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Wednesday, March 24, 2021

Come for Caribbean Escape, Stay for COVID Shots

 When Weehawken, New Jersey, resident Hemal Trivedi decided to get away to a Caribbean island this winter, she wasn't expecting to be vaccinated against COVID-19 by the time she flew home.

But that's exactly what happened, for her, her husband, and four other friends in their 30s and 40s who stayed on St. Croix from late December to early March, working remotely and enjoying each other's company.

"We wanted a winter escape and we realized this opportunity would never happen again, so we said we should all go somewhere together," Trivedi told MedPage Today. "Getting the vaccine was just a happy accident."

MedPage Today spoke with several travelers from the mainland who went to the island, which is part of the U.S. Virgin Islands (USVI), who received the vaccine as an added benefit, or who were able to secure an appointment before heading south.

It's not clear exactly how widespread vaccine tourism to the island is, or how large of a surplus the island has, but officials insist that supply is robust.

At the same time, it's been an uphill battle to convince vaccine-hesitant residents to get their shots, but USVI Gov. Albert Bryan, Jr. said during a Monday press briefing that vaccine tourism isn't a worry for the territory.

"Our real concern is not if we're getting vaccine tourism," Bryan said during the briefing. "Our real concern is, do we have enough vaccines for everybody? We're seeing 90 to 100 walk-ins on each island per day, and we're able to serve them. There are no lines. As long as we're able to do that, it will not be as much of a concern to us."

He estimated only about 3% of the territory's 33,862 doses administered as of Monday went to vaccine tourists. About 30% of the population have had a first dose, and about 13% have received two doses, he said.

While Caucasians make up a larger proportion of vaccine recipients than they do in the community, that could indicate vaccine tourism, Bryan said, but "more likely it means Caucasians living in the Virgin Islands are more apt to take the vaccine and take it quicker."

He said everyone on the island should be encouraged to go and get a vaccine, "because it is a privilege now. Nowhere else in the U.S. can you just walk in and get a vaccine, anybody over 16. We need to take advantage of that."

'Shot in the Arm' for a Battered Economy?

Rob DeRocker, a 62-year-old communications and real estate professional based in Tarrytown, New York, owns a condo on St. Croix and comes down most winters. (Also, his business includes promoting the USVI.) This year, he arrived in early January, and the next day made an appointment for a vaccine the following week. His wife, 66, came down in mid-February and received her first dose 2 days later.

"I was initially reluctant to get the shot, because I didn't want to deprive others, but I kept being reassured that the supply is not an issue," DeRocker told MedPage Today. Several younger friends had received theirs, he said, and "it was an open secret by February that if you wanted one, you could get it here."

Trivedi said her vaccine opportunity arose after a friend overheard a group of people at the pool of the condo they were renting talking about getting vaccine appointments. The six friends were all able to put their names on a list that would notify them about extra doses.

"We were on the beach when we got the text message saying, 'come now to get vaccinated!'" Trivedi said. "We dropped everything and went to the clinic."

Michael and Joanie Berg of Maplewood, New Jersey, were looking for a winter getaway after a few stressful events. When they heard that they could probably get the vaccine in St. Croix, they were sold.

"It wasn't the reason for coming here, but it was a nice bonus," Joanie Berg told MedPage Today.

The couple, in their late 30s, was able to make a vaccine appointment a few days before flying down. They'll receive their second dose at the end of the month, a few days before flying home.

The Bergs received their vaccine through Plessen Healthcare's vaccine clinic on St. Croix. Angela East, the company's corporate administrator and vaccine coordinator, told MedPage Today that Plessen gives between 180 and 230 shots each day, making them one of the top providers in the territory.

East didn't have numbers on vaccines given to tourists, but said, "we're not going to turn you away because you're not from St. Croix."

Sometimes, it's obvious that people seeking shots aren't residents, she said: "Last week a tour group from Puerto Rico pulled up in a safari bus to get the vaccine."

Vaccine hesitancy among residents is also starting to lift, from her perspective. "Once you tap into one or two core influencers at churches or in a neighborhood, then more people become open to it," she said.

Plessen and others want to ensure that supply remains adequate for all who want it, which is one reason they're eager to vaccinate.

"We're getting adequate supply based on the fact that we are distributing effectively," she said. "[Allocation] has to do with the population but also with the number of vaccines we're distributing."

In an interview conducted through a USVI health department representative, Monife Stout, territorial immunization director, said that supply and distribution are "fluid, with the public demand to be vaccinated and the increase in federal allotments." The current federal weekly allocation to the entire territory -- which encompasses St. Croix, St. Thomas, and St. John -- is 2,340 doses of Pfizer's vaccine, 1,100 doses of Moderna's, and 100 doses of Johnson & Johnson's, Stout said.

"The number has increased twice already and will continue as the presidential administration approves and vaccines are produced," Stout said.

When asked about the surplus on St. Croix, Stout noted that some of the USVI's "larger providers and federally qualified health centers that have high vaccination rates are on St. Croix. Most of these providers have satellite offices from which vaccines are offered, enabling a wider reach of persons to be vaccinated."

Fighting Vaccine Hesitancy

On March 1, USVI opened up vaccination to all residents ages 16 and up -- mainly as an effort to increase local uptake.

The three islands count about 100,000 people as residents, the majority being Afro-Caribbean, with about half on St. Thomas (which has the territory's major cruise port) and half on St. Croix. St. John, which is mostly a national park, has only about 4,000 residents.

The governor's goal is to vaccinate 50,000 residents by July 1.

Convincing residents to take the vaccine hasn't been easy. Trivedi and DeRocker described seeing vans driving through towns with people using megaphones to advertise the availability and safety of the vaccine.

"It reminded me of elections in India," said Trivedi, who originally hails from Mumbai.

During a press briefing last Friday, the territory's medical director, Tai Hunte-Ceasar, MD, expressed frustration about vaccine hesitancy, delivering an impassioned plea for everyone to get vaccinated, her voice cracking as she talked about health officials growing very tired.

"We are still struggling to get our people to come get vaccinated," she said. "We've opened it up to the entire population, there are no barriers. Yet we still have individuals who are contemplating the benefit."

Hunte-Ceasar answered MedPage Today's questions about addressing vaccine hesitancy through a department of health spokesperson, noting that vaccine hesitancy was a problem in the territory before COVID.

"However, we have seen a significant increase in the acceptance of the vaccine over a gradual process that has been consistent throughout the nation," she said. "We launched a vaccine education/confidence campaign with agency presentations to provide Q&A sessions. These presentations increased the acceptance of the vaccine tremendously."

As well, the government sponsored a media campaign, she said. "This, paired with community engagement through outreach, has worked to combat hesitancy throughout the territory."

Each island has a community vaccination center, in addition to other vaccination locations, with longer lists for St. Croix and St. Thomas.

Still, COVID-19 cases continue to crop up, especially on St. Croix, officials said. Over the most recent 10-day period (March 12 to March 22), there were 91 new positives, with 68 on St. Croix and 23 on St. Thomas. Three patients were hospitalized, with one ventilated, on St. Croix; one was hospitalized and ventilated on St. Thomas.

It's not clear whether those cases were locally transmitted, or brought in by tourists. However, DeRocker sees vaccine tourists being more of a boon than a detriment to the economy.

"It's bringing people to St. Croix for the first time," he told MedPage Today. "If they stay for 3 weeks, that's a substantial investment of time and money."

Indeed, the Bergs told MedPage Today they'd come back to St. Croix, possibly for a very long time: "This is the place we've decided we'd like to retire someday," Michael said.

https://www.medpagetoday.com/special-reports/exclusives/91785

EU Commission to Propose Making it Easier to Block Covid-19 Vaccine Exports

 The European Commission is proposing to make it easier for European Union governments to block Covid-19 vaccine exports, a step that would likely escalate tensions with the U.K. and potentially damage ties with other countries.

The proposal will be debated at a meeting of EU leaders on Thursday and Friday where it looks likely to receive backing. However, the real test of its significance will be the guidance handed down by leaders on how broadly the export ban should be used.

Struggling with its own vaccine program, the EU's executive in late January allowed member states to stop vaccine exports from the bloc provided the move had backing from the European Commission.

However, the instrument has been used just once, when Italy blocked a batch of vaccines destined for Australia. Since late January, the EU has shipped 380 vaccine batches abroad, totalling more than 40 million vaccines, including more than 10 million to the U.K. despite the continued difficulties facing the bloc's vaccine campaign.

The commission has been contemplating barring exports to the U.K., whose own vaccine program has moved rapidly but which hasn't exported any vaccines. Senior U.K. and EU officials have been in talks in recent days on a possible compromise which would prevent British vaccine imports, which have so far mainly been of the Pfizer vaccine, being hit.

Those discussions have centered around ideas for sharing vaccine production from the Dutch-based plant Halix which is manufacturing vaccine ingredients for AstraZeneca. EU officials confirmed on Wednesday reports that millions of vaccines produced at the plant have been filled and finished at a site in Italy. No export request has yet been made for the vaccines.

Under the European Commission's proposal, EU governments would be able to take into account new criteria in deciding whether to stop an export. One would be whether the recipient country was also exporting vaccines or vaccine ingredients to the EU. Another would be how advanced the country was in vaccinating its own population or the epidemiological situation there in general.

EU officials said Wednesday the intention of the broader mechanism was to secure the EU's vaccine supply but they said it wouldn't allow EU member states to seize vaccine stocks produced by a company and that the aim is not to introduce sweeping new export bans.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-EU-Commission-to-Propose-Making-it-Easier-to-Block-Covid-19-Vaccine-Exports-32773637/

Biogen sues Teva over MS generic

 A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity (diroximel fumarate), according to a lawsuit filed by Biogen and Alkermes.

The complaint, filed Wednesday, March 17, at the District Court for the District of Delaware asked the court to block the copycat drug until the patents have fully expired.

Biogen and Alkermes sued the US-Israeli generic drug maker company after it filed an  Abbreviated New Drug Application, number 214206, at the US Food and Drug Administration (FDA) seeking approval to manufacture and sell a generic version of Vumerity.

According to Biogen and Alkermes, Teva’s generic infringes three patents that protect Vumerity, which Alkermes licenses exclusively to Biogen.

The patents, US numbers 8,669,281; 9,090,558; and 10,080,733 are set to expire in September 2033, according to the FDA's Orange book.

Biogen launched Vumerity in November 2019, as a successor to its blockbuster MS treatment, Tecfidera (dimethyl fumarate).

According to a report in science journal FiercePharma, the drug generated $11 million in the first half of 2020, a disappointing performance for Biogen as it faces competitive threats to its multiple sclerosis business.

 In July 2020, Biogen CEO Michel Vounatsos told the journal that the next five months would be "critical" for the medicine, and that the company’s sole focus would shift from Tecfidera to Vumerity.

This commitment came after a west Virginia court invalidated Biogen's patents covering Tecfidera in June 2020, paving the way for Mylan to roll out a generic version of the drug.

The decision came as a major blow to Biogen, which relied on Tecfidera for almost a third ($4.4 billion) of its 2019 sales.

https://www.lifesciencesipreview.com/news/biogen-sues-teva-over-ms-generic-4401

Rite Aid down 18% after lower 2021 guidance on 'soft' flu season

 Shares of Rite Aid Corp. RAD, -2.38% fell more than 18% in the extended session Wednesday after the drugstore chain lowered its guidance for fiscal 2021, saying its bottom line was "significantly" hampered by a "soft" cold and flu season, the ongoing pandemic, and "challenging" weather. Same-store sales fell about 5.6% in the quarter ended in February, mostly due to a decline of nearly 37% percent in cough, cold and flu-related categories, the company said. Rite Aid also said it had administered about 1 million COVID-19 vaccines in March to date. The company said it expects fiscal 2021 revenue of about $24 billion, with same-store sales expected to increase about 3.5% compared with fiscal 2020. It called for a net loss between $90 million and $100 million for the year, and an adjusted EBITDA between $425 million and $435 million. Liquidity is about $1.7 billion, it said. Rite Aid is scheduled to report fourth-quarter results on April 15. The stock ended the regular trading day down 2.4%.

https://www.marketwatch.com/story/rite-aid-stock-down-18-after-lower-2021-guidance-on-soft-flu-season-2021-03-24

20 most popular websites targeted for COVID-19 phishing attacks

 Cybercriminals have been doubling down on phishing scams, posing as major brands such as Microsoft and LinkedIn, to steal user login credentials and other personal information, according to a report from threat intelligence firm Palo Alto Unit 42. 

The cybersecurity firm found that COVID-19 vaccine-related phishing attacks increased by 530 percent from December 2020 to February, and phishing attacks relating to and/or targeting pharmacies and hospitals rose by 189 percent during that same timeframe, according to the March 24 report. 

For its analysis, Palo Alto Unit 42 examined a set of all phishing URLs detected globally between January 2020 and February, pulling sets of specific keywords or phrases that served as indicators for each COVID-19-related topic, such as personal protective equipment, testing kits, treatments and vaccines. 

The attackers create fake websites that mimic the company's authentic login page so that when users input their information, the data is sent to the attacker. The user then is redirected to the true company webpage. 

Here are the 20 most popular brands targeted during the pandemic, listed in order of most attempted attacks. 

1. Microsoft 
2. Yahoo
3. Webmail
4. Outlook 
5. PayPal 
6. Google Accounts 
7. LinkedIn 
8. Facebook 
9. USAA 
10. DHL 
11. WeTransfer
12. SFExpress
13. Chase 
14. OneDrive
15. Wells Fargo 
16. Netflix
17. Excel 
18. AOL 
19. Apple ID 
20. Square 

https://www.beckershospitalreview.com/cybersecurity/20-most-popular-websites-targeted-for-covid-19-phishing-attacks-microsoft-linkedin-more.html

FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting

 After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later this week. 

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015.

Tanezumab is now the most developed of the two remaining drugs in development in the NGF class, in pain caused by osteoarthritis.

But first FDA arthritis and safety experts will run the rule over trial evidence at a joint meeting – and a review prepared by FDA staffers ahead of the meeting on Wednesday and Thursday does not bode well.

While the committee’s decision is not binding, the FDA usually follows the advice of its experts when making a final decision on whether to approve drugs.

According to the document the FDA reviewers are “not sufficient to mitigate the risk of RPOA [Rapidly Progressive Osteoarthritis Rheumatology]” and may not even ensure the “benefits of tanezumab outweigh the risks of RPOA”.

The FDA pointed out that of the small number of patients developing RPOA, 15% needed total joint replacement and after early signs of trouble 60% needed their joints replacing.

In one large study mentioned in the document of tanezumab 11 patients out of 998 on the highest dose developed RPOA (1.1%) while at the lower dose, three out of 1,002 patients developed the condition.

Stopping the drug after progression to more serious disease does not appear to be effective in preventing further damage to joints, the FDA added.

There is also a concern about mild nerve pain, with the most common from this being carpal tunnel syndrome.

Balanced against this is a “modest” benefit and “no convincing evidence of a superior efficacy” compared with non-steroidal anti-inflammatory drugs (NSAIDS), the FDA added.

Regeneron and Teva’s fasinumab is the only other serious contender from the class, which is in late stage clinical development.

Johnson & Johnson axed development of its rival fulranumab five years ago and returned rights to Amgen, although at the time the company said the decision was not based on any emerging safety concerns.

Amgen doesn’t seem to have done anything with fulranumab since – it is not mentioned the company’s pipeline round-up – meaning the search for a new class of non-addictive painkillers may continue for some time.

https://pharmaphorum.com/news/fda-worried-pfizer-lilly-pain-drug-safety-ahead-of-key-meeting/

Better late than never for Boehringer in Covid-19

 Think of companies that have been active against Covid-19, and Boehringer Ingelheim does not immediately spring to mind. Still, the German group used its 2020 financial results to highlight its work here, in particular an inhaled monoclonal antibody, BI 767551, in phase I/II development.

But this project will not reach regulators until the end of the year, Boehringer’s chief executive officer, Hubertus von Baumbach, told attendees of the group’s annual press conference. With the pandemic hopefully all but over by then, the company looks like it has missed the boat on Covid-19.

Boehringer executives laughed off such concerns, with Michel Pairet, the company’s global head of innovation, telling Evaluate Vantage: “I’d be very happy if we don’t need our beautiful antibody.”

“If it’s over, it’s over, but it’s worth the effort,” added Carinne Broillon, who leads Boehringer’s human pharma division.

Inhaled, not injected

If the worst happens and antibodies are still needed by this time next year, Boehringer hopes that BI 767551 could address the whole spectrum of Covid-19, from prophylaxis to ambulatory patients and all the way through to hospitalised patients.

This is because, being inhaled, the antibody can reach higher concentrations in the lung than systemic antibodies.

Still, Mr Pairet conceded that it might not just be lack of penetration that has scuppered antibodies in the hospital setting. “It is possible that what creates severe disease is tissue damage, and it might be too late for an antibody to work. In that case, neither the intravenous or inhaled antibodies will work. But we will test this hypothesis.”

Aside from BI 767551, Boehringer has little else to show for its work in Covid-19, despite trumpeting the fact that it started R&D for potential therapies early in the first quarter of 2020.

Another project here was the TRPC6 inhibitor BI 764198, which went into phase II last October. But Mr von Baumbach admitted that results with that project had disappointed, and the group had terminated development in Covid-19; trials in kidney disease are ongoing.

Boehringer’s final potential weapon against the pandemic is its stroke drug alteplase, which is in phase II/III; the theory is that it could treat the thrombi that can cause death in severe Covid-19 patients.

The group’s IPF drug Ofev is also being tested, but only in investigator-sponsored trials.

According to Mr von Baumbach, last year Boehringer spent €40-50m on Covid-19 research. He expects the spend in 2021 to be “significantly higher”. Perhaps this is an investment worth making, but it might be too little, too late.

Selected anti-Covid-19 antibodies with novel delivery
ProjectCompanyRoute of admin.SettingStatus
BI 767551/ DZIF-10cBoehringer Ingelheim/Cologne University Hospital/University of Marburg/German Center for Infection ResearchInhalationTreatment and prophylaxisPh1/2, NCT04631705; infused version also in ph1/2, NCT04631666
COVI-DROPS/ STI-2099Sorrento TherapeuticsIntranasal TreatmentIND filed Nov 2020
AR-711 Aridis PharmaceuticalsInhalation TreatmentPh1/2/3 trial slated for H2 2021
AR-713 Aridis PharmaceuticalsInhalation Treatment (targets variants)Ph1/2/3 trial slated for H2 2021
InvisimaskEureka TherapeuticsIntranasalProphylaxisMouse data reported in Dec 2020; IND in preparation
NI007Neurimmune/EthrisInhalationTreatmentDeal signed in April 2020, clinical development does not appear to have started
Source: Evaluate Pharma, company releases.

https://www.evaluate.com/vantage/articles/news/better-late-never-boehringer-covid-19