White House Blocks FDA Guidelines for COVID-19 Vaccine
New guidelines produced by the Food and Drug Administration (FDA) to ensure the safety of a vaccine to protect against the novel coronavirus are being blocked by White House officials. The new guidelines would almost certainly guarantee that a vaccine would not be ready and approved by Election Day, according to The New York Times.
An administration official told Reuters that the approval process was pending and there was no connection to Election Day.
The thorniest issue seems to be that the FDA guidelines mandate that vaccine developers follow patients enrolled in their trials for a minimum of two months before seeking approval for the vaccine under an Emergency Use Authorization license, according to the AP.
The recommendation from the FDA about the follow-up period is designed to make sure the vaccine is safe. A senior administration official confirmed that the White House was blocking the guideline, arguing there was "no clinical or medical reason" to wait two months, as the AP reported.
Two weeks ago, when the FDA signaled that it would issue tougher standards to increase transparency and increase public trust in the safety and efficacy of a vaccine, Trump signaled he may not be open to the tougher standards, dismissing it as a political move, according to The Hill.
During the weeks that the FDA has tried to implement stricter guidelines to ensure safety and efficacy, FDA Administrator Stephen Hahn has vowed that any and all decisions about approving a potential vaccine would be made by career scientists, not politicians, according to the AP.
White House Chief of Staff Mark Meadows has blocked the guidelines from moving forward, arguing the two-month follow up of patients would alter the rules in the midst of clinical trials. He also suggested that Hahn was bowing to pressure from career scientists, according to The New York Times.
In the face of White House resistance, the FDA is looking for a workaround, which includes handing off the standards to an advisory committee that must meet publicly before an emergency authorization license is granted. The idea behind the maneuver would be to have the committee adhere to the guidelines, even when confronted by the Trump administration's resistance to them, as The New York Times reported.
The administration's move to block the guidelines is undermining the public's trust that a vaccine is safe and effective. If one is released without public trust, that may make people resistant to receiving it, which would derail an immunization campaign.
"We cannot allow a lack of transparency to undermine confidence in the vaccine development process," Michelle McMurry-Heath, the president and chief executive officer of the trade group BIO, wrote in a letter sent Thursday evening to Trump's health secretary, Alex M. Azar II, as The New York Times reported. "The public must have full faith in the scientific process and the rigor of FDA's regulatory oversight if we are to end the pandemic."
Dr. Peter Marks, the head of FDA's vaccine division, in an online interview last week with the nonprofit Friends of Cancer Research, said the guidelines are simply an effort to educate the public on what the FDA is requiring of the drug manufacturers, according to the AP. "The companies know what we're expecting," he said.
Of the companies working on a vaccine, only Pfizer has said it may have a vaccine's safety and efficacy data complete before Election Day. Other vaccine candidates produced by Moderna, AstraZeneca, and Johnson and Johnson are under development under longer timelines, as the AP reported.
Additionally, FDA scientists have been discussing the contents of the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.
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By Teri Schultz
Europe is in a panic over the second wave of COVID-19, with infection rates sky-rocketing and GDP plummeting. Belgium has just announced it will no longer test asymptomatic people, even if they've been in contact with someone who has the disease, because the backlog in processing is overwhelming. Other European countries are also struggling to keep up testing and tracing.
Meanwhile in a small cabin in Helsinki airport, for his preferred payment of a morsel of cat food, rescue dog Kossi needs just a few seconds to tell whether someone has coronavirus.
<div id="bfda0" class="rm-shortcode" data-rm-shortcode-id="c60b1a0dedbedbe5e0ce44284aff852f"><blockquote class="twitter-tweet twitter-custom-tweet" data-twitter-tweet-id="1308390775328251906" data-partner="rebelmouse"><div style="margin:1em 0">Covid-19 dogs started their work today at the Helsinki Airport at arrival hall 2B. Dogs have been trained to detect… https://t.co/nw4mrw6eJM</div> — Helsinki Airport (@Helsinki Airport)<a href="https://twitter.com/HelsinkiAirport/statuses/1308390775328251906">1600779644.0</a></blockquote></div><p>If it were left to Kossi and his pals, crowds of potential virus carriers could be cleared in a fraction of the time for a fraction of the cost with none of the physical discomfort that accompanies the current nasal swab test based on the polymerase chain reaction (PCR) method.</p>
No Human Nose Needed<p>A dog can sniff a cloth wiped on a wrist or neck and immediately identify if it comes from someone who has contracted the virus as much as five days before any symptoms appear which would lead a person to go into isolation. "A dog could easily save so so, so many lives," University of Helsinki veterinary researcher Anna Hielm-Bjorkman told DW, who says their testing has shown an accuracy level of nearly 100%.</p><p>It was originally her idea to see whether Kossi, a talented disease-detection dog, could redirect his skills in sniffing out mold, bedbugs and cancer to detecting the new virus just as it started to spread in Europe. "It took him seven minutes to figure out 'okay, this is what you want me to look out for," Hielm-Bjorkman said. "So that totally blew our minds."</p><p>Susanna Paavilainen, the executive director of the Wise Nose scent-detection foundation and the woman who saved Kossi from euthanasia in a Spanish shelter eight years ago, immediately started retraining her dogs to find the coronavirus.</p><p>Miina, who used to track a young girl's blood sugar levels by scent, quickly came on board, along with two others already working in disease detection. In all, they hope to train 15 dogs in the first phase.</p><p>Hielm-Bjorkman said once they discovered the new capabilities, while the normal academic procedure would be to test, publish and get peer-reviewed, their first instinct was to get the dogs into service. "[Researchers] who are actually publishing," she noted wryly, "are not at the airports."</p>
Wags, Not Wages<p>But for that, they needed permission and ideally, some funding. Vantaa Deputy Mayor Timo Aronkyto, who is also responsible for airport security, saw the benefit straight away. "It took me two minutes," he told DW.</p><p>However, his funding options were limited to about $390,000 total for the four-month pilot project aiming to prove that results from the dog tests are at least as accurate as the PCR test. Anyone who tests positive at the voluntary canine site is requested to go to the medical unit for confirmation.</p><p>The interest of Aronkyto, a trained physician, is rooted in both health and wealth. "Our testing at the airport costs more than 1 million [euros] (USD $1.2 million) a month at the moment," he said, explaining he expects that to go up to €3 million (USD. $3.5 million) per month in winter. "These dogs would be much cheaper," he pointed out.</p><p>He's optimistic support will grow as data from the current pilot project accumulates, explaining there is already work underway to change Finnish legislation so eventually sniffer dogs would have the same "authority" as customs dogs.</p><p>Aronkyto anticipates one animal performing both functions in the near future. He plans to continue this level of funding from his city budget into next year but that doesn't train new dogs nor expand the capacity beyond the four that split shifts currently at the airport, even as infection rates rise.</p>
Helsinki Hesitates<p>Notably, however, the Finnish government has not signaled it would like to pick up the program itself, despite a huge surge in publicity and, as Hielm-Bjorkman and Paavilainen emphasize, interest from other countries. Travelers have been eager to participate, waiting in line more than an hour at times.</p><p>Finnish ambassador in Ramallah, Palestine, Paivi Peltokoski, praised the experience after a recent trip but, apparently, her enthusiasm is not overly contagious.</p>
<div id="d9823" class="rm-shortcode" data-rm-shortcode-id="61d382f115fe66a44eb793d9ebee3d94"><blockquote class="twitter-tweet twitter-custom-tweet" data-twitter-tweet-id="1318564228450615299" data-partner="rebelmouse"><div style="margin:1em 0">I was tested negative by two #coronadogs upon arrival at the #Helsinki airport in #Finland. Later a medical test ve… https://t.co/cGlWQn8DJb</div> — Päivi Peltokoski (@Päivi Peltokoski)<a href="https://twitter.com/PaiviPeltokoski/statuses/1318564228450615299">1603205184.0</a></blockquote></div><p>"If the government would see this already as something that they would believe in," Hielm-Bjorkman said, she could envision training hundreds of dogs, stationing sniffers at concert halls or sports matches or elderly care homes. She adds there's a need for a "paradigm shift" for both medical professionals and the public.</p><p>Usually it's doctors telling patients if they're sick, she explained, and "here it's a dog handler."</p>
Little Political Will on German Project<p>This situation is not limited to Finland. In Germany researchers also <a href="https://www.dw.com/en/german-sniffer-dogs-show-promise-at-detecting-coronavirus/a-54300863" target="_blank" rel="noopener noreferrer">announced promising results</a> with canines <a href="https://www.dw.com/en/coronavirus-german-military-training-sniffer-dogs/a-54062180" target="_blank" rel="noopener noreferrer">detecting COVID-19</a>, but no dogs have been used anywhere so far. And then, says Professor Holger Volk of the University of Veterinary Medicine Hanover, there has been insufficient political will or funding to move the project forward, something he called "very troubling" especially with a resurgent infection rate.</p><p>"When we started this whole project, we we did it because we wanted to help to stop the pandemic," Volk told DW. "It's really has been a very frustrating ride. I have had a lot of naysayers in the whole process. If I wasn't a very determined person, having done a lot of research, I would have probably stopped it."</p><p>He agrees with Hielm-Bjorkman's assessment that "it's just not in the perception of doctors that dogs are able to do this precise work." But he also echoes her faith in the vast potential of their discovery. "If you had a dog who could sniff every day quickly your cohort of workers, for example," he said, "think about the impact. You could continue having a workplace."</p><p>Speaking of workplaces, Susanna Paavilainen is starting to think if Finland doesn't want to unleash the dogs' potential at home, she and Kossi might accept one of the many requests from all over the world to provide training. "We can move because Kossi likes warm weather," she says, petting her star sniffer.</p>
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