
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.
- CDC Tells States to Prepare for a Vaccine Before November Election ›
- Trump and FDA Misrepresent Data as They Tout Blood Plasma ... ›
- Drugs Touted by Trump for COVID-19 Increase Heart Risks, Studies ... ›
- Sanders Rips Trump's Push to Rush COVID Vaccine - EcoWatch ›
New fossils uncovered in Argentina may belong to one of the largest animals to have walked on Earth.
- Groundbreaking Fossil Shows Prehistoric 15-Foot Reptile Tried to ... ›
- Skull of Smallest Known Dinosaur Found in 99-Million-Year Old Amber ›
- Giant 'Toothed' Birds Flew Over Antarctica 40 Million Years Ago ... ›
- World's Second-Largest Egg Found in Antarctica Probably Hatched ... ›
EcoWatch Daily Newsletter
A federal court on Tuesday struck down the Trump administration's rollback of the Obama-era Clean Power Plan regulating greenhouse gas emissions from power plants.
- Pruitt Guts the Clean Power Plan: How Weak Will the New EPA ... ›
- It's Official: Trump Administration to Repeal Clean Power Plan ... ›
- 'Deadly' Clean Power Plan Replacement ›
Trending
By Jonathan Runstadler and Kaitlin Sawatzki
Over the course of the COVID-19 pandemic, researchers have found coronavirus infections in pet cats and dogs and in multiple zoo animals, including big cats and gorillas. These infections have even happened when staff were using personal protective equipment.
Gorillas have been affected by human viruses in the past and are susceptible to the coronavirus. Thomas Fuhrmann via Wikimedia Commons, CC BY-SA
- Gorillas in San Diego Test Positive for Coronavirus - EcoWatch ›
- Wildlife Rehabilitators Are Overwhelmed During the Pandemic. In ... ›
- Coronavirus Pandemic Linked to Destruction of Wildlife and World's ... ›
- Utah Mink Becomes First Wild Animal to Test Positive for Coronavirus ›
By Peter Giger
The speed and scale of the response to COVID-19 by governments, businesses and individuals seems to provide hope that we can react to the climate change crisis in a similarly decisive manner - but history tells us that humans do not react to slow-moving and distant threats.
A Game of Jenga
<p>Think of it as a game of Jenga and the planet's climate system as the tower. For generations, we have been slowly removing blocks. But at some point, we will remove a pivotal block, such as the collapse of one of the major global ocean circulation systems, for example the Atlantic Meridional Overturning Circulation (AMOC), that will cause all or part of the global climate system to fall into a planetary emergency.</p><p>But worse still, it could cause runaway damage: Where the tipping points form a domino-like cascade, where breaching one triggers breaches of others, creating an unstoppable shift to a radically and swiftly changing climate.</p><p>One of the most concerning tipping points is mass methane release. Methane can be found in deep freeze storage within permafrost and at the bottom of the deepest oceans in the form of methane hydrates. But rising sea and air temperatures are beginning to thaw these stores of methane.</p><p>This would release a powerful greenhouse gas into the atmosphere, 30-times more potent than carbon dioxide as a global warming agent. This would drastically increase temperatures and rush us towards the breach of other tipping points.</p><p>This could include the acceleration of ice thaw on all three of the globe's large, land-based ice sheets – Greenland, West Antarctica and the Wilkes Basin in East Antarctica. The potential collapse of the West Antarctic ice sheet is seen as a key tipping point, as its loss could eventually <a href="https://science.sciencemag.org/content/324/5929/901" target="_blank">raise global sea levels by 3.3 meters</a> with important regional variations.</p><p>More than that, we would be on the irreversible path to full land-ice melt, causing sea levels to rise by up to 30 meters, roughly at the rate of two meters per century, or maybe faster. Just look at the raised beaches around the world, at the last high stand of global sea level, at the end of the Pleistocene period around 120,0000 years ago, to see the evidence of such a warm world, which was just 2°C warmer than the present day.</p>Cutting Off Circulation
<p>As well as devastating low-lying and coastal areas around the world, melting polar ice could set off another tipping point: a disablement to the AMOC.</p><p>This circulation system drives a northward flow of warm, salty water on the upper layers of the ocean from the tropics to the northeast Atlantic region, and a southward flow of cold water deep in the ocean.</p><p>The ocean conveyor belt has a major effect on the climate, seasonal cycles and temperature in western and northern Europe. It means the region is warmer than other areas of similar latitude.</p><p>But melting ice from the Greenland ice sheet could threaten the AMOC system. It would dilute the salty sea water in the north Atlantic, making the water lighter and less able or unable to sink. This would slow the engine that drives this ocean circulation.</p><p><a href="https://www.carbonbrief.org/atlantic-conveyor-belt-has-slowed-15-per-cent-since-mid-twentieth-century" target="_blank">Recent research</a> suggests the AMOC has already weakened by around 15% since the middle of the 20th century. If this continues, it could have a major impact on the climate of the northern hemisphere, but particularly Europe. It may even lead to the <a href="https://ore.exeter.ac.uk/repository/handle/10871/39731?show=full" target="_blank" rel="noopener noreferrer">cessation of arable farming</a> in the UK, for instance.</p><p>It may also reduce rainfall over the Amazon basin, impact the monsoon systems in Asia and, by bringing warm waters into the Southern Ocean, further destabilize ice in Antarctica and accelerate global sea level rise.</p>The Atlantic Meridional Overturning Circulation has a major effect on the climate. Praetorius (2018)
Is it Time to Declare a Climate Emergency?
<p>At what stage, and at what rise in global temperatures, will these tipping points be reached? No one is entirely sure. It may take centuries, millennia or it could be imminent.</p><p>But as COVID-19 taught us, we need to prepare for the expected. We were aware of the risk of a pandemic. We also knew that we were not sufficiently prepared. But we didn't act in a meaningful manner. Thankfully, we have been able to fast-track the production of vaccines to combat COVID-19. But there is no vaccine for climate change once we have passed these tipping points.</p><p><a href="https://www.weforum.org/reports/the-global-risks-report-2021" target="_blank">We need to act now on our climate</a>. Act like these tipping points are imminent. And stop thinking of climate change as a slow-moving, long-term threat that enables us to kick the problem down the road and let future generations deal with it. We must take immediate action to reduce global warming and fulfill our commitments to the <a href="https://www.ipcc.ch/sr15/" target="_blank" rel="noopener noreferrer">Paris Agreement</a>, and build resilience with these tipping points in mind.</p><p>We need to plan now to mitigate greenhouse gas emissions, but we also need to plan for the impacts, such as the ability to feed everyone on the planet, develop plans to manage flood risk, as well as manage the social and geopolitical impacts of human migrations that will be a consequence of fight or flight decisions.</p><p>Breaching these tipping points would be cataclysmic and potentially far more devastating than COVID-19. Some may not enjoy hearing these messages, or consider them to be in the realm of science fiction. But if it injects a sense of urgency to make us respond to climate change like we have done to the pandemic, then we must talk more about what has happened before and will happen again.</p><p>Otherwise we will continue playing Jenga with our planet. And ultimately, there will only be one loser – us.</p>By John R. Platt
The period of the 45th presidency will go down as dark days for the United States — not just for the violent insurgency and impeachment that capped off Donald Trump's four years in office, but for every regressive action that came before.
- Biden Announces $2 Trillion Climate and Green Recovery Plan ... ›
- How Biden and Kerry Can Rebuild America's Climate Leadership ... ›
- Biden's EPA Pick Michael Regan Urged to Address Environmental ... ›
- How Joe Biden's Climate Plan Compares to the Green New Deal ... ›