For the Pfizer vaccine -- the FDA head extended the booster to front-line workers such as teachers. Otherwise the actions of the FDA head were completely in-line with the committee and CDC recommendations.
In short, most people being hospitalized with a severe Covid infection...are not vaccinated. wrbtrader
Data suggests mRNA booster dose generates stronger antibody response after J&J shot https://www.reuters.com/business/he...ronger-antibody-response-after-jj-2021-10-13/ People who received Johnson & Johnson's (JNJ.N) COVID-19 vaccine will have a stronger neutralizing antibody response if they get an mRNA shot as the second dose, Axios reported on Tuesday, citing a person who has seen data collected by the U.S. National Institutes of Health (NIH). J&J has asked the U.S. Food and Drug Administration (FDA) to approve a shot of its own single-dose vaccine as the booster dose. The FDA's advisers are set to consider the need on Friday. The NIH will present the mix-and-match data to the FDA panel on Friday, Axios said. There were limitations to the NIH data, according to the report. Neutralizing antibodies only prevent the virus from entering cells and replicating, and the report said it was unclear how long the response will last. The NIH, FDA and J&J did not immediately respond to Reuters' requests for comment. Two-dose vaccines made by Pfizer Inc (PFE.N) and its German partner BioNTech and Moderna Inc (MRNA.O) use the mRNA technology. The health regulator's outside experts will also discuss the need for an additional dose of Moderna's vaccine on Friday. Scientists at the FDA have said Moderna had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong. read more
White House tells states to get ready to start vaccinating young children against COVID-19 https://abc7.com/white-house-coronavirus-children-vaccination/11119212/ The White House is now actively urging governors across the country to get ready to vaccinate elementary-age kids against COVID-19 starting early November. Federal officials are still waiting for regulatory approval, but are ready to distribute 65 million doses of smaller, pediatric versions of the Pfizer vaccine. In audio obtained by ABC News, White House officials told the governors it had enough pediatric doses on hand for the 28 million children ages 5 through 11 expected to become eligible once federal regulators give the green light. "We've secured plenty of supply, and we'll be putting in place an allocation, ordering and distribution system similar to what we've used for the other vaccines," said President Joe Biden's White House COVID coordinator, Jeff Zients, on the phone call to governors. The American Academy of Pediatrics says after more than 6 million kids tested positive for the virus, infections in children are down as well, but the group adds the case rate among kids is still exceptionally high. While three out of four adults in the U.S. have gotten at least one dose of the vaccine, more than 68 million Americans eligible for the shot have yet to be vaccinated. Concern is growing over a potential COVID resurgence as more Americans are moving indoors due to cooler weather. Starting Wednesday, the Food and Drug Administration's independent advisors will discuss whether to approve booster shots of Moderna's and Johnson & Johnson's vaccines. A decision is not expected until next week at the earliest, and then that recommendation still has to be authorized by the FDA director and later by the director of the Centers for Disease Control and Prevention. Locally, the Los Angeles Unified School District extended its deadline for employees to be vaccinated. The district is now giving workers until Friday to have at least one dose and a second dose by Nov. 15.
Interesting news about Moderna boosters. I was not expecting Moderna which wanes less than Pfizer to be approved for boosters at this time beyond the immunocompromised and elderly. Experts recommend that FDA should authorize Moderna COVID vaccine booster https://www.npr.org/sections/health...hould-authorize-moderna-covid-vaccine-booster A panel of advisers to the Food and Drug Administration on Thursday unanimously recommended that the agency authorize a booster dose of the Moderna COVID vaccine at least six months after completion of the initial two-dose regimen. The recommendation applies to people 65 years and older, those 18 to 64 who are high risk of severe COVID and those people in the same age group whose work or institutional exposure puts them at high COVID risk. The recommendation mirrors the authorization FDA gave to Pfizer-BioNTech in September. The 19-0 vote came after presentations by representatives from the FDA and Moderna and committee discussion. The FDA typically follows the advice of its advisory committees, though it isn't required to. Moderna's COVID-19 vaccine booster is half the dose of the initial shots used in its two-shot vaccination — 50 micrograms of mRNA versus 100 micrograms. To set the stage, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, made introductory remarks as the meeting got underway Thursday morning. "Vaccines still provide strong protection against serious outcomes," he said. "Vaccine effectiveness against mild and moderate disease appears to wane over time. And mild to moderate disease can lead to blood clots and long COVID." The panel heard from researchers from Israel who gave an update on the experience with the Pfizer-BioNTech booster, which uses the same kind of mRNA technology as Moderna's vaccine. "The administration of the booster dose helped Israel dampen infections and severe cases in the fourth wave," said Dr. Sharon Alroy-Preis, director of public health services at the Israel Ministry of Health. An analysis of side effects, including heart inflammation, was reassuring, she said, especially for the most worrisome problems. "I'm very confident about the serious events." Several of the committee members said the Israeli data shed important light on the role of boosters and were persuasive. Some committee members said consistency with the previous action on the Pfizer-BioNTech booster was important, too. "I support this [emergency use authorization] because we've already approved it for Pfizer, and I don't see how we can possibly not approve it for Moderna and not have most U.S. folks completely confused." said Dr. Stanley Perlman of the University of Iowa. "I think it's a pragmatic issue." Just before the committee voted, Dr. Eric Rubin, editor in chief of the New England Journal of Medicine, acknowledged that there was incomplete information and some unanswered questions about the Moderna booster. "The data are not perfect," he said, "but these are extraordinary times, and we have to work with imperfect data."
Let me see, if I inject a foreign substance into a muscle there’s less chance of something going wrong compared to injecting it into a vein, straight into the cardiovascular system. Seeing as how the virus attacks the endothelium, the lining of the veins and organs, leading to blood clots and a host of other cardiovascular problems. Why is it inconceivable that a vaccine, something mimicking the real thing, wouldn’t cause similar problems? I’m not a medical professional but normally don’t they draw back a tad on the syringe to check for blood, hence poking a vein?
Muscles have immune cells Muscles make an excellent vaccine administration site because muscle tissue contains important immune cells. These immune cells recognize the antigen, a tiny piece of a virus or bacteria introduced by the vaccine that stimulates an immune response. In the case of the COVID-19 vaccine, it is not introducing an antigen but rather administering the blueprint for producing antigens. The immune cells in the muscle tissue pick up these antigens and present them to the lymph nodes. Injecting the vaccine into muscle tissue keeps the vaccine localized, allowing immune cells to sound the alarm to other immune cells and get to work. Once a vaccine is recognized by the immune cells in the muscle, these cells carry the antigen to lymph vessels, which transport the antigen-carrying immune cells into the lymph nodes. Lymph nodes, key components of our immune system, contain more immune cells that recognize the antigens in vaccines and start the immune process of creating antibodies. Clusters of lymph nodes are located in areas close to vaccine administration sites. For instance, many vaccines are injected in the deltoid because it is close to lymph nodes located just under the armpit. When vaccines are given in the thigh, the lymph vessels don’t have far to travel to reach the cluster of lymph nodes in the groin. Muscles keep the action localized Muscle tissue also tends to keep vaccine reactions localized. Injecting a vaccine into the deltoid muscle may result in local inflammation or soreness at the injection site. If certain vaccines are injected into fat tissue, the chance of irritation and inflammation reaction increases because fat tissue has poor blood supply, leading to poor absorption of some vaccine components. Vaccines that include the use of adjuvants – or components that enhance the immune response to the antigen – must be given in a muscle to avoid widespread irritation and inflammation. Adjuvants act in a variety of ways to stimulate a stronger immune response. Yet another deciding factor in vaccine administration location is the size of the muscle. Adults and children ages three and older tend to receive vaccines in their upper arm in the deltoid. Younger children receive their vaccines mid-thigh because their arm muscles are smaller and less developed. Another consideration during vaccine administration is convenience and patient acceptability. Can you imagine taking down your pants at a mass vaccination clinic? Rolling up your sleeve is way easier and more preferred. Infectious disease outbreaks, as in flu season or amid epidemics like COVID-19, require our public health system to vaccinate as many people as possible in a short time. For these reasons, a shot in the arm is preferred simply because the upper arm is easily accessible. All things considered, when it comes to the flu shot and the COVID-19 vaccine, for most adults and kids, the arm is the preferred vaccination route. https://theconversation.com/why-do-we-get-shots-in-the-arm-its-all-about-the-muscle-161259 ---------- wrbtrader
Understand that buttttttttttt, I gave up watching the earlier video, the guy is a good sleep-aid however if I understand correctly, accidentally injecting a mRNA vaccine directly into a vein can cause myocarditis. Doh! An attempt was made to correlate incorrectly injecting the vaccine as the reason for the myocardial side-effects and not the vaccine itself. Which I call BS. Due to the nature of the virus and how it attacks the body/endothelial/cardiovascular systems, any vaccine, mRNA or other I would expect some type of cardiovascular inflammation side effects. Imo, those that experience such would be/would have been likely candidates for severe illness.