Experts Tell F.D.A. It Should Gather More Safety Data on Covid-19 Vaccines

Vaccine experts peppered officials at the Food and Drug Administration with a range of questions on Thursday about its guidelines for approving a coronavirus vaccine, pushing the agency on whether it should wait longer to collect more safety data and whether an emergency approval could jeopardize the outcome of the broader clinical trials.

The stakes, the experts said, could not be higher. Even as a vaccine is seen as crucial to ending the pandemic, opinion polls have shown that Americans are increasingly skeptical about the products and worry that the vetting process is being rushed.

“In this particular case, public trust equals success,” said Sheldon Toubman, the consumer representative on the advisory group. “Lack of trust means no success.”

The meeting, which lasted all day and was broadcast on YouTube, also included a presentation by a nonprofit group that interviewed people about their views about a coronavirus vaccine. Several people of color expressed concern about whether the vaccine had been studied in people who are Black, Latino or Native American.

Others said their skepticism had historical roots dating to the Tuskegee Syphilis Study, in which government scientists lied to Black men and allowed them to go untreated for syphilis. “I firmly believe that this is another Tuskegee experiment,” one participant said.

The expert panel was not asked to evaluate a specific vaccine — none of the companies developing one so far have results from large clinical trials — but rather to weigh in on how the F.D.A. should vet the candidates. The agency has said that it will ask the panel for its opinion before approving any coronavirus vaccine for emergency use. The agency typically, but not always, follows the advice of its outside experts.

Four companies are conducting late-stage clinical trials in the United States, and some have estimated they will have preliminary data that may allow them to apply for emergency authorization in certain high-risk groups by the end of November. One of the companies, Moderna, said on Thursday that it had fully enrolled its trial of 30,000 participants, the first company to do so.

Several of the experts said that they believed the agency should ask the companies to wait for more safety data. They said the agency’s current guidelines, which require two months of safety data after a volunteer has received the last dose of a vaccine, were not good enough. Collecting longer-term data would allow them to evaluate potential risks, such as whether immunity to the virus wanes after a few months, or whether rare side effects emerge.

The experts were also asked to give their opinions about what should happen to the clinical trials if the F.D.A. were to approve a vaccine for emergency use based on promising early data. Pfizer has said that if a vaccine is approved for emergency use, the company will be ethically obligated to offer the vaccine to people in the trial who received a placebo instead of the actual vaccine. But this would “unblind” the trial by revealing

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FDA Commissioner Stephen Hahn on COVID Vaccine Safety


And then, finally, we’ve been working with the manufacturers around the quality of their manufacturing, the consistency of it. So that if a vaccine were to be authorized or approved, we could immediately know that quality manufacturing is in place. And again, that process normally takes months.

The last thing to mention is that there’s been manufacturing done at risk, meaning that companies have started manufacturing their vaccines [before the trials are complete], so that if an authorization or approval occurs, the vaccine is ready to go. And as you can see, this really shrinks the development time. But all the steps necessary to ensure safety and efficacy have taken place. And of course, that’s the next thing that we need to see — the data from the phase 3 clinical trials — before any consideration of authorization or approval takes place.

What happens after you see this data? Can you talk about the approval process and what the FDA will be looking for in the phase 3 trial results?

We have made every attempt to be transparent about this, and will continue to do so, so that all Americans understand what we’re doing from a regulatory point of view.

These phase 3 clinical trials are large trials with 30,000 or more participants, and they compare the active vaccine with a placebo to determine whether an infection occurs in a person participating in the trial — because what you’re looking for is a vaccine to prevent infection [with the coronavirus, SARS-CoV-2]. That’s the effectiveness side of things, and in our guidance for vaccine manufacturers [posted to the FDA’s website in June], we were very clear about the criteria: We said the floor for effectiveness would be 50 percent. [This means that the vaccine should be effective at preventing a coronavirus infection or decreasing its severity in at least 50 percent of vaccine recipients. For comparison, the influenza vaccine is between 40 percent and 60 percent effective.]

We also said that safety would be of the utmost importance to us, and on the safety side of things, we’re looking for side effects. Most recently in our guidance for emergency use authorization, we said that we need to see at least two months of follow-up for 50 percent of the participants after they get the final dose of the vaccine. Looking back at other vaccines, our scientists determined that two-month window was when the overwhelming majority of side effects would be seen.

What’s the difference between standard FDA approval and an emergency use authorization when it comes to a vaccine?

When the developers of the vaccine are in their clinical trials, they determine when their data are mature, and there’s an independent board, called a data safety monitoring board, that helps the manufacturers look at the data and determine whether they reached specified criteria. Then, they’ll apply to the FDA for either emergency use authorization (EUA) or a biological license application (BLA), which is the typical process for vaccine approval. Normally, it

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COVID-19 safety precautions at the presidential debate are ‘adequate,’ but may leave some in danger, experts say

Clear dividers are seen on stage as preparations are made for the final presidential debate between President Donald Trump and former Vice President Joe Biden (Photo by BRENDAN SMIALOWSKI/AFP via Getty Images)
Clear dividers are seen onstage as preparations are made for the final presidential debate between President Trump and former Vice President Joe Biden. (Photo by Brendan Smialowski/AFP via Getty Images)

President Trump and former Vice President Joe Biden will face off in the final presidential debate at Belmont University in Nashville on Thursday night, just weeks after the president contracted and recovered from COVID-19. Experts say the precautions that have been taken to prevent the spread of the virus are a step in the right direction, but could still leave some of the estimated 200 attendees at risk.

The Commission on Presidential Debates, which sponsors the event, has reportedly put several protective measures in place, including a mask mandate for attendees, pre-testing ahead of the event and social distancing in the audience. Biden has reportedly already tested negative for the virus, and in an email from Yahoo Life asking about President Trump’s status, a spokesperson for his campaign replied that “the President will be cleared by the White House Medical Unit.” White House chief of staff Mark Meadows told reporters on Thursday the president was tested for COVID-19 on his flight to Nashville and was negative.

The two candidates will be separated by plexiglass dividers, and the Nashville Public Health Department is reportedly also installing separate HVAC systems near each candidate to increase airflow. But in a press conference Thursday morning, Nashville Mayor John Cooper warned that a “surge” in cases was occurring in the city, now averaging 175 new infections a day. “Health experts have warned that we need to double down on masks and social distancing to stop this surge in its tracks,” Cooper said.

Nashville experienced a drop in daily COVID-19 cases in September, but city officials have reported a rapid rise in the last weeks — including 249 cases in the past 24 hours alone. In total, Davidson County, where Nashville is located, has 30,115 cases and 328 deaths since the pandemic began, according to Thursday data from the Tennessee Department of Health.

Although the Centers for Disease Control and Prevention has highlighted the importance of ventilation, Dr. Saskia Popescu, an infection prevention specialist at George Mason University, says that the HVAC systems aren’t necessarily as useful as they seem. “I’m assuming they’re saying that they’re using separate air handling units for the candidates … but I’m not sure how that would be a panacea,” she tells Yahoo Life. “Increasing air exchanges and filtration is the goal.”

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, thinks the precautions taken to protect Trump and Biden are slightly over the top. “I think that they’re just kind of going above and beyond for most of this,” Adalja tells Yahoo Life. “I don’t think that is going to make much of a difference in transmission risk, especially since President Trump is not really a person who can be infected with the virus.” The audience precautions, however, are sufficient.

The fact

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London spin studio owner worries new safety measures will sink group fitness

With new measures in place to curb the spread of COVID-19 for fitness studios, restaurants and personal care providers, one local fitness facility is questioning whether they can survive another financial hit sprung by the ongoing pandemic.

Courtney Grafton opened Lost Cycle, a rhythm-riding, indoor cycling studio in south London, just a little more than a year ago.

Since being allowed to reopen back in July, the studio has been able to offer classes at pre-pandemic capacity while keeping riders and staff two metres apart, but Grafton doesn’t think she’ll be able to keep afloat with the new cap of 10 people, including the instructor, per class. 

“Our classes are built off of an environment of a group fitness class and by limiting that so much, it makes us almost impossible to operate,” she said.

“No one needs to be a mathematician to figure out that the numbers they’re giving us with the amount that it costs me to operate a business do not add up. I cannot survive off of nine people in a class, while still paying [instructors] their regular rate.” 

In the last few months, the studio has been able to weather the storm thanks to constant support from dedicated cyclists in the city who have been keeping the studio’s 21 weekly classes fairly busy, despite an outbreak at Spinco, a cycling studio in Hamilton that has made headlines across the country for being linked to 81 COVID-19 cases. 

“I don’t get to decide how scared someone is,” Grafton said. “I really feel for Spinco … but it’s a full time job to make sure that everything is cleaned properly … You have to really be diligent and treat it very, very seriously every single day. You don’t get a break from it,” she said, adding that her biggest expenses are cleaning supplies, including a steam cleaner staff use on bikes in between each class. 

Keeping bikes two metres apart from one another, steam cleaning them in between rides, having staff wear microphones to reduce the need to shout in class as well as checking every rider’s temperature ahead of class are some of the guidelines the fitness studios has already been following. Now, they’ll have to bring capacity down to 10 and space bikes by three metres, along with the other measures already taken. (Submitted by Courtney Grafton)

On Wednesday, Dr. Chris Mackie, the region’s medical officer of health, cited the outbreak in the Hamilton cycling studio as an example of why he’s decided to implement the new measures, despite the absence any outbreaks linked to fitness facilities in the region. 

“That’s the sort of thing where we’re not going to sit around and wait for a huge outbreak in our community before taking some reasonable actions that will potentially eliminate the possibility of having that level of outbreak at all,” he said. 

“As much as we watch very closely what is happening in our community and learn from the cases and outbreaks we have here,

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South Korean deaths spark flu vaccine safety fears

SEOUL (Reuters) – South Korean officials refused to suspend the country’s seasonal flu inoculation programme on Thursday, despite growing calls to do so following the deaths of at least 13 people who were vaccinated in recent days.

FILE PHOTO: A man gets an influenza vaccine at a hospital in Seoul, South Korea, October 21, 2020. REUTERS/Kim Hong-Ji

Health authorities said they have found no direct links between the deaths, which include a 17-year-old boy, and the vaccines being given under a programme to inoculate some 19 million teenagers and senior citizens for free.

“The number of deaths has increased, but our team sees low possibility that the deaths resulted from the shots,” Jeong Eun-kyeong, director of the Korea Disease Control and Prevention Agency (KDCA), told parliament.

South Korea ordered 20% more flu vaccines this year to ward off what it calls a “twindemic” of people with flu developing potential COVID-19 complications, and overburdening hospitals over the winter.

“I understand and regret that people are concerned about the vaccine,” Health Minister Park Neung-hoo said on Thursday, while confirming the free programme would go ahead.

“We’re looking into the causes but will again thoroughly examine the entire process in which various government agencies are involved, from production to distribution,” he added.

The country’s free vaccine programme uses doses manufactured by local drug makers GC Pharma, SK Bioscience and Ilyang Pharmaceutical Co 007570.KS, along with France’s Sanofi SASY.PA and Britain’s Glaxosmithkline GSK.L. The vaccines are distributed by local companies LG Chem Ltd 051910.KS and Boryung Biopharma Co. Ltd., a unit of Boryung Pharm Co. Ltd. 003850.KS.

GC Pharma, LG Chem, SK Bioscience and Boryung declined to comment. Ilyang Pharmaceutical, Sanofi and GSK did not immediately reply to requests for comment.

It was not immediately clear if any of the South Korean-manufactured vaccines were exported, or whether those supplied by Sanofi and GSK were also being used in other countries.

Kim Chong-in, leader of the main opposition People Power party, said the programme should be halted until the exact causes of the deaths had been verified.

Health authorities said on Wednesday that a preliminary investigation into six deaths found no direct connection to the vaccines. No toxic substances were found in the vaccines, and at least five of the six people investigated had underlying conditions, officials said.

EARLIER SUSPENSION

The free programme has proved controversial from its launch last month. Its start was suspended for three weeks after it was discovered that some 5 million doses, which need to be refrigerated, had been exposed to room temperature while being transported to a medical facility.

Officials said 8.3 million people had been inoculated since the programme resumed on Oct. 13, with around 350 cases of adverse reactions reported.

The government is also offering a paid vaccine programme which, combined with the free programme, aims to inoculate about 30 million of the country’s 52-million population. Under the paid programme, the purchaser can select the vaccine provider from a larger pool that includes the

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50 Sex Offenders Living In Rohnert Park-Cotati: 2020 Safety Map

ROHNERT PARK-COTATI, CA — Although kids most likely will not go trick or treating this Halloween because of the coronavirus, parents can still take an inventory of who is living in their neighborhood. Rohnert Park and Cotati currently have a combined 50 registered sex offenders, two fewer than were living in the cities this time last year, according to public information listed on the California Department of Justice’s Megan’s Law Website.

The state runs the website, which provides information on registered sex offenders, pursuant to California Penal Code § 290.46, “… so that members of the public can better protect themselves and their families.” The information is pulled from California Sex and Arson Registry.

According to state officials, Rohnert Park has 41 offenders, while Cotati has nine. In Sonoma County, there are 604 registered sex offenders, 119 of whom are transients known to stay within the county.

The below maps from the state’s Megan’s Law website show where sex offenders are registered as living in Rohnert Park, Cotati and Sonoma County as of Oct. 20, 2020. Blue markers show registered sex offenders, while red markers show sex offenders currently accused of being in violation of their registration requirements; a marker with a white plus sign means there are multiple offenders living at one location. It should be noted that yellow markers indicate “sexually violent offenders,” none of whom showed up in Patch’s search of Rohnert Park and Cotati.

VIEW INTERACTIVE MAP

Here’s how to find and view an interactive map of sex offenders in your California community. First, visit the Megan’s Law home page. On the right side of the page, you can enter an address and hit “search.”

There’s some information and a disclaimer you’ll need to read; scroll to the bottom, click that you’ve read the info (once you have, of course) and reCAPTCHA, and click “continue.”

Once you’ve arrived at the search page, you can use the menu on the left side of the screen to search by name, address, city, ZIP code or county. If you’re doing a city search, click on “city” and start typing the city name in the empty field on the left side of the page. Click “search” to generate an interactive map. The number at the top of the map indicates how many postable offenders have addresses in the city. Click on “Show List” to see a list of offenders’ names and addresses, as well as transients and those who are in violation, according to the Department of Justice, of registering in their city of residence.

NOT ALL OFFENDERS LISTED

It’s important to keep in mind that the Megan’s Law site does not list every sex offender living in the community. Under California’s Penal Code section 290, the DOJ is only authorized to display certain types of sex offenders online, according to the agency.

People who have been convicted of a registrable sexual offense that falls into one of the following categories can apply for exclusion from Megan’s Law

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States prepare for their own vaccine safety reviews amid worries about Trump’s influence on the FDA

“Frankly, I’m not going to trust the federal government’s opinion,” New York Gov. Andrew Cuomo said in announcing his state’s vaccine review panel. California Gov. Gavin Newsom, who announced his state’s 11 member panel of doctors and scientists on Monday said: “Of course we won’t take anyone’s word for it.”

President Donald Trump’s intense push for a vaccine before the election – which is now virtually impossible given that none of the leading vaccine candidates will be ready by then — on top of administration pressure on the FDA and Centers for Disease Control, have sowed growing public doubt about vaccine safety, particularly as the research into the shots has progressed at an unprecedented breakneck pace.

A CNN poll from earlier this month showed only about half of Americans might get a vaccine, while a more recent Stat News poll revealed 58 percent of the U.S. public said they would get vaccinated as soon as a vaccine was available – a big decline over its prior poll. If large numbers of people spurn the shot, its power to beat back the pandemic is diminished.

States have not yet released a lot of details about their vaccine reviews. The additional layer of oversight raises questions about whether a state agency could impede use of a federally-approved vaccine, and whether they could end up slowing down the pandemic response, rather than enhancing it.

Even though governors say they are protecting their residents in case pressure from the White House leads the FDA to approve a flawed vaccine, some officials and public health advocates are warning that these state interventions could confuse the public and prevent people from seeking a shot even if it is safe and effective.

It is “hard to see how any state could replicate anything like the national, gold standard system” of FDA approval, said former FDA commissioner Mark McClellan, who now heads a major health policy center at Duke.

Critics of the state review panels include both Republicans in Congress as well as nonpartisan public health experts in both the advocacy and academic worlds.

Rep. Greg Walden of Oregon, the outgoing top Republican on the House Energy and Commerce Committee, which oversees the FDA, called the state vaccine panels a “reckless” idea that would “dangerously undermine the FDA” and increase public vaccine hesitancy.

Walden told a recent committee hearing that the FDA had ample safeguards, including an independent data safety monitoring board for each vaccine trial, as well as the outside experts that serve on the FDA’s Vaccines and Related Biological Products Advisory Committee. FDA Commissioner Stephen Hahn has said the advisory panel, which meets for the first time to discuss Covid-19 vaccines this Thursday, will review every vaccine prior to an emergency authorization or approval.

States “would be hard-pressed to find more qualified experts” than those already on the FDA and CDC advisory panels, said Amy Pisani, executive director of the nonprofit Vaccinate Your Family. Their “recommendations will speak for themselves,” she said.

Traditionally the states have

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Sumwalt Stresses Fitness for Duty at NBAA Safety Week

National Transportation Safety Board chairman Robert Sumwalt helped cap off NBAA’s week of virtual safety events with a message of the importance of taking precautions in the air and on the ground to ensure fitness for duty.

Sumwalt spoke on the last day of NBAA’s Virtual Safety Week that brought online many of the events typically held in person during NBAA-BACE, including the Single-Pilot Safety Standdown and National Safety Forum as well as the association’s safety awards. In addition, Virtual Safety Week hosted a Safety Town Hall for the first time.

The NTSB chair participated on October 9 during the National Safety Forum, which carried a theme of “Optimizing Your Personal Performance” and focused on fitness for duty for individuals and organizations through effective sleep management, as well as maintaining a healthy mind and healthy body.

Sumwalt praised NBAA for continuing to host the event virtually and said even though there was a venue change, that did not diminish the quality of the events. He added that this year’s theme was “one of critical importance.”

Four of the issues on the NTSB’s “Most Wanted List” of transportation safety improvements center on “ensuring the transportation workers are of sound, mind, body, and soul—basically being fit for duties,” he noted. These include reducing distractions, fatigue-related accidents, and alcohol and drug impairment in transportation, as well as ensuring medical fitness.

Sumwalt in particular focused on drug impairment, pointing to a study released this year on the incidences of drugs found in the systems of pilots killed in aircraft crashes.

That study updated a similar review conducted in 2014 and found the prevalence of drugs has trended upward. The original study looked at the toxicology results of fatally injured pilots from the years 1990 to 2012, while the most recently released study looked at 952 pilots fatally injured in aircraft crashes from 2013 to 2017.

In 2012, 40 percent were found with at least one drug of any kind in their system. By 2017 that number had risen to almost 50 percent.

Of the pilots examined in the most recent study, 28 percent tested positive for at least one potentially impairing drug, up from 23 percent in the 2014 study, and 15 percent tested positive with at least one drug that pointed to a potentially impairing condition, a 3 percent increase from 2014.

Meanwhile, 10 percent were found to have a controlled substance in their system, up from 8 percent in 2014, and 5 percent tested positive for an illegal drug, up slightly from 4 percent in the 2014 study.

Nearly half the pilots involved had an ATP or commercial pilot certificate, he said, but cautioned that does not necessarily mean they were operating in business aviation. He also cautioned that not all were potentially impairing or illegal drugs, noting many involved slower sedating antihistamines and other over-the-counter cold and allergy medication.

He worried about those with potentially impairing drugs and/or conditions and said “it gets really concerning” with the controlled substances, which are

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