Blog Tag: covid

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines.  The agreement came on the heels of an all-night negotiating session.  The agreement followed years of proposals and negotiations among the WTO members.

Ultimately, the WTO members agreed to a waiver that was limited to “the subject matter of a patent required for the production and supply of COVID-19 vaccines.”  The United States had previously expressed its support for a vaccine-only TRIPs waiver.  Previous proposals by South Africa and India also included COVID-19 tests and treatments, as well as including access to trade secrets.

The agreement allows member countries to “authorize the use of the subject matter of a patent … without the right holder’s consent through any instrument available in the law of the Member.”  However, any country making such a waiver must provide “adequate remuneration” to the patent holder.

WTO Director-General Ngozi Okonjo-Iweala praised the agreement: “[N]ow we have something in hand,” “[i]t’s really exciting now to go to those factories that are starting to set up all over the developing world and start to work with them about how this will actually be made real.”

However, the agreement did not meet with universal praise.  Indian Trade Minister Piyush Goyal stated:

[W]hat we are getting is completely half baked and it will not allow us to make any vaccines. They have no intentions of allowing therapeutic and diagnostics and if at all they try to say that we are the cause for its collapse, I think we should unanimously speak to the world and tell them that no, ideally we want a holistic solution including therapeutic and diagnostics.

Pharmaceutical industry organizations also criticized the WTO agreement, as did some members of the U.S. Congress.

The full text of the agreement is available on the WTO’s website.

FDA: Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19

FDA: Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19

According to the FDA’s Center for Devices and Radiological Health (CDRH) Annual Report, in addition to its significant efforts to fast track the approval of COVID-19 related devices, the CDRH has also maintained its high priority focus on supporting innovation of new medical devices in the United States.

As provided in the Report, according to CDRH Director Jeff Shuren, M.D., J.D., the FDA has now granted emergency use authorization (EUA) or full marketing authorization to over 2,000 medical devices intended to prevent, diagnose, or treat COVID-19 and more than half of CDRH’s workforce has been directly involved in the COVID-19 response.  The Report further states that the CDRH moved quickly with respect to COVID-19 treatment devices to ensure the availability of the wide range of related products shown below, including diagnostic tests, personal protective equipment (PPE), ventilators, and other critical devices and supplies for health care providers and patients.

As one example in the Report, CDRH authorized 15 additional over-the-counter (OTC) COVID-19 tests for at-home use during 2021.  According to CDRH Director Shuren, these were authorized in record times—in some cases in less than a week—highlighting CDRH’s devotion to providing a rapid response to the COVID-19 pandemic.

The report also states that CDRH’s pandemic-related efforts have not brought its other authorizations to a grinding halt, and that the CDRH also managed to clear or approve 13 devices with breakthrough designation and granted market authorization for 103 novel devices during 2021.  “One way that we are measuring the success of our efforts is through tracking the number of innovative medical technologies being brought to the U.S. first so that patients have access to the safest and most innovative devices available,” says Shuren.   “A decade ago, the U.S. was too often behind in this regard. But we are gratified to see our efforts have resulted in 103 novel devices receiving marketing authorization in 2021, despite the unprecedented demands of our pandemic response,” continues Shuren.  “Spurring innovation in developing safer, more effective devices is key to improving patient care and quality of life.”

Giving marketing authorization to 103 novel devices is touted by the Report as “an incredible achievement” in light of the increased demand on CDRH staff resulting from the COVID-19 pandemic.  “This highlights the commitment and dedication of CDRH staff to strengthen public health by bringing innovative devices to patients,” comments CDRH.

In the past ten years, according the Report, the CDRH has issued four times as many approvals, authorizations, and clearances of novel technologies as a result of the innovative policies and approaches developed and implemented by CDRH.  Novel technologies include those brought to market through the Premarket Approval, Humanitarian Device Exemption, and De Novo pathways, as well as a subset of those brought to market through Emergency Use Authorization (EUA), or the Breakthrough Devices Program.

The Breakthrough Devices Program is another program available for emerging companies that provides device manufacturers with an opportunity to engage directly with CDRH’s experts through several different program options to address topics as they arise during device development, evaluation, and premarket review. 

Researchers Develop Face Mask for Detection of SARS-CoV-2

According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath.  Instead of relying on a lab, the personal device uses sensors that use wearable freeze-dried cell-free (wFDCF) technology.  This technology contains the same molecules that cells use to recognize and manipulate nucleic acids and proteins.  According to MedGadget, unlike previous iterations of this technology which store living cells in “tiny aquariums”, wFDCF technology prevents any issues with leakage due to breakage.

To use the mask, a user presses a button on the mask to release water onto reactive wFDCF sensors.  MedGadget reports that results are given within 90 minutes and can be displayed on the inside of the mask for privacy purposes.  According to the scientific article, the wFDCF technology first cleaves viral particle samples in order to release the viral RNA.  Next, target genes located in the viral RNA are amplified via reverse transcription–recombinase polymerase amplification, in order to amplify the sequence that encodes for the spike protein.  A lateral flow assay strip is then used to display visual results similar to a pregnancy test.

“We have essentially shrunk an entire diagnostic laboratory down into a small, synthetic biology-based sensor that works with any face mask, and combines the high accuracy of PCR tests with the speed and low cost of antigen tests,” said researcher Peter Nguyen.  “In addition to face masks, our programmable biosensors can be integrated into other garments [e.g., lab coats] to provide on-the-go detection of dangerous substances including viruses, bacteria, toxins, and chemical agents.”

MIT News reports that the device can also swap in sensors for other pathogens, including influenza, Ebola, and Zika, or sensors they have developed to detect organophosphate nerve agents.

Genetic Engineering and Biotechnology News reports that the research team is “actively searching for manufacturing partners who are interested in helping to enable the mass production of the face mask diagnostic for use during the COVID-19 pandemic, as well as for detecting other biological and environmental hazards.”  The article reports that the authors have already submitted provisional patent applications for the technology.

The original article was published in Nature Biotechnology on June 28, 2021, and is available here.