Changing recommendations for boosters lead to confusion for the vaccinated and their doctors

Author: Carissa Wolf, Frances Stead Sellers, Ashley Cusick, Kim Mueller  1 day ago

Even in Idaho, which has one of the lowest coronavirus vaccination rates in the country, clinics have been gearing up for an onslaught of calls and emails requesting booster shots.

Administrators at the Primary Health Medical Group updated their website Thursday and then set about revising it Friday when government eligibility recommendations for boosters suddenly changed to include workers in high-risk jobs. Even then, the clinic’s chief executive had to figure out which occupations that meant.

“Who’s at high risk? I had to look it up. Is it firemen? I don’t know,” said David Peterman. “This is so confusing to the public and creates mistrust. And we can’t have that right now. Right now, we need the public to say, ‘Let’s get vaccinated.’ And for those that need boosters, we need to say that ‘This is safe, and this is what we need to do.’”

Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings were followed by a dramatic decision Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to go.The deluge of phone calls about booster shots to Primary Health clinics in Southwestern Idaho began weeks ago. On Friday morning, the group’s Garden City clinic, where Maddie Morris fields inquiries, saw an increase in calls, mostly from senior citizens.

“The calls seem pretty nonstop,” the customer service representative said. “It seems like a lot of people are anxious to get a booster.”

Doctors say confusion clouds patients’ willingness to receive boosters. In Idaho, the problem coincides with the primary health-care system’s struggle to meet the demands of the latest covid-19 crush, which earlier this month plunged the state into crisis standards of care — essentially the rationing of health care as demand overwhelms resources.Four patients, two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients

Peterman expects the new booster guidelines to prompt an increase in inquiries just as the number of providers out sick is at an all-time high.

“We went from 40,000 phone calls daily at 21 clinics to 80,000. Eighty thousand! On top of that, we went from maybe 20 of our employees being out a day to 30 to 40,” Peterman said.

“In the next 72 hours, I want [the CDC] to answer our phones,” he said.

Many newly eligible patients are over 65 and not comfortable using the Internet to find information. So the phones keep ringing at Morris’s desk.

“You really can’t take a breather. You just have to jump to the next call,” she said. And Peterman says he has had to ask staffers to take extra shifts and work long into the night to help close the staffing gap.

Much of the muddle stems from legacy systems at the FDA and CDC that were set up to handle routine drug approvals and childhood vaccinations, not a fast-moving public health crisis involving the entire population, said Jay A. Winsten, the founding director of the Center for Health Communications at the Harvard T.H. Chan School of Public Health.

The CDC’s Advisory Committee on Immunization Practices includes infectious-disease specialists, obstetricians and pediatricians who grappled Thursday with questions in which they have no expertise, such as whether offering boosters might undermine public confidence in the vaccines’ efficacy.

“What’s missing from the equation are communication experts,” said Winsten, including specialists in public-opinion polling and behavior change. “They need a seat at the table.”

Health-care providers across the nation have been helping patients for weeks to filter through not just misinformation and disinformation about boosters but also a surfeit of real-time information.

“That’s the biggest problem,” said Clay Marsh, a pulmonary critical care doctor and executive dean for health sciences at West Virginia University. “The amount of information is dizzying,” Marsh said, “It creates chaos.”

Across the New Orleans metropolitan area, new CDC guidelines had failed to trickle down to many administration sites by Friday morning.

The Louisiana National Guard, which helps to run testing and vaccination sites, was still awaiting clarity.

“We are just administering the first and second doses,” said Sgt. Gaynell Leal, a guard spokeswoman. “As far as the booster part of it, that hasn’t come our way yet.”

“The biggest thing is gaining people’s confidence in science,” Leal said. “My civilian job is I’m a funeral director. So I’ve seen this on both sides.”

On the ground, some National Guard-run sites did offer booster shots Friday, but the eligibility benchmarks they used had not yet caught up with the CDC’s latest guidelines.Tracking the coronavirus vaccine

At a drive-through testing and vaccine site in Meraux, La., just east of New Orleans, medics offered booster shots to those who met the requirements laid out on a “self-risk attestation form” issued in mid-August by the Louisiana Department of Health. That form offered a checklist of reasons one might qualify for a third dose, including active cancer treatment, HIV infection, immunodeficiency issues or the use of immunosuppressants. The form did not account for the age or job-related eligibility factors the CDC announced late this week.

In the French Quarter, Tara Thompson, 53, enjoyed a drink in Pirate’s Alley with her husband.

Thompson said that although she took the vaccine to spend time with her elderly parents, she hoped this week’s guidelines would not lead to booster shots soon being pushed on the public.

“I personally don’t want it if I don’t have to have it,” she said. “It’s a matter of trusting the science that seems to be skewed toward the benefit of certain political mind-sets.”

Thompson said she could change her mind if the shots help with travel.

“Or, if the booster shots help Mardi Gras to happen,” she said. “I might consider it then.”

In Chalmette, La., Kerissa Fernandez, 37, wanted more clarity on how the new booster shot guidelines applied to her.

Fernandez, a family nurse practitioner, said she and the staff at the small urgent care clinic she runs with her husband all meet the front-line worker requirement for booster shots. But none of the staffers at the Bayou Urgent Care Clinic had received the Pfizer vaccine, she said.

“I had Moderna. We all got Moderna,” she said. But when the delta variant reached record numbers in Louisiana, she and her husband both ended up with breakthrough infections.

Knowing firsthand the virus’s ability to shape-shift, Fernandez said she and her staff are all eager to get booster shots.

Many newly eligible people say they aren’t waiting for the rules and recommendations to change again. Ann Mackey, 66, qualifies for a booster shot.

“I have a doctor’s appointment next week, so I might see if they can jab me then,” she said from her high-rise apartment in downtown Kansas City, Mo.

The former FDA employee said the government’s conflicting messages have been confusing. She doesn’t understand why she can receive a Pfizer booster, but her friends and family can’t get their third Moderna shot. She is confused about how the government defines “high risk” and who will enforce the newest set of recommendations. And she worries that public confusion will provide another excuse for people to avoid getting their first dose.

“There already is a lot of vaccine hesitancy, and they are just looking for reasons not to get vaccinated,” Mackey said.Americans are sneaking extra coronavirus shots as officials weigh who should get them

Others are considering creative ways to get boosters.

Derek Hoetmer has been following the news closely, hoping he and his wife, a nurse who worked on a covid response team, could get a booster before the Missouri winter.

The problem is that the rules keep changing — and not in the Hoetmers’ favor. They were pleased to wake Friday morning to find the vaccination door had been opened to people in high-risk jobs.

But not wide enough for the Hoetmers, who won’t qualify because their first two doses were Moderna jabs.

With the Missouri winter only two months away, Hoetmer is considering his options. He has heard that other Americans who do not qualify are secretly getting boosters, anyway.

n situation in letter to opposition

Even in Idaho, which has one of the lowest coronavirus vaccination rates in the country, clinics have been gearing up for an onslaught of calls and emails requesting booster shots.© Scott Olson/Getty Images HINES, ILL. – SEPTEMBER 24: Lalain Reyeg administers a coronavirus booster vaccine and an influenza vaccine to Army veteran William Craig at the Edward Hines Jr. VA Hospital on September 24, 2021 in Hines, Ill. (Photo by Scott Olson/Getty Images)

Administrators at the Primary Health Medical Group updated their website Thursday and then set about revising it Friday when government eligibility recommendations for boosters suddenly changed to include workers in high-risk jobs. Even then, the clinic’s chief executive had to figure out which occupations that meant.

“Who’s at high risk? I had to look it up. Is it firemen? I don’t know,” said David Peterman. “This is so confusing to the public and creates mistrust. And we can’t have that right now. Right now, we need the public to say, ‘Let’s get vaccinated.’ And for those that need boosters, we need to say that ‘This is safe, and this is what we need to do.’”

Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings were followed by a dramatic decision Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to get them.

“Everyone is kind of confused,” he said. The current discontent has deep roots. In April, Pfizer chief executive Albert Bourla said a third coronavirus dose was “likely” to be needed. In late July, Pfizer-BioNTech announced that their vaccine’s efficacy waned over time. Data from Israel confirmed a drop. Then, last month, as the delta variant of the coronavirus surged and the World Health Organization decried the distribution of third shots in wealthy countries while poor countries were lacking first doses, President Biden announced that most Americans could begin getting boosters of the Pfizer and Moderna vaccines Sept. 20 — subject to the government’s regulatory processes, which unfolded in recent days and focused only on Pfizer. R22egulators already allowed third shots for the immunocompromised who have received Pfizer or Moderna shots but have not yet made recommendations for all recipients of the Moderna and Johnson & Johnson vaccines.People who got Johnson & Johnson’s coronavirus shot feel left behind in push for boosters

The deluge of phone calls about booster shots to Primary Health clinics in Southwestern Idaho began weeks ago. On Friday morning, the group’s Garden City clinic, where Maddie Morris fields inquiries, saw an increase in calls, mostly from senior citizens.

“The calls seem pretty nonstop,” the customer service representative said. “It seems like a lot of people are anxious to get a booster.”

Doctors say confusion clouds patients’ willingness to receive boosters. In Idaho, the problem coincides with the primary health-care system’s struggle to meet the demands of the latest covid-19 crush, which earlier this month plunged the state into crisis standards of care — essentially the rationing of health care as demand overwhelms resources.Four patients, two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients

Peterman expects the new booster guidelines to prompt an increase in inquiries just as the number of providers out sick is at an all-time high.

“We went from 40,000 phone calls daily at 21 clinics to 80,000. Eighty thousand! On top of that, we went from maybe 20 of our employees being out a day to 30 to 40,” Peterman said.

“In the next 72 hours, I want [the CDC] to answer our phones,” he said.

Many newly eligible patients are over 65 and not comfortable using the Internet to find information. So the phones keep ringing at Morris’s desk.

“You really can’t take a breather. You just have to jump to the next call,” she said. And Peterman says he has had to ask staffers to take extra shifts and work long into the night to help close the staffing gap.

Much of the muddle stems from legacy systems at the FDA and CDC that were set up to handle routine drug approvals and childhood vaccinations, not a fast-moving public health crisis involving the entire population, said Jay A. Winsten, the founding director of the Center for Health Communications at the Harvard T.H. Chan School of Public Health.

The CDC’s Advisory Committee on Immunization Practices includes infectious-disease specialists, obstetricians and pediatricians who grappled Thursday with questions in which they have no expertise, such as whether offering boosters might undermine public confidence in the vaccines’ efficacy.

“What’s missing from the equation are communication experts,” said Winsten, including specialists in public-opinion polling and behavior change. “They need a seat at the table.”

Health-care providers across the nation have been helping patients for weeks to filter through not just misinformation and disinformation about boosters but also a surfeit of real-time information.

“That’s the biggest problem,” said Clay Marsh, a pulmonary critical care doctor and executive dean for health sciences at West Virginia University. “The amount of information is dizzying,” Marsh said, “It creates chaos.”

Across the New Orleans metropolitan area, new CDC guidelines had failed to trickle down to many administration sites by Friday morning.

The Louisiana National Guard, which helps to run testing and vaccination sites, was still awaiting clarity.

“We are just administering the first and second doses,” said Sgt. Gaynell Leal, a guard spokeswoman. “As far as the booster part of it, that hasn’t come our way yet.”

“The biggest thing is gaining people’s confidence in science,” Leal said. “My civilian job is I’m a funeral director. So I’ve seen this on both sides.”

On the ground, some National Guard-run sites did offer booster shots Friday, but the eligibility benchmarks they used had not yet caught up with the CDC’s latest guidelines.Tracking the coronavirus vaccine

At a drive-through testing and vaccine site in Meraux, La., just east of New Orleans, medics offered booster shots to those who met the requirements laid out on a “self-risk attestation form” issued in mid-August by the Louisiana Department of Health. That form offered a checklist of reasons one might qualify for a third dose, including active cancer treatment, HIV infection, immunodeficiency issues or the use of immunosuppressants. The form did not account for the age or job-related eligibility factors the CDC announced late this week.

In the French Quarter, Tara Thompson, 53, enjoyed a drink in Pirate’s Alley with her husband.

Thompson said that although she took the vaccine to spend time with her elderly parents, she hoped this week’s guidelines would not lead to booster shots soon being pushed on the public.

“I personally don’t want it if I don’t have to have it,” she said. “It’s a matter of trusting the science that seems to be skewed toward the benefit of certain political mind-sets.”

Thompson said she could change her mind if the shots help with travel.

“Or, if the booster shots help Mardi Gras to happen,” she said. “I might consider it then.”

In Chalmette, La., Kerissa Fernandez, 37, wanted more clarity on how the new booster shot guidelines applied to her.

Fernandez, a family nurse practitioner, said she and the staff at the small urgent care clinic she runs with her husband all meet the front-line worker requirement for booster shots. But none of the staffers at the Bayou Urgent Care Clinic had received the Pfizer vaccine, she said.

“I had Moderna. We all got Moderna,” she said. But when the delta variant reached record numbers in Louisiana, she and her husband both ended up with breakthrough infections.

Knowing firsthand the virus’s ability to shape-shift, Fernandez said she and her staff are all eager to get booster shots.

Many newly eligible people say they aren’t waiting for the rules and recommendations to change again. Ann Mackey, 66, qualifies for a booster shot.

“I have a doctor’s appointment next week, so I might see if they can jab me then,” she said from her high-rise apartment in downtown Kansas City, Mo.

The former FDA employee said the government’s conflicting messages have been confusing. She doesn’t understand why she can receive a Pfizer booster, but her friends and family can’t get their third Moderna shot. She is confused about how the government defines “high risk” and who will enforce the newest set of recommendations. And she worries that public confusion will provide another excuse for people to avoid getting their first dose.

“There already is a lot of vaccine hesitancy, and they are just looking for reasons not to get vaccinated,” Mackey said.Americans are sneaking extra coronavirus shots as officials weigh who should get them

Others are considering creative ways to get boosters.

Derek Hoetmer has been following the news closely, hoping he and his wife, a nurse who worked on a covid response team, could get a booster before the Missouri winter.

The problem is that the rules keep changing — and not in the Hoetmers’ favor. They were pleased to wake Friday morning to find the vaccination door had been opened to people in high-risk jobs.

But not wide enough for the Hoetmers, who won’t qualify because their first two doses were Moderna jabs.

With the Missouri winter only two months away, Hoetmer is considering his options. He has heard that other Americans who do not qualify are secretly getting boosters, anyway.

“I won’t lie. I’ve thought about that option,” Hoetmer said. “I would rather go about it the right way and not take away someone’s booster shot.”

FDA Issues Warning About Increased Risk Of Heart Inflammation Caused By Moderna Jab

Authors: BY TYLER DURDENMONDAY, AUG 30, 2021 – 02:14 P

Earlier this month, we reported on leaked data from a Canadian study which arrived at a disturbing conclusion: the risk of rare side effects like myocarditis and pericarditis – types of heart inflammation that are potentially deadly in some patients – was at least 2.5x higher in the Moderna jab than in its main competitor, produced by Pfizer-BioNTech.

The leaking of the data to the press was an embarrassment for the FDA and CDC, and so they pledged to investigate. Now, less than two weeks later, the FDA has just announced that it has updated its “fact sheet” to reflect the higher risk of heart inflammation in male patients under the age of 40.

For all patients, the “post-marketing” data examined by the FDA show that the risk of experiencing these side effects is highest within 7 days of receiving the second dose.

Only Pfizer has received full approval from the FDA; the Moderna jab is still technically under the emergency authorization. Whether this will delay or in any way impact the FDA’s approval of the Moderna jab remains unclear.

Here’s the full updated text:

Myocarditis and Pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis

Questions about the link between the mRNA jabs and heart inflammation have been circulating since these side effects were first uncovered in a group of American soldiers reporting acute chest pain after their vaccinations.

The news is weighing on Moderna’s share price, which has fallen substantially since its Aug. 9 peak. It was down more than 3% on Monday afternoon.

Japan probes two deaths after jabs from tainted Moderna batch

Sat, August 28, 2021, 6:10 AM

Japan is investigating the death of two men who received jabs from batches of Moderna’s Covid-19 vaccine suspended from use due to contamination, the health ministry said Saturday.

The men aged 30 and 38 died earlier this month after getting their second Moderna doses from one of three manufacturing lots suspended by the government on Thursday after several vials were found to be contaminated, the ministry said in a statement.

The ministry said the cause of death was still being investigated and “currently, causal relations with the vaccinations are unknown”.- ADVERTISEMENT –

Both men contracted fever after receiving their vaccinations and neither had underlying health conditions or allergic history, the ministry said.

The suspension affects 1.63 million doses of Moderna Covid vaccines, which have been reportedly shipped to over 800 vaccination centres across Japan.

Takeda, which is in charge of sales and distribution of the Moderna shot in Japan, said it received reports from several vaccination centres that “foreign substances” have been found inside unopened vials.

Around 44 percent of Japan’s population has been fully vaccinated, as the country battles a record surge of virus cases driven by the more contagious Delta variant.

Over 15,700 people have died from Covid-19 in the country, and large parts of Japan are under strict virus restrictions.

COVID-19 also attacks the pancreas; one vaccine dose may be enough for those previously infected

Authors: Nancy Lapid February 3, 2021

COVID-19 attacks the pancreas

The new coronavirus directly targets the pancreas, infecting and damaging its insulin producing cells, according to a new study. The findings may help explain why blood sugar problems develop in many COVID-19 patients, and why there have been reports of diabetes developing as a result of the virus. The pancreas has two jobs: production of enzymes important to digestion, and creation and release of the hormones insulin and glucagon that regulate blood sugar levels. In a paper published on Wednesday in Nature Metabolism, researchers report that lab and autopsy studies show the new coronavirus infects pancreas cells involved in these processes and changes their shape, disturbs their genes, and impairs their function. The new data “identify the human pancreas as a target of SARS-CoV-2 infection and suggest that beta-cell infection could contribute to the metabolic dysregulation observed in patients with COVID-19,” the authors conclude. (https://go.nature.com/36Cmtfy)

One vaccine dose might be enough for COVID-19 survivors

COVID-19 survivors might only need one shot of the new vaccines from Moderna Inc and Pfizer/BioNTech, instead of the usual two doses, because their immune systems have gotten a head start on learning to recognize the virus, according to two separate reports posted this week on medRxiv ahead of peer review. In one study of 59 healthcare workers who recovered from COVID-19 and received one of the vaccines, antibody levels after the first shot were higher than levels usually seen after two doses in people without a history of COVID-19. In a separate study, researchers found that 41 COVID-19 survivors developed “high antibody titers within days of vaccination,” and those levels were 10 to 20 times higher than in uninfected, unvaccinated volunteers after just one vaccine dose. “The antibody response to the first vaccine dose in individuals with pre-existing immunity is equal to or even exceeds” levels found in uninfected individuals after the second vaccine dose, the authors of that paper said. “Changing the policy to give these individuals only one dose of vaccine would not negatively impact on their antibody titers, spare them from unnecessary pain and free up many urgently needed vaccine doses,” they said. (https://bit.ly/3je4Zv4; https://bit.ly/2YG0EYf)

Gout drug shows promise for mildly ill COVID-19 patients

Colchicine, an anti-inflammatory drug used to treat gout and other rheumatic diseases, reduced hospitalizations and deaths by more than 20% in COVID-19 patients in a large international trial. COVID-19 patients with mild illness and at least one condition that put them at high risk for complications, such as diabetes or heart disease, received either colchicine or a placebo for 30 days. Overall, the risk of hospitalization or death was statistically similar in the two groups. But among the 4,159 patients whose coronavirus infections had been diagnosed with a gold-standard PCR test, death or hospital admission occurred in 4.6% of those on colchicine versus 60% of those who got a placebo. After taking patients’ other risk factors into account, colchicine was associated with a statistically significant 25% risk reduction, the researchers reported on medRxiv ahead of peer review. Patients taking colchicine also had fewer cases of pneumonia. “Given that colchicine is inexpensive, taken by mouth, was generally safe in this study, and does not generally need lab monitoring during use, it shows potential as the first oral drug to treat COVID-19 in the outpatient setting,” the researchers said. (https://bit.ly/3oDSDgY)

Oxford/AstraZeneca vaccine might work better with doses months apart

Among recipients of the COVID-19 vaccine from Oxford University and AstraZeneca, prolonging the interval between the first and second doses led to better results, researchers said in a paper posted on Monday ahead of peer-review by The Lancet on its preprint site. For volunteers aged 18 to 55, vaccine efficacy was 82.4% with 12 or more weeks between doses, compared to 54.9% when the booster was given within 6 weeks after the first dose. The longest interval between doses given to older volunteers was 8 weeks, so there were no data for the efficacy of a 12-week dosing gap in that group. Europe’s medicine regulator has said there is not enough data to determine how well the vaccine will work in people over 55. Given their findings, the authors say “a second dose given after a three-month period is an effective strategy … and may be the optimal for rollout of a pandemic vaccine when supplies are limited in the short term.”

U.S. probing Moderna vaccine for higher heart inflammation risk – Washington Post

Authors: Reporting by Shubham Kalia in Bengaluru; Editing by Krishna Chandra Eluri and Ramakrishnan M.

Aug 19 (Reuters) – U.S. health officials are investigating reports that Moderna Inc’s (MRNA.O) COVID-19 vaccine may be linked to a higher risk of a rare heart condition in younger adults than previously thought, the Washington Post reported late on Thursday, citing people familiar with the review.

The report quoted a source saying it was too early for the regulators to reach a conclusion, and that additional work was needed before any recommendation was made.

Health regulators in June had added a warning to the literature that accompanies the mRNA vaccines produced by Moderna and Pfizer to flag the rare risk of heart inflammation seen primarily in young males. However, they said the benefit of the shots in preventing COVID-19 continued to outweigh the risks. read more

There might be a 2.5 times higher incidence of myocarditis in those who get the Moderna vaccine compared with Pfizer’s vaccine, the Post quoted a source as saying.

The investigation that is focused on Canadian data suggests that risks of myocarditis might especially be higher for males below the age of 30 or so, according to the report.

Moderna and the U.S. Food and Drug Administration (FDA) did not immediately respond to Reuters’ requests for comment.

No point vaccinating those who’ve had COVID-19: Cleveland Clinic study suggests

Authors: By Dr. Sanchari Sinha Dutta, Ph.D.Jun 8 2021

Scientists from the Cleveland Clinic, USA, have recently evaluated the effectiveness of coronavirus disease 2019 COVID-19) vaccination among individuals with or without a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

The study findings reveal that individuals with previous SARS-CoV-2 infection do not get additional benefits from vaccination, indicating that COVID-19 vaccines should be prioritized to individuals without prior infection. The study is currently available on the medRxiv* preprint server (not peer-reviewed).

Background

In the United States, the US Food and Drug Administration (FDA) has provided emergency use authorization for two mRNA-based COVID-19 vaccines developed by Pfizer/BioNTech and Moderna, which have shown high efficacy against SARS-CoV-2 infection and COVID-19 disease in clinical trials. However, the ability to vaccinate a large part of the global population is limited by vaccine supply.

Further Reading

In order to ensure fair access to vaccines throughout the world, the COVID-19 vaccines Global Access (COVAX) initiative was launched. In many countries, especially those with low socioeconomic status, there is a serious shortage of vaccines. Thus, in order to get the maximum vaccine benefits, the most vulnerable population should be prioritized for the vaccination.

Currently, most countries prioritize vaccination for healthcare and other frontline workers, elderly people, and people with comorbidities.

To further narrow down the prioritization criteria, the scientists in the current study have evaluated the necessity of COVID-19 vaccines for individuals who were previously infected with SARS-CoV-2.

For More Information: https://www.news-medical.net/news/20210608/No-point-vaccinating-those-whoe28099ve-had-COVID-19-Findings-of-Cleveland-Clinic-study.aspx

Evaluation of the safety of mRNA-Moderna in adolescents

Authors: Killian Meara

The vaccine demonstrated an acceptable safety profile in the adolescent population.

A recent study conducted by investigators from the pharmaceutical and biotechnology company, Moderna, has found that their COVID-19 vaccine, mRNA-1273, was both safe and efficacious in preventing COVID-19 in adolescents.

Results from the study were published in The New England Journal of Medicine.

The incidence of COVID-19 in adolescents between the ages of 12 and 17 years was 900 per 100,000 during the time period of April and June of 2021. The aim of the study was to evaluate the safety, efficacy and immunogenicity of the Moderna vaccine in that population.

The ongoing, phase 2-3, placebo-controlled trial randomly assigned healthy adolescents between the ages of 12 and 17 in a 2:1 ratio to receive 2 doses of the vaccine or a placebo, 28 days apart.

The trial included 3,732 participants, of which 2,489 received the therapy and 1,243 received the placebo.

The primary objective was to evaluate the safety of mRNA-1273 in adolescents as compared to that in young adults between the ages of 18 to 25 years. The secondary objectives included an evaluation of the efficacy in preventing either symptomatic or asymptomatic disease.

Findings from the study demonstrated that the most commonly reported adverse reactions in the vaccine group were injection site pain, headache and fatigue. The most commonly reported adverse reactions in the placebo group were similar and no serious adverse events were noted in either group.

Mean ratio of pseudovirus neutralizing antibody titers in the adolescents relative to the young adults was 1.08, with the absolute difference in serologic response being 0.2 percentage points.

There were no reported cases of COVID-19 with an onset of 14 days after the second injection in the vaccine group and 4 cases reported in the placebo group.

“The mRNA-1273 vaccine had an acceptable safety profile in adolescents,” the authors wrote. “The immune response was similar to that in young adults, and the vaccine was efficacious in preventing COVID-19.”

For More Information: https://www.contagionlive.com/view/how-soon-covid-19-vaccine-booster-doses-available-us

CDC Study: Side Effects Of Covid Far More Dangerous Than Any Of Vaccines

The possibility of experiencing a serious adverse effect from the covid shots approved in the U.S. is significantly lower than the chances of severe illness, hospitalization or death from contracting covid, new research from the Centers for Disease Control and Prevention shows. Other studies show covid’s pregnancy impact and vaccine protection against the delta variant.

Bay Area News Group: COVID-19 Far Riskier Than Vaccines, New CDC Study SaysHow risky are the COVID-19 vaccines? A new study by the U.S. Centers for Disease Control and Prevention found that the risk of illness, hospitalization and death following the shots is far lower than the danger from becoming infected with the highly contagious and often deadly virus. Three health threats have surfaced among some vaccinated people: Blood clots and the Guillain-Barre Syndrome neurologic disorder after the Johnson & Johnson shot, and heart inflammation after the Pfizer or Moderna shots, which use a messenger-RNA technology. But the CDC analysis found that the risk in adults from the vaccines to be minimal compared to the virus that causes COVID-19, which has infected 35 million Americans and killed more than 614,000. (Woolfolk, 8/10)

San Francisco Chronicle: Devastating Impact Of COVID On Pregnancy Highlighted By Large UCSF StudyPregnant women infected with the coronavirus are at significantly higher risk for adverse complications, including preterm birth, according to a University of California San Francisco analysis of all documented births in the state between July 2020 and January 2021. In the largest study of its kind, researchers found the risk of very preterm birth, which occurs at less than 32 weeks of gestation, was 60% higher for people infected with the coronavirus during their pregnancy. The risk of giving birth at less than 37 weeks — which is any preterm birth — was 40% higher. (Vaziri, 8/10)

USA Today: Study Showing Antibody Levels Protecting Against COVID-19 Could Speed Creation Of New Vaccines, BoostersEagerly anticipated new research pinpoints antibodies scientists can test for to see if a COVID-19 vaccine is effective. These “correlates of protection” could speed the development of new vaccines or boosters without requiring the enormous clinical trials used to create the first COVID-19 vaccines. Instead, researchers could vaccinate people with a new vaccine or booster, measure their antibodies over the course of several months, and know if it worked. This is “the Holy Grail” in terms of vaccines, and one that hasn’t yet been set for the virus that causes COVID-19, said Peter Gilbert, co-author of the study posted Tuesday to medRxiv, a preprint site where scientific articles can be published prior to being accepted by peer-reviewed journals. (Weise, 8/10)

Reuters: Moderna May Be Superior To Pfizer Against Delta; Breakthrough Odds Rise With TimeThe mRNA vaccine from Pfizer and BioNTech may be less effective than Moderna’s against the Delta variant of the coronavirus, according to two reports posted on medRxiv on Sunday ahead of peer review. In a study of more than 50,000 patients in the Mayo Clinic Health System, researchers found the effectiveness of Moderna’s vaccine against infection had dropped to 76% in July – when the Delta variant was predominant – from 86% in early 2021. Over the same period, the effectiveness of the Pfizer/BioNTech vaccine had fallen to 42% from 76%, researchers said. While both vaccines remain effective at preventing COVID hospitalization, a Moderna booster shot may be necessary soon for anyone who got the Pfizer or Moderna vaccines earlier this year, said Dr. Venky Soundararajan of Massachusetts data analytics company nference, who led the Mayo study. (Aug. 9)

Also —

The Washington Post: Johnson & Johnson Coronavirus Vaccine Recipients Worry They Chose The Wrong Brand New research offers encouraging evidence about how the Johnson & Johnson vaccine stacks up against its competitors — and the delta variant — according to infectious-disease specialists. However, there are still lingering questions about booster shots. Earlier clinical trials showed the Johnson & Johnson vaccine was 66 percent effective overall in preventing moderate to severe disease four weeks after the shot, with effectiveness varying depending on location. Its competitors from Pfizer and Moderna, on the other hand, recorded 90 percent-plus effectiveness against the coronavirus. Anthony S. Fauci, the nation’s leading infectious-disease expert, has said all three vaccines are effective. (Beachum, Bever and Iati, 8/10)

CIDRAP: Viral COVID-19 Detected In Singing, Talking, Breathing Between breathing, singing, and talking, researchers detected SARS-CoV-2 RNA copies mostly from talking and singing (94%), and 85% of all viral particles were detected in fine aerosols, according to a small study late last week in Clinical Infectious Diseases. The researchers had 22 COVID-19 patients at Singapore’s National Centre for Infectious Diseases breathe for 30 minutes, talk for 15 minutes, or sing for 15 minutes into a G-II exhaled breath collector. Thirteen patients (59%) had detectable SARS-CoV-2 levels, of whom three were asymptomatic and one was presymptomatic. Variables such as age, sex, virus variant, and clinical symptoms were not significantly associated with detectable viral RNA in aerosols, but median day of illness was, with a higher likelihood earlier on in a patient’s illness (median, 3 vs 5 days after illness onset). (8/9)

Scientists explain possible causes of anaphylaxis following mRNA COVID-19 vaccination

Authors: By Angela Betsaida B. Laguipo, BSN

In an effort to stem the spread of the coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pathogen, vaccination efforts have been implemented in most countries.

Two of the vaccines developed to prevent SARS-CoV-2 infection are the novel messenger ribonucleic acid (mRNA) vaccines: the Pfizer-BioNTech (BNT162b2) and the Moderna (mRNA-1273) vaccines.

Despite this vaccine type’s novelty, mRNA vaccines have been studied by scientists for decades. Moreover, both vaccines underwent extensive testing and rigorous clinical trials to determine their safety and efficacy.

Against the backdrop of a global public health emergency, clinical trials and regulatory body approval for both mRNA vaccines had been compressed into a shorter timespan than usual for novel pharmaceuticals like these. However, no safety measures had been compromised in the process, and all of the usual protocols were still followed within this expedited timeframe.

The pharmaceutical companies made this possible by conducting overlapping clinical trials, which involve human testing and occur in three phases that scale up each time. Meanwhile, some regulatory bodies – like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK –  conducted a ‘rolling review’ of the trial data for both vaccines as and when it was made available. This is an emergency measure that is employed to speed up the process in pressing instances like global pandemics.

This said, as with all pharmaceuticals, a small subset of individuals are unfortunately susceptible to adverse reactions, something which is not always detected at the clinical trial level. This includes, though is not limited to, anaphylaxis or allergic reactions to ingredients that vaccines sometimes contain or are stored in.

A new report from a team of scientists at the Centre for Research in Molecular Modeling, Department of Chemistry and Biochemistry, Concordia University in Canada, has aimed to determine the potential causes of anaphylaxis or allergic reactions reported in some individuals after receiving COVID-19 vaccines, including the mRNA vaccines by Pfizer-BioNTech and Moderna.

For More Information: https://www.news-medical.net/news/20210601/Scientists-explain-possible-causes-of-anaphylaxis-following-mRNA-COVID-19-vaccination.aspx

“Herd Immunity Is Not A Possibility”: Dr. Malone Vindicated After Oxford Prof Warns Over New Variants

Authors: Dr. Malone, TYLER DURDEN

In one of the most appalling examples of Big Tech silencing scientists who refuse to withhold their criticisms of the mRNA technology behind the Moderna and Pfizer-BioNTech COVID vaccines, Dr. Robert Malone, a pioneer who helped develop mRNA vaccine technology, saw the credit for his contribution to medicine effectively erased from the Internet by Wikipedia after he raised concerns about potential long-term autoimmune issues and other complications potentially arising from mRNA jabs.

He has also shared other medical heresies, including the possibility that ‘imperfect’ vaccines might actually help foster more virulent COVID variants due to a phenomenon called ‘ADE’ – antibody-dependent enhancement. Essentially, what doesn’t kill the virus makes it stronger. In retaliation for sharing these views, Dr. Malone was ridiculed by colleagues  as a conspiracist and an “anti-vaxxer”.

But earlier this week, Dr. Malone saw his views subtly vindicated by an unexpected source: a British scientist and academic named Professor Sir Andrew Pollard, who is the director of the Oxford Vaccine Group. During a briefing, Sir Pollard warned Parliament that the UK likely won’t ever achieve herd immunity, thanks to the delta variant.

In remarks that risked undermining the government’s vaccination campaign, Sir Pollard, a professor of pediatric infection and immunity, warned Parliament on Tuesday that achieving herd immunity is likely “not a possibility” thanks to variants like delta. Recently, a group of scientists estimated that the threshold for herd immunity might now be as high as 90% due to the delta variant. According to Pollard, we’re learning for the first time that herd immunity is magical thinking – and has always been magical thinking.

Since those who are vaccinated can still be infected by variants, “there is virtually nothing the UK can do” to eradicate COVID completely.

“We know very clearly with coronavirus that this current variant, the Delta variant, will still infect people who have been vaccinated, and that does mean that anyone who’s still unvaccinated, at some point, will meet the virus,” Pollard said.

He said it was unlikely that herd immunity will ever be reached, saying the next variant of the novel coronavirus will be “perhaps even better at transmitting in vaccinated populations.”

For More Information: https://www.zerohedge.com/covid-19/herd-immunity-not-possibility-dr-malone-vindicated-after-oxford-prof-warns-over-new