FDA warns against using Innova's rapid COVID-19 antigen tests

 The FDA issued a stark warning to the public urging them to stop using rapid COVID-19 antigen tests developed by Innova Medical Group, the company previously tapped by the U.K. government for hundreds of millions of kits to help regularly screen the country’s population.

The move follows a Class I recall, the FDA’s most serious, launched by Innova in late April amid “significant concerns” about the test’s accuracy—and alongside an official warning letter delivered to the company this week.

The agency’s first recommendation was straightforward: “Stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test. Destroy the tests by placing them in the trash or return the tests to Innova using the FedEx return label that was included with the recall letter that Innova sent to customers.”

Though Innova previously applied for a regulatory green light, the test has not been authorized or approved by the FDA for use in the U.S.—however, during inspections of the company’s California facilities in March and April, FDA investigators said they found the test was already being sold and distributed.

The FDA also said that the labeling of the diagnostic, which comes in different versions, included performance claims that did not match up with results seen in clinical studies—and that the data Innova submitted for review “was identical to data previously provided by other manufacturers” in separate requests for an emergency COVID authorization, raising additional questions.

Innova’s kit includes a nasal swab and a lateral flow test strip, which in less than a half-hour produces colored lines to display a positive reading, similar to a pregnancy test. However, the FDA said that false-negative and false-positive results may lead to delayed diagnoses, inappropriate treatment and the further spread of the virus.

The U.K. government previously purchased more than 380 million rapid tests from Innova, to help set up programs capable of screening millions of people per day—in the run-up to offering free COVID-19 testing nationwide at least twice per week. 

A November 2020 analysis by researchers at the University of Oxford found Innova’s tests could be more or less accurate depending on who was using them—ranging from lab scientists to trained healthcare professionals to the general public—but determined the tests overall had a low failure rate and high specificity, despite some variations seen in production batches.

Still, Innova’s test and antigen diagnostics more broadly have been seen as less accurate compared to gold-standard, lab-based PCR screening. The company previously contracted with the Chinese manufacturer Xiamen Biotime Biotechnology to produce the tests for international distribution. 

In its message to the public, the FDA said that a person should consider being retested if they used Innova’s diagnostic within the past two weeks.

https://www.fiercebiotech.com/medtech/place-them-trash-fda-warns-against-using-innova-s-rapid-covid-19-antigen-tests

Oxford spinout spies hidden mechanics of DNA and disease with single-pair resolution method

 A spinout from the University of Oxford has found a new way to depict and analyze DNA with super-fine resolution, allowing them to peer into what they describe as “the dark matter of the human genome” and the molecular basis of many diseases.

Nucleome Therapeutics is working on a method known as micro-capture-C, or MCC, to provide a three-dimensional view of the famously twisting double-helix structure, with the ability to zoom in on individual base pairs.

“Previous methods of determining the large-scale 3D genome structure within cells have been unable to resolve it much below 500 to 1,000 base pairs,” said co-founder James Davies, who helped develop the technology at Oxford’s MRC Weatherall Institute of Molecular Medicine alongside Danuta Jeziorska, who serves as Nucleome’s CEO.

Nucleome plans to use its technique to identify the genes at play behind severe COVID—as well as find new drug targets for diseases such as rheumatoid arthritis and multiple sclerosis—with additional reports in the near future. Its latest work on 3D genome mapping was published this week in Nature.

The researchers equate the process with looking at a city’s skyline, representing the full strand of DNA within a cell. While before they could only make out the shape of small buildings from a distance, now they can see how it’s built up from individual bricks—with all 6 billion of them representing a single letter of the genetic code.

“3D genome analysis is key to understanding the largely untapped dark matter of the genome,” Jeziorska said. “Better resolution of 3D genome maps improves the accuracy and confidence of linking disease-relevant genetic changes to genes.”

This could include the coronavirus pandemic and may help provide a better understanding of why some people require intensive care while others may show no symptoms at all.

“For example, at the moment we know that there is a genetic variant which doubles the risk of being severely affected by COVID-19,” Davies said. “However, we do not know how the genetic variant makes people more vulnerable to COVID-19.”

By providing a more detailed view into DNA’s larger structure, drugs aimed at these genetic targets may have a better chance of making it through clinical trials, he added.

In the Nature publication, the researchers report that MCC could spot the physical interactions between gene-regulating proteins and the DNA code itself at base-pair resolution—even though one targeted string may be controlled by genes located tens of thousands to millions of base pairs further along the chain—or maybe a mile away, by bricks in a wall on the other side of the city.

https://www.fiercebiotech.com/medtech/oxford-spinout-spies-hidden-mechanics-dna-and-disease-single-pair-resolution-method

U.S. Says It Will Push COVID Vaccine Waivers, but 'May Take Time'

 The Biden administration is committed to efforts to waive intellectual property rights for COVID-19 vaccines and will raise the issue with the World Trade Organization (WTO), but it may take time, U.S. Trade Representative Katherine Tai said on Thursday.

"We will actively participate in text-based negotiations at the WTO that will be needed to make this happen. And this may take time given the complexity of the issues involved, but our goal remains to get vaccines to as many people as fast as possible," Tai said in remarks to an AFL-CIO union event.

U.S. President Joe Biden last month backed a proposed patent waiver for vaccines targeting the novel coronavirus that advocates say could help boost availability amid the pandemic.

But the pharmaceutical industry has opposed the waiver from the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), saying it would stifle innovation and do little to effectively increase vaccine supplies that it says are hampered by trade and manufacturing barriers.

Tai defended the administration's support saying: "extraordinary circumstances call for extraordinary measures." In the meantime, "we're doing everything that we can to ramp up vaccine production capacity as quickly as we can," she added.

https://www.usnews.com/news/world/articles/2021-06-10/us-says-it-will-push-covid-vaccine-waivers-but-may-take-time

Venezuela Says Payments to COVAX Vaccine System Have Been Blocked

 Venezuelan officials said on Thursday the country's government has been unable to complete a payment required to receive coronavirus vaccines because transfers to the global COVAX vaccine program had been blocked.

The government of President Nicolas Maduro for months said it was unable to pay for the COVAX program because of U.S. sanctions, and then in March announced that it had made almost all the required $120 million payment.

Vice President Delcy Rodriguez in a televised broadcast on Thursday said the government had been unable to pay down the remaining $10 million because four operations had been blocked.

"The financial system that also hides behind the U.S. lobby, has the power to block resources that can be used to immunize the population of Venezuela," Rodriguez said.

Foreign Minister Jorge Arreaza later tweeted a copy of aletter from COVAX saying it had received information from Swissbank UBS that four operations, totaling $4.6 million,"were blocked and under investigation."

It was not immediately evident who blocked the operations or why.

UBS, when asked for comment, said that for legal and regulatory reasons it is "unable to comment on matters relating to potential client relationships."

COVAX did not immediately reply to a request for comment.

The COVAX letter notes Venezuela has expressed interest in the Johnson & Johnson and Novavax vaccines.

Maduro's government this year began negotiating with opposition leader Juan Guaido to pay for COVAX vaccines using funds frozen in the United States via Washington's sanctions against Maduro.

In March, Venezuelan officials announced they had managed to pay for the vaccines on their own, and have since backed away from talks over using the frozen funds.

In recent weeks, authorities have started vaccinating medical personnel and senior citizens using doses provided by Russia and China. Participants have complained about confusion in the process, and opposition leaders say it lacks transparency.

Venezuela has reported 246,764 coronavirus cases and 2,764 deaths, although critics say the actual figures are likely higher due to underreporting and limited testing.

https://www.usnews.com/news/world/articles/2021-06-10/venezuela-says-payments-to-covax-vaccine-system-have-been-blocked

U.S. government workers can return to offices without Covid-19 vaccine

 U.S. government employees should not be required to be vaccinated against Covid-19 before returning to their workplace or made to disclose their vaccination status, according to guidance set to be released by the Biden administration on Thursday.

Workers may voluntarily disclose this information and federal agencies can base their safety protocols, in part, on whether employees are vaccinated, the guidance said.

In a 20-page memo seen by Reuters, the acting heads of three agencies that oversee the federal workforce also urged agencies to consider more flexible arrangements for some employees, including permanent part-time remote work and working outside of normal business hours.

The guidance comes as many U.S. government employees who have been working remotely during the pandemic prepare to return to their offices. It comes on the same day the U.S. Department of Labor issued an emergency rule for protecting workers in healthcare settings.

The federal government employs more than 4 million people, making it the largest employer in the United States. Nearly 60% of federal employees worked remotely during the pandemic, up from about 3% previously, according to Thursday’s memo.

The guidance requires agencies to submit draft proposals by next week and more detailed final plans, including reopening schedules, by July 19.

The memo is signed by the acting heads of the Office of Management and Budget (OMB), the Office of Personnel Management and the General Services Administration.

Jason Miller, deputy director for management at OMB, said in a statement that the guidance underscores that worker safety is a top priority as agencies plan to reopen offices.

“This moment in time provides a unique opportunity to look at the federal government’s role as a model employer, as we strive to implement consistent yet flexible government-wide practices that will foster effective, equitable, and inclusive work environments,” Miller said.

The officials also said that agencies’ “eventual post-pandemic operating state may differ in significant ways from (their) pre-pandemic operating state.”

That could mean untethering some workers from physical offices, which would enable agencies to recruit nationwide and share office space while decreasing the amount of time employees spend commuting, they said.

The officials cautioned that agencies may have to bargain with unions before implementing certain policies, such as changes to work schedules and safety protocols. About 30% of federal workers are represented by unions.

https://www.cnbc.com/2021/06/10/us-government-workers-can-return-to-offices-without-covid-19-vaccine.html

CDC Says U.S. Travelers Can Avoid Wearing Masks in Outdoor Transit Hubs, Ferries

 The U.S. Centers for Disease Control and Prevention said on Thursday it will no longer require travelers to wear masks in outdoor transit hubs and in outdoor spaces on ferries, buses and trolleys, due to the lower risk of coronavirus transmission outdoors.

The change is the first in the CDC's transit mask policy announced in January and came after a lengthy review by the White House Office of Management and Budget's regulatory arm.

The CDC said it made the change "because of the lower risk of transmission outdoors ... Masks are still required indoors on all forms of transportation" regardless of vaccination status. 

The change means people can take masks off outdoors while waiting for a train, in an outdoor courtyard of an airport or in open-air transit modes.

The change came after the Biden administration held extensive discussions with transit unions and other groups. The administration is considering other modest changes to its indoor transit mask policies, including potentially allowing vaccinated airline workers to remove their masks in rooms not accessible to the public.

The CDC in May said fully vaccinated people do not need to wear masks outdoors and can avoid wearing them indoors in most places.

In April, the Biden administration extended face mask requirements across all U.S. transportation networks through Sept. 13 to address the spread of COVID-19.

The Federal Aviation Administration said this week it has received approximately 2,900 reports of unruly behavior by passengers since Jan. 1, including about 2,200 reports of passengers refusing to comply with the federal face mask mandate.

The CDC mask mandate issued in January requires masks in nearly all transportation modes, including on ride-share vehicles.

Many U.S. states have completely rescinded mask requirements and transit is the only remaining place where mask use is mandated.

President Joe Biden imposed the transit mask mandate after his predecessor, Donald Trump, rejected CDC recommendations to do so.

https://www.usnews.com/news/top-news/articles/2021-06-10/cdc-says-us-travelers-can-avoid-wearing-masks-in-outdoor-transit-hubs-ferries

China invites Taiwanese to come to get vaccinated against COVID

 China's government said on Friday that it welcomed Taiwanese to come and get vaccinated against COVID-19 and called on Taiwan to remove obstacles and allow its people to receive the "highly effective" Chinese shots.

China claims democratically ruled Taiwan as its own territory and has repeatedly offered to send vaccines to the island, which is battling a spike in domestic infections but has expressed concern about the safety of Chinese shots and has not cleared them for use.

China's Taiwan Affairs Office said in a statement two Chinese-made vaccines had been granted emergency use authorisation by the World Health Organization and its shots were in use or approved by more than 90 countries, showing their safety and efficacy.

Taiwan people can come to China to get vaccinated against COVID-19, provided they strictly comply with China's pandemic control measures, the office said.

It urged Taiwan's government to "quickly remove artificial obstacles for mainland vaccines being sent to Taiwan and allow the broad mass of Taiwan compatriots to receive the safe and highly effective mainland vaccines".

About 62,000 Taiwanese had been vaccinated in China as of May 31, it added, though many Taiwanese live and work there already.

Only 3% of Taiwan's 23.5 million people have received at least one shot, though millions of doses are on order. Japan donated 1.24 million AstraZeneca Plc shots last week and the United States has pledged 750,000 doses, which have yet to arrive.

Still, China's offer is not likely to be attractive to many Taiwanese. A poll by Taipei's National Chengchi University last month showed most people would not be willing to get a Chinese vaccine.

A Taiwan security official looking into Chinese activities told Reuters the offer was another example of a Beijing influence campaign to sway public opinion on the island.

"This could be attractive for some people but the problem is not many people can afford the costs," the official said, pointing to the expense and weeks in quarantine needed to travel between Taiwan and China.

https://asia.nikkei.com/Spotlight/Coronavirus/COVID-vaccines/China-invites-Taiwanese-to-come-to-get-vaccinated-against-COVID