Pfizer says its COVID-19 vaccine is safe, effective in kids ages 5 to 11

https://thehill.com/policy/healthcare/572967-pfizer-says-its-covid-19-vaccine-is-safe-effective-in-kids-ages-5-to-11

COVID vaccine for kids 5-11: Pfizer says low dose safe, effective

Pfizer on Monday announced that testing showed that its COVID-19 vaccine was “safe” and “well tolerated” by children ages 5 to 11 and “robust neutralizing antibody responses” were observed.

The pharmaceutical company said that a “favorable safety profile” had been observed in its trial of the vaccine among children under the age of 12. For its trial, the company used doses a third of what is administered to people ages 12 and up.

“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer CEO Albert Bourla said.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the [Food and Drug Administration (FDA)] and other regulators with urgency,” he added.

Pfizer’s trial included 2,268 participants between the ages of 5 and 11. According to the company, the doses resulted in side effects comparable to what was observed among the trial for patients ages 16 to 25. It also said that it expects to include its results in an upcoming submission to the FDA for emergency use authorization.

In the U.S., no COVID-19 vaccines have been approved for children under the age of 12, leaving many children and the adults who are in close proximity to them particularly vulnerable during the most recent surge brought on by the delta variant.

National Institute of Health Director Francis Collins on Sunday said he believed parents and teachers should be placed in the same category as health care workers in terms of COVID-19 risk, due to their close contact with children who are ineligible to be vaccinated.

In August, the number of pediatric hospitalizations in the U.S. due to COVID-19 reached a record high of nearly 2,000. While children are generally believed to be less likely to develop severe cases of the coronavirus, new variants continue to pose the potential threat of causing more severe symptoms.

This announcement comes shortly after an advisory panel for the FDA voted last week in favor of recommending a third dose of the Pfizer-BioNTech vaccine for people over 65 and in certain high-risk groups. The panel voted against administering a third dose to all vaccine-eligible people.

According to the Centers for Disease Control and Prevention, nearly 75 percent of the eligible population — ages 12 and up — has received at least one dose of a COVID-19 vaccine. Around 64 percent of those over the age of 12 are fully vaccinated.

20 Years Since 9/11: Why the U.S. Should Vaccinate the World

When will a coronavirus vaccine be ready? | Coronavirus | The Guardian

Earlier this week, David States and Bill Gardner argued that the U.S. should lead the developed nations in a program to immunize the entire human population. The Washington Post reported that President Biden is expected to call for a global vaccine summit conference.

David and Bill wrote that we should do this because it would save many lives. Perhaps this is all that needs to be said. We also argued that the U.S. stood to benefit if we could substantially reduce the number of global covid cases. This would reduce U.S. coronavirus exposure and slow the rate of evolution of new coronavirus variants. The economic cost to the U.S. of a more severe pandemic could easily be greater than the cost of making and distributing the vaccine. If so, the global vaccination effort would pay for itself.

There is, however, another moral argument for global vaccination, this one tied to 9/11 and the ensuing global war on terror. Since 9/11, the U.S. has engaged in 20 years of warfare in countries across the world.

The consequences of that war have been catastrophic. According to the Watson Institute at Brown University,

At least 801,000 people have been killed by direct war violence in Iraq, Afghanistan, Syria, Yemen, and Pakistan… The U.S. post-9/11 wars have forcibly displaced at least 38 million people in and from Afghanistan, Iraq, Pakistan, Yemen, Somalia, the Philippines, Libya, and Syria. This number exceeds the total displaced by every war since 1900, except World War II.

Of course, much of that violence was committed by al-Qaeda, ISIS, or the Syrian government. Some of the civil wars that have followed 9/11 might have happened anyway. Nevertheless, Americans failed to limit their 9/11 response to the specific individuals who carried out the attacks. This was a principal cause of the ensuing death and displacements.

So now, the U.S. is known not only for baseball and democracy but also for drone strikes and torture. If we led an effort to vaccinate the world, it would be one of the largest humanitarian actions in history. We should do this to set an example and balance the effects of the global war on terror.

CommonSpirit Health mandates COVID-19 vaccination for employees in 21 states

About Us | Serving the Common Good | CommonSpirit Health

CommonSpirit Health is requiring full COVID-19 vaccination for its 150,000 employees, the Chicago-based health system said Aug. 12. 

The requirement applies to employees at CommonSpirit’s 140 hospitals and more than 1,000 care sites and facilities in 21 states. It includes physicians, advanced practice providers, volunteers and others caring for patients at health system facilities. 

“As healthcare providers, we have a responsibility to help end this pandemic and protect our patients, our colleagues and those in our communities —  including the most vulnerable among us,” Lloyd H. Dean, CEO of CommonSpirit, said in a news release. “An abundance of evidence shows that the vaccines are safe and highly effective. Throughout the pandemic we have made data-driven decisions that will help us best fulfill our healing mission, and requiring vaccination is critical to maintaining a safe care environment.”

The compliance deadline for the vaccination requirement is Nov. 1, although the implementation date will vary by region in accordance with local and state regulations. Employees who are not in compliance and do not obtain a medical or religious exemption risk losing their jobs.

How a Vaccine Slowed the Spread of Chicken Pox

How a Vaccine Slowed the Spread of Chicken Pox - HISTORY
The highly contagious disease dates to ancient times and spread easily in households and classrooms—until the development of a vaccine.

Chickenpox is a highly contagious disease caused by the varicella-zoster virus that leads to itchy skin eruptions, which are sometimes compared to a “dew drop on a rose petal.” 

Until the development of a chickenpox vaccine in the late 20th century, the disease was a common childhood illness that could cause serious health problems in people who didn’t contract the disease until adulthood. More than four million people got chickenpox every year in the United States, resulting in more than 10,000 hospitalizations and 100 deaths. Since vaccinations began, those numbers dropped significantly.

The CDC reports that fewer than 350,000 people contract the disease per year, and that there are fewer than 1,700 hospitalizations and 20 deaths annually from chickenpox.

Where Did Chicken Pox Come From?

There’s evidence of chickenpox dating back to ancient times, and the earliest known use of the term “chickenpox” dates to 1691—although it’s not clear how it got this name. It’s believed the disease was brought to the Americas in the 15th century by European explorers and settlers. Once on the continent, it (and other diseases) spread among Native Americans since Indigenous people had not previously been exposed to the virus.

Before the 18th century, diseases that appeared to produce “pox,” or skin eruptions, were commonly lumped together. This included chickenpox, smallpox and syphilis, which was known as “large pox” or the “great pox.” The first scientist to provide a detailed description of chickenpox differentiating it from smallpox was the English physician William Heberden. In 1767, he noted the physical differences between the two diseases, and also recorded that people who’d had chickenpox “were not capable of having it again.”

It wasn’t until later that scientists realized chickenpox was related to shingles. In the late 19th and early 20th centuries, Hungarian pediatrician James von Bokay observed several instances in which younger people seemed to contract chickenpox after being exposed to someone with shingles, a disease that can cause nerve damage if not treated properly. This led him to suggest that there was a link between the two diseases.

Scientists later confirmed this theory by discovering that after a person recovers from chickenpox, the varicella-zoster virus stays in his or her body, and can cause the person to develop shingles later on. 

Chicken Pox Virus Is ID’d in the 1950s

In the 1950s, scientists isolated the varicella-zoster virus for the first time, paving the way for efforts to vaccinate against chickenpox and shingles. After that, it took several decades to develop and distribute vaccines for these illnesses. The U.S. Food and Drug Administration approved the first chickenpox vaccine in 1995 and the first shingles vaccine in 2006.

Compared to other childhood vaccines, the chickenpox vaccine was a relatively late development. Maurice Hilleman, who helped develop a measles vaccine in the 1960s, had also tried to push for a chickenpox vaccine around that time. However, diseases ended up receiving higher priority depending on the rate of death and disability associated with them, writes epidemiologist René Najera, editor of The History of Vaccines, an online resource by The College of Physicians of Philadelphia, in an email to HISTORY.

“As a result, chickenpox fell toward the bottom of the list because it is a relatively mild disease in children,” he says. As new vaccines helped control more severe childhood diseases, chickenpox moved higher up on the list.

Contagiousness of Chickenpox

The CDC estimates that a person with chickenpox can spread it to up to 90 percent of the people with whom they come into contact who haven’t previously had chickenpox or the vaccine. In addition, the period in which a person is contagious lasts for several days. It begins one or two days before the chickenpox eruptions begin to show, and lasts until all the fluid-filled skin lesions have scabbed over. Typically, chickenpox lasts for 4 to 7 days.

Before the vaccine, chickenpox spread easily in households and classrooms, and was especially dangerous for adults who had never had it. Both children and adults may experience fever, fatigue and body aches with chickenpox, but in adults these symptoms can be more severe. Adults are 25 percent more likely than children to die from chickenpox, according to the National Foundation for Infectious Diseases. The disease can lead to health complications like bacterial infections, swelling of the brain and pneumonia.

Although the chickenpox vaccine has greatly slowed the spread of the disease in schools, outbreaks occur in some parts of the United States where parents have declined to vaccinate their children. This is similar to the way that childhood diseases like measles, which went from common to uncommon in the late 20th century, began to break out in schools again in the 21st century.

Still, with the widespread adoption of the chickenpox vaccine, the disease “has joined polio and measles in the list of infectious diseases that are candidates for eradication,” Najera says. So far, the only human disease that vaccines have globally eradicated is smallpox, but scientists and doctors hope to one day add more to the list of diseases that have been vanquished by vaccines.

Benjamin Franklin’s fight against a deadly virus: Colonial America was divided over smallpox inoculation, but he championed science to skeptics

Benjamin Franklin's fight against a deadly virus: Colonial America was divided  over smallpox inoculation, but he championed science to skeptics

Exactly 300 years ago, in 1721, Benjamin Franklin and his fellow American colonists faced a deadly smallpox outbreak. Their varying responses constitute an eerily prescient object lesson for today’s world, similarly devastated by a virus and divided over vaccination three centuries later.

As a microbiologist and a Franklin scholar, we see some parallels between then and now that could help governments, journalists and the rest of us cope with the coronavirus pandemic and future threats.

Smallpox strikes Boston

Smallpox was nothing new in 1721. Known to have affected people for at least 3,000 years, it ran rampant in Boston, eventually striking more than half the city’s population. The virus killed about 1 in 13 residents – but the death toll was probably more, since the lack of sophisticated epidemiology made it impossible to identify the cause of all deaths.

What was new, at least to Boston, was a simple procedure that could protect people from the disease. It was known as “variolation” or “inoculation,” and involved deliberately exposing someone to the smallpox “matter” from a victim’s scabs or pus, injecting the material into the skin using a needle. This approach typically caused a mild disease and induced a state of “immunity” against smallpox.

Even today, the exact mechanism is poorly understood and not much research on variolation has been done. Inoculation through the skin seems to activate an immune response that leads to milder symptoms and less transmission, possibly because of the route of infection and the lower dose. Since it relies on activating the immune response with live smallpox variola virus, inoculation is different from the modern vaccination that eradicated smallpox using the much less harmful but related vaccinia virus.

The inoculation treatment, which originated in Asia and Africa, came to be known in Boston thanks to a man named Onesimus. By 1721, Onesimus was enslaved, owned by the most influential man in all of Boston, the Rev. Cotton Mather.

etching of an 18th century man in white wig
Cotton Mather heard about variolation from an enslaved West African man in his household named Onesimus. Bettman via Getty Images

Known primarily as a Congregational minister, Mather was also a scientist with a special interest in biology. He paid attention when Onesimus told him “he had undergone an operation, which had given him something of the smallpox and would forever preserve him from it; adding that it was often used” in West Africa, where he was from.

Inspired by this information from Onesimus, Mather teamed up with a Boston physician, Zabdiel Boylston, to conduct a scientific study of inoculation’s effectiveness worthy of 21st-century praise. They found that of the approximately 300 people Boylston had inoculated, 2% had died, compared with almost 15% of those who contracted smallpox from nature.

The findings seemed clear: Inoculation could help in the fight against smallpox. Science won out in this clergyman’s mind. But others were not convinced.

Stirring up controversy

A local newspaper editor named James Franklin had his own affliction – namely an insatiable hunger for controversy. Franklin, who was no fan of Mather, set about attacking inoculation in his newspaper, The New-England Courant.

frontpage of a 1721 newspaper
From its first edition, The New-England Courant covered inoculation. Wikimedia Commons

One article from August 1721 tried to guilt readers into resisting inoculation. If someone gets inoculated and then spreads the disease to someone else, who in turn dies of it, the article asked, “at whose hands shall their Blood be required?” The same article went on to say that “Epidemeal Distempers” such as smallpox come “as Judgments from an angry and displeased God.”

In contrast to Mather and Boylston’s research, the Courant’s articles were designed not to discover, but to sow doubt and distrust. The argument that inoculation might help to spread the disease posits something that was theoretically possible – at least if simple precautions were not taken – but it seems beside the point. If inoculation worked, wouldn’t it be worth this small risk, especially since widespread inoculations would dramatically decrease the likelihood that one person would infect another?

Franklin, the Courant’s editor, had a kid brother apprenticed to him at the time – a teenager by the name of Benjamin.

Historians don’t know which side the younger Franklin took in 1721 – or whether he took a side at all – but his subsequent approach to inoculation years later has lessons for the world’s current encounter with a deadly virus and a divided response to a vaccine.

Independent thought

You might expect that James’ little brother would have been inclined to oppose inoculation as well. After all, thinking like family members and others you identify with is a common human tendency.

That he was capable of overcoming this inclination shows Benjamin Franklin’s capacity for independent thought, an asset that would serve him well throughout his life as a writer, scientist and statesman. While sticking with social expectations confers certain advantages in certain settings, being able to shake off these norms when they are dangerous is also valuable. We believe the most successful people are the ones who, like Franklin, have the intellectual flexibility to choose between adherence and independence.

Truth, not victory

etching of Franklin standing at a table in a lab
Franklin matured into a well-known scientist and statesman, with many successes aided by his open mind. Universal History Archive/Universal Images Group via Getty Images

What happened next shows that Franklin, unlike his brother – and plenty of pundits and politicians in the 21st century – was more interested in discovering the truth than in proving he was right.

Perhaps the inoculation controversy of 1721 had helped him to understand an unfortunate phenomenon that continues to plague the U.S. in 2021: When people take sides, progress suffersTribes, whether long-standing or newly formed around an issue, can devote their energies to demonizing the other side and rallying their own. Instead of attacking the problem, they attack each other.

Franklin, in fact, became convinced that inoculation was a sound approach to preventing smallpox. Years later he intended to have his son Francis inoculated after recovering from a case of diarrhea. But before inoculation took place, the 4-year-old boy contracted smallpox and died in 1736. Citing a rumor that Francis had died because of inoculation and noting that such a rumor might deter parents from exposing their children to this procedure, Franklin made a point of setting the record straight, explaining that the child had “receiv’d the Distemper in the common Way of Infection.”

Writing his autobiography in 1771, Franklin reflected on the tragedy and used it to advocate for inoculation. He explained that he “regretted bitterly and still regret” not inoculating the boy, adding, “This I mention for the sake of parents who omit that operation, on the supposition that they should never forgive themselves if a child died under it; my example showing that the regret may be the same either way, and that, therefore, the safer should be chosen.”

A scientific perspective

A final lesson from 1721 has to do with the importance of a truly scientific perspective, one that embraces science, facts and objectivity.

19th-century photo of a smallpox patient
Smallpox was characterized by fever and aches and pustules all over the body. Before eradication, the virus killed about 30% of those it infected, according to the U.S. Centers for Disease Control and Prevention. Sepia Times/Universal Images Group via Getty Images

Inoculation was a relatively new procedure for Bostonians in 1721, and this lifesaving method was not without deadly risks. To address this paradox, several physicians meticulously collected data and compared the number of those who died because of natural smallpox with deaths after smallpox inoculation. Boylston essentially carried out what today’s researchers would call a clinical study on the efficacy of inoculation. Knowing he needed to demonstrate the usefulness of inoculation in a diverse population, he reported in a short book how he inoculated nearly 300 individuals and carefully noted their symptoms and conditions over days and weeks.

The recent emergency-use authorization of mRNA-based and viral-vector vaccines for COVID-19 has produced a vast array of hoaxes, false claims and conspiracy theories, especially in various social media. Like 18th-century inoculations, these vaccines represent new scientific approaches to vaccination, but ones that are based on decades of scientific research and clinical studies.

We suspect that if he were alive today, Benjamin Franklin would want his example to guide modern scientists, politicians, journalists and everyone else making personal health decisions. Like Mather and Boylston, Franklin was a scientist with a respect for evidence and ultimately for truth.

When it comes to a deadly virus and a divided response to a preventive treatment, Franklin was clear what he would do. It doesn’t take a visionary like Franklin to accept the evidence of medical science today.

FDA authorizes Pfizer coronavirus vaccine for adolescents 12 to 15 years old

https://www.washingtonpost.com/health/2021/05/10/coronavirus-vaccine-for-kids/?fbclid=IwAR0RKJNrlP3TiTDrvPuczKSHIPmTRds8kdAepwOCSqlrzdDHgGcm9vlBYk8

FDA authorizes Pfizer COVID-19 vaccine in adolescents 12 and up

The Food and Drug Administration cleared the first coronavirus vaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.

The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.

“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”

Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.

In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.

Children rarely suffer serious bouts of covid-19, the illness caused by the coronavirus. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total. But that exceeds the number of children who die in a bad flu season.

Children appear to be less efficient at spreading the virus, although their role in transmission is still not fully understood — another reason for pediatric vaccinations.

Clinicians also worry that with a new virus with many unknowns, the possibility exists for long-term impacts of infection, even from the mild or asymptomatic courses of illness common among children.

The Pfizer-BioNTech vaccine, already authorized for adolescents 16 and older, was the first to be tested in younger adolescents. The FDA’s decision will provide a potential path for other vaccine-makers to follow, most of which have launched or plan to initiate trials of their vaccines in teenagers and younger children.

The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults. Researchers took blood samples and measured antibody levels triggered by the shots and foundstronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.

Robert W. Frenck Jr., the researcher who led the adolescent trial at Cincinnati Children’s Hospital Medical Center, said the study was designed to test whether it triggered immune responses, not whether it prevented disease. But because of the number of children who became ill in the placebo arm of the trial, it also became evident the vaccine offered robust protection.

“That really points out how much covid there is in the adolescent community,” Frenck said.

The data has not been published or peer-reviewed, but Kathryn M. Edwards, a pediatric infectious-disease specialist at Vanderbilt University Medical Center, said the results announced by Pfizer were “pretty exciting — it looked very effective and the immune responses were really good.”

Edwards said she is comfortable the benefits of vaccinations are clear among teens, noting that while children, in general, are at lower risk of severe covid-19 than adults, older adolescents seem to be more like adults in their risk for covid-19 than the very youngest children.

Audrey Baker, 15, and Sam Baker, 12, rolled up their sleeves for shots in the Pfizer-BioNTech trial at Cincinnati Children’s Hospital Medical Center. Audrey said she had no hesitation about signing up, and misses little things about how life used to be — eating out in restaurants and seeing family.

“I just trusted the science,” Audrey said. “I knew it was tested in adults. I was really just joining, hoping that maybe I could get vaccinated and help out science.”

Sam said he was more hesitant, in part because participating meant many follow-up lab tests. But he decided to do it and thinks he may have gotten the vaccine in the trial because he developed a headache and fever after his second dose.

Their mother, Rachel Baker, said she felt relief because of Sam’s symptoms.

The biggest benefit has been that I feel a weight off my shoulders,” Rachel said. “We haven’t changed how we do anything. … We’re still masking, we’re still social distancing, but we’re a bit calmer about it all.”

H. Cody Meissner, a pediatrician at Tufts Medical Center and a member of an external advisory committee to the FDA, said he thinks a pediatric vaccine is needed. But he said he would like to see more safety data because the messenger RNA technology at the core of vaccines from Pfizer-BioNTech and the biotechnology company Moderna does not have a long, established safety record, and its first large-scale use began in December.

Meissner abstained from the December vote that overwhelmingly recommended authorization of the Pfizer-BioNTech vaccine for people 16 and older, because he thought the vaccine should be authorized in people 18 and older.

“For those who are eager to get it, it’s important for them to understand that this is very rarely a severe disease in young adolescents, number one, and this is an entirely new vaccine,” Meissner said. “I just don’t want people to get too swept up in fear of hospitalization and death from covid-19 for the first few decades of life.”

But many other physicians take comfort knowing that 250 million shots of messenger RNA vaccine have been given in the United States alone. Serious side effects, such as a risk of anaphylaxis, are extremely rare. Because the trial in teens was an “immune bridging” trial designed to test whether the vaccine triggered immune responses similar to those in adults, researchers did not need to recruit tens of thousands of people to see if those who received a vaccine were protected against illness. The immune bridging technique is commonly used to expand access to vaccines that have been proved effective and safe to adolescents or other populations.

The expansion of eligibility to children will probably ignite debates in families about when to get vaccinated, and among policymakers about whether it should be required.

Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, said she thinks it is unlikely children will be mandated to receive a coronavirus shot until the vaccines win full approval and not just emergency use authorization.

She predicted that acceptance of the vaccine will evolve as more children are vaccinated and depend on the state of the pandemic. She noted that when vaccines are introduced, the rollout often starts slowly before accelerating.

“Nervousness about a new vaccine is normal, especially when it’s for kids,” Reiss said. “Parents that are nervous now might feel different in a few months, once their friends’ kids have gotten vaccinated. And the views of the kids are also going to matter — if teens are going to think this is going to make their lives easier.”

Opening up vaccinations to children may sharpen a debate unfolding globally about the equity of vaccine access. Talaat said that while she can’t wait for her kids to have access to a vaccine, she is troubled by the global inequities as high-risk front-line workers or older people still don’t have access to vaccines in countries where the coronavirus is out of control.

Moderna announced Thursday that an initial analysis of its teen trial found its vaccine was 96 percent effective among participants who received at least one dose. Moderna is in discussions with regulators about the data. Pfizer-BioNTech and Moderna are testing their vaccines in children as young as infants. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.

Trials in younger children are expected to take longer, because researchers must step down gradually in age and determine a safe and effective dose. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said data from tests in children as young as 2 years old may be available by September or October, with data on children as young as 6 months possible by the end of the year.

Within each age category, a separate risk-benefit assessment may take place. In the youngest children, given the low risk from the coronavirus, side effects may figure more prominently into the analysis, for example. Researchers may end up choosing a lower dose of vaccine. The understanding of children’s role in transmission may also evolve and help guide vaccine use and public policy.

“We are proceeding carefully, cautiously,” Edwards said. “We’re using the same rigid guidelines we use in all vaccines, and we take this very seriously. I think as time goes on and more information becomes available, some of the questions may be easier to address.”

WHO classifies triple-mutant COVID-19 variant from India as global health risk

WHO classifies triple mutant COVID-19 variant in India as global health risk  - The Filipino Times

The World Health Organization said Monday that the coronavirus variant first identified in India last year will be reclassified as a “variant of concern,” indicating that it has become a global health threat.

The B.1.617 variant has been found to spread more easily than the original virus, with some evidence indicating that it may evade some of the protections provided by the vaccines, according to a preliminary study. But the shots are still considered effective. The agency will provide more details on Tuesday.

The highly contagious, triple-mutant variant is also the fourth variant to be designated as a global concern, prompting enhanced tracking and analysis. The other variants are those first detected in Britain, South Africa and Brazil.

“We are classifying this as a variant of concern at a global level,” said Maria Van Kerkhove, WHO technical lead on COVID-19, per Reuters. “There is some available information to suggest increased transmissibility.”

A variant is labeled as “of concern” if it is shown to be more contagious, more deadly or more resistant to current vaccines and treatments, according to the WHO.

The global agency said the predominant lineage of B.1.617 was first identified in India in December, although an earlier version was spotted in October 2020.

The variant has already spread to other countries, and many nations – including the U.S. – have moved to end or restrict travel from India.

“Even though there is increased transmissibility demonstrated by some preliminary studies, we need much more information about this virus variant and this lineage and all of the sub-lineages,” said Maria Van Kerkhove, the WHO’s technical lead for COVID-19.

India reported a record-high of daily coronavirus cases, averaging about 391,000 new daily cases and about 3,879 deaths per day, according to Johns Hopkins University data.

More than a year into the pandemic, we’re still figuring out what risks we’re willing to take

Charting the pandemic over the next 12 months — and beyond - STAT

When the Centers for Disease Control and Prevention last week issued guidelines for what vaccinated people can safely do, the agency employed the word “risk” 43 times.

The word often carried a modifier, like so: increased risk, residual risk, low risk, potential risk, minimal risk, higher risk. The CDC did not define “low,” “minimal” or “higher,” instead using broad brushstrokes to paint a picture of post-vaccination life.

For example: “Indoor visits or small gatherings likely represent minimal risk to fully vaccinated people.”

On Wednesday, CDC director Rochelle Walensky said she could not give a definitive answer to what a “small” gathering is, because there are too many variables.

“If we define a small- and medium-sized gathering, we actually also have to define the size of the space that it’s in, the ventilation that is occurring, the space between people. And so, I think we should get back to the the general concepts,” Walensky said.

The situation has left people where they’ve been since the start of the pandemic: forced to play the role of amateur epidemiologist.

In the early days of the pandemic, we wondered if we could catch the coronavirus from a passing jogger and if our groceries, fresh from the store and resting on the kitchen counter, threatened to kill us. Science has attenuated some of our earliest fears. But more than a year into this crisis, we’re still trying to perform complicated risk calculations while relying on contradictory research and shifting CDC guidance.

Risk analysis is not something humans are necessarily good at. We rely on anecdotes more than scientific data. The questions we ask rarely have a simple yes or no answer. Risk tends to be on a sliding scale. Outside of self-isolation, there is no obvious way to drive the risk of viral transmission to zero, nor is risky behavior guaranteed to result in a dire outcome. We have no choice but to live probabilistically.

The risk landscape keeps changing as well. The virus is mutating, and there are many different variants in circulation. Many people are now fully vaccinated, some only partially vaccinated (in between shots, for example), some unvaccinated and some armored with a level of immunity through natural infection. Add the extreme variation in disease severity because of age and underlying conditions, and the risk equations get so long we may run out of chalkboard.

The restrictions imposed by governments have sometimes made little sense. Casinos were open before schools in some states. Mask mandates outdoors remained in place even when indoor dining became permitted.

“It seems to me if we are going to have indoor dining, we should have mask-free jogging,” Harvard epidemiologist Marc Lipsitch said in an email.

One thing that is incontrovertibly true: The coronavirus vaccines are remarkably safe and effective, and people should get vaccinated if possible.

“These are off-the-scale good,” said Amesh Adalja, an infectious-disease doctor and senior scholar at the Johns Hopkins Center for Health Security. “These are much better than vaccines that we rely on every year, like the flu vaccine.”

Even for people sold on vaccines, there remain lingering questions about what is and isn’t safe, and what is and isn’t the proper way to go about daily life in an increasingly vaccinated society. Here, we present some answers, with the caveat that our knowledge of the coronavirus, SARS-CoV-2, is still evolving, as is the virus itself.

Q: Why do I still need to wear a mask after I’m fully vaccinated?

A: You don’t need to wear a mask outdoors when fully vaccinated, except in crowds (such as at a sports stadium or a concert), nor do you have to wear one indoors among other vaccinated people or members of your own household.

But there are situations where you still need to mask up. You could still get infected with the coronavirus, and although it would most likely be mild or asymptomatic, you could transmit the virus to another person. Again, the odds of that happening are low, and there is encouraging data from Israel that suggests vaccinations dramatically reduce community spread.

But remember: A vaccination campaign is not simply about protecting the vaccinated individual. The goal is to build immunity broadly. Moreover, many communities still require masks in public settings — so it’s the law. It’s also polite — you don’t want to make people guess if you’ve been vaccinated or not. That probably will change when infection rates plummet and vaccinations are far more widespread.

“It is also a show of solidarity that we are still in this together,” said Maria Van Kerkhove, technical lead for the World Health Organization’s covid-19 response. “It’s about you and your community, your family, your friends, your workplace, your loved ones. It’s not just about you.”

At some point, viral transmission will plummet. We’re a long way from that point. As long as the virus is circulating in our communities, we need to use what we can to limit the spread and drive down the infection rate.

“Because [the vaccines] are not perfect, that’s precisely why we are urging people to be cautious,” Surgeon General Vivek H. Murthy said in a recent White House covid-19 task force news briefing. “We have great confidence in vaccines. We understood they are not perfect.”

Q: If you’re vaccinated, are you definitely protected against the coronavirus?

A: You’re very likely protected from symptomatic illness. That’s why Adalja, echoing the consensus, said, “These vaccines are something that will change your life.”

In clinical trials, the Pfizer and Moderna vaccines were about 95 percent effective in blocking symptomatic illness after two shots. The one-shot Johnson & Johnson vaccine was not quite as effective but just as good at preventing severe illness and death — which is the highest public health priority in a pandemic like this.

Q: But aren’t there also breakthrough infections?

A: As of April 26, the CDC had documented 9,245 breakthrough infections among fully vaccinated people. But look at the denominator: Those cases were among more than 95 million people. That’s fewer than 1 in 10,000 people vaccinated. (The agency noted that this is probably an undercount because of lack of testing and surveillance.) Of those rare breakthrough cases known to the CDC, 27 percent were asymptomatic and only 9 percent required hospitalization.

Adalja said people need to focus on probabilities and not anecdotes.

“This is kind of a cognitive bias that people have with many kinds of risk. It’s just like when there’s a shark attack in Australia. How much coverage does that get?” he said.

Q: Should people who got the Johnson & Johnson vaccine worry about blood clots?

A: If you notice unusual and serious side effects, such as severe headaches, contact your doctor. But the risk is extremely low. Federal regulators reauthorized the use of the vaccine after a 10-day pause, having found 15 cases of a serious clotting disorder among the 7 million people who had received the vaccine at that time. By any calculation, the risk of a bad vaccine reaction is much less than the risk of getting a serious case of covid-19.

Paul A. Offit, a pediatrician at Children’s Hospital of Philadelphia who is an expert on vaccination, suggests that the Johnson & Johnson coronavirus vaccine suffers from bad timing. Had it been approved first, before the Pfizer and Moderna vaccines, its many virtues would have been celebrated and the rare side effects minimized.

He noted that the Johnson & Johnson vaccine is “refrigerator stable” for up to five weeks. The vaccine is appealing to public health officials because it’s one-and-done and can be more easily deployed in remote locations and in places where recipients are homebound.

Q: How long will natural or vaccine-induced immunity last?

A: No one knows, but the initial evidence is encouraging, said Alessandro Sette, a professor of immunology at the La Jolla Institute for Immunology. A research paper published by Sette and fellow researchers in January showed that 90 percent of people who recovered from a coronavirus infection had robust levels of immunity eight months after they became sick. Immunity did not suddenly drop after eight months — that was merely the limit of the research period.

“Ninety percent having a good immune response also means 10 percent don’t. That is a reason for vaccinating and being careful even if you had the disease,” Sette said.

Immunity post-vaccination also appears durable, and there is less variability in levels of antibodies and other immune system cells following a vaccination than following a natural infection, Sette said.

Because this is a novel disease, and vaccines have not been widely deployed for very long, it is too soon to know how long antibodies will last. But Sette pointed out that the immune system has other weapons against invasive viruses, including “killer T-cells,” which continue to be able to recognize infected cells and kill them, preventing viral replication.

Q: Do the vaccines work against these new virus variants? And shouldn’t we be worried about a new variant that has even scarier, vaccine-evading mutations?

A: The immune response generated by vaccines is sufficiently protective against coronavirus variants to prevent most people from getting seriously ill.

Infectious-disease experts do worry about future mutations that could allow the virus to exhibit vaccine evasion. That said, there are limits to how much the virus can mutate — how much it can change its structure — and still function, according to Sette.

“The virus has to walk a tightrope,” he said. The virus can mutate to escape the effect of a specific antibody, but “it can’t change too much.”

He added, “While the virus has surprised us this year in a number of ways, the data we’ve seen so far does not suggest there’s an infinite number of ways the virus can mutate and escape immune recognition and still be as infectious.”

Q: When will we reach herd immunity?

A: No one knows what level of immunity would throttle virus transmission, and it probably varies from one environment to another and from one season of the year to another. But in the United States, at least, vaccinations have already had an effect. The virus increasingly is slamming into immune-system walls. Eventually, with enough vaccinations, most of the people who get infected will be dead-end alleys for the virus.

The virus appears destined to pop up in smaller outbreaks that could be more easily contained. But the virus won’t disappear, especially because it continues to spread at catastrophic rates in many countries that have low levels of vaccination. The only infectious disease-causing virus ever eradicated is smallpox.

For now, successful navigation of the pandemic may simply mean taking steps to reduce the threat of a serious case of covid-19 (as best as anyone can determine it) to the level of other threats that we typically tolerate, and which don’t tend to keep us awake at night.

Taking a deeper look at vaccine hesitancy

https://mailchi.mp/097beec6499c/the-weekly-gist-april-30-2021?e=d1e747d2d8

The American public’s attitude toward COVID-19 vaccination has evolved rapidly since the end of last year. The share of adults who report they have either already been vaccinated or intend to get the vaccine as soon as possible continues to rise (currently about 62 percent), while the share who say they will “wait and see” continues to shrink (now 17 percent). Importantly, however, the share who say they will either “definitely not” get vaccinated or only do so “if required” (currently 20 percent) has remained stubbornly consistent since December.

As the US reaches a vaccine tipping point, with more COVID vaccines available than people willing to be vaccinated, it will be important to understand this vaccine-hesitant population more clearly. A recent consumer segmentation analysis found that this group falls into four major behavioral profiles, shown on the right side of the graphic above. 

The next phase of vaccine rollout must specifically address the key concerns of individuals in each of these different segments. For example, the “watchful” group, the easiest to persuade, will likely respond to a more transparent vaccination process and the amplification of positive vaccination testimonials. On the other hand, “system distrusters,” generally comprised of younger, lower-income minorities, would benefit most from hearing community leaders discuss vaccine safety. Unfortunately, the largest segment of vaccine-hesitant Americans, the “misinformation believers”, will also be the most difficult to turn. These individuals are more likely to hold rigid, politically driven beliefs.

While countering misinformation by leveraging trusted influencers may help convince some, this group may be the hardest to persuadealthough their participation will be crucial to hitting any goal of “herd immunity” by this fall.

Cartoon – Anti-Vaccine or Pro-Disease?

Vaccine hesitancy among the top 10 global health threats