EU drug regulator prepares to issue advice on J&J COVID-19 vaccine

 Experts at the European Medicines Agency are preparing to present the conclusions of their investigation later on Tuesday into possible links between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual clotting disorders detected in the U.S.

Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined. Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the U.S.

J&J advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.

The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts worry the temporary halt on J&J's shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts.

Last week, South Africa suspended its use of the vaccine in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.

The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting.

With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.

It's not yet clear if there might be a similar mechanism with the J&J vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are made with the same technology. They train the immune system to recognize the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body.

Earlier this month, the EU drug regulator said there was a “possible link” between the AstraZeneca shot and rare blood clots but said the benefits of vaccination far outweigh the risks of COVID-19. It noted the risk is less than the blood clot risk that healthy women face from birth control pills.

https://www.fox43.com/article/news/health/coronavirus/vaccine/eu-drug-regulator-advice-jj-covid-19-vaccine/507-e4932a72-68c1-4155-80c8-b173ee76b6af

Eisai Lecanemab (BAN2401) Phase 2b study in early Alzheimer's disease published

 BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer's Disease with Lecanemab, an Anti-Aβ Protofibril Antibody, in the peer-reviewed journal Alzheimer's Research & Therapy.  The manuscript describes results from Study 201, a Phase 2b proof-of-concept study that explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline in patients with early Alzheimer's disease. The manuscript concluded that the analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the pivotal Phase 3 study Clarity AD aims to confirm. 

The lecanemab Clarity AD Phase 3 study completed enrollment last month with 1,795 symptomatic patients with early Alzheimer's disease. Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase designed to confirm safety and efficacy of lecanemab in subjects with early Alzheimer's disease. Eisai expects the 18-month results to be available in September 2022. Additionally, the Phase 3 AHEAD 3-45 study is currently exploring lecanemab in individuals with preclinical Alzheimer's disease, defined as persons that are clinically asymptomatic, but have intermediate or elevated brain Aβ levels.

"It's great to see the promising results from the Phase 2b study published. The aim of the Clarity AD study is to confirm these results, thereby offering a disease modifying treatment to millions of Alzheimer's disease patients around the globe, which have no such treatment available today," said Gunilla Osswald, CEO, BioArctic.

https://www.prnewswire.com/news-releases/lecanemab-ban2401-phase-2b-study-in-early-alzheimers-disease-published-in-peer-reviewed-journal-alzheimers-research--therapy-301272183.html

Connecticut to lift all COVID-19 restrictions, except masking, on May 19

 Connecticut will lift all COVID-19 restrictions with the exception of the mask mandate on May 19, Gov. Ned Lamont announced Monday.

The state plans to move forward in two stages, Lamont announced, both contingent on declining coronavirus metrics and rising vaccination rates.

First, on May 1, the state will lift all outdoor restrictions, including allowing bars to operate outdoors without serving food. Then, on May 19, the state will do away with the remaining restrictions. That means bars will be able to open indoors, event venue and stadium capacity limits will be removed and social distancing requirements will be dropped. In addition, gathering restrictions for private events will be eliminated.

“I think we’ve earned May 1 as a time we can be outside,” Lamont said at a Monday afternoon press briefing. “And let’s see how it goes. Assuming it goes well, May 19 we can open up some more.”

Lamont also said that he’s lifting the social distancing requirement in part because businesses, especially restaurants, have been diligent about keeping up safety precautions on their own.

“At this point I think I’m going to pass over that judgment to the restaurants because they have pretty good judgment on how to do it safely,” the governor said.

In a press release, the Connecticut Restaurant Association praised Lamont and said that “the faster we move on from this pandemic, the faster our businesses and our economy can recover.”

“More than a year after this pandemic began, local restaurant owners and employees can finally see light at the end of the tunnel,” said Scott Dolch, the association’s executive director, in a press release. “Today’s news gives restaurants a plan and a timeline for recovery.”

The one exception to the reopening is the indoor mask mandate, which will remain in effect at least until the governor’s emergency powers expire on May 20. If that expiration date remains in place, the state legislature could also mandate masking.

“I think we’re going to mandate that you continue to wear the mask in school... probably we’re going to require indoor masking a little longer, until you’re vaccinated,” Lamont said.

The governor’s reopening announcement comes as the state pushes forward with its vaccination effort — about half of Connecticut residents have now received at least one dose of a COVID-19 vaccine, according to The New York Times, placing Connecticut among the top three fastest states for per capita vaccinations.

Even so, the state’s cases, hospitalizations and deaths are not as low as they were over the quiet summer months, when the virus seemed to temporarily loosen its hold on Connecticut.

Lamont and his team said at Monday’s press briefing that the governor consulted with one public health expert — acting public health commissioner Dr. Deidre Gifford — about the reopening decision.

“The commissioner ... spoke to her counterparts in other states to get the answers that the governor needed,” said Paul Mounds, the governor’s chief of staff.

The governor also added that he’s in constant communication with other health care providers such as the hospital systems.

But some medical experts say they have concerns about the reopening.

Dr. Ulysses Wu, the system director of infectious diseases at Hartford HealthCare, said there are ways to reopen safely, but that he doesn’t agree with Lamont’s plan to drop the social distancing requirement in mid-May.

“I still believe social distancing needs to happen at this point,” he said.

The key to a safe reopening, Wu said, is for residents to continue masking, social distancing and hand washing, even after vaccination.

“Do I think we can do it? Absolutely. But we’ve got to do it safely,” Wu said.

Dr. Richard Martinello, Yale New Haven Health’s medical director of infection prevention, said he has particular concerns about a lack of social distancing indoors.

“Especially if it’s a situation where people aren’t masked, if this is a bar, I think that lack of physical distancing is going to be problematic if we continue to see levels of COVID in our community similar to what we have right now,” Martinello said.

He added, though, there are a lot of factors to consider.

Martinello pointed to ongoing vaccination efforts, which help to control the virus, but also rising circulation of more contagious variants, which are not helpful. Plus, he said, there are other potential reasons to reopen, including that it could help ease mental health concerns for people who have struggled during the pandemic.

“There’s some real pros and cons to this,” Martinello said. “I think I lean toward being very concerned that this is premature.”

But it’s difficult to say exactly when is the right time to reopen, according to Dr. Luke Davis, a clinician at Yale New Haven Hospital and an epidemiologist at Yale’s School of Public Health.

“I don’t know what the best time or the optimal time would be,” Davis said. “But I think, just given that we haven’t seen a dramatic spike in cases over the last four weeks or so since the last relaxing of restrictions was put forward ... I’m open to seeing what’s happening in the coming weeks.”

State surpasses 8,000 deaths; weekly positivity dips

Also on Monday, Lamont announced that Connecticut surpassed 8,000 coronavirus-linked deaths, a grim milestone even as the state continues to rollout vaccinations to all adults.

https://www.courant.com/coronavirus/hc-news-coronavirus-daily-updates-0419-20210419-7b5k47ujrnbq5n7wfjt7kyktym-story.html

Sputnik V demonstrates 97.6% efficacy, making it world's most efficient COVID-19 vaccine

 The Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) today announced that the Sputnik V vaccine demonstrated efficacy of 97.6%, based on the analysis of data on the infection rate of coronavirus among those in Russia vaccinated with both components of Sputnik V.

The Ministry of Health of Russia maintains a register of persons who have been vaccinated, as well as citizens who have got infected with COVID as part of the Unified State Information System in Healthcare.

According to the data from 3.8 million Russians vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021 as part of the mass-scale civil vaccination program, the infection rate starting from the 35th day from the date of the first injection was only 0.027%.

At the same time, the incidence among the unvaccinated adult population was 1.1% for a comparable period starting from the 35th day after the launch of mass-scale vaccination in Russia.

The following formula was used to calculate the vaccine's efficacy:

The data and calculations of the vaccine’s efficacy will be published in a peer-reviewed medical journal in May.

Sputnik V is approved for use in 60 countries with a total population of 3 billion people. Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.

https://rdif.ru/Eng_fullNews/6722/

NY Requires Nursing-Home Workers To Sign Paperwork If They 'Opt Out' Of COVID Jab

 Now that nearly 130MM Americans have received at least one dose of the coronavirus vaccine, the CDC announced Monday that all adults aged 16 and over across the US are now eligible to receive the vaccine.

Almost 130MM people 18 or older have received at least one dose of a vaccine, or 50.4% of the total adult population, the CDC pointed out. Almost 84MM adults, or about 32.5% of the population, have been fully vaccinated.

What's more, Dr. Anthony Fauci hinted on Sunday that the US government will likely move to resume use of Johnson & Johnson’s COVID-19 vaccine this week, though possibly with restrictions or broader warnings about the rare, but potentially deadly, blood clots.

The news comes just as demand for vaccines in the US appears to be reaching an inflection point, as more states report growing stockpiles of unused jabs as demand for vaccinations tapers off.  Dr. Scott Gottlieb has warned that a demand crisis might be at hand in the US, putting the entirely theoretical 70% herd immunity threshold out of reach - at least temporarily.

Clearly, public health officials across the country are starting to worry about waning vaccine demand, because after nearly half of New York nursing home workers refused the vaccine, the state's Department of Health us taking steps to pressure nursing homes to get these compliance numbers up. While some health care workers say they haven't yet had an opportunity to get the jab, Zero Hedge has been chronicling reports about health-care workers declining the jabs in surprising numbers, in states from California to New York and elsewhere.

Like the old saying goes, "sh*t rolls down hill," and as the state leans on nursing homes to raise staffer vaccination numbers, the homes are being required to force employees who refuse the vaccine to sign "paperwork" affirming their decision.

As the New York Post reported last night, New York's health department brass are now requiring nursing homes in the state to give every worker an opportunity to get vaccinated. And if they refuse, they must sign paperwork recording their decision to "opt out" of the vaccination process. Nursing homes that don't comply could face serious fines, according to the New York Post.

Nearly half of New York’s nursing home workers haven’t gotten the COVID-19 vaccine — so the state Department of Health is now putting more pressure on the facilities to bridge the gap, The Post has learned.

Health department brass issued new guidance late Thursday that requires nursing homes to offer “an opportunity to receive” the jab to all consenting residents and staff by April 29 and within two weeks of a new hire or a new admission, records obtained by The Post show. Both staff and residents who opt out will need to sign paperwork acknowledging that they are declining. Facilities that don’t comply with the new rules may be penalized up to $2,000 per violation, the DOH

[...]

They’re trying to get people vaccinated and they’re trying to incentivize it,” said Michael Balboni, the Executive Director of Greater New York Health Care Facilities Association, said of the new requirement.

Only 60 percent of workers in the facilities statewide have gotten the shot since December - and just 56 percent of staff in the five boroughs have received the vaccine, the latest DOH vaccination numbers show.

By comparison, 80 percent of nursing home residents statewide have been vaccinated and 73 percent in the city have gotten the jab.

One nursing home official claimed the guidelines were released without enough consultation and argued that facilities might have trouble meeting the 2-week vaccination rule simply because they don't have enough jabs. But as we noted above, there could be other reasons - even justifiable reasons - why nursing home workers refuse the vaccine.

While it's not clear what immediate purpose this paperwork would serve, the ominous notion that the state will be taking names of those who refuse could be interpreted as an implicit threat for a large subset of the state's health-care workers (and a group that was severely impacted, with vast numbers catching the virus last spring as it tore through state nursing homes while Gov. Andrew Cuomo shopped around his book deal).

https://www.zerohedge.com/covid-19/ny-requires-nursing-home-workers-sign-paperwork-if-they-opt-out-covid-jab

Bunion medical device maker Treace Medical Concepts sets terms for $150 million IPO

 Treace Medical Concepts, which makes a medical device system for the treatment of bunions, announced terms for its IPO on Monday.

The Ponte Vedra, FL-based company plans to raise $150 million by offering 9.4 million shares (33% insider) at a price range of $15 to $17. At the midpoint of the proposed range, Treace Medical Concepts would command a fully diluted market value of $935 million.

Treace Medical Concepts is a commercial-stage orthopedic medical device company targeting the surgical treatment of bunions. The company's proprietary Lapiplasty 3D Bunion Correction System is a combination of novel instruments, implants, and surgical methods designed to improve the traditional approaches to bunion surgery. More than 25,000 Lapiplasty Procedures have been performed in the US since 2015, when the Lapiplasty System received 510(k) clearance.

Treace Medical Concepts was founded in 2014 and booked $57 million in sales for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol TMCI. J.P. Morgan, Morgan Stanley, SVB Leerink and Stifel are the joint bookrunners on the deal. It is expected to price during the week of April 19, 2021.

Relevant Profile: TMCI

https://www.renaissancecapital.com/IPO-Center/News/80899/Bunion-medical-device-maker-Treace-Medical-Concepts-sets-terms-for-$150-mil

Hearing care services provider hear.com files for a $100 million US IPO

 hear.com, a hearing care services provider being spun out of WS Audiology, filed on Monday with the SEC to raise up to $100 million in an initial public offering.

hear.com states that it is the largest online provider of expert, medical-grade hearing care globally. The company first meets its consumers online, then engages with them via telephone. Consumers that decide to continue with hearing tests and fittings can do so in person through the company's global network of over 5,000 locations or remotely through its proprietary teleaudiology solution Clinic-in-a-Box.

The Utrecht, Netherlands-based company was founded in 2012 and booked $194 million in revenue for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol HCG. Morgan Stanley, J.P. Morgan, Deutsche Bank, Goldman Sachs, BofA Securities, William Blair and Truist Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: HCG

https://www.renaissancecapital.com/IPO-Center/News/80923/Hearing-care-services-provider-hear.com-files-for-a-$100-million-US-IPO