As usual, the Chinese are ahead of us. Also as usual, the ways they get there are not necessarily pretty. China’s Sinovac plans to test COVID vaccine on children before the company is sure the inoculation works in adults https://fortune.com/2020/09/18/sinovac-test-covid-vaccine-children-safety/
FDA finds Pfizer vaccine to be safe and effective... Pfizer's COVID vaccine candidate detailed in extensive FDA report, backing up previous findings on safety and effectiveness https://www.usatoday.com/story/news...n-fda-immunization-safe-effective/3860002001/ The U.S. Food and Drug Administration Tuesday morning released a 53-page report summarizing data from Pfizer and BioNTech's COVID-19 candidate vaccine trial. The data supports earlier findings that the vaccine is safe and will prevent 95% of people from becoming sick with COVID-19. The companies are asking the FDA for authorization to use the vaccine in people ages 16 and up. They have also begun testing the vaccine in ages 12-15, but have not yet accumulated enough data to request authorization in that age group. The report provides more detail on how certain groups of people fared with the vaccine, including people over 65, those with pre-existing medical conditions, like diabetes, and those who are Black and/or Hispanic – all of whom appeared to be as well protected as the general population. Roughly one-third of participants met the definition of obesity, lower than the general population of the United States, but still high. The average age of participants was 51. They appeared to be as well or better protected than everyone else, countering the concern that the vaccine might not work as well in people with conditions Dr. William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee, said he received a briefing on the material in recent days, though he would not say who presented the briefing or who else received it. "The group I was with who heard the data arrived interested and left the presentation enthusiastic," Schaffner said. "The extraordinary thing is that there were no major areas of concern." This is a developing story. Check back for updates.
UK probing if allergic reactions linked to Pfizer vaccine https://www.wral.com/uk-investigates-possible-allergic-reactions-to-covid-19-shot/19421018/ British regulators warned Wednesday that people who have a history of serious allergic reactions shouldn’t receive the new Pfizer-BioNTech vaccine as they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program. The U.K.’s Medical and Healthcare Products Regulatory Agency is looking into whether the reactions were linked to the vaccine. The two people affected were staff members with the National Health Service who had a history of allergies, and both are recovering. Authorities have not specified what their reactions were. In the meantime, the regulator has issued the warning for anyone who has had a significant allergic reaction to a vaccine, medicine or food. That includes anyone who has been told to carry an adrenaline shot or others who have had potentially fatal allergic reactions. “As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday,’’ Professor Stephen Powis, medical director for the NHS in England, said in a statement. “Both are recovering well.” The medical regulatory agency also said vaccinations should not be carried out in facilities that don’t have resuscitation equipment. Pfizer and BioNTech said they were working with investigators “to better understand each case and its causes.'' Late-stage trials of the vaccine found “no serious safety concerns,” the companies said. More than 42,000 people have received two doses of the shot during those trials. “In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee,” the companies said. Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who weren’t previously known to have severe allergies. Even in non-emergency situations, health authorities must closely monitor new vaccines and medications because studies in tens of thousands of people can’t detect a rare risk that would affect 1 in 1 million. Dr. Peter Openshaw, a professor of experimental medicine at Imperial College London, said there is a “very small” chance of an allergic reaction to any vaccine. The MHRA last week gave emergency authorization to the Pfizer-BioNTech vaccine, making Britain the first country to allow its widespread use. The U.K. began its mass vaccination program on Tuesday, offering the shot to people over 80, nursing home staff and some NHS workers. It's not clear how many people have received the jab so far. As part of its emergency authorization for the vaccine, the MHRA required healthcare workers to report any adverse reactions to help regulators gather more information about safety and effectiveness. The agency is monitoring the vaccine rollout closely and “will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental,” he said. “The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.” Dr. June Raine, head of the medical regulatory agency, informed a Parliamentary committee about the reactions during previously scheduled testimony on the pandemic. “We know from the very extensive clinical trials that this wasn’t a feature” of the vaccine, she said. “But if we need to strengthen our advice, now that we have had this experience in the vulnerable populations, the groups who have been selected as a priority, we get that advice to the field immediately.”
He has nothing left and trying to lessen the possibility that his legacy has gone to crap. Simply, he's hoping to claim a small victory here but voters will not let him forget that +287k Americans have died from Covid-19 while he played it down, mocked it, called it a democratic hoax, called it kung-fu virus, it'll just go away, taunted democrats for wearing a face mask, unable to protect the WhiteHouse from infection, he himself was hospitalized and given a medical cocktail that nobody else would have had access too... Then losing an election to the the former vice president of Obama / Biden administration and to a women of color... Him and his cult will never be able to get over this type of a defeat. In my opinion...this small victory will not save his legacy because of their attempts to disenfranchise voters and undermining Democracy. wrbtrader
So I am reading there are allergic reactions to the vaccine in England. Does anyone here the background to explain how mRNA messaging works. Will this little piece of code go away over time? Can it morph? What are the long term risks?
The official CDC party line explanation is here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html I do think though that there are production reasons for going with an mRNA vaccines rather than just effectivity. From the beginning, I have always been curious about why just your basic, old school, inject- dead-virus-material types of vaccine would not work fine. To add to my curiosity, the Chinese and Russians have taken this pathway. Note, I am not saying anything about their crappy testing and safety- just saying that they are following a proven approach whereby you inject dead virus material such that the immune system can learn to produce antibodies but there is no chance of live virus material growing, or shouldn't be anyway. Over time though, I read in a couple places that if the mRNA type vaccine is approved it lends itself to ramping up bigtime much, much faster than the production technique for a dead-virus vaccine. So production factors come into the decision making I think, and the mRNA has an advantage there it is alleged.
It's interesting that Clinton's loss, similarly devastating to democrats, was immediately followed by, "how could this happen? Who voted for Trump, and why? What did we do wrong? Why were the pollsters so wrong?" Etc. Fast forward to now and republicans are, "this is fake, it was cheating, Trump won."