Homepage / Technology / Herpes vaccine company backed by Peter Thiel vows future testing will follow FDA guidelines
Menyelami Dunia Slot Thailand: Keseruan dan Peluang Kemenangan Besar Menyelami Dunia Slot Thailand: Pengalaman Bermain yang Tak Terlupakan 1xbet 독점 프로모션 코드 2024년 1월: Xnumxxcompletesports 1xbet 독점 프로모션 코드 2024년 1월: Xnumxxcompletesports

Taya365 Casino Login⁚ A Comprehensive Guide

Get ready for the ultimate craigslist sex experience Stake Casino Russia официальный Сайт Для Онлайн Игр И Бонусов Welcome on ultimate dating platform for ssbbw lesbians 1win: Spor Bahisleri Ve Internet Casino Bonus 500% Καζίνο Και Στοιχηματική Σε Έναν Ιστότοπο Get started on mature sex dating sites now “horseshoe Casino Baltimore Wikipedia Judi Online, Kenali Bahaya, Ciri-Ciri Kecanduan, dan Penanganannya Cassino Apresentando Bônus De Boas-vindas: Veja As Opções Disponíveis Casino Mostbet ᐈ Oficiální Stránky Online Kasin V České Republice Casino E Apostas Desportivas No Brasil Bônus 5000 Brl No Depósito Entrar Beginner’s Explained Casino Wagering: Tips & Strategies Beginner’s Explained Casino Wagering: Tips & Strategies Лучшие Букмекерские Конторы Онлайн Рейтинг Бк 2024 “Slot Machine Nedir? Türkiye’deki Çevrimiçi Slot Rehberi Keep Everything You Win At Usa No First Deposit Casinos “roleta Online Jogos De Roleta Virtual » Betfair Casino Лучшие Онлайн Казино Рейтинг Топ 10 Для Игры На 2024 день” 1xbet 보너스 사용법 알아보기 메인 계정과 보너스 계정의 차이 코리아벳 برنامج المراهنات الرياضية تحميل التطبيق العميل Eg 1xbet Com Коэффициенты Букмекеров%3A Что Такое же Как Рассчитать в Ставках На Спорт Лучшие Букмекерские Конторы Рейтинг Букмекеров Топ Бк 2024 Онлайн Ставки на Спорт Лучшие Букмекерские Конторы Рейтинг Букмекеров Топ Бк 2024 Онлайн Ставки на Спорт Mostbet Türkiye Çevrimiçi Kumarhane Mostbet Casino “топ Приложений Для Ставок На Спорт 2024%3A Букмекеры На Android И Ios “How To Play Roulette: Rules & Betting Как 1win Обзор Удовлетворяет Разнообразные Потребности Пользователей Os 15 Melhores Sites De Apostas Esportivas Gates of Olympus’ýn Slot Oyunlarýnda En Büyük ve Çarpýcý Ödüller Gates of Olympus ile En Ýyi, Karlý ve Avantajlý Kazanç Fýrsatlarý Gates of Olympus’ýn En Popüler ve Ödüllü Makineleri Největší Image Hazardu V Evropě: Proslulé Kasino Versus Monte Carlu Láká Na Neobyčejnou Atmosféru” Jak znaleźć legalne kasyno online? Mostbet Tr Resmî Net Sitesinde Giriş Empieza Kayıt Olm Our Cms Play 17, 800+ Totally Free Us Online Online Casino Games No Download” The Benefits of Learning a Second Language “australia’s #1 Online Gambling Establishment Guide 2024 Kde Sony Ericsson Natáčel Film On Line Casino Roya Leon Casino Έως 1 500 Ανά Κατάθεση! 6 Best Gay Online Dating Sites (2023) – Join 100% Totally Free LGBTQ+ Programs! 1win: Casino Ve Bahisçi Resmi Web Sitesi 2024, Online Spor Bahisleri, 1win Giriş” 4 Ways To Beat The Slots Лучшие Игровые Автоматы Онлайн%3A Играйте желающим В Казино Start your hookup journey with sugar mummies now Online Bitcoin Gambling Enterprises: A Comprehensive Overview Learn A Few Of The Top Benefits Of Mobile Casino Gambling Online Casino Slots Bitcoin Gambling Establishments: The Future of Online Gambling Online Casino Sites that Accept PayPal: A Convenient and Secure Settlement Alternative The Advantages of Playing Online Casino Online Basics of the Free Casino Bonus Video Slots What You Must Know Discover the Excitements of Free Blackjack Online The Best Bitcoin Gambling Enterprises that Accept Bitcoins What Are Zaza Pills? A Comprehensive Overview Understanding Varicose Veins: Reasons, Symptoms, and Treatment Options Online Payday Loans in South Africa: Whatever You Need to Know The Ultimate Guide to Online Free Live Roulette Live Roulette Benefit: Whatever You Need to Know Top Bitcoin Gambling Enterprises Overview Todo lo que necesitas saber sobre los mini préstamos Online Live Roulette Bonus: A Guide to Optimizing Your Payouts Instant Play Online Gambling Establishment: The Ultimate Guide What You Need to Understand About Free Spins Benefits The Power of One Card Tarot Readings Unlocking the Mysteries of Card Analysis Tarot The Art of Tarot Card Card Reading: A Comprehensive Guide Tarot Card Cards Free Analysis: Opening the Mysteries of Your Future Best Totally Free Spins No Down Payment: A Guide to Winning Big Without Investing a Penny Mastercard in Online Gambling Enterprises: Your Guide to Safe and Secure Gambling Decreasing Your Cholesterol: A Comprehensive Overview to a Healthier Heart “Fairly Sweet Bonanzaana Sayfamıza Hoş Geldiniz! Eğlenceli Oyunlar Christian Counselor y mentor Nancy Pina Ayuda Consumidores plan Logro en Citas online y Vida “Durante İyi Slot Oyunları Ücretsiz Casino Oyunları” Top Twelve Online Gambling Canada Sites For Real Money In 2025 لعبة كراش Car Crash في 1xbet: الدليل الشامل موقع مراه Mostbet Registrace Z Česko Pokyny Pro Registraci A Ověření Účtu While 1win advertises 247 support response times can vary depending on the. About 1win gaming and situs 1win. Sports Covered Based on the provided text 1Wins sports betting platform includes. About 1win товары букмекер and site 1win é confiavel. Languages Supported While definitive confirmation of all supported languages requires direct verification. About how to use bonus casino in 1win online and 1win hacks. A. About 1win iphone скачать and تحميل 1win. Despite some negative feedback the overall user sentiment towards 1Win in Mozambique. About 1win 앱 안드로이드 and como recargar en 1win. The provided text mentions 247 support for 1win users in Bangladesh and. About jet 1win and 1win android app download. Seguridad de las Transacciones en 1Win 1Win utiliza protocolos de seguridad avanzados. About 1win mine hack and 1win register login app. In Bangladesh 1Wins operational legality stems from its Curaçao eGaming license 8048JAZ2018-040. About букмекер 1win and 1win dota team. What is the easiest way to get sluts around me? 1win Скачать На Андроид Бесплатное Приложение С официального Сайта Преимущества автоматизации рабочих процессов в букмекерские конторы “1win Uzbekistan ⬅️ Rasmiy Sayti Bukmekerlik Kompaniyasining” VDcasino’ýn Slot Oyunlarýnda En Büyük ve Çarpýcý Gelirler VDcasino’ýn En Popüler ve Tercih Edilen Makineleri “mostbet Com’da Oynamak Mı Istiyorsunuz? Buradan Giriş Yapın Sweet Bonanza Hangi Siteden Oynanır?” проем На Официальный Сайт Ставкибет Online Casino Sites Nationwide December 2024 Sweet Bonanza: Eğlenceli Slot Oyununun Detayları Sázková Kancelář On-line Sportovní Výsledky Some Sort Of Kasin

Technology

Herpes vaccine company backed by Peter Thiel vows future testing will follow FDA guidelines

The CEO of a herpes vaccine company at the center of a controversy over an off-shore clinical trial on Friday said that future testing of the drug will follow U.S. Food and Drug Administration oversight rules, as demanded by a new group of financial backers that includes venture capitalist Peter Thiel.

In an impassioned interview, Rational Vaccines Chief Agustin Fernandez said he feared that the great promise of the vaccine developed by the late university professor William Halford was being overshadowed by criticism over Halford’s decision to test the drug using American patients on the West Indian nation of St. Kitts and Nevis without monitoring by the FDA or an institutional review board (IRB), as is traditional.

“I just need to defend my friend, who is dead,” Fernandez told CNBC. “Your kids will not know herpes, your grandkids will not know herpes because of Bill.”

“People are missing the story here. They’re defaming a dead scientist, [who] is really a hero,” said Fernandez, a Hollywood movie producer who co-founded Rational Vaccines with Halford in 2015 out of a shared desire to help herpes sufferers.

As many as 1 in every 6 people between the ages of 14 and 49 has genital herpes, according to the federal Centers for Disease Control and Prevention.

“This guy is eradicating herpes: Let’s talk about that,” he said of Halford, a Southern Illinois University professor who died in June of brain cancer. “Nobody’s saying that we’ve lost one of the greatest scientific minds in America.”

Fernandez spoke two days after health regulators in St. Kitts said they were investigating the 2016 vaccine trial after learning it was conducted in that nation without prior approval.

“The Ministry of Health will always ensure that all research involving human participants follow international standards, which protect the safety and security of persons involved,” regulators said.

Rational Vaccines last October announced that its “potentially revolutionary Theravax vaccine” had achieved groundbreaking results in its Phase 1 clinical trial.

Fernandez said the trial had showed the drug’s promise both as a vaccine that would prevent herpes infections, and as a therapeutic treatment to alleviate the often painful outbreak of sores that people with herpes can suffer.

Fernandez also said that he now understands it is necessary from now on to conduct further trials following FDA oversight standards if Rational Vaccines hopes to market the vaccine in the United States.

“As a businessman, and as my investors [require] … we need the FDA,” Fernandez said.

Fernandez, who is not a scientist or an expert on pharmaceuticals, said he did not know at the time that Halford’s decision to conduct that trial of the vaccine in St. Kitts in 2016 with 20 American patients would end up drawing the ire of medical ethicists.

Nor did Fernandez know, he said, that it was traditional for such drug trials to either be monitored by the FDA or by an institutional review board.

“I didn’t know what an IRB was,” Fernandez said.

But he said that this past spring — about six months after the first trial was concluded — when Halford and he met with Thiel’s representative to discuss Thiel investing in the vaccine’s development, the representative “yelled” at Halford for arguing that his decision to do the testing without FDA monitoring was motivated by a desire to help herpes sufferers without unnecessary delay.

Thiel’s rep “said, ‘We want to help people too, but we want to help a billion people, and we need to go through the FDA,’ ” Fernandez recalled.

The PayPal co-founder Thiel and a group of other investors committed $7 million to Rational Vaccines on Aug. 23, with the condition that future testing of the vaccine comply with FDA standards, Fernandez said.

Thiel, who did not respond to a request for comment from CNBC, himself invested $4 million, according to Fernandez.

Last Sunday, a story by Kaiser Health News focused on Thiel’s investment, and highlighted the fact that the 2016 trial “did not rely on traditional U.S. safety oversight.”

The article noted that “Thiel has been a vocal critic of the FDA, claiming in an interview that its approval process was so unwieldy ‘you would not be able to invent the polio vaccine today.’ “

Jonathan Zenilman, chief of the infectious disease division of Johns Hopkins Medical Center, told Kaiser Health News, referring to the vaccine trial, “What they’re doing is patently unethical.”

“There’s a reason why researchers rely on these protections,” Zenilman said. “People can die.”

An FDA spokeswoman told CNBC, “The FDA does not comment on individual cases or speculate on hypothetical situations.”

“However, generally speaking, the FDA believes that the oversight of clinical investigations, including review by an IRB, is critically important and notes it is a regulatory requirement for clinical investigations subject to FDA regulations,” the spokeswoman said.

But Fernandez told CNBC that “I wasn’t aware of an ethical problem then, and I’m not aware of an ethical problem now.”

Asked why Halford decided to do the clinical tests without traditional monitoring, Fernandez said, “the truth is, only Dr. Halford can answer that.”

Fernandez speculated that Halford, who was terminally ill for years, was trying to help a number of herpes sufferers, particularly after being asked for help from two such people who ended up committing suicide.

“I suggesting that he, in his conscience, felt that he would move as quickly as possible and not have another death on his head,” Fernandez said.

“He was fighting cancer the entire time,” Fernandez said. “He knew he was never going to make a dime from this.”

“Whatever Bill did, he did for the greater good.”

Fernandez said Halford told participants in the trial that the trial was not approved by the FDA, and required them to each sign an informed consent form to participate.

“The narrative that is out there is that this guy duped some people into getting injections and they are victims,” Fernandez said. “And that is not the case.”

Fernandez said that all of the participants in the trial were suffering from chronic herpes outbreaks, and a number of them were suffering outbreaks even while taking the herpes treatment drug Valtrex.

One of those participants, a 48-year-old truck driver from New Jersey named Richard Mancuso, told CNBC that he had sought to participate the trial after suffering from two to three herpes outbreaks every month for the prior 20 years.

Mancuso said he was interviewed by Halford for three hours before Halford agreed to admit him to the trial, and that the professor told him that “you really have to think about this seriously, because there are risks involved, this is an experimental vaccine, and I cannot make any promise.”

“He was really clear what the situation was,” Mancuso said of Halford.

However, Halford did not inform Mancuso that FDA or IRB monitoring was traditional for a clinical trial, Mancuso said.

Mancuso received three injections during separate visits to St. Kitts. He said his outbreaks began tapering off, and that he last had an outbreak on March 27.

“Oh, my God, he gave me my life back,” said Mancuso when asked what he thought of Halford. “It doesn’t get much better than that.”

Mancuso said he gets “a little upset over” criticism of Halford’s decision to conduct the trial without FDA monitoring. He has posted a video response to the Kaiser Health News story on his Facebook page.

“He knew he had very little time to help people,” Mancuso told CNBC. “Nobody has $5 billion and 15 years to get a vaccine approved… he’s a professor, he’s on a professor’s salary.”

The Southern Illinois University School of Medicine, where Halford worked, when asked for comment by CNBC, referred to a statement the school issued earlier this week.

“Rational Vaccines licensed the patent rights from SIU School of Medicine to advance the clinical application of the vaccine and is required to abide by all applicable laws and regulations in pursuit of those development objectives,” the school said in that statement.

“The 2016 clinical trial was conducted solely by Rational Vaccines. Dr. Halford’s involvement was as the Chief Scientific Officer of Rational Vaccines, not as a faculty member of SIU School of Medicine. The company ran the clinical trial independently of SIU involvement.”

Source: Tech CNBC
Herpes vaccine company backed by Peter Thiel vows future testing will follow FDA guidelines

Comments are closed.