Skip to main content

New top story from Time: Pfizer-BioNTech Have Started Testing Their COVID-19 Vaccine in Children Under 12

https://ift.tt/3vWOQjL

Alejandra and Marisol Gerardo are nine years old but already making a little bit of history. The twin sisters are among the first young children to get vaccinated with a COVID-19 shot in Pfizer-BioNTech’s study of its vaccine in kids under age 12.

Alejandra and Marisol had their blood drawn in the morning on March 24, then got their first dose of the two-dose vaccine later that afternoon. “Their primary concern was, ‘is it going to hurt,’” says their father, Dr. Charles Gerardo, chief of emergency medicine at Duke University School of Medicine. “They’re not too worried about the long term side effects; they’re looking at the moment, not the future.”

Testing the vaccine in younger children will answer critical questions about how much immunity the shots can provide, and potentially give parents and education officials more confidence in re-opening schools. While it appears that younger children don’t get as sick with COVID-19 as older teens and adults do, how these children’s immune systems respond to the virus, and to the vaccine, remains a black box. The trial will also help provide some clarity on those questions.

Pfizer-BioNTech says it will test the same vaccine that is currently authorized for emergency use in the U.S. for those 16 years and older, but this time in children aged six months to 11 years. The company is currently wrapping up a study of its two-dose shot in adolescents aged 12 to 15 years in the U.S. and Europe.

The latest pediatric trial will follow the same three-phased approach as the adult study, with Phase 1 involving 144 children aged five to 11 years at Duke, Boston Children’s Hospital, Cincinnati Children’s Hospital and Johns Hopkins, who will all receive the vaccine but be randomly assigned one of three dosages. If the vaccine is safe in this age group, children aged two to four years will be tested, and if safe in that group, the youngest children from six months to two years will get the vaccine. Depending on the immune responses these children generate, the scientists at Pfizer-BioNTech will make a decision about the safest and most effective dose with which to proceed in its Phase 2 and Phase 3 studies.

Those will include a total of about 4,500 children broken down in the same age categories, this time randomly assigned to receive either the vaccine or placebo in a 2:1 ratio. The results will be analyzed after six months to determine if the children receiving the vaccine both generated a stronger immune response than those getting placebo, and that the response was on par with responses in vaccinated adults. If that’s the case, then Pfizer-BioNTech will submit the data to the U.S. Food and Drug Administration to expand authorization to younger children, and hopefully start vaccinating them by early next year.

Dr. Emmanuel Walter, professor of pediatrics and chief medical officer at the Duke Human Vaccine Institute who is overseeing the trial there, says the study will answer important questions about the safety and dosing of the vaccine for children—specifically whether younger children will need a different dose than adolescents and adults. The trial will test a dose about one-third that of the current adult dose, another that is about half of the adult dose, as well as the adult dose. While the Pfizer-BioNTech COVID-19 shot is the first mRNA technology-based vaccine of any kind to gain FDA authorization, Walter says it’s likely to be safe in children. “I don’t think it’s the platform so much that I would worry about for young children—I feel comfortable giving the mRNA to young children. I think the questions of will they have side effects, will the vaccine be tolerable to children, and do we need to use a smaller dose in young kids, are the biggest things.”

So far, Walter says that they have seen an “overwhelming” response to the pediatric trial, with parents like the Gerardos expressing interest in enrolling their children. Both Gerardo and his wife, who is an infectious disease physician at Duke, are vaccinated, and he says before his daughters joined the trial, they discussed volunteering with the girls. “They understand that the results are going to impact other kids, and that’s one of the lessons we wanted to teach them with this experience,” he says. “That this was one of the ways to contribute to help other people.”

Comments

Popular posts from this blog

Breaking News LIVE: Top Headlines This Hour https://ift.tt/30mZeTB

The total number of global coronavirus cases has surpassed 35 million, including more than 1,066,000 fatalities. More than 27,629,990 patients are reported to have recovered. Follow this breaking news blog for live updates on the coronavirus pandemic as it continues to pose a challenge for health workers and scientists who are in a race against time to produce a vaccine/medicine. 

Trump nominates Amy Coney Barrett as next justice of Supreme Court https://ift.tt/36gC99f

President Donald Trump nominated Judge Amy Coney Barrett to the Supreme Court on Saturday, capping a dramatic reshaping of the federal judiciary that will resonate for a generation and that he hopes will provide a needed boost to his reelection effort.

New top story from Time: Elaine Thompson-Herah Breaks 100-m Olympic Record, Further Cementing Jamaica’s Sprint Legend

https://ift.tt/3igRaxq Elaine Thompson-Herah knew she had it won, the 100-m race on Saturday night at the Olympic Stadium in Tokyo, Japan. So the defending 100-m Olympic champion pointed at the scoreboard before the finish, just like fellow Jamaican, Usain Bolt, did at the 2008 Beijing Games. Her final time in the race was 10.61 seconds, a new Olympic record, breaking Florence Griffith-Joyner’s 10.62 mark from the 1988 Olympics. It was the second-fastest 100-m time in history. If she hadn’t pointed, could Thompson-Herah have broken Flo-Jo’s world record mark, 10.49 seconds, that was also set in 1988? [time-brightcove not-tgx=”true”] “Most definitely, if I wasn’t celebrating,” Thompson-Herah said after the race. Did she regret it at all? “No. No. No. No.,” said Thompson-Hearh, the Jamaican flag still draped over her shoulder from her victory lap. A gold medal and Olympic record was good enough; and it was a celebration to remember. Jamaica swept the 100-m race on Saturda...

FOX NEWS: Miniskirt named 'most iconic fashion statement of all time' in British survey

Miniskirt named 'most iconic fashion statement of all time' in British survey It’s official: Nobody remembers your sweet Members Only jacket from 1983. via FOX NEWS https://ift.tt/2yTg1Dn

4th Street Transit Lane Offers Muni a Path Forward

4th Street Transit Lane Offers Muni a Path Forward By Bonnie Jean von Krogh A new transit lane was installed last week   on 4th Street in SoMA as part of the previously approved 4th Street Transit Improvement Project . As the first transit lane put in place during the COVID-19 pandemic, this change will help protect Muni passengers as congestion returns to city streets. Transit lanes allow buses to complete trips in less time and turn around back into service more quickly. That means with our limited resources, we can provide more Muni service with the same number of buses, reducing crowding and maintaining better physical distancing onboard. The benefits that transit lanes provide – saving time and avoiding congestion – have become critically important during COVID-19 to protect the health of Muni passengers. Physical distancing requirements mean that Muni’s passenger capacity is cut in a third from pre-COVID levels. When buses ...

FOX NEWS: Woman who had to cancel birthday trip because of coronavirus recreates entire vacation at home in viral video

Woman who had to cancel birthday trip because of coronavirus recreates entire vacation at home in viral video There will be no crying for this birthday. via FOX NEWS https://ift.tt/2Xwfa4W

Sushant Singh Rajput Death Case LIVE Updates: Actor's sister Shweta Singh Kirti hits back at Rhea Chakraborty https://ift.tt/3hEjyXe

Rhea Chakraborty's deleted WhatsApp chat has put the Narcotics Control Bureau (NCB) in action. The team began their investigation on Thursday and reached Goa in search of Gaurav Arya, who was in contact with Sushant Singh Rajput's girlfriend Rhea in connection to buying and selling drugs. The move came after NCB filed an FIR against the actress and two others. On the other hand, Rhea Chakraborty's claims that Sushant's family didn't love him and he hadn't met his father in five years received a sharp reply from Sushant's sister Shweta Singh Kirti.

New top story from Time: What to Watch For In Donald Trump and Joe Biden’s First Presidential Debate

https://ift.tt/3kSr0zp Four years ago, Donald Trump prepared to debate his general-election opponent for the first time. Down in the polls to an experienced, traditional pol, he had been reduced to spreading weird rumors and casting doubt on the legitimacy of the vote, even as questions swirled about his personal finances. Now Trump is the incumbent president, and the conditions could not be more different as he prepares for his first debate with Democratic nominee Joe Biden on Tuesday: a nation wracked by disease, disorder and disasters; an election neither candidate is treating like a foregone conclusion. And yet the similarities to 2016 are striking, from new questions about Trump’s taxes to another open Supreme Court seat . The main similarity, of course, is Trump—a singular political figure who has intensely polarized the nation. The debate, scheduled to begin at 9 p.m. Eastern at Case Western Reserve University in Cleveland, is especially momentous because voters ha...

New top story from Time: Swimmer Killed in Apparent Shark Attack Off Maine Coast

https://ift.tt/30QB2IN HARPSWELL, Maine — A woman was killed in an apparent shark attack off the coast of Maine on Monday, a rare occurrence that has only been recorded once before in the state by an unprovoked shark. Maine Marine Patrol said a witness saw the woman swimming off the shore of Bailey Island when she was injured in what appeared to be a shark attack. Two kayakers helped the person get to shore, and an ambulance provided further assistance, but she was pronounced dead at the scene, Marine Patrol said. The name of the woman was not available on Monday. There has only been one recorded unprovoked shark attack in Maine, New England shark expert James Sulikowski told the Portland Press Herald. Sulikowski, who researches for Arizona State University, said it’s possible the shark mistook the person for food. The state Marine Patrol is urging swimmers and boaters to use caution near Bailey Island and to avoid swimming near schooling fish or seals.

New top story from Time: ‘We’re Nowhere Close to the Deal’. Coronavirus Aid Package Talks Break Down as Trump Rejects Help for Cities

https://ift.tt/3098lHW WASHINGTON — President Donald Trump on Wednesday dismissed Democratic demands for aid to cash-strapped cities in a new coronavirus relief package and lashed out at Republican allies as talks stalemated over assistance for millions of Americans. Another lawmaker tested positive for the virus. Republicans, beset by delays and infighting, signaled a willingness to swiftly approve a modest package to revamp a $600 weekly unemployment benefit that’s running out. But House Speaker Nancy Pelosi, D-Calif., roundly rejected that approach as meager, all but forcing Republicans back to the negotiating table. Without action, the aid expires Friday. “We’re nowhere close to the deal,” said White House chief of staff Mark Meadows. He said they’re “miles apart.” Stark differences remain between the $3 trillion proposal from Democrats and $1 trillion counter from Republicans, a standoff that is testing Trump and Congress ahead of the November election and putting...