Friday, December 18, 2020

Capping a nearly year-long effort, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of Moderna’s mRNA vaccine against SARS-CoV-2, the virus that causes Coronavirus Disease 2019 (COVID-19), after the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted yesterday 20-0, with 1 abstention, that the benefits of the vaccine outweigh its risks.

This comes less than 1 week after the FDA granted emergency use authorization to a similar vaccine made by Pfizer and BioNTech.

During yesterday’s deliberations, the advisory committee discussed plans to unblind participants in existing clinical studies, and considered whether scientific integrity requires placebo control of continuing studies. One possible solution that was discussed is a blinded crossover design. An additional research question is how to study whether vaccines protect against asymptomatic transmission. The committee member who abstained from the final vote said that expanded access would be better than emergency use authorization. Generally, the FDA adheres to the recommendations of its advisory committees, with only rare exceptions.

The Pfizer/BioNTech and Moderna mRNA vaccines are the first two of their kind: they contain ribonucleic acid (RNA) encased in lipid nanoparticles. The nanoparticles deliver the RNA to cells in the body of the person receiving the vaccine. Ribosomes, which are parts of all cells, then translate the RNA into spike protein which then produces an immune response.

The emergency use authorization of a second vaccine comes as a welcome addition to the first, since no one single company can make enough vaccine for every person in the world (5–8 billion doses will be necessary for herd immunity depending on whether the vaccines prevent asymptomatic transmission or not). Also, the Moderna vaccine must be stored at -20°C (-4°F) which, while very cold, is easier to attain than the -70°C (-94°F) ±10°C required for storage of the Pfizer/BioNTech vaccine which requires vast quantities of dry ice and special, ultra-low-temperature freezers.

In the United States, the first shipment of each vaccine (for example, 3 million doses of the Pfizer-BioNTech vaccine) will be reserved for health-care workers and nursing homes. Pfizer expects to manufacture 20 million doses of their vaccine in time to be administered this year, and 100 million by March. After nursing-home residents and health-care workers, the next people in line to receive the vaccines will be those over 65 years of age and those with significant co-morbidities and risk factors, and some essential workers. The general public in the United States can expect to have vaccines available in their doctors’ offices or pharmacies later in the spring of 2021.

The vaccine is designed to be taken twice; the second dose of the Moderna vaccine should be administered 4 weeks after the first. The second dose of the Pfizer/BioNTech vaccine should be administered 3 weeks after the first, and people should take the same brand twice.

The legal authority for emergency-use authorization is in section 564 of the Federal Food, Drug, and Cosmetic Act. An EUA is less than a full approval, and represents a determination by the FDA that

• The disease must be serious or life-threatening.
• The vaccine may be effective to prevent, diagnose, or treat the disease.
• The known and potential benefits of the vaccine outweigh the known and potential risks of the vaccine.
• No adequate, fully-approved, alternative product is available to prevent the disease.

The vaccine development process normally takes 5–20 years, but scientists developed the new vaccines in record time by building on their experience with SARS and by performing many of the development, manufacturing, and testing steps in parallel.

COVID-19 is a respiratory and hematologic disease caused by SARS-CoV-2, a positive-sense single-stranded RNA virus believed to have originated in bats. The virus typically causes a cold-like or flu-like illness, but illness severity ranges widely from no symptoms at all to death, and it is very contagious. Although many cases are asymptomatic (50% of all transmission is from asymptomatic and pre-symptomatic persons), the disease has killed over 1.5 million people (294,874 of whom are in the United States) in only a year.

Donald Trump had directed the FDA commissioner to issue the EUA for the first (Pfizer/BioNTech) vaccine by the end of the day on Friday, December 11. Researchers continue to test 63 different vaccines against the coronavirus on humans.

[edit]

• “FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine” — Food and Drug Administration, December 18, 2020
• “Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement” —  December 16, 2020
• “Moderna announces longer shelf life for its COVID-19 vaccine” — Moderna, December 16, 2020
• “FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine” — Food and Drug Administration, December 11, 2020
• “Covid-19 Vaccine Tracker” — The New York Times, December 11, 2020
• “Who will get the coronavirus vaccine first?” — The New York Times, December 11, 2020
• “Covid-19 Live Updates: F.D.A. Expected to Issue Pfizer Vaccine Authorization on Friday Evening” — The New York Times, December 11, 2020
• Reis Thebault, Meryl Kornfield, Carolyn Y. Johnson, Laurie McGinley, Paulina Firozi, Kim Bellware, Erin Cunningham, Hamza Shaban, Miriam Berger. “U.S. sets death record again as FDA advisers recommend Pfizer-BioNTech vaccine” — The Washington Post, December 10, 2020
• Josh Dawsey and Laurie McGinley. “White House orders FDA chief to authorize Pfizer-BioNTech vaccine Friday or submit his resignation” — The Washington Post, December 11, 2020
• Fernando P. Polack, M.D., Stephen J. Thomas, M.D., Nicholas Kitchin, M.D., Judith Absalon, M.D., Alejandra Gurtman, M.D., Stephen Lockhart, D.M., John L. Perez, M.D., Gonzalo Pérez Marc, M.D., Edson D. Moreira, M.D., Cristiano Zerbini, M.D., Ruth Bailey, B.Sc., Kena A. Swanson, Ph.D., et al., for the C4591001 Clinical Trial Group. “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine” — New England Journal of Medicine, December 10, 2020
• “Public hearing of the Vaccines and Related Biological Products Advisory Committee” —  December 10, 2020
• “Covid 19 Vaccine U.S. Distribution Fact Sheet” — Pfizer, November 20, 2020
• “COVID-19, SARS-CoV-2 and the Pandemic (Lecture 1)” — MIT, September 3, 2020
• “COVID-19, SARS-CoV-2 and the Pandemic (Lecture 8: Vaccines)” — MIT, September 3, 2020
• “Coronavirus Resource Center” — Johns Hopkins University, December 11, 2020
• “Morbidity and Mortality Weekly Report” — Centers for Disease Control, December 11, 2020

Thursday, May 29, 2008

David Tchappat, a popular housemate recently evicted from the television reality program Big Brother Australia, has spoken out critically of his childhood experiences in the controversial religious group “Raven-Taylor-Hales Brethren“, referred to in Australian media as “Exclusive Brethren”. Tchappat was a participant in the edition Big Brother Australia 2008, and was voted off the show on May 25.

Tchappat, 33, a former police officer and presently a firefighter, left the controversial group at age 19. He says he attempted to leave at age 17 but was brought back by members of the group and “interrogated” by group leadership for months. Up until he left he had never eaten in a restaurant, listened to the radio or been to the movie theater. According to Macquarie National News, Tchappat’s former community numbers number approximately 15,000 in Australia. Raven-Taylor-Hales Brethren is a sect of Protestant Christianity and a breakaway group from Exclusive Brethren.

Due to his departure from the group, Tchappat had to break off contact with family members still inside the organization, though at times he speaks with his parents. Members do not vote in elections because they feel it contradicts their belief that God should determine who is in power, but they provide finances to the Liberal Party of Australia. Tchappat’s cousin Andrew left the group a few months after he did.

After getting to know his fellow Big Brother Australia housemates for three weeks, Tchappat recounted some of his experiences in his former religious group. “Look, I don’t like to say it’s a cult, but it basically is. My whole life was controlled. I didn’t have a say in it myself,” he said on one episode. He grew up in the Raven-Taylor-Hales Brethren community in Gosford, New South Wales, and explained: “It’s based on Christian values but it’s very strict. So I had no TV, no radio, no computer, never been to a movie or a restaurant or kissed a girl – you name it, I didn’t do it.”

In an interview Tuesday with former Big Brother Australia runner-up Tim Brunero on Macquarie National News, Tchappat said he is planning on releasing a book about his experiences growing up in the controversial religious group. “I’ve spent the last two years writing it. It just happened that I got into Big Brother in the tail-end of it. Obviously there’s a few more chapters to add, but I’m really pumped, it’s an interesting story,” he said. He plans to title the book Losing my Religion.

He was also interviewed by ninemsn on Tuesday, and said he does not regret discussing his experiences in Raven-Taylor-Hales Brethren on Australian national television. “I’m an example of how you can go out and be successful. I say to people that if you are thinking about leaving, and you’re serious, take a punt and give it a go. You can always go back if you don’t like it.” Former members of the group were inspired by Tchappat’s comments and empathized with his experiences in posts to Big Brother Internet message boards.

Prime Minister of Australia Kevin Rudd criticized the Raven-Taylor-Hales Brethren group in August 2007. At the time he was leader of the Australian Labor Party, and requested that then-Prime Minister John Howard reveal what took place in a private meeting with senior members of the religious group. “I believe this is an extremist cult and sect. I also believe that it breaks up families,” said Rudd to reporters in Adelaide according to The Sydney Morning Herald. He noted that the organization was being investigated by the Australian Federal Police for prior election activities, and wanted to know how much funding had been given by the group to the Liberal Party.

During his election campaign Rudd called on Australian federal agencies including the anti-money laundering agency Australian Transaction Reports and Analysis Centre (AUSTRAC), the Australian Federal Police, the Australian Taxation Office, and the Australian Electoral Commission to investigate the activities of Raven-Taylor-Hales Brethren. In spite of Rudd’s criticism of Raven-Taylor-Hales Brethren, the religious group was guaranteed AUD10 million in taxpayer funding for its school facilities in January 2008. Rudd had promised during his election campaign to maintain education funding levels for non-government schools if he became Prime Minister.

Australia media reported on May 18 that Rudd rejected a request from former members of Raven-Taylor-Hales Brethren to investigate the group. 34 ex-members of the religious group had sent a letter to the Prime Minister’s office asking him to investigate how they were treated in the organization. A spokesman for Rudd said that the ex-members should instead take their request to the police, and that a government investigation would raise religious freedom issues. Rudd’s chief of staff David Epstein said that the Prime Minister “does not resile from the views he expressed last year” and “remains concerned about the reported imposition of doctrines that weaken family bonds”.

Australian Greens spokeswoman Christine Milne told Australia’s ABC News said that the well-being of children still in the group should be of primary concern. “The issue here is not about religious freedom, it is about what this cult is doing to destroy families and effectively to undermine the law,” said Milne.

Ex-member Peter Flinn, who wrote the letter sent to Rudd which was signed by 33 other former members, was disappointed by the Prime Minister’s response. “We just want to highlight other equally fundamental human rights, such as access to family who remain Brethren members, a right callously denied for decades,” he said in a statement in The Sydney Morning Herald. Senator Bob Brown of the Australian Greens party has proposed a government inquiry into the group’s public funding, tax concessions and possible practices that harm children.