03.16.21
First children vaccinated in Moderna's Phase 2/3 pediatric trial The first children have been vaccinated in Moderna's Phase 2/3 pediatric Covid-19 vaccine trial, the company announced Tuesday in a statement.
The clinical trial, called the KidCOVE study, will enroll approximately 6,750 children in the US and Canada between the ages of 6 months and 11 years old.
The trial is broken into two parts. In part one, different doses of the vaccine are being tested on the children. Children between the ages of 6 months and 1 year old will receive two doses of the vaccine, spaced about 28 days apart, at either a 25 or a 50 or a 100 microgram level. Children between the ages of 2 and 11 will receive two doses of the vaccine, spaced about 28 days apart, at either a 50 or a 100 microgram level.
The findings of part one will be used to determine which dose will be used in part two. For part two, the trial will expand to include children who are given a saline placebo shot, which does nothing. The children will be followed for 12 months after their second injection.
Moderna is not the only Covid-19 vaccine currently being tested in children, as the Pfizer/BioNTech Covid-19 vaccine is being studied in children as well. Johnson & Johnson has announced plans to study the vaccine in adolescents, ages 12 to 18. Childcare programs get new CDC guidance The US Centers for Disease Control and Prevention updated its guidance for childcare programs during the pandemic last week, emphasizing the importance of mask-wearing for everyone 2 years of age and older, as well as air ventilation and other strategies.
When it comes to spacing, the CDC is also reviewing data to see if physical distancing in schools should be changed to advise people to stay at least 3 feet apart, instead of at least 6 feet apart, according to a federal official.
Vaccines and testing were not among the "key" strategies the agency laid out. The guidance instead called them "additional layers" of Covid-19 prevention.
"I also want to stress that our childcare guidance emphasizes the importance of Covid-19 vaccination as an additional layer of prevention for childcare workers," CDC Director Dr. Rochelle Walensky said during a White House briefing last week. "I strongly encourage America's childcare workers to get vaccinated."
Walensky also warned that there have been "concerning" declines in childhood vaccinations against other infectious diseases, such as the MMR vaccine that protects against measles, mumps and rubella. She urged parents to make sure their children are up to date on their vaccines.
"On-time vaccination throughout childhood is essential because it helps to provide immunity before children are exposed to potentially life-threatening diseases. During the pandemic, we have seen substantial declines in pediatrician visits, and because of this, CDC orders for childhood vaccinations dropped by about 11 million doses -- a substantial and historic decline," Walensky said. What the next CDC guidelines for the fully vaccinated could look like Some people celebrated when the CDC came out with its long-awaited guidelines for people who are fully vaccinated last week. Others were hoping for more -- especially regarding travel.
In a statement to CNN, CDC spokesman Jason McDonald said the agency "may update its travel recommendations for fully vaccinated people as more people are vaccinated and we learn more about how vaccines work in the real world. This is something we will be closely watching in the United States."
McDonald added that "several new virus variants have spread globally and in the U.S. through travel. Because of the increased risk for both fully vaccinated and unvaccinated individuals, everyone, regardless of vaccination status, should still take all CDC-recommended precautions before, during, and after travel."
Andy Slavitt, the Biden administration's Covid-19 senior adviser, told CNN that as more people get fully vaccinated -- currently, about 11.5% of the population has -- the more CDC will add to its advice.
Slavitt said there will be a distinct shift in the way the CDC gives advice next time. It will move away from the kind of binary messaging in this first set. The next version of the guidelines, Slavitt said, will instead describe activities as being more in a low, medium or high risk category. Card games with grandpa are back, regardless of your vaccination status You can hug your vaccinated grandpa and stay to play cards with him at his nursing home, even if you haven't been vaccinated, according to new Covid-19 guidance for nursing homes from the Centers for Medicare and Medicaid Services.
These recommendations are a little different than the ones released last week by the CDC for fully vaccinated people in the general population, which allow meeting indoors in small groups without masks or physical distancing -- even for the elderly.
Vaccinated or not, nursing home residents are still a fragile patient population, so infection control is important, CMS says. For nursing home residents and visitors, even if vaccinated, CMS still wants people to wear a well-fitted face mask, wash their hands and try to keep physically distant, a spokesperson for the agency said in an email. But the new CMS guidelines offer many other new freedoms.
"CMS recognizes the psychological, emotional and physical toll that prolonged isolation and separation from family have taken on nursing home residents, and their families," Dr. Lee Fleisher said on the agency's website. Fleisher is CMS' chief medical officer and director of CMS' Center for Clinical Standards and Quality. "This is an important step that we are taking, as we continue to emphasize the importance of maintaining infection prevention practices, given the continued risk of transmission of COVID-19."
Under the new guidance, visitors don't need a Covid-19 test result to see family, nor do they need to show proof of vaccination. The guidelines strongly encourage everyone to get vaccinated, though.
Visits should be restricted if the Covid-19 county positivity rate is more than 10% or less than 70% of the residents in the facility are fully vaccinated. Families should also hold off on visits with residents in quarantine or if they have a positive Covid-19 test. But wait, there's more!
From the desk of Dr. Gupta It has been just over a year since the World Health Organization declared Covid-19, the disease caused by the novel coronavirus, a pandemic -- a term CNN actually began to use days earlier.
Loosely speaking, a pandemic is an outbreak of a virus that can cause illness or death, where there is sustained person-to-person transmission of that virus, and evidence of its spread in different geographic locations. Check, check and check.
Still, to call it a pandemic felt momentous and weighty. It was not a decision CNN (or I, personally) took lightly. We didn't want to panic people, but we felt we had to call it what it was. And so we did that on March 9, 2020.
Now, over a year later, I was able to reflect on this momentous turning point with Maria Van Kerkhove, WHO's technical lead for the coronavirus response.
Van Kerkhove told me that WHO had been steadily sounding the alarm since January 30, 2020, when Director-General Tedros Adhanom Ghebreyesus declared the situation a "public health emergency of international concern" -- the highest level of health alert under international law.
And at that moment, there were countries that decided to listen and act.
"It wasn't about rich or poor countries. It was about experience. It was about those countries that knew the threat that this was; they heeded our warnings," Van Kerkhove told me.
What has often struck me is that while infectious disease outbreaks typically crush poorer countries, this novel coronavirus has disproportionately affected many of the world's wealthiest nations. Consider there are close to 9,000 cases per 100,000 people in the United States. Compare that to India, where it's about 1/10th of that -- even though they have some of the most population-dense areas in the world.
As they say, money can't buy everything, especially good health. "You can have really, really good medical systems in countries ... the best treatments in the world. But that doesn't make up for the fundamentals of public health," Van Kerkhove pointed out.
Now that we are in the second year of the pandemic, the cavalry in the form of vaccines has arrived. But with it, a more contagious and, possibly in some cases, a more deadly enemy.
So while we are beginning to see some semblance of normal life in countries around the world, we must remember that we have all been humbled by this virus and we cannot take any of our progress in this fight for granted. CNN Health's The Results Are In with Dr. Sanjay Gupta shows up in your inbox every Tuesday.
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