Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Sep 17, 2021 • 3:31 pm CDT

The Wyoming Department of Health (WDH) announced on September 15, 2021, the detection of a rare but severe case of pneumonic plague in a northern Fremont County resident.

This human plague case is the 7th thought to be acquired in Wyoming since 1978.

Other recorded Wyoming cases include a 1978 out-of-state case acquired in Washakie County, a 1982 Laramie County case, a 1992 Sheridan County case that resulted in death, a 2000 Washakie County case, a 2004 out-of-state case acquired in Goshen County, and a 2008 out-of-state case caught in Teton County.

Dr. Alexia Harrist, the WDH epidemiologist, stated in a press statement, 'while the risk for humans to contract plague is very low in Wyoming, the disease has been documented throughout the state in domestic and wild animals.'

“It’s safe to assume that the risk for plague exists all around our state,” Dr. Harrist added.

“While the disease is rare in humans, it is important for people to take precautions to reduce exposure and to seek prompt medical care if symptoms consistent with plague develop.”

According to the European Centre for Disease Prevention and Control, 30 cases of pneumonic plague were reported in the Republic of Madagascar on September 10, 2021.

The plague was first introduced into the United States in 1900 by rat-infested steamships that had sailed from affected areas, mainly from Asia, says the U.S. CDC.

The last urban plague epidemic in the United States occurred in Los Angeles from 1924 through 1925.

Pneumonic plague is the most severe form and is the only form that can be spread from person to person. Pneumonic plague can develop from inhaling infectious droplets or may develop from an untreated bubonic or septicemic plague, says the CDC.

A plague vaccine is no longer available in the United States. 

However, U.S. FDA inventors confirmed in October 2020 they developed a candidate oral vaccine against plague.

This vaccine consists of a synthetic gene construct that expresses a Y. pestis F1-V fusion antigen linked to a secretion signal, resulting in large amounts of the F1-V antigen. The F1-V synthetic gene fusion is cloned within Ty21a, an attenuated typhoid fever strain licensed for human use as a live oral bacterial vaccine.

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Sep 17, 2021 • 2:11 pm CDT

The U.S. CDC's Morbidity and Mortality Weekly Report published on September 17, 2021, disclosed among U.S. adults without immunocompromising conditions, vaccine effectiveness (VE) against COVID-19 hospitalization from March to August 15, 2021, was higher for the:

  • Moderna SpikeVax vaccine (93%),
  • Pfizer-BioNTech Comirnaty vaccine (88%), and
  • Janssen vaccine (71%).

Although these real-world data from the CDC suggest some variation in levels of protection by each vaccine, these FDA-Approved or Authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization.

'Understanding differences in VE by vaccine product can guide individual choices and recommendations regarding (potential) vaccine boosters.'

However, the findings in this CDC report are subject to at least six limitations, including but not limited to product-specific VE by SARS-CoV-2 betacoronavirus variant, including against Delta variants (B.1.617.2 and AY sublineages), not being evaluated.

Finally, antibody levels were measured at only a single time point 2–6 weeks after vaccination, and changes in antibody response over time and cell-mediated immune responses were not assessed.

MMWR and Morbidity and Mortality Weekly Reports are the U.S. Department of Health and Human Services service marks.

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Sep 17, 2021 • 1:07 pm CDT

After experiencing a brief decline in COVID-19 cases, the United States again sees an increase in cases throughout the country. This increase is related to the highly contagious Delta (B.1.617.2) coronavirus variant.

The less a virus spreads, the less opportunity for new variants to emerge, wrote the U.S. CDC on September 17, 2021.

The SARS-CoV-2 virus that causes COVID-19 has been mutating and producing new variants since 2020. The CDC continues to study and monitor all known variants.

On August 30, 2021, the World Health Organization classified the Mu (B.1.621) variant as a Variant of Interest (VOI).

While the CDC has not designated Mu as a VOI at this time, it reached a peak in the USA in late June 2021 and has steadily declined since then.

Getting vaccinated may be the best way to prevent new variants from emerging.

According to the CDC, people infected with the Delta variant, including fully vaccinated people with symptomatic breakthrough infections, can transmit the virus to others.

There were fewer viral genetic materials for prior virus variants in samples taken from fully vaccinated people who had breakthrough infections than unvaccinated people with COVID-19.

For people infected with the Delta variant, similar amounts of viral genetic material have been found among unvaccinated and fully vaccinated people.

However, like prior variants, the amount of viral genetic material may go down faster in fully vaccinated people when compared to unvaccinated people. This finding means fully vaccinated people will likely spread the virus for less time than unvaccinated people.

'Vaccination is the best way to protect yourself, your family, and your community. High vaccination coverage will reduce the spread of the virus and help prevent new variants from emerging.'

'The CDC recommends that everyone aged 12 years and older gets vaccinated against COVID-19 as soon as possible.'

Note: The UK updated its Variants of Concern or under Investigation data up to September 15, 2021.

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Sep 17, 2021 • 12:22 pm CDT

The U.S. CDC published the 2020-2021 Influenza Season Reported for Week #36, ending September 11, 2021, which found 2.3% of patient visits were due to Influenza-like Illness (ILI).

While influenza virus circulation remains very low at this point in the 2021-2022 flu season, increases in ILI activity are likely due to the circulation of other respiratory viruses

These viruses include respiratory syncytial, parainfluenza, human metapneumovirus, respiratory adenoviruses, coronavirus, rotavirus, and norovirus.

Furthermore, based on mortality surveillance data available on September 16, 2021, about 21% of the deaths during week #36 were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 4,358 PIC deaths reported last week, 3,564 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, and one listed influenza.

This indicates that current PIC mortality is due primarily to COVID-19 and pneumonia, but not influenza.

And, just (1) influenza-associated pediatric death that occurred during the 2020-2021 season has been reported to CDC.

Influenza vaccines protect people against respiratory viruses research indicates will be most common during the upcoming flu season. The CDC recommends most people over the age of six months receive an annual flu shot.

Most U.S. FDA Approved flu vaccines are listed on this Precision Vaccinations webpage.

Additionally, a few things are different for the 2021-2022 flu season, and the CDC has updated its FAQs.

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Sep 17, 2021 • 8:43 am CDT

During the U.S. FDA's Vaccines and Related Biological Products advisory meeting held on September 17, 2021, Sara Oliver M.D., MSPH, presented updates to COVID-19 Epidemiology and COVID-19 Vaccine Effectiveness.

Dr. Oliver's presentation indicates the Delta coronavirus variant has significantly reduced protection against infection (including asymptomatic or mild infections) from the 380 million COVID-19 vaccines administered in the USA during the June-July timeframe.

The U.S. CDC reported data on September 16, 2021, representing about 54.2% of the US population had been fully vaccinated with a COVID-19 vaccine.

The vast majority of COVID-19 vaccines administered in 2021 are the Comirnaty and SpikeVax vaccines.

COVID-19 vaccines effectively prevent mild symptoms, severe disease, and hospitalizations due to COVID-19 disease. But it is still possible for a fully vaccinated person to become infected if exposed to the SARS-CoV-2 betacoronavirus.

The CDC reported fatal Breakthrough Cases reached 2,675 as of September 7, 2021.

Note: Dr. Oliver confirmed that the CDC's COVID-19 vaccine effectiveness calculations had not included the impact of natural immunity generated from a previous SARS-CoV-2 infection.

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Sep 17, 2021 • 7:48 am CDT

The European Centre for Disease Prevention and Control (ECDC) announced on September 15, 2021, over 671 million COVID-19 vaccines have been distributed to twenty-nine EU/EEA countries since the pandemic began in 2019.

The ECDC reported over 71% of these vaccines had been administered to adults.

There are six COVID-19 vaccines in use throughout Europe. The European Medicines Agency publishes information on four Authorized COVID-19 vaccines and the five participating in the Rolling Review process. 

The ECDC's vaccine tracker presents real-time data on current trends, segmented by country and COVID-19 vaccine.

The ECDC is an agency of the European Union.

Note: Certain COVID-19 vaccines from China, India, and Russia are not included in this analysis. 

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Sep 17, 2021 • 7:20 am CDT
Eli Lilly and Company

The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention of SARS-CoV-2 coronavirus infection, Eli Lilly and Company announced on September 16, 2021.

This FDA authorization follows the national reopening of product distribution earlier this month.

The neutralizing antibodies can be used together to treat high-risk individuals 12+ years of age who have not been fully vaccinated against COVID-19, or are not expected to mount an adequate immune response to complete COVID-19 vaccination, and have been exposed to the SARS-CoV-2 virus, or who are at high risk of exposure in institutional settings.

In a placebo-controlled Phase 3 study, bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80% in nursing home residents.

Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, commented in a press release, "We're pleased that this expansion will help us provide antibody therapies as post-exposure prophylaxis to help prevent the spread of COVID-19 to some of the most at-risk individuals in the U.S."

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.

And Etesevimab is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor.

Carl Hansen, Ph.D., CEO, and President of AbCellera, added, “More than 535,000 patients have been treated with bamlanivimab alone or together with etesevimab, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives."

"With this expanded authorization, these antibodies, which are effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus.”

Indianapolis, IN-based Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world.

Sep 16, 2021 • 4:27 pm CDT

Today, Massachusetts-based Moderna, Inc. announced that Health Canada had Approved the New Drug Submission for SPIKEVAX™, known as COVID-19 Vaccine Moderna.

SpikeVax is now Apporved for active immunization to prevent COVID-19 in individuals 12 years of age and older.

The Moderna COVID-19 vaccine was initially authorized in Canada under an Interim Order for individuals 18 years of age and older granted by Health Canada on December 23, 2020. On August 27, 2021, Health Canada expanded the Interim Order authorization for the Moderna COVID-19 vaccine to include adolescents 12 years of age and older.

Health Canada approved the New Drug Submission for SPIKEVAX based on clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the U.S.

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after administering the second dose.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing. It has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. To learn more, visit www.modernatx.com.

Sep 16, 2021 • 2:04 pm CDT

The US Centers for Disease Control and Prevention (CDC) reported six measles cases were confirmed in three jurisdictions as of September 13, 2021. This new CDC data indicates four cases were confirmed over the past month. 

In 2020, thirteen individual cases of measles were confirmed in 8 jurisdictions by the CDC.

While the CDC did not disclose which jurisdictions reported the new measles cases, Wisconsin and Virginia recently announced cases related to inbound international travelers, including from Afghanistan.

Additionally, Stripes reported on September 16th, the US military will inoculate thousands of Afghan evacuees with measles and chickenpox vaccines at U.S. Air Force and Army bases in Germany.

Although measles was declared eliminated in the USA in 2000, almost 1,300 cases were reported in 2019, most related to international travelers. That outbreak was the most significant measles outbreak since 1992.

From a global perspective, almost 41 countries delayed or may put off measles campaigns for 2020 or 2021 due to the COVID-19 pandemic. Unfortunately, these decisions increase the risk of bigger measles outbreaks worldwide, including in the USA.

The CDC's updated top ten measles list as of August 13, 2021, shows the countries of Nigeria (6,170), Pakistan (6,032), and Afghanistan (1,273) reporting measles cases.

Measles is caused by a single-stranded, enveloped RNA virus with one serotype and is highly contagious. Outbreaks can happen in areas where people may be unvaccinated or under-vaccinated.

According to the CDC, around 90% of people who are not protected will become infected following exposure to the measles virus.

The measles virus is transmitted by direct contact with infectious droplets or airborne spread when an infected person breathes, coughs, or sneezes.

And the measles virus can remain infectious in the air for up to two hours after an infected person leaves an area.

People exposed to measles who cannot readily show that they have evidence of immunity against measles should be offered post-exposure prophylaxis. To potentially protect or modify the clinical course of disease among susceptible persons, the CDC suggests either administering an MMR vaccine within 72 hours of initial measles exposure or immunoglobulin within six days of exposure.

However, do not administer MMR vaccine and IG simultaneously, as this practice invalidates the benefits of the MMR vaccine.

Measles can be easily prevented with a measles-containing vaccine, such as the measles-mumps-rubella (MMR) vaccine. Or the combination measles-mumps-rubella-varicella (MMRV) vaccine can be used for children aged 12 months through 12 years.

One dose of MMR vaccine is approximately 93% effective at preventing measles, says the CDC.

Note: Measles vaccines include the M-M-R II, Proquad vaccines, and Priorix is available in most countries.

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Sep 16, 2021 • 9:10 am CDT

A new study published in the New England Journal of Medicine today found a single dose of typhoid conjugate vaccine (TCV) is safe and 84% effective in protecting against typhoid in Malawi.

These are the first efficacy results from Africa and part of a five-year, multi-country project to accelerate the introduction of TCV, stated a University of Maryland School of Medicine press release.

This study's findings are critical as typhoid is an increasing public health threat across sub-Saharan Africa due to the emergence and spread of multi-drug resistant strains. An estimated 19,000 deaths occur each year in sub-Saharan Africa, which includes Malawi.

The vast majority of these infections occur in school-age and pre-school children.

In 2017, the World Health Organization recommended TCV for children six months of age and older in typhoid endemic settings.

The Typbar TCV vaccine contains polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid. Typbar TCV is the only approved vaccine for children and infants less than two years of age.

The ongoing study is being conducted through a partnership between the University of Maryland School of Medicine's Center for Vaccine Development and Global Health and others. It is part of the Typhoid Vaccine Acceleration Consortium.

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Sep 15, 2021 • 4:19 pm CDT

The World Health Organization (WHO) published Influenza Update N° 402 on September 13, 2021, which disclosed the GISRS laboratories tested more than 282,929 specimens during the last period.

The results showed less than 1% (1,580) were positive for influenza viruses, of which 983 (62.2%) were typed as influenza A and 597 (37.8%) as influenza B.

The WHO reported:

  • In the temperate zones of the southern hemisphere, influenza activity remained at inter-seasonal levels.
  • In the temperate zones of the northern hemisphere, influenza activity remained at inter-seasonal levels. 
  • In the Caribbean and Central American countries, sporadic influenza B/Victoria lineage virus detections were reported from Mexico. 
  • In tropical South America, no influenza detections were reported in this period. 

Separately, the UK's Respiratory Datamart reported no influenza-positive sample detected in week #36. In addition, other indicators for influenza such as hospital admissions and GP influenzalike illness consultation rates remain very low.

The U.S. CDC recommends annual influenza vaccination for most people over the age of 6-months.

Influenza vaccines are manufactured differently, and different preparations have different indications as licensed by the U.S. FDA. The types of influenza vaccines include inactivated influenza vaccines and live attenuated influenza vaccines.

Additionally, two new influenza vaccines have been licensed for use in people aged 65 and older: a quadrivalent high-dose influenza vaccine and a quadrivalent adjuvanted influenza vaccine.

An updated overview of influenza vaccines for the 2021-2022 flu season is published on this webpage.

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Sep 15, 2021 • 8:18 am CDT

The U.S. FDA Vaccine Advisory Committee's 167th meeting for September 17, 2021, has released the agenda and presentation materials. 

The Vaccines and Related Biological Products (VRBPAC) committee will meet in an open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for the mRNA Comirnaty vaccine to administer a third dose, or “booster” dose, in individuals 16 years of age and older.

The U.S. FDA currently approves Comirnaty as a two-dose regimen. Countries such as Israel launched 3rd dose programs in late July 2021.

Additional discussing are also planned. Materials for this meeting will be available on the VRBPAC Committee meeting's page.

All meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

The Lancet published a Viewpoint on September 13, 2021, co-authored by former U.S. FDA staff and other immunologists, explaining their suggestion regarding receiving a third COVID-19 vaccination.

These vaccine researchers stated, 'Current evidence does not appear to show a need for boosting in the general population, in which efficacy against severe COVID-19 remains high. Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently.'

Note: The U.S. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

Sep 14, 2021 • 7:30 pm CDT

New York-based Regeneron Pharmaceuticals, Inc. announced today the U.S. Department of Defense and Department of Health and Human Services would purchase 1.4 million additional doses of the REGEN-COV (casirivimab and imdevimab) Antibody Cocktail at the cost of $2,100 per dose.

Under the new agreement, Regeneron will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022. Regeneron expects to begin delivering the additional REGEN-COV doses in September, with the vast majority delivered in Q4 2021.

The U.S. government confirmed it would continue to provide REGEN-COV at no cost to patients.

"More than a year and a half into this pandemic, too many people are still being hospitalized and dying due to COVID-19," said Leonard S. Schleifer, M.D., Ph.D., President and CEO of Regeneron, in a related press statement.

"While vaccination remains the first line of defense to decrease the burden of COVID-19, REGEN-COV is a key tool that reduces the risk of hospitalization or death by 70% in high-risk individuals when given early in the course of the infection."

"Recently, there has been a greater demand for REGEN-COV, and we will provide additional doses to the U.S. government as quickly as possible."

REGEN-COV is an investigational medicine authorized by the U.S. FDA under an emergency use authorization to treat people at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings.

Regeneron (NASDAQ: REGN) is a leading biotechnology company located in Tarrytown, NY, that invents life-transforming medicines for people with serious diseases. Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the USA.

Sep 14, 2021 • 12:24 pm CDT

The Virginia Department of Health (VDH) announced on September 14, 2021, it has identified five individuals diagnosed with measles, a highly contagious illness that is spread through coughing, sneezing, and contact with droplets from the nose, mouth, or throat of an infected individual. 

The people confirmed that measles recently traveled from Afghanistan as part of the United States government’s emergency evacuation efforts, reported the VDH.

The Richmond and Henrico Health Districts (RHHD) have worked with a Richmond area hospital to identify and notify individuals potentially exposed at the hospital on September 10th.

In addition, the Piedmont Health District is working with federal partners to identify measles exposures at Fort Pickett in Nottoway County, VA. 

The US Department of Defence Secretary John F. Kirby said on September 13, 2021, 'Operation Allies Welcome flights into the United States remain paused at the request of the CDC for at least seven additional days from today because of recently diagnosed cases of measles among Afghans who recently arrived in the United States.'

The health departments in Northern Virginia announced on September 11th that they were working together to identify people who may have been exposed at Dulles International Airport and other locations. 

Most Americans are vaccinated against measles as children, which confers lifetime immunity. However, as of August 6, 2021, two measles cases have been confirmed by the U.S. CDC in 2021.

Since the New York-based measles outbreak in 2018-2019, a greater focus had been placed on under-vaccinated children traveling internationally.

But the COVID-19 pandemic changed vaccination rates.

As of May 15, 2020, the Vaccine Tracking System indicated a decrease in orders for measles-containing vaccines. This decline began the week after the COVID-19 national emergency was declared on March 13, 2020.

However, measles cases surged in 2019, reaching the highest level in 23 years, reported the World Health Organization and the US Centers for Disease Control and Prevention (CDC).

And the Pan America Health Organization recently reported about 13% fewer children received their first dose of the MMR vaccine during 2020, compared to the year before. And a study found 32.9% of individuals in Brazil aged 10–40 years old had no antibodies against measles.

Measles is easily preventable through effective vaccines given as part of the measles, mumps, and rubella vaccine series. Two doses are recommended for most individuals, with the first dose given at age 12 to 15 months and the second before kindergarten entry, at age 4 to 6 years.

The M-M-R-II and Proquad vaccines offer measles protection, say the CDC.

The VDH says, 'Clinicians should keep measles as a possible diagnosis when evaluating individuals who have recently entered or returned to the USA.'

'Furthermore, a series of vaccinations are a requirement of parole for the Afghan nationals, including the measles vaccination and additional age-appropriate vaccinations,' confirmed the US Department of State during an Operation Allies Welcome briefing on September 14, 2021.

For more information on measles, visit www.vdh.virginia.gov/epidemiology/epidemiology-fact-sheets/measles-rubeola/. And a history of measles in America is published at this link.

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Sep 14, 2021 • 11:22 am CDT

EClinicalMedicine, an open-access peer-reviewed clinical journal published by The Lancet, found the Sputnik Light vaccine effectively prevented disease among 415,000 seniors living in the Province of Buenos Aires in Argentina.

According to this observational study published on September 12, 2021, the single component of the Sputnik Light vaccine has demonstrated 78.6-83.7% general efficacy against COVID-19 in subjects aged 60-79 years old.

Furthermore, Sputnik Light demonstrated efficacy against hospitalizations at 82.1-87.6%.

These researchers concluded by saying, 'Similarly to other COVID-19 vaccines, the administration of one dose of Sputnik Light (Gam-COVID-Vac) was effective for a wide range of COVID-19–related outcomes.'

Sputnik Light is a recombinant human adenovirus 26 serotype (rAd26) vaccine based on a well-studied platform of human adenoviral vectors, which cause the common cold. As of September 14, 2021, the Sputnik Light vaccine is available in over (18) countries:

Note: This study did not receive outside funding, and the researchers did not disclose any industry conflicts of interest.

The first limitation of this study lies in the observational nature of the study design. In addition, cohort studies differ from clinical trials in several aspects; as the unvaccinated population does not receive a placebo, any behavioral change in the vaccinated population, such as modifying prevention measures and social distancing, might be a source of systematic uncertainty. 

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