A Pennsylvania physician accused of prescribing ivermectin and hydroxychloroquine to treat and prevent COVID-19 has been terminated from Tower Health, PennLive reported Feb. 4.
Edith Behr, MD, is allegedly linked to Christine Mason, a woman who used a Facebook account to connect people to a physician for hydroxychloroquine and ivermectin prescriptions. A social media user claimed Dr. Behr was the source of the prescriptions and reported her to authorities and her employer, according to PennLive.
West Reading, Pa.-based Tower Health officials became aware of the allegations against Dr. Behr Feb. 2 and took immediate action.
“Tower Health became aware yesterday of the allegations involving Dr. Edith Behr prescribing ivermectin and hydroxychloroquine for the treatment of COVID-19,” Tower Health said in a Feb. 3 statement to PennLive. “We investigated the matter and, as a result, Dr. Behr’s employment with Tower Health Medical Group has been terminated effective immediately.”
Dr. Behr was a surgeon at Phoenixville (Pa.) Hospital, which is owned by Tower Health, according to the report.
Ivermectin and hydroxychloroquine have not been approved by the FDA for prevention or treatment of COVID-19.
What they’re saying: “The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said in a statement.
“The totality of real-world data and the full [Biologics License Application] for Spikevax in the United States reaffirms the importance of vaccination against this virus,” Moderna CEO Stéphane Bancel said.
The big picture: The rise of the Omicron variant forced vaccine makers to reevaluate the effectiveness of their vaccines, which were developed based on eaarlier forms of the virus.
Studies show that Moderna and Pfizer-BioNTech’s vaccines still overwhelmingly prevent severe disease and hospitalizations, especially when the first two doses are reinforced with a booster shot.
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer antivirals appear to work against the omicron variant, FDA officials stressed that these drugs are authorized only for certain patients and they are not a substitute for vaccination.
Merck’s oral antiviral drug molnupiravir now has FDA emergency use authorization for treating mild-to-moderate Covid-19, a Thursday decision that comes one day after the regulator authorized use of a pill from Pfizer. The FDA actions come as the highly infectious omicron variant becomes the dominant strain of the novel coronavirus, fueling a rise in Covid-19 cases that is pushing hospitals to capacity across the country.
The Merck and Pfizer antivirals both work by interfering with the virus’s ability to replicate, though in different ways. Molnupiravir introduces errors into the genetic code of SARS-CoV-2, while Paxlovid targets a key viral enzyme called main protease. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said both drugs should work against omicron.
“The available data that we have indicate that both Paxlovid and molnupiravir are effective against omicron,” Cavazzoni said, speaking during a Thursday morning media briefing. “Both drugs interfere with aspects of the virus’s replication apparatus, and that apparatus is preserved across variants.”
Molnupiravir’s authorization, which comes three weeks after an FDA advisory committee meeting for the drug, covers its use in adults diagnosed with Covid-19 who are at a high risk of their disease progressing to hospitalization or death. The Merck drug is to be used when other treatment options are not accessible or appropriate. It can only be prescribed to those 18 and older because the drug can affect bone and cartilage growth.
Authorized use of Pfizer’s antiviral, Paxlovid, extends to pediatric patients. The FDA’s guidelines state the drug may be used for treating Covid-19 patients 12 and older weighing at least 40 kg (about 88 pounds). The FDA did not convene an advisory meeting for the Pfizer drug. John Farley, director of FDA’s Office of Infectious Diseases, said there were no pressing scientific questions about Paxlovid that would benefit from an advisory committee discussion.
Both molunupiravir and Paxlovid are available only by prescription. The FDA said treatment with these drugs should begin as soon as possible after a positive Covid-19 diagnosis, and within five days of the start of symptoms. These drugs aren’t for patients who are already hospitalized. Earlier this year, Merck stopped testing molnupiravir in those who are hospitalized after an early look at Phase 2 trial data indicated that the drug was unlikely to help these patients.
Authorization of Merck’s antiviral is based on a placebo-controlled clinical trial enrolling non-hospitalized adults with Covid-19 who were at high risk of progressing to severe disease or hospitalization. These higher risk patients include those who have a chronic medical condition or those who had not or could not receive a Covid-19 vaccine. The main goal was to measure the percentage of people hospitalized or dead from any cause during the 29 days after the course of treatment. The FDA said that of the 709 people in the study who received molnupiravir, 6.8% were hospitalized or died. By comparison, 9.7% of the 699 people given a placebo were hospitalized or died. During the follow-up period, one patient treated with molnupiravir died compared to nine of those given a placebo. Side effects reported include diarrhea, nausea, and dizziness.
In the clinical trial for Pfizer’s antiviral, Paxlovid led to an 88% reduction in Covid-19-related hospitalization or death from any cause compared to placebo. Of the 1,039 patients treated with Paxlovid, 0.8% of patients were hospitalized or died during the 28-day follow-up period, compared to 6% of those given a placebo.
Farley said that patients should consult with their physician to determine the best treatment. While molnupiravir is indicated for those who don’t have other treatment options, there are some groups of patients in which Paxlovid would not be appropriate. Examples include patients taking other medications that could interact with the Pfizer drug, Farley said. Paxlovid is also not recommended for patients who have severe kidney problems or cirrhosis of the liver. The key feature of both drugs is that they are oral, which enables patients to take these medication at home. Authorized antibody therapies from Regeneron, Eli Lilly, partners Vir Biotechnology and GlaxoSmithKline, and Roche, are infusions that must be administered in a clinical setting.
Patients take Merck’s molnupiravir as four pills, twice a day. Patients prescribed Pfizer’s Paxlovid must take more pills. The drug is taken with ritonavir, a drug that slows the breakdown of Paxlovid and helps it remain in the body for a longer period of time. Dosing of the Pfizer drug requires two tablets of Paxlovid and one of ritonavir, twice daily. The duration of treatment for both the Merck and Pfizer antivirals is five days.
1. While “vaccination” briefly appeared onscreen in a list of options, it didn’t merit a mention in the video.
2. The surgeon general listed guidance on “emerging” treatments that was … remarkably on point.
The absence of focus on vaccines in the video is unfortunate, if entirely in keeping with the GOP’s willingness to play to its anti-vax base. That’s bad, but not surprising.
What was surprising was No. 2. The information Ladapo shared about treatments was fairly accurate. In the video, he told Floridians to ask their doctor about monoclonal antibodies, fluvoxamine, and inhaled budesonide should they come down with Covid-19.
I’ve been reporting on the Covid-19 treatment beat for much of this year, and I’ve uncovered a massively confusing pile of contradictory information. But those are the top three treatments I’d recommend sick loved ones talk to doctors about, and while there’s much we still don’t know, solid science suggests they have real promise.
That said, the fact that such important (and accurate) information stood out in a government PSA indicates just how dismal the state of public communications on treatments is — and just how much misinformation and distrust are hampering the fight against Covid-19.
What should you take if you get Covid-19?
There’s been little public health communication about which treatments to pursue if you get Covid-19, perhaps because for much of the pandemic, it’s been unclear what options are better for mild Covid than just resting at home. While in 2021 the best treatment recommendations have gotten clearer, public health messaging over the last year has rightly been focused on vaccination.
The official CDC page on what to do if you get sick with Covid-19 advises you to wear a mask, wash your hands, and clean high-touch surfaces to avoid infecting those around you. If your breathing deteriorates or you show signs of severe illness like confusion or an inability to stay awake, the CDC advises you to go to the hospital.
All sound guidance — but what it doesn’t offer is advice on a question that patients who aren’t sick enough for hospitalization might desperately need to know: What medication should I take if I come down with Covid-19?
Meanwhile, large, high-quality, peer-reviewed, and published randomized controlled trials (RCTs) have found promise for cheap therapies that are already FDA approved for other purposes and have an established safety profile.
Research underway will help provide a better understanding of both of these therapies, but there’s enough evidence that some doctors are already prescribing them to patients. If you have the opportunity to enroll in an ongoing clinical trial of these medications, you can get access to a potentially promising treatment and help contribute to our scientific understanding of whether these treatments really work.
Another exciting treatment in the pipeline is Paxlovid, an antiviral developed by Pfizer that showed impressive 90 percent efficacy in preventing hospitalization — so effective that in November, the clinical trial stopped enrolling new participants because investigators concluded it’d be unethical to put them in the control group. It has not yet been approved by the FDA, but it might be a game changer if, as is expected, it’s approved in January.
Why is it so hard to find good guidance about treatments?
The US government has communicated little about Covid-19 treatment options. NIH guidelines about treatments like fluvoxamine haven’t been updated since this past spring, meaning results from recent high-quality studies haven’t been incorporated into that guidance. Without it, physicians considering whether to prescribe these medications can’t turn to official public health resources for help.
From a certain perspective, that reticence is understandable. Learning which Covid-19 treatments work is very hard. While large-scale RCTs found promising evidence for fluvoxamine and inhaled budesonide, “promising” is still the most we can say — it could absolutely turn out that the real-world effects are much smaller than hoped for, or even fail to materialize altogether.
But it’s precisely because this area is so difficult to navigate for doctors and patients that the CDC, FDA, and NIHcould play an important role in pointing out good treatments — yet it’s a role they have been puzzlingly reluctant to play.
Perhaps because of the dearth of formal federal government guidance on treatments — and because of politically driven crazes over drugs like hydroxychloroquine and ivermectin, which evidence thus far suggests do little to fight Covid-19 — Florida media hasbeencritical of Ladapo’s PSA and its recommendations.
But that justified irritation shouldn’t get in the way of a needed conversation about the possible benefits and drawbacks of monoclonal antibodies, fluvoxamine, and budesonide. As the US braces for an omicron surge that is likely to hit even vaccinated people, effective treatment is going to be essential for saving lives. Yes, promoting vaccines is a must, but tens of thousands of Americans are getting sick each day, which makes clear, accurate communication about which treatments to ask your doctor about extremely important.
The more society and public health get aligned on what works, the better off we’ll be in confronting omicron and other future variants.
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Sunday said vaccine developers have “a pretty good degree of confidence” that fully vaccinated individuals who have received a COVID-19 booster are protected against the omicron variant.
Appearing on CBS’s “Face the Nation,” Gottlieb said that there is no indication that the omicron variant first detected in South Africa makes individuals more ill than other previously detected variants, and that there have been anecdotal accounts of people experiencing mild cases of COVID-19, though he pointed out that initial cases appear to have been clustered among young people.
“The question here is going to be whether or not a fully boosted individual someone who’s had three doses of vaccine has good protection against this variant right now,” said Gottlieb, who now sits on Pfizer’s board of directors.
“If you talk to people in vaccine circles, people who are working on a vaccine, they have a pretty good degree of confidence that a boosted vaccine, so three full doses of vaccine, is going to be fairly protective against this new variant,” said Gottlieb.
However, Gottlieb stressed that data on the omicron data is sparse, with no clinical studies or test tube studies having been completed. He estimated that studies testing the blood of vaccinated people against the omicron variant could be out by the end of this week or some time next week.
“Now, I would expect that those studies are going to show that the neutralization against this virus declined substantially. But that doesn’t mean that the vaccines won’t be effective,” he said.
Federal officials waited months before making all American adults eligible for a COVID-19 booster shot — meaning millions of Americans may not have the strongest possible protection as they head into holiday travel.
Why it matters: Critics say the confusing process undermined what has now become a critical effort to stave off another wave of the pandemic.
Most vaccinated people, even without a booster, still have very strong protection against serious illness or death. But a third shot drastically increases people’s defenses against even mild infections, which could in turn help reduce the virus’ spread.
And some vulnerable vaccinated adults are at risk of serious breakthrough cases.
What they’re saying: “We have a consensus. Boosters are very important in maintaining people’s defenses against COVID. We need to get as many people vaccinated and boosted [as possible] as the winter sets in,” David Kessler, the chief science officer of Biden’s COVID response, said in an interview.
Context: Preliminary data released months ago suggested a significant decline in the vaccines’ effectiveness at preventing infection, although they held up well against severe disease.
Based on that data, the Biden administration had hoped to begin allowing booster shots in September for any American adult who was at least eight months removed from their second dose.
The CDC and the FDA opted instead to only authorize boosters for seniors, people with high-risk medical conditions and people at high risk of infection, before opening them last week to everyone at least six months out from their initial shots.
In the meantime, red and blue states alike decided to ignore the CDC and open up booster eligibility on their own, and breakthrough infections have become increasingly common.
Millions of people who weren’t technically eligible for boosters got them anyway, and a large portion of the most vulnerable patients still haven’t gotten one.
Where it stands: Only 41% of vaccinated Americans 65 and older have received a booster shot, as have 20% of all vaccinated adults, per the CDC.
“Some of us were there several months ago. Some wanted more data. In the end, there’s a convergence of opinions. It’s the way an open scientific public health process should work,” Kessler said.
Between the lines: The U.S. drug approval process — with its insistence on high-quality data and careful expert reviews — is the world’s gold standard precisely because it moves deliberately. Regulators have been trying this whole time to figure out how to adapt that system to a fast-moving pandemic.
Some federal officials, as well as many outside experts, said there wasn’t enough data to make a broad booster recommendation earlier this fall.
Early on, many public health experts also argued that it was unethical to give Americans a third shot while much of the rest of the world awaited their first shots.
Israel embraced boosters before the U.S. beginning over the summer, and its emerging data has been key to making the case that boosters are needed and can help bring surges under control. However, experts still don’t know how long the enhanced protection they give will last.
What they’re saying: “Some argued early on that the primary series was good enough and we should conserve doses for the world. What’s emerging is that all people in the world are going to need to be boosted,” a senior administration official said.
“Everyone has a different threshold for how much data they need in making a decision,” the official added. “What made this different is that there’s a pandemic underway, and many saw we were heading into a winter surge.”
Two pieces of hopeful news on the COVID front this week.
First, pharmaceutical manufacturer Merck announced this morning that molnupiravir, the oral antiviral drug it developed along with Ridgeback Biotherapeutics, reduced hospitalizations among newly diagnosed COVID patients by 50 percent. A five-day course of the drug was so successful in Merck’s clinical study that an independent monitoring group recommended halting the study and submitting the pill to the Food and Drug Administration (FDA) for emergency use authorization. Molnupiravir is activated by metabolism, and upon entering human cells, is converted into RNA-like building blocks, causing mutations in the COVID virus’s RNA genome and interfering with its replication. For that reason, the drug is unlikely to be prescribed during pregnancy, but otherwise the therapy seems to hold great promise in adding to the limited armamentarium available to fight the pandemic. One possible concern: the drug’s price tag. The federal government has agreed to purchase 1.7M courses of the drug at $700 per course, and with most insurance companies having returned to normal cost-sharing for COVID treatments, the drug may be out of reach for some patients. Still, a major clinical development to be celebrated, and more to come as Merck’s drug is vetted by the FDA.
At $20 to $40 per dose, with costs fully absorbed by the federal government, and remarkable effectiveness at preventing severe disease, hospitalizations, and deaths, vaccines remain far and away our best frontline weapon for fighting the COVID pandemic. Promising, then, that the much-debated vaccine mandates have begun to demonstrate success in increasing vaccination rates, even among those who have thus far resisted getting the shot.
Despite concerns about massive staffing shortages among hospitals resulting from the implementation of its mandate, the state of New York found that 92 percent of healthcare workers had been vaccinated by Monday, when the mandate went into effect. That was a 10-percentage-point increase from a week earlier, holding promise that the Biden administration’s planned federal mandate for healthcare workers could have the desired effect.
California’s mandate for healthcare workers went into effect yesterday, and was credited with boosting vaccination rates to 90 percent at many of the state’s health systems. Among private employers considering mandates, the experience of United Airlines may also be instructive: its employee mandate led to the vaccination of more than 99 percent of its workers, resulting in the termination of only 700 of its 67,000 employees. Of course, everyone prefers carrots to sticks, but sweepstakes and bonuses have only gotten so far in encouraging people to get vaccinated—now it appears mandates have a useful role to play as well.
With 56 percent of the population fully vaccinated, the US now ranks 43rd among nations, just ahead of Saudi Arabia and far behind most of Europe. In the next few days we’ll reach the grim milestone of 700,000 COVID deaths in this country—anything that helps stop that number from growing further should be welcome news.
FDA on Monday issued its full approval for the Pfizer-BioNTech vaccine, making it the first Covid-19 vaccine to receive approval from the agency.
Up until now, the vaccine—which FDA said will be marketed under the brand name Comirnaty—was authorized for use under an emergency use authorization (EUA). Now, however, the vaccine is fully approved for the prevention of Covid-19 in individuals ages 16 and older.
FDA said the vaccine will remain available under an EUA for individuals ages 12 to 15. A third dose of the vaccine is also still available under the EUA for certain immunocompromised individuals.
Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said FDA “evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing process, including inspections of the manufacturing facilities.”
“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” Marks added.
What does FDA’s approval mean for you?
This new FDA approval, new guidance from the federal government, and new regulations from schools and private business have the potential to shift the posture of the currently unvaccinated. Today, just over 70% of American adults have had at least one dose Covid-19 vaccines. The question now is, how far can we get? The answer is up to you.
It may feel like decisions about the treatment and prevention of Covid-19 are out of your control. And while federal agencies and private businesses are making decisions quickly, every one of you has a vital role to play in this next phase of the pandemic. But there are three constituencies I want to speak to directly.
Many employers have been hesitant to come down hard on vaccine mandates or implementing clear consequences for the unvaccinated (such as submitting to weekly tests). Much of that fear had to do with the fact that vaccines were only approved for emergency use. Today’s announcement of the full approval of the Pfizer-BioNTech vaccine should offer many employers enough comfort to move forward with vaccine mandates. In fact, on the heels of announcing full approval, New York City announced that it would require all education staff to be vaccinated. I expect to see more employers inside and outside of health care following suit. If you are still questioning whether a vaccine mandate is appropriate, we recommend asking yourselves these five questions:
Are you complying with federal and state guidance?
Is a Covid-19 vaccine mandate the best way to achieve your goals?
How will you manage individuals who have legitimate exemptions if you impose a Covid-19 vaccine mandate?
How will you collect ‘proof of vaccination’?
How will you address workforce retention concerns?
Since the start of the Covid-19 crisis, we’ve recommended that providers adopt a single source of truth mentality to combat misinformation associated with the virus, it’s treatment, and concerns over vaccination. Today, vaccine skepticism is largely why adults continue to pass on their shot, and while the FDA’s full approval of the Pfizer-BioNTech vaccine isn’t going to appease all of their fears, full approval really does matter to some vaccine hesitant patients, at least according to polling from the Kaiser Family Foundation.
Your job is to identify those patients, offer custom outreach that shares the good news of full approval, and direct patients to the right next steps. The more customized the communication can be, the better. But there are some common principles everyone can take when developing strong Covid-19 vaccine communication strategies. In fact, we’ve built a readiness assessment for this purpose. And while this readiness assessment was built for initial rollout, the questions within should continue to guide your organization in addressing key factors such as patient navigation, equity in vaccine access, public health messaging, and vaccine hesitancy and mistrust.
The best communication strategy generates action—action for the patient (e.g., making an appointment for their first dose) but also action steps for frontline providers. Leaders must make sure that their staff is equipped to recognize vaccine hesitancy vs. skepticism, which is rooted in misinformation. Leaders must train staff to listen to personal narratives and not merely default to scientific facts, and leaders must make sure clinicians feel equipped to ease potential patient concerns.
Doctors must also be equipped to handle individual conversations with patients and discuss what this full approval means. Since patients typically turn to their doctors as a top, trusted source of insight, frontline clinicians are more important than ever in driving vaccine confidence. Yet in a recent poll from SymphonyRM, 41% of patients lost trust in their doctors amid the pandemic—and among those individuals, just over half noted it was because their provider rarely or never communicated with them about Covid-19. To regain trust and communicate the importance of the full approval, frontline clinicians should be prepared to proactively communicate and answer the following questions:
How does full approval differ from an emergency use authorization? Under what conditions is a full approval granted?
Why did the FDA decide to grant this approval? What data or evidence led to their increased confidence in the vaccine?
How should patients view this approval? What concerns, fears, or questions about the vaccine should this approval counter?
How might this full approval lead to increased mandates or pushes for vaccination, and what does that mean for patients?
Doctors should also continue to be prepared to answer any skepticism or misinformation about the full approval, which may come up during these discussions. In a July poll from KFF, 34% of unvaccinated adults were not at all confident about the safety of Covid vaccines, and 31% were not too confident. Today’s full approval should be used as an opportunity to help increase patient confidence in the safety of the vaccine.
The best defense we have against this virus is vaccination, and full approval of the Pfizer-BioNTech vaccine gives employers, providers, and frontline clinicians the shot in the arm they need to keep motivating Americans to get vaccinated (pun intended). It’s up to you to capitalize on the momentum of the FDA announcement, whether through your own vaccine regulations or through direct communication to the “watchful waiters” who have been waiting for this moment to get vaccinated.
Just a month ago, even as signs of a fourth wave of COVID-19 infections in the U.S. were blossoming in the lower Midwest, the memory of a long, miserable winter kept us warm. Even places with burgeoning case rates were far below their catastrophic peaks over the holidays, when a combination of cold weather and defiant travelers contributed to a third wave in infections and deaths that drowned out the previous two spikes in April and July of 2020.
This is regrettably no longer the case. In four states—Hawaii, Louisiana, Mississippi and Florida—the current number of daily new COVID-19 infections, averaged across seven days, has surpassed that winter peak, even with a substantial percentage of the population having received a complete dosage of the COVID-19 vaccine (though not nearly as many as public officials would prefer).
Hawaii is something of an anomaly, as its winter peak was not nearly as high as in colder, more accessible regions. But several other states threaten to join this quartet in the near future. Oregon’s daily rate of new infections is at 36.5 per 100,000 residents, or 99% of the peak value on Dec. 3, 2020. Nationwide, the rate is 37.7, just under 50% of the winter peak of 76.5.
What is perhaps most sobering about this surge is that COVID-19-related deaths, which typically lag behind case surges by about two weeks, are starting to rise again. No state has yet surpassed the winter peak in deaths, but at 65%, Louisiana very well may. That figure is still 15% nationwide, well below the Jan. 13, 2021 peak of 1.04 fatalities per 100,000 people. It is currently at 0.16.
When it comes to the pandemic, no one wants to sound like Chicken Little. The sky might not be falling. But neither is the national case rate, or the number of people dying.
With the Delta variant now accounting for more than 83 percent of all new COVID cases in the US, daily new case counts more than quadrupling across the month of July, and hospitalizations—particularly in states with low vaccination rates—beginning to climb significantly, we appear to have entered a new and uncertain phase of the pandemic, now being dubbed a “pandemic of the unvaccinated”.
Welcome news, then, that this week the American Hospital Association (AHA) publicly encouraged its members to put in place vaccine mandates for their employees. While several large health systems have taken the lead in implementing vaccine mandates, including Trinity Health, the Livonia, MI-based Catholic system that operates hospitals across 22 states, Phoenix, AZ-based Banner Health, Houston Methodist in Texas, and the academic giant NewYork-Presbyterian, others have been more reticent to compel employees to get vaccinated, citing concerns over employee privacy and the potential for workforce backlash.
The New York Timesreports that a quarter of all hospital employees remain unvaccinated nationwide, with many facilities reporting that more than half of their healthcare workers have not gotten the COVID vaccine. In our discussions with health system executives, one consideration frequently cited is the desire for full Food and Drug Administration (FDA) approval of the new vaccines before mandates are put in place.
In a CNN town hall meeting this week, President Biden suggested that approval could come as soon as the end of August, although other reports point to likely approval much later, potentially not until January of next year. Facing a new variant of the virus that is much more transmissible and possibly more virulent than earlier strains, hospitals—and their patients—can’t afford to wait that long.
For safety’s sake, hospitals should quickly put in place vaccine mandates, with appropriate exceptions.