Cue Health to develop omicron-specific portable COVID test with BARDA backing

 Cue Health is working to develop an omicron-specific COVID-19 test to help healthcare professionals quickly identify the variant through a project backed by the U.S. government.

With funding from the Biomedical Advanced Research and Development Authority, better known as BARDA, Cue aims to provide the targeted diagnostic alongside its current molecular COVID-19 test, which has been shown to detect all coronavirus variants including omicron. The new, cartridge-based, nasal swab test will also be compatible with the company’s portable reader.

Cue’s 20-minute nucleic acid amplification test relies on identifying a portion of the coronavirus’s genome that makes up its inner nucleocapsid protein—as opposed to the RNA that codes for its spike protein, which carries several mutations in the omicron variant.

Following the rise of the delta variant last year—but before the emergence of omicron—Cue signed onto a project with Google Cloud to help connect its point-of-care tests and provide real-time data on the spread of new coronavirus strains.

The Fierce 15 winner’s system aims to provide public health officials with geographic information tracking COVID-19 cases—and, in the future, potentially keep tabs on other infectious diseases with separate tests for influenza and respiratory syncytial virus.

When it comes to the new test, Cue is no stranger to BARDA and government funding. The company first received $30 million from the agency in 2018 to develop its initial, over-the-counter system for the flu and other respiratory diseases.

After pivoting to address the COVID pandemic, Cue received another $13 million in March 2020 to support its coronavirus work and secured an FDA emergency authorization for its test in June. It then won full over-the-counter approval in March 2021. In between, the company inked a $481 million contract with the Department of Defense to dramatically scale up production.

https://www.fiercebiotech.com/medtech/cue-health-to-develop-omicron-specific-portable-covid-test-barda-backing

Singular Genomics upped to Buy from Neutral by B of A

 Target $21

https://finviz.com/quote.ashx?t=omic

COVID vaccine can lengthen menstrual cycle: study

 Following reports from scores of women online who said that the COVID vaccine had altered their menstrual cycles, a government-funded study has ultimately confirmed their claims.

Now, a new study published Thursday in the journal Obstetrics & Gynecology has revealed that many of those vaccinated against COVID-19 saw a slight delay — by less than one day, on average — in the onset of their menstrual periods, compared to unvaccinated women.

However, it did not substantially affect the number of bleeding days, according to findings from more than 4,000 participants.

For the ongoing, yearlong study — announced in September and funded by a $1.67 million grant from the National Institutes of Health — scientists retrieved data from a fertility tracking app utilized by women aged 18 to 45 who were not using hormonal contraception, which typically regulates a period into a stricter schedule.

About 2,400 participants were vaccinated with either the Pfizer (55%), Moderna (35%) or Johnson & Johnson (7%) vaccines. The remaining 1,500 women were unvaccinated and included in the study as a control group.

The average increase in women’s cycles after the first vaccine dose was 0.64-day (about 15.36 hours), and 0.79-day (about 18.96 hours) following the second dose.

Lead author Alison Edelman of the Oregon Health & Science University told Agence France-Presse that the jab’s impact is now believed to be minimal and temporary, an outcome she called “very reassuring” — and validating for the women who reported the changes.

“It validates that there is something real here,” Dr. Hugh Taylor, the chair of the department of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, told the New York Times.

Researchers believe that the change may be related to immune system response. “We know that the immune system and the reproductive system are interlinked,” said Edelman. 

According to the International Federation of Gynecology and Obstetrics, a margin of change fewer than eight days within the average 28-day cycle is considered normal — and most women in the study experienced an increase in cycle length by little more than 15 to 19 hours.

Among the vaccinated, researchers followed women beginning three consecutive cycles prior to vaccination, plus three more following the shot, while the control group was observed for six consecutive cycles, generally.

On average, women saw an increase in their menstrual cycles by less than one full day.

Obstetrics & Gynecology

Researchers noted that women who experience the greatest change in their periods were vaccinated at the start of the follicular phase of their menstrual cycle, which begins around day six, following the menses (bleeding) stage.

“Our goal is to provide menstruating people with information, mainly as to what to expect, because I think that was the biggest issue: Nobody expected it to affect the menstrual system, because the information wasn’t being collected in the early vaccine studies,” said Diana Bianchi, director of the National Institute of Child Health and Human Development, in a statement to Washington Post’s the Lily last year.

They also hope their study will help quell vaccine hesitancy — by giving patients as much information as possible. “We were worried this was contributing to vaccine hesitancy in reproductive-age women,” said Bianchi.

Taylor told the Times that the results of the study should be encouraging to women.

“I want to make sure we dissuade people from those untrue myths out there about fertility effects,” Taylor said. “A cycle or two where periods are thrown off may be annoying, but it’s not going to be harmful in a medical way.”

https://nypost.com/2022/01/07/covid-vaccine-can-lengthen-the-menstrual-cycle-study/

White House to ask Congress for billions more in COVID-19 aid

 White House officials are reportedly preparing to ask Congress for tens of billions of dollars in additional COVID-19 aid.

The funding plan hasn’t been finalized but is likely to focus on COVID therapeutics — such as an antiviral pill — and ramping up vaccine distribution, sources told the Washington Post on Friday.

Money to help with the global vaccine effort is also expected to be included in the plan, the sources added.

Officials in the White House’s Office of Management and Budget and the Department of Health and Human Services are working on the longer-term spending package. The formal request is expected to be made in the coming weeks.

Sources told the outlet the additional funding is necessary due to the rapid spread of the Omicron variant, which has caused a surge in COVID-19 cases. The White House has said it currently has sufficient funds to deal with the outbreak.

More than $100 billion in COVID-related spending was already approved as part of the $1.9 trillion American Rescue Plan that was passed in March 2021.

White House officials reportedly are preparing to ask Congress for billions of dollars in extra COVID-19 aid after the spread of the Omicron variant.

Photo by BRENDAN SMIALOWSKI/AFP via Getty Images

Former President Donald Trump approved nearly $900 billion in COVID-related funding in December 2020 as part of a larger $2.3 trillion pandemic aid and spending package.

Prior to that, Congress had allocated $3 trillion to combat the pandemic in the wake of widespread shutdowns in March 2020.

It is unclear if any additional funding requests would be supported by Republican lawmakers.

A sign advocating for mask wearing to protect against COVID-19 is seen on the National Mall in Washington, DC.

AFP via Getty Images

White House press secretary Jen Psaki told reporters Wednesday that the administration has “constant conversations” with lawmakers on additional anti-pandemic funding, but added that the US is “in a very different place than we were a year ago or six months ago.”

Reports emerged earlier this week that indicated lawmakers were discussing additional stimulus spending that would support restaurants, performance venues, gyms and minor league sports teams.

https://nypost.com/2022/01/07/wh-to-ask-congress-for-billions-more-in-covid-aid-report/

NY healthcare workers will soon be required to get booster shot

 All New York healthcare workers will be required to get a COVID booster shot as soon as next week, Gov. Kathy Hochul said Friday.

The plan must still be technically approved by the state Department of Health’s rule-making body, the Public Health and Health Planning Council, but it is expected to easily get the OK, Hochul said. The council is on track to meet Tuesday, Jan. 11. 

“We anticipate swift approval, and it’ll take effect immediately,” said Hochul during a press conference at her Manhattan office Friday.

Workers will be required to get the shot within two weeks of the proposed requirement passing.

“We’ll make sure that we are doing everything we can — all those levers, all those buttons, we can push — and this is why we wanted to make sure to get those healthcare workers boosted as well,” Hochul said of the state’s coronavirus-fighting steps. 

Gov. Hochul’s plan still needs to be approved by the state’s Public Health and Health Planning Council.

Alexi Rosenfeld/Getty Images

The new requirement would permit a medical exemption, but there will be no test-out option for other workers, who were already ordered to be vaccinated.

Hochul, asked about healthcare workers who may refuse the extra shot, said there should be less of any issue because the idea isn’t new. She noted the controversial mandatory vaccination requirement that already took effect earlier this fall. She added that a worker shortage is creating an overwhelming crush of need.

“They overcame the hurdle,” she said of the workers, who had to get vaxxed. 

“Those who had overcome a hurdle, I believe they will view this, as ‘I did this once, I will do it again.

“We are already losing healthcare workers because of them testing positive without symptoms. They’ve been going home. … It’s been a source of enormous stress,” she said.

Gov. Hochul said she doesn’t expect healthcare workers to refuse the extra shot.

REUTERS/Mike Segar/File Photo

“We think it’s worth it to ask them to just do the right thing one more time.”

Hochul made waves earlier this fall when she approved a mandatory vaccination requirement for all healthcare workers in private and public facilities – including hospitals, nursing homes and long-term care facilities.

The rule faced legal challenges from staffers who sought medical exemptions, but none prevailed in court.

https://nypost.com/2022/01/07/ny-healthcare-workers-soon-required-to-get-covid-booster-shot/

AstraZeneca, Neurimmune in Development/License Pact on Cardiomyopathy Therapy

 AstraZeneca PLC said Friday that it has signed an exclusive global collaboration and license agreement with Neurimmune for the development and commercialization of NI006, a treatment for transthyretin amyloid cardiomyopathy.

The pharmaceutical giant said its rare disease group Alexion will pay Neurimmune an upfront payment of $30 million, with the potential for additional milestone payments of up to $730 million based on development, regulatory and commercial milestones. In addition, further low-to-mid teen royalties will be paid on net sales of any approved medicine resulting from the agreement.

Under the deal, Alexion will be granted an exclusive worldwide license to develop, manufacture and commercialize NI006.

NI006 is designed to treat transthyretin amyloid cardiomyopathy by enabling the removal of amyloid fibril deposits in the heart, with the potential to treat patients with advanced stages of the condition.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Neurimmune-Sign-Exclusive-Collaboration-and-License-Agreement-for-NI006-37487223/

Congressional watchdog warns U.S. health agency unprepared to take over COVID vaccine program

 

The U.S. Department of Health and Human Services (HHS) appears unprepared to assume full responsibility for the nation's COVID-19 vaccine program, including activities currently managed by the Pentagon, according to a draft government watchdog report reviewed by Reuters.

The report cites a failure to ensure HHS has enough staff or a clear timeline for taking over those additional responsibilities. The COVID-19 vaccine program, dubbed "Operation Warp Speed," by the Trump administration in May 2020, involved hundreds of officials from multiple agencies.

The program has invested more than $30 billion to develop, manufacture and purchase vaccines, including from Moderna Inc and Pfizer Inc and German partner BioNTech SE that have been used to inoculate nearly 200 million Americans, as well as shots that have not been authorized for U.S. use.

It continues to oversee approval and funding of other potential COVID-19 vaccines and treatments. In May 2021, the Biden administration ordered HHS to begin assuming responsibilities of the program shared with the Department of Defense (DOD) by the end of 2021, according to the report by Congress' auditing agency, the Government Accountability Office (GAO).

The GAO, however, said "it is unclear" whether HHS was prepared to take over the program given that a majority of the Pentagon's current responsibilities - including coordinating vaccine distribution, safeguarding the doses, and offering legal advice to federal agencies involved in the effort - had not been transferred to HHS by late last year.

"Without fully ensuring HHS readiness, HHS and DOD face an increased risk of interruptions in their remaining work, such as addressing ongoing vaccine needs for boosters or for any emerging COVID-19 variants," the agency wrote.

The report found HHS had not ensured "it has sufficient workforce capacity" nor arranged "a schedule to manage the remaining vaccine development, manufacturing and distribution activities," risking a loss of capabilities.

GAO, an independent agency tasked by Congress to audit how federal programs are managed, declined to comment on the draft. The agency prepared the report at the request of the House of Representatives' COVID subcommittee and is expected to publish it soon.

Questions about HHS' ability to fully take over vaccine and therapeutic efforts comes as the Biden administration grapples with a record surge https://www.reuters.com/world/us/us-reports-nearly-1-mln-covid-19-cases-day-setting-global-record-2022-01-04 in COVID-19 due to the rapidly spreading Omicron variant that is disrupting returns to schools and businesses after the winter holidays.

An HHS spokesperson said the "long-planned" transition had been "successfully" completed on Jan. 1.

"Institutionalizing these functions within HHS ensures we are able to build on the progress to date, retain expertise and skills (including a number of DOD employees that transferred to HHS), and continue providing the necessary tools to the American people to respond to the COVID-19 pandemic," the spokesperson said. The spokesperson declined to discuss the extent to which the Pentagon remains involved in the program.

UNPRECEDENTED MISSION Before COVID-19, HHS's office of the assistant secretary for preparedness and response (ASPR) was set up to oversee pandemic response. The Trump administration relied heavily on the Pentagon to help with the unprecedented task of producing, purchasing and distributing vaccines nationwide in the months following emergence of the new and deadly coronavirus.

As of last September, DOD had assigned 76 officials from various branches of the military to work on the program, GAO said. A Pentagon spokesperson told Reuters "HHS has assumed the lead for the COVID-19 vaccine and therapeutic mission," adding that DOD continues to award COVID contracts for medical supplies in conjunction with HHS and is "continuing to provide limited on-the-job training in a few areas to ensure the HHS workforce has all the tools and background information required to ensure the operation is successful." The Pentagon said it is no longer helping HHS with vaccine transportation.

One top federal official with knowledge of the program's operations said even if HHS has not fully assumed all responsibility, the Pentagon will help ensure a smooth transition. The official, who was not authorized to speak about it and asked to remain anonymous, called Dec. 31, "an aspirational deadline."

"If HHS is really not ready to assume all of the responsibilities, the government is not going to just drop the ball," the official said. While the Pentagon has agreed to help select contractors, the administration has not officially settled on any other shared responsibilities and "therefore it is unclear what that support may entail or for how long," the GAO said. Even with Pentagon support, a Reuters examination https://www.reuters.com/world/the-great-reboot/us-rushed-contracts-covid-19-suppliers-with-troubled-plants-2021-12-02 revealed problems with oversight of the contracts for COVID-19 vaccines, therapeutics, tests and other medical products.

Less than 20% of the companies awarded contracts were experienced manufacturers with a clean FDA record for their U.S. plants in the two years prior, and four of every five either had no U.S. manufacturing experience, poor domestic inspection results or serious recalls before their awards, Reuters found.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Exclusive-Congressional-watchdog-warns-U-S-health-agency-unprepared-to-take-over-COVID-vaccine-prog-37488525/