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J&J says review of illness that led to pause of coronavirus vaccine trial could take days

(Reuters) – Johnson & Johnson said on Tuesday it would take a few days at least to hear from a safety monitoring panel about its review of the company’s late-stage COVID-19 vaccine trial after announcing that the large study had been paused due to an unexplained illness in one participant.

The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill. That trial remains on pause.

U.S.-based J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the U.S. Food and Drug administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo.

J&J said such pauses are normal in big trials, which can include tens of thousands of people. The company said the trial is still on track to continue adding patients over the coming months.

It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.

Former FDA chief said on Twitter the trial said that the oversight of safety boards for the COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Experts and officials have voiced concerns that U.S. President Donald Trump could put pressure on vaccine makers to rush an unsafe or ineffective vaccine to market.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines both use modified, harmless versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.

FILE PHOTO: The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid/File Photo

They are both also

J&J says review of illness that led to coronavirus vaccine trial pause could take days

By Carl O’Donnell and Manas Mishra

(Reuters) – Johnson & Johnson said on Tuesday it would take at least a few days for an independent safety panel to evaluate an unexplained illness of a study participant that led to a pause in the company’s COVID-19 vaccine trial.

J&J shares fell more than 2% following news of the pause and safety review. Rival AstraZeneca Plc’s U.S. trial for its coronavirus vaccine candidate – which uses a similar technology – has remained on hold for more than a month after a participant in the company’s UK trial fell ill.

J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as by its own clinical and safety team.

The data board, which is also reviewing AstraZeneca’s U.S. trial, is required to submit its findings to the U.S. Food and Drug Administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo. Mammen added that J&J remains on track to complete recruitment for its 60,000-person trial in the next two to three months.

EVIDENCE OF ‘INTEGRITY’

The company said such pauses are not unusual in large trials.

It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.

J&J has said it expects to have enough data to apply for U.S. regulatory clearance by the end of the year. Pfizer Inc and Moderna Inc have said they expect to be able to apply for FDA clearance for their vaccine candidates even sooner.

Former FDA chief Scott Gottlieb said on Twitter that the oversight of safety boards for COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Health experts have voiced concerns that U.S. President Donald Trump could put pressure on the FDA and drugmakers to rush an unsafe vaccine to market to bolster his re-election prospect. He has repeatedly said a vaccine could be available prior to the Nov. 3 election.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant. While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial remains on hold.

J&J vaccine trial hits pause as US doubles down on antibody therapies

Johnson & Johnson (JNJ) announced late Monday it was pausing shots in its late-stage coronavirus vaccine trial due to an adverse event, but plans to continue enrolling patients and stick to the current manufacturing timeline.

It is still unknown if the participant was receiving a placebo or the vaccine, a point that will be determined by an independent advisory group, known as the Data Safety Monitoring Board (DSMB). Another vaccine using similar technology from AstraZeneca (AZN) is still on hold after a serious adverse event from a trial participant triggered a halt in September. The trial has continued in the U.K., but remains on hold in the U.S.

“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies,” J&J said statement late Monday, reiterating that “studies may be paused if an unexpected serious adverse event (SAE)” occurs that may or may not be related to the trials. The company promised a “careful review of all of the medical information before deciding whether to restart the study.”

Mathai Mammen, head of research and development at Janssen, J&J’s pharmaceutical arm, said the information is kept confidential from the company until the DSMB reviews it.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during an investor call Tuesday.

The two frontrunner candidates in the U.S., Moderna (MRNA) and Pfizer (PFE) with BioNTech (BNTX), are using technology that has never been approved, but have so far not hit any significant adverse events.

Meanwhilel, Pfizer’s non-peer-reviewed data showed some side effects, but nothing that would trigger a halt. Pain at the point of injection and fatigue are considered normal vaccine side effects — seen frequently after flu shots.

Monoclonal antibodies

There are over 7.6 million cases in the U.S. (Graphic: David Foster/Yahoo Finance)
There are over 7.6 million cases in the U.S. (Graphic: David Foster/Yahoo Finance)

The experimental treatment used by President Donald Trump while he was at Walter Reed Military Medical Center is gaining momentum as the country awaits a vaccine by the end of the year.

Monoclonal antibody treatments, which are lab-produced antibodies from a sample of recovered patients, has been seen as a bridge between standard treatments and a vaccine, as well as an alternative for those who cannot be given a vaccine. That is because it can both treat and defend against the virus.

Trump received a high dose of Regeneron’s (REGN) antibody cocktail, which sparked the company and Eli Lilly (LLY), which is also developing an antibody treatment, to apply for emergency use authorizations (EUA). The U.S. Food and Drug Administration (FDA) has yet to provide an update on these filings from last week, but analysts have anticipated authorizations following Trump’s treatment.

Meanwhile, Operation Warp Speed announced a collaboration with AstraZeneca to test and produce a monoclonal antibody cocktail, which would be provided for free once authorized by the FDA.

Adding to the portfolio of candidates, the National Institutes of Health (NIH) announced Tuesday it

Lenox Hill Hospital Expansion Battle Resumes After Pandemic Pause

UPPER EAST SIDE, NY — The battle over an ambitious expansion plan by Lenox Hill Hospital is showing signs of coming back to life after going dormant for several months while the hospital responded to the coronavirus pandemic.

In a community meeting last month, Lenox Hill officials revealed changes to the multibillion dollar expansion project, which notably scrapped a controversial, 490-foot-tall residential tower on Park Avenue that would have helped fund the expansion.

The hospital will present a revised plan Tuesday, during a meeting convened by Manhattan Borough President Gale Brewer between local leaders and hospital representatives.

Starting last year, neighbors rose up in fierce opposition to the project by owner Northwell Health, which was also slated to include a 516-foot hospital tower on Lexington Avenue.

Community Board 8 voted overwhelmingly last October to oppose the plan, and a preservation-oriented group called Committee to Protect Our Lenox Hill Neighborhood sprung up to fight the project, citing its “unacceptable” size and the environmental hazards brought on by a decade-long construction project.

This spring, the committee went on an abrupt hiatus, as the group acknowledged the poor optics of fighting a hospital’s expansion while its workers served on the front lines of a global pandemic.

“We want to explicitly thank Northwell Lenox Hill and all of the other New York City hospitals, especially the doctors, nurses and staff for the incredibly brave and selfless work they are doing to protect us all,” a message on the group’s website reads.

Now, the activity has resumed — on Sept. 15, Brewer’s task force between hospital and community leaders held its first meeting in months, where hospital leaders announced the removal of the apartment tower.

An initial rendering of Lenox Hill Hospital's planned expansion at Lexington Avenue and East 76th Street, presented to Community Board 8 in March 2019. (Northwell Health)
An initial rendering of Lenox Hill Hospital’s planned expansion at Lexington Avenue and East 76th Street, presented to Community Board 8 in March 2019. (Northwell Health)

“We will conclude meetings this month and we look forward to seeing Northwell’s proposal enter the public review process,” Brewer spokesperson Aries Dela Cruz said Monday.

Meanwhile, expansion opponents are pursuing a new angle of attack, rolling out statements from health care advocates questioning the project from an equity perspective.

Mark Hannay, director of the advocacy group Metro New York Health Care for All, suggested that Lenox Hill should focus its resources in the outer boroughs, which have been hard-hit by COVID-19, rather than expanding its presence on the hospital-rich Upper East Side.

“If the COVID-19 pandemic crisis has shown anything, it is that access to hospital care across our city is grossly unequal, and beds are much more needed in Lower Manhattan and the outer boroughs,” Hannay said in a statement. “Our public officials need to urge Northwell to rethink their entire plan for Lenox Hill and their larger role across our city.”

Anthony Feliciano, director of the Commission on the Public’s Health System, another community-based health advocacy group, suggested that the expansion was driven by financial concerns, rather than public health.

“This is about profit, not healthcare equity — and

HHS pushes back against Nevada’s rapid test pause for Covid-19

The federal government is pushing back on an order from Nevada’s department of health to suspend rapid Covid-19 tests in nursing homes — suggesting the decision “can only be based on a lack of knowledge or bias,” according to a letter signed by Dr. Brett Giroir, assistant secretary for the U.S. Department of Health and Human Services.

The move comes one week after the Nevada Department of Health and Human Services mandated that long-term care facilities in the state stop using two Covid-19 antigen tests that had been supplied by the federal government.

Full coverage of the coronavirus outbreak

State health officials in Nevada said the antigen tests, which can deliver results within 15 minutes, had an unusually high number of false positives. That indicates a person is infected when in fact he or she is not.

Covid-19 antigen tests are designed to detect certain proteins on the surface of the coronavirus. More sophisticated tests — called PCR tests — look for the virus’s genetic material in a sample. These are more accurate, but can take up to three days to get a result.

The federal government began rolling out the antigen tests, made by Quidel and Becton, Dickinson and Company, to nursing homes nationwide in August.

Quick results are important, because “nursing homes have accounted for as much as 40 percent” of the overall Covid-19 deaths in the U.S., Giroir said Friday on a call with reporters.

Download the NBC News app for full coverage of the coronavirus outbreak

But within a month of that test rollout, the Nevada department of health said it began to receive “anecdotal reports” of false positives. By October, health officials in the state determined the rate of false positives was 60 percent.

That’s a major problem, said Dr. Michael Wasserman, president of the California Association of Long Term Care Medicine. “If you have a large number of false positives, it will throw your facility into complete chaos and panic.”

“We’re already in a pandemic,” Wasserman said. “We don’t need more chaos.”

On Oct. 2, health officials in Nevada sent a letter to its nursing home facilities advising them “to immediately discontinue the use of all Covid-19 point of care (POC) antigen tests until the accuracy of the tests can be better evaluated.”

Part of the issue relates to staffing, which is already a stretched resource at many nursing facilities.

Indeed, the tests were meant for workers inside nursing homes, including possible asymptomatic staffers.

“This is obviously necessary to keep an unaware infected individual from coming into a nursing home, and starting a potentially devastating outbreak,” Giroir said. He added that if an individual does have a false positive, it would be detected by a PCR test within 48 hours, and the person could return to work. (The Centers for Disease Control and Prevention recommends that positive antigen tests are confirmed with a PCR test.)

But Wasserman said the false positives can decimate a nursing home’s staff.

“You already have people who

Border exemptions introduced for families, students and compassionate reasons; Ontario will ‘pause’ social bubbles

COVID-19 In Canada
COVID-19 In Canada

Canada introduces exemptions to border restrictions

Beginning on Oct. 8, certain extended family members of Canadian citizens and permanent residents, and people who want to come to Canada for compassionate reasons, will be able to enter the country.

Family members who qualify include:

  • Individuals in an exclusive dating relationship with a Canadian citizen or permanent resident for at least one year, who have physically spent time with each other, and these individuals’ dependent children

  • Non-dependent children (adult children who do not meet the definition of a dependent child in the Immigration and Refugee Protection Regulations)

  • Grandchildren, grandparents and siblings (including half and step siblings)

Pre-arrival approval is required, with more details on the application process set to be revealed next week, and each individual must be staying in Canada for more than 15 days.

Marco Mendicino, Minister of Immigration, Refugees and Citizenship, said individuals in an exclusive dating relationship must have been dating for a period of at least one year and are required submit a notarized declaration of their relationship status to relevant authorities.

Beginning on Oct. 20, international students who are studying at a designated learning institution, that has been approved by their provincial or territorial government as having a COVID-19 readiness plan, will also be able to enter Canada.

Mendicino stressed that travellers should not make any travel plans until they have received all the necessary pre-arrival authorizations.

Anyone coming into Canada needs to following all the public health measures in place, including the 14-day quarantine requirement.

Patty Hajdu, Minister of Health, said foreign nationals coming into Canada on compassionate grounds can apply for a “limited release” from the mandatory quarantine.

She explained these “very specific” situations include being with someone you love to say goodbye at the end of their life, or a funeral or end of life ceremony. This exemption will be allowed in coordination with provincial or territorial government and must be approved before arrival.

Hajdu stressed that the COVID-19 cases in Canada, at this point, are largely related to community transmission, not travel.

Bill Blair, Minister of Public Safety and Emergency Preparedness, specified that only about two per cent of cases in Canada are related to travel.

“That isn’t an argument for reducing our efforts at the border and rather, in fact, it’s evidence of the efficacy of the work that we have done, effectiveness of both the public health response…and the efforts of our border service officers,” he said.

“The robust travel restrictions we’ve put into place to protect the health and safety of Canadians remains in effect,” Mendocino stressed. “The pandemic is an ongoing threat and we need to continue to be cautious and restrictive about who can enter into Canada.”

“We recognize, however, that these restrictions shouldn’t keep loved ones apart.”

Canada ‘scaling up’ federal public health presence at border

Blair confirmed Friday that the federal government is “dramatically scaling up” public health presence at the Canadian border to cover 36 points of entry, which