From the pandemic, a roadmap for lowering the costs of medicine

‘To speed Covid-19 treatments, federal officials adopted a new, nimbler regulatory posture. The change was long overdue...

‘In recent decades, for example, the FDA — scarred by episodes like the Vioxx debacle and buoyed by scientists’ increased understanding of the body — has pressed drug makers to demonstrate increasingly rigorous understanding of the mechanisms by which their medicines work. Yet, one might argue that these guidelines reflect either hubris or naivete: The vast majority of safe and effective drugs were approved despite uncertainty about their mechanisms of action. Even today, scientists do not completely understand how acetaminophen works, yet the world is a far healthier place for having this drug...

‘In some high-profile cases during the pandemic, the FDA leaned less on mechanistic proof of effectiveness and more on empirical indicators, such as patient survival rates. For instance, when objective data revealed that the steroid dexamethasone helped severely ill patients survive what might otherwise have been deadly coronavirus infections, the FDA was quick to support the drug’s use, despite scientists having only a speculative understanding of how the steroid works against the disease. To be sure, the FDA must continue to prioritize its mandate to protect patients and clinical trial volunteers. But the pandemic has shown that safety and speed need not be an either-or proposition.’

Read here (Undark, Mar 25, 2021)

FDA says single-dose shot from J&J prevents severe Covid

‘Johnson & Johnson’s single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released Wednesday by U.S. regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.

‘The long-anticipated shot could offer the nation a third vaccine option and help speed vaccinations by requiring just one dose instead of two. Food and Drug Administration scientists confirmed that overall the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness. The agency also said J&J’s shot is safe.’

Read here (AP, Feb 25, 2021)

Feds may cut Moderna vaccine doses in half so more people get shots, Warp Speed adviser says

‘The federal government is in talks with Moderna about giving half the recommended dose of the company's Covid-19 shot to speed up immunization efforts, the head of the Trump administration's vaccine rollout said on Sunday.

‘Operation Warp Speed chief adviser Moncef Slaoui said there is evidence that two half doses in people between the ages of 18 and 55 gives “identical immune response” to the recommended one hundred micorogram dose, but said the final decision will rest with the FDA.’

Read here (Politico, Jan 3, 2021)

Rapid Covid-19 home test developed in Australia approved for emergency use in US

‘A rapid, over-the-counter Covid-19 test developed by Australian firm Ellume has been given emergency approval in the United States. The US Food and Drug Administration (FDA) approved the Brisbane-based company’s 20-minute Covid-19 Home Test on Tuesday as the US battles the virus that has infected 16.5 million people and killed more than 300,000 people in the country.

“By authorising a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” the FDA commissioner, Stephen Hahn, said in a statement.’

Read here (The Guardian, Dec 16, 2020)

What an FDA committee weighed in voting for the Pfizer Covid vaccine

‘An all-day hearing of the Food and Drug Administration’s vaccine advisory committee closed, on Thursday evening, with a vote to recommend an Emergency Use Authorization of the Pfizer-BioNTech covid-19 vaccine for people sixteen and older. 

‘The proceedings involved a great deal of data and technical talk, but might be quickly summarized this way: there are things we still do not know about the vaccine, but nothing that we do know looks bad. Indeed, the vaccine looks very, very good. And its known goodness applies to a diverse range of populations, including Black and Latinx and older people. An F.D.A. analysis of the raw data, released earlier this week, confirmed previous reports that the vaccine’s efficacy in preventing disease in trial participants was close to ninety-five per cent. That number held up under questioning from committee members, who represented a range of specialties, from pediatrics to virology, throughout the eight hours of the hearing. 

‘Amid a pandemic—on a day when more than three thousand people in this country were reported to have died from covid-19—that result is far more than it would have been reasonable to hope for even a couple of months ago. As Dr. Doran Fink, of the F.D.A., said in one of the day’s presentations, there is no “adequate, approved, and available alternative.” It was a long day, but a reassuring and even energizing one.’

Read here (The New Yorker, Dec 11, 2020)

‘This was a gift to us’: Ivermectin effective for Covid-19 prophylaxis, treatment

‘Numerous studies have provided evidence supporting the use of ivermectin to prevent and treat COVID-19, according to the Frontline COVID-19 Critical Care Alliance. Paul Marik, MD, FCCM, FCCP, founder of the alliance and a professor and chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School, said that ivermectin “is a safe drug that is exceedingly cheap.”

‘He added that “what is truly remarkable — this was a gift to us — ivermectin has high activity against COVID-19.” In a press conference, researchers said that ivermectin is an FDA-approved anti-parasitic drug that has been available for approximately 40 years and previously earned researchers a Nobel Prize.’

Read here (Healio, Dec 8, 2020)

FLCCC Alliance: Review of the emerging evidence demonstrating the efficacy of Ivermectin in the prophylaxis and treatment of COVID-19

Read PDF here (FLCCC Alliance, Dec 7, 2020) 

Blunders eroded US confidence in early vaccine front-runner

‘On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the F.D.A.’s blessing for the coronavirus vaccine it was developing with the University of Oxford?

‘But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.

‘A few hours after the conference call, the story broke about the halted trials. That was how key F.D.A. officials heard the news, according to people with knowledge of the discussions.’

Read here (New York Times, Dec 8, 2020)

Is emergency use authorisation the best way to get a Covid-19 vaccine to the public?

‘While an emergency use authorization may be the speediest way for public health officials to begin a vaccination campaign, it may not end up shaving that much time off of a more traditional route to government approval. Using a different expedited process, the FDA cleared a novel Ebola vaccine in just six months. Polls have shown that many Americans are wary of getting a COVID-19 vaccine. Other paths toward granting official approval to COVID-19 vaccines may get vaccines to the public almost as quickly as emergency use authorization can—while providing the public with greater reassurance that those vaccines are safe and effective.’

Read here (Bulletin of the Atomic Scientists, Nov 23, 2020)

FDA authorises first at-home coronavirus test

‘The Food and Drug Administration has authorized the first prescription at-home coronavirus test, in a long-awaited milestone. The test, developed by Lucira Health, can be used by people who are at least 14 years old when their health provider suspects they have Covid-19, the FDA said late Tuesday. The test can be used on younger people, but in that case a health care provider must collect the sample.

‘The test involves swabbing the inside of the nose, placing the swab in a vial and swirling it before putting the vial in a "test unit." The process gives results in 30 minutes or less. FDA medical device director Jeff Shuren said the test, which can be fully run outside a lab or health care settings, represents a significant step forward.’

Read here (Politico, Nov 17, 2020)

White House blocking strict guidelines for vaccine approval

‘The White House has blocked new Food and Drug Administration (FDA) guidelines that would have likely prevented a vaccine from being approved before next month's presidential election, the New York Times and the Associated Press reported, citing Trump administration officials.

‘The FDA had proposed stricter guidelines for the emergency approval and release of a coronavirus vaccine. One such requirement involved following vaccine trial candidates for two months to ensure there were no side effects and that the vaccines provided lasting protection from the virus. FDA Commissioner Stephen Hahn has previously said that scientists, not politicians, will decide whether the vaccines work and are safe.’

Read here (DW, Oct 6, 2020)

Evidence for convalescent plasma coronavirus treatment lags behind excitement

‘But so far, there’s little evidence that plasma actually helps patients, and the decision could confound efforts to study its effects, says former FDA commissioner Robert Califf, who now heads clinical policy and strategy at Verily and Google Health in South San Francisco, California... Convalescent plasma has been tested only in small trials without the statistical power to provide firm conclusions... “It’s a potential therapy that could work, and I don’t think it’s out of bounds to make it available” with an authorization, says Califf. “But we ought to be really emphasizing in public-service announcements that participation in randomized trials is a first priority.” 

[This story was written before the US Food and Drug Administration issued an emergency-use authorisation on August 23 to treat COVID-19 with convalescent plasma.]

Read here (Scientific American, August 24, 2020)

WHO cautious on Covid-19 plasma as US issues emergency authorisation

‘The World Health Organisation on Monday (Aug 24) was cautious about endorsing the use of recovered Covid-19 patients' plasma to treat those who are ill, saying that evidence that it works remains "low quality" even as the United States issued emergency authorisation for such therapies. So-called convalescent plasma, which has long been used to treat diseases, has emerged as the latest political flashpoint in the race to find therapies for Covid-19. The US Food and Drug Administration (FDA) on Sunday authorised its use after President Donald Trump blamed the agency for impeding the rollout of vaccines and therapeutics for political reasons.’

Read here (Reuters, August 24, 2020)

What to know about Covid-19 tests, from PCR to antigen to antibody

‘People often talk about COVID-19 testing like it means only one thing. But in reality, the U.S. Food and Drug Administration (FDA) has so far granted emergency-use authorization to more than 200 different tests meant to detect a current or past infection from SARS-CoV-2, the virus that causes COVID-19. Most recently, the agency made headlines for approving the first such test that uses saliva samples, the aptly named SalivaDirect test out of the Yale School of Public Health.

‘These COVID-19 tests fall into three main categories: PCR, antigen and antibody. Dr. Aneesh Mehta, chief of infectious diseases services at Emory University Hospital in Atlanta, Ga., broke down the differences between them—and what to keep in mind if you decide to get tested.’

Read here (Time Magazine, August 20, 2020)

Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorisation

‘A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA). With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDirect, they note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.‘

Read here (Yale News, August 15, 2020)

The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro

• Ivermectin is an inhibitor of the COVID-19 causative virus (SARS-CoV-2) in vitro.
• A single treatment able to effect ~5000-fold reduction in virus at 48 h in cell culture.
• Ivermectin is FDA-approved for parasitic infections, and therefore has a potential for repurposing.
• Ivermectin is widely available, due to its inclusion on the WHO model list of essential medicines.
  
  

Abstract: Although several clinical trials are now underway to test possible therapies, the worldwide response to the COVID-19 outbreak has been largely limited to monitoring/containment. We report here that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 h post infection with SARS-CoV-2 able to effect ~5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrants further investigation for possible benefits in humans.

Read here (Science Direct, June 2020)

US FDA grants an EUA for the first CRISPR-based diagnostic test

‘The US FDA granted an EUA for the first CRISPR-based diagnostic test for SARS-CoV-2. CRISPR technologies have been developed for a wide variety of uses, including gene editing and gene drives. The Sherlock CRISPR SARS-CoV-2 test kit works by programming a CRISPR molecule to detect specific parts of the SARS-CoV-2 virus. Once the CRISPR system binds to its target site, a signal is released that can then be detected by researchers running the test. Sherlock stands for “Specific High-sensitivity Enzymatic Reporter unLOCKing.” With the appropriate, corresponding instrumentation, this test kit could be used at the point of care, and results can be reported within minutes.’

Download here (US FDA, May 6, 2020)

FDA steps up scrutiny of coronavirus antibody tests to ensure accuracy

‘The action was the latest about-face in the administration’s coronavirus response as it seeks to fix a flawed testing response that has been criticized as either too restrictive or too lenient. Earlier this year, the FDA agency was hammered for moving too slowly in allowing academic medical centers and others to develop diagnostic tests for the virus that might have made them more widely available. Then, critics say, it swung too far in the other direction in allowing the antibody tests to go unvetted.

‘The result, they complained, was a flood of products of dubious quality that confused hospitals, doctors and consumers — “a wild, wild West” environment, said Scott Becker, chief executive officer of the Association of Public Health Laboratories, which represents state and local public laboratories.’

Read here (Washington Post, May 4, 2020)

Coronavirus saliva test gets FDA emergency use approval, Rutgers University says

• The Food and Drug Administration granted emergency use authorisation for a coronavirus test relying on saliva samples developed by a Rutgers University-backed entity, Rutgers said Monday.
• The test could increase, by tens of thousands of tests per day, the number of screenings for Covid-19, Rutgers said.
• The test was developed by Rutgers’ RUCDR Infinite Biologics and its collaborators, Spectrum Solutions and Accurate Diagnostic Labs.

Read here (CNBC, April 13, 2020)