https://www.streetinsider.com/dr/news.php?id=17335944 AstraZeneca (AZN) COVID19 vaccine study put on hold due to suspected adverse reaction in participant in the UK - STAT
The question then becomes whether AstraZeneca put it on hold or regulators required it. Big difference in the world of drug approval. Researchers stop and start studies repeatedly to examine patients with adverse reactions in most drug approval processes. A regulatory hold would be more serious though, and we have not heard that. AZN is in phase 3. Out of phases 1 and 2, 60% of the thousand people who took the vaccine had side effects. Side effects are not alway or even usually show stoppers. Sometimes it just tells the researchers that there is a dosage problem so that they need to lower the dosage or more to 2 shots rather than 1. In general mild side effects that are tolerable are considered to be desirable because a slight fever for a day or two indicates that the body is treating it as a disease that requires antibodies. You dont want a situation which you have with some people who are so efficient at kicking off the virus that they do not even create antibodies. On the other hand, you dont want the reaction to the vaccine to be so strong that it discourages people from taking the vaccine. Such is the road they walk. And that all vaccine developers walk. For all vaccines not just covid. Side effects not immediately bad. Not immediate good. Have to examine. Apparently they ran in to an outlier.
Some scientists spot 'unlikely' patterns in Russia vaccine data https://www.reuters.com/article/us-...s-in-russia-vaccine-data-letter-idUSKBN2602Q5 Twenty-six scientists, most of them working at universities in Italy, have signed an open letter questioning the reliability of the data presented in the early-stage trial results of the Russian COVID-19 vaccine, named “Sputnik-V”. Addressing the editor of The Lancet, the international peer-reviewed medical journal in which Moscow’s Gamaleya Institute published its early-stage trial results, the scientists said they saw patterns in the data that looked “highly unlikely”. The letter, published on the personal blog page of one of the signatories, said the Phase I/II trial results data showed multiple participants reporting identical antibody levels. “On the ground of simple probabilistic evaluations the fact of observing so many data points preserved among different experiments is highly unlikely,” the open letter said. However, the scientists said they were basing their conclusions on summaries of the Russian trial result data, published in the journal, rather than the original data itself. “In lack of the original numerical data, no conclusions can be definitively drawn on the reliability of the data presented, especially regarding the apparent duplications detected,” the letter said. The Gamaleya Institute, which developed the vaccine, rejected the critique. “The published results are authentic and accurate and were examined by five reviewers at The Lancet,” Denis Logunov, a deputy director at the institute, said in a statement. He said his institute submitted the entire body of raw data on the trial results to The Lancet. “We presented specifically the data that was produced (by the trial), not the data that is supposed to please Italian experts,” Logunov said. Naor Bar-Zeev, deputy director at John Hopkins Bloomberg School of Public Health, who peer reviewed the Russian data, defended his analysis of the research. “Science must maintain a balance between incredulity, skepticism and trust. That trust is borne out through plausibility, repeatability and falsifiability.” “The results are plausible, and not very different to those seen with other AdV vectored products,” he said. The researchers had provided more detail than was needed for the review and responded to his questions “intelligently and in a matter-of-fact and confident but understated manner”. “Bottom line, I saw no reason to doubt the legitimacy of these results over others I have read and reviewed. But of course one can never know,” he said in an email. A spokeswoman for the Lancet said the journal had invited the study’s authors to respond to the questions raised in the open letter. It was following the situation closely, she said. Russia published results on Friday of its Phase I/II trial, which included 76 participants and was conducted in June-July this year. Participants developed a positive immune response and no serious side effects, the study’s authors said. A Phase III trial, involving 40,000 participants, was launched on Aug. 26. Around 31,000 people have already subscribed to take part, Health Minister Mikhail Murashko said.
Coronavirus: Oxford University to resume vaccine trial after pause BBC - https://tinyurl.com/y5hm4s7l Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after being paused due to a reported side effect in a patient in the UK. On Tuesday, AstraZeneca said the studies were being paused while it investigated whether the adverse reaction was linked with the vaccine. But on Saturday, the university said it had been deemed safe to continue. Health Secretary Matt Hancock welcomed the news that the trials would resume. "This pause shows we will always put safety first. We will back our scientists to deliver an effective vaccine as soon as safely possible," he added. The university said in a statement that it was "expected" that "some participants will become unwell" in large trials such as this one. It added that the studies could now resume following the recommendations of an independent safety review committee and the UK regulator, the Medicines and Healthcare Products Regulatory Agency. It would not disclose information about the patient's illness for confidentiality reasons, but the New York Times reported that a volunteer in the UK trial had been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections. The World Health Organization (WHO) says nearly 180 vaccine candidates are being tested around the world but none has yet completed clinical trials. Hopes have been high that the vaccine might be one of the first to come on the market, following successful phase 1 and 2 testing. Its move to Phase 3 testing in recent weeks has involved some 30,000 participants in the US as well as in the UK, Brazil and South Africa. Phase 3 trials in vaccines often involve thousands of participants and can last several years. The government's chief scientific adviser, Sir Patrick Vallance, told the Downing Street press conference on Wednesday what had happened in the Oxford trial was not unusual. Risk of 'losing control' The news comes after Prof Sir Mark Walport, a member of the government's scientific advisory group Sage, warned the UK was "on the edge of losing control of the virus". He told BBC Radio 4's Today programme: "You've only got to look across the Channel to see what is happening in France and what's happening in Spain." Official figures released on Saturday showed a further 3,497 people have tested positive with the virus in the UK. It is the second day in a row that number of daily reported cases has exceeded 3,000. It brings the overall number of confirmed cases so far to 365,174. Meanwhile, the government figures revealed that a further nine people have died within 28 days of testing positive for Covid-19, bring the UK death toll to 41,623. (More at above url)
China Injects Hundreds of Thousands With Experimental Covid-19 Vaccines https://www.msn.com/en-us/news/worl...th-experimental-covid-19-vaccines/ar-BB18W5Ta A Chinese pharmaceutical company has injected hundreds of thousands of people with experimental Covid-19 vaccines, as its Western counterparts warn against administering mass vaccinations before rigorous scientific studies are complete. China National Biotec Group Co., a subsidiary of state-owned Sinopharm, has given two experimental vaccine candidates to hundreds of thousands of people under an emergency-use condition approved by Beijing in July, the company said this week. Separately, Chinese drugmaker Sinovac Biotech Ltd. said it has inoculated around 3,000 of its employees and their family members, including the firm’s chief executive, with its experimental coronavirus vaccine. The three vaccine candidates are still undergoing Phase 3 clinical trials, which involve testing a vaccine’s safety and effectiveness on thousands of people. Six other leading Covid-19 vaccine candidates are also in this final phase, according to the World Health Organization. Regulators in individual countries usually determine whether to let the broader public use a vaccine only after its testing is complete. The U.S., U.K. and Germany, where some of the leading candidates originate, haven’t yet approved any Covid-19 vaccine for use outside of clinical trials. Public-health experts say front-line medical workers should be given priority in any emergency use of unapproved vaccines. The Chinese government gave approval for members of the military to receive an experimental vaccine developed by CanSino Biologics Inc. in June, then authorized emergency use of other vaccine candidates for medical workers and border inspectors in July. Nine Western pharmaceutical companies promised in a joint statement this week not to file for regulatory approval or authorization of their experimental Covid-19 vaccines until formal clinical testing was complete. In an opinion column published Thursday, eight senior officials at the U.S. Food and Drug Administration said that they wouldn’t allow politics to influence their assessment of Covid-19 vaccine candidates, after President Trump called for a vaccine to be made widely available before the Nov. 3 presidential election. The U.K.’s AstraZeneca PLC, which is developing one of the leading candidates, this week paused clinical trials that aim to enroll 30,000 people after a woman in its U.K. study developed an unexplained illness. Trials could restart depending on the outcome of an independent review of the potential safety concern. In contrast, China and Russia appear eager to start using their homegrown vaccines, seeking to restart their economies and claim a global public-relations victory. Last month, Russia claimed to be the first country to approve a Covid-19 vaccine based on early-stage trials. Officials there have said they expect to start mass vaccinations by the end of the year. China, which says it has largely stamped out the new coronavirus within its borders, has also taken an aggressive approach to vaccinations. Among the hundreds of thousands of people who have been injected with experimental vaccine doses from CNBG, the Sinopharm subsidiary, are mainland China-based employees of Hong Kong-based Phoenix Satellite Television Holdings Ltd. Phoenix Television said last week that it injected its employees under China’s emergency-use policy, but didn’t say how many received vaccines. Sinopharm’s chairman Liu Jingzhen, in an interview with Phoenix Television, suggested the drugmaker would offer its vaccines to more Chinese journalists, especially those working abroad. “With the virus exploding overseas, these types of vaccines should give everyone hope,” Mr. Liu said. Zhou Song, a senior official at CNBG, said on the company’s social-media account that not a single person who received a vaccination was infected with the new coronavirus or experienced any obvious adverse reactions. Mr. Zhou also said the company wasn’t vaccinating women who were pregnant or breast-feeding. CNBG didn’t say if it informed the people it vaccinated of potential risks. Mr. Zhou said the injections given so far, including to Chinese laborers working on overseas infrastructure projects, have shown the vaccines’ effectiveness. While the Chinese infrastructure workers aren’t part of the company’s formal clinical trials, Mr. Zhou said that the company had collected data in multiple countries showing that their vaccinations had protected them for several months. Liu Peicheng, a spokesman for Sinovac, which said it has injected 3,000 employees and their family members, said the company’s recent vaccinations were purely voluntary and that it had disclosed to recipients the potential risks of taking the vaccine before the completion of clinical trials. He said the company had made the offer to its employees because it believed they were exposed to a higher risk of infection. “We are not here to show the safety of the vaccine to the public,” Mr. Liu said of the emergency use. China has promised to share any successful vaccine with other countries, many of them of strategic interest to Beijing, including the Philippines, Indonesia and Brazil. Sinovac has agreed to provide 100,000 vaccine doses, free, to Bangladesh. The U.S. has said that its own citizens would get priority in any successful vaccine. It has already committed to buying vaccines developed in the U.K. and Germany. CNBG said it has received orders for 500 million doses from overseas, the most among Chinese drugmakers, though it didn’t specify which countries put in orders. The company is conducting Phase 3 clinical trials in the United Arab Emirates and Argentina. The company’s vaccine regimen may require people to get injected with two or three doses. CNBG said it would be able to produce around 100 million doses of its Covid-19 vaccines by the end of the year and then up to one billion doses annually.
What is inevitable and uncontrollable by the Americans is that the outcomes from these various Russian and Chinese vaccinations (which are also being distributed in places such as Singapore and Brazil) will have an impact on the decisions and attitudes that Americans have toward vaccines as we go forward. Even though we may continue to and should continue to follow our more rigorous development guidelines it is a fact of life that anything good of bad happening elsewhere in the world is going to go into the mix of how receptive people are toward vaccines, and how hopeful they should be. We may be off in December saying we are hopeful that a vaccine will be approved by the end of the year and hope it works, and people may be thinking "yeh well why not, the chinese have been doing it for months so why should we not be hopeful and expect the Americans to get their fingers out of their arses and get going." Or it could go the other way, where companies and the government are hopeful in December about starting in with vaccines and people are thinking "forgettaboudit, we saw what happened with the Chinese and Russian vaccines." No punchline here positive or negative. Just sayin that right now people are looking to every bump, fart, and wiggle going on in test labs and drug trial studies as to what the future might look like but that is about to change. Real world experiences by others will be part of the picture too. The Russians and the Chinese will of course lie through their collective arses about the outcomes and even if they tell the truth they are not reliable anyway. But, as I said, they are also distributing bigtime in Singapore and Brazil and other places depending on which vaccination. Probably that is good thing for getting the truth out- the people on the ground there are less likely to cover-up what the real live experience seems to be. I wont replay my earlier posts but a couple of those vaccines are just ground up and killed common cold adenovirus so I don't think there is a lot of high risk dracula stuff going on. I dont recommend it for us without proper trials and they are gonna do it and are doing it anyway so it is going to happen anyway. But if they start killing people it becomes a harder sell for an american vaccine even if it is an entirely different product and been through entirely different testing. The Chinese and the Russians talk about phases 1,2,3 just as the Americans do. Except to them phase 1 is Monday, Friday is phase 2, next week is phase 3 and then you are good to go. I guess they must be better at it than we are.
Sure, but Joe is going to fix any concerns about american vaccines and Trump interference by making sure that we get a Chinese vaccine instead. He has Hunter working on it right now. cha-ching, cha-ching.
This is a lengthy but good read... The Great Vaccine Race: Inside the Unprecedented Scramble to Immunize the World Against COVID-19 https://time.com/5887199/coronavirus-vaccine-race/