The biotech firm Moderna has begun testing its COVID-19 vaccine in young children and babies as young as six months old.
The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority have collaborated with Moderna on the study.
Moderna plans to enroll 6,750 participants in the US and Canada in the trial, called the KidCOVE study. Researchers will evaluate the safety of the two-dose vaccine given 28 days apart.
The US has not approved a COVID-19 vaccine for people under 16 years old. Researchers prioritized adults in initial vaccine trials, as severe COVID-19 illness in children is rare.
According to Cleveland Clinic, clinical trials in children differ from those in adults because of the increased layers of protection — both parents and children must agree to participate. Immune systems also vary depending on the age of the child, resulting in more complex trials relative to adult studies.
“We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” Moderna CEO Stéphane Bancel said in a press release.
In the chart below from the CDC website, you can see the total deaths broken out per age group. Out of 396,265 deaths, 93 were from children under four years of age.
FDA Denies That Four Volunteers Developed Bell's Palsy From Pfizer's Covid-19 Vaccine Shot
According to U.S. regulators, four people that received Pfizer’s Covid-19 vaccine in a trial developed Bell’s palsy which causes temporary facial paralysis.
The Food and Drug Administration (FDA) said Bell’s palsy could not have been caused by the vaccine but doctors should keep track of anyone else who gets it going forward.
This isn’t the first time it’s been linked to vaccines, but scientists have ultimately ruled that shots did not trigger Bell’s in all but one case – a Swiss flu vaccine that was sold during the 2001-2002 flu season there, then promptly taken off the market.
So far, the FDA said that the number of Bell’s palsy cases seen in the Pfizer vaccine trial was ‘consistent with the background frequency of reported Bell’s palsy in the vaccine group that is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time,’ but will keep a close watch on future cases.
The four cases of Bell’s palsy were the only side effect that the FDA saw as ‘imbalanced’ with more occurring in the vaccine group than the placebo group, and fewer than 0.5 percent of the trial participants had serious side effects.
Among the four people who developed Bell’s palsy, one saw facial paralysis or weakness within three days after they received the shot. But the participant’s face returned to normal about three days after that.
Although doctors are not sure exactly what causes Bell’s palsy, there are some factors that can leave someone more prone to getting it such as diabetes or an upper respiratory infection like the cold or flu.
They don’t believe that Pfizer’s vaccine is the cause of the issue but if given the green light to move forward, the FDA says Pfizer will be required to track data on future vaccine recipients if they develop temporary facial paralysis.
CDC Says Teachers Do Not Need To Be Vaccinated To Reopen Schools
Teachers do not need to be vaccinated in order for schools to reopen according to the Centers for Disease Control and Prevention.
In cites such as Chicago and Los Angeles, teachers unions are resisting the effort to put teachers back in the classrooms without proper precautions in place, including vaccinations.
According to a Wednesday report from CNBC, newly appointed CDC Director Rochelle Walensky says that teachers do not need to be vaccinated against COVID-19 before schools can reopen.
In statements during a COVID-19 White House press briefing, Walensky said, “There is increasing data to suggest that schools can safely reopen and that safe reopening does not suggest that teachers need to be vaccinated. Vaccinations of teachers is not a prerequisite of reopening schools.”
She also explained that a CDC advisory committee has placed teachers in the “1B” category — the same as essential workers — to receive vaccines, placing them second in line for priority to receive the injections.
The CDC has stated that there is “little evidence” of widespread coronavirus transmission in schools and many schools across the country have been open for in person teaching for a while with little to no issues.
Full story at the Blaze.
