Category: Vaccine

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Scientists infect volunteers with Zika in hunt for vaccines, treatments – Reuters

October 23, 2023

Aedes aegypti mosquitoes are seen in a cage at the CNEA (National Atomic Energy Commission), in Ezeiza, in the outskirts of Buenos Aires, Argentina April 12, 2023. REUTERS/Agustin Marcarian/File photo Acquire Licensing Rights

Oct 21 (Reuters) - Researchers in the United States have shown for the first time they can safely and effectively infect human volunteers with Zika virus, a step towards learning more about the disease and developing vaccines and treatments.

The study known as a "controlled human infection model" has previously been controversial for Zika because of the risks to participants and lack of treatments.

But U.S. regulators and the World Health Organization ruled the new model, developed by a team at the Johns Hopkins Bloomberg School of Public Health, was safe and scientifically important.

Zika is a viral infection spread by mosquitoes, which is usually mild or asymptomatic.

But a major outbreak in the Americas in 2015 and 2016 showed it can be dangerous for pregnant women and foetuses, causing devastating birth defects such as microcephaly, a disorder in which a child is born with an abnormally small head and brain.

There are no vaccines or treatments, and the outbreak in the Americas ended before new ones could be fully tested. Infections have dwindled worldwide since, with about 40,000 reported last year from that region.

But the WHO has warned that surveillance can be patchy, and transmission patterns for Zika are not well understood. Climate change is also likely to boost the spread, which is already established in 91 countries.

Anna Durbin, the Johns Hopkins professor who led the study, said developing countermeasures was essential because infections could re-surge.

Also significant, she added, was the mental health burden on pregnant women in endemic regions, who worry about the virus and their babies but have limited protection options.

Durbin and her colleagues used two strains of Zika to infect 20 female volunteers who were not pregnant or lactating. All developed laboratory confirmed infections, with mild illness. Eight others got a placebo.

To minimize the risks, the patients were admitted to an inpatient unit and monitored until they were free of the virus. They agreed to use birth control methods for two months.

The next step is evaluating the strains in male volunteers, in part to assess how long the virus, which can be sexually transmitted, stays infectious in semen.

Durbin said several vaccine manufacturers have already asked to use the strains to test experimental products.

The data was presented as an abstract at the annual meeting of the American Society of Tropical Medicine and Hygiene in Chicago.

Reporting by Jennifer Rigby; Editing by Clarence Fernandez

Our Standards: The Thomson Reuters Trust Principles.

Jen reports on health issues affecting people around the world, from malaria to malnutrition. Part of the Health & Pharma team, recent notable pieces include an investigation into healthcare for young transgender people in the UK as well as stories on the rise in measles after COVID hit routine vaccination, as well as efforts to prevent the next pandemic. She previously worked at the Telegraph newspaper and Channel 4 News in the UK, as well as freelance in Myanmar and the Czech Republic.

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Scientists infect volunteers with Zika in hunt for vaccines, treatments - Reuters

CDC report highlights disparities in flu outcomes and vaccination … – News-Medical.Net

October 23, 2023

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States are more likely to be hospitalized with flu, as well as less likely to be vaccinated against flu, according to a new CDC Vital Signs report. CDC is working to increase flu vaccination rates by using proven strategies to raise awareness of how serious flu can be and break down barriers to vaccination.

The Vital Signs report looked at flu hospitalization rates from 20092022 and flu vaccination coverage from 20102022 by race and ethnicity, from two data sources, the Influenza-Associated Hospitalization Network (FluSurv-NET) and Behavioral Risk Factor Surveillance System (BRFSS).

Flu vaccines are the best way to protect against flu and its potentially serious complications. Improving access to and trust in flu vaccines among people is critical to help reduce inequities."

Debra Houry, M.D., M.P.H. CDC Acting Principal Deputy Director

Flu vaccination coverage has been consistently lower among Black, Hispanic, and AI/AN adults since 2010. During the 20212022 season, flu vaccination coverage was 54% among White and Asian adults, 42% among Black adults, 38% among Hispanic adults, and 41% among AI/AN adults.

Black, Hispanic, and AI/AN adults were hospitalized with flu at higher rates than White adults during most seasons from 2009 to 2022.* Compared to White adults, hospitalization rates were nearly:

There are many reasons for disparities in severe outcomes of flu, including lack of access to health care and insurance, missed opportunities to vaccinate, and misinformation and distrust that contribute to lower levels of confidence in vaccines. People from certain racial and ethnic minority groups have higher rates of asthma, diabetes, obesity, and other chronic conditions. These increase the risk for serious flu complications. Racism and prejudice also are known to worsen inequalities.

Over the past two years, CDC began programs to address barriers to flu vaccination and raise awareness about its importance, specifically among people from racial and ethnic minority groups. These include the Partnering for Vaccine Equity (P4VE) program and a targeted, national flu vaccination campaign. These programs use proven actions to help increase vaccination among people from racial and ethnic minority communities.

Health care providers, state and federal officials, and individuals can work together to fight flu by taking steps to increase vaccine uptake in everyone, including people from racial and ethnic minority groups.

For more information about this report, go to http://www.cdc.gov/vitalsigns.

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FDA Approves PENBRAYA, the First and Only Vaccine for the … – Pfizer

October 23, 2023

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. PENBRAYA combines the components from two meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally.1

As a pioneer in vaccines, one of our goals is to deliver vaccines that evolve the paradigm and help simplify the standard of care in the U.S., said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. Today marks an important step forward in the prevention of meningococcal disease in the U.S. In a single vaccine, PENBRAYA has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities.2 PENBRAYA reduces the total number of doses needed for individuals to be fully vaccinated against the five most common serogroups, thereby streamlining the standard of care and potentially increasing the number of adolescents and young adults vaccinated.3 According to the U.S. Centers for Disease Control and Prevention (CDC), combining vaccines into fewer shots may mean that more adolescents and young adults get their recommended vaccines on time, resulting in fewer delays in protection against serious diseases.4 Routine use of PENBRAYA could also reduce IMD cases and associated mortality, the rate of long-term consequences of infection (sequelae) in survivors and costs associated with controlling outbreaks.5

Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups6, said Jana Shaw, MD, Pediatrics Infectious Disease Specialist, Upstate Golisano Children's Hospital in Syracuse, NY. For the first time, we have a single vaccine that helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.

The FDAs decision is based on the positive results from the Phase 2 and Phase 3 trials, including a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently U.S. licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.

The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults.

About PENBRAYA Regulatory Review

In September 2022, Pfizer announced positive results from a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the PENBRAYA compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe. This trial was followed by the FDAs acceptance of PENBRAYAs Biologics License Application (BLA) in December 2022.

Indication for PENBRAYA

PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.

PENBRAYA is administered as a two-dose series given six months apart.

Important Safety Information for PENBRAYA

View the full Prescribing Information. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.

U.S. Indication for TRUMENBA (meningococcal group B vaccine)

TRUMENBA (meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.

Important Safety Information

You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

For the full prescribing information for TRUMENBA, please visit http://www.pfizer.com.

Indication for Nimenrix in the European Union

Nimenrix is indicated for active immunization of individuals from the age of six weeks and above against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135, and Y. Nimenrix is not licensed in the U.S.

Important Safety Information

Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) should not be given to anyone with a history of a severe allergic reaction after a previous dose of Nimenrix.

Individuals with weakened immune systems may have a reduced immune response. The most common adverse reactions were loss of appetite, irritability, drowsiness, pain at the injection site, fatigue, redness at the injection site, and swelling at injection site.

Tell your healthcare provider if you are pregnant, or plan to become pregnant.

Ask your healthcare provider about the risks and benefits of Nimenrix. Only a healthcare provider can decide if Nimenrix is right for you or your child.

You are encouraged to report negative side effects of vaccines to Pfizer. In the United States, to report suspected adverse reactions, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov

About Pfizer: Breakthroughs That Change Patients Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of October 20, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about PENBRAYA, including its potential benefits, an approval in the U.S. for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age, and its potential recommendation, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PENBRAYA; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our 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 our clinical studies; whether and when any biologic license applications may be filed in particular jurisdictions for PENBRAYA; whether and when any such applications that may be pending or filed for PENBRAYA may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether such product candidate will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PENBRAYA; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PENBRAYA and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

Category: Prescription Medicines

1Pardo de Santayana, C.et al.(2023)Epidemiology of invasive meningococcal disease worldwide from 2010-2019: A literature review, Epidemiology and infection. Available at:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10126893/. Accessed August 2023. 2 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of Meningococcal disease in adolescence: prospective, matched-cohort study. Pediatrics. 2009;123:e502-e509. Available at: https://pubmed.ncbi.nlm.nih.gov/19254985/. Accessed August 2023. 3 National Library of Medicine. Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35357651/. Accessed August 2023 4 Centers for Disease Control and Prevention. Combination Vaccines. Available at: www/cdc.gov/vaccines/parents/why-vaccinate/combination-vaccines.html. Accessed September 2023. 5 National Library of Medicine. Potential Public Health Impact of a Neisseria Meningitidis A, B, C, W, and Y Pentavalent Vaccine in the United States. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/33615973/. Accessed August 2023. https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htmhttps://pubmed.ncbi.nlm.nih.gov/19254985/ 6 Vaccination coverage among adolescents aged 13-17 years national Available at: https://www.cdc.gov/mmwr/volumes/72/wr/pdfs/mm7234a3-H.pdf. Accessed September 2023.

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FDA Approves PENBRAYA, the First and Only Vaccine for the ... - Pfizer

John Legend says he wants to keep his family protected with updated COVID vaccine – KWTX

October 23, 2023

(CBS NEWS) - John Legendisnt taking chances when it comes to keeping his family healthy.

In aninterview with CBS MorningsWednesday, the singer andfather of four, 44, shared why he thinks its important to get vaccinated against COVID-19.

I believe in making sure everyone in my family is protected, he said. The thing about the virus is, it changes, it mutates, and so its good to have vaccines that are updated.

Legend partnered with vaccine maker Pfizerearlier this yearto promote booster shots against Omicron variants. Now, just a month after the FDA and CDC signed off onupdated COVID vaccinesfrom Moderna and Pfizer, Legend is using his voice to encourage others to get the shots, which are retargeted for newer variants ahead of thefall virus season.

I think whats gonna happen in the future is were gonna have updates every year, just like we get a flu shot every year, Legend added. If you care about keeping your family healthy and keeping your family protected, I think getting the vaccine update is a great way to help do that.

The new shots are similar to previously approved formulas, but were updated to target the XBB variants of the virus, which became dominant last winter.

Updated COVID booster shots still provide the best protection we have against the disease, especially the most severe forms of COVID, Emily Smith, a global health expert and author of The Science of the Good Samaritan,told CBS Newsin an email last month. Even though we continue to have new variants of COVID pop up, the good news is that the updated booster shots still work against the current variants circulating, including the newest variants.

The new COVID-19 shots come as health authorities are also promoting other new vaccinesnow available for RSV, or respiratory syncytial virus, in addition to the annual seasonal flu vaccine.

Alexander Tin contributed reporting.

2023 CBS Interactive Inc. All Rights Reserved.

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This Vaccine Protects Against Cancerbut Not Enough Boys Are … – WIRED

October 23, 2023

It wouldnt be an overstatement to call the HPV vaccine a medical miracle.

Its like the gift that keeps giving, says Mark Jit, a professor of vaccine epidemiology at the London School of Hygiene & Tropical Medicine. Not only is it the sole vaccine that can prevent cancer, we discover its an even better vaccine as time goes on, he says.

Since its development and rollout in the mid-2010s, the HPV vaccines prowess at heeding off cervical cancer rates has been remarkable. Over an 11-year period in the United Kingdom, cases of cervical cancer fell by 87 percent among those who received the vaccine compared to those who didnt. Its conceivable that one day, a whole form of cancer could be effectively eliminated.

And the vaccines dont just protect against cervical cancer. They can also prevent head and neck, vaginal, anal, and penile cancer, as well as protecting against genital warts in both genders. But theres the rub: Although these vaccines protect against cancers that affect both men and women, boys and men arent offered the vaccine in two-thirds of countries where they are available. In those places, half the people who could benefit are missing out on a potentially life-saving intervention. But thats starting to change.

When the rollout of HPV vaccines was first gearing upand their price was still highit made sense to target the most at-risk group, says Jit, that being girls between the ages of 9 and 14. But in the intervening decade or so, the vaccines have dropped significantly in price. Over the same period, research showcasing the benefits of gender-neutral HPV vaccine campaigns has compounded. From a social justice and equality point of view, it makes sense to vaccinate men and women, says Kit Yates, a mathematical biologist at the University of Bath. Failure to do so means men are left at risk, and this places the onus on women to protect men from HPV, rather than sharing the burden.

A barrier to wider rollout in recent years has been uneven supply: as eligible groups expanded, demand shot up. The makers of the vaccines couldnt keep up, and there was a major squeeze, meaning many low-income countries had to go without. But supply has started to ramp up again, and Indiathe worlds largest vaccine producerdebuted its own home-grown vaccine last year.

New research has also shown that just one dose offers sufficient protection, meaning the usual two-dose regime can be halved and double the people can be included in national rollouts. Now is the time we can start asking, actually, are there other groups that should be vaccinated? says Jit.

A Very Common Problem

HPV, or human papillomavirus, is the everyman STI. Between 80 and 90 percent of people will acquire it at some point in their lives, typically through skin-to-skin contact. Odds are that you, reader, will probably pick up the virusif you havent already. Luckily, for most carriers it wont have an impact; you can be asymptomatic for your whole life.

But for a small chunk of carriers, HPV can lead to potentially fatal cases of cancer; of the around 200 types of HPV, scores are cancer-causing. HPV becomes cancerous by sneaking into the body and burrowing itself into cells, where it photocopies itself. Most infections wont take root, and your body will boot them out within a year or two. But some persistent infections can linger on, changing normal cells to abnormal cells, which can lead to cancer if untreated.

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This Vaccine Protects Against Cancerbut Not Enough Boys Are ... - WIRED

DRIVE-THROUGH FLU VACCINE CLINICS – Good Morning Wilton

October 23, 2023

Waveny/Visiting Nurse and Hospice is offering drive-through flu vaccine clinics at its 22 Danbury Rd. location on Thursday, Oct. 26, and Thursday, Nov. 2.

The clinics are scheduled to run from 2-4:30 p.m. with no need to get out of the car. A registered nurse will greet each car, making it easy for someone with mobility issues.

The vaccines administered are regular quadrivalent and adjuvanted doses for people over 65 years of age.

Waveny/Visiting Nurse and Hospice is also offering a homebound flu vaccine program for people who qualify. For more information, reach out to Christine Burns at 203.762.8958, ext. 312 for more details.

Waveny/Visiting Nurse will bill directly to Medicare, Aetna Managed Care Medicare and Anthem Blue Cross/Blue Shield.

For more information on the clinics, visit the Visiting Nurse website.

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UMass Amherst research finds adult vaccination rates increase when out-of-pocket costs decrease – EurekAlert

October 19, 2023

image:

Brandyn Churchill

Credit: UMass Amherst

AMHERST, Mass. Adults are more likely to follow government vaccination recommendations when they do not have to pay out of pocket for the vaccine, according to a new study by a University of Massachusetts Amherst researcher. The findings provide important insights into vaccine take-up, as public health officials have experimented with everything from free concert tickets to lotteries with cash prizes to increase COVID-19 vaccination rates.

Though much is known about the strong efficacy of vaccine recommendations for children and adolescents, which are often supported by government funding and requirements for school attendance, this research is among the first to explore how to increase vaccination rates among adults.

Analyzing data from the shingles vaccine,Brandyn Churchill, assistant professor of resource economics at UMass Amherst, and Laura E. Henkhaus, health economist and data scientist with Hill Physicians Medical Group, found that the number of people taking the vaccine nearly doubled after the Affordable Care Act (ACA) required private insurers to cover vaccinations recommended by the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices, as part of preventive care coverage.

Adults are very price sensitive when it comes to their vaccine decision making, Churchill says. Cost matters. Age-targeted vaccine recommendations alone dont appear to do a lot for vaccine take-up among adults if the cost is coming out of their wallet.

Churchill and Henkhaus show that prior to the ACA preventive care insurance mandate, adults aged 60 and over, who were recommended to receive the shingles vaccine, were no more likely than their 59-year-old counterparts to be vaccinated. After the ACA mandate took effect in 2010, shingles vaccination increased from 3.1 to 5.9 percentage points for people aged 60 and over.

The research finds a similar increase for people aged 50 to 59 after recommendations for the shingles vaccine were expanded to cover adults aged 50 and over, and private insurance was required to cover it beginning in 2019. This coincided with a more effective and more costly version of the vaccine. Currently, the recommended two doses cost about $200 each.

Churchill notes people with a college education and those who had more contact with the health care system were more likely to take the shingles vaccine after it was fully covered by insurance. This might say something about an awareness that they knew they were eligible to get it without patient cost sharing, he says.

Caused by a reactivation of the chickenpox virus, shingles is an infection that can produce a painful rash with fluid-filled blisters. It affects more than one million people in the U.S. each year.

While shingles is not a communicable disease and its mortality rate is very low, the studys findings provide important guidance for policies promoting vaccination against communicable diseases, such as influenza and COVID-19.

With the COVID vaccines, clearly cost is not the only factor at play, but anything that would increase the cost to adults would likely further reduce vaccine take-up among that group resulting in potentially serious public health effects, Churchill concludes. COVID vaccines continue to be available withno out-of-pocket costfor most Americans.

The full paper, The Roles of Cost and Recommendations in Driving Vaccine Take-Up, appears in theAmerican Journal of Health Economics.

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The Roles of Cost and Recommendations in Driving Vaccine Take-Up

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Who gets hurt by RFK Jr.’s anti-vaccine work – Madison.com

October 19, 2023

When 12-year-old Braden Fahey collapsed during football practice and died, it was just the beginning of his parents' nightmare.

Deep in their grief a few months later, Gina and Padrig Fahey received news that shocked them to their core: A favorite photo of their beloved son was plastered on the cover of a book that falsely argues COVID-19 vaccines caused a spike of sudden deaths among healthy young people.

Padrig and Gina Fahey hold a photo of their son, Braden, 12, as they stand for a portrait in California on Wednesday, Sept. 6, 2023. Braden collapsed at football practice in August 2022 and died of a malformed blood vessel in the brain. The Faheys couldnt understand how Bradens face appeared on the cover of the book Cause Unknown, which was co-published by an anti-vaccine group led by Robert F. Kennedy Jr., or why his name appeared inside it. (AP Photo/Godofredo A. Vsquez)

The book, called "Cause Unknown," was co-published by an anti-vaccine group led by Robert F. Kennedy Jr., President John F. Kennedy's nephew, who is now running for president. Kennedy wrote the foreword and promoted the book, tweeting that it details data showing " COVID shots are a crime against humanity."

The Faheys couldn't understand how Braden's face appeared on the book's cover, or why his name appeared inside it.

Braden never received the vaccine. His death in August 2022 was due to a malformed blood vessel in his brain. No one ever contacted them to ask about their son's death, or for permission to use the photo. No one asked to confirm the date of his death which the book misdated by a year. When the Faheys and residents of their town in California tried to contact the publisher and author to get Braden and his picture taken out of the book, no one responded.

"We reached out in every way possible," Gina Fahey told The Associated Press in an emotional interview. "We waited months and months to hear back, and nothing."

How could a member of one of the most influential political dynasties in American history be involved in such a shoddy, irresponsible project, the Faheys wondered?

FILE - Presidential candidate Robert F. Kennedy Jr., speaks during a campaign event at the Adrienne Arsht Center for the Performing Arts of Miami-Dade County, Thursday, Oct. 12, 2023, in Miami. (AP Photo/Wilfredo Lee, File)

Braden's story is just one example of how Kennedy, son of the late Sen. Robert F. Kennedy, has used his famous name to disseminate false information about vaccines and other topics in a time when spreading conspiracy theories has become a powerful way to grow a constituency. An AP examination of his work and its impact found Kennedy has earned money, fame and political clout while leaving people like the Faheys suffering.

Now, Kennedy's decision to drop his Democratic bid for president and run as an independent gives him a new spotlight in an election that's currently heading toward a rematch between President Joe Biden and former President Donald Trump. There's concern in both parties that he could emerge as a spoiler who could affect the outcome of the campaign in unexpected ways. And at a time when Republicans in the 2024 race also are sowing doubt about vaccine effectiveness, it threatens to further promote harmful misinformation that already has cost lives.

One mom told AP about how she had delayed important care for her child because she believed Kennedy's vaccine falsehoods. A former elected leader described being harassed by Kennedy's followers. Doctors and nurses recounted how his work has hurt people in the U.S. and abroad.

Kennedy's campaign did not respond to several emails seeking comment for this article, but after AP contacted Kennedy and others involved in the book last week, the president of Skyhorse Publishing, which co-published it, texted the Faheys, offering to talk. Gina Fahey told AP she felt he reached out only after it became clear the situation could harm his reputation.

Padrig and Gina Fahey hold a bat dedicated to their son, Braden, by his baseball travel team Wednesday, Sept. 6, 2023, in California. Braden, 12, collapsed at a football practice last August and died of a malformed blood vessel in the brain. (AP Photo/Godofredo A. Vsquez)

"There's still that lack of compassion that was always there from the beginning," she said, adding that she is hesitant to engage with them now because she doesn't trust their intentions. "It's only now that they're reaching out, days prior to knowing this story is going to be released."

Braden's parents have read vicious comments from people who falsely blame vaccines for their son's death. They say seeing Braden's memory being misrepresented by Kennedy and others has been deeply painful.

"When you barely feel like you can even come up for air, you just get smacked back down again by this," Gina Fahey said.

"It's very manipulative. And you know, he's making money off of our tragedies," she said, adding, "How could you want somebody running our country that operates like that?"

Padrig and Gina Fahey stand for a portrait next to a tribute to their son, Braden, in California, on Wednesday, Sept. 6, 2023. Braden, 12, collapsed at a football practice last August and died of a malformed blood vessel in the brain. The Faheys have read vicious comments from people who falsely blame vaccines for their son's death. They say seeing Bradens memory being used and misrepresented by Robert F. Kennedy Jr. and others has been deeply painful. (AP Photo/Godofredo A. Vsquez)

Many years before anti-vaccine activists exploited the pandemic to bring their ideas to the American mainstream, Kennedy, an environmental lawyer, was among the most influential spreaders of fear and distrust around vaccines. He has long advanced the debunked idea that vaccines cause autism. He has said vaccines had caused a "holocaust," and has traveled the world spreading false information about the pandemic.

In recent years, Kennedy has used his name and rhetorical skills to build his anti-vaccine group, Children's Health Defense, or CHD, into an influential force that spreads false and misleading information. An AP investigation previously revealed how Kennedy had capitalized on the pandemic to build CHD into a multi-million-dollar misinformation engine.

One of the ways Kennedy and CHD have made money is through the sale of books. Kennedy's longtime publisher, Skyhorse, joined with CHD to create a book series that has published titles including "Vax-Unvax," "Profiles of the Vaccine Injured," and the book that included Braden Fahey, "Cause Unknown."

A picture of Braden Fahey, bottom left, is seen in "Cause Unknown," a book that falsely implies COVID-19 shots were behind a wave of youth deaths, Wednesday, Sept. 6, 2023, in California. Fahey, who had never received a COVID-19 vaccine, collapsed at football practice in August 2022 and died of a malformed blood vessel in the brain. The book was published by Skyhorse, Robert F. Kennedy Jr.'s longtime publisher, in partnership with Kennedy's anti-vaccine nonprofit group, Children's Health Defense. Kennedy wrote the foreword for the book. (AP Photo/Godofredo A. Vsquez)

Written by Edward Dowd, a former executive at BlackRock, that book is built on the false premise that sudden deaths of young, healthy people are spiking. Experts say these rare medical emergencies are not new and have not become more prevalent.

"We are just not seeing anything that suggests that," said Dr. Matthew Martinez, of Atlantic Health System in Morristown Medical Center, who researches cardiac events among professional athletes.

The AP found dozens of individuals included in the book died of known causes not related to vaccines, including suicide, choking while intoxicated, overdose and allergic reaction. One person died in 2019.

AP asked Kennedy's campaign, CHD, Dowd and Skyhorse president Tony Lyons several questions about the book, including why they chose to feature Braden, why they didn't speak to his family first and what steps they took to fact check.

The only person to respond was Lyons, who also co-chairs the Kennedy Super PAC American Values 2024.

In emails, Lyons did not address why Braden specifically was chosen for the cover but defended his inclusion by saying that news stories and his obituary did not mention his cause of death.

Hundreds of deaths are cited in the book, though Lyons said it only attributes nine of them to the vaccine. Lyons said Braden's death and others are never explicitly attributed to the vaccine, and that the book explores many possible reasons for deaths that have appeared in headlines since 2021.

Still, the book several times refers to its "thesis" that mass administration of COVID-19 vaccines caused a spike in deaths. Braden's parents said his appearance in the context of the book implies he died of the vaccine, putting his death in a false light.

Lyons said he was unaware of the Faheys' efforts to contact his company and asked AP to share with them his contact information. He said he would make some corrections in future editions, including to Braden's date of death, but said they were studying whether to remove him from the book or the cover.

Lyons told the AP that Children's Health Defense has a publishing deal with Skyhorse, though he would not say how much money CHD has received through it.

Kennedy also has a consulting deal with Skyhorse that personally paid him $125,000 since August 2022 for scouting out books for the company, according to a financial disclosure he filed. Lyons said that deal has so far resulted in 27 books of different genres including children's books, mysteries and cookbooks, but declined to name them.

Lyons also praised Kennedy's record of environmental work, such as protecting New York's Hudson River, and other work he's done to take on powerful corporate interests and what Kennedy sees as government corruption. Those are also topics Kennedy has focused on during his presidential campaign.

The platform Kennedy built for himself has an impact. In a study of verified Twitter accounts from 2021, researchers Francesco Pierri, Matthew DeVerna and others working with Indiana University's Observatory on Social Media found Kennedy's personal Twitter account was the top "superspreader" of vaccine misinformation on Twitter, responsible for 13 percent of all reshares of misinformation, more than three times the second most-retweeted account.

The messages Kennedy shares have convinced a significant slice of the public, some of whom attend his campaign events proudly wearing pins with crossed-out syringes or repeating Kennedy's talking points about vaccine ingredients.

Kennedy's anti-vaccine organization has a lawsuit pending against a number of news organizations, among them The Associated Press, accusing them of violating antitrust laws by taking action to identify misinformation, including about COVID-19 and COVID-19 vaccines. Kennedy took leave from the group when he announced his run for president but is listed as one of its attorneys in the lawsuit.

FILE - Robert F. Kennedy, Jr., speaks against proposed Democratic bills that would add new doses of vaccines to attend school, during a protest rally on behalf of New York state families against the vaccination of children at the Capitol, Wednesday, Jan. 8, 2020, in Albany, N.Y. (AP Photo/Hans Pennink, File)

Many people have staked their lives and the lives of their families on the views espoused by Kennedy and others who oppose vaccines.

The AP spoke to mothers who once identified as anti-vaccine and counted themselves among Kennedy's most devoted followers.

"I thought he was heroic, because he was saying the things publicly that other people were too afraid to say," said Lydia Greene.

Greene, who lives in the Canadian province of Alberta, declined all vaccines for her son after buying into the claims by Kennedy and other anti-vaccine "gurus" that vaccines cause autism. When her son started to show signs of autism, Greene discounted it out of hand.

"I couldn't even see his autism because in the anti-vax movement, autism is the worst outcome that can happen to a child. And when they talk about their vaccinated autistic kids, it's often with a tone of resentment and how they talk about how their life is ruined, their marriage is ruined, and it's just this kid is damaged," Greene said. "And so when my son was different, I couldn't see that stuff about him."

She said she did not recognize his condition until she "came out of the rabbit hole of anti-vax."

"I realized I had wasted so much valuable time where he should have been in occupational therapy, speech therapy, evidence-based therapy for autism," Greene said.

Kennedy's Children's Health Defense produces articles, newsletters, books, podcasts, even TV shows on its own CHD.TV. Greene said those articles often validate anxious parents' fears no matter how irrational while making them feel like someone powerful is listening.

FILE - Robert F. Kennedy Jr., is broadcast on a large screen as he speaks during an anti-vaccine rally in front of the Lincoln Memorial in Washington, Sunday, Jan. 23, 2022. (AP Photo/Patrick Semansky, File)

Today, Greene believes the group exploited her.

"That's what CHD does," Greene said. "They find parents when they're vulnerable. And hack into that."

Because of his national profile, Kennedy's work has ripple effects beyond the most devoted anti-vaccine activists.

Medical professionals told the AP that vaccine disinformation spread by Kennedy and other influencers makes the patients they serve wary about lifesaving vaccinations.

Sharon Goldfarb, is a family nurse practitioner in Berkeley, California, who spent the worst of the pandemic caring for people on society's margins: people with no homes; people who were living in the country illegally; people with serious mental health needs. She has seen firsthand the consequences of vaccine misinformation and refusal.

"It's disturbing because he has a huge family name," Goldfarb said. "When you're a trusted public figure and you have a trusted family name, you have to answer to a higher authority. I just don't get it."

Dr. Todd Wolynn, a Pittsburgh pediatrician who works to clarify the facts about vaccines on social media, said despite Kennedy's lack of clinical experience, he has an outsized influence on his followers.

"He uses a very big platform to amplify disinformation that leads people down a path to make a decision that's not evidence based," Wolynn said. "And as a result, it puts their own lives, the lives of their children, the lives of their family, in harm's way."

Though Kennedy did not respond for this story, he has long said that he is not anti-vaccine, and only wants vaccines to be rigorously tested. The Centers for Disease Control and Prevention explains that vaccines undergo thorough testing before they are authorized or approved in the U.S. and they are monitored for safety after they are introduced to the public.

COVID-19 vaccines were initially developed under the Trump administration, through the program Operation Warp Speed. But what his Republican-led administration viewed at the time as a point of pride has since become a topic of criticism in Republican circles, including among GOP presidential candidates who have expressed skepticism about the immunizations.

The Republican candidate and biotech entrepreneur Vivek Ramaswamy said in a July podcast interview that if he'd had the facts he would not have gotten vaccinated against COVID-19. The administration of Florida Gov. Ron DeSantis, who is also running as a Republican, has broken with CDC guidance to advise Floridians under 65 not to get the latest COVID-19 booster.

That kind of rhetoric, along with the conspiracy beliefs that Kennedy has shared about other subjects, like 5G, "can impact the smooth running of societies," said Daniel Jolley, a University of Nottingham social psychology professor, who has published several papers on conspiracy thinking and its impacts.

While skepticism is important, proper evaluation of the evidence is key, Jolley said. Anyone pushing conspiracy theories while running for president makes the theories seem normal.

"It's that kind of rhetoric that I think is really damaging," Jolley said. "You worry when you think about the next pandemic or the next event or the next issue that's going to come our way."

Jolley wonders: Will people listen to doctors or experts next time?

Kennedy's role in legitimizing anti-vaccine activism has not been limited to the U.S. Perhaps the most well-known example was in 2019 on the Pacific island nation of Samoa.

That year, dozens of children died of measles. Many factors led to the wave of deaths, including medical mistakes and poor decisions by government authorities. But people involved in the response who spoke to AP said Kennedy and the anti-vaccine activists he supported made things worse.

In June 2019, Kennedy and his wife, the actress Cheryl Hines, visited Samoa, a trip Kennedy later wrote was arranged by Edwin Tamasese, a Samoan local anti-vaccine influencer.

Prime Minister Tuilaepa Sailele Malielegaoi, foreground right, shakes hands with Robert F. Kennedy Jr. before he left the the 57th Independence Celebration in Mulinuu, Samoa, on June 1, 2019. At foreground left is Kennedy's wife, actress Cheryl Hines. Kennedy said the trip was arranged by Edwin Tamasese, a local anti-vaccine influencer. (Misiona Simo/Samoa Observer via AP)

Vaccine rates had plummeted after two children died in 2018 from a measles vaccine that a nurse had incorrectly mixed with a muscle relaxant. The government suspended the vaccine program for months. By the time Kennedy arrived, health authorities were trying to get back on track.

He was treated as a distinguished guest, traveling in a government vehicle, meeting with the prime minister and, according to Kennedy, many health officials and the health minister.

He also met with anti-vaccine activists, including Tamasese and another well-known influencer, Taylor Winterstein, who posted a photograph of herself and Kennedy on her Instagram.

"The past few days have been profoundly monumental for me, my family and for this movement to date," she wrote, adding hashtags including #investigatebeforeyouvaccinate.

A few months later, a measles epidemic broke out in Samoa, killing 83 people, mostly infants and children in a population of about 200,000.

Public health officials said at the time that anti-vaccine misinformation had made the nation vulnerable.

The crisis of low vaccination rates and skepticism created an environment that was "ripe for the picking for someone like RFK to come in and in assist with the promotion of those views," said Helen Petousis-Harris, a vaccinologist from New Zealand who worked on the effort to build back trust in the measles vaccine in Samoa.

Petousis-Harris recalled that local and regional anti-vaccine activists took their cues from Kennedy, whom she said "sits at the top of the food chain as a disinformation source."

"They amplified the fear and mistrust, which resulted in the amplification of the epidemic and an increased number of children dying. Children were being brought for care too late," she said.

Kennedy's campaign did not respond to emails seeking comment about Samoa, though he says on his campaign website that he had no role in the outbreak. He also said in an interview for a forthcoming documentary, "Shot in the Arm," that he bears no responsibility for the outcome.

"I had nothing to do with people not vaccinating in Samoa. I never told anybody not to vaccinate. I didn't, you know, go there for any reason to do with that."

But people who worked on the Samoan measles response told AP the credibility he gave to anti-vaccine forces when he met with them had an impact.

Moelagi Leilani Jackson, a Samoan nurse who worked on the vaccination campaign to stem the scourge of measles, said she remembered that after Kennedy's visit, the anti-vaccine influencers "got louder."

"I feel like they felt they had the support of Kennedy. But I also think that Kennedy was very well, he came in and he left," she recalled. "And other people picked up the pieces."

FILE - Robert F. Kennedy, Jr., left, stands with protesters at the Capitol in Olympia, Wash., on Feb. 8, 2019, where they opposed a bill to tighten measles, mumps and rubella vaccine requirements for school-aged children. (AP Photo/Ted S. Warren, File)

A few weeks after his trip to Samoa, Kennedy appeared in Sacramento, California, where lawmakers were debating a bill to make it more difficult to get a vaccine exemption. The bill was sponsored by Democratic state Sen. Richard Pan, a pediatrician.

As a crowd gathered outside the capitol, Kennedy stood to speak. Two large posters behind him featured Pan's image, with the word "LIAR" stamped across his face in blood-red paint. Pan told AP he felt the staging was intended to incite the crowd against him.

"So he's rallying to have people attack me, essentially, personally," said Pan, who is no longer in office.

Within months, one anti-vaccine extremist assaulted Pan, streaming it live on Facebook. Another threw blood at Pan and other lawmakers.

Kennedy has repeatedly brought up the Holocaust when discussing vaccines and public health mandates, comparisons that Pan said amount to an "indirect call to violence" against health advocates.

"Who creates an atmosphere where they think what's appropriate is to actually physically assault a legislator? It's people like Robert F. Kennedy, Jr." Pan said.

Pan said it's one of many instances when Kennedy has whipped people up against public health advocates. Kennedy also wrote a bestselling book attacking Anthony Fauci, who has received death threats.

Those attacks have prompted criticism from Kennedy's sister, Kerry Kennedy, who invoked the Kennedy family history of political violence their father and uncle were both assassinated when she told the AP in 2021: "Attacking doctors and scientists is irresponsible because many have received death threats. This can deter people from those professions. Our family knows that a death threat should be taken seriously."

Kerry Kennedy and three other siblings on Oct. 9 issued a statement denouncing Kennedy's independent candidacy, calling it "dangerous" and "perilous" to the country.

Pan said that Kennedy's rhetoric, which often demonizes scientists and health care professionals, is part of a strategy to intimidate and silence them.

"When you call something a holocaust, it is incitement to violence," Pan said.

"The real consequence of Robert F. Kennedy, Jr. is we have dead children, and we have people who are in good faith doing their best to try to protect people, including children, who are basically being threatened and even assaulted because of his rhetoric and his lies," said Pan, who is now running for mayor of Sacramento, a nonpartisan position. "That harms America."

Associated Press video journalist Terry Chea contributed to this report.

The Associated Press receives support from several private foundations to enhance its explanatory coverage of elections and democracy. See more about AP's democracy initiative here. The AP is solely responsible for all content.

Donald Trump, Republican

Former President Donald Trump, aiming to become only the second commander-in-chief ever elected to two nonconsecutive terms, announced in November that he is seeking the Republican presidential nomination in 2024.

In order to make America great and glorious again, I am tonight announcing my candidacy for president of the United States, Trump told a crowd gathered at Mar-a-Lago, his waterfront estate in Florida, where his campaign will be headquartered. - CNN

Nikki Haley, Republican

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Who gets hurt by RFK Jr.'s anti-vaccine work - Madison.com

Bill Ford Says Electric Vehicles Are Being Politicized Like the Vaccine – Yahoo News

October 19, 2023

(Bloomberg) -- Ford Motor Co.s executive chair pointed to polarization in US politics as one of the reasons the automaker is slowing production of its first electric pickup.

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Blue states say EVs are great and we need to adopt them as soon as possible for climate reasons, Bill Ford said in an interview with the New York Times. Some of the red states say this is just like the vaccine, and its being shoved down our throat by the government, and we dont want it. I never thought I would see the day when our products were so heavily politicized, but they are.

Ford announced last week it was temporarily cutting a shift at its Dearborn, Michigan, plant that assembles F-150 Lightning pickups, citing quality checks and supply chain issues. On Tuesday, General Motors Co. said it would delay opening its second electric-truck factory in Michigan to better manage capital investment while aligning with evolving EV demand.

US President Joe Biden and former President Donald Trump have starkly different views on EVs. Biden wants half of new-vehicle sales to be electric by the end of the decade and has signed several laws in his first term that offer incentives to consumers, car and battery manufacturers and charging operators. Trump skipped a Republican presidential candidate debate last month to argue to blue-collar voters in Michigan that shifting to EVs will doom the auto industry.

EVs also are becoming part of the culture wars at the state level. Whereas California and other states mandate that zero-emission vehicles make up an increasing share of manufacturers sales, lawmakers in Wyoming introduced legislation early this year that would have banned the sale of EVs in the state by 2035. The bill didnt advance.

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Bill Ford Says Electric Vehicles Are Being Politicized Like the Vaccine - Yahoo News

Novavax’s Prototype COVID-19 Vaccine Nuvaxovid Receives Full Approval in Singapore – Global Biodefense

October 19, 2023

Novavax, Inc. today announced that Singapores Health Sciences Authority (HSA) has granted full approval for Novavaxs prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for active immunization to prevent COVID-19 inindividuals aged 12 and older.

The company announced the approval in an Oct. 18 press release.

NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavaxs unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavaxs Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels.

For the 2023-2024 vaccination season,Novavax has developed an updated COVID-19 vaccine which has been authorized for use in the U.S.The updated vaccine induces neutralizing antibody responses against currently circulating variants XBB.1.5, XBB.1.16, XBB.2.3,BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6.Additional non-clinical data demonstrated that Novavaxs vaccine induced CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavaxs vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.

Todays full approval of our prototype vaccine will enable us to file for approval of our updated protein-basednon-mRNA COVID-19 vaccine in the coming weeks. We continue to work closely with HSA to ensure a protein-based vaccine is part of the portfolio for Singaporeans to protect themselves against COVID-19.

In clinical trials, the most common adverse reactions associated withNovavaxs prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

About the PREVENT-19 Phase 3 TrialThe PRE-fusion protein subunitVaccineEfficacyNovavaxTrial COVID-19 (PREVENT-19) was a randomized, placebo-controlled, observer-blinded Phase 3 trial conducted in the U.S. and Mexico to evaluate the efficacy and safety of NVX-CoV2373 as a primary series and as a booster in adults and adolescents to prevent SARS-CoV-2 infection. As a primary series, the primary endpoint was the first occurrence of polymerase chain reaction (PCR)-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second dose in 29,960 adult participants aged 18 and older at baseline without protocol violations prior to illness. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Full results of the trial were published in The New England Journal of Medicine.

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Vaccine maker Novavax Inc (NVAX.O) on Monday said it has shipped millions of doses its updated COVID-19 shots to distributors after receiving the go-ahead from U.S. regulators. The U.S. FDA authorized the updated vaccine last week for emergency use in individuals aged 12 years and older, but batches of the shots needed additional clearance from the FDA before they could be released. Novavax said it expects the shots to be available at U.S. pharmacies this week. Reuters

The Medicines and Healthcare products Regulatory Agency or MHRA in the United Kingdom has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid or NVX-CoV2373 for individuals aged 12 and older. Business Insider

As the updated COVID vaccines roll out around the country, one more competitor has joined the mix. In early October the U.S. Food and Drug Administration authorized a new booster shot made by the company Novavax. Like the mRNA-based Pfizer and Moderna shots, it targets a SARS-CoV-2 variant, XBB.1.5, which is a descendant of Omicron. It is the first protein vaccine to appear in more than a year, which some public health experts say is encouraging news for people who are hesitant the mRNA vaccines that have been widely used throughout the pandemic. Scientific American

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Novavax's Prototype COVID-19 Vaccine Nuvaxovid Receives Full Approval in Singapore - Global Biodefense

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