Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data.
Three experts who sat on an advisory committee for the FDA have now resigned over the decision.
The advisory committee reviewed the data behind Aduhelm last November and voted overwhelmingly against approval. Of the 11 advisors on the committee, 10 voted “no” on the question of whether Biogen had collected enough evidence to indicate that the drug is effective. The remaining advisor voted “uncertain.”
The US Food and Drug Administration on Monday approved the antibody drug Aduhelm (generic name aducanumab) to treat Alzheimer’s disease. Aduhelm is the first new Alzheimer’s drug to earn FDA approval since 2003. It’s also the first drug to target a theoretical cause of the irreversible neurodegenerative disease—clumps of beta-amyloid peptides that build up in the brains of Alzheimer’s patients—rather than just treating the disease’s symptoms.
The approval is, without a doubt, a landmark. It could provide hope to millions of patients, who currently have few options. And, given those limited options, it will certainly provide a massive money-maker for its developer, Biogen, which has already set the list price for a year’s worth of Aduhelm at $56,000. Analysists estimate that the drug will bring in $5 billion to $6 billion worth of sales per year in the US alone.
But, the FDA’s approval is far from a celebrated decision and the drug is far from a clear success. Since the FDA’s approval yesterday, researchers and pharma watchers have called the agency’s decision “disgraceful,” “a grave error” and a “dangerous precedent” that will end up “eroding confidence in the agency as a whole.”
The CDC said at the time that it was merely following the science for masking. The agency and its director, Rochelle Walensky, highlighted fresh, real-world studies demonstrating COVID-19 vaccines’ high efficacy and ability to lower transmission risks. But the update was also part of an overt effort to encourage vaccination among the vaccine hesitant by emphasizing the perks of being vaccinated—like not needing to wear masks anymore and reclaiming other bits of normal life.
That messaging shift came as states across the country started to see their pace of vaccination slow despite a glut of vaccine doses. Numerous polls have indicated that most of the people eager to get vaccinated already have. Now, with just 62 percent of the US adult population vaccinated, much of the remaining unvaccinated portion is either hesitant or resistant to being vaccinated. It’s that group of people the CDC was trying to reach with the new mask guidance.
Moderna’s COVID-19 vaccine appears safe and highly effective in adolescents ages 12 to 17, according to the top-line results of a small clinical trial the company announced Tuesday.
The company plans to submit the trial data to the US Food and Drug Administration early next month, seeking authorization for expanded use in the age group.
If the FDA grants the authorization, Moderna’s vaccine will be the second COVID-19 vaccine available for use in kids as young as 12 in the US. Earlier this month, the FDA authorized the Pfizer-BioNTech vaccine for use in adolescents ages 12 to 15. (The Pfizer-BioNTech vaccine was initially authorized for use in people ages 16 and up, while Moderna’s was initially authorized for use in people ages 18 and up.)
The US Food and Drug Administration on Wednesday announced a big change in the way doses of Pfizer-BioNTech’s COVID-19 vaccine can be handled. From now on, undiluted vials of the mRNA vaccine can stay at normal refrigerator temperatures for up to a month rather than the previous limit of just five days.
The change has the potential to significantly ease storage issues and promote the use of the highly effective vaccine, which has been hindered in some settings by its ultra-cold storage requirements.
For long-term storage, the vaccine still requires ultra-cold freezer temperatures—between -80°C to -60°C (-112°F to -76°F). But the vials can be transported and temporarily stored at normal freezer temperatures—between -25°C to -15°C (-13°F to 5°F)—for up to two weeks. According to yesterday’s update, the undiluted vials can then be thawed and kept at normal refrigerator temperatures—between 2°C to 8°C (35°F to 46°F)—for up to a month. Once the vials are diluted and ready for use, they must be used within six hours, according to the FDA’s detailed handling guide.
When contract-manufacturer Emergent BioSolutions contaminated at least 15 million doses of Johnson & Johnson’s COVID-19 vaccine and millions more doses of AstraZeneca’s vaccine at its Baltimore facility earlier this year, the company had been collecting monthly payments of $27 million from the US government—payments intended to help Emergent avoid just such a manufacturing disaster.
That’s according to a preliminary report from a Congressional investigation, conducted by two House committees—the Select Subcommittee on the Coronavirus Crisis and the Committee on Oversight and Reform. The report was released today and includes a number of troubling new details about the ongoing Emergent scandal.
The monthly “reservation fees” Emergent received were paid out of a questionable $628 million contract from May 2020. The money was intended to help Emergent maintain a state of “cleanliness and readiness” to produce vaccine under proper manufacturing standards and practices. But, as Ars previously reported, an inspection by the Food and Drug Administration in April found that to be far from the case.
An FDA pathway that’s greased the gears for COVID-19 vaccines and drugs has paved the way for something else: a new take on electroencephalography (EEG), the established brain-monitoring technique in which metallic electrodes are placed on the scalp to measure the brain’s electrical activity.
On May 17, DC-based startup iCE Neurosystems announced a version of FDA approval for a subcutaneous electrode called iCE-SG, designed to monitor the brain’s electrical activity from beneath the skin of the scalp. That electrode comes on the back of a 2020 Emergency Use Authorization (EUA) for iCE Neurosystems’ software platform called iCEWav, which was used in a D.C. area hospital to monitor the brain activity of patients in medically-induced comas during the Covid-19 pandemic.
iCE Neurosystems electrode and software are, essentially, a new take on traditional EEG. The electrode is designed to sit beneath the scalp for days and analyze brain activity, and the software component is designed to integrate that data with vital signs like heart rate or blood pressure.
“For the first time we’ve got this massive, high-fidelity, continuous, integrated data set from both brain and body,” says Alan Waziri, a neurosurgeon and company co-founder. “That allows us to really understand what’s happening in the brain to drive timely clinical decisions, and fundamentally change outcomes for these patients.”
iCE was founded by Waziri and colleagues from his time as a resident at Columbia University Medical Center in 2017. As of 2021, the company has nine full–time employees, and has raised a total of $4.5 million, including a recent round of $2.95 million from private investors in April 2021.
The subcutaneous electrode and software combination is part of iCE Neurosystems bigger picture: to create a full platform for continuous monitoring of the brain.
There are examples of use cases where continuous monitoring may prove beneficial. For instance, a 2019 New England Journal of Medicinestudy suggested that specialized EEG monitoring might detect signs of consciousness in otherwise unresponsive patients. That study was authored by Jan Claassen the director of Critical Care Neurology at Columbia who is also co-founder and minority shareholder at iCE Neurosystems.
Another 2019 paper suggests that continuous monitoring via EEG was associated with fewer deaths in hospitals. But only 22,728 of the over 7 million people analyzed in the study had access to continuous EEG.
Waziri’s aim is to increase that number. Subcutaneous electrodes, he’s betting, are a first step. The iCE-SG electrodes should be easy to install and don’t require the technical expertise usually required to prepare and administer an EEG, explains Waziri. Other scientists have also noted technical expertise needed to use and interpret traditional EEG is cumbersome and has stood in the way of long-term EEG monitoring.
FDA approval documents note that the iCE-SG devices are approved to remain beneath the skin for 14 days, but Waziri says he’s obtained continuous monitoring of brain activity for up to 35 days. A long-term EEG analysis, by comparison, might last several days.
“It’s almost like placing an IV,” Waziri says. “Basically a routine clinician at the bedside can place these in under five minutes.”
On the other hand, the platform alone can’t address the need for expertise to interpret this data. Waziri’s answer to that question is to make this data shareable.
Within a hospital, data collected by platform is stored on the cloud. However, a hospital could opt into sharing data on another platform iCECloud Knowledge with other medical institutions.
“From participating institutions, all the data we collect gets put in there and is made available to anyone who is using our system,” he says. “Our goal is to almost kind of crowdsource the analysis of the data.”
So far, iCENeurosystems has pursued two forms of FDA approval for the software and the electrode.
The electrode and the full platform have received FDA premarket approval through the 510(k) pathway – a type of pre-market approval that allows a medical device to go to market without additional FDA review because it’s substantially similar to other products already on the market (In this case, that tech is a traditional EEG). The iCEWav system was granted 510(k) approval in March 2020 and the electrode received it in March 2021.
This pathway is one of the most expedient ways to get a medical device onto the market, but has also faced criticism because it doesn’t require a device to be tested for safety or efficacy through clinical trials. Waziri says there “haven’t been any complications” from the devices.
Additionally, iCEWave has done time in the clinical setting in a major D.C. hospital, though Waziri won’t disclose which one.
In early 2020, the DC based startup iCE Neurosystems was in the midst of testing iCEWav when the pandemic hit. Some Covid-19 patients required intense cardiopulmonary support that required use of medically induced comas. Technicians typically use EEG to monitor these patients, but iCE Neurosystems also received a trial run, says Waziri, as the hospital was looking for long-term methods of monitoring patients brain activity without having technicians visit multiple times per day.
“They had our system in place because we were running a clinical trial in patients with cardiac arrest, and they asked us if they could use the system for monitoring their critically ill COVID patients. They actually applied to the FDA and the FDA granted emergency use authorization for the software,” Waziri says.
So far Waziri and iCENeurosystems hasn’t published any peer-reviewed data from that trial at the D.C. area hospital, but he says the company has two forthcoming manuscripts.
Meanwhile, Waziri says that iCE Neurosystems is working towards getting more devices into more hospitals. He says they’re in talks with an additional five hospitals, with the goal of beginning a Series A funding raise in mid 2022.
On Wednesday, the CDC’s Advisory Committee on Immunization Practices recommended that the CDC approve the use of the Pfizer/BioNTech COVID-19 vaccine for the 12- to 15-year age group. The decision comes two days after the FDA granted an emergency use authorization for the same age group and will help the US further limit the pool of people who can spread infections or foster the evolution of new viral variants. Formal CDC approval could come quickly, given recent history.
Given the FDA’s earlier decision, the move might seem anticlimactic. But having the FDA and CDC officially on the same page is reassuring, and several state-run vaccination programs are awaiting the CDC’s OK before expanding into that age group. Private providers and insurance companies were also varied in their response to the FDA’s decision and were waiting for the CDC.
The data that supported the approval was pretty decisive, as a small Phase III clinical trial of 2,260 adolescents saw 16 cases of COVID-19, with every single one occurring in the placebo group. Side effects were similar to those experienced by older people, with a brief period of flu-like symptoms. The committee was tasked with considering whether the benefits outweighed the risks; given the minor side effects and the increasingly obvious benefits of vaccination, it’s not a surprise that the vote in favor of approval by the committee was 14 in favor, none opposing, and a single recusal. The CDC director, Rochelle Walensky, is overwhelmingly likely to follow the committee’s recommendation, most likely before the day is over. (We’ll update this story if and when this occurs.)
White House officials told governors in a call Tuesday that there are no new doses available for order. It’s unclear if the federal government will be able to distribute doses through other channels, such as those that provide vaccines directly to pharmacies and community health centers.
The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US.
The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening.
In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.
The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.
Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.
“We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters. “We’ll see what happens,” he added, leaving open the possibility of future orders.
By July 4—two months from today—the Biden administration wants to have 70 percent of American adults vaccinated with at least one dose of a COVID-19 vaccine and 160 million adults fully vaccinated.
Currently, over 147.5 million people have received at least one shot, which is 44 percent of the overall population and includes 56 percent of adults (people ages 18 and up). Over 105 million people are fully vaccinated, which is nearly 32 percent of the overall population and includes nearly 41 percent of adults.
The administration’s new goal would mean that close to 100 million shots would have to go out in the next 60 days or so, President Joe Biden said in an address Tuesday afternoon.
The Food and Drug Administration is planning to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a report by The New York Times.
The Times cited unnamed federal officials who did not have authorization to speak publicly about the FDA’s plans. If the FDA does authorize use of the vaccine in the teen group in the week, the Centers for Disease Control and Prevention’s vaccine advisory panel will likely meet a day later to review the clinical trial data and make a recommendation on use, the Times reported.
The lead water technician for Real Water—a Las Vegas-based company that produces “alkalized” bottled water now linked to liver failure cases—testified that he had no relevant experience to be a water technician when he was promoted to the position last August.
Real Water’s lead technician, Casey Aiken, 40, is a former vacuum and timeshare salesman who began working for Real Water last June after losing his job as a strip club promoter. According to a taped deposition from late March that was obtained by the Las Vegas Review-Journal, Aiken was promoted from his job of loading bottled water onto shipping pallets to the company’s lead technician after “a couple hours” of training.
In late November, just a few months after Aiken’s promotion, five infants and children who drank the water developed acute non-viral hepatitis, which led to acute liver failure, health officials say. The children ranged in age from 7 months to 5 years. Real Water’s branded water was the only common link between the cases.
India’s skyrocketing surge of COVID-19 cases has launched the country into the most harrowing crisis yet in the pandemic.
While international aid pours into the country, many have called for the US to donate millions of doses from its stockpile of AstraZeneca’s COVID-19 vaccine to India, which has vaccinated less than 2 percent of its population and is running out of doses.
AstraZeneca’s vaccine is widely used around the world, including in India, but it is not yet authorized for use in the US. Even if it does earn authorization here, Biden administration officials say it’s unlikely that the US will need the vaccine, given the healthy quantity of supplies of the three COVID-19 vaccines already authorized in the country made by Moderna, Pfizer-BioNTech, and Johnson & Johnson.
The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.
Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.
About 88 percent of Americans support the pause of Johnson & Johnson’s COVID-19 vaccine, and the pause did not increase vaccine hesitancy, according to fresh data from the Axios-Ipsos Coronavirus poll.
The finding is likely to hearten public health experts, who have faced criticism and concern that the pause could erode confidence in vaccine safety and fortify already high-levels of vaccine hesitancy in the country.
The Centers for Disease Control and Prevention, along with the Food and Drug Administration, recommended a pause in the use of the Johnson & Johnson vaccine on April 13 after linking the one-dose vaccine to six cases of a rare blood-clotting condition, one of which was fatal. The six cases occurred among more than 6.8 million people given the vaccine, suggesting that if the blood clots are, in fact, a side effect of the vaccine, they are an extremely rare side effect.
The US Food and Drug Administration last week asked Emergent BioSolutions to stop making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to a regulatory filing Emergent released Monday.
The FDA had begun an inspection of the contract manufacturer’s facility on April 12 but requested on April 16 that production be halted “pending completion of the inspection and remediation of any resulting findings,” the filing reads. Any vaccine materials already made at the plant will be held in quarantine.
If you or a loved one has ever undergone a tumor removal as part of cancer treatment, you’re likely familiar with the period of uncertainty and fear that follows. Will the cancer return, and if so, will the doctors catch it at an early enough stage? C2i Genomics has developed software that’s 100x more sensitive in detecting residual disease, and investors are pouncing on the potential. Today, C2i announced a $100 million Series B led by Casdin Capital.
“The biggest question in cancer treatment is, ‘Is it working?’ Some patients are getting treatment they don’t benefit from and they are suffering the side effects while other patients are not getting the treatment they need,” said Asaf Zviran, co-founder and CEO of C2i Genomics in an interview.
Historically, the main approach to cancer detection post-surgery has been through the use of MRI or X-ray, but neither of those methods gets super accurate until the cancer progresses to a certain point. As a result, a patient’s cancer may return, but it may be a while before doctors are able to catch it.
Using C2i’s technology, doctors can order a liquid biopsy, which is essentially a blood draw that looks for DNA. From there they can sequence the entire genome and upload it to the C2i platform. The software then looks at the sequence and identifies faint patterns that indicate the presence of cancer, and can inform if it’s growing or shrinking.
“C2i is basically providing the software that allows the detection and monitoring of cancer to a global scale. Every lab with a sequencing machine can process samples, upload to the C2i platform and provide detection and monitoring to the patient,” Zviran told TechCrunch.
C2i Genomics’ solution is based on research performed at the New York Genome Center (NYGC) and Weill Cornell Medicine (WCM) by Dr. Zviran, along with Dr. Dan Landau, faculty member at the NYGC and assistant professor of medicine at WCM, who serves as scientific co-founder and member of C2i’s scientific advisory board. The research and findings have been published in the medical journal, Nature Medicine.
While the product is not FDA-approved yet, it’s already being used in clinical research and drug development research at NYU Langone Health, the National Cancer Center of Singapore, Aarhus University Hospital and Lausanne University Hospital.
When and if approved, New York-based C2i has the potential to drastically change cancer treatment, including in the areas of organ preservation. For example, some people have functional organs, such as the bladder or rectum, removed to prevent cancer from returning, leaving them disabled. But what if the unnecessary surgeries could be avoided? That’s one goal that Zviran and his team have their minds set on achieving.
For Zviran, this story is personal.
“I started my career very far from cancer and biology, and at the age of 28 I was diagnosed with cancer and I went for surgery and radiation. My father and then both of my in-laws were also diagnosed, and they didn’t survive,” he said.
Zviran, who today has a PhD in molecular biology, was previously an engineer with the Israeli Defense Force and some private companies. “As an engineer, looking into this experience, it was very alarming to me about the uncertainty on both the patients’ and physicians’ side,” he said.
This round of funding will be used to accelerate clinical development and commercialization of the company’s C2-Intelligence Platform. Other investors that participated in the round include NFX, Duquesne Family Office, Section 32 (Singapore), iGlobe Partners and Driehaus Capital.
Out of an abundance of caution, US officials on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine. Officials linked the vaccine to six peculiar illnesses in which people developed life-threatening blood clots in combination with low levels of blood platelets, the cell fragments in blood that form clots. One person died from their condition and another is in critical condition.
It’s unclear if the vaccine caused the illnesses. Even if it did, the illnesses would represent an exceedingly rare side effect. The six cases occurred among more than 6.8 million people in the US who received the Johnson & Johnson vaccine. That would make it a side effect seen in fewer than one in a million. The risk of hospitalization and death from COVID-19, which the vaccine protects against, easily exceeds those odds. Without question, the benefits of the vaccine outweigh the potential risks.
Still, with robust supplies of vaccine from Moderna and Pfizer-BioNtech—neither of which have been linked to these unusual cases—US officials took the cautious route of pausing Johnson & Johnson’s vaccine while they investigate the cases further and inform clinicians about how to spot and treat any others that may arise. This latter point is critical because if doctors try to use standard blood clot treatments in these vaccine-linked cases, the outcomes can be fatal.
On Tuesday morning, the US Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.
Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.
This is not the first vaccine to create extremely rare clotting issues. They’ve also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.
The Food and Drug Administration on Wednesday admonished Nevada-based company Real Water for being uncooperative in a multi-state health investigation linked to its “alkalized” water products. The company is accused of poisoning its customers, causing acute liver failure and other serious health problems in adults, children, and pets.
On March 16, the FDA and the Southern Nevada Health District announced that they were investigating cases of acute non-viral hepatitis (resulting in acute liver failure) in five infants and children, all of whom consumed the company’s alkaline water. The water was the only common link between the five children and infants. Since then, customers have filed several lawsuits making similar claims, including three Californian women who filed a federal lawsuit in Nevada March 22 seeking class-action status.
In an investigation update Wednesday, the FDA said its work has been hamstrung by Real Water’s failure to hand over critical records for two of its product facilities. Real Water has also failed to notify its distributors of the March 24 recall of all its water products, which are still being offered for sale by online retailers, the FDA noted. In addition, the FDA reported that the company is still promoting its products on social media, despite the recall and serious health claims.
About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine were ruined, and future vaccine shipments will be delayed. This all follows a mix-up at a manufacturing facility in Baltimore, according to multiple media reports.
The mishap with Johnson & Johnson’s vaccine began before the Food and Drug Administration had authorized the facility to produce the vaccine. Now, that authorization has been delayed and shipments are stalled.
The new estimate is still high, according to an independent board of experts tasked with overseeing the vaccine’s trial and data analysis. The trial’s Data and Safety Monitoring Board (DSMB) sent a highly unusual letter to AstraZeneca soon after the Monday press release, noting that trial data it had seen during February and March meetings suggested that the vaccine’s efficacy was actually between 69 percent and 74 percent.
“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter stated. “The point that is clear to the board is that the [vaccine efficacy number]… they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”
After a day-long meeting Friday, an advisory panel for the US Food and Drug Administration voted 22 to 0 to recommend issuing an Emergency Use Authorization for Johnson & Johnson’s single-shot, refrigerator-stable COVID-19 vaccine.
If the FDA accepts the panel’s recommendation and grants the EUA—which it likely will—the country will have a third COVID-19 vaccine authorized for use. Earlier this week, FDA scientists released their review of the vaccine, endorsing authorization.
Agency watchers expect the FDA to move quickly on the decision, possibly granting the EUA as early as tomorrow, February 27. The FDA moved that fast in granting EUAs for the two previously authorized vaccines, the Moderna and Pfizer/BioNTech mRNA vaccines.
Johnson & Johnson’s single-shot COVID-19 vaccine is effective and has a “favorable safety profile,” according to scientists at the Food and Drug Administration.
The endorsement comes out of a review released by the regulatory agency Wednesday. The FDA has been looking over data on Johnson & Johnson’s vaccine since February 4, when the company applied for Emergency Use Authorization. The agency’s green light is a positive sign ahead of this Friday, February 26, when the FDA will convene an advisory committee to make a recommendation on whether the FDA should grant the EUA. The FDA isn’t obligated to follow the committee’s recommendation, but it usually does.
If Johnson & Johnson’s vaccine is granted an EUA, it will become the third COVID-19 vaccine available for use in the US. The other two vaccines are both two-dose, mRNA-based vaccines, one made by Pfizer and its German partner BioNTech and the other from Moderna, which developed its vaccine in collaboration with researchers at the US National Institutes of Health.
The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.
If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.
With concerning coronavirus variants erupting around the world, the US Food and Drug Administration is ironing out how to rapidly review vaccine tweaks that better protect against the mutants—and the regulatory agency is turning to its experience with annual flu shots to do so.
In a statement late Thursday, the regulatory agency said it is actively hashing out what kind of “streamlined” clinical data makers of authorized COVID-19 vaccines could submit. The agency expects to have a draft of its guidance in the next few weeks.
The announcement suggests that makers of authorized vaccines will not be required to submit reams of data from large, months-long clinical trials, as they did for their initial authorizations. Still, data on any altered vaccine—however pared down—would still have to be enough to convince FDA scientists that a next-generation shot is safe and effective against variants. Vaccine alterations may include changes to the initial vaccine design or additions of new vaccine components, the FDA said.
Johnson & Johnson on Thursday announced it has applied to the US Food and Drug Administration for an Emergency Use Authorization for its one-shot COVID-19 vaccine.
If the EUA is granted, the vaccine will be the third authorized for use in the US against the pandemic coronavirus, likely boosting the vaccine supply in the coming months and helping to hasten immunization country-wide.
J&J’s application to the FDA comes just a week after the company revealed top-line results of its Phase III clinical trial, which found the vaccine to be 66 percent effective overall at preventing moderate and severe COVID-19. J&J’s vaccine—made by its vaccine developer Janssen Pharmaceuticals—was 85 percent effective at preventing severe disease. In the trial, severe disease was defined as testing positive for the virus as well as having signs consistent with severe systemic illness, respiratory failure, shock, or organ failure, or being admitted to an intensive care unit, or dying. The company reported that no one who received the vaccine was hospitalized or died during the trial.
Google is introducing features that will allow users to take vital health measurements using just the camera they already have on their smartphone, expanding health and fitness features typically only available on dedicated wearables to a whole new group of people. Beginning next month, and available initially on Google Pixel phones exclusively (but with plans to offer it for other Android devices in future), users will be able to measure both their heart rate and their respiratory rate using just their device’s camera.
Typically, taking these measurements has required specialized hardware, including red or green light-based heart rate monitors like those found on the Apple Watch or on fitness trackers like those made by Google-acquired Fitbit. Google’s hardware and software teams, including the Google Health unit led by Director of Health Technologies Schwetak Patel, have managed to develop computer vision-based methods for taking these measurements using only smartphone cameras, which it says can produce results that are comparable to clinical-grade measurement hardware (it has produced a study to validate these results, which it’s making available in pre-print format while it seeks peer review through an academic journal).
For respiratory rate, the technology relies on a technique known as ‘optical flow,’ which monitors movements in a person’s chest as they breathe and uses that to determine their breathing rate. In its clinical validation study, which covered both typical individuals in good health, and people with existing respiratory conditions, Google’s data indicates that it’s accurate to within 1 breath per minute across all participants.
For heart rate, Google is initially using the camera to detect “subtle color changes” in a user’s finger tip, which provide an indicator about when oxygenated blood flows from your heart through to the rest of your body. The company’s validation data (again, still subject to external review) has shown accuracy within 2% margin of error, on average, across people with a range of different skin types. Google is also working on making this same technology work using color changes in a person’s face, it says, though that work is still in the exploratory phase.
Google is going to make these measurement features available to users within the next month, it says, via the Google Fit app, and initially on currently available Pixel devices made by the company itself. The plan is then to expand the features to different Android devices running Android 6 or later, sometime “in the coming months.”
Image Credits: Google
“My team has been working on ways that we can unlock the potential of everyday smart devices,” Patel said in a press briefing regarding the new features. This would include smart devices in the home, or a mobile phone, and how we leverage the sensors that are starting to become more and more ubiquitous within those devices, to support health and wellness.”
Patel, who is also a computer science professor at the University of Washington and who has been recognized with an ACM Prize in Computing Award for his work in digital health, said that the availability of powerful sensors in ubiquitous consumer devices, combined with advances in AI, have meant that daily health monitoring can be much more accessible than ever before.
“I really think that’s going to be a really important area moving forward given that if you think about health care, the journey just doesn’t end at the hospital, the four walls of the hospital,” he said. “It’s really this continuous journey, as you’re living your daily life, and being able to give you feedback and be able to measure your general wellness is an important thing.”
It’s worth noting that Google is explicit about these features being intended for use in a person’s own tracking of their general wellbeing – meaning it’s not meant as a diagnostic or medical tool. That’s pretty standard for these kinds of features, since few of these companies want to take of the task of getting full FDA medical-grade device certification for tools that are meant for general consumer use. To that end, Google Fit also doesn’t provide any guidance or advise based on the results of these measurements; instead, the app provides a general disclaimer that the results aren’t intended for medical use, and also offers up some very high-level description of why you’d even want to track these stats at all.
Many of the existing dedicated wellness and health tracking products on the market, like the Oura ring, for instance, provide more guidance and actionable insight based on the measurements it takes. Google seems intent on steering well clear of that line with these features, instead leaving the use of this information fully within the hands of users. That said, it could be a valuable resource to share with your physician, particularly if you’re concerned about potential health issues already, in place of other less convenient and available continuous health monitoring.
Patek said that Google is interested in potentially exploring how sensor fusion could further enhance tracking capabilities on existing devices, and in response to a question about potentially offering this on iPhones, he said that while the focus is currently on Android, they ultimate goal is indeed to get it “to as many people as possible.”
Another COVID-19 vaccine is almost ready to begin being distributed – a single-shot inoculation made by Johnson & Johnson’s Janssen pharmaceutical subsidiary. The company just released an efficacy report based on data from its Phase 3 trial, which found that the new vaccine is 66% effective overall in preventing moderate to severe incarnations of COVID-19 in those who received the jab, and 85% effective in preventing sever disease.
Those numbers aren’t as impressive as the reported figures for the Moderna and Pfizer/BioNTech vaccines that are already being distributed via emergency FDA approval, both of which reported 90+% efficacy. But Johnson & Johnson’s vaccine is a single shot rather than a two-course treatment, which should make it much easier to distribute much more quickly. The vaccine also showed 100% efficacy in preventing hospitalization or death among participants in the trial, 28 days after vaccination, which is a key measure when considering the broader impact of COVID-19 on healthcare resources, and efficacy varied by region, with the jab proving 72% effective in the U.S. across moderate and severe cases vs. 66% globally.
It’s also important to note that Johnson & Johnson’s Phase 3 trial is happening amid the emergence of new strains of the virus, including much more contagious versions like the UK and South African variants. At the time that both Moderna and BioNTech released their trial data, these variants hadn’t yet emerged or been confirmed by pandemic researchers.
All of which is to say, despite headline numbers that appear to fall short relative to the data we’ve seen from Moderna and Pfizer, this Johnson & Johnson report is actually very encouraging. The company says it expects to file a request for an Emergency Use Approval (EUA) from the FDA in February, which could see it begin to be distributed next month, adding yet another weapon in the arsenal to combat the global pandemic.
The US Food and Drug Administration on Monday issued a first-of-its-kind alert to try to block the import of toxic hand sanitizers from Mexico, which have been flooding the market amid the COVID-19 pandemic.
Last June, the regulatory agency began issuing alerts and warnings for consumers about dangerous and counterfeit hand sanitizers, many of which were made in Mexico. Since then, the FDA has issued alerts on 226 products. An FDA survey conducted between April and December found that 84 percent of products tested from Mexico were not in compliance with FDA regulations.
Many of the concerning products are labeled as containing safe alcohols but actually contained methanol, an extremely poisonous form of alcohol associated with incorrectly distilled liquors that can cause blindness and even death. The FDA discovered some other products containing another toxic ingredient, 1-propanol, while others simply contained insufficient amounts of safe alcohols for sanitation. (Safe alcohols for hand sanitizers include ethanol, aka ethyl alcohol, at concentrations above 60 percent or isopropyl alcohol at concentrations above 70 percent).
TikTok has a vaping problem. Although a 2019 U.S. law made it illegal to sell or market e-cigarettes to anyone under the age of 21, TikTok videos featuring top brands of disposable e-cigarettes and vapes for sale have been relatively easy to find on the app. These videos, set to popular and upbeat music, clearly target a teenage customer base with offers of now-unauthorized cartridge flavors like fruit and mint in the form of a disposable vape. Some sellers even promote their “discreet” packaging services, where the vapes they ship to customers can be hidden from parents’ prying eyes by being placed under the package’s stuffing or tucked inside other products, like makeup bags or fuzzy slippers.
In February 2020, the FDA first began to take enforcement action against illegally marketed e-cigarette devices, including those offering flavors besides tobacco or menthol, as well as those targeted towards minors — an action that was designed to target Juul.
As a result, disposable vapes like Puff Bar were adopted by some young people who were still in search of flavors like bubblegum, peach, strawberry and others. These cheaper disposables were easy to find, and continued to be available at convenience stores and gas stations.
But they’re also all over TikTok, ready to be shipped with anyone with a way to pay.
What’s more, when this content is reported to TikTok, it’s not always taken down.
TechCrunch found vape sellers marketing on TikTok who have been using the app to communicate with customers through both videos and comments. They also direct viewers to what appear to be illegally operating websites. Their TikTok videos often show off the seller’s current inventory of vapes, including disposables like Puff Bar in teen-friendly flavors.
Essentially, the sellers are using TikTok as a way to create vape advertisements they don’t have to pay for that are capable of reaching young consumers — an audience whose interest in vaping hasn’t necessarily declined because of the FDA’s action.
According to nonprofit tobacco control organization Truth Initiative’s latest study, use of Juul decreased between 2019 and 2020, but it remains the most popular e-cigarette brand among 10th and 12th graders who were current vapers at 41%. The report also found that disposable products such as Puff Bar (8%) and Smok (13.1%) have gained during this time.
“Taken together, the 2020 National Youth Tobacco Survey (NYTS) and the new e-cigarette sales data report illustrate how the current federal policy enabled youth to quickly migrate to menthol e-cigarettes (especially Juul menthol pods) when mint-flavored products were removed from the marketplace, and for inexpensive, flavored disposable e-cigarettes such as Puff Bar to soar in popularity,” Truth stated in September 2020.
“With kid magnet names like cotton candy and banana ice, the market share of disposable products nearly doubled in just 10 months from August 2019 to May 2020,” it said.
The scale of the problem on TikTok is also significant.
Today, U.S. teens account for an estimated 32.5% of TikTok’s U.S. active users, according to third-party estimates published by Statista. The company has around 100 million monthly active users in the U.S., it said last year.
Meanwhile, videos tagged with popular vape and e-cigarette brands and keywords have racked up hundreds of millions of views.
For example, the hashtag for leading vape brand Juul (#juul) has 623.9 million views on TikTok, as of the time of writing.
These are just the views associated with the hashtag itself. For every search, there are multiple variations. For instance, #puffbars, #puffbarplus and #puffbardealer have 66.8 million views, 9.6 million views and 8.9 million views, respectively. Tags like #juulgang (590.4 million views) have become popular enough that anti-vaping content creators have adopted them as a means of counter-programming against vaping content.
These trends are particularly concerning given the large, young demographic that uses TikTok. A third of its U.S. users may be 14 or under, in fact.
In addition to the popular vaping hashtags prevalent on TikTok, we uncovered numerous vape sellers operating under obvious account names such as “@puffsonthelow,” “@PuffUniverse” and “@Puffbarcafe,” for example. Their pages were filled with vape videos boldly marketing their current selections, hashtagged with vape-related terms like #puffbarchallenge, #puffplus, #vapetricks and others.
In some cases, we found vape sellers had even tagged their videos with #kids and other trending tags.
Knowing that their target market is often teenage vapers, many videos depicted how the seller could package the vape inside another product or hide it in the stuffing so parents wouldn’t find out. We saw videos of vapes packaged underneath candy, inside makeup bags, inside socks, underneath other lager products, and more.
Through links published to the account’s profile or referenced in the videos, TikTok users are redirected to the sellers’ websites or even Discord channels where they would only sometimes be presented with an age verification pop-up.
Often, they could just add items to a basket and check out. Many sellers also directed their customers to pay using PayPal, Venmo and/or Cash App, instead of accepting standard credit card payments.
None of this is legal, according to the Campaign for Tobacco Free Kids, a leading American nonprofit focused on reducing tobacco consumption, particularly among youth.
“It’s illegal to market these products or to engage in marketing that appeals directly to anybody under the age of 21,” Matt Myers, the president of the Campaign for Tobacco Free Kids, told TechCrunch. “And it’s illegal to actually conduct a sales transaction without age verification.”
Image Credits: TikTok screenshot
Plus, he adds, clicking a box on a website that says “I’m over 21,” does not qualify as a legal age verification for making these sales.
The FDA hasn’t issued specific guidance around online retail, but the law is clear that checking IDs is required to ensure retailers aren’t selling to underage users. That’s not happening with a pop-up box, and often there’s no box at all.
In addition, the FDA reminded TechCrunch that Congress recently established new limits on the mailing and delivery of e-cigarettes and other tobacco products through the United States Postal Service and through other carriers, which should limit access to these sorts of products through online retail purchases.
Myers, however, points out that the current FDA guidelines have made enforcement of this sort of “social” vape marketing more difficult than necessary.
“The images you’re seeing, the use of influencers, and the kinds of offers you’re seeing are governed by a federal standard by the FDA, which is very broad and very general,” Myers says. “The FDA’s failure to articulate clear, specific guidelines means that everyone is in a constant what I call ‘whack-a-mole.’”
Enforcement, then, often depends on the FDA stepping in, which Myers says happens “on a very sporadic basis.”
“In many respects, the behaviors, the actions and the things you’re seeing do violate the law. But the mechanisms for implementing it that were put in place under this past administration are woefully weak and inadequate,” he says.
Image Credits: screenshots of TikTok
Another complicating factor is that public health groups — like the Campaign for Tobacco Free Kids, for instance — don’t have a relationship with TikTok, as they do with other social networks.
Over the last couple of years, over 100 public health groups came together to ask leading social networks like Facebook, Instagram, Twitter and Snapchat to clamp down on tobacco-related content and the use of influencers in marketing. As a result of these efforts, Facebook and Instagram implemented new rules to prohibit social media influencers from promoting tobacco-related products and developed algorithms to pick up on that sort of content.
Overall, the health organizations have reported seeing a reduction in tobacco and vape content on top social platforms, but these efforts have not yet included TikTok.
The Campaign for Tobacco Free Kids has not given TikTok a comprehensive review, Myers admits, due to the app still being relatively new. But from what the organization has seen so far, TikTok is of growing concern.
“We’ve seen some of the most egregious marketing, use of influencers, direct offers of sale to young people [which] appear to be gravitating over to TikTok,” Myers says. “And we don’t see any evidence that TikTok has actually done anything.”
TikTok can’t claim ignorance of the problem, either.
Image Credits: TikTok screenshot
When a vape seller who unabashedly advertised “no ID check” was reported to TikTok through its built-in reporting mechanism, TikTok’s content moderation team said the content didn’t violate its guidelines. This same response was given when other vape sellers were reported, as well. (See below.)
TikTok claims this shouldn’t be happening. The company told us that it will remove accounts dedicated to posting vaping or e-cigarette content as soon as it becomes aware of them, and will reset account bios that link to off-platform tobacco or vaping sites.
It also says its Community Guidelines prohibit content that suggests, depicts, imitates, or promotes the possession or consumption of tobacco by a minor, and content that offers instruction targeting minors on how to buy, sell, or trade tobacco.
Image Credits: screenshots of TikTok reports
Reached for comment over whether it was aware of the problems on TikTok, an FDA spokesperson said it does not discuss specific compliance and enforcement activities.
However, an FDA spokesperson said the agency will closely monitor retailer, manufacturer, importer, and distributor compliance with federal tobacco laws and regulations and take corrective action when violations occur. In addition, the FDA said it conducts routine monitoring and surveillance of tobacco labeling, advertising and other promotional activities, including activities on the internet.
What’s been making matters more confusing is that the FDA has been accepting premarket applications for flavored vape devices, but has so far refused to list which companies — Puff Bar or otherwise — may have filed for these. That means health organizations don’t know which products the FDA has under review.
However, the agency told TechCrunch that regardless of whether a premarket application has been submitted, it’s enforcing lack of marketing authorization for any product where the manufacturer “is not taking adequate measures to prevent youth access to these products.”
That statement would then include these online Puff Bar retailers and their TikTok marketing efforts.
The FDA added that it has taken action against Puff Bar, specifically, in recent days.
It sent a warning letter to Cool Clouds Distribution, Inc. d/b/a Puff Bar, last July, notifying the company that it was marketing new tobacco products that lacked marketing authorization and that such products, as a result, were adulterated and misbranded.
Earlier this month, as part of an ongoing joint operation with the FDA, U.S. Customs and Border Protection seized 33,681 units of e-cigarettes, which included disposable flavored e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow, we’re told.
TikTok confirmed the activity we’re documenting is in violation of its guidelines and policies, but could not explain why there’s been such a disconnect between that policy and its enforcement actions.
“We are committed to the safety and well-being of our TikTok community, and we strictly prohibit content that depicts or promotes the possession or consumption of tobacco and drugs by minors,” a TikTok spokesperson told TechCrunch. “We will remove accounts that are identified as being dedicated to promoting vaping, and we do not allow ads for vaping products.”
The US Food and Drug Administration is under siege from the Trump Administration, which is forcing through a steady stream of changes in its final days that threaten the remaining independence of the regulatory agency.
Perhaps the most dramatic meddling came on Monday, when FDA officials were blindsided as the agency cycled through three different top lawyers. FDA’s Chief Counsel, Stacy Cline Amin—a Trump appointee—resigned Monday, which FDA Commissioner Stephen Hahn announced in an email. Hahn’s email also included the news that career civil servant Mark Raza, the FDA’s principal deputy chief counsel, would serve as Cline Amin’s replacement on an acting basis. But that decision was abruptly overturned Monday night when the Department of Health and Human services tweeted that James Lawrence, deputy general counsel for the HHS, would serve as the FDA’s new chief counsel until January 20.
“We were all very surprised,” a senior FDA official told Politico. “But it’s consistent with all the fire bombs that keep getting thrown over the fence.”
President-elect Joe Biden is reportedly planning to ditch the current Trump administration policy of withholding half of all available COVID-19 doses to ensure that the requisite second doses are available, according to a report by CNN.
Instead, the incoming administration plans to release the full available supply to states and jurisdictions.
“The President-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” TJ Ducklo, a spokesman for Biden’s transition, told CNN. “He will share additional details next week on how his administration will begin releasing available doses when he assumes office on January 20th.”
With the pandemic continuing to surge to new heights, debate has erupted among experts about how to get the most protection as quickly as possible from the limited supply of COVID-19 vaccines currently available.
Suggestions floated so far include delaying the second of a two-dose regimen for maybe three to four months rather than doling them out in the planned three-to-four-week intervals evaluated in large clinical trials. With this change, more people can get a first dose now, offering some protection. Another possibility is simply cutting doses by half, which would immediately double the number of people who can be vaccinated now. And regulators in the United Kingdom have introduced the idea of mixing regimens—with some people getting their first dose of a vaccine by one manufacturer and then getting a second dose of vaccine from a different manufacturer based on availability at the time.
Evidence supporting these suggested tweaks in the vaccine rollout are shaky at best. But some experts argue that the dire state of the pandemic warrants a new, perhaps riskier approach.
Late Friday, the Food and Drug Administration issued an emergency authorization to a COVID-19 vaccine from a company called Moderna. The move follows an enthusiastic endorsement of the vaccine following an evaluation of clinical trial data by the FDA’s Vaccines and Related Biological Products Advisory Committee. Moderna already has millions of doses prepared, and the federal government has pre-issued a large order for more, which will enable more extensive vaccinations than would be possible previously, where the agency had only issued an authorization to the Pfizer/BioNTech vaccine.
The authorization was considered to be a matter of time following the release of safety and efficacy data from a large clinical trial that had enrolled over 30,000 people. Emergency Use Authorizations require that a product or treatment meet a number of criteria, including the declaration of a medical emergency, which was done earlier this year, and the lack of an FDA approved alternative. (FDA approval is distinct from an Emergency Use Authorization, so the authorization of the Pfizer/BioNTech vaccine isn’t a barrier to further authorizations.)
Beyond that, the product must be considered likely to be effective, and its potential benefits need to outweigh its potential risks. The votes from the members of the Vaccine Advisory Committee were unanimous that the benefits outweighed the risks, a conclusion that was well supported by the clinical trial data. That cleared the way for Friday’s Authorization, which took place on a similar schedule to the authorization of the Pfizer/BioNTech vaccine the week prior.
Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the agency as it decides whether to grant an emergency use authorization similar to the one it gave the Pfizer/BioNTech vaccine.
After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.
Emergency use authorizations have a number of requirements once a health emergency has been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It’s that final question—the risk versus benefit balance—that the advisory committee was called to address.
GeneMe, Poland-based biotechnology company with a COVID-19 test, has secured a €5.2M round of seed funding led by Robin Tombs, co-Founder of Yoti and previously of Gamesys, and other angel investors.
The startup has developed and patented a universal protein (polymerase) for RT-LAMP testing, which allows the production of highly accurate, rapid, molecular genetic COVID tests. It has three molecular NAAT COVID-19 tests: FRANKD, SAVD, and ICED. FRANKD is CE IVD-approved and FDA EUA-applied, and its solution is already utilized in over twenty countries. FRANKD has been identified, through official research made by the Scottish government, as the most accurate, rapid COVID-19 test on the market. The FRANKD solution has already been used by Heathrow Airport, Virgin Atlantic and TV show Britain’s Got Talent.
Dawid Nidzworski, CEO of GeneMe said: “We’re interested not only in health issues, but also in genetic predispositions, such as talents, sports abilities, learning problems, or caffeine metabolism. In the future, everyone will be able to conduct genetic analysis at home.”
Robin Tombs, Co-Founder of Yoti said: “GeneMe’s innovative approach will be highly disruptive over coming years, enabling more regular testing at point of care at much lower cost.”
GeneMe is a spin-oout from The Institute of Biotechnology and Molecular Medicine (IBMM), an independent biomedical research institution.
Recently, the company announced a partnership with U.S.-based BIOLYPH, the world leader in lyophilization services, to scale up FRANKD and SAVD significantly.
GeneMe’s patented technology simplifies the entire testing procedure compared to standard laboratory-based RT-PCR tests. RT-LAMP tests are more effective, which means results can be trusted. GeneMe’s testing technology can also be assembled at point-of-care, which makes it possible to integrate highly accurate testing stations at places of work and in locations with high throughput, such as international borders.
The global COVID-19 diagnostics market size is estimated at $84.4B in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 3.1% from 2021 to 2027 (Grand View Research).
The FDA’s ability to issue Emergency Use Authorizations isn’t limited to treatments; the administration can also hand them out for medical equipment and tests. And today, it approved the first over-the-counter, at-home SARS-CoV-2 test kit. The kit detects the presence of a protein found on the surface of the virus and sends the results to a user’s smartphone via a Bluetooth connection. While it’s less accurate than the diagnostic approaches used by large testing centers, the FDA cited an accuracy of over 90 percent when issuing the authorization.
This isn’t the first at-home test kit given approval by the FDA. In November, the FDA issued an Emergency Use Authorization to a company called Lucira, which is offering a test that requires a prescription. Lucira’s test is based on sensing the virus’ genetic material, using a series of enzyme-catalyzed reactions that work at room temperature.
The new test comes from a company called Ellume and is based on identifying the presence of one of the virus’ proteins. Typically, these tests rely on the use of antibodies to the protein, typically linked to a chemical that can induce a color change; Ellume tags its antibodies with fluorescent quantum dots. The sample—in Ellume’s case, a swab of material from the nose—flows across the device while mixing with antibodies, producing a change in color at a specific location on the device.
The US Food and Drug Administration may finalize authorization for the first COVID-19 vaccine later today, Friday, which would accelerate an already breakneck regulatory pace in the wake of intense pressure and threats from the Trump Administration.
According to multiple reports, the FDA was expecting to finalize the Emergency Use Authorization for the two-dose Pfizer/BioNTech COVID-19 vaccine early Saturday. That final sign off would land less than 48 hours after the agency’s independent advisory committee endorsed granting the EUA in a vote late Thursday of 17 to 4, with one abstention.
Earlier this week, the FDA released a briefing of its own review of the Pfizer/BioNTech mRNA vaccine, finding it “highly effective” and with a “favorable safety profile.”
The COVID-19 vaccine developed by Pfizer and BioNTech should be granted an Emergency Use Authorization from the US Food and Drug Administration, according to a committee of independent experts advising the agency.
The committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—made the recommendation today in a vote of 17 in favor, 4 against, and 1 abstain. Specifically, committee members voted in the affirmative to the question:
Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?
If the FDA follows the recommendation and grants authorization, the vaccine will be widely accessible to people 16 years and older and distribution of the vaccine will likely to begin in the coming days.
“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, in a statement. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
It’s pretty inarguable that anything that reduces the friction consumers face in getting tested for SARS-CoV-2, the virus that causes COVID-19, is a good thing. It’s also in line with a broader push to increase healthcare access for consumers in an effort to reduce costs.
When customers purchase the COVID-19 test kit, they register the kit on the company’s website and then follow the instructions given there. Tests results are delivered through a corporate portal and a healthcare provider is available to assist customers who test positive on how to proceed with a course of treatment.
The company said its kit should not be viewed as a substitute for visits to a healthcare professional and is intended for use by adults 18 or older.
It’s important to note that the LabCorp PCR test has not been cleared or approved by the FDA and is being authorized under an emergency use authorization.