instead of being an asshole...lying about vaccines.. you might wish to discuss the science... you fucking moron... lying piece of stupid shit. Its the scientific concept of ADE for future variants we are discussing. We all know these initial vaccines are fine so far with respect to ADE. That is not what we are talking about. However as they fade and high risk get infected again... and or new variants come out... you can not rule out ADE... stop being a lying fuck about important science. you have seen this before... you lying dirtbag.... now take the scientific concept and understand what may happen with new variants. "Current Covid-19 vaccines (either mRNA or viral vectors) are b"ased on the original Wuhan spike sequence. Inasmuch as neutralizing antibodies overwhelm facilitating antibodies, ADE is not a concern. However, the emergence of SARS-CoV-2 variants may tip the scales in favor of infection enhancement. Our structural and modeling data suggest that it might be indeed the case for Delta variants." Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination? - Journal of Infection
This just in, if you have had two AZ doses and somebody calls you to say they have a Moderna going to waste and would you like it. You only have yourself to blame. I'm out at a thing, have a raging case of the shits coming on, dizzy, shaking and the bathroom has a toilet the size of a teacup!
Well OK, I managed to get a little sleep, around 10.30am I was beginning to feel normal, just chilling in my cinema now at the country house. Feel OK. So the initial reaction to AZ+AZ+Moderna was a bit heavy after 12 hours but by 24 not an issue really.
Pfizer says COVID-19 vaccine works in kids ages 5 to 11 https://www.wral.com/pfizer-says-covid-19-vaccine-works-in-kids-ages-5-to-11/19885325/ Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek U.S. authorization for this age group soon — a key step toward beginning vaccinations for youngsters. The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children. North Carolina state health director Dr. Elizabeth Tilson said Monday morning that, in the past two weeks, children in the 0 to 17 age group had the highest case rates of any age group for the first time during the pandemic. High school and middle school students have the highest rates of spread, while younger children and preschoolers have a lower rate, she said. Young children are also less likely to become severely ill when compared with teenagers. "Thankfully rates of hospitalizations are low amongst children in general," Tilson said. "They do have relatively mild to moderate illness." According to Tilson, children can spread COVID-19 to older children and adults, which is another risk. "There are numerous, numerous studies that children are quite efficient spreaders to their households," she said. "They're very good at spreading it to those members of the household who may have a higher risk of severe disease and death from COVID.” Tilson said, with the recent news from Pfizer, a vaccine could be available for the 5-11 age group this this fall, and kids as young as 6 months could have access by the end of the year. For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press. The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said. “I think we really hit the sweet spot,” said Gruber, who’s also a pediatrician. Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators. Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids. An outside expert said scientists want to see more details but called the report encouraging. "These topline results are very good news,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. The level of immune response Pfizer reported “appears likely to be protective.” Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what's the right dose and that it works safely. Cuba last week began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3. While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country. “I feel a great sense of urgency” in making the vaccine available to children under 12, Gruber said. “There’s pent-up demand for parents to be able to have their children returned to a normal life.” In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated like her parents and both teen brothers have. Her mother, Dr. Nisha Gandhi, a critical care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family hasn’t eased up on their masking and other virus precautions until they learn if Maya received the real vaccine or a dummy shot. Once she knows she’s protected, Maya’s first goal: “a huge sleepover with all my friends.” Maya said it was exciting to be part of the study even though she was “super scared” about getting jabbed. But “after you get it, at least you feel like happy that you did it and relieved that it didn’t hurt," she told the AP. Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune “bridging" study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer’s Gruber said once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else. A second U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.
2nd dose of J&J COVID-19 vaccine results in stronger protection, company says The shots, given two months apart, can offer 94% protection against infections. https://abcnews.go.com/Health/2nd-dose-jj-covid-19-vaccine-results-stronger/story?id=80138043 A second dose of Johnson & Johnson's COVID-19 vaccine given two months after the first leads to stronger protection, according to the company. The new data, announced in a press release, adds to a growing body of evidence suggesting that booster shots could enhance vaccine protection against breakthrough infections -- though experts agree all three vaccines are still doing their job to protect against more serious illness. Compared to the Pfizer and Moderna vaccines, Johnson & Johnson's single-shot vaccine always had slightly lower efficacy. Peak efficacy from the two-shot Pfizer and Moderna vaccines was 95% and 94%, respectively, against symptomatic illness. But two Johnson & Johnson shots, given two months apart, resulted in a similarly high effectiveness level: 94% protection against any symptomatic infection in the U.S., and 100% against severe disease. With Pfizer's booster shots now up for formal review from the Food and Drug Administration, and Moderna's shortly to follow, the new data will likely factor into regulators' decision about if and when additional shots are appropriate for the nearly 14.9 million people who received the Johnson & Johnson vaccine. All three currently authorized vaccines are still working well to dramatically reduce the risk of being hospitalized, but as months pass and with the emergence of new COVID-19 variants, the vaccines are losing their power to prevent more mild breakthrough infections. The new Johnson & Johnson data also raises questions about when to give an additional shot for the country's only single shot vaccine. New data describing a booster two-months later found a marked increase in antibody levels. But prior data, already published, found that a booster shot given six months after the first dose results in even higher antibody levels. "With the two-month boost interval, there was a four-fold increase in antibody titters. But when a booster was given after six months, it led to a 12-fold increase in antibody titers," Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, whose lab helped develop the J&J vaccine, told ABC News. "This suggests that the efficacy might be even greater when the booster is given at this later point in time," Barouch said. Regulatory authorities will need to weigh the available evidence and determine the appropriate timing for booster shots for all three vaccines. In prepared remarks, J&J Chief Scientific Officer Dr. Paul Stoffels said the single-shot vaccine still provides "strong and long-lasting protection" while also being "easy to use, distribute and administer.""At the same time," Stoffels said, "we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly." According to Barouch, "the data supports the single-shot vaccine as the bedrock for providing robust and durable protection. But giving a boost two to six months later increases immune responses and augments protection to very high levels."
Quite so. As I argued early on, the allegations/evidence that JandJ was less effective could easily just be a dosing issue. JandJ wanted to/hoped for a one-shot product which has marketing advantages but might not be as effective. That does not mean that the vaccine is less effective, it just means that the dosing and administration may not be. You really need to see a two-shot regimen-compared to two shot regimen of the other vaccines. And now we see that. The virus and the human body do not understand the english language or how humans categorize things. A "booster shot" of JandJ is just a second shot. Arguably down the road they may call a third shot of JandJ a booster shot, since the second shot of JandJ seems to get you to an equivalency level with the other two-shotters, which are now moving to a third third shot as a booster. Yeh. whatever. Just language stuff. It is all about whatever the most efficacious dosage and administration is.
More follow-up on the J&J "booster"... Covid booster dose gives 100% protection against severe infection – study Johnson & Johnson study looks at impact of booster two months after original vaccination https://www.irishtimes.com/business...tion-against-severe-infection-study-1.4679957 A booster dose of Johnson & Johnson’s Covid-19 vaccine provided 100 per cent protection against severe disease when given two months after the first inoculation, according to widely anticipated data that suggests it increases the potency of the one-time shot. The booster was 94 per cent effective at preventing symptomatic Covid infections in the US portion of the Phase III trial, and 75 per cent effective overall when it was given 56 days after the initial dose, the company said in a statement Tuesday. A second study found the additional shot spurred a 12-fold increase in production of antibodies against Covid when it was given six months after the first. The results come as many developed nations turn to booster shots to address waning protection from some vaccines and the rise of the more infectious delta variant, which is sparking new outbreaks globally. The move has raised questions about the level of protection afforded by the existing shots and the equitable distribution of the vaccines now available. “Our single-shot vaccine generates strong immune responses and long-lasting immune memory,” Mathai Mammen, global head of research and development for Johnson & Johnson’s Janssen drug unit, said in the statement. “When a booster of the Johnson & Johnson Covid-19 vaccine is given, the strength of protection against Covid-19 further increases.” The time period between the initial vaccine and the booster shot was significant, the research showed. When the second dose was given two months after the first shot, it triggered a four-to-sixfold increase in antibody levels – less than the 12-fold gain seen when it was given six months after the initial injection. Most vaccinated people in Ireland have received the two-dose messenger RNA vaccines made by Pfizer and BioNTech, with a smaller group getting J&J’s single shot inoculation. Originally, 2.1 million doses of the J&J vaccine were scheduled for delivery this year but it suffered supply issues and was then phased out by the HSE in favour of the Pfizer jab. Booster Decision The US Food and Drug Administration is nearing a decision on whether to authorize a third shot of the Pfizer-BioNTech vaccine for vulnerable people who have already received the normal two-dose schedule. Last Friday, a panel of FDA advisers rejected Pfizer’s proposal to broadly recommend a third dose, and instead voted in favour of only giving it to people at high risk, including those 65 and older. The agency, which doesn’t have to abide by the panel’s advice, is expected to make a decision within days. Moderna, which also makes a two-dose mRNA vaccine for Covid, has applied to the FDA for emergency authorisation of its Covid-19 booster shot. The agency is expected to consider the application in the coming weeks. That has left the smaller number of people who received the J&J vaccine, which proved less effective than the mRNA shots in clinical trials, waiting for clarity on whether they too will need boosters, and if so , when. Separately in its statement, J&J said that a single dose of its vaccine provided strong protection that remained stable through July. The real world study compared 390,000 people in the US given J&J’s shot to 1.5 million who were unvaccinated. The immunisation reduced hospitalisations by 81 per cent and infections by 79 per cent, the company said. There was no evidence the protection ebbed over time, including after the delta variant came to dominate, it said. J&J has provided the available data to US regulators and plans to submit it to regulators elsewhere as well as the World Health Organization. – Bloomberg
Top model projection: Covid to decline through March. Expect around 9,000 cases a day and less than 100 deaths a week. *without a new variant coming along. Basis for decline is twofold: 1. Delta is running out of people to infect amd 2. Vaccine rates. https://www.npr.org/sections/health...a-steady-decline-in-covid-cases-through-march Interestingly though, they see Covid in the coming months to become more localized, spreading sporadically in populations without immunity.
F.D.A. Authorizes Pfizer Booster Shots for Older and At-Risk Americans Regulators said that people over 65 or at high risk of severe Covid-19 were eligible for an extra shot, setting up a staggered national booster campaign. https://www.nytimes.com/2021/09/22/us/politics/pfizer-boosters-fda-authorize.html After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTech’s coronavirus vaccine to get a booster shot at least six months after their second injection. The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming severely ill with Covid-19 or are at risk of serious complications from the disease due to frequent exposure to the coronavirus at their jobs. The authorization sets up what is likely to be a staggered campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for possibly tens of millions of vaccinated people to receive boosters at pharmacies, health clinics, doctors’ offices and elsewhere. Roughly 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention. About half of them are 65 and older. Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to learn whether they, too, can get boosters. The F.D.A.’s decision will be followed as soon as Thursday by a recommendation from the C.D.C., which issues guidance on vaccine policy for clinicians and public health officials throughout the United States. An advisory committee of the C.D.C. is now in the midst of a two-day meeting on the issue. But even if the C.D.C. takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the F.D.A.’s eligibility criteria. The ruling followed weeks of internal disagreement at the F.D.A., where some vaccine regulators openly challenged the idea of offering booster shots to the general population. Public health experts and state officials have criticized what they said were confusing public messages from the Biden administration about who should be eligible for a booster shot and when. Regulators have significantly slowed the booster rollout that top federal health officials drafted and President Biden announced in mid-August. At the time, Mr. Biden said that pending regulatory approval, he wanted to offer third shots to every American adult who had been fully vaccinated with the Pfizer-BioNTech or Moderna vaccine at least eight months earlier, starting this week. But so far the F.D.A. has cleared booster shots only for Pfizer-BioNTech recipients, and not all of them. Regulators are expected to take up whether to authorize the shots for recipients of the Moderna and Johnson & Johnson vaccines in short order. Wednesday’s authorization made the United States the most recent wealthy nation to offer people booster doses, joining a list that includes Germany, France, Israel and Britain. Some public health experts say those doses should instead be directed to countries that have vaccinated far fewer of their residents. At a virtual Covid-19 summit on Wednesday, Mr. Biden pledged an additional 500 million doses of Pfizer-BioNTech’s vaccine to countries that need them. The F.D.A.’s ruling could set off a spirited debate about who falls into the eligible subgroups, especially those who are considered at special risk because of their jobs. At a meeting last Friday, members of the agency’s advisory committee of experts said that health care workers should be eligible for boosters because of their work, and a senior F.D.A. regulator said that teachers fit in the same category. There was also a push to include some inmates and staff at jails and prisons because of risks tied to incarceration. Those specific recommendations will be left to the C.D.C. The F.D.A.’s decision to include those who are at high risk of severe Covid-19 captures another significant swath of the population. An estimated 60 percent of Americans suffer from obesity or other chronic medical conditions that heighten their risk of suffering from severe Covid-19, but not all of them might be included. Pfizer had asked the F.D.A. to approve a third shot for all recipients of its vaccine who were 16 and older, six months or more after their second injection. Regulators scrambled to collect and review safety and efficacy data fast enough to meet the administration’s goal of offering shots this week. At a dramatic meeting last week, members of the F.D.A.’s outside advisory committee said the available data was too limited to justify additional injections for so many people and voted 16 to 2 against approving Pfizer’s request. Some of the committee’s experts were concerned that Pfizer’s clinical trial results on boosters included only about 300 volunteers, a point that was brought up repeatedly by the C.D.C.’s experts. But the advisory committee voted unanimously for the narrower option reflected in the regulatory decision. The F.D.A. not only narrowed Pfizer’s request, but authorized the third shot on an emergency basis instead of fully approving it. As a practical matter, since the F.D.A. fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, physicians have had broad latitude to prescribe a third dose to people they deemed in need of one. Many Americans have already sought extra shots on their own, typically by finding a cooperative pharmacist or pretending to be unvaccinated. “There’s anxiety about this public expectation that everyone should go get a booster,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies. “If we pull back on that, then states are going to get left holding the bag.” Dr. Jesse L. Goodman, a former chief scientist at the F.D.A., said that because of some uncertainty around the benefits of boosters, regulators were right to grant only an emergency clearance for the shots while continuing to study their safety and performance. “A stepwise approach is very judicious,” he said. Some state health officials greeted the F.D.A.’s move enthusiastically. Dr. Clay Marsh, West Virginia’s Covid-19 czar, said that his state’s success vaccinating older residents early meant that they were overdue for extra protection. He also said that strained hospitals in the state could not afford to lose more staff, and that booster doses could protect frontline workers from milder infections that would require them to stay at home. Anxious would be an understatement,” he said of those waiting for extra shots. “We’ve asked them to be patient with us. We’ve gotten texts and emails from people saying they’re living like hermits again with Delta variant, asking when is it going to be safe.” The decision is the latest in a series of important ones that the F.D.A. is expected to make in the next few weeks. Ahead lie complex decisions on whether to authorize booster shots for recipients of the Johnson & Johnson and Moderna vaccines, whether to authorize the use of Moderna’s vaccine for children ages 12 to 17, and whether to authorize Pfizer-BioNTech’s vaccine for children between the ages of 5 and 11. Top federal health officials have said they needed to publicly announce plans for a booster campaign so that states could prepare for a rollout. But some state officials said it was a challenge to sort out conflicting messages from federal officials. For instance, the president said people should be eligible for a booster eight months after their second shot, but the F.D.A. set the interval at six months. Patrick Allen, the director of the Oregon Health Authority, said that the switch has thrown off the state’s planning and caused officials there to “scramble” to prepare for many more residents who now could be eligible. “We thought at an eight month window we were going to be OK with supply and demand, with our core infrastructure being clinics and pharmacies. But if we have 350,000 people eligible at the beginning, we’re going to have some challenges,” he said, referencing estimates the state has made. At least one county is now preparing to reopen a fairgrounds site for booster doses, he said.
Wilenski added to FDA recommendation healthcare workers and 50+ with underlying medical conditions. I never thought 65+ was the smart way to go with Pfizer, originally I thought they would do 55+ above but 50+ with underlying works too. ***To anyone arguing against boosters in America in favor of sending first dose shots around the world. No. The US has suffered outsized disease and loss of life comparatively. We need to stop the spread and loss of life wherever, however we can ASAP. That includes right here in the US.