The Nobel Prize in Medicine was awarded Monday to two scientists whose work led to the mRNA vaccines against COVID-19.

As countries prepared to roll out those shots, The Associated Press took a look at how the vaccines were developed so quickly. Below follows the original story, first published on Dec. 7, 2020.

___

How could scientists race out COVID-19 vaccines so fast without cutting corners? A head start helped — over a decade of behind-the-scenes research that had new vaccine technology poised for a challenge just as the coronavirus erupted.

“The speed is a reflection of years of work that went before,” Dr. Anthony Fauci, the top U.S. infectious disease expert, told The Associated Press. “That’s what the public has to understand.”

Creating vaccines and having results from rigorous studies less than a year after the world discovered a never-before-seen disease is incredible, cutting years off normal development. But the two U.S. frontrunners are made in a way that promises speedier development may become the norm — especially if they prove to work long-term as well as early testing suggests.

“Abject giddiness,” is how Dr. C. Buddy Creech, a Vanderbilt University vaccine expert, described scientists’ reactions when separate studies showed the two candidates were about 95% effective.

“I think we enter into a golden age of vaccinology by having these types of new technologies,” Creech said at a briefing of the Infectious Diseases Society of America.

Both shots — one made by Pfizer and BioNTech, the other by Moderna and the National Institutes of Health — are so-called messenger RNA, or mRNA, vaccines, a brand-new technology. U.S. regulators are set to decide this month whether to allow emergency use, paving the way for rationed shots that will start with health workers and nursing home residents.

Billions in company and government funding certainly sped up vaccine development — and the unfortunately huge number of infections meant scientists didn’t have to wait long to learn the shots appeared to be working.

But long before COVID-19 was on the radar, the groundwork was laid in large part by two different streams of research, one at the NIH and the other at the University of Pennsylvania — and because scientists had learned a bit about other coronaviruses from prior SARS and MERS outbreaks.

“When the pandemic started, we were on a strong footing both in terms of the science” and experience handling mRNA, said Dr. Tal Zaks, chief medical officer of Massachusetts-based Moderna.

Traditionally, making vaccines required growing viruses or pieces of viruses — often in giant vats of cells or, like most flu shots, in chicken eggs — and then purifying them before next steps in brewing shots.

The mRNA approach is radically different. It starts with a snippet of genetic code that carries instructions for making proteins. Pick the right virus protein to target, and the body turns into a mini vaccine factory.

“Instead of growing up a virus in a 50,000-liter drum and inactivating it, we could deliver RNA and our bodies make the protein, which starts the immune response,” said Penn’s Dr. Drew Weissman.

Fifteen years ago, Weissman’s lab was trying to harness mRNA to make a variety of drugs and vaccines. But researchers found simply injecting the genetic code into animals caused harmful inflammation.

Weissman and a Penn colleague now at BioNTech, Katalin Kariko, figured out a tiny modification to a building block of lab-grown RNA that let it slip undetected past inflammation-triggering sentinels.

“They could essentially make a stealth RNA,” said Pfizer chief scientific officer Dr. Philip Dormitzer.

Other researchers added a fat coating, called lipid nanoparticles, that helped stealth RNA easily get inside cells and start production of the target protein.

Meanwhile at the NIH, Dr. Barney Graham’s team figured out the right target — how to use the aptly named “spike” protein that coats the coronavirus to properly prime the immune system.

The right design is critical. It turns out the surface proteins that let a variety of viruses latch onto human cells are shape-shifters — rearranging their form before and after they’ve fused into place. Brew a vaccine using the wrong shape and it won’t block infection.

“You could put the same molecule in one way and the same molecule in another way and get an entirely different response,” Fauci explained.

That was a discovery in 2013, when Graham, deputy director of NIH’s Vaccine Research Center, and colleague Jason McLellan were investigating a decades-old failed vaccine against RSV, a childhood respiratory illness.

They homed in on the right structure for an RSV protein and learned genetic tweaks that stabilized the protein in the correct shape for vaccine development. They went on to apply that lesson to other viruses, including researching a vaccine for MERS, a COVID-19 cousin, although it hadn’t gotten far when the pandemic began.

“That’s what put us in a position to do this rapidly,” Graham told the AP in February before the NIH’s vaccine was first tested in people. “Once you have that atomic-level detail, you can engineer the protein to be stable.”

Likewise, Germany’s BioNTech in 2018 had partnered with New York-based Pfizer to develop a more modern mRNA-based flu vaccine, giving both companies some early knowledge about how to handle the technology.

“This was all brewing. This didn’t come out of nowhere,” said Pfizer’s Dormitzer.

Last January, shortly after the new coronavirus was reported in China, BioNTech CEO Ugur Sahin switched gears and used the same method to create a COVID-19 vaccine.

Moderna also was using mRNA to develop vaccines against other germs including the mosquito-borne Zika virus — research showing promise but that wasn’t moving rapidly since the Zika outbreak had fizzled.

Then at the NIH, Graham woke up on Saturday Jan. 11 to see Chinese scientists had shared the genetic map of the new coronavirus. His team got to work on the right-shaped spike protein. Days later, they sent Moderna that recipe — and the vaccine race was on.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Years of research laid the groundwork for speedy COVID-19 shots appeared first on The Hemet & San Jacinto Chronicle.

COVID-19 vaccines are unlikely to trigger a rare inflammatory condition linked to coronavirus infection in children, according to an analysis of U.S. government data published Tuesday.

The condition, formally known as multisystem inflammatory syndrome in children, involves fever plus symptoms affecting at least two organs and often includes stomach pain, skin rash or bloodshot eyes. It’s a rare complication in kids who have had COVID-19, and very rarely affects adults. The condition often leads to hospitalization, but most patients recover.

First reported in the United Kingdom in early 2020, it is sometimes mistaken for Kawasaki disease, which can cause swelling and heart problems. Since February 2020, more than 6,800 cases have been reported in the U.S., according to the Centers for Disease Control and Prevention.

As part of COVID-19 vaccine safety monitoring, the CDC and U.S. Food and Drug Administration added the condition to a list of several potential adverse events of special interest. A few cases reported in people with no detectable evidence of coronavirus infection prompted researchers at the CDC and elsewhere to undertake the new analysis, which was published Tuesday in The Lancet Child & Adolescent Health.

The possibility that the vaccines could somehow prompt the condition is only theoretical and the analysis found no evidence that it did, said co-author Dr. Buddy Creech, a Vanderbilt University pediatric infectious disease specialist who is leading a study of Moderna shots in children.

“We don’t know what the exact contribution of the vaccine to these illnesses is,” Creech said. “Vaccine alone in absence of a preceding infection appears not to be a substantial trigger.’’

The analysis involved surveillance data for the first nine months of COVID-19 vaccination in the U.S., from December 2020 through August 2021. During that time, the FDA authorized Pfizer’s COVID-19 shots for ages 16 and up; expanded that in May to ages 12 through 15; and authorized Moderna and Johnson & Johnson shots for ages 18 and up.

More than 21 million people aged 12 to 20 received at least one vaccine dose during that time. Twenty-one of them developed the inflammatory condition afterward. All had received Pfizer shots, the analysis found. Fifteen of the 21 had laboratory evidence of a previous COVID-19 infection that could have triggered the condition.

The remaining six had no evidence of a previous infection, but the researchers said they could not conclude definitively that they’d never had COVID-19 or some other infection that could have led to the inflammatory condition. Kids with COVID-19 often have no symptoms and many never get tested.

The results suggest that the inflammatory condition may occur after vaccination in 1 in 1 million children who have had COVID-19, and in 1 in 3 million who have no detectable evidence of previous COVID-19 infection.

Most kids who had COVID-19 don’t develop the post-infection illness, but it is estimated to happen at a significantly higher rate than both of those post-vaccination figures. In April to June 2020, the rate was 200 cases per million in unvaccinated infected people aged 12-20 in the U.S.

“Their findings overall are quite reassuring,” Dr. Mary Beth Son of Boston Children’s Hospital wrote in a commentary accompanying the study.

Dr. Adam Ratner, a pediatrician-scientist at New York University Langone Health, said the results show that chances are “super rare” for the shots to prompt an immune response that could lead to the inflammatory condition. By contrast, there’s strong evidence that vaccination protects kids from getting COVID-19 as well as the condition, Ratner said.

Find your latest news here at the Hemet & San Jacinto Chronicle

The post COVID-19 shots unlikely to prompt rare inflammation in kids appeared first on The Hemet & San Jacinto Chronicle.

Hugs with friends. Birthday parties indoors. Pillow fights. School children who got their first COVID-19 shots Wednesday said these are the pleasures they look forward to as the U.S. enters a major new phase in fighting the pandemic.

Health officials hailed shots for kids aged 5 to 11 as a major breakthrough after more than 18 months of illness, hospitalizations, deaths and disrupted education.

Kid-sized doses of the Pfizer-BioNTech vaccine cleared two final hurdles Tuesday — a recommendation from CDC advisers, followed by a green light from Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention.

At a Decatur, Georgia, pediatrician’s office Wednesday, 10-year-old Mackenzie Olson took off her black leather jacket and rolled up her sleeve as her mother looked on.

“I see my friends but not the way I want to. I want to hug them, play games with them that we don’t normally get to,” and have a pillow fight with her best friend, Mackenzie said after getting her shot at the Children’s Medical Group site.

With the federal government promising enough vaccine to protect the nation’s 28 million kids in this age group, pediatricians’ offices and hospitals began inoculating children, with schools, pharmacies and other locations planning to follow suit in the days ahead.

Brian Giglio, 40, of Alexandria, Virginia, brought his 8-year-old son, Carter, in for vaccination at Children’s National Hospital in Washington, D.C., where kids with underlying conditions got first dibs. Carter has Type 1 diabetes that puts him at risk for complications if he were to become infected.

“Carter is the last in our house to get vaccinated and he was always the one that we had the most concern about,’’ Giglio said. “And so today is like a hallway pass for us to begin living life again and we couldn’t be more thankful to everybody that’s been involved in this process to helping us feel that freedom that we feel today.’’

Carter said he can’t wait to leave masks behind once he’s fully vaccinated, so he can smell the things he used to be able to smell without it.

“I’m ready to trash it,” he said, though the CDC still recommends masks in schools and indoor public spaces where virus activity is high, even for the fully vaccinated.

Cate Zeigler-Amon, 10, was first in line Wednesday for a drive-through vaccination at Viral Solutions in Atlanta. The girl bounced around the car in excitement before the shot, which she broadcast live on her computer during morning announcements at her elementary school.

Afterward, Cate said she was “very, very, very excited and very happy,” looking forward to hugging her friends and celebrating her birthday indoors next month “instead of having a freezing cold outside birthday party.”

Hartford Hospital in Connecticut vaccinated seven youngsters Tuesday night, minutes after CDC’s director gave the OK, and three more early Wednesday. Mostly staffers’ children, the kids were waiting for the CDC announcement, said Eric Arlia, senior pharmacy director for Hartford HealthCare in Connecticut.

One girl squeezed her eyes shut and a boy barely flinched as they got their shots and other waiting kids applauded, local media video showed.

“It feels like another important step on the journey to being able to vaccinate as many people as we can and put the pandemic to an end,’’ Arlia said.

The vaccine — one-third the dose given to older children and adults and administered with kid-sized needles — requires two doses three weeks apart, plus two more weeks for full protection. That means children who get vaccinated before Thanksgiving will be covered by Christmas.

“The timing before winter holidays is very fortunate,” said Dr. Jennifer Shu, whose Children’s Medical Group office in Decatur, Georgia, began vaccinating first thing Wednesday. “This age group will be able to spend holidays with friends and family more safely than they have been able to since the start of the pandemic.”

Sarah Kerr’s children, ages 6 and 7, are Shu’s patients and she hopes to get them vaccinated by week’s end. Her kindergartner son has a chromosome disorder, receives special education and is at risk for severe illness if he got infected, Kerr said.

“My son, who can’t wear a mask and has been fully dependent on those around him to protect him, it will give him a line of defense,’’ Kerr said. “My daughter has had to sit out on some social things because we’ve had to be so careful for his sake. She’s been so understanding but it has been hard on her.”

Thousands of pediatricians pre-ordered doses, and Pfizer began shipments soon after the Food and Drug Administration’s decision Friday to authorize emergency use. Pfizer said it expects to make 19,000 shipments totaling about 11 million doses in coming, and millions more will be available to order on a weekly basis.

Authorities said they expect a smooth rollout, unlike the chaos that plagued the national one for adults nearly a year ago.

Asked about parents having trouble finding vaccine appointments, White House coronavirus coordinator Jeff Zients said the vaccines.gov website will be updated by Friday for parents to search for locations near them. He said the kid vaccination campaign will be at full speed next week as Pfizer continues to ship millions more doses to locations around the country.

And he said more than 6,000 vaccination clinics are being planned at schools around the country before the winter holiday break.

Walgreens planned to start kids’ vaccinations Saturday and said parents could sign up online or by calling 1-800-Walgreens. CVS was also accepting appointments online and by phone at select pharmacies starting Sunday.

Many locations planned mass vaccination events in coming days. And while many pediatricians’ offices were expecting strong demand at least initially, almost two-thirds of parents recently polled by the Kaiser Family Foundation said they would wait or not seek out vaccines for their kids.

Hannah Hause, a Colorado mother of four children ages 2, 5, 7 and 8, is among them. She’s vaccinated but wants to see how the child vaccines play out and are studied in the larger childhood population.

“It’s not studied long-term. It just makes me nervous,” she said. “As long as I can wait, I will wait.”

At a White House briefing Wednesday, Walensky authorities thoroughly reviewed all available data on the vaccine’s safety, efficacy and the immune response it generates before recommending shots for kids.

“The safety of our children is of the upmost importance to me,’’ she said.

Surgeon General Vivek Murthy said he plans to get his 5-year-old son vaccinated. “Ultimately we want every child in our country to be safe from COVID and to get back to the lives they loved,” Murthy said.

Government authorities said pediatricians and family doctors, whom parents depend on to give routine childhood vaccinations, could help build trust.

Dr. Ada Stewart, a Black family physician in Columbia, South Carolina, who works at a clinic for underserved patients, said she’s ready to start vaccinating younger children. She’s seen the toll the virus has taken on them — not just in family illness and death but with school disruptions, slipping grades and mental strain.

School closures throughout the pandemic have disproportionately burdened children of color, widening academic gaps and worsening mental health, according to data presented Tuesday to CDC advisers. It showed more than 2,000 COVID-related school closures in just the first two months of the current school year.

But Stewart thinks demand for kids’ shots will be mixed.

“Because many of my patients are Black, Indigenous and people of color, I’ve seen the full spectrum,’’ from parents eager to get their children vaccinated to those who are more hesitant “because of a history of mistrust in the medical community,’’ said Stewart, past president of the American Academy of Family Physicians.

Her message to both is the same: “Vaccines work, they’re safe, they’re effective and they save lives.’’

A Pfizer study of 2,268 children found the vaccine was almost 91% effective at preventing symptomatic COVID-19 infections. The FDA examined 3,100 vaccinated kids in concluding the shots are safe.

Some skeptics have questioned the need for kids to get vaccinated since they are less likely than adults to develop severe COVID-19. But with the delta variant, they get infected and transmit “just as readily as adults do,’’ Dr. Anthony Fauci said at a recent White House briefing.

Infected kids have also contributed to the U.S. toll — almost 46 million infections and more than 740,000 deaths.

Since the pandemic began, at least 94 children aged 5 to 11 have died from COVID-19, more than 8,300 have been hospitalized and over 5,000 have developed a serious inflammatory condition linked to the coronavirus. Black and Latino youngsters and those with chronic conditions are among the hardest hit.

But while some health authorities say minorities should be over-represented in COVID-19 vaccine studies because they are disproportionately affected by the virus, nearly 80% of kids in Pfizer’s study were white. Black youngsters totaled 6%, Latinos 21%, Asians 6% and less than 1% were American Indian or Alaska or Hawaii natives.

Kye’vontay Jordan, 7, who is Black, has diabetes and his shot at Children’s National in Washington, D.C., gave his dad peace of mind.

“Now I can sleep not worrying about him going to school,” said Brian Jordan. “Being exposed to the coronavirus could really affect him and mess him up.”

Find your latest news here at the Hemet & San Jacinto Chronicle

The post Roll up your sleeves: Kids’ turn arrives for COVID-19 shots appeared first on The Hemet & San Jacinto Chronicle.