COVID Weekly Recap: A significant change to FDA’s authority over laboratory tests. New guidance on FDA inspections. FDA clarity on diagnostic and face mask policies.

Top stories: FDA officially schedules its AdComm for COVID vaccines. Convalescent plasma has a diagnostics problem. FDA still silent on HHS’ laboratory developed test policy. FDA asks Supreme Court to lift injunction.

Welcome to our COVID Weekly Recap, AgencyIQ’s weekly wrap-up of the top regulatory developments related to COVID-19. The following analysis was available to AgencyIQ subscribers earlier this week as part of our daily regulatory intelligence briefings, as well as dozens of other pieces of analysis. Contact us to find out how you can become a subscriber to AgencyIQ.

FDA officially schedules its AdComm for COVID vaccines. Missing from the agenda: Discussion of an actual vaccine.

By Alexander Gaffney, MS, RAC

August 27, 2020

The FDA has officially announced the date and agenda for its much-anticipated meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). But anyone who was hoping that the committee might have met to discuss specific vaccines for COVID-19 will be disappointed.

  • The meeting agenda is set to discuss “in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.”
  • But: “No specific application will be discussed at this meeting.”
  • The lack of specific discussion is surprising given prior statements made by FDA officials. In a statement in Health Affairs last week, FDA leadership committed to convene the VRBPAC “when data from trials becomes available.” While it’s possible that the FDA could convene multiple meetings of its VRBPAC, the FDA has not made any indications that others are being planned.
  • Stephen Hahn’s Tweets from this week also made clear his intent that the committee discuss specific  “The committee’s discussion and recommendations are not binding on FDA but will be important in our deliberations. Plus the public will be able to see the data that we have been asked to evaluate,” he wrote. (Emphasis added)
  • What data? As of now, it’s unclear which data might be reviewed by the Committee, which is scheduled for October 22nd—nearly two months from today.
  • FDA officials have been clear about the impact of VRBPAC’s review: “By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness to provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations,” FDA leaders, including Commissioner Stephen Hahn and CBER Director Peter Marks, wrote in Health Affairs.
  • Another risk: The public session. The VRBPAC meeting is likely to be one of the closest-watched meetings in FDA history. But like most FDA advisory committee hearings, there will be an hour-long open session available to the public. That risks giving vaccine skeptics and other conspiracy theorists a significant public platform from which to pontificate. The FDA said it may “conduct a lottery to determine the speakers for the scheduled open public hearing session” if demand for speaking slots exceeds available time, which it almost certainly will.

Convalescent plasma has a diagnostics problem

By Laura DiAngelo, MPH

August 25, 2020

 

This weekend, President Trump announced that FDA had granted an Emergency Use Authorization (EUA) for the use of convalescent plasma as a therapeutic for COVID-19. But while much of the public was focused on whether the FDA should have granted authorization, its use may have another significant problem: A lack of methods to quantify antibody levels present in donated plasma.

  • Convalescent plasma is a blood product that has historically been used as a therapeutic treatment for other coronaviruses, including SARS and MERS. Convalescent plasma is a kind of antibody therapy derived from the blood of individuals who have recovered from the virus. The immunological response from the recovered individual, present in their plasma, is intended to bolster a currently-sick individual’s immune system to fight the virus.
  • The President has touted the use of convalescent plasma as a treatment for the pandemic since early in 2020. Despite limited evidence and concerns from leadership at the National Institutes of Health (NIH), the FDA granted HHS an EUA for convalescent plasma over the weekend.
  • Like all blood products, the availability of convalescent plasma is contingent on donations. To be eligible, prospective donors must meet all established regulatory requirements for blood donation and additional requirements for COVID-19 convalescent plasma, including having recovered from laboratory-confirmed COVID-19. The FDA laid out these eligibility criteria in a guidance issued in March.
  • Ideally, donors should have a certain level of COVID-19 antibodies, according to the guidance. As an antibody therapy, donating convalescent plasma should require a minimum titer level of antibodies that an individual needs to have in order to fight the virus effectively (“neutralizing antibodies”). For COVID, the FDA set that level at 1:160 as identified by a quantitative assay, which is a diagnostic that can actually identify the levels of antibodies rather than a binary “positive” or “negative” outcome.
  • However, we don’t have any quantitative assays for COVID-19. Although the FDA recently authorized a semi-quantitative test, which can estimate the level of antibodies in an individual, there isn’t yet any diagnostic available that can quantify COVID-19 antibody levels.
  • The EUA for convalescent plasma specifies that donations should be tested with an assay called the Ortho VITROS SARS-CoV-2 IgG test and provides a cutoff for consideration as “high titer” COVID-19 convalescent plasma (signal-to-cutoff value of 12). However, according to that test’s instructions for use it is a qualitative test, not a quantitative one. Donated plasma that does not meet the “high titer” threshold would still be eligible for use under the EUA, at the provider’s discretion “based on an individualized assessment of benefit-risk.”
  • Data on convalescent plasma’s efficacy in treating COVID-19 was collected under the Mayo Clinic-administered national Expanded Access protocol. However, without a quantitative assay to determine antibody levels in donated plasma, the convalescent plasma used in that research “had no minimum neutralizing-antibody titer level.” This means that plasma products from recovered individuals were used as antibody treatment even if they did not meet the minimum recommendation from the FDA.
  • Without quantitative assays for identifying neutralizing antibody levels, it will be difficult to assess the efficacy of convalescent plasma as an antibody therapy going forward. FDA diagnostic chief Tim Stenzel has called for increased development in this area for the past several weeks on regular calls with industry, but it’s not clear if such a diagnostic yet exists. 

Lacking the ability to identify eligible convalescent plasma, FDA acknowledges that updates are needed

By Laura DiAngelo, MPH

August 26, 2020

 

Over the weekend, HHS received an EUA for convalescent plasma to treat COVID-19. The problem: there aren’t any authorized diagnostics that can identify eligible donors.

  • Convalescent plasma is an antibody therapy derived from the blood of individuals who have recovered from the virus. Typically, identifying an eligible donor for convalescent plasma would require that individual have a certain titer level of antibodies in their blood. As AgencyIQ outlined yesterday, there is no authorized FDA diagnostic (called a quantitative assay) that can identify such a level. The FDA’s guidance outlining the minimum levels of antibodies that are recommended for convalescent plasma donation were issued in March.
  • Over the weekend, HHS received an EUA for the use of convalescent plasma to treat COVID-19. However, the diagnostic specified in the EUA is a qualitative diagnostic according to its instructions for use, rather than a quantitative assay. This raises concerns about the validity of the methodology by which eligible donors are identified, and the concept of using antibody therapy when there is no validated tool for measuring antibody levels.
  • FDA’s Stenzel confirmed that the diagnostic guidelines for quantitative assays—or those that are validated for use to measure antibody levels rather than give a binary outcome—are in the process of being updated. In response to a question about how the policies will be updated given the convalescent plasma EUA and the need for validated quantitative assays, Stenzel said “we’re working on an updated template that will cover broadly those topics, including semi-quant, quant, titering” to set “the pathway forward for some of those claims.”
  • What’s next for the interaction of biologics and diagnostics? Vaccines. One caller brought up an emerging question: diagnostics for use with vaccines to set an antibody baseline. “That might be a great question to ask of our colleagues over at CBER who are focused on vaccine development,” said Stenzel, “I think potentially knowing an exposure history may or may not be important.”

FDA still silent on HHS’ laboratory developed test policy

By Laura DiAngelo, MPH

August 26, 2020

 

FDA IVD Chief Tim Stenzel declined to answer questions about a recent policy from HHS that exempted LDTs from FDA oversight during the pandemic at an August 26 call with industry.

  • Laboratory Developed Test (LDT) policy came to the forefront last week when HHS issued a notice that these diagnostics, which are developed by clinical laboratories rather than traditional manufacturers, would no longer be required to submit an Emergency Use Authorization (EUA) application for review by the FDA. While LDTs are not subject to pre-market requirements in regular situations, the FDA takes a different tact during public health emergencies.
  • Additionally, the agency has long held that it should have more regulatory oversight—not less—over LDTs. The policy represented an about-face on diagnostic regulation for the administration, and apparently was not run past FDA diagnostics experts before its publication.
  • Stenzel refused to speak on the policy, stating at the opening of this week’s town hall that “we will not be answering any general questions about the HHS statement of last week.” When one questioner asked if the policy would extend to other types of LDTs over which the FDA has recently worked to extend oversight—including personalized genomics (PGx)—Stenzel urged the caller to reach out to him independently.
  • This is the first time that FDA has acknowledged the LDT policy publicly. However, Stenzel continued to refer all questions on the subject of FDA regulation of LDTs to HHS.

FDA releases new hand sanitizer testing method

By Lily Rosenfield

August 25, 2020

 

A new laboratory testing method released by the FDA aims to help ensure the quality of hand sanitizer products and avoid the inadvertent introduction of methanol into those same products.

  • Quick background: The rapid spread of COVID-19 cases in the US saw the supply of alcohol-based hand sanitizers disappear, leading the FDA to temporarily exercise enforcement discretionto allow “certain entities that are not current regulated by FDA as drug manufacturers” to prepare and distribute ethanol or ethyl alcohol-based hand sanitizers. This included both distilleries and pharmaceutical compounders (such as 503A facilities).
  • Contaminated sanitizer on the market: After expanding distributors to new groups, multiple hand sanitizers with high concentrations of methanol had been observed on the market by the agency. The FDA responded with Warning Letters and requests for voluntary recalls, since methanol can be deadly if ingested and toxic when absorbed through the skin. The Agency advised the public not to use any hand sanitizers recalled by the manufacturer and or labeled as containing methanol and most companies complied with the request to recall.
  • Under a recent updated guidance the FDA established a limit of no more than 630 ppm of methanol in an ethanol sanitizer. “Any alcohol (ethanol) or IPA that contains more than 630 ppm methanol is not consistent with this temporary policy and may be considered evidence of substitution and/or contamination,” FDA wrote. Separately, the USP is also working on a revised standard for ethanol to tighten testing requirements for methanol.
  • The new testing method is intended to assess the quality of finished hand sanitizers and—with validation—can determine that harmful levels of impurities are not present. Specifically, this gas chromatography-mass spectrometry (GC-MS) method can detect methanol, benzene, acetaldehyde, and 1,1-diethoxyethane, and other impurities, all of which have listed concentration ranges for this testing method.
  • However: Many of the same entities having trouble with methanol impurities in their hand sanitizer probably aren’t keeping track of FDA guidance on impurities and may not have access to the laboratory equipment that the FDA is recommending.
  • The risks of impurities aren’t trivial. As AgencyIQ has previously noted, methanol is toxic, and the FDA has warned that “Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.”

FDA moving forward with asymptomatic testing for COVID-19 despite CDC guidelines

By Laura DiAngelo, MPH

August 26, 2020

 

Recent changes to the Centers for Disease Control and Prevention (CDC)’s COVID-19 testing guidelines no longer recommend testing for asymptomatic individuals. However, FDA in vitro diagnostic (IVD) Chief today touted new testing methods for asymptomatic populations on his weekly call with diagnostic developers.

  • CDC’s testing guidelines were updated recently to no longer recommend that individuals who do not show symptoms of COVID-19 should be tested for the virus following exposure to a person known to have been infected with the virus. Widespread testing of asymptomatic individuals has been viewed as a way to understand population prevalence and prevent community spread, and has been recommended by public health researchers and officials including former FDA Commissioners Gottlieb and McClellan.
  • FDA is still encouraging asymptomatic testing. On a town hall call today, diagnostics chief Timothy Stenzel and deputy chief Toby Lowe highlighted asymptomatic testing as a crucial component of the US testing strategy, noting that they had recently updated the FDA’s COVID-19 diagnostic webpage with more comprehensive information for providers on ordering tests for asymptomatic patients. The agency is now recommending “repeated use of rapid point-of-care” tests for asymptomatic patients for groups of people in congregate settings (e.g., schools, workplaces or institutional living). Stenzel went on to elaborate that such testing, which he referred to as “serial testing,” is a priority for his Office.
  • “We absolutely see value in clearly being able to identify folks who are asymptomatic,” said Stenzel. “The focus is on identifying those who are potentially infective,” he said. FDA may be open to authorizing tests that are less sensitive than typical but are meant to be done multiple times, with a set time interval in between, he said. “We’re flexible, we’re adaptable, we see the value of having a lot more tests out there,” he added.
  • FDA vs CDC? However, this focus from the FDA is now in direct conflict with the official testing guidelines from the CDC. It’s unclear where the guidelines’ changes came from, however, as reports from the agency are raising questions about political interference at the public health agency from the administration. If so, this would follow recent significant concern about interference at the FDA (see below).
  • A new test could mark a change in approach: As of this writing, Abbott has just received an Emergency Use Authorization (EUA) for a $5 rapid antigen test with a 15 minute turnaround time. The test will be CLIA waived, meaning that it can be conducted at any clinical laboratory in the US (and anywhere with a CLIA certificate of waiver from CMS, which includes some school districts). The test is currently only authorized for individuals “suspected of” COVID-19 infection by their provider and within 7 days of symptom onset. This is exactly the type of test that FDA references in the updated asymptomatic testing questions on their FAQ page where the agency is urging providers to consider for off-label use of these types of tests with asymptomatic populations.

Is the Yale SalivaDirect test technically a medical device? It’s not clear, actually

By Laura DiAngelo, MPH

August 26, 2020

 

A caller at the August 26 town hall with FDA Device Center (CDRH) in vitro diagnostics (IVD) chief Time Stenzel raised an interesting question: Yale’s SalivaDirect COVID-19 diagnostic was authorized as a diagnostic but is distributed as a methodology. This begs the question: Is it a medical device?

  • SalivaDirect is a molecular diagnostic methodfor the identification of COVID-19. It is a real-time reverse transcription polymerase chain reaction test (rRT-PCT), authorized for emergency use under an EUA earlier this month. Although it was the third diagnostic to be authorized for use with saliva, it was the first to be authorized using saliva as the sole and primary sample matrix. It was developed by the Yale School of Public Health.
  • Methodology versus medical device: SalivaDirect does not require any proprietary equipment to be purchased from Yale. Unlike most molecular diagnostics, labs running SalivaDirect aren’t required to do an extra step to extract nucleic acid, which means the lab doesn’t need to use an extraction kit. Additionally, Yale was able to validate SalivaDirect’s methodology on a variety of reagents and with a variety of instruments—receiving authorization for use with components from Bio-Rad, ThermoFisher, AmericanBio, New England Biolabs, Integrated DNA Technologies and Twist biosciences. For a laboratory to run the diagnostic, they must contact Yale and receive the authorized set of instructions—rather than being sent a test kit—and then build from the components specified and run the test kit independently following the instructions for use.
  • This raises regulatory questions. If the test that is distributed is not a physical test, but rather a method to build the test from commercially available components—is it actually a medical device?
  • FDA says yes. “The Yale SalivaDirect test was authorized as a test,” according to Deputy IVD Chief Toby Lowe on a call today. “It is a complete test that was authorized, not a method. The test that was authorized consists of the instructions for use that were authorized and all of the components that are specified in the instructions for use.”
  • The question is reminiscent of 3D printingin which an entity with a 3D printer can use a computer-aided design (CAD) drawing to create a physical object. From an FDA regulatory point of view, the input design (the CAD) is not a medical device, but the resulting object that comes out of the printer (Read AgencyIQ’s analysis of the regulation of 3D printing here)
  • So what’s the difference? It seems that the difference between a 3D printed object, in which the method itself is not a device, and the SalivaDirect, in which it is, is the components from which SalivaDirect is comprised. A (high-complexity certified) laboratory that wants to run the diagnostic does not build it from scratch, as they would a 3D printed device. Instead, they source a variety of commercially-available components that are not actually raw ingredients, but instruments and reagents sold by manufacturers. When all of these components are assembled, that is the device that is SalivaDirect, as authorized under its EUA, but it would also appear that the method for bringing these components together is considered a medical device—at least, the instructions for use that were authorized under the EUA.
  • FDA is supportive of this idea so far. “We welcome this kind of creativity” said IVD Chief Stenzel, going on to support “quote open source unquote” diagnostics as a practice to avert the shortage issues still plaguing diagnostic testing in the US.

FDA issues warning about hand sanitizers bottled in food or drink containers

By Lily Rosenfield

August 27, 2020

 

Today the FDA issued a warning to consumers about hand sanitizer being packaged and distributed in containers ordinarily meant for food and drinks. This type of presentation puts users at risk of accidentally ingesting the products, which could lead to serious injury or death, the FDA said.

  • Quick background: The rapid spread of COVID-19 cases in the US saw the supply of alcohol-based hand sanitizers disappear, leading the FDA to temporarily exercise enforcement discretion to allow “certain entities that are not currently regulated by FDA as drug manufacturers” to prepare and distribute ethanol or ethyl alcohol-based hand sanitizers. This included both distilleries and pharmaceutical compounders (such as 503A facilities).
  • Packaging concerns: The statement from the agency highlights discovering hand sanitizer is being packaged in “beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles.” Additional concerns were brought up regarding food flavoring of the hand sanitizers. By altering packaging and creating an appetizing scent, consumers may ingest the products believing it to be the food or drink typically packaged in these containers.
  • Toxicity is no joke:While AgencyIQ has previously discussed the risks of methanol impurities in hand sanitizers, ingesting any hand sanitizer can also be highly toxic. The FDA highlighted the increase in reported adverse events related to ingesting hand sanitizer. Drinking a small amount can be lethal to small children, and cardiac and nervous system effects as well as hospitalizations have been reported by others.
  • FDA action: The FDA is working with manufacturers to recall products of concern and will continue to update its list of hand sanitizers not recommended for consumer use.
  • Previous guidance: Updated guidance documents from earlier this month included requirements for denaturing to deter children from accidentally ingesting hand sanitizers – another measure to prevent life-threatening events. Additional updates to further deter ingestion of these products could be eminent if adverse events continue to be reported.

FDA asks Supreme Court to lift injunction during appeal over mifepristone

By Aaron Badida, JD

August 27, 2020

 

Following a series of legal setbacks, the FDA has asked the Supreme Court to step in and lift an injunction suspending its Risk Evaluation and Management Strategies (REMS) requirements for dispensing mifepristone,

  • Mifepristone is a medical pregnancy termination measure, indicated for use up to 70 days into gestation. Originally approved in 2000, the first generic for mifepristone was approved in 2019. This drug is indicated for use in the provision of medical terminations, including medical management for miscarriages. However, both the drug and its generics are subject to a rigorous list of Risk Evaluation and Management Strategies (REMS), including the requirement that the drug “may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider.” That rule requiring in-person dispensing has been suspended under COVID-19 emergency procedures, recognizing the risks posed to individuals having to obtain the drug at a health care facility.
  • The story so far: The ACLU and the American College of Obstetricians and Gynecologists originally sued the FDA in early 2020, arguing that in-person prescribing requirements for mifepristone posed serious access challenges to patients during the pandemic.
  • The FDA initially challenged the suspension of mifepristone’s in-person dispensing REMS requirement under COVID-19 emergency procedures, recognizing the risks posed to individuals having to obtain the drug at a health care facility. The agency claimed that it was not an undue burden under a recent Supreme Court decision, but the Maryland District Court disagreed. That lawsuit attracted support from members of Congress, and in July a federal judge ruled against the FDA. The opinion stated that during the pandemic the in-person requirement “impose[s] a ‘substantial obstacle in the path of women seeking abortion’” and removed the in-person requirement on the grounds of the due process clause in the Fifth Amendment. In early August, the FDA asked for an injunction of the ruling.
  • FDA now wants the rule back in effect until the case is done. The agency intends to appeal the district court decision to the Fourth Circuit, and hopes to put the REMS back in effect while the case is litigated. The Fourth Circuit recently denied the same request, leaving SCOTUS as the court of last resort.
  • The FDA’s petition to the highest court in the nation argued that it was not the place of the judiciary to “second guess” the FDA’s “expert judgment” in matters of public health.

FDA says CARES Act drug manufacturing data portal not ready

By Aaron Badida, JD

August 24, 2020

 

The FDA’s Division of Drug Information has announced that it will not be able to meet the deadline for propping up an electronic data submission portal for manufacturing volume data, as required by the CARES Act. The measure is designed to prevent drug shortages.

  • Drug shortages quickly emerged as a significant issue when the coronavirus hit the U.S. The rapid increase in patients in respiratory distress from COVID-19, coupled with a surge in demand for medications needed to assist with ventilation, led to a shortage of drugs like sedatives and muscle relaxers. Legislators were alerted to the severe vulnerabilities in the drug supply chain as countries like India and China—the source of significant quantities of active pharmaceutical ingredients—shut down amid the pandemic.
  • Some reporting requirements already exist. Section 506C of the FD&C Act requires manufacturers of life-supporting, life sustaining or drugs that prevent debilitating diseases to report when a manufacturing issue might cause a shortage. The agency issued guidance in March 2020, broadening its policy to include reporting demand-related shortages due to COVID-19.
  • The CARES Act requirement can help prevent additional shortages. The CARES Act specifically required all registered drug manufacturers to submit an annual report to the FDA. The report is to include the “amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed by the registrant for commercial distribution.” The requirements were supposed to take effect on September 23, 2020, but the agency now says it won’t have the submission portal in place to receive the reports and make use of them by then.
  • The Goal: By identifying supply chain vulnerabilities, the agency can work to proactively identify and plan for potential shortages. For example, the FDA is authorized to prioritize reviews of drugs in the application process that could mitigate shortages. The CARES Act also allows the agency to monitor shortages of active pharmaceutical ingredients (APIs), which is important since the same APR may be used in multiple drugs.
  • A work in progress: According to the announcement, “FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information.”

Advance refund bill would leverage orphan drug tax incentive

By Aaron Badida, JD

August 24, 2020

 

Reps. Dean Phillips (D-Minn.) and Jackie Walorski (R-Ind.) introduced the “Innovation and Growth Now by Investing in Tomorrow’s Enterprises Act” (IGNITE Act), a bill aimed at leveraging existing orphan drug tax incentives.

  • “Orphan drugs” are those intended to treat rare diseases or have a low margin for commercial profitability. Under the Orphan Drug Act of 1983, drugs treating diseases affecting fewer than 200,000 patients (or those that are unlikely to make up the cost of development on the market) are eligible to receive a tax credit worth 25 percent of all related development costs. They also get 7 years of marketing exclusivity during which time a generic version of the same drug may not be approved.
  • The bill would allow sponsors of these drugs to get an advance refund of this credit. IGNITE would allow the credit to be claimed 1) by “reducing deposits or payments” of employment (payroll) taxes and federal withholding and 2) for any remaining amount, as an overpayment of any “unused business credit…attributable to the orphan drug credit.”
  • The credit amount may not exceed the excess of $25,000,000 less the advance of net operating loss carryovers. This is designed to provide some immediate financial relief to companies advancing rare disease therapies in the wake of COVID-19.
  • COVID-19 research and operating losses are also accounted for. Separate from the orphan drug tax credit, the bill would also allow for some corporations that have net operating losses (or loss carryover) or have expensed research related to COVID-19 to claim advance refunds. According to Rep. Phillips’ office, IGNITE would “[a]llow growth companies to monetize up to $100 million worth of accumulated net operating losses (NOLs) which were generated within the previous five years at the 21 percent corporate rate.”

What we’re watching

How long does it take to review a vaccine for COVID-19, and what’s the fastest a review could possible happen? A normal FDA review takes about 12 months. The FDA is then able to do priority reviews in about 8 months. However, it sometimes pulls out the stops for products and reviews them in just a few months. For example, the target review timeline for its Real-Time Oncology Review program is about 20 weeks.

But the real question is: How fast can the FDA possible move if it was motivated to approve a new vaccine? Could it complete a full review in days or a few weeks?

Data points: 

-80C

As USA Today reports, the Trump administration is looking to proactively set up logistics for distributing a COVID-19 vaccine once it’s authorized by the FDA. Vaccines transportations and distribution typically require a cold chain, or a “temperature-controlled supply chain” with products stored at certain temperatures—and systems to ensure they stay at that temperature—to ensure their efficacy.

 

However, different vaccines require different temperature-based storage considerations. One of the vaccines currently under the administration’s COVID-19 vaccine expediting program, Operation Warp Speed, would require storage at -80C (-112 Fahrenheit), just 9.2 degrees Celsius higher than the coldest temperature ever recorded on the planet EarthUSA Today reports that the administration is looking to the United Parcel Service to help facilitate distribution.

Quotable

“At the end of the day, I know my patients never cared about relative versus absolute benefits. They just wanted to understand if the juice is worth the squeeze. The totality of data was in support of a promising benefit and safety.” 

 

FDA Commissioner Stephen Hahn, speaking to Bloomberg in a wide-ranging interview about his misrepresentation of data regarding the efficacy of convalescent plasma over the weekend. At the time, Hahn mistakenly said that the antibody therapy could have helped 35 out of every 100 individuals with the coronavirus, which is not supported by any available data. Hahn acknowledged that he had misinterpreted the statistic, which he maintains refers to relative risk reduction, rather than absolute risk.

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