…Honestly I have been more or less doing this since they decided there were no cases in the US up to well after there were over 100 deaths.
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Mark Mothersbaugh, co-founder of Devo, nearly died from COVID-19.
FaceTiming with his family kept him alive
As Mark Mothersbaugh lay in a Cedars-Sinai hospital bed in early June after contracting the novel coronavirus, a ventilator tube snaking into his throat to help him breathe, the Devo cofounder and acclaimed film and TV composer came to believe that he was recovering from a vicious beating in downtown Los Angeles.
“There’s a bookstore I love there where I get stationery supplies, and in my mind I had been there,” Mothersbaugh, 70, said Thursday afternoon, sitting on the patio of the Hollywood Hills home he shares with his wife, Anita Greenspan, and two teenage daughters. “I was convinced for about two weeks that I had been hit by a brick by somebody in Little Tokyo.”
Wearing chrome-framed eyeglasses, his nose and mouth covered by a black mask branded with the logo of his Mutato Musika commercial music company, Mothersbaugh touched his right temple while recalling the experience, as if searching for a head wound.
“I felt blood from being hit. I was handcuffed to a parking deck downtown. I had this whole elaborate story of how these kids sold me to an ambulance company that then got some sort of a payment for delivering COVID patients to their ICUs. I totally believed it,” he said.
Mothersbaugh’s delusions lasted more than two weeks during his time both on and off the ventilator. In fact, the artist didn’t contract the virus that causes COVID-19 while shopping in Little Tokyo. He caught it shuttling between his house and his Sunset Strip offices and studios in late May. His family was in Palm Springs. After he tested positive, he insisted on isolating by himself.
Three harrowing months later, Mothersbaugh and his family are back together and virus free. His experience, he says, was devastating. It was also unfortunately instructive, as it confirms an argument that he and his groundbreaking band, Devo, have been making for nearly 50 years.
“Everything’s become more devolved than I would have imagined possible,” he said. “For anybody that’s doubting whether the coronavirus and COVID-19 is real, it’s really real.”
He’s seen the doubters first hand. As he was recovering at home, a houseful of TikTok influencers across the street threw massive parties despite the shutdown and made news when Mayor Eric Garcetti shut off the property’s power. De-evolution is really real too.
Adjusting his mask, Mothersbaugh recalled the circumstances that led to his hospitalization.
He’d been taking the coronavirus seriously, he said. As news spread of its dangers, he’d avoided in-studio recording sessions for the four animated films he’d been scoring, instead conferencing in to observe and consult. But still, on at least one occasion near the end of May while working at Mutato, he unintentionally found himself in the company of a number of people he didn’t know.
When symptoms arrived a few days later, he thought his exhaustion was from juggling too many things at once. Then he took his temperature. It read 103. At first he thought he was reading the thermometer wrong. He told his wife, and she immediately started making calls.
Recalls Mothersbaugh, “A nurse came over the next morning and said, ‘You should be in ICU.’ I said, ‘That’s ridiculous.’ She replied that she’d been a nurse for three decades: ‘You need an ambulance right now.’”
From Greenspan’s perspective, the virus steamrolled through her husband’s system. “It went from, ‘I don’t feel good’ on Tuesday to an ambulance to Cedars on Saturday. It was terrifying.” She believes that the nurse, Patricia Lineweaver, saved Mothersbaugh’s life.
Mothersbaugh spent much of the next 18 days on his back, tilted up in his hospital bed in the intensive care unit. Isolated, like all of those infected with the virus, from everyone except essential medical personnel, he lost all track of time and space. Tubes and machines cuffed him in place. At one point, he tried to break free of all the stuff attached to him and they had to secure his arms and legs.
During video calls with Greenspan and their daughters, 19-year-old Hui Hui and Margaret, 16, Mothersbaugh pressed them for information about the Little Tokyo brick-throwing incident. Had they found his attackers? Did they have any suspects? “Some of the delusions were very dark,” Mothersbaugh recalled. “Like, ‘Oh no, I have to get out of this place.’”
As he drifted in and out of consciousness, he remembers “a lot of people coming in on stretchers and people going out on stretchers.”
Another extended departure from reality involved Devo, the band he cofounded at Kent State after four students were killed by National Guard members in 1970.
While attached to the ventilator, he said: “I wrote a whole new Devo album and put together a whole live show.” In his hallucination, the band performed it on the streets of Hollywood — through the use of augmented reality. “We were standing on top of these projections, which were growing somehow.”
In reality, while Mothersbaugh was fighting for his life, in the outside world, Devo’s trademark “energy domes,” the flower pot-shaped red headgear the band wore during its early 1980s peak, were becoming a meme on social media. Someone at the company that manufacturers the domes realized that another of its products, plastic face shields, could easily be affixed to the hats to create a Devo dome-shield.
As both the meme and the virus advanced, Greenspan and their daughters kept a constant vigil through video calls.
During one crucial moment, Mothersbaugh believes they helped him stay tethered to the present.
His voice turning soft, he remembered “a time where I just felt exhausted. Like, ‘I could just float down this river right now, and it would be really peaceful. It wouldn’t be a freak-out. It wouldn’t be something I’d be scared of. I could really just do that.’ I really thought about it.
“And then it just happened that [Greenspan] called me, and she and the kids were on my phone, saying, ‘You’re getting out of there soon. Get off of that machine.’ I don’t know if everybody is lucky enough to have somebody do that for them.”
For Mothersbaugh, the message he most wants to convey is: “If you have anyone that you know who’s in ICU with COVID, contact them and keep them in touch with the outside world, because it’s easy to lose track of where you are and why you are. I had no idea I was on a ventilator for 10 days. Time meant nothing.”
Greenspan said that when the nurses finally removed the ventilator tube from her husband’s mouth, the first thing he said was, “Has anybody seen my glasses?”
Nearly two months after being discharged, the TikTokkers are gone and Mothersbaugh is back at work. He says he’s still feeling a few fading after-effects. Holding out his left hand, which is trembling slightly, he described “a little thing with my nerves.” Worse, though, is the overall physical toll, which he described as “creepy.”
“Before COVID, I was like, ‘Yeah, I’m starting to feel about 50 now, and I’m 70.’ When I was in the hospital, I was feeling like I was about 90. And now I’m back to 70, and I’m trying to get back to 50. That’s my goal.”
He says he’s been recovering by completing a visual art project he’s spent decades working on, one involving his long history in postcard art. In collaboration with artist Beatie Wolfe, Mothersbaugh has launched Postcards for Democracy, which the two describe as “a demonstration to support the 225-year-old U.S. Postal Service and the right to vote.” The aim is to help fund the Postal Service in advance of the November election.
Sighing through his face mask, Mothersbaugh said, “I remember at the end of 2019 talking to somebody and saying, ‘You know, I think 2020 is going to be a whole lot better.’ It kind of cracks me up to think about now.”
He added, with a hint of feigned enthusiasm, “We’re all getting to live through a pandemic. Who would have thought?”
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right?! I mean I just don’t know how I feel about this vaccine 
Do we trust science coming out of this FDA? This administration brought back asbestos like it was no big thing. Now they approve a vaccine we all really need, magically right in time for the election? I just don’t know…
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Are you kidding??? I will be all over a vaccine that successfully completes phase III trials and publishes peer-reviewed data illustrating their successes.
At least you know they won’t mandate it, a solid chunk of their base is comprised of “vaccine skeptics” or whatever.
Well, yeah. I’m just concerned about rushing the phase III trials to meet an election deadline for our President. Vaccines can only help us if they’re both safe and effective.
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Here’s a list of all the vaccines currently in phase 3 testing
Coronavirus Vaccine Tracker
Filter the list of vaccines:
PHASE 3
Moderna develops vaccines based on messenger RNA (mRNA) to produce viral proteins in the body. They have yet to bring one to the market. The government has bankrolled Moderna’s efforts on a coronavirus vaccine with nearly $1 billion. In partnership with National Institutes of Health , they found that the vaccine protects monkeys from the coronavirus. In March, the company put the first Covid-19 vaccine into human trials, which yielded promising results, After carrying out a Phase 2 study they launched a Phase 3 trial on July 27. The final trial will enroll 30,000 healthy people at about 89 sites around the United States. On August 11, the government awarded the company an additional $1.5 billion in exchange for 100 million doses if the vaccine proves safe and effective.
In July, Moderna lost a patent dispute over some of their vaccine technology. The following month, the company stated that it could not be certain it was the first to make the inventions claimed in their patents, including its coronavirus vaccine.
Updated Aug. 17PHASE 2 PHASE 3 COMBINED PHASES
The German company BioNTech entered into collaborations with Pfizer , based in New York, and the Chinese drug maker Fosun Pharma to develop an mRNA vaccine. In May they launched a Phase 1/2 trial on two versions of the vaccine. They found that both versions caused volunteers to produce antibodies against SARS-CoV-2, as well as immune cells called T cells that respond to the virus. They found that one version, called BNT162b2, produced significantly fewer side effects, such as fevers and fatigue, and so they chose it to move into Phase 2/3 trials. On July 27, the companies announced the launch of a Phase 2/3 trial with 30,000 volunteers in the United States and other countries including Argentina, Brazil, and Germany.
In that same month, the Trump administration awarded a $1.9 billion contract for 100 million doses to be delivered by December and the option to acquire 500 million more doses. Meanwhile, Japan made a deal for 120 million doses. In August, Pfizer said it was on track to seek regulatory review of their vaccine as early as October 2020. If approved, Pfizer has said they expect to manufacture over 1.3 billion doses of their vaccine worldwide by the end of 2021.
Updated Aug. 21PHASE 3 APPROVED FOR LIMITED USE
The Chinese company CanSino Biologics developed a vaccine based on an adenovirus called Ad5, in partnership with the Institute of Biology at the country’s Academy of Military Medical Sciences . In May, they published promising results from a Phase 1 safety trial, and in July they reported that their Phase 2 trials demonstrated the vaccine produced a strong immune response. In an unprecedented move, the Chinese military approved the vaccine on June 25 for a year as a “specially needed drug.” CanSino would not say whether vaccination would be mandatory or optional for soldiers. On August 9, the Saudi health ministry announced that CanSino Biologics would run a Phase 3 trial in Saudi Arabia, and later in the month they also started a trialin Pakistan.
Updated Aug. 27PHASE 3 APPROVED FOR EARLY USE
The Gamaleya Research Institute , part of Russia’s Ministry of Health, launched a Phase 1 trial in June of a vaccine they called Gam-Covid-Vac Lyo. It is a combination of two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene. In July, the chair of the upper house of Russia’s Parliament said the country might start vaccine production by the end of the year.
On Aug. 11, President Vladimir V. Putin announced that a Russian health care regulator had approved the vaccine, renamed Sputnik V, before Phase 3 trials had even begun. Vaccine experts decriedthe move as risky, and Russia later walked back the announcement, saying that the approval was a “conditional registration certificate,” which would depend on positive results from Phase 3 trials. Those trials, initially planned for just 2,000 volunteers, were expanded to 40,000.
Updated Aug. 28PHASE 2 PHASE 3 COMBINED PHASES
A vaccine in development by the British-Swedish company AstraZeneca and the University of Oxford is based on a chimpanzee adenovirus called ChAdOx1. A study on monkeys found that the vaccine provided them protection. In May, the United States awarded the project $1.2 billion in support. Their Phase 1/2 trial revealed that the vaccine was safe, causing no severe side effects. It raised antibodies against the coronavirus as well as other immune defenses. The vaccine is now in Phase 2/3 trials in England and India, as well as Phase 3 trials in Brazil, South Africa, and the United States.
In August the European Union reached an agreement for AstraZeneca to deliver 400 million doses if the trials yield positive results. AstraZeneca has indicated they might be able to start delivering emergency vaccines as early as October, depending on the outcome of the studies. The company has said their total manufacturing capacity for the vaccine, if approved, stands at two billion doses. India’s Serum Institute has already produced millions of doses to be used in trials.
Updated Aug. 17PHASE 3 APPROVED FOR LIMITED USE
The private Chinese company Sinovac Biotech is testing an inactivated vaccine called CoronaVac. In June the company announced that Phase 1/2 trials on 743 volunteers found no severe adverse effects and produced an immune response. Sinovac then launched a Phase 3 trial in Brazil in July and another in Indonesia the following month. Reuters reported that the Chinese government gave the Sinovac vaccine an emergency approval for limited use in July. Meanwhile, Sinovac has been preparing to manufacture the vaccine, reaching an agreement to supply Indonesia with at least 40 million doses by March 2021.
Updated Aug. 31PHASE 3
The Wuhan Institute of Biological Products developed an inactivated virus vaccine, which the state-owned Chinese company Sinopharm put into clinical tests. The Phase 1/2 trial showed that the vaccine produced antibodies in volunteers, some of whom experienced fevers and other side effects. They launched Phase 3 trials in the United Arab Emirates in July, and in Peruand Morocco the following month. Sinopharm’s chairman said in August that the vaccine could potentially be ready for public use by the end of 2020. Sinopharm said that the Chinese government approved one of their two inactivated virus vaccines for emergency use in July, but it was not clear which one got the approval.
Updated Aug. 31PHASE 3
Sinopharm is also testing a second inactivated virus vaccine, this one developed by the Beijing Institute of Biological Products . In Phase 3 trials in the United Arab Emirates, 5,000 people are receiving the Wuhan Institute version, while another 5,000 are receiving the Beijing Institute one. Sinopharm said that the Chinese government approved one of their two inactivated virus vaccines for emergency use in July, but it was not clear which one got the approval.
Updated Aug. 8PHASE 3
The Bacillus Calmette-Guerin vaccine was developed in the early 1900s as a protection against tuberculosis. The Murdoch Children’s Research Institute in Australia is conducting a Phase 3 trialcalled the BRACE to see if the vaccine partly protects against the coronavirus.Note: Vaccines will be added to the tracker when they reach Phase 1, and tracked until they succeed or fail.
Did we miss something? To notify The Times of new developments, send updates to [email protected].
Tracking the Coronavirus
Additional reporting by Andrew Kramer, Carlos Tejada and Li Cao.
Note: Early versions of the tracker combined two vaccines by Sinopharm into one entry. Subsequent reporting confirmed they are two different vaccines. A previous version of the tracker stated that Pfizer had reached a deal with the EU, when in fact the deal was made by AstraZeneca.
Sources: World Health Organization, National Institute of Allergy and Infectious Diseases, National Center for Biotechnology Information, New England Journal of Medicine.
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The problem is, Trump’s cut out phase III testing and is rushing forward blindly. It’s not good, and it’s bound to make people wary.
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As the C.D.C. prepares for two vaccines, here are some answers to a few of the most common questions.
In planning documents sent last week to public health agencies around the country, the U.S. Centers for Disease Control and Prevention described preparations for two coronavirus vaccines simply referred to as Vaccine A and Vaccine B.
But the technical details, including the time between doses and storage temperatures, match well with the two vaccines furthest along in U.S. clinical tests, made by Moderna and Pfizer.
Some experts are concerned about what they see as a rushed process. “It’s hard not to see this as a push for a pre-election vaccine,” said Saskia Popescu, an infection prevention epidemiologist in Arizona.
Still, public health experts agree that agencies at all levels of government should urgently prepare for what will eventually be a vast, complex effort to vaccinate hundreds of millions of Americans.
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THIS is the part that really scares me.
How do these vaccines work?
Moderna and Pfizer are testing a new kind of vaccine that has never before been approved for use by people. It contains genetic molecules called messenger RNA that are injected into muscle cells, which treat them like instructions for building a protein.
How well do they work?
Both vaccines have gone through extensive early tests, but it is not known if they’re safe and effective.
So they’re rushing out a never-before-tried vaccine.
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Trump ignores lessons of pandemic failures as election looms
The fatal flaw of President Donald Trump’s botched pandemic response has been a yearning for a quick return to normality that is dangerous and unattainable while the coronavirus still lies in wait.
And now he may be making the same mistake again.
When he is not diverting attention from the health crisis by stoking controversy over racial injustice and unrest in US cities, Trump has returned to his aggressive push to get the economy firing on all cylinders. A new demand for a full slate of college football games follows his earlier demands for all kids and students to get back to class.
But while the President is surely channeling the fatigue of millions of Americans with the pandemic, his demand for reopening without offering solutions that could restore a semblance of regular life safely is another apparent sign he’s prioritizing his political prospects over science.
With 184,000 Americans already dead, White House officials are hoping that Trump’s dive into cultural warfare following protests and unrest over police brutality will to some extent cover over his liabilities on the pandemic, sources told CNN reporters. Following last week’s Republican National Convention that largely ignored the virus,Trump is making yet another premature declaration of victory over the worst public health disaster in 100 years.
“We’ve done a great job in Covid but we don’t get the credit,” Trump said on Fox News on Monday.
But the unspoken reality of that approach is that many more Americans will contract Covid-19 before the election, and thousands more will die. That is likely to play into efforts by Democratic presidential nominee Joe Biden to crush Trump’s hopes of a second term by lambasting his failures during the pandemic.
“Mr. Trump, you want to talk about fear?” Biden asked on Monday.
“Do you know what people are afraid of in America? They’re afraid they’re going to get Covid. They’re afraid they’re going to get sick and die, and that is in no small part, it’s because of you.”
New CNN reporting reveals that White House officials have all but given up hopes of stopping the pathogen and are now returning to a forceful state opening strategy. The shift comes amid fierce political pressure from the White House on government agencies to approve new treatments and even a vaccine before Phase 3 trials are complete – in a move that could provide a short-term political payoff for the President while he is locked in a tough reelection fight but could have dire scientific consequences.
“We risk a blow-back. We risk one step forward, three steps backwards,” Dr. Tom Frieden, a former director of the Centers for Disease Control and Prevention, told CNN’s Chris Cuomo on Monday night.
“That’s what happened with this administration opening too soon in southern states. That’s what’s happening in schools opening where there’s lots of COVID, and having to slam shut again,” he added. “We don’t want that to happen with a vaccine, because vaccines are precious. They’re our most powerful tools to control a pandemic.”
Discord inside coronavirus task force
Trump’s growing impatience coincides with multiple reports that the White House is growing receptive to the herd immunity, a theory reportedly advanced by the President’s favorite new adviser Dr. Scott Atlas.
The concept relies on allowing the virus to spread to build community resistance. Independent medical experts warn such an approach could lead to several million US deaths in the long-term. Atlas has forcibly denied he backs such a strategy. Yet an administration official told CNN many of his policies appear to point to such an approach. And even if the administration has not formally endorsed herd immunity, its failure to corral the pandemic and resistance to full-throated promotion of social distancing and masks – flagrantly demonstrated by Trump’s Republican convention speech at the White House last week – means that it is almost falling into such a counter-virus plan by default.
“Whether the number is 2 million, 1 million Americans dead, it’s unacceptable,” said Dr. Peter Hotez, Dean of the School of Tropical Medicine at Baylor University, told CNN’s “New Day” on Tuesday.
Sources told CNN that that key players around Trump inside the administration have all but given up hope of quelling the virus with the aggressive suppression and mitigation efforts advocated by trusted medical experts like Dr. Anthony Fauci.
While US infections and deaths are declining, they remain at levels unseen in most of the developed world. There are flashing warning signs through the Midwest. Surging cases in colleges that have welcomed students back point to the inexorable threat from the disease. And there are already fears that the Labor Day holiday could produce a spike in infections much as Memorial Day did, ahead of a feared fall resurgence.
Some colleges and smaller schools have succeeded with rigorous testing and quarantine programs with safe openings. But every day brings more stories of the broader reopening going off the rails. At least 37 states are reporting a total of 25,000 positive cases of Covid-19 at colleges and universities.
Time is running out before the election
Trump’s demands for swift openings of state economies earlier this year helped unleash a wave of sickness and death across sunbelt states that had escaped the initial peaks of infection that hammered New York and California.
But two months before Election Day, and with time running out for the rocketing economic bounce-back he has promised, Trump is again ignoring the potential consequences of a rapid return to normal.
“We’re opening it up and we’re opening it up to record numbers,” he said in New Hampshire on Friday night. “Democrats are keeping their states shut down and hurting people that live in those states.”
After months of lockdowns and stay at home orders, Americans are impatient to have their lives back. And it may be time to rebalance the risk between becoming infected and living with a semblance of normality. But in a dereliction of duty, Trump’s administration has failed to put in place measures like a massive test and tracing program that might make such a goal possible and limit its potential danger.
Trump, instead, is focused on other things.
On Tuesday, the President revealed that he has spoken to the commissioner of the Big Ten to try and get its games back on, after the college powerhouse conference postponed its season over coronavirus concerns, including shortages of testing capabilities and concerns over the long-term health impact of the disease on athletes. Several other conferences plan to go ahead with games, and Trump piled pressure on the Big Ten to follow suit.
“We’re pushing very hard. … I think they want to play, and the fans want to see it, and the players have a lot at stake, including possibly playing in the NFL,” he told reporters.
The President’s initiative – which does not appear to include new measures to solve the issues that caused the season pause – looks like yet another attempt to downplay science in a bid to recreate normality. While the prospect of no fall football is unthinkable, the Big Ten just happens to include several schools in crucial Midwest swing states like Michigan, Minnesota, Pennsylvania, Iowa, Wisconsin and Ohio, which may explain the sports-fan-in-chief’s concern.
The college football push is the latest sign of the deficit in Trump’s approach to the virus. Time and again the US experience – one being learned in the rest of the world – is that the virus just doesn’t go away. The only way to reopen colleges, businesses, restaurants and travel is to conquer it.
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Unlikely that a COVID-19 vaccine will be ready in October, but not impossible, Fauci says
https://mobile.reuters.com/article/amp/idUSKBN25U2B0
Top U.S. infectious diseases expert Anthony Fauci said on Thursday it is unlikely a COVID-19 vaccine will be ready by the end of October, but that it is not impossible.
"I think most of the people feel it’s going to be November, December," Fauci said in a CNN interview when asked about the possibility of an earlier release, adding a clinical trial could prompt drug developers to decide a vaccine works sooner. "It is conceivable that you can have it by October, though I don’t think that that’s likely."
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This is where “peer-reviewed” comes in. Peer review is a process designed to address exactly this issue that can take months, and if the person who ends up with it says “yeah this study is poorly-conducted inconclusive garbage” they will toss it and so will whatever journal is asked to publish it. If they say “hey this is fine actually” then hey, I’m in.
Even assuming a vaccine is okay’d this soon it will not be reviewed right away, and the review itself can take quite a while, and with something like this… to me it’s not worth the risk of skipping that step.
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I think we can all agree that it’s ok to feel a little nervous about the efficacy and safety of a coronavirus vaccine developed under the Trump administration. Our concerns seem to be the same. It’s disheartening but understandable given the gaslighting and downright corrupt behavior we have witnessed from the President.
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More evidence that COVID-19 affects us in so many ways we do not yet understand. It is not merely an “old person’s disease.”
PSU football doctor: 30-35 percent of COVID-19-positive Big Ten athletes had myocarditis
https://www.centredaily.com/sports/college/penn-state-university/psu-football/article245448050.html
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looooooooooooooool my husband just got back from the grocery store and he says in the checkout line there was a lady standing next to him who took off her mask to have a coughing fit and didn’t put it back on, and when he and the cashier said something she was like “what? I don’t have covid or anything.” So that’s gross and upsetting.
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Yes, tell us how effective those vaccines which are being sped up to produce are going to be…we’d really like to know.
WTF…
Pandemic control expert Laura Garrett puts out link for Sen Durbin (D-Il) about just that.
09.03.20
Durbin To Operation Warp Speed Vaccine Companies: How Will You Ensure Scientific Integrity In Face Of Political Pressure From President Trump?
SPRINGFIELD – U.S. Senate Democratic Whip Dick Durbin (D-IL) today sent letters to each pharmaceutical company with a vaccine candidate under Operation Warp Speed asking how they plan to maintain scientific and data-based standards in the face of White House political pressure regarding the COVID-19 vaccine approval process. In letters to Moderna, AstraZeneca, Sanofi and GlaxoSmithKline, Merck, Pfizer, Novavax, and Janssen (part of Johnson & Johnson), Durbin highlighted how President Trump’s recent convalescent plasma and hydroxychloroquine controversies with the Food and Drug Administration (FDA) and comments stating a vaccine would be ready by Election Day have only increased public skepticism about the safety and efficacy of a potential COVID-19 vaccine and undermined credibility in the vaccine approval process. Durbin asked the companies to answer a series a questions, including whether any have felt political pressure from the White House to rush the approval process for a COVID-19 vaccine.
“Despite President Trump’s rosy outlook, our public health and biomedical experts have not projected such confidence in the timeline that the President seeks,” Durbin wrote. “Recent public surveys have indicated alarming levels of skepticism among the American public about taking a coronavirus vaccine if shortcuts were taken or if the approval was motivated by politics rather than science… Americans are eagerly seeking a safe and effective vaccine for COVID-19, and there has been significant and swift work to bring several vaccine candidates to clinical trials. To bolster public confidence in the integrity of the vaccine approval process, I request answers to the following questions from you by September 17, 2020.”
Full text of today’s letter to Moderna is available here.
Full text of today’s letter to AstraZeneca is available here.
Full text of today’s letter to Sanofi is available here.
Full text of today’s letter to GlaxoSmithKline is available here.
Full text of today’s letter to Merck is available here.
Full text of today’s letter to Pfizer is available here.
Full text of today’s letter to Novavax is available here.
Full text of today’s letter to Janssen with Johnson & Johnson is available here.
A copy of today’s letter to each company is available below:
September 3, 2020
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Vaccine Makers Plan Public Stance to Counter Pressure on FDA
Drugmakers are planning a public pledge to not send any Covid-19 vaccine to the FDA for review without extensive safety and efficacy data, according to people familiar with the effort.
The joint stance is seen as a bulwark against political pressure being applied on the Food and Drug Administration to get a vaccine out as soon as possible. It is likely to be announced in a multi-company statement as soon as next week. The plans, which could still change, were described by people involved in the effort on condition of anonymity.
The companies involved in the discussions include Pfizer Inc., Moderna Inc., Johnson & Johnson, GlaxoSmithKline Plc, Sanofi and possibly others. All are developing vaccines for Covid-19.
The drug industry has long relied on the FDA as a gold-standard seal of approval for its drugs and vaccines, assuring patients that the products are safe and effective. But in the middle of the pandemic, the agency has made several controversial decisions to allow emergency use of therapies without rock-solid evidence they work.
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It would sure be nice to see Pfizer and GlaxoSmithKline put their names on something that wasn’t shady so hopefully they go through with it.
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