Women Remain Most at Risk of Brain Vein Clots After J&J Vaccine

 Incidence of cerebral venous sinus thrombosis (CVST) remained a rare occurrence after the Johnson & Johnson COVID-19 adenovirus vector vaccine began being administered, researchers said.

The overall age- and sex-adjusted incidence of CVST was 2.34 per 100,000 person-years in Olmsted County, Minnesota, in 2001 to 2015, compared with a peak incidence of 8.65 per 100,000 person-years at 15 days postvaccination per the CDC Vaccine Adverse Event Reporting System (VAERS) database, according to a team led by Aneel Ashrani, MD, MS, of the Mayo Clinic in Rochester, Minnesota.

Those at highest risk of CVST after receiving the Johnson & Johnson product in early 2021 were women ages 30 to 39 (26.52 per 100,000 person-years) and women ages 40 to 49 (29.48 per 100,000 person-years) -- with women in general having a 5.1-fold higher risk after vaccination than they did before the COVID pandemic (13.01 vs 2.53 per 100,000 person-years, P<0.001).

The study authors maintained that the "absolute CVST risk was still low" for these women. "The reason that women had a higher incidence of postvaccination CVST is unclear; concomitant CVST risk factors or autoantibody production might have been involved," they noted in JAMA Internal Medicine.

"In this population-based cohort study, we found that the CVST incidence rate 15 days after Ad26.COV2.S vaccination was significantly higher than the prepandemic rate. However, the higher rate of this rare adverse effect must be considered in the context of the effectiveness of the vaccine in preventing COVID-19," Ashrani's group urged.

Other research has found that severe COVID-19 is associated with more cases of CVST compared with vaccination by an order of magnitude.

Another previous report detailed six cases of CVST with thrombocytopenia -- all in women and all within 6 to 13 days of vaccination -- out of 6.85 million people who had received the Johnson & Johnson vaccine since late February.

That report led to a brief pause in use of the adenovirus vector vaccine in April.

For the present study, Ashrani and colleagues sifted through Olmsted County's prepandemic CVST cases. Of the 39 cases found, 29 were associated with a predisposing venous thromboembolism risk factor, such as infection, active cancer, and recent oral contraceptive use. Median age at CVST diagnosis was 41 years, and 56.4% were women.

In comparison, there were 38 CVST events backed by sufficient details or imaging in VAERS reports from people who received the Johnson & Johnson vaccine from February 28 to May 7 of this year. Of those cases, 27 occurred in women, and the median age was 45 years.

The investigators noted the potential for ascertainment bias in their study, since they included only "objectively diagnosed" CVST cases. They also cautioned that reporting to VAERS is voluntary.

Disclosures

The study was supported by grants from the NIH's National Heart, Lung and Blood Institute, the Rochester Epidemiology Project, and the Mayo Foundation.

Ashrani and a co-author disclosed grants from the National Heart, Lung and Blood Institute. Another co-author reported grants from the NIH.

Primary Source

JAMA Internal Medicine

Source Reference: Ashrani AA, et al "Age- and sex-specific incidence of cerebral venous sinus thrombosis associated with AD26.COV2.S COVID-19 vaccination" JAMA Intern Med 2021; DOI: 10.1001/jamainternmed.2021.6352.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95380

Amazon lifts mask requirement for vaccinated warehouse workers

 Workers fully vaccinated against COVID-19 will no longer be required to wear face coverings in Amazon warehouses.

The face covering requirement will be lifted starting Tuesday, unless otherwise mandated by federal, state or local regulations, according to an Amazon spokesperson. 

Workers received a notice about the update on Friday, CNBC reported.

“Vaccines are universally available across the U.S. and vaccination rates continue to rise which enables the ability to return to our previous mask policy,” the notice reportedly stated. 

Workers must provide proof of their vaccination status in Amazon’s internal employee portal, according to CNBC. 

The Amazon spokesperson said the company will continue to evaluate temporary COVID-19 safety measures and make adjustments in alignment with public health advice and Amazon’s own medical experts.

The update is the latest from the e-commerce giant as companies grapple with changing COVID-19 conditions. 

Amazon relaxed its mask requirement in May for fully vaccinated U.S. warehouse workers in areas where local regulations did not require face coverings but reinstated the mask guidance regardless of vaccination status in August. 

Amazon has not announced a COVID-19 vaccine mandate for employees.

https://thehill.com/policy/technology/579480-amazon-lifts-mask-requirement-for-vaccinated-warehouse-workers

Novavax COVID-19 vaccine gets first authorization; expects more within weeks: CEO

 Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.

Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.

For Indonesia, the shot will be manufactured by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.

The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.

A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.

“I think we’ll get some doses to COVAX this year,” Erck said. “But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter” of 2022.

Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.

He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”

Novavax had delayed filing for U.S. approval, and Politico reported last month that the company faced production and quality problems.

SII is authorized to make the Novavax vaccine and the U.S. company said it will apply for regulatory authorization for other facilities, such as its plant in the Czech republic, in the coming weeks.

Indonesia is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.

Penny Lukito, chief of the National Agency for Drug and Food Control of Indonesia, did not immediately respond to a Reuters request for comment.

Novavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.

“It will be weeks, not months, for them to review” Novavax’s regulatory submissions and potentially clear the shot for use, Erck said.

The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.

The Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.

https://www.reuters.com/article/health-coronavirus-novavax/update-3-novavax-covid-19-vaccine-gets-first-authorization-expects-more-within-weeks-ceo-says-idUSL4N2RS2MV

Kiniksa Q3 Report, Portfolio Update

 - Q3 2021 ARCALYST® (rilonacept) net revenue of $12.1 million -

- ARCALYST prescribed by more than 200 physicians for recurrent pericarditis since approval -
- Data from Phase 3 trial of mavrilimumab in COVID-19-related ARDS expected in Q1 2022 -
- Data from Phase 2b trial of vixarelimab in prurigo nodularis expected in 2H 2022 -
- Conference call and webcast scheduled for 8:30 am ET today -

Financial Guidance

• Kiniksa expects ARCALYST net revenue for the fourth quarter of 2021 to be between $16.0 million and $17.0 million.

• Kiniksa continues to expect that its cash, cash equivalents and short-term investments will fund its current operating plan into 2023.

Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Monday, November 1, 2021 to discuss third quarter 2021 financial results and to provide a corporate update.

Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1699563. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

https://finance.yahoo.com/news/kiniksa-pharmaceuticals-reports-third-quarter-120000891.html

Justice Dept. Agrees with Rite Aid to Make Online COVID Vax Portal Accessible to DIsabled

 The Justice Department and the U.S. Attorney’s Office for the Middle District of Pennsylvania today announced a settlement agreement with Rite Aid Corporation that will help people with disabilities get information about COVID-19 vaccinations and book their vaccination appointments online. 

Rite Aid’s COVID-19 Vaccine Registration Portal, currently located at https://www.riteaid.com/covid-19, was not accessible to some people with disabilities, including those who use screen reader software and those who have a hard time using a mouse. For instance, the calendar on Rite Aid’s website used for scheduling vaccine appointments did not show screen reader users any available appointment times, and people who use the tab key instead of a mouse could not make a choice on a consent form that they needed to fill out before scheduling their appointment.       

“Equal access to healthcare is one of the most important rights guaranteed by the Americans with Disabilities Act,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “As the nation continues its response to the COVID-19 pandemic — through booster shots, vaccinations for children under 12, and ongoing outreach to those still in need of initial doses — people with disabilities must be able to schedule potentially lifesaving vaccine appointments as easily as people without disabilities can.”    

Under today’s settlement, Rite Aid has agreed to make content about the COVID-19 vaccine, including the forms for scheduling an appointment to get the vaccine, conform to the Web Content Accessibility Guidelines (WCAG), Version 2.1, Level AA. WCAG is a set of voluntary industry guidelines for making information on a website accessible to users with disabilities.  Rite Aid also must regularly test the pages of its website about vaccine scheduling and information and quickly fix any problems that keep people with disabilities from being able to use these pages.

This matter was handled jointly by the Disability Rights Section of the department’s Civil Rights Division and Civil Rights Coordinator Michael Butler of the U.S. Attorney’s Office for the Middle District of Pennsylvania. Title III of the Americans with Disabilities Act (ADA) requires public accommodations like drugstores and grocery stores to provide individuals with disabilities with full and equal enjoyment of goods and services, such as vaccines. The ADA also requires public accommodations to ensure effective communication with people with disabilities, including by using auxiliary aids and services like accessible technology.

https://www.justice.gov/opa/pr/justice-department-secures-agreement-rite-aid-corporation-make-its-online-covid-19-vaccine

Inovio victim to AstraZeneca's 'usual pipeline pruning' as HPV cancer vax deal axed

 AstraZeneca is wielding the ax to a bloated pipeline and Inovio has found itself the latest victim. MedImmune, an AstraZeneca unit, has terminated a collaboration agreement with Inovio for the cancer immunotherapy MEDI0457, which was being developed to target cancers caused by certain types of the human papillomavirus.

The deal, originally signed in 2015, was worth $27.5 million upfront with $700 million in biobucks down the line. Inovio has managed to pick up a couple million dollars through the partnership, but the remaining funds are now off the table.

MedImmune will continue to fund a handful of phase 2 trials still underway as they wrap up. One trial in head and neck cancer recently completed a final data cutoff with a readout expected by year-end 2022, Inovio said. A second externally sponsored trial with MD Andersen will also continue until completion.

Inovio will regain the rights to MEDI0457, which was known as INO-3112 back at the Pennsylvania biotech’s headquarters. But the therapy’s future is still unclear. Inovio will cease any development activities that would have required reimbursement from MedImmune while they consider the next steps.

The news was revealed in an 8-K (PDF) from Inovio issued after-market on Friday, a key biotech method of tying to partly bury bad news. Inovio said the collaboration has so far garnered about $2 million and change from MedImmune. RBC Capital Markets had expected Inovio to collect about $210 million in milestones and double-digit royalties on $300 million in peak sales, according to a Monday note.

Inovio’s therapy has fallen victim to AstraZeneca’s “usual pipeline pruning,” according to RBC—but the cut is “still a disappointment.” This is not the first time the U.K. pharma has axed a collaboration with Inovio. The companies previously cut ties over two preclinical DNA-based oncology vaccine programs in 2019.

The 2015 partnership was also trimmed back in 2019 down to the one vaccine, MEDI0457.

RBC noted “a pattern of pressure” on Inovio’s pipeline, and the end of the MedImmune deal is another stressor. But the biotech’s COVID-19 vaccine INO-4800 is slowly making headway, even as it's fallen behind the first-to-market winners. The vaccine was recently selected to be part of a large phase 3 clinical trial conducted by the World Health Organization.

The goal of the trial is to develop the next generation of shots that can be needle-free. Inovio’s vaccine is given through a device called Cellectra that administers an electrical pulse to the skin to open up the pores for delivery of the medicine.

Inovio's shares were mostly holding steady as the markets opened Monday, down just over 1% to $7.05. 

https://www.fiercebiotech.com/biotech/inovio-falls-victim-to-astrazeneca-s-usual-pipeline-pruning-as-human-papillomavirus-cancer

Digital health firm Better Therapeutics makes Nasdaq debut

 Better Therapeutics has joined the ranks of publicly-listed digital health companies after completing a merger with blank cheque company Mountain Crest Acquisition Corp II.

The company, which specialises in prescription digital therapeutics (DTx) for cardiometabolic diseases, listed on the Nasdaq under the BTTX ticker late on Friday.

Shares initially fell back slightly from an opening price of $10.04 after the merger closed with the special purchase acquisition company (SPAC), but then rocketed to $16.76 in pre-market trading.

The SPAC route to a public listing is increasingly being used by digital health companies as an alternative to an initial public offering (IPO), with other recent examples including DTx specialist Pear Therapeutics and telehealth company Babylon Health.

It can be quicker, simpler and cheaper than an IPO, which can see investment banks taking a sizeable slice of gross proceeds in fees, but also involves less scrutiny of a company’s finances, liabilities and operational processes.

The proceeds of around $70 million will keep the company funded through 2023, and will be used to bring forward Better Therapeutics’ lead prescription DTx for type 2 diabetes – BT-001 – through clinical trials and submission for FDA approval, according to the digital health company.

BT-001 is a tool designed to change behaviours that are the root cause of type 2 diabetes, and is being investigated in a pivotal study as a treatment used under physician supervision for people with uncontrolled diabetes.

The DTx works by blending clinical, behavioural and psychological inputs into a series of therapy lessons and skill-building modules.

Better Therapeutics recently recruited the first patient in a real-world study of BT-001 partnered with US primary care organisation Catalyst Health Network to gauge the long-term impact of the tool.

The cash injection will also be used to advance the digital health firm’s prescription DTx pipeline for other cardiometabolic conditions, which includes BT-002 for hypertension and BT-003 for high blood cholesterol as well as a candidate for non-alcoholic fatty liver disease (NAFLD).

Better Therapeutics meanwhile also gets access to an additional $40 million credit facility, subject to certain milestones being achieved.

“We envision a future where digital therapeutics are often the first prescription written in order to address the root causes of disease caused by patient behaviours,” said Kevin Appelbaum, Better Therapeutics’ co-founder and chief executive

“The completion of this transaction and the capital raised will be instrumental in helping our team lead the way in this transformation, beginning with cardiometabolic diseases,” he added.

https://pharmaphorum.com/news/digital-health-firm-better-therapeutics-makes-nasdaq-debut/