U.S. FDA advisers back Pfizer/BioNTech COVID-19 vaccine for children https://www.reuters.com/business/he...iontech-covid-19-vaccine-children-2021-10-26/ Oct 26 (Reuters) - An expert panel on Tuesday voted overwhelmingly to recommend the U.S. Food and Drug Administration authorize the Pfizer Inc (PFE.N) and BioNTech SE COVID-19 vaccine for children ages 5 to 11, saying the benefits of the shot outweigh the risks. An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning. The vaccine could be available to the younger age group as soon as next week. The FDA is not obligated to follow the advice of its outside experts, but usually does. The vote was 17 in favor with one abstention. If the FDA authorizes the shots for this age group, an advisory panel to the U.S. Centers for Disease Control and Prevention will meet next week to make a recommendation on the administration of the vaccine. The CDC director will make the final call. While children becoming seriously ill or dying from COVID-19 is relatively rare compared with adults, some develop complications, and infections in unvaccinated kids have risen due to the easily transmitted Delta variant of the coronavirus. Data from the American Academy of Pediatrics shows that more than 500 U.S. children have died from COVID-19. It "is the eighth highest killer of kids in this age group over the past year," said Dr. Amanda Cohn, a pediatric vaccine expert at the CDC and a voting member of the panel. "Use of this vaccine will prevent deaths, will prevent ICU admissions and will prevent significant long-term adverse outcomes in children." Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger. In the United States, just 57% of the population is fully vaccinated, lagging other nations such as the UK and France. Still, the percentage of young children who receive the shots may be low. The U.S. vaccination rate for 12- to 15-year-olds trails other age groups at roughly 47%. The World Health Organization since May has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX program for distribution to poorer countries. read more LOWER DOSE Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose of the vaccine in young children, versus 30 micrograms for those age 12 and older. The shot has been authorized for ages 12-15 since May after being cleared for those age 16 and older in December. The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11. read more The advisers paid close attention to the rate of a heart inflammation called myocarditis that has been linked to both the Pfizer/BioNTech and Moderna (MRNA.O) vaccines, particularly in young men. If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said in documents prepared ahead of Tuesday's meeting. Some panel members suggested that due to the myocarditis risk, the vaccine should be given to a narrower group of children, such as those with conditions that make them more likely to be hospitalized. "There are certain kids that should be vaccinated. The question of how broadly to use it, I think it's a substantial one," said Eric Rubin, Editor-in-Chief of the New England Journal of Medicine. If authorized, the Pfizer/BioNTech vaccine is likely to be the only one available to the age group in the United States for some time. On Monday, Moderna released data from its own clinical trial of children ages 6 to 11, and said it would soon ask regulators for authorization in the age group. It is unclear when U.S. regulators will consider that. The company is still waiting for a response to its application filed in June for use of its vaccine in children ages 12 through 17. Pfizer has said it could have data from its clinical trial in even younger children - ages 2 to 4 - by year end.
The key social and academic takeaway from this vaccine news is not mentioned in the article... Parents that soon will be able to have their children vaccinated (assuming the child wants the jab) will not have to worry about their child missing school due to a Covid illness nor a parent needing to miss work to care for a sick child that tests positive for Covid and that may only have mild to no symptoms. Essentially, this allows parents to care for their sick child with Covid and prevents parents from going to work and possibly spreading Covid to co-workers. Simply, Parents will not need to use up their vacation and paid sick leave to care for Covid sick children. As for Myocarditis, they should monitor the children that are very athletic/physically very active, very tall for their age, and have other mild heart issues (e.g. heart murmur). wrbtrader
Allowing vaccinations for children aged 5 to 11 fundamentally changes the landscape in elementary schools in the U.S. Currently many elementary schools are enduring clusters of children with Covid which cause one or more classrooms to be quarantined at home (and have to go to remote learning). Even in schools using masks -- Delta is infectious enough that it is just a matter of time that a cluster occurs in communities with high Covid prevalence (which is just about every county in the U.S. currently). Schools that don't require masks have had severe Covid issues -- many having to shut down entire schools -- this can be seen with Union County and other "no-mask required" counties in North Carolina; their school systems are basically disaster areas when it comes to Covid. Having a good number (even 50%) of the children vaccinated will reduce the spread of Covid in elementary schools. This - in turn - will reduce the number of clusters and classrooms sent home for quarantines. This leads to a ripple effect where mothers (and parents) will be more confident in returning to work without worrying their children are likely to be sent home from school due to Covid outbreaks on any given day. Keep in mind that part of the U.S. labor shortage is due to over 8 million moms making the decision to stay home -- most due to child care situations due to Covid. Vaccinations for children aged 5 to 11 should greatly alleviate this issue. The good news is that pediatricians are reporting there is good demand from parents for their children aged 5-11 to be vaccinated. The faster we can raise the vaccination rate among children, the better things will be... and the faster society will get back to the pre-pandemic normal.
Fourth dose. SPRIZE? Not. Keep em coming. Rollin'........rollin'.......rollin'..........keep those doggies movin'.......don't try ta understand em" CDC says 4th COVID-19 booster dose may be needed for immunocompromised people https://www.foxnews.com/health/cdc-covid-fourth-booster-dose-immunocompromised-people
Vaccinations, Mandates, and Approved Antiviral Therapeutic Treatments are doing their job in the United States. We all remember what happened in September 2020 of last year when we re-open (a crappy re-open) out of the lockdown right before kids went back to school (see graph below)...no vaccines and no mandates. Now compare it to September 2021. https://covid.cdc.gov/covid-data-tracker/#datatracker-home wrbtrader
For everyone claiming that the Pfizer shot is safe for children, just look at all these adverse reactions.
Covaxin may get approval from World Health Organization in 24 hours India had in April applied to the world body for emergency use listing of the vaccine. https://scroll.in/latest/1008645/covaxin-may-get-approval-from-world-health-organization-in-24-hours A World Health Organization technical advisory team on Tuesday said that Bharat Biotech’s Covaxin shots against the coronavirus might get approval within 24 hours, Reuters reported. “If all is in place and all goes well and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so,” WHO spokesperson Margaret Harris said at a press briefing in Switzerland’s Geneva city. India had applied to the World Health Organization for emergency use listing for Covaxin in April. Emergency use listing is a procedure by the World Health Organization to approve vaccines and other products for use during public health emergencies. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer. Last month, the World Health Organization had said that Bharat Biotech began submitting “rolling data” on July 6. In a rolling review, the global health body can analyse information when it comes in from an applicant, thus accelerating the process. On October 18, the World Health Organization said that it cannot “cut corners” while deciding whether it can recommend Bharat Biotech’s Covaxin for an emergency use listing. The global health body had said that the Technical Advisory Group will complete the assessment and “come to a final recommendation whether to grant emergency use listing to the vaccine”. The Drugs Controller General of India had granted approval for restricted emergency use to Covaxin in January. Covaxin and Oxford-AstraZeneca’s locally produced, Covishield, were the first Covid-19 vaccines to be approved in India. So far, the World Health Organizations has approved six vaccines Pfizer, Johnson and Johnson, AstraZeneca-Oxford vaccine, Moderna, Sinopharm, and Sinovac. Meanwhile, a subject expert committee on coronavirus vaccines had on October 12 recommended the emergency use listing for administering Bharat Biotech’s Covaxin among those between the ages of two and 18 years. ̌The Drugs Controller General of India is expected to soon give a final authorisation for use of the vaccine to children and teenagers. The vaccine will be administered in two doses with a gap of 20 days.
FDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11 https://www.statnews.com/2021/10/29/fda-pfizer-vaccine-covid19-children/ The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children. Before the vaccine becomes widely available, it will also need to be recommended by the Centers for Disease Control and Prevention. The decision on that recommendation is made after a meeting of an expert committee, the Advisory Committee on Immunization Practices, or ACIP. The CDC director must then approve ACIP’s recommendations. That committee is scheduled to meet on Nov. 2. “As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock, in a statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.” The Pfizer-BioNTech Covid vaccine for children 5 to 11 should be given as two doses three weeks apart, just like the version for older children and adults, but uses a lower 10-microgram dose, one-third the adult dose. The FDA’s decision, which was widely expected, follows the meeting of the FDA’s advisory panel earlier this week. That panel voted 17-to-0, with one abstention, that the vaccine should be authorized. The FDA and CDC are not bound by the votes of their advisory committees, but generally follow their advice. However, when recommending the authorization, FDA panel members expressed concerns about whether all children needed the vaccine, because the risk of complications from Covid infection in children is generally lower. They also discussed how to balance the risk of a rare side effect, an inflammation of the heart called myocarditis, with the number of Covid cases prevented. FDA modeling predicted that the number of hospitalizations from myocarditis would generally be fewer than the number of Covid hospitalizations prevented. Still, those concerns could still prove a topic of debate for the ACIP when it meets next week. The vaccine was not granted FDA approval, but instead an emergency use authorization. Emergency authorizations are used when the secretary of Health and Human Services has declared a public health emergency to more quickly clear the use of vaccines, treatments, and diagnostic tests. These authorizations lapse when the state of emergency ends. Pfizer’s vaccine was fully approved for those age 16 and older in August, and was previously granted an emergency use authorization for use in adolescents ages 12 to 15. “The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We are confident in the safety, effectiveness and manufacturing data behind this authorization.” The Pfizer product is currently the only Covid vaccine authorized for use in people under the age of 18 in the U.S., though that could change soon. Moderna has filed an application to have its emergency authorization expanded to include youths 12 to 17 years of age; the FDA is expected to rule on the application soon. “This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Pfizer’s chair and CEO, said in a statement. “Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week. With this FDA authorization, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”