Along with the many political and public health questions raised by President Trump’s recent and very public bout with COVID-19 is the issue of when the public might have access to the same monoclonal antibody therapy that he received from doctors last week.
Having seen the President tout the benefits of Regeneron’s experimental antibody cocktail, COVID patients have reportedly been asking physicians about participating in clinical trials of the therapy, which is only available on a “compassionate use” basis outside of ongoing studies.
On Wednesday, Regeneronannounced it had submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the treatment, claiming that early data from ongoing trials showed promise in moderating coronavirus symptoms.
Eli Lilly, which is developing a similar antibody therapy, also announced plans to apply for an EUA, saying its drug has shown the ability to reduce hospitalizations among those infected with the virus.
The US government has already paid Regeneron $450M to access up to 300,000 doses of the therapy, and on Friday a spokesman for the Department of Health and Human Services (HHS) said the government would acquire up to a million doses from Regeneron and Eli Lilly by the end of the year, which it will allocate to hospitals in a similar approach to the way it has distributed Gilead Science’s antiviral drug remdesivir, which the President was also given last week.
News on the availability of potentially effective therapies to mitigate the impact of COVID-19 is welcome, particularly as thetimeline for COVID vaccines appears to be lengthening.
In guidance released this week, the FDA said it would require pharmaceutical companies to submit two months’ worth of data on vaccine safety and efficacy after patients received their final dose, as part of the EUA application process. The data requirement effectively means that, despite repeated promises from the White House, none of the vaccine candidates being developed will be available before the November 3rd Presidential election.
The head of the government’s vaccine program said separately this week that he expects data on vaccines being developed by Pfizer and Moderna to be available by December. As many have predicted, it will take months beyond that for a safe and effective vaccine to be distributed and administered to a majority of Americans.
Challenges will abound: ensuring sufficient manufacturing capacity, managing a complex supply chain, setting up specialized distribution and vaccination centers, and tracking those vaccinated (especially if two shots will be required). A massive public education campaign will also be needed to overcome vaccine hesitancy and ensure widespread immunization. And all of that will take time, and money.
President Trump’s recent and unfortunate illness underscores the importance of paying equal attention to the development of therapies and treatments—which are essentially a holding maneuver to get us through the coming winter and spring, and eventually to the promise of immunity that lies beyond.
“Last night I shared a post on Facebook that said, ‘Hey, the flu shot isn’t about you.’ Sitting here, soaking up every ounce of caffeine before my night shift, I figured I should elaborate.
The flu shot is for Influenza, a severe respiratory illness that can lead to death. Have you ever had it? I have, and it’s awful. You spike fevers, every bone and muscle in your body aches, and no matter how hard you try, you just can’t seem to catch your breath.
You get the flu shot not always for you, but for those around you. For the grandparents, whose bodies are not what they used to be, and they just can’t kick an illness in the butt like when they were young.
For the 30 year old, with HIV or AIDS, who has a weakened immune system.
For the 25-year-old mother of 3 who has cancer. She has absolutely zero immune system because of chemotherapy.
For the newborn baby who was just welcomed into the world, and isn’t quite strong enough to fight off infections on his own.
For the nurses and doctors that take care of you. If they get sick, they can’t go to work and take care of the countless patients that need them.
For the 50-year-old husband who needs a medication for his chronic illness, and that medication also weakens his immune system.
For the pregnant mom that has been trying to get pregnant for years, and now she’s trying to stay healthy for her unborn baby.
For the single dad who can’t take any more sick days and needs to provide for his kids.
For the 7-year-old boy that just wants to play with his friends. But he has a disease that puts him at a higher risk for infection, so he has to stay inside.
The flu shot is NOT always about you. It’s about protecting those around you, who cannot always protect themselves. I have been in the room as a patient has passed away, because of influenza. I have watched patients struggle to breathe, because of influenza. I have busted my butt to provide tylenol, warm blankets, nebulizers, etc. to keep that patient comfortable and fighting a terrible respiratory infection.
The D.C. Health Department is trying to jump-start contact tracing efforts around the White House’s coronavirus outbreak. Tracing has been inadequate so far even as cases spread deeper into the city, Axios’ Marisa Fernandez writes.
The big picture:The White House has decided not to move forward with recommended public health protocols of contact tracing and testing since President Trump tested positive for the virus.
The state of play: Tracing has been done for people who had direct contact with Trump, White House spokesman Judd Deere told the Washington Post.
On Capitol Hill, there’s also no formalized contact tracing program in place, even as lawmakers themselves test positive.
Two infected staffers in Rep. Doug Lamborn’s (R-Colo.) office were told to not disclose to roommates they may have been exposed, WSJ reports.
The bottom line:The White House’s refusal to contact trace is “a missed opportunity to prevent additional spread,” Emily Wroe, a co-leader of a contact-tracing team at Partners in Health, told Nature.
The quarantining of most of the Joint Chiefs of Staff, coming on the heels of President Trump’s COVID-19 diagnosis, is raising fears that U.S. adversaries might seek to exploit a perceived weakness.
Few expect any sort of overt military action, but there are other ways to wreak havoc on the United States.
Chief among them is disinformation. Experts have been warning ever since Trump tested positive for the coronavirus last week that disinformation is likely to kick into overdrive.
Now, with six of the seven members of the Joint Chiefs of Staff waylaid at home, warnings are being amplified about the national security implications of the growing COVID-19 outbreak among U.S. leadership.
“All these kinds of things are just a huge distraction for us where our national security apparatus is consumed with matters domestic and internal,” former Director of National Intelligence James Clapper said at a Washington Post event after news broke of the Joint Chiefs quarantining. “So this is an ideal time for adversaries, particularly in adversary intelligence services, to look for ways to further confuse us, to distract us.”
Adding that “you can bet particularly our good friends the Russians are doing this,” Clapper warned of them “further sowing seeds of disinformation.”
“They will appeal to all the various tribes and continue to capitalize on the polarization in this country,” he said. “So it is a vulnerable time, and it’s an opportunity for them while we’re not looking and not being alert to further sow seeds of disinformation, casting doubt, discord, distrust in the country.”
The quarantining of top military officers stems from the Coast Guard’s No. 2 admiral contracting COVID-19. The Coast Guard announced Tuesday that its vice commandant, Adm. Charles Ray, tested positive for the coronavirus on Monday after feeling mild symptoms over the weekend.
The test result came after Ray met with most of the Joint Chiefs of Staff at the Pentagon on Friday.
That put Joint Chiefs of Staff Chairman Gen. Mark Milley into quarantine, as well as the chiefs of the Army, Navy, Air Force, Space Force and National Guard. The vice chairman, Gen. John Hyten, was also in the meetings and is quarantining.
The only member of the Joint Chiefs who didn’t meet with Ray was Marine Corps Commandant Gen. David Berger, who was traveling.
Berger’s deputy, Gen. Gary Thomas, met with Ray instead and went into quarantine Tuesday. The Marine Corps announced Wednesday evening that he has tested positive for the virus.
Gen. Paul Nakasone, commander of U.S. Cyber Command and director of the National Security Agency, also met with Ray and went into quarantine.
It’s unclear exactly where Ray caught the virus, but his schedule within the incubation period included a visit to the White House, which is now considered the epicenter of a coronavirus outbreak that includes Trump himself.
Ray — along with Milley, Defense Secretary Mark Esper and other top defense officials — attended a White House ceremony for Gold Star families on Sept. 27.
The event happened the day after Trump announced he was nominating Amy Coney Barrett for the Supreme Court, a gathering for which several attendees have since been diagnosed with COVID-19.
Since Trump’s diagnosis, the Department of Defense has sought to allay any national security concerns.
When Trump’s positive test was first announced last week, the Pentagon insisted there has been “no change to DoD alert levels.”
After news broke Tuesday of the Joint Chiefs quarantining, chief Pentagon spokesman Jonathan Hoffman reiterated that “there is no change to the operational readiness or mission capability of the U.S. Armed Forces.”
“Senior military leaders are able to remain fully mission capable and perform their duties from an alternative work location,” Hoffman said in a statement.
The military chiefs are well-equipped to work from home, and besides Ray and Thomas, none have tested positive for the virus yet.
But the development has raised questions about whether adversaries will try to take advantage of the situation nonetheless.
After the military quarantines were revealed, House Armed Services Committee Chairman Adam Smith (D-Wash.) said “the national security implications of the president’s recklessness cannot be overstated” even though the military “can still operate while leadership is quarantined.”
“Since announcing that he tested positive for the virus, the president’s antics have been downright reckless and harmful,” Smith said in a statement. “Our adversaries are always looking for any weakness to exploit. President Trump’s pathetic attempts to exude strength aren’t fooling anyone — Americans know he is weak and so do those who wish us harm.”
Rep. Jackie Speier (D-Calif.), another senior member of the Armed Services Committee, questioned why so many senior military leaders were meeting in person in the first place, as well as attending a White House reception in which they were pictured maskless.
“What if the Joint Chiefs’ responsibilities cannot be done remotely while they are isolating?” Speier wrote in a series of questions on Twitter. “How many other senior military leaders have tested positive? Why weren’t we safeguarding the health of senior military leaders like the natural security asset that it clearly is?”
Barry Pavel, senior vice president and director of the Atlantic Council’s Scowcroft Center for Strategy and Security, stressed that there is “no degradation in operational command and control” from the Joint Chiefs quarantining.
But, he added, adversaries such as Russia and China could misperceive that the United States is distracted and decide to act. For example, he cited concerns about China moving against Taiwan or Russia trying to grab more territory.
Pavel also listed what he called Russia’s “non-kinetic war” against the United States in the cybersecurity, influence and disinformation realm.
“This is a KGB officer’s most wildest dream coming true almost on a daily basis,” he said. “And so I think it’s a big threat. Who knows what proportion of our current public divisions are sown by Russian influence and bots or are just part of our current division. I don’t know the answer to that question. But they’re certainly right now exploiting it.”
To diminish those concerns, Pavel said, the Pentagon should keep emphasizing its military readiness, as well as demonstrating it by taking actions like publicizing a previously planned exercise.
“It’s probably a good idea to keep repeating those messages,” he said, “to be reiterating those messages, sending them publicly, privately, by third parties and through various forms of military activity so adversaries have no misunderstanding about our readiness and capabilities despite the chairman being quarantined in his quarters.”
HENRY KOTULA 