Rockville Lab Can Resume COVID-19 Testing Following Investigation

ROCKVILLE, MD — The Rockville lab ordered by the state to stop processing COVID-19 tests following an investigation into its protocols has been cleared to resume testing, the company announced Wednesday.

“I am pleased that AdvaGenix is approved to resume COVID-19 testing by the Centers for Medicare and Medicaid Services and the Maryland Department of Health,” said AdvaGenix owner Dr. William Kearns. “AdvaGenix has confirmed the integrity of the specimens and accuracy of the tests we’ve conducted.”

AdvaGenix, once the largest supplier of COVID-19 tests for Montgomery County, had to halt testing after state and federal officials visited the lab in August and found deficient practices.

Health officials did not go into specifics but said investigators found “improper laboratory and COVID-19 testing procedures that endanger patient health, safety, and welfare.”

Montgomery County cut ties with the lab shortly thereafter.

Kearns disputed the investigation, saying that the tests were safe and accurate — and that the issues investigators found had to do with a “pre-analytical temperature stability study.”

Before being ordered to stop, AdvaGenix had processed more than 19,000 tests — or roughly 8 percent of the total testing provided to county residents.

After cutting ties with AdvaGenix, the county inked a deal with CIAN Diagnostic Laboratories in Frederick.

Dr. Travis Gayles, the county’s top health official, said the county recently had a conversation with AdvaGenix about its services.

“At this time, based upon our current needs, we have the (testing) capacity but, consistent with what we’ve always said, we continue to explore new partnerships, particularly if there are new opportunities for new technology to integrate into the systems that we have,” he said. “So that’s where we currently stand with AdvaGenix, as well as with other companies that could potentially be able to meet those needs as they arise in the future.”

The county is consistently meeting its goal to test 5 percent of its population per month.

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This article originally appeared on the Rockville Patch

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AstraZeneca and Johnson & Johnson to resume COVID-19 vaccine trials as U.S. daily cases top 71,000

On Friday, both AstraZeneca and Johnson & Johnson announced that their coronavirus vaccine trials are set to resume in the U.S. after hitting pause when volunteers became sick. The Food and Drug Administration gave the green light after investigations found no link between those cases and the vaccine.

The announcement comes as the U.S. recorded more than 71,000 coronavirus cases on Thursday, which is the highest single-day increase since July, according to figures from Johns Hopkins University. A total of 41 states are reporting an increase in average new cases, and 15 states have reported record hospitalizations in the last week.

“This really does become a moment where all Americans have to recognize that each of us individually has a responsibility if we want to turn this around,” said Dr. Francis Collins, director of the National Institutes of Health.

In hot spot Wisconsin, new cases are up nearly 40% compared to two weeks ago. Wisconsin resident Ava Pennicuik, 15, is still suffering from hot flashes and extreme fatigue three months after recovering from COVID-19.

“I still feel sick sometimes. Some days are good and then some days aren’t,” said Pennicuik. “Like one day I’ll have a really bad day and also super dizzy and tired, and I’ll have to take a nap, and the other day, like, I can just do stuff, like, normally.”

The latest data from researchers at the University of Washington says wearing face masks in public could save nearly 130,000 lives in the U.S. this fall and winter.

Katelyn Evans, 16, became the first teen to get an injection as part Pfizer’s COVID-19 vaccine study at Cincinnati Children’s Hospital, the Associated Press reported. It’s part of a push to safely inoculate school-age children.  

“I figured, you know, the more people they test, the more information they get and the sooner they can put out a vaccine to keep everyone safe,” said Evans.

Since the pandemic began, more than half a million American children have been infected with COVID-19. While vaccine trials continue to move forward, the first shots are unlikely to be recommended for kids. Vaccines can’t be given to children unless they’ve been tested in their age group, the AP reported.

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Johnson & Johnson, AstraZeneca coronavirus vaccine trials set to resume

The AstraZeneca vaccine trial, on hold in the United States since early September, also got the greenlight Friday to restart from the Food and Drug Administration, according to a company statement.

When a potential adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data and safety monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy usually restrict details from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons for such halts.

In the Johnson & Johnson trial, which was paused on Oct. 12, a man who received a vaccination suffered a stroke that may have been triggered by an infection. To conclude it was not likely to be related to the shot, investigators probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

The investigation found “no clear cause” of the incident, according to a company statement. It also found no evidence the vaccine triggered the event, the details of which were not disclosed by the company. The independent board that monitors the trial recommended lifting the pause.

“With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it,” Paul Stoffels, chief scientific officer of Johnson & Johnson said in an interview. He did not offer any details of the illness, citing patient privacy.

The company is testing the only vaccine that aims to protect people with a single shot; other prospective vaccines require a return visit and second shot three to four weeks after the first to trigger a protective immune response.

It was the second late-stage vaccine trial put on hold in recent weeks; the vaccine being developed by AstraZeneca and the University of Oxford was halted on Sept. 6 after a British participant developed a neurological problem. While the AstraZeneca study had resumed in the rest of the world, it did not get clearance to restart in the U.S. until Friday.

AstraZeneca spokeswoman Michele Meixell did not provide further information on the illness, but said the FDA reviewed data from the trials running around the world before concluding it was safe to restart. She said the company was adding a new expert panel “to provide advice on diagnosis and causality assessment of neurological events,”in addition to continuing standard company oversight and the independent data and safety committee.

Pausing and unpausing clinical trials happens routinely, and experts have said that the public should be confident the process worked as intended to protect the health and safety of participants.

“We see this all the time during clinical research,” said Carlos del Rio, an infectious diseases physician at Emory University School of Medicine. “As long as the data and safety monitoring

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Johnson & Johnson coronavirus vaccine trial will resume soon

The Johnson & Johnson coronavirus vaccine trial, paused due to an unexplained illness in a participant, will resume very soon. An independent committee investigated the case of a man in the trial who suffered a stroke and concluded it was not related to the vaccine, according to two individuals familiar with the trial who spoke on the condition of anonymity.



a sign on the side of a road: Signs direct volunteers for a coronavirus vaccine trial at a trailer compound in National City, California in early October. (REUTERS/Mike Blake)


© Mike Blake/Reuters
Signs direct volunteers for a coronavirus vaccine trial at a trailer compound in National City, California in early October. (REUTERS/Mike Blake)

The study, the only late-stage human test of a coronavirus vaccine that requires just a single shot, was paused by Johnson & Johnson on Oct. 12. It was the second late-stage trial to pause; testing of the vaccine being developed by AstraZeneca and the University of Oxford has been on hold in the United States since early September after a a British participant developed a neurological problem.

Moncef Slaoui, the head of Operation Warp Speed, told Bloomberg that both trials could resume as early as this week, pending clearance from the Food and Drug Administration.

When an adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data safety and monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy restrict specific details of adverse events from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons behind trial pauses.

In the Johnson & Johnson trial, a man who received a vaccination suffered a stroke that may have been triggered by an infection.

To come to the conclusion that the event was not related to the vaccination, the investigation probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

Johnson & Johnson spokesman Jake Sargent declined to comment.

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AstraZeneca Could Resume US COVID-19 Vaccine Trial This Week As FDA Review Complete: Report

The U.S. Food and Drug Administration (FDA) has completed a review of adverse events observed in participants of AstraZeneca Plc’s (NASDAQ: AZN) COVID-19 vaccine clinical trial, according to Reuters.

What Happened: The U.S. trial of the British company’s vaccine candidate could resume as soon as this week, people familiar with the matter told Reuters. It remains unclear how the FDA will characterize the illnesses observed in the participants.

The U.S. FDA could reportedly mandate that researchers conducting the trial include information about the adverse events in participant consent forms.

Why It Matters: AstraZeneca announced in early September that its coronavirus vaccine candidate AZD1222 was moving into phase three clinical trials in the U.S., with about 30,000 participants. The trials, in the U.S. and other countries, were paused later in the month when a trial participant in the United Kingdom suffered complications — exhibiting neurological symptoms.

The trials have since resumed in the U.K, Brazil, India, and South Africa, but remain paused in the U.S., pending FDA approval.

The U.K.’s Medicines and Healthcare products Regulatory Agency determined that the evidence was insufficient to link AstraZeneca’s U.K trial program setback with the vaccine, as per Reuters.

On Tuesday, AstraZeneca also announced the receipt of a “Recommendation of Approval” in the European Union for two of its treatments against heart failure and a lung disorder.

Price Action: AZN stock fell 0.48% to close Tuesday’s trading session at $52.19.

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