FDA approves abortion pills at retail pharmacies

https://mailchi.mp/ad2d38fe8ab3/the-weekly-gist-january-6-2023?e=d1e747d2d8

Under new guidance released by the Food and Drug Administration (FDA) on Tuesday, retail pharmacies can now dispense mifepristone, the first in a two-drug sequence for medication abortions. This move follows a December 2021 change that allows mail-order pharmacies to ship prescribed mifepristone, which previously could only be dispensed in-person by approved clinics. The medication will still require a prescription, and will remain highly restricted, or even illegal, in states that have implemented strict abortion bans.

Pharmacies opting to dispense the drug will face requirements that go beyond other medications, such as keeping the identity of the prescribing provider anonymous. Retail pharmacy chains CVS and Walgreens each announced plans to become certified to dispense mifepristone in locations where it is legal. 

The Gist: Abortion pills, currently used in used in more than half of pregnancy terminations, are becoming more sought-after in the wake of last year’s Supreme Court ruling overturning the federal right to abortion. This FDA action is the latest move by the Biden administration to expand access to abortion—though its impact will be felt unevenly across states, even with the Department of Justice stating the Postal Service can legally deliver the medications anywhere in the US.

10 Key Medtech Themes for 2023

https://medcitynews.com/2023/01/10

We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.

The combination of rapid developments in novel healthcare technology and heightened demand for integrated tech-enabled care has continued to fuel innovation in the medtech industry.  At the same time, medtech innovators – whether in digital health, wearables and AI-driven offerings in healthcare, or diagnostics, telemedicine and health IT solutions – continue to face a patchwork of laws, rules and norms across the world. Life sciences and healthcare innovators and regulators are also looking to medtech to increase access to care and health equity. Here are ten global medtech themes we are tracking in the coming year:

Focus on digital tuck-in acquisitions in medtech M&A

Despite continued uncertainty in the overall financial market, medtech M&A activity continued at a steady pace in 2022.  This year witnessed a rise in tuck-in acquisitions of smaller companies that can be easily integrated into buyers’ existing infrastructure and product offerings, as opposed to significantly sized takeovers of businesses that aren’t squarely aligned with buyers’ existing businesses lines.  Medtech acquirers have been particularly focused on developing their digital capabilities to innovate and reach customers in new ways.  As digitization continues to transform the industry, we expect acquirers to continue to prioritize the value of digital and data assets as they evaluate potential targets.

Continued interest by private equity and other financial sponsors

Private equity firms, healthcare-focused funds and other financial sponsors have continued to display a strong appetite for investing in Medtech companies, with top targets in subsectors such as diagnostics and healthcare IT solutions.  Later-stage medtech companies in particular are gaining a larger share of venture capital funding, as later-stage investments allow financial sponsors to focus on businesses with higher yields, as well as less time to market and capital reimbursement.  Demographic trends, including an aging population and the increasing prevalence of chronic diseases, coupled with healthcare technology advancements have created robust demand for medtech-enabled solutions.  Additionally, medtech offerings have broad applications that can extend beyond stakeholders in a specific therapy area, product category or care setting, offering the ability to satisfy unmet needs with large patient bases.

Strategic medtech collaborations as the new norm

Strategic medtech collaborations and partnerships have become the new norm in our increasingly connected digital healthcare ecosystem.  In response to heightened consumer demand for tech-enabled care, pharmaceutical and medtech companies are collaborating to use digital technologies to engage with consumers, unlocking a vast range of treatments such as personalized medicine.  Additionally, as the market rapidly evolves towards data-driven healthcare, we expect medtech companies to continue to work collaboratively to address existing barriers to data sharing and promote interoperability of healthcare data.

Continued scrutiny by antitrust and competition authorities 

As expected, global antitrust and competition authorities continued to focus on the tech, life sciences and medtech sectors in 2022.  The US, UK and EU authorities have stepped up efforts to investigate and challenge conduct by large pharma and technology companies pursuing mergers and acquisitions.  We expect these authorities to assess similar concerns in the digital health context in an effort to account for the value of combined datasets and the interoperability of various offerings that could be derived from digital health mergers and acquisitions.  Furthermore, geopolitical tensions have resulted in new and expanded foreign investment regimes to improve the resilience of domestic healthcare systems.  Notably this year, the UK government implemented the National Security and Investment Act that allows it to restrict transactions that may threaten national security, including in the AI and data infrastructure sectors.  Sensitive data continues to be a recurring theme for foreign investment review for Committee on Foreign Investment in the US  and that of the EU as well.

Growing importance of data privacy and security

Increasing regulatory attention to sensitive health data and the escalating rise of ransomware attacks has made data privacy and security more important than ever for medtech innovators.  The Federal Trade Commission has issued several statements about its willingness to “fully” enforce the law against the illegal use and sharing of highly sensitive data.  Additionally, several state privacy laws coming into effect in 2023 create new categories of sensitive personal data, including health data, and impose novel obligations on innovators to obtain data-related consents.  As ransomware continues to pose security-related threats, the US Department of Health and Human Services renewed calls for all covered entities and business associates to prioritize cybersecurity.  New standards, such as cybersecurity label rating programs for connected devices, aim to address security risks.  In the EU, medtech providers will need to consider how the launch of the European Health Data Space and newly proposed data regulation, such as the Data Act and AI Act, could impact their data use and sharing practices.

More active engagement with FDA/EMA/MHRA

We expect companies active in the medtech sector, particularly those that make use of AI and other advanced technologies, to continue their conversations with the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), the Medicines and Healthcare Products Regulatory Agency (“MHRA”) and other regulators as such companies grow their medtech business lines and establish their associated regulatory compliance infrastructure. Given the unique regulatory issues arising from the implementation of digital health technologies, we expect the FDA, EMA and MHRA to provide additional guidance on AI/ML-based software-as-a-medical device and the remote management of clinical trials.  2022 saw stakeholders in the life sciences and medtech industries collaborate with regulatory authorities to push forward the acceptance of digital endpoints that rely on sensor-generated data collected outside of a clinical setting.  As the industry shifts to decentralized clinical trials, we expect both innovators and regulators to work together to evaluate the associated clinical, privacy and safety risks in the development and use of such digital endpoints.

Increasing medtech localization in the Asia Pacific region

2022 saw multinational companies (“MNCs”), including American pharma/device makers make an active effort to expand their medtech business lines in the Asia Pacific region.   At the same time, government authorities in the region have been increasingly focused on incentivizing local innovation, approving government grants and prohibiting the importation of non-approved medical equipment. In light of MNCs’ market share of the medical device market in the Asia Pacific region, especially in China, we expect the emergence of the domestic medtech industry to prompt discussions among MNCs, local innovators and government authorities over the long-term development of the global market for medical technology.

Long-term adoption of telehealth and remote patient monitoring technologies 

The Covid-19 pandemic saw the rise of telehealth and remote patient monitoring technologies as key modes of healthcare delivery.  The telehealth industry remains focused on enabling remote consultations and long-term patient management for patients with chronic conditions.  Looking forward, we expect to see increased innovation in non-invasive technologies that can provide early diagnostics and ongoing disease management in a low-friction manner.  At the same time, we anticipate telehealth companies to face increasing scrutiny from regulatory authorities around the world for fraud and abuse by patients and providers.  Consumer and patient data privacy and security in connection with telehealth and remote patient monitoring continue to remain top of mind for regulators as well.

Women’s health and privacy concerns for medtech

We expect to see increased consumer health tech adoption for reproductive care, especially in light of the U.S. Supreme Court’s decision to overturn Roe v. Wade.  Following the Dobbs decision, a number of states introduced or passed legislation that prohibits or restricts access to reproductive health services beyond abortion.  In response, women’s health-focused companies are expanding their virtual fertility and pregnancy, telemedicine and other services to patients.  At the same time, such companies need to assess the legal risks stemming from the collection and storage of their customers’ personal health information, which could then be used as evidence to prosecute customers for obtaining illegal reproductive health services.  We expect companies active in this space to take steps to navigate the patchwork of data privacy and security laws across jurisdictions while establishing clear digital health governance mechanisms to safeguard their customers’ data privacy and security.

Addressing inequities in the implementation of digital healthcare technologies

Medtech innovators and regulators have been increasingly focused on addressing inequities in the healthcare system and the data used to train AI and ML-based digital healthcare technologies.  In 2022, a number of medtech companies collaborated to provide technologies that result in improved patient outcomes across all populations, as well as boost participation of diverse populations in clinical trials.  In parallel, we are seeing increased interest from regulators to reduce bias in digital health technologies and the accompanying datasets, as evidenced by the EU’s proposed AI Act and the UK’s health data strategy. In the US, which currently lacks comprehensive government regulation of AI in healthcare, there have been increasing calls for institutional commitments in the area of algorithmovigilance.  Because of the inaccurate conclusions that may result from biased technologies and data, MedTech companies must prioritize health equity in the implementation of digital healthcare technologies so that everyone can benefit from the latest scientific advances.

In conclusion, the medtech industry has remained resilient amidst the challenging macroeconomic environment.  We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.  At the same time, the rapidly changing legal and regulatory landscape will continue to be a key issue for medtech innovators moving forward. Adopting a global, forward-thinking regulatory compliance strategy can help MedTech companies stay competitive and ultimately, achieve better outcomes for patients.

FDA clears updated COVID-19 vaccines ahead of fall booster campaign

The Food and Drug Administration (FDA) on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron. 

The move comes ahead of a fall campaign to give Americans booster shots, which is expected to launch in the coming days. 

The move marks the first time the vaccines have been updated since the first shots were cleared at the end of 2020, and the updated shots are designed to catch up to evolutions in the virus.

The shots from Pfizer and Moderna target the omicron subvariants BA.4 and BA.5, as well as the original virus. 

The shots can begin going into arms once the final step in the process, a Centers for Disease Control and Prevention committee, clears them, which is expected to occur on Thursday.  

A major question, though, is how many people will actually want the new shots, given that uptake for the existing booster shots has lagged.  

Only about half of people who got the first two shots received the initial booster dose.  

“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert Califf. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”

Seeking to keep up with the ever-evolving virus, the FDA did not wait for the time-consuming process of going through full clinical trials on this tweaked vaccine. But it noted that it is highly confident that the vaccines are safe and effective. The agency pointed to the millions of doses of the original vaccines that have been given, as well as data from another version of the updated vaccine, along with preliminary data on this one.  

Peter Marks, a top FDA vaccine official, compared the process to the annual updates to the flu vaccine that seek to adapt to the changes in that virus.  

“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks said.  

The updated Moderna vaccine is cleared for people 18 and older, and the Pfizer vaccine for people 12 and older.  

For both, people are eligible for the booster shot of the updated vaccine if it has been at least two months since their last shot.  

Federal government adjusts monkeypox vaccine strategy

https://mailchi.mp/11f2d4aad100/the-weekly-gist-august-12-2022?e=d1e747d2d8

This week, the Food and Drug Administration (FDA) announced a change intended to stretch out the limited supply of monkeypox vaccine doses, allowing the shots to reach five times the number of patients. Monkeypox, a disease in the smallpox family, is spread primarily through skin-to-skin contact, often causing patients to develop painful lesions.

Although most cases resolve within a few weeks, the rapid growth in cases, now more than 9K domestically and 30K globally, is still a cause for concern, leading federal officials to declare a public health emergency last week. The FDA is also recommending that providers administer the vaccine between layers of skin, rather than below the skin into fatty tissue. This dosing change will allow providers to extend the nearly half a million doses not yet sent to states, in order to reach the more than 1.6M Americans considered highest risk.

The Gist: The country is now dealing with two public health emergencies from highly contagious diseases simultaneously. While monkeypox isn’t nearly as transmissible, deadly, or overwhelming to the healthcare system as COVID, the public health response has nonetheless been lackluster (and this week’s new COVID guidance suggests that the CDC has largely given up on managing the response, devolving responsibility to individuals in nearly all settings). 

For those hoping that the COVID experience would spark faster action by our public health system, the federal response to monkeypox shows we haven’t applied the lessons learned. Public health authorities aren’t conducting rigorous disease surveillance, testing and treatments remain hard to get, and Congress isn’t dedicating funds for the response. The lack of proactive leadership is likely to result in healthcare providers again bearing the brunt of efforts to manage another unsuppressed viral outbreak. 

U.S. declares public health emergency over monkeypox

The Biden administration has declared the monkeypox outbreak a public health emergency — a move that gives officials more flexibility to tackle the virus’ spread.

Why it matters: New YorkCalifornia and Illinois all declared public health emergencies related to monkeypox in the last two weeks. The World Health Organization has already declared monkeypox a global emergency.

Details: Department of Health and Human Services secretary Xavier Becerra made the announcement Thursday in a briefing on monkeypox.

  • Federal health officials can now expedite preventative measures to treat monkeypox without going through a full federal review, the Washington Post reports.

What they’re saying: “We’re prepared to take our response to the next level in addressing this virus,” Becerra said Thursday. “We urge every American to take monkeypox seriously and to take responsibility to help us tackle this virus.”

  • Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said the declaration will help “exploit the outbreak” and potentially increase access to care for those at risk.
  • Dr. Demetre Daskalakis, the White House national monkeypox response deputy coordinator, said “today’s actions will allow us to meet the needs of communities impacted by the virus … and aggressively work to stop this outbreak.”

State of play: Dr. Robert Califf, the commissioner of the Food and Drug Administration, said the U.S. is “at a critical inflection point” in the monkeypox outbreak, requiring “additional solutions to address the rise in infection rates.”

  • There are 6,600 cases of monkeypox in the U.S. as of Thursday, Becerra said.
  • There were less than 5,000 cases of monkeypox last week, he added.

The big picture: Biden’s decision to declare monkeypox a public emergency allows him to raise awareness of the virus and unlock more flexibility for spending on ways to treat and tackle the virus.

  • About 20% of Americans are worried they’ll contract monkeypox, Axios previously reported. But there are still some gaps in Americans’ knowledge of the virus and how it impacts our population.

What’s next: U.S. health officials said that 800,000 monkeypox vaccine doses will be made available for distribution. But in hotspot states for the monkeypox outbreak, there’s a drastic disconnect between the number of doses that local health officials say they need versus what they have been allotted.

  • The U.S. will receive another 150,000 monkeypox vaccine doses in the strategic national stockpile in September, Dawn O’Connell, administrator at HHS’ Administration for Strategic Preparedness & Response, told reporters Thursday. These were previously scheduled to arrive in October.

COVID vaccine strategy still murky after FDA experts meet

The COVID-19 vaccine strategy for the fall remains beset with unanswered questions after an FDA expert panel on Tuesday spent hours debating how and whether to update the shots.

Why it matters: Time is running short to develop a game plan with existing vaccines losing effectiveness against new variants and more than half of Americans still without a booster dose.

Driving the news: The Vaccines and Related Biological Products Advisory Committee voted 19-2 to recommend an Omicron-specific update to COVID-19 booster vaccines expected to be rolled out within the next few months.

But key questions were left unanswered:

  • The panel didn’t formally decide whether to update shots with the prevalent Omicron strain in circulation, currently the fast-spreading BA.4 and BA.5 subvariants, or the BA.1 lineage that emerged late last year, as the World Health Organization recommended.
  • The consensus appeared to be for a bivalent, or combination, booster combining the original COVID-19 strain that emerged in late 2019 with BA.4 and BA.5.
  • The FDA will continue to evaluate what to do about the primary series of vaccines for the fall.
  • Experts were split on whether there was enough data to recommend the updated shots for kids, or whether more studies are needed on dosage and possible side effects.
  • There also were concerns about what effect an updated vaccine would have on developing nations’ willingness to use older COVID shots to inoculate their populations.
  • And above all, it’s unclear whether all the questions about who gets which shot when will add to public confusion and apathy that’s dogged the vaccination effort in recent months.

What they’re saying: “None of us has a crystal ball and we’re trying to use every last ounce of what we can from predictive modeling and data that’s emerging to try to get ahead of a virus that’s very crafty,” said top FDA vaccine regulator Peter Marks.

  • “Unfortunately, looking in the past doesn’t help us a great deal to look in the future for [a] virus that has baffled a lot of us and made predictions almost irrelevant,” said acting panel chairman Arnold Monto, a University of Michigan epidemiologist.

The timetable: Pfizer-BioNTech said an updated mRNA vaccine could be ready in October if regulatory uncertainties are ironed out. Moderna said it could have large amounts ready in late October or early November. Novavax is still awaiting emergency use authorization for its protein-based shot, but said it could have an updated vaccine by the fourth quarter.

Tower Health fires physician accused of prescribing ivermectin, hydroxychloroquine to treat COVID-19

Tower Health doctor fired for allegedly prescribing ivermectin,  hydroxychloroquine to treat COVID

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.

FDA fully approves Moderna’s COVID vaccine

A health care worker preparing a dose of  Moderna's coronavirus vaccine.

The Food and Drug Administration fully approved Moderna’s mRNA COVID-19 vaccine on Monday, saying it meets its safety and manufacturing requirements.

Why it matters: Moderna’s vaccine, which will now be marketed as Spikevax, is the second coronavirus vaccine to receive full approval after the FDA approved Pfizer-BioNTech’s vaccine in August.

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.

FDA authorizes Merck antiviral, which joins Pfizer pill as oral option for Covid-19

https://medcitynews.com/2021/12/fda-authorizes-merck-antiviral-which-joins-pfizer-pill-as-oral-option-for-covid-19/?utm_campaign=MCN%20Daily%20Top%20Stories&utm_medium=email&hsmi=199382923&_hsenc=p2ANqtz-9Nz1-tRrrLzBQJeS5FfzcMjlOv2UaFSMGIRgd6taLPUDhX7tqQSRwxGuyJM11F-I56sLNv6llkF6vsgXlHc9DojM-kQ&utm_content=199382923&utm_source=hs_email

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.

What should you take if you get Covid-19? 

https://link.vox.com/view/608adc4e91954c3cef03e60dfi7ya.jor/68bd1086

Hey readers, 

Last week, Florida Surgeon General Joseph Ladapo released a public service announcement talking about protecting your health from Covid-19. The PSA stood out for a couple of reasons:

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? 


That’s not because there’s a lack of options. For instance, the FDA has approved monoclonal antibodies as a treatment for Covid-19 patients at risk of progressing to severe disease. They recently expanded this approval to include monoclonal antibodies for children as well. The treatment has to be administered in a clinic, as an IV infusion or as four shots, but it is highly effective, with some high-quality studies finding an 85 percent reduction in the risk of hospitalization or death.

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. 

One medication, fluvoxamine, is an antidepressant that appears to reduce hospitalizations from Covid-19 by about 30 percent. Another, budesonide asthma inhalers, was found in one large RCT to speed at-home recovery considerably and in another to reduce risk of hospitalization. In the US, there’s been no formal guidance on when to consider budesonide, but in the UK, health agencies have advised doctors they can consider prescribing it off-label to help older and at-risk patients recover at home, while in Canada doctors are encouraged to consider budesonide on a case-by-case basis.

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.

The FDA is also in the process of considering molnupiravir, another repurposed drug that looks to be moderately effective, though there are some concerns it could spur new viral variants.

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 NIH could 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 has been critical of Ladapo’s PSA and its recommendations.

Politicians who pander to anti-vax sentiment are harming their constituents, and it’s very reasonable to be frustrated with their conduct. Ladapo is a DeSantis appointee who has forcefully opposed Covid-19 restrictions — and has refused to wear a mask in meetings with immunocompromised legislators — and lots of people are reasonably reading his PSA in that light. 

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.