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FDA could authorize a Covid-19 vaccine for kids by this week. Here’s the most important thing to do while we wait, CDC director says

<i>Shawn Rocco/Duke University/Reuters</i><br/>The FDA's independent vaccine advisory board will meet Tuesday to discuss whether the Pfizer-BioNTech Covid-19 vaccine should be authorized for younger kids.
via REUTERS
Shawn Rocco/Duke University/Reuters
The FDA's independent vaccine advisory board will meet Tuesday to discuss whether the Pfizer-BioNTech Covid-19 vaccine should be authorized for younger kids.

By Susannah Cullinane, CNN

As the number of new daily cases of Covid-19 continues to fall in the US, the country awaits a major milestone that could provide another critical tool in the fight against the pandemic — the first vaccine for children ages 5 to 11.

And Dr. Scott Gottlieb, a former US Food and Drug Administration (FDA) commissioner and current Pfizer board member, said the company is ready to ship out doses for children as soon as the agency signs off.

The FDA’s independent vaccine advisory board plans to meet Tuesday to discuss whether the Pfizer/BioNTech Covid-19 vaccine should be authorized for younger kids.

On Friday, Pfizer released documents on the efficacy of a children’s dose of its Covid-19 vaccine, saying the company found the vaccine was 90.7% effective against symptomatic disease in children ages 5 to 11.

Once the FDA makes its authorization, the issue goes to the US Centers for Disease Control and Prevention’s vaccine advisory group, which is set to meet November 2 and 3, and from there the CDC director signs off on the recommendation.

“If Pfizer does get the authorization on Tuesday from FDA, even before the CDC votes on this on November 2 and 3, they’ll start to ship it into the supply chain,” Gottlieb said on CBS’ “Face the Nation” on Sunday.

“It will be available for use once there’s a hopefully positive vote from CDC. So, it could be as early as November fourth or fifth, that you can go into some locations and get your child vaccinated,” he said.

Expanding the age groups eligible for vaccination couldn’t come soon enough, as Covid-19 cases among children represent about a quarter of all weekly reported cases in the US, according to the American Academy of Pediatrics. About 131,000 new cases were reported among children in the week ending October 14, the group said.

CDC Director Dr. Rochelle Walensky said since many children are vulnerable to the virus in school settings, it’s vital to use preventative measures.

“In my mind, the most important thing right now as we work to get our cases down, as we work to get our children vaccinated, is that we continue the masking to keep our kids in school,” she said on NBC’s “Meet the Press” on Sunday.

Child vaccinations will help tame pandemic, health official says

Overall in the US, case numbers are declining. As of Sunday, the seven-day average of new daily cases was 72,843, according to Johns Hopkins University, about 10,000 fewer than a week prior. The seven-day average of daily deaths was 1,690.

Dr. Ashish Jha, the dean of the Brown University School of Public Health, told CNN last week being able to vaccinate younger children will help tame the pandemic in the US.

“Kids need to get vaccinated because it’s going to be good for them. It’s going to protect them,” Jha said. “Obviously, it’s also going to add population immunity to our broader population. … It is going to be one more important step towards getting to the end of this pandemic.”

Currently, 57.4% of the total US population is fully vaccinated, according to the CDC. More than 66% have received at least one dose of vaccine.

US Surgeon General Dr. Vivek Murthy said Friday, while there are still 65 million unvaccinated Americans, the fact vaccines are now available will likely prevent the coming winter from seeing as much Covid-19 transmission as last winter.

“We are coming into a colder season, we know respiratory viruses do tend to spread during cold weather season, but there’s something we have this winter that we didn’t have last winter and that is millions and millions of people who are vaccinated. It’s a big deal,” Murthy said in an interview with Conversations on Health Care.

But even with all those vaccinated residents and falling case numbers, the threat is still significant. More than 90% of counties — home to more than 319 million people — still have “high” or “substantial” community transmission, according to thresholds set by the CDC.

Because of the stubbornly high transmission rates, Walensky said it’s important to get vaccinated ahead of holiday gatherings, but Halloween can proceed with precautions, even if kids are too young for vaccination.

“I would put on those costumes, stay outside and enjoy your trick-or-treating,” Walensky told Fox News’ Chris Wallace on Sunday. “If you are spread out doing your trick-or-treating, that should be very safe for your children.”

Moderna says trials show its vaccine is effective in children ages 6 to 11

Moderna said Monday interim results of a Phase 2/3 trial showed its Covid-19 vaccine was well-tolerated and generated a robust immune response in children ages 6 to 11.

The trial included more than 4,700 participants between the ages of 6 and 11, and looked at two 50-microgram doses of Moderna’s vaccine given 28 days apart, which is smaller than the 100-microgram dose given to adults. The company compared the antibody response in younger children to the response in young adults in the company’s Phase 3 trial, and found a “strong immune response in this cohort of children one month after the second dose.”

Moderna said it will submit data to the US Food and Drug Administration and other global regulators “in the near term.” Moderna’s vaccine is currently authorized for people age 18 and older. The company requested emergency use authorization for its vaccine for people ages 12 to 17 in June, but FDA authorization has not yet been extended to that age group.

What vaccine approval for kids could mean for mandates

With the prospect of a vaccine for 5- to 11-year-olds on the horizon, some experts and local officials are weighing whether that age group will face vaccine mandates.

When asked about the issue by Fox News, Walensky said, for now, the agency is focused on discussing and analyzing vaccine data in children.

“We are having discussions about authorization, so I think we need to get children vaccinated through this authorization and to get to approval before we can make a judgment there,” she said.

Arkansas Gov. Asa Hutchinson echoed that sentiment Sunday, telling CNN’s “State of the Union” there may come a day when his state mandates Covid-19 vaccinations for schoolchildren, “but that time is not now.”

“We need to have more experience with that. We need to have more public acceptance of it, of the vaccine. And so it could happen down the road. It also depends upon the severity of the Covid outbreak and whether the cases skyrocket again or not,” he said.

Arkansas requires vaccines for diseases such as polio, measles, mumps, rubella, chickenpox and more for kindergarten students.

Newest Delta mutation

The country is much closer to the end of the Delta surge than the beginning, even with the newest variant mutations, Gottlieb says.

“You have seen cases come down all across the country. This new variant, we think it could be more contagious. I don’t think it’s enough to change the overall trajectory,” he told CBS Sunday.

However, Gottlieb also warned while the new Delta plus variant may not significantly impact the direction of the pandemic, it may impact future vaccine formulations.

“I don’t think it will be a new variant that sweeps across the globe and we’re back to square one here,” he said. “I think this is something that will probably push in the direction of eventually reformulating our vaccines, because what we’re seeing is the new mutations are occurring with that Delta lineage.”

“I don’t think anyone should die from Covid now. This is an avoidable death,” Gottlieb added.

While some people may be immunocompromised and not mount as aggressive a response to the vaccine, they can be further protected by additional infusions of monoclonal antibody treatments used off label to prevent infection, according to Gottlieb. They are currently authorized by the FDA to be used post-exposure but not as a prophylactic.

“The drugs can be used in that way, Regeneron is making them available under a compassionate-use basis for that use.” said Gottlieb.

Regeneron and Eli Lilly have authorized monoclonal antibody treatments for Covid-19. Gottlieb added Regeneron has an application for this use before the FDA.

“We should be protecting these lives,” Gottlieb said. “These are fragile lives. We have the tools to do it. We’re not making aggressive enough use of these tools.”

Covid-19’s effect on mental health

New data from the Substance Abuse and Mental Health Services Administration shows the majority of people older than 12 said Covid-19 hurt their mental health, but it also suggests they didn’t turn to drug and alcohol use as a solution, according to a SAMHSA study published Monday.

The SAMHSA report is published annually, but it was pared down because of the pandemic, so it may not paint the usual complete picture of substance use in the United States. It focuses more on mental health and how it was affected by Covid-19. HHS researchers were able to collect survey data only in January-March 2020 and October-December 2020.

“In Quarter 4 of 2020, most adolescents aged 12 to 17 perceived a negative effect of the Covid-19 pandemic on their mental health,” researchers wrote in the report.

Just over 18% of adolescents said the pandemic negatively affected their mental health “quite a bit or a lot,” and an additional 50.8% said it affected their mental health “a little or some.”

In adults older than 18, 18.3% said their mental health was affected quite a bit or a lot, and 54.7% experienced a little or some negative effect.

SAMHSA researchers found that most people older than 12 reported their alcohol stayed about the same as pre-pandemic use, and only 15.4% said they felt they drank more.

For drugs other than alcohol, nearly a third of people older than 12 said they used drugs less than before the pandemic, and 57.5% said their drug use remained about the same.

“Because these data were collected in Quarter 4, these estimates might not reflect temporary increases in alcohol consumption early in the Covid-19 pandemic that were followed by a return to a pattern of alcohol use that was about the same as it was before the Covid-19 pandemic began,” the researchers wrote, adding they also had a similar caution to the drug use statistics.

Worsened mental health was amplified in those with prior mental health conditions.

“We found that adolescents who had had a past-year major depressive episode were much more likely than those who didn’t to perceive that the pandemic had negatively affected their mental health, quite a bit or a lot,” Michael King, a SAMHSA data analyst, said in a media briefing. He said there were similar findings in adults.

The-CNN-Wire
™ & © 2021 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

CNN’s Nadia Kounang, Naomi Thomas, Jen Christensen, Virginia Langmaid, Jamie Gumbrecht and Deidre McPhillips contributed to this report.

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Comments

18 Comments

  1. So you want to jab kids, who have virtually a 100% chance of recovery, and expose them to potentially fatal side effects of the shot? Let’s sacrifice the kids.

      1. That link form MAYO also contains this statement.

        “Because COVID-19 vaccine clinical trials only started in the summer of 2020, it’s not yet clear if the vaccines will have long-term effects.”

        This is the elephant in the room, especially when it comes to children. You can speculate all you want and you can rely on experts who torture puppies to speculate for you if you wish, but my grandkids are not going to use these vaccines due to the above statement combined with their extremely low risk of problems from Covid.

      2. It’s also a fact that most of Europe and a portion of Asia and Africa are so concerned with side effects that they have restricted vaccine use to people over the ages of 55-65. But not here in America. No, we want to shoot vaccine into 6 years olds! These countries include Germany, Sweden, France, Italy, Spain, Denmark, Norway, Iceland, Bulgaria, Congo, Ireland, Netherlands, Indonesia, Cyprus, Portugal, Latvia, Thailand and South Korea. I found at least 18 countries restricting vaccines until more data can gathered to determined risk vs benefit. This isn’t a problem of whether people trust the CDC. The problem is THEY DON’T KNOW! But they are pushing it anyway, and high ranking members of this process are resigning because of it.
        https://www.businessinsider.com/astrazeneca-covid-vaccine-countries-suspend-denmark-thailand-batch-blood-clots-2021-3

          1. You are correct and I should have stated Astrazeneca is not available in USA. But brand isn’t really the issue. Astrazeneca’s health risk is similar to Moderna, which is available in the USA and ALSO currently age restricted in Finland, Iceland, Sweden and Denmark. Pfizer (the vaccine being offered to children in the USA) is regarded as the safest vaccine for younger people, both here and in Europe. My point is, Astrazeneca, Moderna and J&J were all at one time deemed safe. They were distributed to various demographics and THEN data emerged that prompted their restriction. It’s not a great track record. Will Pfizer buck the trend? I hope so. Would I vaccinate my kids? No. The known risks of covid in children does not justify the unknown risks of mRNA vaccination.

      3. Wow thanks Barney. You assume that we can’t do our own research. As harg said, kids still have a 99%+ chance of surviving…AND SO DOES MOST OF THE REST OF THE POPULATION!

        If people have an underlying condition or feel scared about going out in public, then THEY should get vaccinated, wear a mask, or stay home. If you can get vaccinated, still get COVID, and spread it to others, then the whole “get vaccinated to protect others” goes out the window. I am usually pretty quiet on the comments but I can tell that anything regarding the vaccine strikes a nerve with you.

        You also keep harping on the ICU situation with vaccinated vs. un-vaccinated. At this point, the people that want to be vaccinated have been. The rest of the population are willing to take the risk.

        I got COVID a month ago, and got through it easier than a cold. I get that others won’t, but they are the ones that should get vaccinated if they are concerned.

        This mandate BS will actually hurt the workforce. People like Tio, Keysore, and the rest of the Marxists tell people not willing to get jabbed to “don’t let the door hit you on the way out”, or “leave, no one will miss you”. You know what,any good people that make Central Oregon function are gearing up to leave…me included. I already got a good paying job lined up doing nearly the same thing in a red state. KTVZ wants to report the mandate compliance at the deadlines. Many of the exception folks are buying time to get out of this ridiculous blue state.

        I wonder when…if ever…will KTVZ report the staff shortages when essential employees in this state pack up and leave because of the mandates and the media trying to override people’s opinions.

  2. Florida’s Covid rate per 100K is now one-fourth of Oregon’s Covid rate per 100K. Therefore your risk of being exposed to Covid here in Oregon is now four times your risk in Florida.

    Florida issued no mandates to get vaccinated. No mandated mask-wearing. Kept kids in school and businesses open the whole time. They are hiring medical professionals and law enforcement who are unvaccinated. Oregon did the opposite of Florida on all those things. CNN experts can say whatever they want and you can believe it if you want. But look at the graphs from the NYT via Google search.

    Florida is doing something right that Oregon is not. Oregon was headed down until a few days ago, now it is headed back up. I hope that trend does not continue in Oregon.

    Florida has 21.7 million people in 65,758 Square miles of land
    Oregon has 4.21 million people in 98,466 Square miles.

    59% of the population of Florida is fully vaccinated
    62% of Oregon’s population is fully vaccinated

    Obviously, Oregon has a huge natural advantage as far as infectious spread as we have 1/5 as many people in a much larger land area. But still, we are at four times the risk of being exposed to Covid in Oregon as people in Florida are even though Oregon has a higher vaccination rate.

    This all goes against what the experts have told us for over a year. Not what the experts that I know told me for the last 18 months, but of course my experts don’t torture puppies like Fauci’s NIH do, so what do they know?

    https://www.google.com/search?q=oregon+covid+rates&rlz=1C1GGRV_enUS751US751&oq=o&aqs=chrome.1.69i60j69i59j69i57j69i59j69i60l3j69i65.1946j0j7&sourceid=chrome&ie=UTF-8

    https://www.google.com/search?q=florida+covid+rates&rlz=1C1GGRV_enUS751US751&oq=&aqs=chrome.3.35i39i362l6j46i39i199i362i465j35i39i362…8.3282163948j0j15&sourceid=chrome&ie=UTF-8

    1. And not only that, but Florida’s infection rate of 0.80 is 20% less than Oregon at 0.98. This is an important distinction. Case rate, or Covid rate as you called it, is a measure of how many people per 100k test positive per day. Infection rate is a measure of spread, or how many other people each case infects. Oregon’s infection rate is currently 17th in the nation. You know who is doing better? Every red state except three. Of course it’s more complex than simple stats but if health mandates worked, there should be clear evidence by now.

      1. Correct Skiz. All the evidence points to the mandates hurting more than helping. Even the very liberal Bill Mahar pointed out last month that DeSantis was actually following the science and it showed in how he handled the Covid response in his state.

        If your science is correct the results will be evident to everyone. It should be in this case, but when you have falsely so-called news outlets like CNN and their “experts” constantly giving false information it can be difficult to overcome the blind trust in “experts” who are not really experts. Experts get things right and that is why we call them experts. People who do not get things right are not properly called experts. I hope we can get back to true experts and stop banning them from the MSM and social media for speaking out.

  3. From your link Barney. A quote, “The FDA reviewed a study of more than 2,200 U.S. children ages”

    This statement reveals the fact that the FDA does NOT test drugs. They rely on studies provided by the drug company. In this case Pfizer. Those relying on such decisions from the FDA really need to learn how this whole process works. I have seen studies where it was later revealed that anyone in the study group who had any issues with the drug was removed from the study before it was completed. This allows them to then claim the drug is “safe and effective”. If you want to trust Pfizer and their friends at the FDA then get your kids vaccinated. I know how these “studies” are conducted and most are not even close to being unbiased. Big pharma is a business first. They will justify anything, even torturing puppies in the name of progress.

  4. What a load of fear mongering by KTVZ and Barney for posting this story. The story makes it sound like kids are at a huge risk due to covid by using words like “kids are vulnerable” or “we must protect them from the virus”! When in reality kids have an infinitesimally small chance of dying or having complications from covid. You should be ashamed.

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