Next up in hunt for Covid-19 vaccine: Testing shots in kids When the first shots arrive, they're unlikely to be recommended for children. https://www.nbcnews.com/health/health-news/next-hunt-covid-19-vaccine-testing-shots-kids-n1244205 The global hunt for a Covid-19 vaccine for kids is only just beginning — a lagging start that has some U.S. pediatricians worried they may not know if any shots work for young children in time for the next school year. Older adults may be most vulnerable to the coronavirus, but ending the pandemic will require vaccinating children, too. Last week, Pfizer Inc. received permission to test its vaccine in U.S. kids as young as 12, one of only a handful of attempts around the world to start exploring if any experimental shots being pushed for adults also can protect children. “I just figured the more people they have to do tests on, the quicker they can put out a vaccine and people can be safe and healthy,” said 16-year-old Katelyn Evans, who became the first teen to get an injection in the Pfizer study at Cincinnati Children’s Hospital. Multiple vaccine candidates are in final-stage studies in tens of thousands of adults, and scientists are hopeful that the next few months will bring evidence that at least some of them are safe and effective enough for widespread use. But when the first shots arrive, they're unlikely to be recommended for children. Vaccines can’t be given to youngsters unless they’ve been tested in their age group — a major hurdle in efforts to reopen schools and resume more normal activities that are critical to families' well-being. “The public doesn’t understand that,” said Dr. Evan Anderson of Emory University, who has been pushing for pediatric testing of COVID-19 vaccines. While he’s encouraged by Pfizer’s study in adolescents, he finds it “very concerning” that children younger than 12 may not have a vaccine by next fall. Children represent about 10 percent of Covid-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, about 120 have died in the U.S. alone, according to a tally by the American Academy of Pediatrics. That’s about how many U.S. children die from flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus. Overall, Anderson says Covid-19's impact on children is greater than some other diseases that require routine pediatric vaccinations. Aside from their own health risks is the still unanswered question about how easily children can infect others. In a letter to federal health officials, the AAP cited recent evidence that those over age 10 may spread the virus just as easily as adults do. Add missing school and other factors unique to children, and it’s unethical “to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine,” Dr. Sara Goza, president of the pediatrics academy, wrote. Globally, pediatric studies are only hesitantly emerging. In China, Sinovac and SinoPharm have opened studies that can test children as young as 3. A British study of a vaccine by AstraZeneca allows for testing of a low dose in certain children but the company says it won't be recruiting youngsters until it has “sufficient” safety data in adults. In the U.S., Moderna Inc., Johnson & Johnson and Novavax all hope to begin some pediatric research later in the year, in varying age groups. Doing so is critical, said Dr. Robert Frenck, who directs the Vaccine Research Center at Cincinnati Children's. “If we immunize adolescents — and potentially move down into younger children — we’re going to have the effect of keeping those children from getting infected. But then also they don’t bring the infection home to parents and grandparents,” he said. Frenck is finding lots of interest in Pfizer’s adolescent testing, with 90 families seeking more information in just a week after his team issued a call for 16- and 17-year-old volunteers. The researchers plan to enroll 12- to 15-year-olds soon. Katelyn, the suburban Cincinnati volunteer, doesn’t know if she got a dummy shot or the real vaccine. But the high school junior is excited to be part of the study. And with science class still fresh, she grasped the researchers’ explanation of how Pfizer’s vaccine works — using a piece of genetic code to train the body to recognize if the coronavirus comes along. “I’ve learned about DNA and RNA and all that stuff in biology in freshman year. And I guess I didn’t really know, like, how it applied to the real world until now,” she said. It makes sense to start pediatric testing in teenagers and gradually work down in age, Frenck said, because adolescents usually receive adult-sized doses of other vaccines — and so far with Pfizer’s shots, serious safety problems haven’t emerged in adult testing. Assuming Pfizer’s shot is proven to work in adults, Frenck said the key will be if the vaccine revs up adolescents’ immune systems the same way — without different side effects. He said if all goes well, it’s possible scientists may have an answer about the 12-and-older group by spring. But younger children need their own testing. Anderson, a pediatric infectious disease specialist at Children's Healthcare of Atlanta, said those studies may be more complex because smaller tots may need different doses or, because of their typically more robust immune systems, show different reactions to the shots. “It is quite important for us to begin the process because this will take some time to do the studies the right way,” he said.
Let's keep in mind that many of Azar's previous statements proved to be incorrect... Health secretary Alex Azar says all Americans who want a vaccine could get one by spring 2021 https://www.businessinsider.com/alex-azar-vaccine-available-for-all-americans-spring-2021-2020-10 The US is on track to start delivering coronavirus shots before the end of 2020, Health and Human Services Secretary Alex Azar said on Wednesday. Azar said the country should have enough doses for seniors, healthcare workers, and first responders by the end of January — and for all Americans who want a shot by early April. But that timeline hinges on the success of at least one vaccine from two leading candidates: Pfizer and Moderna. US health officials offered a hopeful message on Wednesday: "We're cautiously optimistic that vaccine will become available, although likely in limited quantities, before the end of 2020," Jay Butler, deputy director for infectious diseases at the Centers for Disease Control and Prevention, said at a press briefing. The US might even have two coronavirus vaccines ready before the end of the calendar year, Butler added, since the phase-three trials from Moderna and Pfizer are currently neck-and-neck. Pfizer hopes to show that its vaccine is effective by the end of this month, while Moderna has said the most likely release date for its results will be in November. That would put the US on track to start delivering shots before 2021. "We expect that we would have, by the end of this year, enough vaccine that is FDA-authorized to be able to vaccinate all of the most vulnerable individuals," Alex Azar, Secretary of the Department of Health and Human Services, said. "Then by the end of January, we expect we'd have enough to vaccinate all seniors, as well as our healthcare workers and first responders — and by the end of March to early April, enough vaccine for all Americans who would want to take a vaccine." That's a similar, albeit slightly speedier, timeline than the one put forward by Moncef Slaoui, the chief scientist for Operation Warp Speed, the Trump administration's effort to develop, manufacture, and distribute a coronavirus vaccine. Slaoui told Business Insider this month that he expects there to be enough doses to immunize the most vulnerable populations, particularly the elderly and people with significant comorbidities, by the end of January. By the end of March, he said, there should be enough vaccine to immunize frontline workers and first responders. "Optimistically, I would hope by the summer we are substantially back to normal," Slaoui said. "I would also hope that before the next flu season, we really have this virus under control." Barriers to a vaccine rollout The US is in the midst of its third surge in COVID-19 cases. All but five states have seen new daily cases climb over the past two weeks, according to data from John Hopkins University. The US is now seeing a weekly average of nearly 60,000 new cases per day— a nearly 40% jump from the start of October. "We're seeing a distressing trend here in the United States with COVID-19 cases increasing in nearly 75% of the country," Butler said. Some experts predict this third surge of infections could be the largest yet. Though a few coronavirus treatments may be improving outcomes for some patients, their impact on overall mortality has been minimal so far. A vaccine, however, could foster a level of herd immunity that makes it more difficult for the virus to spread. But any candidate will have to pass several checkpoints before it reaches the public. An independent scientific board will monitor clinical trial data, then decide whether it's promising enough to hand over to the Food and Drug Administration. From there, the FDA would have to determine that the vaccine is safe and at least 50% effective. But that means that even after a vaccine becomes available, Americans will likely have to continue wearing masks, social distancing, and avoiding large gatherings through the end of 2021. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN he would "settle" a vaccine that's 70% to 75% effective, though that's of course still a far cry from 100%. The US is prepared to distribute doses as soon as a shot is approved for emergency use. Within 24 to 48 hours of that approval, people could start receiving injections. But if Pfizer or Moderna's candidates aren't deemed safe and effective, the US will have to wait on the results from four other candidates, which could slow down the timeline. "I wish we had a crystal ball so that we could look at it," Butler said. "I wish I could say everything is going to go 100% according to plan, but we also know that we have to be ready for if it doesn't."
Key COVID-19 Vaccine Review Committee Promises Science Is Guiding Their Process https://time.com/5903162/covid-19-vaccine-committee/ As part of its routine review process, the U.S. Food and Drug Administration (FDA), the agency responsible for evaluating and deciding if the handful of COVID-19 vaccines currently being studied are safe and effective enough to use by people around the world, convened a committee on Oct. 22 to allow experts and the public to learn about and comment on the review process. The FDA’s Vaccines and Related Biological Products Advisory Committee is responsible for reviewing any applications by manufacturers hoping to get vaccines to market. The 18-member committee includes scientists and doctors with infectious disease, virology, and epidemiology expertise from academia, industry and government. Over a period of four and a half hours, the committee, which met virtually, heard from invited speakers from the government agencies responsible for developing testing and distributing COVID-19 vaccines about the latest plans for evaluating how safe and effective the vaccines are. Experts provided updates from the National Institutes of Health (which provided basic research that led to many of the vaccine candidates), the Centers for Disease Control and Prevention (which is responsible for working with state and local health departments to lay out plans for distributing the vaccines if and when they are authorized), the FDA (which provides criteria for what makes a vaccine safe and effective), BARDA (a Department of Health and Human Services office overseeing research and development of treatments against public health threats) and the inter-agency Operation Warp Speed (which is coordinating development, testing and distribution efforts). Marion Gruber, director of the office of vaccines research and review at the FDA’s Center for Biologics Evaluation and Research (CBER), opened the meeting by saying “I want to take a minute to assure the American public that facilitating the development of safe, effective COVID-19 vaccines is the highest priority of my office, CBER and the agency. Today’s discussion provides transparency about the data we will request and evaluate in support of the safety and effectiveness of vaccines.” The FDA confirmed it will consider a COVID-19 vaccine effective if it achieves 50% effectiveness in protecting against the illness. The members and speakers debated about what this protection means, and raised the possibility that it could indicate that immunized people would still get infected, but then not progress on to serious disease. Another key question centered around what type of green light the FDA would give vaccines developed and tested on an accelerated timeline. The traditional approval process can take years from development to market, but the leading COVID-19 vaccine candidates sped from development to human testing in a matter of months. Emergency use authorization, or EUA, would further shorten the review process, as it requires shorter follow-up of people in the studies for effectiveness of the vaccines and their potential side effects (EUAs are allowed during public health crises, such as the pandemic, when the urgency of the need for treatments justifies the shorter research and development time). The FDA guidelines for COVID-19 vaccines currently require at least two months of follow up, although some experts questioned whether that was long enough to truly get a sense of a vaccine’s efficacy. That’s especially true since the coronavirus is so new to the world that the vaccine makers aren’t yet sure what immune reactions are needed to constitute a “strong” or “appropriate” response that would provide protection against infection. FDA scientists reiterated that their guidelines for EUA are generally as stringent as those for full approval, except for the shorter time frame. Another unresolved issue centers around what will happen to ongoing placebo controlled studies if one or more of the vaccines are given EUA ahead of others. Given that the virus is still spreading in parts of the U.S., participants in ongoing trials may want to drop out of their studies and get vaccinated with an authorized shot, once available. But because the trials are all blinded, neither they, nor their doctors, will know if they received the experimental vaccine or a placebo. Those studies would have be unblinded if volunteers will be allowed to drop out, but that would mean researchers will not get the same high quality data on vaccines still being studied if those trials are stopped. “Once a decision is made to unblind it can’t be walked back,” said Doran Fink, deputy director in division of vaccines and related products applications at FDA. “That control [group] is lost forever.” Many speakers also stressed the need to continue to follow trial participants in order to collect more data on the vaccines’ effectiveness and side effects. The FDA noted that all of the participants will be followed for two years even after the trials end. During the public comment period, patient advocates and other infectious disease experts argued that the FDA should consider at least a six month follow-up period before allowing any manufacturer to request authorization or approval. That’s in stark contrast to the Trump Administration’s view; the White House initially opposed even the two month window. Members and speakers also raised the importance of addressing vaccine hesitancy, and the need to understand and address the many reasons why people have expressed reluctance to get vaccinated if and when COVID-19 shots become available. These range from general vaccine skepticism, to mistrust of the government and science, and more specific concerns about COVID-19 immunizations that have been developed in record time and seem to be rushing through the testing process. Some people may also intentionally wait to get vaccinated because they are skeptical of the first shots to come off the assembly line, which could keep infections percolating for longer. “People may be waiting to see what the first candidates are, and even waiting for a more ‘favorable’ candidate,” said Dr. Janell Rough, medical officer and program lead in the division of viral diseases at the CDC. “That’s not a message we want to convey.” Shifting those views may be one of the bigger challenges facing a massive COVID-19 immunization effort. Federal and state pubic health officials are taking this into consideration as they formulate plans for distributing the vaccines when they become available. All 64 state and local health groups in the country have submitted their plans for ordering and distributing vaccines. The CDC is now reviewing those plans and will work with local officials to refine them and provide resources necessary to educate the public about the vaccines themselves as well as the need for getting vaccinated more broadly.
Moderna Covid-19 Vaccine Nears; Passes Key Milestone In Final Testing https://www.investors.com/news/technology/mrna-stock-moderna-covid-19-vaccine-passes-key-milestone/ Moderna (MRNA) announced Thursday that it had met a key milestone for final-phase testing of its Covid-19 vaccine candidate, as it moves close to applying for Emergency Use Authorization. MRNA stock rose. he company said it now has enlisted its goal of 30,000 participants in Phase 3 clinical trials, generally considered a minimum sampling by regulators in order to complete a comprehensive test program. Finding enrollees can be difficult in test programs, officials say. Enrollment must meet explicit parameters by, for example, including all ethnicities and at-risk patient populations. Moderna has been testing thousands of patients up to now, and more than 25,650 of the participants already in Phase 3 tests have received a second vaccination. Since participants get the vaccines 28 days apart, it shows progress for the Phase 3 trials. Most of the Covid-19 vaccine candidates require two vaccinations spaced days apart. Once it accrues two months of median safety follow-up data, the company said it would file for the emergency authorization, known as an EUA. That's based on an assessment of whether the potential vaccine benefits outweigh potential risks. Moderna's news coincides with Thursday's meeting of the FDA's vaccine advisory committee. The panel, officially the Vaccines and Related Biological Products Advisory Committee, was to meet all day Thursday to review what data is needed to support the approval of safe and effective vaccines. Moderna and the team of Pfizer (PFE) and BioNTech (BNTX) are leading the race for a Covid-19 vaccine. The chief executives of Pfizer and Moderna have said their companies could report Phase 3 test data in November and shortly thereafter file for EUA with the U.S. Food and Drug Administration. In mid-September, Pfizer and BioNTech said they would reach the 30,000-participant level for their vaccine candidate's Phase 3 trials that month, and were expanding the test to 44,000 participants. MRNA Stock: Pioneer In Technology BioNTech and Moderna are pioneers in mRNA technology, which is contained in their vaccine candidates. It tells the body to produce a structure similar to the spike protein found on SARS-CoV-2. That's the type of coronavirus that causes Covid-19. This will trigger the immune system to create disease-fighting antibodies and T-cells. The fast-emerging mRNA technology has the potential to fight cancers and many diseases, but as yet there are no commercial mRNA vaccines. In late September, Johnson & Johnson (JNJ) began its final-phase clinical trials for its Covid-19 vaccine candidate, planning to enroll 60,000 participants. J&J, however, paused its Phase 3 testing on Oct. 12 after a participant became seriously ill. U.K.-based AstraZeneca (AZN) became the first vaccine company to launch Phase 3 trials, in July, but it paused its testing on Sept. 6 when a participant became ill. On Sept. 12 the U.K. gave the company the green light to resume clinical trials, but the U.S. still has not. Novavax (NVAX) is the fifth and so far only other company in Phase 3 trials on a Covid-19 vaccine candidate. In late September, it announced a Phase 2/3 clinical trial with 10,000 participants initially. Shares Up 250% In 2020 On the stock market today, MRNA stock jumped 3.6% to 70.84. Shares peaked July 21 at 95.21. MRNA stock skyrocketed 250% in 2020, but shares have been volatile. A bevy of large and midsize drug companies are feverishly developing possible Covid-19 vaccines and treatments. Currently, MRNA stock is forming a cup-with-handle base, with a possible buy point of 81.47. MRNA stock has a Relative Strength Rating of 97. That puts it among the top 3% of all stocks in the past 12 months. Its broader Composite Rating, however, is a relatively modest 77. The CR looks at range of fundamental and technical factors.
Germany readies for coronavirus vaccine before end of year: Bild https://www.reuters.com/article/us-health-coronavirus-germany-vaccine-idUSKBN277344 Germany is making preparations to start vaccinations against the coronavirus before the end of the year, Bild daily reported on Friday. The health ministry plans to create 60 special vaccination centres to ensure the vaccines can be stored at the proper temperature and has asked the country’s 16 federal states to provide addresses for them by Nov. 10, Bild reported without citing its sources. At a video conference earlier this week, Health Minister Jens Spahn, who himself tested positive for the coronavirus on Wednesday, said Germany’s BioNTech was close to getting a vaccine approved, Bild cited participants as saying. Asked when he expected the first vaccinations, Spahn replied: “That could happen before the end of the year,” participants told Bild. BioNTech is developing its vaccine in partnership with Pfizer Inc. Last month, Germany awarded $745 million in funding to biotech firms BioNTech and CureVac to speed up work on COVID-19 vaccines and expand German production capacity. On Tuesday, Pfizer and BioNTech announced the start in Japan of combined Phase I and Phase II clinical trials of their mRNA-based vaccine candidate against the coronavirus. Their U.S. vaccine trial could yield initial results as soon as later this month. Germany’s infection rates have been accelerating. Data released on Thursday showed the number of confirmed cases rose by more than 10,000 in a single day for the first time.
you are a fuckin idiot. I am not urging anyone to do anything you piece of shit. Anyone with a brain would want to see a a safety review. Even Gavin Newsom agrees. My kids have all their shots. We spread them out instead of letting them get batched. Worked out well so far. I suppose you are a moron who would blindly take Bill Gates' vaccines.
AstraZenca restarts COVID-19 trials, J&J likely early next week Trump predicts a COVID-19 vaccine could be ready in 'weeks' https://www.foxbusiness.com/lifestyle/astrazeneca-covid-19-vaccine AstraZeneca, the global biopharmaceutical company, has resumed clinical trials for a coronavirus vaccine after being cleared by federal health regulators to do so, the company said Friday. The Food and Drug Administration concluded it was safe for the company and Oxford University to restart trials after more than a month following concerns about a volunteer in the United Kingdom who became ill during research testing. Trials had resumed in other countries, including Brazil, South Africa and Japan. The voluntary pause was initiated Sept. 6 so independent monitoring committees could examine safety data, the company said. “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic," AstraZeneca Chief Executive Pascal Soriot said in a statement. "We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.” The company has worked in tandem with Oxford Univerity to develop a coronavirus vaccine. Results from late-stage trials are expected later this year, depending on the rate of infection within communities where trials are being conducted, the company said. Johnson & Johnson also said it was planning a restart. "Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway" the company disclosed in a statement. The company paused its late-stage clinical trial last week after an "unexplained illness" was reported in a participant. No clear cause of the illness was identified, the company said. The resumption of the trials come as pharmaceutical companies continue to race to find a COVID-19 vaccine. During Thursday's presidential debate, President Trump said a vaccine would be ready by the end of the year, despite previous statements from his administration saying otherwise.
Correct, when it comes to Covid... no vaccine, no data, no science can stop you for lying and being a fuckin idiot.
jem: " I want my life back to normal asap just like 2019 when everything was open." Reality: "The only way to get back to normal quickly is to have the largest number of people possible vaccinated for COVID-19 as soon as possible." jem: "I'm not taking the vaccine. I'm not taking the vaccine. I'm not taking the vaccine". SAD!