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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.

California regulators launch review of long, deadly delays in L.A. County specialty care

Los Angeles, CA, August 24, 2019 - Majid Vatandoust, a 49-year old heating and air conditioning technician from Canoga Park, who went to LAC clinic Mid-Valley for a check-up in early 2014. He had unintentionally lost about 20 pounds and routine tests found he was anemic and had blood in his stool, all early indicators of potentially deadly colon cancer. His doctor put in a request via eConsult for a colonoscopy but was denied, his medical records show. The gastroenterologist who turned down the request without ever seeing Vatandoust said the test used to detect blood in Vatandoust's stool was "not valid for patients under 50 years old." Thousands of patients in L.A. County's public hospital system who endure long, sometimes deadly delays to see medical specialists, a Times investigation has found. Doctors, nurses and patients describe chronic waits that leave the sick with intolerable pain, worsening illnesses and a growing sense of hopelessness. According to a Times data analysis of more than 860,000 requests for specialty care at the L.A. County Department of Health Services, a sprawling safety-net system that serves more than 2 million, primarily the region's poorest and most vulnerable residents. (Robert Gauthier / Los Angeles Times)
Majid Vatandoust died of colon cancer at age 52, three years after a request for a colonoscopy was denied by a specialist working for L.A. County despite tests that showed clear indicators of the disease. (Robert Gauthier / Los Angeles Times)

As current and former doctors in Los Angeles County’s public hospital system condemn delays in providing specialist care, California regulators have launched a review of the long, sometimes deadly waits faced by patients who need treatment from one of the nation’s largest public health systems.

The actions come in the wake of a Times investigation that found patients of the Los Angeles County Department of Health Services face agonizing delays to see specialists after referrals from primary care providers, leaving many with intolerable pain, worsening illnesses and a growing sense of hopelessness. The Times report included several patients who died of the conditions they waited to have treated.

The California Department of Health Care Services will review whether any managed care plan that offers Medi-Cal — the government-subsidized program that covers low-income Californians and most county patients — violated its contract with the state to provide adequate access to care, an agency spokeswoman said.

“Any untimely death is a tragedy, and our hearts go out to the families suffering the loss of a loved one. The wait times outlined by The Times are unacceptable,” Michelle Baass, undersecretary of the California Health and Human Services Agency, said in a statement. “Timely access to care is a fundamental patient right.”

The review is the second underway by the state. The California Department of Managed Health Care began an investigation of the county’s wait times this year in response to questions from The Times about delays in specialist appointments.

Baass is overseeing both inquiries after her boss, state Health Secretary Dr. Mark Ghaly, recused himself. Ghaly is married to the director of the Los Angeles County safety-net hospital system, Dr. Christina Ghaly.

The average wait to see a specialist in the L.A. County system was 89 days, according to a Times data analysis of more than 860,000 requests for specialty care at the county’s Department of Health Services, which serves more than 2 million people, primarily the region’s poorest and most vulnerable residents.

Even patients waiting to see doctors whose prompt care can mean the difference between life and death — neurologists, kidney specialists, cardiologists — endured delays that stretched on for months, according to the data, which consisted of nonemergency requests from primary care providers to specialists from 2016 through 2019.

Several doctors who now work for the county or recently left called for reform, including better communication between primary care providers and specialists as well as a dramatic increase in hiring of specialists.

Dr. Michael Hochman, a primary care physician and associate professor of clinical medicine at USC’s Keck School of Medicine, who has practiced at safety-net health systems on both coasts, said Los Angeles County’s is “the least effective system that I’ve worked at in my 14

Alabama closes out week with uptick in coronavirus deaths: Week in review

Things have been relatively calm in Alabama’s fight with the coronavirus over the past few weeks, but an uptick in reported virus deaths over the last four days is a discouraging sign as the state gets ready for colder weather.

The Alabama Department of Public Health reported just over 6,750 new virus cases in Alabama this week. It also reported 103 total deaths – the first time in more than a month the state has reported at least 100 total virus deaths in a week.

[Can’t see the chart? Click here.]

And 90 of those deaths were reported in the last four days alone, as the state has reported double digit death totals in each of the last four days.

The 7-day average for total coronavirus deaths rose to 14.1 on Friday, the highest it’s been since Sept. 17. Prior to Thursday, that number hadn’t risen past 10 in two weeks.

A large number of the confirmed deaths reported this week came near Alabama’s coast. Mobile and Baldwin counties saw a combined 24 virus deaths between Saturday, Oct 3. and Friday, Oct. 9.

The state has now suffered 2,653 virus deaths since March. Because of the way deaths are reported, there is a lag between when someone dies of the virus and when they are listed in the state’s data. It’s unclear when the deaths reported this week actually occurred. The state reports deaths by date of death on its coronavirus dashboard, but it sometimes takes weeks for deaths to show up in that chart, and hundreds of deaths currently included in ADPH’s cumulative total don’t have a date assigned yet.

ADPH reported 6,767 new total virus cases this week, including around 4,900 confirmed cases and 1,900 probable cases. That case total represents a slight increase over the previous week, but is still down from two weeks prior.

[Can’t see the chart? Click here.]

The state’s caseload has been relatively flat since Labor Day. There was a slight uptick in cases in late September, which was at least partially caused by a backlog of cases from a private lab entering the system, according to ADPH.

But the 7-day average for new daily cases has increased by only around 100 cases since Labor Day itself. The average then was 855 cases per day. As of Friday, it stood at 966.

On Friday the state reported nearly 1,500 new cases, after showing significantly lower numbers for most of the week.

The state also reported nearly 12,000 new tests on Friday, which was also a significant increase, and could indicate another backlog of data entering the system.

[Can’t see the chart? Click here.]

The state’s positivity rate was 13.3 percent on Friday, and has hovered between 12 and 14 percent over the last few weeks.

Hospitalizations have remained mostly flat in the state over the past several weeks – though hospitals in Tuscaloosa and Auburn reported increases this week. The 7-day average for current virus hospitalizations statewide hasn’t risen past 800 since Sept.

Pelosi proposes experts review a president’s mental fitness under 25th Amendment

House Democrats, who have accused President Donald Trump of acting erratically as he battles the coronavirus, on Friday introduced a proposal to establish a panel to determine a president’s fitness for office under the Constitution’s 25th Amendment.

The move comes after House Speaker Nancy Pelosi said Thursday that Trump was in an “altered state,” but said Friday the measure wouldn’t apply to him.

“This is not about President Trump. He will face the judgment of the voters. But he shows the need for us to create a process for future presidents,” Pelosi told reporters at Capitol Hill news conference as she introduced the bill.

“This legislation applies to future presidents, but we are reminded of the necessity of action by the health of the current president,” she added. “It’s not about any of us making a judgment about the president’s well-being.”

When pressed by reporters if she thinks it’s time to invoke the 25th Amendment concerning Trump, Pelosi responded: “That’s not for us to decide.”

The measure would create an expert panel – with members appointed by Democratic and Republican leaders of the House and Senate – to conduct a medical exam at the direction of Congress to “determine whether the President is mentally or physically unable to discharge the powers and duties of the office,” according to the text of a version of the proposal introduced in 2017 by Rep. Jamie Raskin of Maryland.

(MORE: In information vacuum, experts say Trump’s steroid treatment may hold clues to health status)

Raskin, a former constitutional law professor and member of the House Judiciary Committee, said the panel would include doctors as well as former presidents and Cabinet secretaries, who would each serve four-year terms.

“The population is getting older, politicians are getting older,” he said in an interview earlier this week. “It’s not hard to think that there will be future situations where the president’s physical and mental state may create issues for us. So, we just need to make sure that we have a structure and a process in place to address it.”

PHOTO: Speaker of the House Nancy Pelosi delivers remarks during a news conference to introduce legislation establishing a Commission on Presidential Capacity in the Capitol, in Washington, Oct. 2020. (Shawn Thew/EPA via Shutterstock)

Pelosi has repeatedly expressed concerns in public and private this week about President Trump’s health amid his treatment for COVID-19.

Trump, at the direction of his doctors, has been taking dexamethasone, a steroid used to reduce lung inflammation in COVID patients, that can, in some cases, prompt psychiatric side effects, including mood swings, rage and psychosis.

“The president is, shall we say, in an altered state right now,” Pelosi said Thursday during an interview with Bloomberg TV. “I don’t know how to answer for that behavior.”

She continued, “There are those who say when you are on steroids or have COVID-19, there may be some impairment of judgment.”

(MORE: All the president’s medicine: How doctors are treating Donald Trump)

Dr. Sean Conley, Trump’s

Pelosi to propose experts review a president’s mental fitness under 25th Amendment

House Democrats, who have accused President Donald Trump of acting erratically as he battles the coronavirus, on Friday will introduce a proposal to establish a panel to determine a president’s fitness for office under the Constitution’s 25th Amendment.



a person wearing a costume: Speaker of the House Rep. Nancy Pelosi gestures during the Weekly News Conference on Capitol Hill, Oct. 8, 2020 in Washington, DC.


© Tasos Katopodis/Getty Images
Speaker of the House Rep. Nancy Pelosi gestures during the Weekly News Conference on Capitol Hill, Oct. 8, 2020 in Washington, DC.

The move comes after House Speaker Nancy Pelosi said Thursday Trump was in an “altered state,” but has said it likely wouldn’t apply to him.

The measure would create an expert panel – with members appointed by Democratic and Republican leaders of the House and Senate – to conduct a medical exam at the direction of Congress to “determine whether the President is mentally or physically unable to discharge the powers and duties of the office,” according to the text of a version of the proposal introduced in 2017 by Rep. Jamie Raskin of Maryland.

(MORE: In information vacuum, experts say Trump’s steroid treatment may hold clues to health status)

Raskin, a former constitutional law professor and member of the House Judiciary Committee, said the panel would include doctors as well as former presidents and Cabinet secretaries, who would each serve four-year terms.

“The population is getting older, politicians are getting older,” he said in an interview earlier this week. “It’s not hard to think that there will be future situations where the president’s physical and mental state may create issues for us. So, we just need to make sure that we have a structure and a process in place to address it.”



a person wearing a costume: Speaker of the House Rep. Nancy Pelosi gestures during the Weekly News Conference on Capitol Hill, Oct. 8, 2020 in Washington, DC.


© Tasos Katopodis/Getty Images
Speaker of the House Rep. Nancy Pelosi gestures during the Weekly News Conference on Capitol Hill, Oct. 8, 2020 in Washington, DC.

Pelosi, who will reintroduce the measure with Raskin on Friday, has repeatedly expressed concerns in public and private this week about President Trump’s health amid his treatment for COVID-19.

Trump, at the direction of his doctors, has been taking dexamethasone, a steroid used to reduce lung inflammation in COVID patients, that can, in some cases, prompt psychiatric side effects, including mood swings, rage and psychosis.

“The president is, shall we say, in an altered state right now,” Pelosi said Thursday during an interview with Bloomberg TV. “I don’t know how to answer for that behavior.”

She continued, “There are those who say when you are on steroids or have COVID-19, there may be some impairment of judgment.”

(MORE: All the president’s medicine: How doctors are treating Donald Trump)

Dr. Sean Conley, Trump’s doctor, who has provided little information about the president’s condition and repeatedly contradicted himself in press conferences over the weekend, claimed to reporters on Monday that Trump has not displayed any neurological symptoms from the coronavirus, or side effects from his treatment.



Donald Trump wearing a suit and tie: President Donald Trump gestures as he returns to the White House, Oct. 5, 2020, after leaving Walter Reed National Military Medical Center, in Bethesda, Md.


© Alex Brandon/AP
President Donald Trump gestures as he returns to the White House, Oct. 5, 2020, after leaving Walter Reed National Military Medical Center, in Bethesda, Md.

Republicans on Thursday accused

EU launches a rolling review of the Pfizer-BioNTech coronavirus vaccine

A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.

Eva Marie Uzcategui | Bloomberg | Getty Images

The European health regulator is reviewing a COVID-19 vaccine being developed by Pfizer and BioNTech in real-time, days after launching a similar assessment process for AstraZeneca’s vaccine.

The European Medicines Agency (EMA) said on Tuesday its human medicines committee was evaluating the first batch of data on the vaccine, and would continue to do so until enough data is available for a final decision. 

Pfizer and BioNTech said in a joint statement the start of the review is based on data from laboratory and animal testing, as well as early testing on humans, while continuing talks to submit data as it emerged.

The EMA is using “rolling reviews” to speed up evaluations of vaccines during the pandemic by studying data as it is submitted, rather than waiting for all data to be made available along with a formal application.

Last week, it began reviewing AstraZeneca and Oxford University’s vaccine, AZD1222 or ChAdOx1 nCoV-19, increasing chances of the British vaccine becoming the first to be approved in the region for the disease which has killed more than a million people globally.

While AZD1222 uses a weakened version of a chimpanzee common cold virus to build immunity against Covid-19, Pfizer and BioNTech’s vaccine, called BNT162b2, uses ribonucleic acid, a chemical messenger that contains instructions for making proteins.

When injected in people, BNT162b2 instructs cells to make proteins that mimic the outer surface of the novel coronavirus, which the body recognizes as a foreign invader and mounts an immune response against it.

Pfizer’s vaccine is currently being evaluated in late-stage studies in the United States, Brazil, South Africa and Argentina.

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American Medical Association petitions Supreme Court to review Title X ‘gag order’

Oct. 1 (UPI) — The American Medical Association led a petition to the U.S. Supreme Court on Thursday to review a Trump administration revised rule banning federally funded family planning clinics from referring women for abortions.

The petition, filed alongside the American Civil Liberties Union, Planned Parenthood and the National Family Planning and Reproductive Health Association, calls on the court to weigh conflicting decisions in a pair of appeals courts regarding the so-called “gag rule” earlier this year.

Under the revised rule issued by the Department of Health and Human Services in 2019, the government said it would require “clear financial and physical separation” between Title X-compliant facilities and those that provide abortions or abortion referrals.

“The AMA strongly believes that our nation’s highest court must step in to remove government overreach and interference in the patient-physician relationship. Restricting the information that physicians can provide to their Title X patients blocks honest, informed conversations about health care options — an unconscionable violation that is essentially a gag rule,” AMA President Susan Bailey said in a statement.

In February, the 9th U.S. Circuit Court of Appeals upheld the rule, stating that it allows family clinics to mention abortion, but not to refer or encourage it, and that it was a “reasonable interpretation” of federal law and was not “arbitrary and capricious,” as challengers including Planned Parenthood had argued.

However, the 4th U.S. Circuit Court of Appeals blocked enforcement of the federal rule in Maryland earlier this month, saying the Trump administration’s rule revision “failed to recognize and address the ethical concerns of literally every major medical organization in the country.”

“The petitioners argue that until the Ninth CIrcuit’s erroneous decision is corrected, the administration’s gag rule is harming patient care and causing physicians and other health care professionals to violate ethical obligations by preventing Title X clinics from providing full information to patients about all of their reproductive care options,” AMA said.

The petition also comes as the Senate prepares to confirm President Donald Trump’s nomination to the Supreme Court, Amy Coney Barrett, shifting the court’s makeup to a 6-3 conservative majority following the death of Justice Ruth Bader Ginsburg.

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EU agency starts ‘rolling review’ to speed OK for vaccine

LONDON (AP) — The European Medicines Agency has started a “rolling review” process for the COVID-19 vaccine being developed by Oxford University and AstraZeneca, a move it hopes will speed any eventual approval.

In a statement Thursday, the EU regulator said instead of waiting for all of the required vaccine data to be submitted before beginning its assessment, the EMA has begun analyzing the preliminary information from scientists on the Oxford vaccine.

That data suggests the vaccine “triggers the production of antibodies and T-Cells,” referring to immune system cells that target the virus. The agency said it was waiting for data from ongoing late-stage tests of the vaccine involving thousands of people, which it hopes will be shared in the coming weeks and months.

“The rolling review will continue until enough evidence is available to support a formal marketing authorization,” the EMA said.


The agency said it could not estimate how long this process might take, but that it would be quicker than the normal evaluation procedure. A similar process was used to issue an approval for remdesivir, one of the only licensed drugs to treat COVID-19. That approval was issued in just over one month while the standard process can take nearly seven months.

Oxford’s vaccine is designed to reduce disease and transmission. It uses a harmless virus — a chimpanzee cold virus, engineered so it can’t spread — to carry the coronavirus’ spike protein into the body, which should trigger an immune response. The tests are looking at both one-shot and two-shot vaccine doses.

Initial information suggested the vaccine provoked a strong immune response in volunteers and is safe, but longer-term data is needed.

AstraZeneca, which is manufacturing the vaccine, has signed numerous private deals to provide millions of doses to countries including Britain, the U.S., France, Germany and Canada. The first deliveries are expected this fall, before being licensed.

Last month, Britain’s trial of the Oxford vaccine was paused for several days after a U.K. woman in the trial reported severe neurological symptoms. Although the study has since restarted, a similar trial in the U.S. is awaiting further examination from the Food and Drug Administration before the research can continue.

Several other vaccines are undergoing late-stage testing in China, Russia, the U.S., Brazil and other hard-hit countries.

In August, Russia became the first country in the world to license its Sputnik V COVID-19 vaccine. The shot is still being tested in advanced trials but has been offered to key workers, several high-profile politicians and one of President Vladimir Putin’s daughters.

On Thursday, authorities in Belarus began testing Sputnik V in 100 volunteers in Minsk, the capital.

Several Chinese vaccine makers, including Sinovac Biotech Ltd, have also injected thousands of their employees and family members with their experimental shots, under an emergency use provision. The Chinese military has also approved the use of a vaccine it developed with CanSino Biologics Inc., a biopharmaceutical company, in military personnel.

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Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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