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Pfizer to enroll kids as young as 12 in COVID-19 vaccine study

(Reuters) – Pfizer Inc will enroll participants as young as 12 in its large, late-stage COVID-19 vaccine trial to understand how it works in a wider age group.

While severe COVID-19 symptoms are extremely rare in infected children, they can pass on the virus to high-risk groups such as the elderly.

That makes determining the effectiveness of a potential vaccine in children crucial, as vaccines work differently in kids and adults, the FDA said in its guidelines https://www.fda.gov/media/139638/download in June.

The U.S. Food and Drug Administration (FDA) granted permission to the drugmaker and German partner BioNTech SE to enroll younger participants this month, according to an update on the U.S. company’s website https://www.pfizer.com/science/coronavirus/vaccine on Monday.

Last month, Pfizer scaled up its trial to about 44,000 participants, from up to 30,000, to enroll people as young as 16 and those with chronic, stable HIV, hepatitis C and hepatitis B.

The company said on Tuesday it would enroll children in its study based on satisfactory safety data in older adolescents and young adults, but did not specify a timeline.

Pfizer is racing to develop a safe and effective vaccine for the new coronavirus with rivals such as Moderna Inc, AstraZeneca Plc and Johnson & Johnson.

Late-stage vaccine trials initiated by Moderna, J&J and Novavax Inc are testing their respective candidates only in adults.

AstraZeneca’s U.K. vaccine trial, targeting more than 12,000 volunteers, will have one out of 11 subgroups with children 5 to 12 years of age. Chief Executive Officer Pascal Soriot said last month that tests on children had not yet started.

(Reporting by Manojna Maddipatla in Bengaluru and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Shinjini Ganguli)

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Exclusive: Moderna Vaccine Trial Contractors Fail to Enroll Enough Minorities, Prompting Slowdown | Top News

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest along in the U.S. race for a vaccine seen as essential to ending a pandemic that has claimed over a million lives worldwide. It received more than $1 billion in government funding to develop and produce its candidate, and another $1.5

AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen

COVID-19 Patients May Continue to Experience Chronic Fatigue-Like Symptoms

Charles Lapp, MD

Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.
Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.
Charles Lapp, MD, at a recent AIM ImmunoTech Inc. planning meeting on COVID-19-induced chronic fatigue in ‘Long Haulers,’ at the Hunter-Hopkins Center, Charlotte, N.C.

OCALA, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) is pleased to announce that it has received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM’s flagship pipeline drug Ampligen.

These patients — commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / “Long Haulers” because of the persistence of their symptoms — will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active participants can be Long Haulers, according to the new trial protocol amendment. AIM is currently preparing the IRB-approved protocol for submission to the U.S. Food and Drug Administration (“FDA”).

“It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS,” according to Charles Lapp, MD, a global expert in ME/CFS. “The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario.”

Many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors met the CDC criteria for chronic fatigue syndrome (See: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/415378). There is now increasing evidence that patients with COVID-19 — the disease caused by SARS-CoV-2 — can develop a similar, ME/CFS-like illness (See: https://jamanetwork.com/journals/jama/fullarticle/2768351). AIM CEO Thomas K. Equels states, “With millions of U.S. cases of COVID-19 already on record we can expect a tidal wave of new U.S. cases of COVID-19 sufferers who will exhibit serious chronic fatigue-like symptoms. In addition, unpublished data from AIM indicates that ME/CFS patients respond better to Ampligen the earlier they receive the drug, so enrolling ‘Long Haulers’ earlier in their diagnosis could potentially benefit these patients while also providing valuable information for all ME/CFS patients.”

In June, AIM filed a provisional utility patent application for Ampligen as a potential therapy for COVID-19-induced ME/CFS-like illness (See: https://aimimmuno.irpass.com/AIM-ImmunoTech-Files-Provisional-Patent-Application-for-the-Use-of-AmpligenR-as-a-Potential-Therapy-for-COVID-19-Induced-Chronic-Fatigue).

About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing

Moderna vaccine trial contractors fail to enroll enough minorities: sources

Tony Potts, a 69-year-old retiree living in Ormond Beach, receives his first injection as a participant in a Phase 3 COVID-19 vaccine clinical trial sponsored by Moderna at Accel Research Sites on August 4, 2020 in DeLand, Florida.

Paul Hennessy | NurPhoto | Getty Images

Private contractors hired by Moderna to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But Covid-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of Covid-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) Covid-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest

Exclusive: Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown

CHICAGO (Reuters) – Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants to determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyder/File Photo

To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centers to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.

Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.

But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.

And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among the first likely to be eligible for a new vaccine, experts said.

Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to test the Moderna vaccine at five sites, said efforts to enroll volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.

“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he said.

Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13% to reflect the actual U.S. population.

During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.

Increased trial participation could help address distrust between communities of color and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.

One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.

“We are essentially making up” for the commercial sites, said one CoVPN investigator not authorized to speak publicly.

Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial sites with outreach programs staffed by doctors and nurses with ties to minority communities.

“That’s not something that is part of the business model of commercial research organizations,” Corey said.

Moderna is one of the furthest along in the U.S. race for a vaccine seen as essential