Moderna says its low-dose COVID shots work for kids under 6 https://www.wral.com/moderna-says-its-low-dose-covid-shots-work-for-kids-under-6/20200995/ Moderna’s COVID-19 vaccine works in babies, toddlers and preschoolers, the company announced Wednesday -- and if regulators agree it could mean a chance to finally start vaccinating the littlest kids by summer. Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6. The company also is seeking to have larger doses cleared for older children and teens in the U.S. Early results from the study found that tots developed high levels of virus-fighting antibodies from shots containing a quarter of the dose given to adults — although just like with all ages, the vaccine was less effective against the super-contagious omicron mutant. “The vaccine provides the same level of protection against COVID in young kids as it does in adults. We think that's good news,” Dr. Stephen Hoge, Moderna's president, told The Associated Press. The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older. Outside experts caution that Moderna has revealed only limited data, and the Food and Drug Administration will have to determine if those high antibody levels translate into what's most important for vaccination — protection against severe illness — for tots like they do for adults. "Not a home run" but the shots still could be helpful for the youngest children, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. Parents have anxiously awaited protection for younger tots, disappointed by setbacks and confusion over which shots might work and when. Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn't prove strong enough. Those results are expected by early April. Vaccinating the littlest “has been somewhat of a moving target over the last couple of months,” Dr. Bill Muller of Northwestern University, who is helping study Moderna's pediatric doses, said in an interview before the company released its findings. “There’s still, I think, a lingering urgency to try to get that done as soon as possible.” The younger the child, the smaller the dose being tested. Moderna enrolled about 6,900 kids under 6 — including babies as young as 6 months — in a study of the 25-microgram doses. They developed levels of antibodies just as strong as young adults who get full-strength shots, the company said. COVID-19 vaccines in general don’t prevent infection with the omicron mutant as well as they fended off earlier variants -- although they do still offer strong protection against severe illness. Moderna's study in tots was conducted during the omicron surge and found the same trend: While there were no severe illnesses, the vaccine proved about 44% effective at preventing milder infections in babies up to age 2, and nearly 38% effective in the preschoolers. Still, the kids' high antibody levels “should translate into higher efficacy against severe infections,” Goodman said. While the study wasn't large enough to detect very rare side effects, Moderna said the small doses were safe and that mild fevers, like those associated with other common pediatric vaccines, were the main reaction. Booster doses have proved crucial for adults to fight omicron and Moderna currently is testing them doses for children, either a third shot of the original vaccine or an extra dose that combines protection against the original virus and the omicron variant. The FDA will determine whether to authorize emergency use of little-kid shots once Moderna submits its full data. Then the Centers for Disease Control and Prevention would recommend who should get them — and Goodman said there may be debate about shots for higher-risk children or everyone. While COVID-19 generally isn’t as dangerous to youngsters as to adults, some do become severely ill. The CDC says about 400 children younger than 5 have died from COVID-19 since the pandemic’s start. The omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge. Parents may find it confusing that Moderna is seeking to vaccinate the youngest children before it's cleared to vaccinate teens. While other countries already have allowed Moderna’s shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. A Moderna request to expand its shots to 12- to 17-year-olds has been stalled for months. The company said Wednesday that, armed with additional evidence, it is updating its FDA application for teen shots and requesting a green light for 6- to 11-year-olds, too. Hoge said he’s optimistic the company will be able to offer its vaccine “across all age groups in the United States by the summer.” Moderna says its original adult dose -- two 100-microgram shots -- is safe and effective in 12- to 17-year-olds. For elementary-age kids, it’s using half the adult dose. But the FDA never ruled on Moderna’s application for teen shots because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots are a far higher dose than Pfizer's. About 1.5 million adolescents have used the Moderna vaccine in other countries, “and so far we've seen very reassuring safety from that experience," Hoge said. The heart risk also seems linked to puberty, and regulators in Canada, Europe and elsewhere recently expanded Moderna vaccinations to kids as young as 6. “That concern has not been seen in the younger children,” said Northwestern’s Muller.
So tell us what percentage of the vaccinated population died in Canada. And tell us what percentage of the unvaccinated population which died of Covid in Canada. Canada has a very vaccinated population. And it should be noted that the death rate among the unvaccinated in Canada is more than 20 times greater than the vaccinated. Once again you fall for propaganda from anti-vaxxers. You really should understand Base Rate Fallacy.
Canada Vaccination Adverse Stats The percentage numbers about the Adverse Effects from Covid vaccinations have remained steady since the start of vaccination in Canada. Latest report is below as of March 11th, 2022. Children between 5 to 11 years old still have the lowest adverse events while 40 - 49 years old age group has the highest. Overall, excellent vaccination statistics: 0.051% adverse events among Canada's population of 81.02% fully vaccinated. Yet, 0.011% were considered to be serious adverse events. A closer look at who is being vaccinated in Canada Deaths Reported from Vaccination Up to and including March 11, 2022, a total of 309 reports with an outcome of death were reported following vaccination. Although these deaths occurred after being vaccinated with a COVID-19 vaccine, they are not necessarily related to the vaccine. Based on the medical case review using the WHO-UMC causality assessment categories, it has been determined that: 164 reports of deaths could not be assessed due to insufficient information 99 reports of deaths are unlikely linked to a COVID-19 vaccine 46 reports of death are still under investigation https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19.html wrbtrader
FDA authorizes second COVID booster shot for Americans 50 and older https://www.usatoday.com/story/news...icans-50-and-older-pfizer-moderna/7198420001/ People age 50 and up are eligible for a second booster dose of COVID-19 vaccine at least four months after their first, the Food and Drug Administration said Tuesday. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in a statement. The Centers for Disease Control and Prevention has to sign off on the booster before it becomes available. It's not clear how soon that may happen. A second booster dose of an improves protection against severe COVID-19 and is not associated with new safety concerns, the FDA said. But when and whether individuals gets one remains a personal decision that should be based on age, health status and the course of the pandemic, experts said. "Obviously, the older you are, the higher the risk; and the more underlying conditions the higher the risk," said Dr. Tom Frieden, the former director of the Centers for Disease Control and Prevention, who now heads Resolve to Save Lives, an initiative to prevent epidemics and cardiovascular disease. But Frieden said if he had a healthy 55-year-old patient who was already vaccinated and boosted, he'd be less concerned about getting that person another shot. "If you want to get one, fine. If you don't, it's really up to you," Frieden said he'd tell that patient. According to the FDA's decision, people 50 and over who received a booster shot of any authorized or approved COVID-19 vaccine more than four months ago can now get a second Pfizer-BioNTech or Moderna booster at no cost. Anyone 12 or older with a weakened immune system because of medical treatment or conditions is also eligible for an additional shot aimed to provide them the same level of protection someone with a healthy immune system received after three doses. Immunocompromised adults can receive a Moderna booster, though it is not authorized for use in minors. For the Pfizer-BioNTech vaccine, the booster will be identical to all previous shots, while with Moderna, a booster contains half the original 100-microgram dose. Although the initial shots provide good protection against hospitalization and death from COVID-19, a booster shot was better at preventing severe infection from the omicron variant that emerged near the end of last year. Some data suggests a second booster shot would help combat fading immunity after the third shot. The FDA cited an ongoing study among Israeli health care workers, 154 of whom received a fourth shot with the Pfizer-BioNTech vaccine and 120 who were boosted a second time with Moderna. Two weeks later, both groups saw at least a 10-fold increase in levels of antibodies capable of fighting off COVID-19, while antibody levels continued to fall among those who didn't receive an additional booster. No new safety concerns were raised in either group. Other studies, some not yet officially peer reviewed and published, also show a decline in vaccine effectiveness three to six months after the initial booster, and that a second booster can improve protection against severe disease. "The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations," the agency said in a statement. Some experts have raised concerns that an extra booster does not provide enough benefit to healthy people to justify its use. The same Israeli study offered as evidence in favor of a fourth shot concludes that "a fourth vaccination of healthy young health care workers may have only marginal benefits. Older and vulnerable populations were not assessed." Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, said he has seen no convincing evidence that healthy people need extra protection against severe disease beyond the initial vaccines. A second booster only offers a little extra protection against any infection with COVID-19 and it's not clear how long that benefit lasts, he said. Stéphane Bancel, CEO of Moderna said in a statement that boosters are needed to provide continued protection against COVID-19. "The virus continues to evolve, and we are currently on the verge of another potential wave driven by the BA.2 variant," he said. "Now, healthcare providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks." Dr. Megan Ranney, an emergency physician at Rhode Island Hospital and a public health expert at the Alpert Medical School of Brown University, said if she were in her 50s or 60s and healthy, she'd wait to get another shot. The pandemic is at a low point in the United States right now, so there's relatively little risk of infection. She'd rather get a booster closer to the time of an outbreak, when it would be more likely to protect against infection. "I would not be rushing out to get a booster today," she said. "If you get it too early, that's not going to help, either."
Get back to us with the hospitalization and death rates of the boosted in Ontario. Noting that the unvaccinated are over 20 times more likely to die from Covid.