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Second In-N-Out Burger Restaurant in California Shut for Ignoring Covid Rules

Second In-N-Out Burger Restaurant in California Shut for Ignoring Covid Rules

The FDA’s vaccine advisers voted 17-0 with one abstention on Tuesday to recommend EUA for the vaccine, which is formulated at one-third the dose of the vaccine used for people 12 and older.

Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.

Shots can’t be administered yet — the question now goes to the US Centers for Disease Control and Prevention. The CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, meet November 2 to discuss whether to recommend use of the vaccine among US children. Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine.
The White House says it has a plan already in place for distributing vaccines to children. Vaccines could be administered as soon as the CDC signs off.
Pfizer’s Covid-19 vaccine was previously authorized for children ages 12 to 15. The vaccine is approved for people age 16 and older.
The American Academy of Pediatrics welcomed the decision.
“Authorization of the vaccine for younger children is an important step in keeping them healthy and providing their families with peace of mind. The vaccine will make it safe for children to visit friends and family members, celebrate holiday gatherings, and to resume the normal childhood activities that they’ve missed during the pandemic,” Dr. Lee Savio Beers, president of the organization, said in a statement.
“Pediatricians are standing by to talk with families about the vaccine and to administer the vaccine to children as soon as possible.”
“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,” Acting FDA Commissioner Dr. Janet Woodcock said 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 FDA said those ages 5 to 11 account for 39% of Covid-19 cases in children.
“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said in a statement.
“We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” he added.
The US Food and Drug Administration issued emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children.
Pfizer said it would start shipping the orange-topped pediatric doses of the vaccine immediately.
FDA officials urged parents to vaccinate their children if the CDC signs off.
“While we have heard from some parents that their children have had Covid-19 and their symptoms were mild or hardly noticeable, it’s important to note the data from the CDC show that among children 5 to less than 12 years of age, there have been about 1.9 million reported cases of Covid-19,” Woodcock told a news conference.
“This includes more than 8,300 Covid-19-related hospitalizations through September of this year in this age group,” she added. “Tragically, Covid-19 was among the top 10 leading causes of death for children 5 through 11 years of age in the US,” Woodcock said.
According to the US Centers for Disease Control and Prevention, 170 children 5-11 have died of Covid-19.
“These are really starting statistics,” Woodcock said.
Back in the 1980s, scientists in the U.K. performed an experiment that — at first glance — sounds unethical. “Volunteers came into the lab, and someone squirted virus up their nose,” says computational biologist Jennie Lavine.

The researchers took a liquid packed with coronavirus particles and intentionally tried to make 15 volunteers sick.

Ten people got infected. The other five fought off the virus, says Lavine, who’s now at the biotechnology company Karius but was at Emory University when she spoke to NPR.

Then the researchers waited a year and repeated the experiment. They wondered: Did getting sick from the coronavirus the first time protect people from the second exposure a year later? Or could people get reinfected a year later?

Now, this coronavirus injected up the volunteers’ noses wasn’t SARS-CoV-2, the coronavirus that causes the disease COVID-19, Lavine is quick to point out. “No. No. Nobody got very sick. I think they measured disease severity by how many tissue boxes a person used. The experiment was performed with all of the proper ethical considerations.”
The researchers were studying another coronavirus, called 229E, that causes only a mild cold in humans. But the results of that experiment offer some intriguing insights into the possible endgame of the COVID-19 pandemic. After this delta-variant surge wanes this winter, as scientists forecast, what’s next? Will the virus come back next year? And the year after that?

Why there was early hope of eradicating SARS-CoV-2
When COVID-19 erupted worldwide, there was some hope we could put the genie back into the bottle, so to speak. That is, the world could completely wipe out the virus from the human population as it did for the first SARS coronavirus back in 2003.
But as the current virus spread rapidly from continent to continent and cases exploded in every nook and cranny, the hope shifted to local eradication. Perhaps some regions could reach herd immunity via exposure and vaccinations and thus push out the virus from their communities and keep it out with travel restrictions and immunization requirements.

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“It’s like, OK, if we’re not going to be able to fully eliminate SARS-CoV-2 from the world,” Lavine says, “then maybe we would achieve local eradication, like we do for measles or polio.”

For that to be possible, the virus must be stable, says virologist Paul Bieniasz, of Rockefeller University. Its genetic sequence can’t mutate or change over time; that way, the vaccine’s protection can last for a long time. “If you have a measles infection or a course of the vaccine, you have essentially lifelong protection,” he says, because that virus doesn’t evolve much.

But not all viruses are like that. For instance, influenza viruses mutate really rapidly, and those mutations can decrease a vaccine’s effectiveness. That’s one reason you can get reinfected with the flu over and over again — “and why we have to update vaccines every year,” says molecular biologist Kathryn Kistler, of the

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