechanism for platelet activation and have recently discovered another mechanism. In a test tube, we can block this activation with commonly used medicines.
We also see a lot of variation in how platelets from healthy people respond to PF4 and VITT antibodies. We think that this variation in responses is a reason why some people get VITT. We are doing more work to find out the differences between platelets of high and low responders.
Another major puzzle with VITT is why so many people have clots in the brain. To put this into perspective, spontaneous clots in the brain are very rare. They only affect around three or four people in a million a year, yet over half of the patients with VITT had these clots.
There are some theories about why clots in the brain happen more in patients with VITT. These include the speed of blood flow, and the stickiness of PF4 and antibodies to the blood vessels. Recently, Canadian scientists showed that patients whose antibodies stick to PF4 the strongest are most likely to get clots in the brain.
Although adenoviral vaccines have saved millions of lives, they have fallen out of favour in developed countries because of the risk of VITT. However, these vaccines are still widely used in low-income countries. They are highly effective, cheap, and much easier to store and transport than mRNA vaccines such as the Pfizer-BioNTech and Moderna jabs.
Improving the knowledge of VITT has also prompted scientists to look more closely at other patients with unexplained blood clots. Remarkably, more and more patients with clots, low platelets, and VITT-like antibodies are being found. These cases are unrelated to vaccination.
Recently, a VITT-like syndrome was reported in two patients after adenovirus infection rather than vaccination. Testing for these antibodies will probably become routine for patients with unexplained blood clots.
Most importantly, imagine a new pandemic that is a lot more dangerous than Covid-19 perhaps a third of people who catch it die. There would be panic and chaos. We would desperately need adenoviral vaccines despite the risk of VITT. Thats why its important to understand VITT inside and out.
Richard Buka is Haematology Registrar and Clinical Research Fellow, University of Birmingham.
Samantha Montague is Postdoctoral Research Fellow, Institute of Cardiovascular Sciences, University of Birmingham.
Vials containing Pfizer/BioNtech vaccine against the coronavirus disease (COVID-19) are displayed after being used during the second booster vaccination program held at a church, in Santiago, Chile, February 7, 2022. REUTERS/Ivan Alvarado Acquire Licensing Rights
NEW YORK, Oct 31 (Reuters Breakingviews) - Its hard to imagine Pfizer (PFE.N), which invented one of the main vaccines that protect against Covid-19, is worth less now than it was before the pandemic. Yet thats what the pharmaceutical companys $170 billion market capitalization suggests, with year-long fears about declining vaccine demand coming to fruition in third-quarter results. Its an over-reaction, even if Pfizers Covid therapies were to prove worthless.
Pfizer reported plummeting demand for its Covid vaccines and treatments, with an overall revenue decline of over 40% compared to last year, and a $2.4 billion loss that included a $5.6 billion charge for Covid inventory write-offs. Pfizer now thinks 2023 revenue from shots and pills for the disease will total about $12.5 billion, over a 75% decrease from last year.
Thats more than accounted for in the stock. Pfizers non-Covid revenue this year should be around $47 billion and is growing around 7% a year. Peers trade at around 5 times sales, and if Pfizer did too its enterprise value would be about $235 billion. Instead its almost 20% less, and the stock is worth one-fifth less than it was at the end of 2019. Whats more, Pfizer has made a string of cashacquisitions totaling about $70 billion since 2020, suggesting the pandemic should have left it stronger, even if its line-up of Covid defenses is getting only weaker. (By Robert Cyran)
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As the United States heads into the cold-weather months, respiratory virus season has also arrived, with cases of influenza and COVID-19 likely to increase.
The Centers for Disease Control and Prevention (CDC) currently recommends that everyone 6 months and older stay up-to-date and get a flu vaccine and a COVID vaccine, and that it's safe to get both at the same time.
"For flu and COVID, not only does the vaccine reducethe chance of getting sick, it certainly even for those people who get sick reduces their chance of getting severely sick," Dr. Cameron Wolfe, a professor of medicine in the division of infectious diseases at Duke University School of Medicine, told ABC News.
Here's what you need to know about what vaccines are available, and who is eligible to receive them:
For COVID-19, there is an updated vaccine that's formulated to target variants that are currently circulating that are related to XBB, an offshoot of the Omicron variant.
There are formulations made by Pfizer-BioNTech and Moderna for those aged 6 months and older, and a formulation made by Novavax for those aged 12 and older.
"There's a different number of doses that you have to get depending on how many vaccines you've already received in the past," Dr. Shivanjali Shankaran, an associate professor in the department of internal medicine in the division of infectious diseases at Rush University in Chicago, told ABC News.
For those who are between 6 months and 4 years old, the CDC recommends getting two doses of Moderna or three doses of Pfizer if they are unvaccinated. If they've been previously vaccinated, the CDC recommends one or two doses of Moderna or Pfizer, depending on the previous number of doses.
For those aged 5 to 11, the CDC recommends one dose of either Moderna or Pfizer, regardless of previous vaccination status.
When it comes to Americans aged 12 and older, it's recommended that those who are unvaccinated receive one dose of Pfizer or Moderna or two doses of Novavax. Those who have been previously vaccinated are recommended to receive one dose of the Pfizer, Moderna or Novavax updated vaccine.
Those who are moderately or severely immunocompromised may require more doses.
"There's the gain for any individual by taking the vaccine and there's the most gain for people who are immunosuppressed, have heart or lung conditions, or older adults," Wolfe told ABC News. "You know, if you're a 25-year-old who lives with a patient who's had a lung transplant, this is not a bad thing for you to get. In fact, it would be highly encouraged."
For the majority of those aged 6 months and older, the CDC recommends receiving the standard quadrivalent flu vaccine, which protects against four different strains of the virus. If this is an infant or childs first time getting a flu vaccination they should get two doses this season, each at least four weeks apart.
However, for those who are aged 65 and older, the CDC recommends getting one of three vaccines: the high-dose flu shot, the adjuvanted flu shot, or the recombinant flu vaccine, all of which are quadrivalent.
The high-dose shot contains four times the amount of antigen that is, the protein molecule identified with the virus to trigger a stronger immune response, while the recombinant shot contains three times the amount of antigen. The adjuvanted shot is made with an ingredient an adjuvant that helps create an even stronger immune response.
"There is a broadly available shot, of course, [but] there is a high-dose vaccine that's a stronger dose and provides that additional protection, because those who are older in age have more of a challenge to mount an effective response. So getting that high-dose shot or adjuvant is important, because it can provide that critical protection," said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children's Hospital and ABC News contributor.
Traditionally, flu vaccines are made using an egg-based manufacturing process, so if someone has an egg allergy they can instead receive the cell-culture-based flu vaccine, which uses influenza viruses grown in cell cultures rather than in eggs. However, the CDC says the standard vaccine should be safe to receive, even for those allergic to eggs.
"The flu vaccines that are available this year are safe to be taken if you do have an underlying egg allergy," Shankaran said. "As long as someone can monitor you, which I think most places do, anyway."
There is also a nasal spray flu vaccine, made with a live modified virus, which can be given to those between ages 2 and 49. It's specifically not recommended for those who are immunosuppressed or pregnant.
Health officials typically suggest getting the flu shot by Halloween but stress that it's never too late, because the flu season can last into the spring months.
In addition to the vaccines that are now available, there are several clinical trials for both flu and COVID vaccines that are currently undergoing clinical trials.
This includes a flu vaccine from Pfizer using mRNA technology, which was used to develop the COVID-19 vaccine. There's also an mRNA universal flu vaccine, developed by researchers at the National Institute of Allergy and Infectious Diseases Vaccine Research Center.
Pfizer, Moderna and Novavax are also all working to develop a combination COVID-19 and flu vaccine that would offer protection from both viruses in a single shot.
"I do think that having a combo shot if the clinical data suggests that it's safe and effective, clearly will be more appealing to people to have things available in a single shot as opposed to multiple shots, especially if it's challenging for people now that they're trying to chase both COVID and flu vaccines, and maybe not always available at the same time," said Brownstein. "It creates convenience, and potentially just more ease of administration overall, and hopefully reduced costs."
