A panel of external experts is meeting on Thursday to consider whether the Food and Drug Administration should grant emergency use authorization to the Covit-19 vaccine, which developed the Pfizer and BioNtech vaccine, which appeared to be highly effective in phase 3 clinical trials. . Earlier this week, the United Kingdom began using the vaccine, now known by the working name BNT162b2. On Wednesday, Canada’s drug regulator announced that it had approved the emergency use of the vaccine. The United States begins its process with the Thursday meeting of the Vaccines and Related Biological Products Advisory Committee or VRPPAC. The release of the Covid-19 vaccine in the United States will begin within a few days if the group recommends an EU grant, and if it follows FDA advice. It is widely believed that the ad will vote to recommend the VRBPAC vaccine and that the FDA will release the EUA; In a statement to the panel published online on Tuesday, FDA scientists supported the vaccine’s safety and efficacy. But this means no questions asked and no worries raised throughout the day. (The draft agenda can be found here.) VRPPAC members come to a meeting ready to kick the tires hard on behalf of the American public. Below is our live broadcast of the meeting. We post updates and analyzes throughout the day in reverse chronological order. How many vaccine EUAs can the FDA provide? 9:50 a.m .: An interesting question here: If the FDA approves a Govt-19 vaccine, is it not possible to grant emergency utilization approvals for the future? Janet Lee, a biologist and panelist at the University of Arkansas, raised the issue after an FDA official outlined the rules governing the EU. One of them is a rule that the EUA is guaranteed when there is not enough, approved product for a particular symptom. When it comes to Covid-19, does it not mean that once the FDA gives full approval to the first vaccine, it will be excluded from providing EUs to those who come? The answer is no, says Doreen Fink, deputy director of the FDA’s immunization division. If the approved product is only available in limited distribution – as the first approved Covit-19 vaccine is guaranteed – the FDA will still be able to provide EUAs for intelligence products. This means that we will not miss such meetings for months to come. But it also means that if the United States achieves its goal of receiving hundreds of millions of vaccines in the summer, the next generation of Covid-19 vaccines will have to go through the FDA’s standard, non-UAV process. – Damien Kart NEJM Editorial: The vaccine is a ‘success’ 9:30 am: While today’s FDA panel is underway, one of the invited experts – and a voting member of the panel – has already made the Pfizer / Bioentech Govt vaccine a “success.” Harvard D.H. Eric Rubin, an immunologist at the San School of Public Health, co-authored an admirable editorial on the vaccine, which was published in the New England Journal of Medicine this morning. While highlighting minor issues in clinical trial design, Rubin wrote that vaccine results are “impressive enough to sustain any imaginary analysis”. He adds: “It was a success. Most vaccines have taken decades to develop, but it is likely to move from conception to large-scale implementation within a year. The sequence of the virus that led to the development of the specific antiviral RNA sequence required to design the vaccine was not determined until widely determined by the Chinese Centers for Disease Control and Prevention in January 2020. There is a lot of credit to come around: to the scientists who shared the data, to the people who developed the basic methods and implemented them to develop a vaccine, to the medical examiners who did high quality work in the health emergency system, to the thousands of participants in the test, and to the governments that helped create the performance standards and the market for the vaccine All of these stand as a template for many of the Govit-19 vaccines currently in development, some of which have already completed Phase 3 trials. The results of the Phaser 3 test of Pfizer / Bioendech were also released at the NEJM this morning. – Adam Fierstein Here we go! 9 a.m .: The meeting is called to order. If you want to do check-in, it does streaming here. The virtual audience for this meeting is expected to be large and global. The world is watching how US agencies evaluate the effectiveness and safety of the Covit-19 vaccine and how it thinks about prioritizing vaccine allocation. How do we know? Nearly 32,000 computers in more than 66 countries and most parts of the United States were streaming the December 1 meeting of the Advisory Committee on Immunization Practices, an expert panel that assists disease control and prevention centers in evaluating vaccines and prioritizing their use. . It is not uncommon for an ACIP meeting to attract so much attention. During that meeting, ACIP members recommended that health workers and residents of nursing homes first be prescribed the Govt vaccine. VRBPAC audiences will be large. The FDA considers gold to be the standard for regulatory bodies. This is what companies need to apply to bring a drug or vaccine to market in order to provide its source data, and the agency’s scientists are reviewing to ensure that the claims made by the drug or vaccine sponsor are supported by evidence. Pro Tip: If you are wondering how long it will take for the FDA to determine Pfizer’s emergency application authorization application after today’s meeting, this afternoon discussion will be important. Norman Baylor, former director of the Office for Vaccines Research and Review, said on Wednesday that if team members seemed to agree with the positive tone of the FDA’s review of the vaccine, things could move very quickly if they voted unanimously to recommend an EU offer. However, Bayler, now head of biological consulting and chief executive, said VRPPAC members – who have been clinging to Pfizer data in preparation for the meeting – could raise red flags. – Helen Franzwell FDA questions – and placebo issue 8:45 a.m .: The FDA has released the questions that will be charged on the panel. The big, voting question is not surprising: “Based on the available scientific evidence, are the benefits of the Pfizer-Bioentech Covit-19 vaccine greater than the risks of use for individuals 16 years of age and older?” This. It would be a big surprise if the committee did not vote in favor, however I look forward to a discussion of the meaning of each “yes”. In addition to the voting question, there are two debating questions: 1. “Please discuss any gaps in the programs described today in the explanatory documents for further evaluation of vaccine safety and efficacy in people receiving Pfizer-Bioendech vaccination under the EUA.” 2. “Pfizer has proposed a plan to pursue blind, placebo-controlled follow-up in current trials if the vaccine becomes available under the EUA. Discuss Pfizer’s plan, including how to deal with blind, placebo-controlled follow-up in current trials. “I want to focus a little on the second thing. This can be a major issue for all vaccine studies. Volunteers on these clinical trials are usually roughly assigned to receive placebo, but expect that they will be replaced as soon as the vaccine becomes effective. Experts, especially those on the VRPPAC panel, generally prefer to postpone the moment of vaccination for placebo patients. Once it arrives, the ability to compare the vaccine to a placebo to determine efficacy and side effects is lost.But there is another problem, which is that once a vaccine is available, patients may try to get it out of the test, which is even worse than changing them from the perspective of getting good data. STAT received a Pfizer memo a month ago, saying the company’s plan is to quickly replace those who are eligible for the vaccine with patients. There will be a lot more discussions about the project, especially as time is allotted for this issue at 10:50. – Matthew Herber VRPPAC Agenda 6 p.m .: Good day, everyone. In honor of our promise to be a historic day, a group of us at STAT — Matt, Adam, Damian and I – will be monitoring the day’s discussions and live-blogging. For starters, we will introduce you to the team members. The FDA has a very serious conflict of interest policy for VRPPAC members. Anyone involved in any of the Covid-19 clinical trials – even a member working at a university that serves as a testing ground, is “contradictory,” meaning that equally rigorously explored temporary alternatives are named in their place. The opening part of the meeting, which begins at 9 a.m. EST, is about setting the schedule for the following discussion. This includes a discussion of what is currently happening in the United States, plans for monitoring vaccine-induced adverse events, and a presentation on distribution. At 10:50 a.m. or EST (VRBPAC discussions may run for a long time) there will be an important discussion about what steps can be taken to ensure that the provision of EUAs for some vaccines does not interfere with efforts to run placebo-controlled trials for others. They are in the pipeline. This is a thorny but important issue. After the initial lunch, Pfizer will give a presentation on the vaccine. The FDA will then make a presentation, which the agency wants their advice to team members and wants them to answer any questions they may have by keeping votes. Then, starting at 3:10 pm EST (or thereafter), the group members will begin their discussions. It’s crisis time. – ஹெலன் பிரான்ஸ்வெல் சூழல் கோவிட் -19 தொற்றுநோய் உலகெங்கும் பரவி வருகிறது, ஆனால் குறிப்பாக அமெரிக்காவில், இந்த கிரகத்தில் எந்தவொரு நாட்டிலும் அதிக எண்ணிக்கையிலான வழக்குகள் மற்றும் இறப்புகள் உள்ளன. 15.3 மில்லியனுக்கும் அதிகமான அமெரிக்கர்கள் கோவிட் -19 நோயால் பாதிக்கப்பட்டுள்ளனர் மற்றும் 288,000 க்கும் அதிகமானோர் இறந்துள்ளனர். ஆபரேஷன் வார்ப் ஸ்பீட் என்ற இராணுவத் தலைமையிலான திட்டத்தின் மூலம் கோவிட் தடுப்பூசிகளை விரைவாகக் கண்டுபிடிப்பதற்கும் உற்பத்தி செய்வதற்கும் நாடு பல பில்லியன் டாலர்களை முதலீடு செய்துள்ளது. தடுப்பூசிகள் விதிவிலக்கான வேகத்தில் உருவாக்கப்பட்டாலும், அமெரிக்கர்கள் எவ்வளவு விரைவாக தடுப்பூசி போடுவார்கள் என்ற மதிப்பீடுகளில் நிலையான சரிவு ஏற்பட்டுள்ளது. ஆபரேஷன் வார்ப் ஸ்பீட் தற்போது டிசம்பர் இறுதிக்குள் 20 மில்லியன் மக்களுக்கு போதுமான தடுப்பூசி இருக்கும் என்று மதிப்பிடுகிறது – இருப்பினும் கிடங்குகளில் தடுப்பூசிகள் மற்றும் ஆயுதங்களில் தடுப்பூசிகள் இரண்டு வெவ்வேறு விஷயங்கள். தடுப்பூசி போட விரும்பும் ஒவ்வொரு அமெரிக்கரும் 2021 ஆம் ஆண்டின் இரண்டாவது காலாண்டின் இறுதியில் தடுப்பூசியை அணுக முடியும் என்று நிர்வாகம் இப்போது மதிப்பிடுகிறது. வியாழக்கிழமை விசாரணை அந்த செயல்முறையைத் தொடங்குகிறது. – ஹெலன் பிரான்ஸ்வெல்
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