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Tag: coronavirus vaccine

#EndorseThis: Randy Rainbow Wants His Covid-19 Vaccine

President Joe Biden is so dull. No threats of violence, no loony racist statements, and no deeply offensive conduct. Is this even a president? Yes, he's the kind of president who once made America great -- and most of us have never been more thankful to be bored, as Randy Rainbow reminds us so cleverly in this new video. (Trump gets a helpful horror cameo.)

The brilliant parodist who got us through the former guy's four years of insanity returns with a spoof of that mellow classic Mr. Sandman. Going nuts in quarantine, poor Randy only has only one demand for President Biden: "Bring my vaccine. Keep me protected from COVID-19." He'd like to go out. Frankly, he has places to go and people to see...

Everyone waiting to be vaccinated is thinking the same thing, but we know Biden is working on it. In the meantime enjoy Randy's hilarious lyrics.


MR. BIDEN (Bring My Vaccine) - A Randy Rainbow Song Parody www.youtube.com

How Inequity Gets Built Into Our Vaccination System

Reprinted with permission from ProPublica

It's a fact that simply being eligible for a vaccine in America doesn't mean that you can instantly get one. Yet the ability to get to the front of the line isn't the same for everyone. ProPublica has found that, whether intentionally or not, some vaccine programs have been designed with inherent barriers that disadvantage many people who are most at risk of dying from the disease, exacerbating inequities in access to health care.

In many regions of the U.S., it's much more difficult to schedule a vaccine appointment if you do not have access to the internet. In some areas, drive-through vaccinations are the only option, excluding those who do not have cars or someone who can give them a ride. In other places, people who do not speak English are having trouble getting information from government hotlines and websites. One state is even flat-out refusing to allow undocumented workers with high-risk jobs to get prioritized for vaccination.

The vaccine supply is too low to inoculate everyone who is eligible, and competition for appointments is fierce.

"My nightmare scenario is that we have this two-tiered health system where there are people who are wealthy, privileged or connected, and then there's everybody else," Dr. Jonathan Jackson, director of the Community Access, Recruitment, and Engagement Research Center at Massachusetts General Hospital and Harvard Medical School, told ProPublica. "Once we hit that saturation point where the first tier has all gotten their vaccines, the narrative will shift to blame. It'll be 'Why haven't you taken care of this yet?'"

For People With Disabilities, Vaccine Appointments Can Be A Struggle

From the moment her 69-year-old father, Jose Balboa, became eligible for the vaccine in January, Kristine Mathason spent part of each day on the phone and online trying to get him a shot. She found available appointments a few times, but couldn't find a way to actually take her father to the vaccination sites. Balboa is paralyzed on his left side after a stroke and needs a wheelchair to get around. In Miami, where he lives, most vaccine sites are drive-up only.

Mathason doesn't have a van that can accommodate Balboa's wheelchair, and she isn't able to lift her father out of it. To move him between his bed and the chair, his home health aides use a patient lift. This isn't possible when trying to get him into a car, Mathason said, as the door gets in the way of either a lifting device or two people trying to support him at once. In the past when family members tried to move him, Balboa fell.

Mathason said she was "willing to jump through all the hoops" to get Balboa the vaccine. "He's super high-risk: He's diabetic, he had a stroke 17 years ago," she said. "He has high blood pressure. My half brother who lives with him works at a restaurant, so that's like a high-risk job. We do our best."

Mathason checked out every other avenue she can think of, but each was a dead end. She looked into renting a van, but she's been out of work because of the pandemic and couldn't afford it. She thought about Uber, but wheelchair access and the cost of waiting in a drive-through were prohibitive. "He's just one of those people who unfortunately is falling through the cracks," she said.

A county service offers scheduled rides for seniors, but it only provides drop-off services and wouldn't take Balboa through a drive-through. There was an additional Catch-22: The scheduled rides require 24 hours' notice for pickup, but the local hospital that offers walk-up appointments schedules them less than 24 hours in advance. The health department in Miami-Dade County directed questions to the Florida state health department, which did not respond to requests for comment.

According to data from the Centers for Disease Control and Prevention, about 14% of adults in Florida have disabilities that affect mobility, which the CDC defines as serious difficulty walking or climbing stairs. While some people with mobility limitations may be able to access a car more easily than Balboa, he and his family were left with very few options.

"I just wish they had thought about people like my dad," Mathason said. "What about the people who don't have a me who's trying to move heaven and earth to get him an appointment? What about the people who just don't have a car and can't get anywhere?"

After more than a month of searching, Balboa got a call from the medical center he goes to for doctor visits. The center had gotten a supply of doses, and they picked him up and took him to the site in one of their wheelchair-accessible vans. On February 24th, he got his first shot.

If You Can't Use the Internet, You Might Have Fewer Options

Eneyda Morales, a 40-year-old mother of three in East Hampton, New York, was diagnosed with breast cancer two years ago and is still undergoing treatment. Four days a week, she works at a bagel shop near her home. "I'd like to get a vaccine because of the health issues I have and because I work in a place where I have to serve people," Morales said in Spanish. But she's not sure how she's actually going to get a vaccine; while many Americans are hunting for information online, Morales doesn't own a computer, nor does she know how to use one. She has a smartphone, but she primarily uses it for simple searches like looking up addresses. The only computer at her home is the one her 8-year-old daughter's school provided for classwork.

New York state has a vaccination hotline for scheduling appointments by phone, but only for vaccines administered at state-run sites. The state site closest to Morales is about 60 miles away, an hour and a half by car. If Morales wants to get an appointment closer to home, she'll need to contact local hospitals and pharmacies directly. The state hotline's automated message tells callers that the quickest way to get information about eligibility and appointment scheduling is online.

Morales plans to seek help from OLA of Eastern Long Island, a local nonprofit, to schedule an appointment closer to home on one of her days off. Without their help, she said, she wouldn't know where to begin searching.

Some states that have tried to provide offline options for booking vaccine appointments have stumbled. A phone line set up in Maryland was inundated with callers, who complained of being put on hold and then hung up on. In Tennessee, Shelby County's decision to allow internet users to sign up first meant all the slots were snapped up by those with web access before phone appointments even opened.

About ten percent of U.S. adults don't use the internet, according to the Pew Research Center. Americans who are older, have less income, have less education or are nonwhite are less likely to go online, researchers found.

People Who Don't Speak English May Have Trouble Getting Information

Gladys Godinez, the daughter of retired meatpacking workers, is an organizer for Solidarity with Packing Plant Workers who lives in Lexington, Nebraska. Her parents, like many of the immigrant workers she represents, are not fluent in English. Nebraska's Spanish-language vaccine website offers a hotline to schedule appointments by phone. Godinez wanted to see what people in her parents' situation were up against if they didn't have a tech-savvy English speaker to help, so she called the number on Feb. 2. She said it took 15 minutes for someone to pick up the phone; that person answered in English.

Godinez said she was told that no one who could speak Spanish was available. She tried to insist: "I said, 'Please, I would really like to be able to register for the vaccine.' I said it in Spanish. She said, 'We don't have anybody that can talk to you in Spanish.' So I just said 'gracias' and hung up."

Nebraska's Department of Health and Human Services said that since February 13, 25 percent of each hotline shift is staffed by fluent Spanish speakers, but each call center agent can connect with interpretation services as needed. A spokesperson for the department did not comment on Godinez's experience.

Language isn't the only potential barrier facing immigrant workers in Nebraska. In January, Gov. Pete Ricketts was asked if undocumented immigrants in meatpacking facilities would be included in the state's upcoming vaccination push. His response was discouraging: "You're supposed to be a legal resident of the country to be able to be working in those plants. So I do not expect that illegal immigrants will be part of the vaccine with that program."

Godinez said the governor's words did a lot of damage even for people who are legal residents. "That scared a lot of individuals," she said. "Just Spanish-speaking individuals living their life, they have legal status, they're already scared of being profiled. Now here is your governor saying, 'Sorry, not sorry, undocumented workers are not going to get the vaccine.'"

Later that day, the governor's communications director tweetedthat "while the federal government is expected to eventually make the vaccine available for everyone in the country, Nebraska is going to prioritize citizens and legal residents ahead of illegal immigrants." Nebraska's Department of Health and Human Services told ProPublica that proof of citizenship is not a requirement to receive the vaccine.

The federal government, even under the Trump administration, has encouraged undocumented immigrants to get vaccinated. According to a report by the Kaiser Family Foundation about immigrant vaccine access, Arizona has specifically prioritized undocumented immigrants, while Virginia and New Jersey have prioritized migrant workers. Several states, including Utah, have emphasized that undocumented immigrants are eligible for the vaccine and their personal information will not be shared with authorities. Oregon and Washington have discussed doing outreach to immigrant communities to make sure they have the right information.

Health care workers and advocates are also trying to make access to COVID-19 vaccines more realistic for undocumented residents. In Baltimore, local nonprofit CASA de Maryland is hiring people to knock on doors to share vaccine information and pushing for its Baltimore office, located in a COVID-19 hot spot, to become a vaccination site.

Drive-Through Vaccine Sites Exclude People Without Cars

Los Angeles's Chinatown is about a mile from Dodger Stadium, one of the largest vaccination sites in the country. Despite the short distance, many of the neighborhood's seniors have no way to get vaccinated at the stadium; the site is drive-up only, and many of them have no cars. Sissy Trinh, executive director of the Southeast Asian Community Alliance, which has been providing aid to families in Chinatown and nearby Lincoln Heights during the pandemic, said community members face various hurdles that local government and testing sites haven't accounted for.

Along with lacking access to cars, many of the seniors served by SEACA primarily speak Chinese dialects, Vietnamese, Khmer or Spanish and aren't internet users. Trinh and her colleagues have been scrambling to figure out how to get these seniors vaccinated. They considered hiring Ubers or Lyfts, but the cost of paying drivers to wait in line would be too high for the small nonprofit. SEACA also can't bus the seniors together to a vaccination site for fear of exposing them to potential infection.

In late February, Los Angeles Mayor Eric Garcetti announced that the city would send a mobile vaccination clinic to Chinatown and a few other neighborhoods prioritized for their medically vulnerable residents. The city reserved 800 doses for Chinatown. SEACA helped get them to residents, scheduling appointments from its waiting list of 2,500 people, translating documents for them and recruiting volunteers who are fluent in Cantonese, Taishanese, Teochew or Vietnamese.

Trinh said she's excited that some doses are finally reaching seniors in the neighborhood, but she wishes officials had started planning for this when the pandemic started. "I know a lot of people were rushing to figure out how to get PPE to people and updating stay-at-home orders," she said. "But there should have been a dedicated team to figure out the vaccine rollout." Los Angeles officials said they hope to open additional mobile clinic sites by the end of March.

In Pima County, Arizona, health officials are also using mobile clinics to bring vaccines to high-risk residents. Baltimore and Fort Worth, Texas, are among other places attempting to overcome transportation barriers by using mobile sites.

Unclear Communication Leaves People Anxious And Unable To Plan

James, 82, lives in Chesterfield County, Virginia, outside of Richmond. (He asked to be identified only by his first name for privacy reasons.) Like many Americans, he turned first to his primary care physician for information about the vaccine. "I contacted my physician's office to find out if they'd let me, as a patient, know when I'd get the vaccine, and they said, 'Oh, no, no, we're not going to do that.'" They instead directed him to the Virginia Department of Health. So James went on the state health department's website. "I filled in all their little boxes, and that was it — I never heard a word," he said. "I had no idea whether I'm registered or not." He also tried registering on his county health department's website, and had the same experience. "You don't know whether you're talking to a computer or to a garbage can," he said. "When you're filling it in, where does the form go? I'm concerned that when I finally get to go to the vaccine site, someone's going to say I'm not registered."

James contrasted the experience to online shopping: "When you go buy something off the web, you get an immediate response from the vendor saying, 'Thank you for your purchase.' Why can't they do that? Say thank you for your registration?"

Virginia's initial vaccine registration system indeed provided no email confirmation, but the new system, implemented on Feb. 16, now provides "an immediate acknowledgement on the screen" as well as an email or text message, according to health department spokesperson Melissa Gordon. She added that "it is not practical to give an exact place 'in line' or estimated appointment time frame, because clinics are put together based on capacity, eligibility and equity drivers that change over time." The only thing the email confirmation can do, she said, is to "notify the recipient that their information had been transferred to the new statewide system and no other action was needed." Residents who signed up under the old system, including James, eventually got an email to acknowledge their registration, albeit weeks after they filled in the form. Gordon added, "Unfortunately, it may be several weeks or months before everyone can get an appointment."

Confusion over "When's it going to be my turn?" has only increased as states start to expand access to people with underlying health conditions, with criteria that can be hard to interpret. Some Massachusetts residents with asthma, for example, are at a loss as to whether they qualify, WBUR recently reported. Massachusetts has "moderate to severe" asthma on its list of eligible medical conditions, but what counts as "moderate" asthma is ambiguous.

James has been waiting for the vaccine so he can safely visit his children and four grandchildren, who range in age from 11 to 28. In the absence of information from his local health department, he's been relying on the news to glean details about the rollout. He said he read about one couple who drove nearly five hours each way from the Richmond area to Abingdon to get a vaccine. James thinks it's not worth going that far, especially since that could involve an overnight stay somewhere. "I'll just sit around and wait and mind my p's and q's," he said.

The experience so far has made him "lose faith in the whole process," he said. "The president can get on TV and say he's purchased 600 million, 600 billion of these things, and I say, 'Fine, but where is this stuff? Tell me, when is it going to be on my street?'"

Why Biden’s Vaccine Promise Can’t Be Fulfilled Until Summer

Reprinted with permission from ProPublica

President Joe Biden has ordered enough vaccines to immunize every American against COVID-19, and his administration says it's using the full force of the federal government to get the doses by July. There's a reason he can't promise them sooner.

Vaccine supply chains are extremely specialized and sensitive, relying on expensive machinery, highly trained staff and finicky ingredients. Manufacturers have run into intermittent shortages of key materials, according to the U.S. Government Accountability Office; the combination of surging demand and workforce disruptions from the pandemic has caused delays of four to 12 weeks for items that used to ship within a week, much like what happened when consumers were sent scrambling for household staples like flour, chicken wings and toilet paper.

People often question why the administration can't use the mighty Defense Production Act — which empowers the government to demand critical supplies before anyone else — to turbocharge production. But that law has its limits. Each time a manufacturer adds new equipment or a new raw materials supplier, they are required to run extensive tests to ensure the hardware or ingredients consistently work as intended, then submit data to the Food and Drug Administration. Adding capacity "doesn't happen in a blink of an eye," said Jennifer Pancorbo, director of industry programs and research at North Carolina State University's Biomanufacturing Training and Education Center. "It takes a good chunk of weeks."

And adding supplies at any one point only helps if production can be expanded up and down the entire chain. "Thousands of components may be needed," said Gerald W. Parker, director of the Pandemic and Biosecurity Policy Program at Texas A&M University's Scowcroft Institute for International Affairs and a former senior official in the Department of Health and Human Services office for preparedness and response. "You can't just turn on the Defense Production Act and make it happen."

The U.S. doesn't have spare facilities waiting around to manufacture vaccines, or other kinds of factories that could be converted the way General Motors began producing ventilators last year. The GAO said the Army Corps of Engineers is helping to expand existing vaccine facilities, but it can't be done overnight.

Building new capacity would take two to three months, at which point the new production lines would still face weeks of testing to ensure they were able to make the vaccine doses correctly before the companies could start delivering more shots.

"It's not like making shoes," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica. "And the reason I use that somewhat tongue-in-cheek analogy is that people say, 'Ah, you know what we should do? We should get the DPA to build another factory in a week and start making mRNA.' Well, by the time a new factory can get geared up to make the mRNA vaccine exactly according to the very, very strict guidelines and requirements of the FDA ... we already will have in our hands the 600 million doses between Moderna and Pfizer that we contracted for. It would almost be too late."

Fauci added that the DPA works best for "facilitating something rather than building something from scratch."

The Trump administration deployed the Defense Production Act last year to give vaccine manufacturers priority in accessing crucial production supplies before anyone else could buy them. And the Biden administration used it to help Pfizer obtain specialized needles that can squeeze a sixth dose from the company's vials, as well as for two critical manufacturing components: filling pumps and tangential flow filtration units. The pumps help supply the lipid nanoparticles that hold and protect the mRNA — the vaccines' active ingredient, so to speak — and also fill vials with finished vaccine. The filtration units remove unneeded solutions and other materials used in the manufacturing process.

These highly precise pieces of equipment are not typically available on demand, said Matthew Johnson, senior director of product management at Duke University's Human Vaccine Institute, who works on developing mRNA vaccines, but not for COVID-19. "Right now, there is so much growth in biopharmaceuticals, plus the pinch of the pandemic," he said. "Many equipment suppliers are sold out of production, and even products scheduled to be made, in some cases, sold out for a year or so looking forward."

In the meantime, the shortage of vaccines is creating widespread frustration and anxiety as eligible people struggle to get appointments and millions of others wonder how long it will be before it is their turn. As of February 17, the U.S. had distributed 72.4 million doses and administered 56.3 million shots, but fewer than 16 million people have received both of the two doses that the Pfizer and Moderna vaccines require for full protection.

The Biden administration has said it is increasing vaccine shipments to states by 20 percent, to 13.5 million doses a week, and encouraged states to give out all their shots instead of holding on to some for second doses. But now that second-dose appointments are coming due, many jurisdictions are having to focus on those and stepping back from vaccinating uninoculated people. Even as the total number of vaccinations increased last week, the number of first doses fell to 6.8 million people, down from 7.8 million three weeks ago, according to Centers for Disease Control and Prevention data.

At best, it will take until June for manufacturers to deliver enough doses for the roughly 266 million eligible Americans age 16 and over, according to public statements by the companies.

That includes expected deliveries of Johnson & Johnson's one-dose vaccine, which is widely expected to win emergency authorization from the FDA shortly after a public advisory committee meeting on Feb. 26. But Johnson & Johnson has fallen behind in manufacturing. The company told the GAO it will have only 2 million doses ready to go by the time the vaccine is authorized, whereas its $1 billion contract with HHS scheduled 12 million doses by the end of February. It's not clear what held up Johnson & Johnson's production line; the company has benefited from first-priority purchases thanks to the DPA, according to a senior executive close to the manufacturing process. A Johnson & Johnson spokesman declined to comment on the cause of the delay, but said the company still expects to ship 100 million U.S. doses by July.

Vaccine Supply Won't Cover All Until Late Spring

Public statements from vaccine developers Pfizer, Moderna and Johnson & Johnson illustrate how many people could be covered by the available U.S. supply from now until the end of the summer.

Moderna declined to comment on "operational aspects" of its manufacturing, but "does remain confident in our ability to meet contracted quantities" of its vaccine to the U.S. and other nations, a spokesperson said in a statement. Pfizer did not respond to ProPublica's written questions.

Ramping up production is especially challenging for Pfizer and Moderna, whose vaccines use an mRNA technology that's never been mass-produced before. The companies started production even before they finished trials to see if the vaccines worked, another historic first. But it wasn't as if they could instantly crank out millions of vaccines full blast, since they effectively had to invent a novel manufacturing process.

"Putting together plans 12 months ago for a Phase 1 and 2 trial, and making enough to dose a couple hundred patients, was a big deal for the raw material suppliers," said Johnson, the product manager at Duke University's vaccine institute. "It's just going from dosing hundreds of patients a year ago to a billion."

Raw materials for the Pfizer and Moderna vaccines are also in limited supply. The manufacturing process begins by using common gut bacteria cells to grow something called "plasmids" — standalone snippets of DNA — that contain instructions to make the vaccine's genetic material, said Pancorbo, the North Carolina State University biomanufacturing expert.

Next, specific enzymes cultivated from bacteria are added to cause a chemical reaction that assembles the strands of mRNA, Pancorbo said. Those strands are then packaged in lipid nanoparticles, microscopic bubbles of fat made using petroleum or plant oils. The fat bubbles protect the genetic material inside the human body and help deliver it to the cells.

Only a few firms specialize in making these ingredients, which have previously been sold by the kilogram, Pancorbo said. But they're now needed by the metric ton — a thousandfold increase. Moderna and Pfizer need bulk, but also the highest possible quality.

"There are a number of organizations that make these enzymes and these nucleotides and lipids, but they might not make it in a grade that is satisfactory for human consumption," Pancorbo said. "It might be a grade that is satisfactory for animal consumption or research. But for injection into a human? That's a different thing."

Johnson & Johnson's vaccine follows a slightly more traditional method of growing cells in large tanks called bioreactors. This takes time, and the slightest contamination can spoil a whole batch. Since the process deals with living things, it can be more like growing plants than making shoes. "Maximizing yield is as much of an art as it is a science, as the manufacturing process itself is dependent on biological processes," said Parker, the former HHS official.

The vaccine developers are continuing to find tweaks that can expedite production without cutting corners. Pfizer is now delivering six doses in each vial instead of five, and Moderna has asked for permission to fill each of its bottles with 15 doses, up from 10. If regulators approve, it would take two or three months to change over production, Moderna spokesman Ray Jordan said on Feb. 13.

"It helps speed up and lighten the logistical side of getting vaccines out," said Lawrence Ganti, president of SiO2, an Alabama company that makes glass vials for the Moderna vaccine. SiO2 expanded production with $143 million in funding from the federal government last year, and Ganti said there aren't any hiccups at his end of the line.

Despite the possibility of sporadic bottlenecks and delays in the coming months, companies appear to have lined up their supply chains to the point that they're comfortable with their ability to meet current production targets.

Massachusetts-based Snapdragon Chemistry received almost $700,000 from HHS' Biomedical Advanced Research and Development Authority to develop a new way of producing ribonucleoside triphosphates (NTPs), a key raw material for mRNA vaccines. Snapdragon's technology uses a continuous production line, rather than the traditional process of making batches in big vats, so it's easier to scale up by simply keeping production running for a longer time.

Suppliers have told Snapdragon that they have their raw materials covered for now, according to Matthew Bio, the company's president and CEO. "They're saying, 'We have established suppliers to meet the demand we have for this year,'" Bio said.

Mollie Simon and Caroline Chen contributed reporting.

Keep Hope Up As Pandemic Ebbs — But Don’t Let Guard Down

Are we at the beginning of the end or the end of the beginning? Let's call it the middle.

The COVID-19 numbers are going decisively lower, both infections and deaths. Millions, meanwhile, are getting the vaccine and becoming mostly immune to the disease.

Still, the seven-day average of American deaths from this virus continues in the thousands. And it would be much higher if more of us let our guard down by ignoring calls to wear masks, socially distance, and sanitize hands.

We each make our own policy for how far to go. There are the absolutists, who take no chances. They see no friends and never enter a restaurant, much less step on a plane.

Then there are moderates, like yours truly, who always wear a mask in public but do gather with their "pod" of careful friends. We eat in establishments that take precautions.

Finally, there are those who don't care at all and do nothing protective. They risk their own life and the lives of others.

As we move into a somewhat less scary phase of this disease, we moderates probably have the most to think about. That's because we were always open to weighing more options.

Consideration No. 1: mask-wearing. Of course we'll continue wearing masks. But two masks with one of tight-fitting cloth, as Dr. Anthony Fauci advises? On public transportation, OK. But as the risk of infection heads down, perhaps we can lighten up and wear just a lightweight mask while on a walk.

Infectious-disease experts now believe that outdoor activities rarely cause the disease to spread unless people are in close conversation. They say that with a few exceptions, we can safely jog or bike without a mask.

That said, hospitals are still rationing medical-grade N95 masks even as their stockpiles grow, according to the Associated Press. Why? They remain traumatized by the terrifying mask shortage of a year ago and don't want to be caught short-handed again. They also fear a future surge in cases. (More on that later.)

We moderates continue to frown on the mask-less multitudes who crowd at super-spreader events. A recent example would be the bar parties following the Tampa Bay Buccaneers' Super Bowl win. Health officials in Florida warn of a possible coronavirus spike as a result. For people like me, the difference now is we take all that reckless behavior less personally.

Consideration No. 2: traveling. Early in the pandemic, I flew across the country on a JetBlue flight with few passengers and distanced seating. I would not go on a crowded jet. Now that I've had my first shot, I worry less about flying. When I get the second one, I'll hop right on.

Consideration No. 3: guilt. As frontline workers, the elderly and other vulnerable people get their protective vaccinations, less stigma is attached to easing up a bit on the restrictions.

However, unsettling thoughts remain. New coronavirus variants are reportedly more infectious and not as easily tamed by some of the vaccines. Variants are reportedly reinfecting people who survived the early version of the disease. And, undoubtedly, more variants are coming at us.

To reach herd immunity, 60 to 90 percent of the population must be vaccinated or protected by prior infection, according to medical experts. If the 15 percent of Americans who say they'll never get the vaccine follow through on that vow, that goal could be hard to reach.

The hope in this country is that the pandemic will end around summer. As the scourge shows more definite signs of weakening, we who tried to do the right things may be able to relax — if just a little. This will be a strange time.

Follow Froma Harrop on Twitter @FromaHarrop. She can be reached at fharrop@gmail.com. To find out more about Froma Harrop and read features by other Creators writers and cartoonists, visit the Creators webpage at www.creators.com.

Poll: Americans Trust Teachers -- Not Politicians -- On Reopening Schools Safely

For weeks, congressional Republicans have lashed out at teachers and Democrats for prioritizing safety in determining how and when to fully return to in-person education.

A new poll shows a majority of Americans are not buying their latest attempt to demonize teachers.

According to a Morning Consult/Politico poll released Wednesday, 55 percent of American voters do not want to reopen schools until teachers have been vaccinated against the coronavirus. Just 34 percent prefer to reopen schools immediately.While studies have not found massive coronavirus spread in the classroom, especially when safety precautions are taken, outbreaks have occurred.

But some lawmakers have been claiming falsely that it is complete safe to reopen schools right away.

"The science is unequivocally clear: Schools are safe to reopen," tweeted Rep. Nancy Mace (R-SC) on Monday. "But instead of following the science, the Biden administration is caving to teachers' unions. This is irresponsible & unacceptable. #ReopenSchools."

"The Biden Administration needs to put kids first, not the teachers unions," said Rep. Ken Buck (R-CO) on Sunday. "The science is clear: we need to reopen our schools now."

"@POTUS seems to have forgotten his campaign promise to 'follow the science.' Science says children can safely return to school, yet he is siding with corrupt teachers unions," tweeted Rep. Ronny Jackson (R-TX) last Friday. "Democrats are bankrolled by the teachers unions, but our nation's schoolchildren should come first!"

"Yet another Democrat sides with a teachers' union over students and this time, ignores the advice of the CDC Director! Shame on Joe Biden," tweeted Rep. Debbie Lesko (R-AZ) on February 5.

Republicans have sought for years to scapegoat public educators for the nation's ills, frequently targeting and working to crush teachers unions. The GOP platform includes language pushing for public funding for private schools and blasting Democrats' so-called efforts "to placate the leaders of the teachers' unions."

But according to the results of the Morning Consult poll, 54 percent of voters trust local teachers unions to determine whether to reopen schools in the fall, with an equal percentage expressing trust for local school boards. Just 34 percent said they don't trust local unions "much" or "at all."

Half of those surveyed said they trust national teachers unions to make the call on reopening.

The survey also found just 21 percent of those polled gave congressional Republicans a "good" or "excellent" rating for their handling of the pandemic, compared to 69 percent who rated them "just fair" or "poor." Biden received 54 percent positive ratings and 41 percent negative for his response to the virus.

Polls conducted since the start of the pandemic continue to show that most Americans do not want to rush to reopen schools before it is safe to do so.

A poll conducted by the National Parents Union, a coalition of parents and advocacy organizations, in January found half of American parents believe widespread vaccination is "absolutely necessary" for them to feel safe about returning their kids to the classroom.

And 68 percent of parents and 77 percent of teachers polled in August and September 2020 by Hart Research Associates for the American Federation of Teachers, the NAACP, the League of United Latin American Citizens, and the Alliance to Reclaim Our Schools said protecting the health of staff and students should be the top factor in determining when and how to resume in-person learning.

Despite the poll results, last week a group of House Republican doctors — and a few pretending to be physicians — signed a letter demanding President Joe Biden immediate reopen schools despite the ongoing pandemic. "Being Members of Congress with medical backgrounds and direct patient care experience," the 16 representatives wrote, "we remain concerned for the health and education of our children if they cannot return to the classroom."

Published with permission of The American Independent Foundation.

Kamala Harris Says Teachers Should Get Vaccine Priority

Speaking in her first sit-down network television interview since taking office, Vice President Kamala Harris stressed the importance of getting educators vaccinated since their work is so important and they work in an environment where protective measures are tough to implement. “Teachers should be a priority," said Harris on Wednesday. “They should be able to teach in a safe place .... So teachers should be a priority along with other frontline workers." Harris told Today show host, Savannah Guthrie that only about half the states are giving vaccine priority to teachers and called on state...

Fauci: Vaccines for Young Children Could Be Authorized by September

ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

Children as young as first graders may be able to get the coronavirus vaccine by the time school starts in September, presuming trials are successful in those age groups, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica.

“We're in the process of starting clinical trials in what we call age de-escalation, where you do a clinical trial with people 16 to 12, then 12 to 9, then 9 to 6," Fauci said. When asked what was the youngest age group that might be authorized for the vaccine by September, he said, “I would think by the time we get to school opening, we likely will be able to get people who come into the first grade."

As optimistic as Fauci is, several pediatricians and infectious disease experts said they wish the pediatric trials would move more quickly. In addition to restoring stability to the education system and parents' work schedules and keeping kids and those around them safe, vaccinating children is essential to helping the country, as a whole, reach herd immunity and decrease the threat of new variants.

Otherwise, “we're going to have tens of millions of individuals in our communities that are able to maintain the virus. And when that happens, what that allows is for these unusual variants to emerge that may have the ability to evade our immunity," said Dr. Buddy Creech, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program.

Despite the need, Pfizer is the only manufacturer whose pediatric vaccine trials are far enough along to potentially have data on elementary-school age children by the end of the summer.

Pfizer has finished enrolling participants in its study of 12- to-15-year-olds and anticipates having data in “the early part of 2021," according to a spokeswoman. “From there, we will plan to finalize our study in 5-11 year olds," she added. As Pfizer completes its trials in adolescents, then 5- to 11-year-olds, it'll need to submit the data to the Food and Drug Administration for review and get authorization for the vaccine's use in those age groups before it's available; currently in the U.S., the vaccine is indicated only for those ages 16 and up.

Moderna is still enrolling participants in its trial for adolescents ages 12 to 18, and it is “on track to provide updated data around mid-year 2021," the company said in an emailed statement. Stéphane Bancel, Moderna's chief executive officer, has said that the company's goal is to have data from the adolescent study in advance of the 2021 school year. Moderna said it'll begin an age de-escalation study in children ages 11 years to 6 months this year, but Bancel has said that the company doesn't expect clinical data until 2022.

Johnson and Johnson hasn't started any pediatric studies yet. “We are in discussions with regulators and partners regarding the inclusion of pediatric populations in our development plan," a spokesman said. Novavax, similarly, hasn't begun any trials in children, and a company spokeswoman said it couldn't share any details at this time. The University of Oxford, which partnered with AstraZeneca in developing a vaccine, will begin tests in 12- to 18-year-olds next month, according to Bloomberg News.

The American Academy of Pediatrics has been “really advocating to try and make these trials happen with the same urgency that they happen for adults," said Dr. Sean O'Leary, who is vice chair of its committee on infectious diseases.

The manufacturers will need to prove vaccines are safe and effective in younger bodies. The adult trials paved much of the way, but researchers still need to study how kids' immune systems react and to confirm the optimal dosage. And even if the shots are authorized by September, there will need to be enough supply on hand in order to get school children immunized before school doors open.

It's essential to act expeditiously, O'Leary said. “I would love to see a vaccine available for all children in time for the next school year."

Why It's Important to Vaccinate Kids

Early on in the pandemic, some thought that children might be entirely immune. That's clearly been disproven. Out of more than 20 million U.S. cases where age information is available, about 2.2 million, or 11 percent, have been in children under 18. Some get very ill, though this is rare. As of February 8, the Centers for Disease Control and Prevention has tracked more than 2,000 cases of what's known as multisystem inflammatory syndrome in children (MIS-C), a serious condition associated with COVID-19 that can result in cardiac dysfunction and kidney injury; 37 percent of the cases recorded were in Latino children and 32 percent in Black children.

It's also become evident that children are capable of transmitting the virus to some extent. On one hand, kids aren't super-spreaders: COVID-19 is clearly dissimilar to influenza or the common cold virus, Vanderbilt's Creech pointed out. “You put one of those in a classroom, then in a few days, it's overrun," he said. “That's not what we see with COVID." But exactly how infectious children are remains somewhat unclear, in part because schools have not been fully open, making it hard to gather data, said Dr. Yvonne Maldonado, a pediatrician and professor of global health and infectious diseases at Stanford University. Studies from other countries, while informative, may not always extrapolate well to the U.S., she added.

So while the “preponderance of data" points to children being less likely to infect people when compared with adults, “they certainly do," said O'Leary, who is also a professor of pediatrics at the University of Colorado School of Medicine. “So, if you've got vulnerable people in the household and your seven-year-old comes home with COVID, it's not to say they can't give it to anybody else. They absolutely can. It's just a bit less likely."

It's important to note that the vaccines have only been proven — so far — to prevent disease and not infection (data on that is harder to gather and takes longer to prove), which means it's not guaranteed yet that vaccinated individuals can't spread the coronavirus.

But there are some inklings of hope that vaccination can at least reduce onward transmission. So if this bears out, the more people who are vaccinated in a community, including children, the more likely transmission will drop overall.

“Our current chaos about children not being in schools is just terrible for children, and I think a lot of the concern would be assuaged if children were immunized," said Dr. Sarah Long, professor of pediatrics at the Drexel University College of Medicine. “That doesn't mean to me that they can't get the infection or transmit it every once in a while, but it would reduce those possibilities tremendously."

Long is also a member of the CDC's Advisory Committee on Immunization Practices, where she has been reviewing the trial data and helping to make recommendations on how the vaccines should be used. She continued: “There are real virus control reasons, there are real societal reasons and there are economic reasons, because if children can't go to school, people can't work."

O'Leary said children as young as 6 months, which is the youngest age that Moderna plans to test, can get vaccinated so long as trial data shows the vaccines to be safe and effective. Infants under 6 months are likely to be protected by antibodies transferred through the placenta if the pregnant mother is vaccinated, he added.

How Vaccines Will Be Studied In Kids

The pediatric vaccine trials will not be as large as the final stage adult trials, which enrolled 30,000 or more participants, giving a placebo to half and the vaccine to half. Pfizer's 12- to 15-year-old study has enrolled 2,259 participants and Moderna's adolescent trial is a similar size, aiming for about 3,000 participants. In both trials, some teens will receive a placebo.

That's enough to prove safety and benefit, experts said, in part, because the adult trials have already paved the way. To show the vaccine is safe, among the many things that Pfizer is tracking includes the percentage of participants reporting “local" reactions such as pain at the injection site, redness and swelling, as well as the percentage of participants reporting systemic reactions such as fever, headache, chills, vomiting, diarrhea, muscle pain and joint pain.

After the trials are completed, tracking for any safety issues will continue in the real world as physicians and patients will be encouraged to report to the FDA and CDC any side effects they think may be due to the vaccine.

Doctors said they'd want to make sure that there are no signs that the vaccine overinflames the immune system or causes any allergic or autoimmune responses. “I think most people that are developing these vaccines feel like the vaccine is not going to trigger MIS-C, but it's something that will be monitored for very closely both in the trials and more importantly, post-licensure," added O'Leary, from the University of Colorado. Maldonado said she'll also be on the lookout for any cases of Guillain-Barré syndrome, which is often a concern when it comes to vaccines, but she noted that no significant increases in cases were seen in any of the adult trials.

When it comes to proving benefit, the pediatric trials will focus on a different metric than the adult trials. The adult trials' primary efficacy measure was to compare how many vaccinated people wound up sick with COVID-19 symptoms compared with those who received the placebo and whether the vaccine impacted the severity of illness. Since children rarely are hospitalized due to COVID-19, the vaccine's ability to reduce severe cases would be hard to measure unless the trials enrolled an enormous number of children.

Instead, Pfizer's and Moderna's adolescent trials will focus on evaluating participants' immune response by measuring antibodies, according to Pfizer's spokeswoman and Moderna's clinical trial website.

Scientists haven't yet identified an “immune correlate of protection," which is usually defined to be the level of antibodies in the blood at which they can feel confident that a person is going to be protected from infection. Some vaccines that have been approved, like the one for measles, have an immune correlate of protection identified, while others don't.

In the absence of a definitive immune correlate of protection, the trials would compare antibody levels in children with those found in adults and extrapolate that the efficacy should then be similar. The FDA and advisory groups like the CDC's Advisory Committee on Immunization Practices would then need to discuss whether the evidence is compelling. If scientists are able to identify an immune correlate of protection, however, “and you can demonstrate that kids get that with the vaccine, that's even more satisfying," O'Leary said.

One final difference in pediatric studies is the potential for lower doses. Moderna has said that it will run its studies of children under 12 testing lower doses first.

“As we go down in age, we give the smallest possible dose of vaccine that we think is reasonable, and then we steadily increase until that point when we get that magic 'Goldilocks' level at which it works great and the side effects are tolerable," Vanderbilt's Creech explained. “I don't think one dose fits all."

A Call To Speed Pediatric Trials

Some pediatricians and infectious disease experts said they were eager for pediatric studies to move faster.

“My understanding is that the entity formerly known as Operation Warp Speed had a lot of involvement with those adult trials, but with pediatric clinical trials, they're not having the same degree of involvement," O'Leary said. “So it's more up to the manufacturers, and from my perspective, these manufacturers don't have the financial incentive to conduct these trials with the same urgency that they did with the adult trials."

Stanford's Maldonado added that she's concerned that there's not as much pressure on the manufacturers to recruit children of diverse backgrounds as there was for the adult trials.“I think it's important to get those kids in to understand factors around the actual vaccine and also to get buy-in of those communities where we're seeing more hesitancy. We want to make sure they are feeling comfortable about being represented," she said.

While O'Leary is not as confident as Fauci that we'll see Pfizer's data on younger kids by September, he feels very optimistic about the availability of a vaccine in the coming months for kids as young as 12, who tend to get sicker than the younger age group.

“I think that's a really big deal," he said.

Biden Now Delivering Vaccines At Ten Times Rate Promised By Trump

Reprinted with permission from American Independent

More than two million coronavirus vaccine doses were administered each day over the past weekend, as the Biden administration ramped up the inoculation process. That is more than 10 times the pace Donald Trump promised during his unsuccessful 2020 presidential campaign.

According to the New York Times tracker, 2,218,752 doses of the vaccine were given out on Saturday and 2,172,973 on Sunday. This has raised the daily average to about 1.4 million a day.

This increased pace has been a priority for President Joe Biden and his team — and puts them well ahead of his stated promise of "100 million Covid-19 shots in the arms of the American people" in his first 100 days in office. He has since upped his goal to 150 million doses in that time.

Trump made a big deal of his administration's "Operation Warp Speed" effort to help some pharmaceutical companies develop coronavirus vaccines. He lavished praise on himself, predicting in December that, "Years from now, they'll be talking about it, they'll be talking about this great, great thing that we did with the vaccines. A truly unprecedented, amazing medical miracle."

But his administration did little to prepare to actually distribute the vaccinations. "The process to distribute the vaccine, particularly outside of nursing homes and hospitals out into the community as a whole, did not really exist when we came into the White House," Biden White House chief of staff Ron Klain told NBC News last month.

In fact, during his first debate against Biden, Trump set a goal that was actually less than one-tenth of the weekend's pace.

"Well, we're going to deliver it right away. We have the military all set up. Logistically, they're all set up. We have our military that delivers soldiers and they can do 200,000 a day," he boasted. "They're going to be delivering. It's all set up."

At that rate, vaccinating 330 million Americans with the two-dose regimen would have taken about nine years.

Trump's administration later upped its goal to 20 million doses in 2020 — a goal they did not come close to meeting.

So far, more than 31.5 million Americans have received the first dose of either the Moderna or Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention. More than 9.1 million of those have already received the second dose as well.

A previous version of this story said President Joe Biden's new goal for vaccinations in his first 100 days of office is 1.5 million. It is actually 150 million vaccinations, up from 100 million.

Published with permission of The American Independent Foundation.