Over 42,000 Adverse Reaction Reports Revealed In 1st Batch Of Pfizer Vax Docs

 The FDA's excruciatingly slow release of data related to Pfizer's COVID-19 vaccine has already borne fruit, and it's damning despite a trickle of just 500 pages per month out of 329,000 pages - which will take until 2076 to complete.

As first reported by Kyle Becker, there were a total of 42,086 case reports for adverse reactions (25,379 medically confirmed, 16,707 non-medically confirmed), spanning 158,893 total events.

More than 25,000 of the events were classified as "Nervous system disorders."

Since the vaccine has been publicly administered, there have been over 913,000 reports of adverse events in the OpenVAERS global database.

And that's just what's been reported.

https://www.zerohedge.com/covid-19/over-42000-adverse-reaction-reports-revealed-first-batch-pfizer-vax-docs

3rd US omicron case detected in Colorado

 Colorado health officials on Thursday reported that the third confirmed U.S. case of the COVID-19 omicron variant has been detected in their state.

The Colorado Department of Public Health and Environment (CDPHE) said in a statement that it has confirmed the first omicron case in Colorado.

"The case was identified in an adult female resident of Arapahoe County who had recently traveled to Southern Africa for tourism," the CDPHE said. "She is experiencing minor symptoms and is isolated and recuperating at home. She had been fully vaccinated and was eligible for the booster vaccine but had not received it yet."

Omicron in Colorado, per @CDPHE pic.twitter.com/DambvNffWN

— Matt Sebastian (@mattsebastian) December 2, 2021

Omicron cases have also previously been confirmed in California and Minnesota.

Colorado State Epidemiologist Rachel Herlihy said in a press conference on Thursday that the infected resident had followed public health guidelines when traveling, such as wearing a mask.

According to Herlihy, whole genome sequencing of the the woman's test was completed Thursday morning. Close contacts of the resident have so far tested negative.

Herlihy told reporters that the infected Colorado resident travelled through numerous countries in Africa and returned to Colorado late last week. At the time of her return, she was not symptomatic.

The Colorado health official noted that mild cases of omicron have been reported anecdotally, but pointed out that these cases appear to have been clustered in younger people who are less likely to develop severe illness due to COVID-19.

The Centers for Disease Control and Prevention (CDC) on Wednesday confirmed the first U.S. case of the omicron variant in California. Like the Colorado woman, the San Francisco resident who tested positive was fully vaccinated and had recently travelled to southern Africa.

In Minnesota, a fully vaccinated adult man was confirmed to have tested positive for the omicron variant on Thursday. The Minnesota man's mild symptoms had resolved by the time he got tested for COVID-19.

Though no cases of omicron have been confirmed in New York, New York City Mayor Bill de Blasio (D) said on Thursday that people should assume the variant is already present in the city.

"We are aware of a case of the Omicron variant identified in Minnesota that is associated with travel to a conference in New York City, and we should assume there is community spread of the variant in our city,” he said.

Since omicron's emergence, health experts have stated that it is still unclear how well the strain evades immunity offered by currently available COVID-19 vaccines. Numerous vaccine developers have hypothesized that oral COVID-19 treatments and booster shots should be effective against the variant.

Officials and health experts have said it will take a few weeks of testing before the omicron variant is better understood.

In response to the omicron variant's spread, the Biden administration has implemented a travel ban on eight African countries where the strain is believed to be prevalent. This measure has been blasted by health officials as being ineffective, though administration officials have argued it will buy time for the U.S. to better prepare for omicron.

https://thehill.com/homenews/state-watch/584090-third-us-omicron-case-detected-in-colorado

Most advanced lab-grown human embryos prompt question: Are they getting too real?

 The stem cells were no more than a week old when scientists moved them from their slick-walled plastic wells into ones lined with a thin layer of human endometrial tissue. But in that time, the cells had multiplied and transformed, organizing themselves into semi-hollow spheres. Per the instructions of the chemical cocktail in which they’d been steeping, they were trying to turn into embryos.

Video cameras captured what happened next: The balls of cells rotated until they were cavity-side-up, before finally touching down and grabbing onto the endometrial layer, a cellular proxy for a human uterus. Days later, when the scientists dipped paper test strips into the wells, pink lines appeared. Their Petri dishes were pregnant.

“These experiments clearly point out the fact that we are able to model in the dish the first touch between the embryo and the mother,” stem cell biologist Nicolas Rivron told reporters at a press conference.

On Thursday, Rivron and his colleagues at the Institute of Molecular Biotechnology of the Austrian Academy of Sciences in Vienna reported in Nature that they’ve learned to efficiently manufacture realistic models of human embryos from stem cells. These so-called blastoids aren’t the first successful attempt to recapitulate the developmental stage that embryos reach between four and seven days post-fertilization — when they’re a blastocyst made up of about a hundred cells and ready to implant into the walls of the uterus — but they appear to be the most advanced yet.

These synthetic embryos were made by mixing induced pluripotent stem cells with a brew of biochemical signals capable of coaxing them into forming spherical structures that include the beginnings of three distinct cell lineages — outer layers representing the future placenta and amniotic sac, and an inner clump of cells with the potential to develop into a fetus.

“This is a very, very close model of a real, complete human embryo,” said Insoo Hyun, director of research ethics at the Harvard Medical School Center for Bioethics, who was not involved in the study. “It’s probably the closest I’ve seen.”

The field of synthetic embryology has exploded in recent years. A parade of increasingly lifelike models that mimic portions of an embryo’s journey to personhood promise to shed light on critical moments of human development while providing a more flexible and ethical alternative to the study of human embryos, which has been historically limited by regulations and the willingness of IVF donors.

As the science of synthetic embryology gets more sophisticated, the models become more useful. But each advance raises a new round of ethical questions about where embryo models end and embryos begin. If it divides, organizes, and develops like an embryo, does it matter how it was made? Should an embryo derived from stem cells get the same legal and ethical rights as one produced when sperm met egg?

“At some point we have to ask, ‘when does an embryo model become so good that it functionally becomes an embryo?’” said Hyun. “And for me, that question starts to get raised here.” It’s not that the latest work on blastoids was unethical, he clarified. On the contrary, it met all the guidelines issued by the International Society for Stem Cell Research (ISSCR), which Hyun helped write. The latest version, issued in May, prohibits scientists from transferring blastoids, which contain all the cell types necessary for development, into a human or animal uterus. “It was a really well-done paper, I thought it was kind of stunning actually,” said Hyun. “It just opens up these other questions.”

Already this year, five other groups around the world have independently reported methods for making blastoids, with varying degrees of efficiency and complexity. Two teams — one at Monash University in Australia, one from the University of Texas Southwestern Medical Center in Dallas and Kunming Medical University in China — published their results in Nature in March. Both teams also showed that their artificial structures formed similarly to real blastocysts. But both reported that only about 10% of the reprogrammed cells made the transition, and some of the structures contained cells not typically found in human blastocysts. Two other teams, one based in China and one based in the U.S. and the U.K., showed similar results while working with extended pluripotent stem cells. Another group, from the U.K., reported in Cell Stem Cell in June achieving much higher efficiencies — between 30% and 80% of their stem cells expanded into blastoids. The Austrian group’s blastoids were even more efficient, forming more than 70% of the time.

“It’s been a big year for blastoids,” said Jianping Fu, a bioengineer at the University of Michigan whose lab created some of the earliest human embryo models from stem cells in 2017.

In 2018, Fu and Rivron joined Hyun and several others in writing an editorial urging lawmakers to ban the use of stem-cell based synthetic embryos for reproductive purposes while preserving their use for some types of research. They encouraged regulators to treat embryo models in the same way many nations dealt with cloning in the late 1990s and early 2000s. “We think that the intention of the research should be considered the key ethical criterion by regulators, rather than surrogate measures of the equivalence between the human embryo and a model,” they wrote.

Hyun said he still stands by those recommendations, to a point, even if it makes the slippery-slope crowd nervous. “The further along you get in modeling pregnancy, the harder it is to justify those experiments on the grounds that there’s no other way to answer your research question,” said Hyun. Scientists have been able to glean insights into the earliest stages of development by studying human embryos donated by families who’ve undergone IVF. Tissue from aborted fetuses has provided clues about later stages of pregnancy. But from the time an embryo implants until the time a person realizes they’re pregnant, scientists have virtually no way of knowing what’s going on.

“It’s a total black box,” said Hyun. “But it maxes out at about 28 days. And what most people don’t realize is that means there’s a natural limitation on how long you could justify an experiment with synthetic embryos. Once you traverse the black box of development, there’s no need to keep going in the dish.”

Although it’s not required by law or the latest ISSCR guidelines, which relaxed the long-held “14-day rule” barring research on embryos older than two weeks, the Austrian researchers did not allow their artificial embryos to develop past 13 days. But Rivron said he does not expect any of the blastoids to have the ability to develop into a complete embryo, even if allowed the chance.

A few years ago, his team successfully grew blastocysts in the lab from mouse stem cells. Ever since, they’ve been implanting the blastoids into the uteruses of living mice and crossing their fingers. But they’ve never successfully made any mice pups. Rivron said he’d expect the same thing for their human blastoids if they were implanted into a functioning uterus (an experiment the ISSCR’s guidelines, as well as laws in a handful of countries, expressly forbid). After implantation on the uterus-in-a-dish, the blastoids didn’t grow or organize as well as what you’d expect from real embryos in a real womb, said Rivron. “These are very nice models, but we are far from any potential of using them for reproduction.”

So how does he expect scientists might use them instead? A logical application would be to use them for drug discovery and screening — a process that would require large numbers of these embry(ish)os. “Now that we have formed a reliable embryo model, we can uniquely understand the molecules at play, and I believe that these molecules will actually become tomorrow’s medicines to enhance fertility or to be used as contraceptives,” said Rivron. His group is already working with collaborators to test an FDA-approved drug that prevented the innermost cells of the blastoid from forming. Because those cells instruct the outer cells to become sticky, disrupting them could offer a hormone-free way to prevent embryos from implanting.

Other as-yet-discovered drugs could possibly enhance the implantation process, thereby improving the odds of getting pregnant. Compared to creating a fully competent synthetic embryo, using existing models to find and develop drugs is achievable on a relatively short timescale, said Rivron. “This is not something that requires 10 years.”

Other scientists have other ideas. Fu said an obvious immediate application would be to use large numbers of blastoids to systematically figure out better recipes for the medium that IVF clinics use to culture embryos prior to implantation. “There are a lot of unknowns in how culture medium conditions affect the growth and development of human embryos, including successful implantation,” said Fu. “Those are questions that can better be answered now.”

To Martin Pera, a stem cell researcher at the Jackson Laboratory, an even more powerful application would be to use these models to better understand how organisms precisely alter the expression of genes in different types of cells during early development. “It’s a very dynamic time, epigenetically,” said Pera.

Since the 1990s, some scientists have argued for the fetal origins of adult disease; that the intrauterine environment, especially during times of bodily stress, may predispose a developing fetus to worse health outcomes later in life. “We need models to replicate that, and this is an important start,” Pera said.

https://www.statnews.com/2021/12/02/lab-grown-human-embryos-prompt-question-are-they-getting-too-real/

Some suggest Omicron variant may have evolved in animal host

 When Covid-19 variants arise, the accepted wisdom is that the constellation of mutations they contain developed in an immunocompromised person who contracted the virus and couldn’t shake the infection. But some scientists have an alternative theory for where the latest variant of concern, Omicron, may have acquired the unusual mutations that stud its spike protein.

They speculate the virus could have evolved in another animal species.

The theory goes that some type of animal, potentially rodents, was infected with the SARS-CoV-2 virus sometime in mid-2020. In this new species, the virus evolved, accumulating roughly 50 mutations on the spike protein before spilling back over into people.

Kristian Andersen, an immunologist at the Scripps Research Institute, is among those who has been raising the idea that Omicron may have emerged from a reverse zoonotic event.

(A zoonotic event is when an animal pathogen starts to infect and spread among people. A reverse zoonosis is when such a virus passes back into an animal species.)

“I know that most people think that these [come from] immunocompromised individuals, and I do think that that’s plausible, but to be perfectly honest, I actually think this reverse zoonosis followed by new zoonosis seems more likely to me given just the available evidence of the really deep branch, and then the mutations themselves, because some of them are quite unusual,” Andersen told STAT.

“I don’t think we should dismiss that possibility, because I think it’s definitely on the table.”

A number of other scientists who study the evolution of viruses have told STAT they think the idea isn’t out of the question. Some place more weight on the theory that variants develop in immunocompromised people, while others feel there isn’t enough evidence at this point to favor one option over the other.

“Personally, I think it’s probably more likely it was circulating undetected, in an immunocompromised individual,” Emma Hodcroft, a molecular epidemiologist at the Institute of Social and Preventive Medicine in Bern, Switzerland, said via email. Having said that, though, Hodcroft insisted that it is important to explore the hypothesis.

“I would certainly consider it a plausible alternative hypothesis to the evolution during a persistent infection in a human,” said Andrew Rambaut, a professor of molecular evolution at the Institute of Evolutionary Biology in Edinburgh. He cautioned that coming up with a definitive answer won’t be quick.

“I am not sure we will be in a position to say for sure for a while,” Rambaut wrote in an email.

One of the peculiar traits of SARS-2 underpins this thinking. It is what virologists describe as a promiscuous virus; it is capable of infecting a number of species. Dogs and house cats. Large cats. Mink. White-tailed deer. Given how easily the virus seems to jump from species to species, people studying it assume this list will grow.

The original virus that came out of Wuhan, China, in early 2020 did not infect rodents. But as variants — Alpha, Beta, Delta — started to emerge, those viruses could infect rodents.

Robert Garry, a professor of microbiology and immunology at Tulane Medical School, has been tracking the SARS-2 mutations that have arisen. Seven are associated with rodent adaptation — the changes that seemed to allow the virus to infect mice, rats, and related species. All seven of those mutations are in Omicron, Garry noted. He believes it’s a toss-up whether the variant developed in an animal or a human host, but if it’s the former, his bet would be on rodents.

Getting a firm answer might require enormous luck. Scientists are looking at various animal species to see if they can be infected with SARS-2; were they to find viruses like Omicron in any, that would swing the needle.

But Michael Worobey, a professor of evolutionary biology at the University of Arizona, thinks one could do some experiments on selected species of wild animals to see if they can be infected and if, when infected, similar patterns of viral evolution occur.

Studying the molecular clock of viruses that spread in animals — looking at the speed at which they evolve and comparing it to SARS-2 evolution in humans — could also provide some clues, said Worobey, who initially thought Andersen’s idea was not impossible, but not the likeliest of explanations for Omicron. After hearing details of the explosive outbreak in white-tailed deer, he’s rethinking the idea.

For Worobey, the question is whether any animal species can become chronically infected with SARS-2 — in effect, whether there are animal species in which SARS-2 lingers in the way it does in immunocompromised people. That could put positive selective pressure on the virus — in other words give it an incentive to mutate to stay ahead of the animal’s immune response.

“It does move my thinking in terms of Omicron possibly having come from a reservoir, if there are [animal] reservoirs that do chronic infections,” he said.

Part of what leads Andersen to wonder about an animal source is the fact that the variant traces back to viruses that were spreading over a year ago. “That in itself you need to be able to explain,” he said.

Angela Rasmussen, a coronavirus virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, agreed.

“I think it’s pretty obvious to everybody … that this virus has been on an independent evolutionary track for quite some time and it’s very surprising, which to me just kind of goes back to say well, the idea that this could be … plausible,” she said.

Regardless of whether this variant emerged in another species or not, given SARS-2’s ability to jump species, it is possible the world will face animal-derived variants in the future, Garry warned. The upshot of that? “We’re going to have to keep tweaking the vaccines.”

https://www.statnews.com/2021/12/02/some-experts-suggest-omicron-variant-may-have-evolved-in-an-animal-host/

Second U.S. case of Omicron variant indicates domestic transmission

 Health officials on Thursday reported the country’s second Covid-19 infection from the Omicron variant in a Minnesota resident who notably did not travel internationally recently, unlike the first case.

The case in Minnesota is an adult male who had been vaccinated and, in early November, received a booster shot. He lives in Hennepin County, which includes Minneapolis, state health officials said. He developed mild symptoms on Nov. 22, was tested on Nov. 24, and no longer has symptoms. 

The man had been in New York City in the days leading up to feeling sick and attended the Anime NYC 2021 convention at the Javits Center from Nov. 19 to Nov. 21. Minnesota health officials are collaborating with New York City authorities and the Centers for Disease Control and Prevention on their case investigation.

“The primary goal of vaccination all along has been to prevent severe disease so it’s very encouraging that vaccines are still successful in that regard,” Jan Malcolm, Minnesota’s health commissioner, said at a briefing.

State officials said one close contact of the man has tested positive on a rapid test, but they haven’t yet confirmed the case or sequenced the virus from that possible infection.

The new case demonstrates that there is at least some local transmission of the Omicron variant and that it had arrived in the U.S. before the Biden administration imposed travel restrictions on Botswana and South Africa — where early cases of the variant were detected — and six neighboring countries. Some two dozen countries have now reported cases. 

The case also indicates that the variant was in the United States even before the global research community knew about the threat the variant potentially posed. It will likely add fuel to the calls for the Biden administration to lift its travel ban on the southern African nations, which are seen by scientists as penalizing the region where researchers have simultaneously been praised for their speedy detection work and for sharing their findings quickly and transparently. 

Experts have said it was likely Omicron was spreading in the United States at some level, and it was just a matter of time before genomic sequencing of infections started detecting it. 

According to the anime convention’s website, attendees had to show they had at least one dose of a Covid-19 vaccine, but could attend immediately after getting a shot. It takes days if not more than a week for the vaccine-elicited protection to kick in.

Some 46,000 people attended the convention in 2019, according to its site.

The first U.S. Omicron infection was detected by researchers in San Francisco and announced Wednesday. The person, whose age and sex were not provided, had recently returned from a trip to South Africa. The person was vaccinated and had not had a booster shot, and reported only mild symptoms.

Experts urge people showing symptoms of Covid-19 to get tested and to report relevant travel history to authorities. 

Scientists are scrambling to better understand the Omicron variant. They initially raised alarms about because its number and combination of mutations suggested it may be able to escape some amount of immune protection, and because limited epidemiological evidence in South Africa suggests it can compete with the highly transmissible Delta variant. But experts stress they still need to learn much more about Omicron’s transmissibility, severity, and immune evasion before they can assess how much of a threat it is to the world, and to vaccine protection. 

https://www.statnews.com/2021/12/02/second-us-case-omicron-variant-indicates-domestic-transmission/

Truepill preps launch of virtual COVID-19 service for oral antivirals

 Telehealth, diagnostics and pharmacy business Truepill will launch a new virtual care platform in the coming weeks that it says will provide “end-to-end” care for people with COVID-19.

The on-demand, online service will combine virtual consultations and next-day delivery of oral antiviral medicines – assuming those become available to patients in the US.

Closest to emergency use authorisation (EUA) and launch is Merck & Co and Ridgeback’s molnupiravir, which was narrowly backed by an FDA advisory committee yesterday, with Pfizer’s Paxlovid (PF-07321332/ritonavir) following closely behind.

Oral antivirals are highly anticipated because they could be given to patients at home and prevent them developing more severe symptoms, reducing the burden on hospitals during the crisis.

Truepill’s service consists of a landing page for patients that serves as a portal for sharing test results and symptoms, and a booking system for telehealth consultations. Any prescribed COVID-19 medication will be dispensed with overnight shipping or routing to a patient’s local pharmacy.

There will be on-demand patient support from the off, and Truepill also said it plans to add follow-up visits via telehealth early next year. It says the whole process from reporting symptoms to receiving the medicines should take 24-48 hours.

That’s crucial, as antiviral therapy needs to be administered early on in the course of infection to have an impact. In Merck’s molnupiravir trials, patients were only eligible for participation if they were within five days of symptom onset.

Truepill’s senior vice president for telehealth, Andy Rink, said that authorisation of oral antivirals “has the potential to significantly reduce the devastating impacts of the pandemic.”

However, he went on to say that in order for that to happen “there needs to be a system in place for rapid, mass distribution to impacted populations.”

Molnupiravir seems likely to be granted an EUA, despite a worrying fall-off in efficacy in its phase 3 trial, as it will be the only option for a few weeks at least.

The drug’s ability to prevent hospitalisations and death in mild-to-moderate COVID-19 patients at risk of severe disease fell from 48% midway through the study to 30% will additional follow-up. In contrast, Paxlovid’s trial showed an efficacy of 89%.

The latest venture isn’t Truepill’s first foray into COVID-19 care. Earlier this year it launched a COVID-19 wellness programme that combines testing, contact-tracing and digital healthcare tools aimed at the employer market.

Last month, the company closed a $142 million fourth-round financing that swelled its value into unicorn territory at $1.6 billion.

https://pharmaphorum.com/news/truepill-preps-launch-of-virtual-covid-19-service-for-oral-antivirals/

Virtual care companies rush to ease access to Covid-19 antivirals

 As two new antiviral pills for Covid-19 approach emergency authorization, experts are concerned that a lack of public health infrastructure — especially easy access to fast-turnaround testing and quickly filled prescriptions — will prevent them from making a meaningful dent in the pandemic.

“We know that these antivirals are going to have a window of opportunity where their effectiveness is optimal, and it can be difficult to get an appointment and get a prescription,” said infectious disease specialist Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

Virtual care companies think they could speed up the process of getting patients the antivirals in the three to five days from symptom onset when they are most effective. This week, digital health company Truepill announced it would soon launch a platform to support telehealth consultations, prescriptions, and next-day delivery of the new drugs, from Merck and Pfizer, when authorized. Carbon Health, which has both brick-and-mortar clinics and virtual care, plans to extend its acute Covid care program to include the oral antivirals. And direct-to-consumer company Ro says it has the capability to prescribe and deliver the drugs and expects to make them available through its platform.

“I do think there could be a great opportunity here to leverage all the telehealth that’s developed over the pandemic, and even was going on before the pandemic, to be able to get prescriptions into the hands of people much faster than the traditional route,” said Adalja.

But that opportunity hinges on all the rest of the pieces falling into place at the right time. For the pills to live up to their full potential, people need to be able to procure and pay for tests, receive their results quickly, and connect right away with a health care provider if they test positive for Covid.

If all those steps go according to plan, online platforms, by virtue of their distributed workforce of virtual providers, could get prescriptions in some hands faster while allowing Covid-positive patients to quarantine. When a patient enrolls in Carbon Health’s Covid-19 program online, “we make sure they have a thorough virtual assessment within 24 hours of showing symptoms,” said medical director of program development Aaron Weinberg, also national director of Carbon for Research. “The clock starts as soon as someone contacts us.”

Once patients meet with a Carbon Health provider and receive a positive test result, they might receive a prescription for monoclonal antibodies, a pulse oximeter to self-monitor their symptoms, or soon, an antiviral prescription.

Truepill is making an even more explicit guarantee of speed, with plans to offer its teleconsultation and delivery services as a plug-and-play tool for existing healthcare systems, providers, and payers, said Andy Rink, vice president of telehealth at Truepill. “We will basically allow any patient that has tested positive for Covid and qualifies for these medications under the [emergency use authorization] guidelines to get the medication within 24 hours,” he said.

How quickly digital pharmacies can get the antivirals to a patient’s door will depend significantly on supply. The drugs, like vaccines and other Covid-19 therapeutics, will be distributed state-by-state according to need. To ensure timely delivery after a teleprovider prescribes the drug, Truepill will arrange for access in one of two ways: shipping them overnight through one of the company’s own pharmacy centers, or arranging pickup or delivery from a retail pharmacy, using publicly available information to determine which locations have the drugs in stock. “We can take that information and get it to the provider at the point of that visit, so we can get it to the right location, the first time,” said Rink.

Truepill expects to complete its platform within two weeks, and is talking with groups that may implement it. “We have groups of providers that are interested in taking our existing solution and using it for their patients, even patients that have a primary care doctor already,” said Rink — primarily with the advantage of finding a reliable supply of the drug. They’re also talking with payers, employer groups, and existing direct-to-consumer companies.

Until those partnerships are solidified, it’s unclear what the impact will be on increasing access in underserved patient groups — particularly older adults and lower-income individuals, who are less likely to have access to or use telemedicine. Telehealth has also seen lower use among non-white, uninsured, and rural patients.

“I worry that we have this tendency to herald technological breakthroughs, while really setting ourselves up for breakdown in delivery to those who are going to need it most,” said Alyssa Bilinski, a public health policy expert at Brown University.

It’s possible that telehealth companies could, if not increase access for the most underserved patients, lighten the burden for some in-person providers or shorten wait times for certain patients. Direct-to-consumer pharmacy companies like Ro, Nurx, and Hims & Hers — many of which started by providing convenient online prescriptions for erectile dysfunction medications or birth control — have increasingly expanded their offerings, including Covid-19 testing, and added telehealth services. These companies could capitalize on their own network of teleproviders to support antiviral access, or deploy a platform like Truepill’s.

“Companies that have been successful doing it with other medications, lifestyle medications, I think they’re perfectly poised to do it,” said Adalja.

But each of these routes to digital prescription and delivery could run into obstacles. Not every virtual care network has teleproviders licensed in every state; someone looking for a quick prescription might hit a dead end when they realize a platform doesn’t serve them. And while platforms will typically require users to fill out an intake survey that asks questions about the antiviral drugs’ indications, patients with complex medical histories should be especially careful to make sure a new teleprovider takes any contraindications or potential drug interactions into consideration.

“Given their potential advantage in terms of access, one could see direct to consumer telemedicine companies playing a more substantial role,” said Mehrotra. “However I suspect that the vast majority of people will still turn to their usual PCP or go to a local urgent care or retail clinic.”

Primary care offices are capable of writing prescriptions after virtual visits, too, of course. In a study led by Michael Anne Kyle, postdoctoral fellow in the Department of Health Care Policy at Harvard Medical School, researchers found that many primary care offices offered testing and virtual visits during the pandemic. “But the wait times to get an appointment were usually outside the window … needed to start antivirals,” Kyle wrote in an email.

Rink said Truepill’s platform will allow users to order an at-home test online, but acknowledged that “given the five-day window, it’ll be hard to get all that done — get the test, get it delivered, have the visit, get the medication.” So patients who turn to virtual care companies for an antiviral prescription will likely have taken an at-home antigen test. That means the biggest beneficiaries of virtual platforms could be those who have had the means and ability to stock up on those tests. “We’re seeing a lot of people order tests ahead of time to have at home,” said Rink.

In a move to increase testing access, the Biden administration said it would soon require private insurers to reimburse Americans for the cost of rapid, at-home antigen tests. But access may still present a challenge for patients who don’t have the approximately $30 to pay for a test upfront, or for those who can’t find tests on shelves.

If telehealth is to play a role, then, it will have to be just one part of a systemic effort to enable access to rapid testing, diagnosis, and treatment with the new antivirals.

“So much less attention has been paid to the full cascade of steps,” said Bilinski. “That starts with educating people to get tested, then getting the test and the quick test turnaround, but then having to know that you want to seek a prescription, having some kind of consultation with someone who can prescribe, and then getting that prescription filled.” Any breakdown in that chain of events could be the one that keeps the pills from achieving their full impact.

https://www.statnews.com/2021/12/02/covid19-antivirals-carbon-truepill/