New vaccine strategy targets SARS-CoV-2’s stable S2 subunit, offering broad protection against evolving variants – News-Medical.Net

New vaccine strategy targets SARS-CoV-2’s stable S2 subunit, offering broad protection against evolving variants – News-Medical.Net

‘Incredibly promising:’ Researchers encouraged by early results of breast cancer vaccine – News 5 Cleveland WEWS

‘Incredibly promising:’ Researchers encouraged by early results of breast cancer vaccine – News 5 Cleveland WEWS

December 20, 2023

CLEVELAND, Ohio Researchers think the early results from a trial vaccine could be a breakthrough in the fight against an aggressive and deadly form of breast cancer.

This month, Cleveland Clinic and Anixa Biosciences released positive new data from the first phase in the trial of an unnamed vaccine for triple-negative breast cancer.

According to the Centers for Disease Control, one in eight women will be affected by breast cancer in their lifetime. The Cleveland Clinic says about 15% of those cases are triple-negative breast cancer, which spreads more quickly and can be more difficult to treat than other types of cancer.

Jenni Davis recalled the feeling of dread when she was diagnosed with the disease.

You shift how you live when you think about those things, Davis said.

The mother of three visited her doctor after discovering a lump in her left breast. Within weeks of the diagnosis, she began chemotherapy, the first of 26 rounds of radiation and a double mastectomy.

[There was] not a lot of time to process what was happening, Davis said. I have children and my mom and husband and stepdad, everybody. It was difficult.

A team at the Cleveland Clinic successfully treated the Lisbon, Ohio native. But Davis said the progress was tempered by the thought of the cancer returning.

It was in the front of my mind every day, every single day, she said.

Triple-negative breast cancer (TNBC) survivors face a more than 40% chance of the disease coming back. The second occurrence is often more aggressive and difficult to treat. Davis said the statistics made it an easy decision to take part in a vaccine trial for the disease.

I am beyond grateful that I got to be a part of this trial and I'm excited for where it's heading, she said.

Davis was the first human participant in the study of an unnamed vaccine developed with decades of research at the Cleveland Clinic.

Sixteen patients participated in the first phase of the trial. The women, all TNBC survivors with a high risk of developing the cancer again, received three vaccinations given once every two weeks.

Researchers say the early results are encouraging.

Im making some very bold statements based on the results of 16 women, but the data is incredibly promising and we hope as we go forward that we will have as good or better results in larger numbers of women, said Dr. Amit Kumar, the CEO and chairman of Anixa Biosciences.

The biotechnology company is manufacturing the vaccine in collaboration with the Cleveland Clinic. Results released by Anixa in early December show all of the trial participants experienced some immune response from the vaccine. 75% of the women had especially robust cancer-fighting immune responses.

Dr. Kumar is hopeful expanded study of the vaccine will corroborate the early findings. He believes the research and methods used for the TNBC vaccine could help advance the prevention of other diseases.

It may take a few decades, but one day we may have vaccines for multiple types of cancers, he said.

Trial participants, including Davis, report little to no side effects from the vaccine. Davis said its eased her mind and helped her focus on her family and life, rather than a potential future cancer battle.

I look forward to everyone being able to get it, I look forward to my girls being able to get it one day, she said. Its just something I am so thankful for.

Anixa and the Cleveland Clinic are scaling up the first phase of the vaccine trial to include more participants. A second phase set to begin in mid to late 2024 will include a controlled group receiving the standard of care to compare to the group receiving the vaccine.

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Vaccines reduce the risk of long COVID in children – Nature.com

Vaccines reduce the risk of long COVID in children – Nature.com

December 20, 2023

Uptake of COVID-19 vaccinations for children in the United States has been low, even when compared with the rates of influenza vaccination in this age group.Credit: Jeff Kowalsky/AFP via Getty

Vaccinated children are less likely than unvaccinated children to develop long COVID, the myriad of symptoms that can last for months to years following a SARS-CoV-2 infection, according to a forthcoming US study1.

This is really important data, says Jessica Snowden, a paediatric infectious-disease specialist at the University of Arkansas for Medical Sciences in Little Rock. She says that in the United States, COVID-19 vaccines are recommended for children as young as 6 months old. But uptake has been low. This will demonstrate to families how important it is that we protect our kids, not just from acute COVID, but from the longer-term impacts of COVID as well.

For the study, Anna Yousaf, a medical officer at the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, and her colleagues enrolled 1,600 children and collected weekly nasal swabs from them for more than a year to check for the SARS-CoV-2 virus. The team narrowed the study to 622 participants aged 5 to 17 years who caught COVID-19; 28 went on to develop long COVID. The researchers then calculated the odds of vaccinated and unvaccinated children experiencing ongoing symptoms.

The results, presented in October at the annual health-care conference IDWeek in Boston, Massachusetts, and due to be published in the coming months, demonstrated that vaccination reduced the likelihood of developing at least one long COVID symptom by 34% and of developing two or more symptoms by 48%. Yousaf says that this is likely to be an underestimate, because the study only looked at children who had an infection; it did not consider that the vaccine can reduce the chances of developing the infection, which also decreases the likelihood of long COVID.

Danilo Buonsenso, a paediatric infectious-disease specialist at the Gemelli University Hospital in Rome, says that the study design was rigorous but points out that it defined long COVID as the persistence of symptoms after one month, whereas the World Health Organization describes long COVID as symptoms that last for at least two months. He says the study also relied on self-reporting of long COVID and not a clinical diagnosis a problem because long COVID includes several broadly defined symptoms that children might experience on a regular basis. Both issues will make it hard to calculate the real incidence of long COVID in children, but Buonsenso says the comparison between vaccinated and unvaccinated children is still statistically robust. It confirms that vaccinations can reduce the burden of long COVID, but not eliminate it, he says.

The findings line up with several recent studies suggesting that vaccines reduce the incidence of long COVID in adults (see, for example, ref. 2). However, paediatric data are limited a major issue because children are not little adults, Snowden says. Their bodies and immune systems are growing and therefore respond to infection and vaccination differently from adults. As such, it was never a guarantee that the vaccine would have the same protective benefit against long COVID. Studies like this show that kids are worth looking at in and of themselves, Snowden says.

These data are another argument in favour of vaccination, Buonsenso says, particularly for newborns who have not yet been exposed to COVID-19. Some European countries do not recommend the vaccine for younger children, in part because so many have already been exposed to the virus and thus have some immunity.

Even in the United States, where the vaccine is recommended as an annual booster for children as young as 6 months, vaccination remains uncommon. As of mid-December, 7.8% of US children had received their autumn COVID-19 vaccine, well below the rate of influenza vaccination, at 43.3%. Yousaf thinks that this is because the Omicron variant of SARS-CoV-2 is often thought of as a milder strain causing light colds that dont necessarily lead to long COVID. Indeed, a recent US household survey found that the rate of long COVID in children was merely 1.3% in 2022, but that still translates to thousands of kids whose health is affected, meaning they might not be able to run around, play or go to school. If you read the individual stories, the impact of long COVID on a childs life can be very severe, Yousaf says.

COVID is not going away, Snowden says. We are fortunate that so far, the variants are less severe as weve gone forward. But thats not a guarantee. And so anything we can do to protect our children from the long-term impact of COVID is critical.


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Vaccines reduce the risk of long COVID in children - Nature.com
Maternal Flu Shot Protects Infants Against Severe Disease – Medpage Today

Maternal Flu Shot Protects Infants Against Severe Disease – Medpage Today

December 20, 2023

Maternal influenza vaccination was effective at protecting infants under 6 months against severe disease, a case-control study showed.

While overall effectiveness was 34% (95% CI 12-50) against markers of severe disease -- hospitalizations and emergency department (ED) visits combined -- effectiveness was significant for hospitalizations (39%, 95% CI 12-58) but not for ED visits in secondary analyses, according to Leila Sahni, PhD, MPH, of Baylor College of Medicine and Texas Children's Hospital in Houston, and colleagues.

Effectiveness was also greater for infants less than 3 months of age (53%, 95% CI 30-68) and when mom was vaccinated during the third trimester (52%, 95% CI 30-68), they reported in JAMA Pediatrics, though they noted that secondary analyses should be considered exploratory.

"Infants younger than 6 months are at high risk of influenza-associated complications but are not eligible for vaccination given the absence of licensed influenza vaccines for this age group," Sahni and colleagues wrote. "Maternal influenza vaccination is safe, immunogenic, and can prevent laboratory-confirmed influenza and its complications in both mothers and infants."

However, "recent evidence, particularly from the U.S. after the H1N1 pandemic and data on maternal effectiveness by timing during pregnancy are limited," they added. "Updated data are needed on maternal vaccine effectiveness and data to determine optimal timing of vaccination to benefit the pregnant person and their infant."

Further results from secondary analyses showed that effectiveness of maternal influenza vaccination wasn't significant when mothers were vaccinated during their first or second trimesters.

"These findings, particularly the timing of maternal vaccination, weren't surprising to us," Sahni told MedPage Today in an email. "However, this speaks to the complexity of maternal vaccination timing, and the need to balance benefit to the mother who should ideally be vaccinated before influenza season begins, which may occur early in pregnancy, against benefit to the infant, which we found was greatest when vaccination occurs later in pregnancy."

"Additional studies should investigate the timing of vaccination during pregnancy and the benefit to the mother and infant," Sahni added.

Vaccine effectiveness was 47% against influenza B (95% CI 13-68) but it wasn't significant against influenza A, the researchers found; nor was it effective against influenza A subtypes H1N1 or H3N2 in those secondary endpoint analyses.

Sensitivity analyses excluding infants with positive test results for A/H3N2 and mothers with prior season vaccination yielded vaccine effectiveness of 43% (95% CI 17-60) and 42% (95% CI 20-58), respectively, the researchers added.

The study "strengthens the evidence that infants benefit when persons receive the quadrivalent-inactivated influenza vaccine during pregnancy," Katherine Poehling, MD, MPH, of Atrium Health Wake Forest Baptist, in Winston-Salem, North Carolina, and colleagues wrote in an accompanying editorial, noting that guidelines from the CDC and the American College of Obstetricians and Gynecologists recommend that pregnant patients receive the inactivated influenza vaccination during the flu season. "With only half of pregnant persons receiving the influenza vaccine in this study and nationally, there is a huge opportunity to improve vaccine coverage and health outcomes for all pregnant persons and newborns."

Opportunities to optimize the health of mothers and their babies include expanding vaccine registries from children to persons of all ages, having all clinicians who see pregnant persons strongly recommend flu vaccination during pregnancy, and having obstetric and pediatric clinicians collaborate on approaches to improve access to, confidence in, and coverage of vaccines and preventive care, they added.

"These data are very encouraging and provide us with updated evidence supporting the benefit of influenza vaccination during pregnancy to protect both the pregnant person and their infant from serious influenza illness," Samantha Olson, MPH, co-first author of the study and epidemiologist with the CDC's Influenza Division, told MedPage Today in an email.

For this prospective, test-negative case-control study, Sahni and colleagues used data from the CDC's New Vaccine Surveillance Network from the 2016/2017 through the 2019/2020 influenza seasons. Infants younger than 6 months of age with an ED visit or hospitalization for acute respiratory illness were included from seven pediatric medical centers in the U.S. Infants with an influenza-negative molecular test were included as controls.

Among 3,764 infants included in the study, 53% were born to vaccinated mothers, including 94 of 223 (42%) infants with influenza and 1,913 of 3,541 (54%) control infants. Among the 2,007 vaccinated mothers, 54% had vaccination verified by immunization information systems or medical records and 46% had self-reported vaccination with timing.

Study limitations included that information about maternal influenza infection during or after pregnancy was not included, nor were data on influenza vaccination prior to conception or postpartum.

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

The study was supported in part by the CDC.

Authors reported relationships with the NIH, Sanofi, Quidel, Merck, AstraZeneca, Pfizer, GSK, Cepheid, Viracor, AbbVie, Ark Biopharma, Meissa, Moderna, and Shionogi.

Editorialists reported relationships with Optum, Organon Nexplanon, and DynaMed EBSCO Industries.

Primary Source

JAMA Pediatrics

Source Reference: Sahni LC, et al "Maternal vaccine effectiveness against influenza-associated hospitalizations and emergency department visits in infants" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2023.5639.

Secondary Source

JAMA Pediatrics

Source Reference: Zuber MJ, et al "Influenza vaccination in pregnancy -- rolling up sleeves for pregnant persons and infants" JAMA Pediatr 2023; DOI: 10.1001/jamapediatrics.2023.5630.


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Maternal Flu Shot Protects Infants Against Severe Disease - Medpage Today
Why Is COVID-19 Vaccine Player CureVac Stock Plummeting Today? – Yahoo Finance

Why Is COVID-19 Vaccine Player CureVac Stock Plummeting Today? – Yahoo Finance

December 20, 2023

A German court has invalidated a patent central toCureVac N.V's(NASDAQ: CVAC) lawsuit againstBioNTech SE(NASDAQ: BNTX) related to seeking fair compensation for infringement of a portfolio of CureVac's intellectual property rights utilized in Comirnaty, BioNTech, andPfizer Inc's(NYSE: PFE)mRNA COVID-19 vaccine.

The rulingrepresentsthe first decision on validity in ongoing patent litigation between CureVac and BioNTech in Germany, involving eight CureVac intellectual property rights.

Proceedings continue regarding the seven remaining rights, for which validity, infringement, and potential damages will be decided individually.

Following the decision, a ruling on infringement of the German part of EP 1 857 122 B1, scheduled for December 28, 2023, before the Regional Court Dsseldorf, will likely be postponed.

The stakes remain high for CureVac in this legal conflict, Reuters highlighted, citing analysts, the potential transformation of its financial status if even a fraction of the revenues were awarded.

Earlier, a regional German court halted a separate patent infringement trial brought by CureVac against BioNTech, awaiting decisions from German and European patent offices regarding the validity of CureVac's intellectual property rights, indicating the complexities and delays in the legal proceedings.

CureVac and Pfizer/BioNTech are in alegal tussleover the vaccine patent in the U.S. as well.

In May, CureVac was granted to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts to the Eastern District of Virginia. The transfer is expected to significantly accelerate the progress of the litigation, allowing for a likely 2024 trial date.

Last month,Acuitas Therapeuticsfiled a lawsuit in Virginia federal court against Germany-based CureVac, accusing it of failing to credit Acuitas on patents relatedto COVID-19 vaccines.

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Price Action:CVAC shares are down 33.9% at $3.848, and BNTX stock is up 2.69% at $106.36 on the last check Tuesday.

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Hiltzik: The coming toll in vaccine-preventable diseases – Los Angeles Times

Hiltzik: The coming toll in vaccine-preventable diseases – Los Angeles Times

December 20, 2023

Forecasting the future is difficult. But heres an easy prediction: The anti-vaccination movement in the U.S. and globally is going to result in the deaths of more children.

This grim portent comes to us courtesy of UNICEF, which is reporting that 30,601 confirmed cases of measles have been reported in Europe and Central Asia this year through Dec. 5.

Thats up from 909 cases in those regions in 2022, or an increase of 3,266%.

There is no clearer sign of a breakdown in immunization coverage than an increase in cases of measles.

Regina De Dominicis, UNICEF

UNICEF expects the final annual tally to be considerably higher, because the measles rate nearly doubled in October and November, marking a longer-term surge.

There is no clearer sign of a breakdown in immunization coverage than an increase in cases of measles, says Regina De Dominicis, UNICEFs regional director for Europe and Central Asia.

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In the United States, measles has remained more or less under control since the 2019 spike to 1,274 cases: 41 cases reported so far this year, down from 121 in 2022.

The 2019 surge was attributed to pockets of unvaccinated people spreading the virus. A spike also appeared in 2014, when more than half the 667 cases were attributed to unvaccinated Amish communities in Ohio.

That epidemiological pattern is what should give you qualms about what lies ahead for the U.S. Thats because the anti-vaccine movement is in full cry across the country, fueled by right-wing ideology and the presidential campaign, such as it is, of prominent anti-vaccine agitator Robert F. Kennedy Jr.

This 2014 map showed the surging incidence across the world of measles (red), whooping cough (green), mumps (brown), rubella (blue), polio (orange) and other (yellow). In the developed world, the cause was anti-vaccine sentiment; in the Third World, it was the unavailability of vaccines.

(Council on Foreign Relations)

A key factor spurring the spread of anti-vaccine propaganda is the politicization of the COVID-19 vaccines. One leading public health advocate has called that phenomenon an accelerant for the anti-vaccine movement, which likens it to a can of gasoline in the hands of an arsonist.

For anti-vaxxers, it has been only a short step from opposition to COVID vaccine mandates to opposition to all childhood immunization mandates. This has often proceeded under the banner of health freedom, the idea being that individuals should have the untrammeled right to decide for themselves what to put or not put in their bodies.

That may be marginally defensible when it concerns individuals decisions to eat or drink themselves to death, but obviously vaccination is in a different category: A vaccine defends not only patients themselves, but everyone around them fellow pupils, teachers, family members, strangers with whom they come into contact.

Vaccination works best when it reaches coverage of about 95% of a population, producing what is sometimes described as herd immunity, in which a disease is so well suppressed that even the few unvaccinated members are protected.

It doesnt take a very large decline in vaccine coverage to spur a surge in disease incidence. Consider the record in Britain. Through 1997, about 91% of British schoolchildren had received the measles/mumps/rubella (MMR) vaccine.

In 1998, the Lancet, a then-respected British medical journal, published a notorious article claiming a link between the MMR vaccine and autism, and by 2004 the vaccine uptake had fallen to 80%. Measles cases soon surged from an average of about 100 a year through 2005 to 1,280 in 2008 and 1,920 in 2012. By then the vaccination rate had begun to recover, but as of last year it was still below 90%.

That article, by the way, was fully retracted by the Lancet in 2010 and its principal author, Andrew Wakefield, stripped of his medical license. He has since surfaced in the U.S. as a star of the domestic anti-vaccine movement, rubbing shoulders with Kennedy and his gang.

Kennedys entry into the political fray poses a particular peril to public health because political reporters, who may be tasked with interviewing him on policy, may be ill-equipped to challenge the fire hose of misinformation and disinformation he dispenses with cocksure certainty.

When a reporter gets it right, compliments are warranted, so lets examine an interview that CNNs Kasie Hunt conducted with Kennedy on Dec. 15. Hunt came armed. When she quoted Kennedy as saying, There is no vaccine that is, you know, safe and effective, he responded, I never said that.

Hunt cut Kennedy off on the spot and ran a clip from an interview in which he said, yep: There is no vaccine that is, you know, safe and effective.

Kennedy mumbled and bumbled for a moment or two, then confessed to a bad choice of words and eventually retreated to his oft-repeated assertion that none of the vaccines currently recommended for children have ever been tested in a pre-licensing safety study.

Unfortunately, at that point, Kennedy had Hunt at a disadvantage. His assertion was carefully phrased to sound as though the Food and Drug Administration waved through all the childhood vaccines without a second thought. In other statements, Kennedy has made clear that he means that the vaccines have not been subjected to placebo-controlled randomized, double-blinded trials. This is the core of Kennedys claim that hes not anti-vaccine, but merely an advocate for vaccine safety.

As Ive written before, this is misleading to the point of being a flagrant lie.

The truth is that the FDA doesnt allow vaccines on the market unless theyve been safety-tested. When a vaccine is introduced as a treatment for a disease for which no safe and effective vaccine exists, its subjected to one of those randomized, placebo-controlled trials.

Once its approved, however, that standard for later generations of the same vaccine is different. As explained by vaccine specialist Paul Offit of Childrens Hospital of Philadelphia, subjecting those vaccines to placebo-controlled testing, say by injecting them with water or a saline solution instead of the vaccine, would be unethical, because it would require depriving half of the subjects of a known treatment.

The vaccines currently recommended for children are later-generation versions of shots that were placebo-tested. So are the COVID-19 vaccine boosters on the market today.

Offit points to what may be the most famous randomized trial in history, the 1954 test of Jonas Salks polio vaccine, in which about 200,000 first- and second-graders got the vaccine and 200,000 got salt water. Offit tells us that Salk didnt want to structure the trial that way because polio was paralyzing 50,000 American kids a year and killing 1,500, and he felt it was wrong to deprive 200,000 of protection.

In the event, 16 of the child subjects died of polio during the study, all in the placebo group, and 36 were paralyzed, 34 of them in the placebo group. They gave their lives and health for nothing. Even today, when a clinical trial establishes that a treatment is safe and effective, its often halted early, so the placebo patients can get the treatment without waiting.

Hunt let this claim by Kennedy slide, perhaps because she couldnt be prepared in advance for all the lies he was ready to spin out. But the claim was part of his known arsenal, so perhaps she should have been ready.

With RFK Jr. running for President, says veteran pseudoscience debunker David Gorski, being ready with clips to bring home the evidence are not enough. Reporters on the Kennedy beat must develop a deep knowledge of the antivaccine claims that hes been making since at least 2005 and then using that knowledge every time he tries to deny being antivaccine. By his recknoning, Kasie Hunt did way better than average with RFK Jr., but journalists need to do better still.

Fighting back against the anti-vaccine propaganda spewed out by Kennedy and his cohort has never been as desperately crucial as it is today.

Thanks to the sustained assault on vaccination and science waged by right-wingers devoted to burnishing their own partisan bona fides rather than working in the public interest, vaccine coverage of kindergarten children has been declining since 2019 and remains well below the 95% target, according to the Centers for Disease Control and Prevention.

The share of children with a nonmedical exemption from vaccination, such as a parents purported religious or moral objections, reached 3% in the 2022-23 school year, the highest exemption rate ever reported in the United States, the CDC reports.

In Florida, that hotbed of anti-science folderol purveyed by Republican Gov. Ron DeSantis and his handpicked surgeon general, the anti-vaccine charlatan Joseph Ladapo, school vaccine rates for non-COVID diseases fell in 2022 to the lowest level in 10 years. Its rate fell again this year, by an appalling 0.6 percentage points to 4.5%, the 12th worst in the nation.

States with responsible leaders respond to trends that threaten public health to that degree. After Californias 2010 outbreak of whooping cough (pertussis) 9,120 cases, the most since 1947, the majority among unvaccinated children the Legislature eliminated almost all nonmedical exemptions for childhood immunization. Californias exemption rate of 0.2% in 2022-23 was the third best in the nation, after West Virginia and New York.

Can vaccine resisters be reached with a rational counterargument? One would think so. They tend not to be low-income, low-information residents two of the most-vaccinated states are West Virginia and Mississippi.

Rather, they tend to come from more affluent, educated families, the sort of people who think theyre so smart they can decide healthcare policies for themselves, no matter how complex the issue.

In this respect, however, theyre just being stupid and irresponsible. They should be receptive to reason. Lets hope that it doesnt take outbreaks of dangerous diseases like measles in their school districts to open their eyes.


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Hiltzik: The coming toll in vaccine-preventable diseases - Los Angeles Times
EU Hoarding Then Dumping COVID Vaccines Highlights Pandemic Accord Equity Challenge – Health Policy Watch

EU Hoarding Then Dumping COVID Vaccines Highlights Pandemic Accord Equity Challenge – Health Policy Watch

December 20, 2023

Vials of Pfizers COVID-19 vaccine.

Days after government officials took a break from frenetic pandemic accord negotiations, news broke that European countries had destroyed at least 215 million unwanted COVID-19 vaccine doses valued at over 4 billion.

The 19 countries surveyed dumped 0.7 doses per resident with Estonia and Germany being the most wasteful, according to Politico, which broke the story this week.

In 2021, the European Union (EU) bought the equivalent of three doses per resident in secret deals with drug companies hoarding these when African countries did not have access to any vaccines, not even for health workers.

Ending this cycle of waste and want is at the heart of the current pandemic agreement negotiations hosted by the World Health Organization (WHO). The talks are due to conclude in May 2024 with an agreement to govern countries conduct during pandemics but parties seem to have entrenched disagreement about how best to ensure equitable access to vaccines and other medical products in future pandemics.

The Peoples Vaccine Alliances Piotr Kolczyski said that the EU appears not to have learnt from its COVID mistakes, based on the positions it has taken during the pandemic agreement negotiations.

The EU pumped unprecedented public funding into COVID-19 vaccines with no strings attached to ensure universal access. Yet, instead of learning from its mistakes, public funding conditionalities have been deleted from the draft Pandemic Agreement, and the EU is now trying to remove the remaining transparency and equity measures too, said Kolczyski, who is the EU Health Policy Advisor at Alliance and Oxfam.

Several countries and non-state actors involved in the pandemic agreement negotiations advocate for governments that have invested public money in the development of pandemic products to retain a stake in these via measures such as shares or joint intellectual property (IP) so that private companies do not call the shots during pandemics.

However, the EU and the US have been lukewarm about this proposal.

Meanwhile, the four global co-convenors of the COVID-19 vaccine access platform, COVAX, urged in a joint statement on Tuesday that future global pandemic preparedness and response architecture be informed by COVAX learnings.

Noting that COVAX would close at the end of December, the Coalition for Epidemic Preparedness Innovations (CEPI), vaccine alliance Gavi, UNICEF and the WHO, highlighted three key learnings.

The first is the need to design, invest in and implement an end-to-end solution to equitable access ahead of time that centres on the needs of the most vulnerable.

While vaccine nationalism will persist in future pandemics, they urge mechanisms to mitigate it including by diversifying vaccine manufacturing so all regions have access to supply.

The third lesson is the need to take financial risks to avoid potentially deadly delays to the development, procurement and delivery of medical countermeasures.

Money left over from COVAX will be redirected to implement some of these lessons, including investing $1 billion in the establishment of an African Vaccine Manufacturing Accelerator (AVMA) to support African vaccine manufacturing, a measure announced recently by the Gavi board.

In addition, a First Response Fund will be established to ensure financing for a vaccine response is immediately available in the event of a future pandemic, they note.

Meanwhile, Tuesday also saw the launch of a new South-South partnership, the Health Development Partnership for Africa and the Caribbean (HeDPAC) to strengthen health cooperation between Africa and the Caribbean.

Promoting technology transfer for pharmaceutical manufacturing, building regulatory capacity, and enhancing universal health coverage will be core HeDPAC strategies, according to a statement released via the WHO.

COVID-19 left an indelible scar on our global solidarity and the right of all people to good health, said Prime Minister Mia Mottley of Barbados. It is our shared responsibility to ensure that the inequity of the global response to COVID-19 is not repeated. This is the kind of action that will allow us to help people where they need it most.

HeDPAC will also focus on strengthening the health workforce in the two regions, and sharing innovative solutions in primary health care, with a special emphasis on climate resilience, and maternal and child health.

The seventh meeting of the Intergovernmental Negotiating Body (INB) negotiating the pandemic agreement ended late on 7 December with a rapid and vapid report back likely indicating that the negotiations remain difficult.

While informal inter-sessional meetings are set to continue in early January, the INB meets for the eighth time from 19 February to 1 March 2024.

A ninth meeting is also planned before the World Health Assembly at the end of May at which the pandemic agreement is due to be presented.

Image Credits: Photo by Mat Napo on Unsplash, @CEPI .

Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.


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EU Hoarding Then Dumping COVID Vaccines Highlights Pandemic Accord Equity Challenge - Health Policy Watch
United Workers’ Job Bias Suit Over Covid Vaccine Mandate Trimmed – Bloomberg Law

United Workers’ Job Bias Suit Over Covid Vaccine Mandate Trimmed – Bloomberg Law

December 20, 2023

United Airlines Inc. convinced a federal judge to dismiss several claims from a proposed class lawsuit over the companys handling of workers with religious or medical objections to receiving Covid-19 vaccination.

The ruling Monday by the US District Court for the Northern District of Texas rejected allegations by two of the workers leading the suit that they were denied accommodation for their religious beliefs when they were told to mask up at work and regularly submit Covid tests if they didnt want to be vaccinated. Those allegations failed to plausibly state that the workers experienced an adverse employment action, the ...


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Treating green tech like COVID vaccines will only benefit the rich – POLITICO Europe

Treating green tech like COVID vaccines will only benefit the rich – POLITICO Europe

December 20, 2023

Press play to listen to this article

Voiced by artificial intelligence.

Max Lawson is co-chair of the Peoples Vaccine Alliance and head of inequality policy at Oxfam International.

This years United Nations Climate Change Conference COP28 the global climate summit hosted by a petrostate has ended with a grossly inadequate set of commitments that wont come close to ending fossil fuel extraction. And, in its wake, theres already another scandal on the horizon.

Government delegations think green technologies will be essential in averting climate breakdown. The problem, however, is that almost 80 percent of corporations patenting climate tech are in rich countries, with the blueprints and know-how hidden behind strict intellectual property protections.

This means were facing the possibility that green technologies may only benefit the rich.

The world has stood at this crossroads before and not that long ago. As health campaigners know all too well from the COVID-19 pandemic and many health crises before it, corporations that patent life-saving technologies rarely respond to emergencies with altruism. Rather, their governments tend to close ranks, protecting monopoly profits over humanitarian considerations.

Rich countries hoarded the worlds supply of COVID-19 shots and monopolized their production, while vaccine factories in the global south sat idle. In response, South Africa and India led over 100 countries at the World Trade Organization (WTO), calling for the suspension of intellectual property rules on COVID-19 vaccines, tests and treatments. But despite the devastating death tolls borne by the worlds poorer countries, the rich ones blocked any meaningful measures that could have compelled corporations to share vaccine blueprints.

It was this state of affairs that early on in the pandemic led us to establish the Peoples Vaccine Alliance a coalition of civil society organizations, humanitarians, politicians and experts dedicated to ensuring that everyone, everywhere could access COVID-19 vaccines, tests and treatments. And though rich countries and Big Pharma ultimately blocked the intellectual property waiver, the movement created unprecedented pressure for an end to pandemic profiteering.

It was in everyones interests both rich countries and poorer ones to ensure rapid vaccination for the whole world, contain the virus and prevent deadly mutations, but we were failed by governments and corporations hell-bent on maximizing profits. By the end of 2021, COVID-19 vaccines had created nine new billionaires, while their unequal rollout had led to one preventable death every 24 seconds.

The same can now be said of climate breakdown. Patents and trade secrets may have barely been mentioned at COP28, but a similar showdown is brewing over the rights to climate technologies.

U.N. Secretary-General Antnio Guterres has urged governments to remove intellectual property barriers and treat key renewable technologies [] as global public goods. And WTO Director General Ngozi Okonjo-Iweala, who has seen this all play out before, has urged governments to prepare domestic legislation to overcome intellectual property barriers, warning that this is the time to get ready for climate-induced health crises.

Industry lobbyists, meanwhile, are already using the specter of a climate intellectual property waiver to stifle attempts at getting COVID-19 tests and treatments to global south countries. In February, business groups lambasted the United States International Trade Commission with warnings that helping overcome COVID-19 patents could be a slippery slope toward God forbid! the sharing of climate technologies with poorer countries.

Big business is gearing up for a fight, and the climate justice movement needs to step in.

Moving away from fossil fuels to renewable energy is in all our interests and cannot happen in rich countries alone. But fossil fuel corporations have held the global response back, lying, lobbying and suppressing competition to fuel gargantuan profits all enabled by powerful governments. The investments of 125 of the richest billionaires produce 393 million tons of carbon pollution every year thats a million times more than the average person while the poorest communities that have contributed the least to the climate crisis are already suffering the worst consequences.

Technology transfer is a crucial part of helping global south countries adapt and respond to climate breakdown, and it should be seen as a fundamental part of loss and damage. Governments cannot ignore the threat posed by intellectual property rules. And while it remains to be seen whether global south countries will propose a waiver for climate technologies, India has reportedly already considered the idea.

Ultimately, this all comes down to a question of trust. Can we trust big business, the super-rich and their governments to accept lower profits out of the goodness of their hearts?

With COVID-19, this approach led to a global vaccination disparity so vast that it was dubbed vaccine apartheid. And unless the climate movement takes on this cause, we may see a green technology apartheid too.


See more here: Treating green tech like COVID vaccines will only benefit the rich - POLITICO Europe
Impact of the gut microbiome on immunological responses to COVID-19 vaccination in healthy controls and people … – Nature.com

Impact of the gut microbiome on immunological responses to COVID-19 vaccination in healthy controls and people … – Nature.com

December 20, 2023

World Health Organization (accessed 14 July 2023). https://covid19.who.int/.

Polack, F. P. et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N. Engl. J. Med. 383, 26032615 (2020).

Article CAS PubMed Google Scholar

El Sahly, H. M. et al. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. N. Engl. J. Med. 385, 17741785 (2021).

Article CAS PubMed Google Scholar

Antonelli, M. et al. Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study. Lancet Infect. Dis. 22, 4355 (2022).

Article CAS PubMed PubMed Central Google Scholar

Baden, L. R. et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N. Engl. J. Med. 384, 403416 (2021).

Article CAS PubMed Google Scholar

Carazo, S. et al. Estimated protection of prior SARS-CoV-2 infection against reinfection with the Omicron variant among messenger RNAvaccinated and nonvaccinated individuals in Quebec, Canada. JAMA Netw. Open 5, e2236670 (2022).

Article PubMed PubMed Central Google Scholar

Connors, J., Bell, M. R., Marcy, J., Kutzler, M. & Haddad, E. K. The impact of immuno-aging on SARS-CoV-2 vaccine development. Geroscience 43, 3151 (2021).

Article CAS PubMed PubMed Central Google Scholar

Soiza, R. L., Scicluna, C. & Thomson, E. C. Efficacy and safety of COVID-19 vaccines in older people. Age Ageing 50, 279283 (2021).

Article PubMed Google Scholar

Lynn, D. J. & Pulendran, B. The potential of the microbiota to influence vaccine responses. J. Leukoc. Biol. 103, 225231 (2018).

Article CAS PubMed Google Scholar

McDermott, A. J. & Huffnagle, G. B. The microbiome and regulation of mucosal immunity. Immunology 142, 2431 (2014).

Article CAS PubMed PubMed Central Google Scholar

Baradaran Ghavami, S. et al. Cross-talk between immune system and microbiota in COVID-19. Expert Rev. Gastroenterol. Hepatol. 15, 12811294 (2021).

Article CAS PubMed Google Scholar

Mezouar, S. et al. Microbiome and the immune system: from a healthy steady-state to allergy associated disruption. Hum. Microbiome J. 10, 1120 (2018).

Article Google Scholar

Li, D., Breiman, A., Le Pendu, J. & Uyttendaele, M. Anti-viral effect of Bifidobacterium adolescentis against noroviruses. Front. Microbiol. 7, 864 (2016).

PubMed PubMed Central Google Scholar

Chiang, B.-L., Sheih, Y., Wang, L., Liao, C. & Gill, H. Enhancing immunity by dietary consumption of a probiotic lactic acid bacterium (Bifidobacterium lactis HN019): optimization and definition of cellular immune responses. Eur. J. Clin. Nutr. 54, 849855 (2000).

Article CAS PubMed Google Scholar

Gill, H. S., Rutherfurd, K. J., Cross, M. L. & Gopal, P. K. Enhancement of immunity in the elderly by dietary supplementation with the probiotic Bifidobacterium lactis HN019. Am. J. Clin. Nutr. 74, 833839 (2001).

Article CAS PubMed Google Scholar

Atarashi, K. et al. Induction of colonic regulatory T cells by indigenous Clostridium species. Science 331, 337341 (2011).

Article CAS PubMed Google Scholar

Chen, J. & Vitetta, L. Inflammation-modulating effect of butyrate in the prevention of colon cancer by dietary fiber. Clin. Colorectal Cancer 17, e541e544 (2018).

Article PubMed Google Scholar

Furusawa, Y. et al. Commensal microbe-derived butyrate induces the differentiation of colonic regulatory T cells. Nature 504, 446450 (2013).

Article CAS PubMed Google Scholar

Lynn, D. J., Benson, S. C., Lynn, M. A. & Pulendran, B. Modulation of immune responses to vaccination by the microbiota: implications and potential mechanisms. Nat. Rev. Immunol. 22, 3346 (2022).

Article CAS PubMed Google Scholar

Vitetta, L., Saltzman, E. T., Thomsen, M., Nikov, T. & Hall, S. Adjuvant probiotics and the intestinal microbiome: enhancing vaccines and immunotherapy outcomes. Vaccines 5, 50 (2017).

Article PubMed PubMed Central Google Scholar

Huda, M. N. et al. Stool microbiota and vaccine responses of infants. Pediatrics 134, e362e372 (2014).

Article PubMed PubMed Central Google Scholar

Harris, V. C. et al. Effect of antibiotic-mediated microbiome modulation on rotavirus vaccine immunogenicity: a human, randomized-control proof-of-concept trial. Cell Host Microbe 24, 197207.e194 (2018).

Article CAS PubMed Google Scholar

Harris, V. C. et al. Significant correlation between the infant gut microbiome and rotavirus vaccine response in rural Ghana. J. Infect. Dis. 215, 3441 (2017).

Article CAS PubMed Google Scholar

Pabst, O. & Hornef, M. Gut microbiota: a natural adjuvant for vaccination. Immunity 41, 349351 (2014).

Article CAS PubMed Google Scholar

Nakaya, H. I. et al. Systems biology of vaccination for seasonal influenza in humans. Nat. Immunol. 12, 786795 (2011).

Article CAS PubMed PubMed Central Google Scholar

Oh, J. Z. et al. TLR5-mediated sensing of gut microbiota is necessary for antibody responses to seasonal influenza vaccination. Immunity 41, 478492 (2014).

Article CAS PubMed PubMed Central Google Scholar

Kim, D. et al. Recognition of the microbiota by Nod2 contributes to the oral adjuvant activity of cholera toxin through the induction of interleukin1. Immunology 158, 219229 (2019).

Article CAS PubMed PubMed Central Google Scholar

Kim, D. et al. Nod2-mediated recognition of the microbiota is critical for mucosal adjuvant activity of cholera toxin. Nat. Med. 22, 524530 (2016).

Article CAS PubMed PubMed Central Google Scholar

Turroni, F. et al. Exploring the diversity of the bifidobacterial population in the human intestinal tract. Appl. Environ. Microbiol. 75, 15341545 (2009).

Article CAS PubMed PubMed Central Google Scholar

Koff, W. C. et al. Development and deployment of COVID-19 vaccines for those most vulnerable. Sci. Transl. Med. 13, eabd1525 (2021).

Article CAS PubMed Google Scholar

Pellini, R. et al. Initial observations on age, gender, BMI and hypertension in antibody responses to SARS-CoV-2 BNT162b2 vaccine. EClinicalMedicine 36, 100928 (2021).

Article PubMed PubMed Central Google Scholar

Stefan, N., Birkenfeld, A. L. & Schulze, M. B. Global pandemics interconnectedobesity, impaired metabolic health and COVID-19. Nat. Rev. Endocrinol. 17, 135149 (2021).

Article CAS PubMed Google Scholar

Mller, L. et al. Age-dependent immune response to the Biontech/Pfizer BNT162b2 coronavirus disease 2019 vaccination. Clin. Infect. Dis. 73, 20652072 (2021).

Article PubMed Google Scholar

Dandachi, D. et al. Characteristics, comorbidities, and outcomes in a multicenter registry of patients with human immunodeficiency virus and coronavirus disease 2019. Clin. Infect. Dis. 73, e1964e1972 (2021).

Article CAS PubMed Google Scholar

Geretti, A. M. et al. Outcomes of coronavirus disease 2019 (COVID-19) related hospitalization among people with human immunodeficiency virus (HIV) in the ISARIC World Health Organization (WHO) clinical characterization protocol (UK): a prospective observational study. Clin. Infect. Dis. 73, e2095e2106 (2021).

Article CAS PubMed Google Scholar

Hoffmann, C. et al. Immune deficiency is a risk factor for severe COVID19 in people living with HIV. HIV Med. 22, 372378 (2021).

Article CAS PubMed Google Scholar

Chang, M. et al. Changes of gut microbiota in pregnant sows induced by 5-Aminolevulinic acid. Res. Vet. Sci. 136, 5765 (2021).

Article CAS PubMed Google Scholar

Mak, J. W. Y. Modulation of gut microbiota to enhance health and immunity (accessed 2 July 2023). https://clinicaltrials.gov/ct2/show/NCT04884776 (2020).

Falahi, S. & Kenarkoohi, A. Host factors and vaccine efficacy: implications for COVID19 vaccines. J. Med. Virol. 94, 13301335 (2022).

Article CAS PubMed Google Scholar

Chen, J., Vitetta, L., Henson, J. D. & Hall, S. The intestinal microbiota and improving the efficacy of COVID-19 vaccinations. J. Funct. Foods 87, 104850 (2021).

Article CAS PubMed PubMed Central Google Scholar

Zhao, T. et al. Influence of gut microbiota on mucosal IgA antibody response to the polio vaccine. npj Vaccines 5, 47 (2020).

Article CAS PubMed PubMed Central Google Scholar

Praharaj, I. et al. Influence of nonpolio enteroviruses and the bacterial gut microbiota on oral poliovirus vaccine response: a study from South India. J. Infect. Dis. 219, 11781186 (2019).

Article CAS PubMed Google Scholar

Ichinohe, T. et al. Microbiota regulates immune defense against respiratory tract influenza A virus infection. Proc. Natl Acad. Sci. USA. 108, 53545359 (2011).

Article CAS PubMed PubMed Central Google Scholar

Hagan, T. et al. Antibiotics-driven gut microbiome perturbation alters immunity to vaccines in humans. Cell 178, 13131328.e1313 (2019).

Article CAS PubMed PubMed Central Google Scholar

Wells, J. M. Immunomodulatory mechanisms of lactobacilli. Microbial Cell Factories 115 (BioMed Central, 2011).

Wexler, H. M. Bacteroides: the good, the bad, and the nitty-gritty. Clin. Microbiol. Rev. 20, 593621 (2007).

Article CAS PubMed PubMed Central Google Scholar

Wright, E. K. et al. Microbial factors associated with postoperative Crohns disease recurrence. J. Crohns Colitis 11, 191203 (2017).

Article PubMed Google Scholar

Chilton, P. M., Hadel, D. M., To, T. T., Mitchell, T. C. & Darveau, R. P. Adjuvant activity of naturally occurring monophosphoryl lipopolysaccharide preparations from mucosa-associated bacteria. Infect. Immun. 81, 33173325 (2013).

Article CAS PubMed PubMed Central Google Scholar

Fix, J. et al. Association between gut microbiome composition and rotavirus vaccine response among Nicaraguan infants. Am. J. Tropical Med. Hyg. 102, 213 (2020).

Article Google Scholar

Zafar, H. & Saier, M. H. Jr Gut Bacteroides species in health and disease. Gut Microbes 13, 1848158 (2021).

Article PubMed PubMed Central Google Scholar

Domingo, M.-C. et al. Cloacibacillus sp., a potential human pathogen associated with bacteremia in Quebec and New Brunswick. J. Clin. Microbiol. 53, 33803383 (2015).

Article PubMed PubMed Central Google Scholar

Dong, T. S. et al. Gut microbiome profiles associated with steatosis severity in metabolic associated fatty liver disease. Hepatoma Res. 7, https://doi.org/10.20517/2394-5079.2021.55 (2021).


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Impact of the gut microbiome on immunological responses to COVID-19 vaccination in healthy controls and people ... - Nature.com
JN.1 Covid cases: Will existing vaccines work against the new variant? Here’s what experts said – Business Today

JN.1 Covid cases: Will existing vaccines work against the new variant? Here’s what experts said – Business Today

December 20, 2023

JN.1 was first detected in the US in September 2023.

India is seeing a sudden surge in Covid-19 cases after the newest variant -- JN.1 sub-variant -- claimed four lives in Kerala. On Tuesday, the Union Health Ministry said that India has reported 260 new coronavirus infections, bringing the total COVID cases to 4.50 crore so far since the virus was detected.

In the wake of surging Covid-19 cases in the country, the government has advised states to remain vigilant in the wake of the detection of the JN.1 variant. A major question that arises following the recent surge is whether the vaccination administered before will be effective now.

JN.1 is closely related to the variant BA.2.86, says the US Centers for Disease Control and Prevention (CDC). JN.1 (also known as Pirola) was first detected in the US in September 2023.

Symptoms of JN.1 are similar to those of other coronavirus variants, including fever, runny nose, sore throat, headache, and mild gastrointestinal issues.

The CDC, in its statement, said: The continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems. At this time, there is no evidence that JN.1 presents an increased risk to public health relative to other currently circulating variants. There is no indication of increased severity from JN.1 at this time.

Earlier experts have said JN.1 contains one additional mutation on the spike protein as compared with Pirola, which is what SARS-CoV-2 uses to latch onto patients' cells and make them sick. It was closely watched by researchers because Pirola contains more than 30 mutations on the spike protein.

In the case of India, most health experts feel that booster doses can help vulnerable patients maintain immunity over time.

As per government data, around 95 per cent citizens have received the first two doses of a Covid-19 vaccine. About a quarter have received the third or booster dose.

Dr Shailesh Sahay, Director of Internal Medicine at Max Hospital- Gurgaon, told India Today: "Vaccinations are essential for reducing the effects of Covid-19 variations, including JN.1. Boosters help the body maintain immunity over time and adjust to new strains."

Dr Sahay further said booster doses could enhance protection with a better immune response. He highlighted the significance of primary preventative measures such as mask-wearing, social distancing, and hand hygiene.

Dr Anita Mathew, Director-Internal Medicine, Fortis Hospital, Mulund, told the Economic Times: "The new variant JN1 is from the Omicron family is able to elude the immunity provided by the latest vaccine, which includes immunity against Omicron."

Dr Anurag Agarwal, a member of WHOs Technical Advisory Group on Sars-CoV-2 Virus Evolution, said: Almost everyone in India has had the infection at least two or three times so far. Most have also received at least two doses of the vaccine. This high, population-level immunity will mean that we are not likely to see the typical pneumonia-like symptoms that were seen during the first and second wave. So vaccinating to reduce the number of infections does not make sense.

What WHO said

The WHO has noted that there is no evidence that JN.1 presents an increased risk to public health relative to the other circulating variants. There is no indication of increased severity from JN.1 at this time.

WHOs technical lead Maria Van Kerkhove in a post on X elaborated on the recent surges, and what precautions can be taken. Respiratory diseases are increasing around the world due to a number of pathogens incl Covid-19, flu, rhinovirus, mycoplasma pneumonia and others. SARS-CoV-2 continues to evolve. JN.1 (sub-variant of BA.2.86) is already a VOI and continues to increase in circulation, she wrote on X.

WHO highlighted that sera from patients who had Omicron breakthrough infections (including XBB), exhibited robust neutralising activity against BA.2.86, suggesting that upcoming XBB.1.5 monovalent vaccines could confer added protection, by triggering the expansion of existing B cells that will enhance cross-protection against BA.2.86 and its descendant lineages (including JN.1). In addition, the existing Covid-19 tests and treatments are also expected to be effective against JN.1.

The Union Health Ministry has said that the existing line of treatment for Covid-19 is expected to be effective against the latest variant as well. It has not issued any special advisory on taking a booster shot.

The ministry has written to states and Union Territories asking them to monitor cases of influenza-like illnesses, conduct adequate testing, and send all positive samples for whole genome sequencing.

Also read:'Ramp-up testing, send samples for sequencing': Centre writes to states as Covid-19 variant JN.1 detected in Kerala


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JN.1 Covid cases: Will existing vaccines work against the new variant? Here's what experts said - Business Today