2 passengers test positive for COVID on first North American cruise since pandemic started

 Two people traveling on the first North American cruise since March 2020 have tested positive for COVID-19.

The passengers on the Celebrity Millennium shared a room and are now in isolation, cruise owner Royal Caribbean said in a statement. Both people are asymptomatic.

All passengers on the cruise were required to be fully vaccinated if they were over age 18. All crew members were vaccinated, according to Royal Caribbean. The ages of the people who tested positive were not released.

In this March 16, 2013, photo, workers prepare for the arrival of the Celebrity Millennium in Hong Kong. (AFP/AFP via Getty Images)

The Celebrity Millennium departed the island of St. Maarten on June 5, making it the first North American voyage since the start of the COVID-19 pandemic. Another ship is scheduled to leave from the Bahamas on June 12.

All adult passengers were required to show proof of vaccination, in addition to a recent negative COVID test, according to Royal Caribbean.

The Celebrity Millennium had been scheduled to return to St. Maarten on June 12. The positive tests were part of a shipwide end-of-cruise testing program, Royal Caribbean said. The company is conducting contact tracing, expediting tests for close contacts and “closely monitoring the situation.”

The cruise industry had been docked since COVID shut down much of North America in March 2020. Last week, Royal Caribbean announced several trips departing from Florida, 

https://www.nydailynews.com/news/national/ny-covid-positive-cruise-celebrity-millennium-restart-20210610-yssqtaj65za3dcxduleabi6jey-story.html

Fake Your COVID Vaccine Card In NY? That Could Come With A Year In Jail

 In the coming months, showing proof of vaccination against COVID-19 will become commonplace before going into a bar, getting on a flight, or going back to school or the office. To deter people who are vaccine-averse and might be tempted to flash fake credentials, New York lawmakers passed a bill Thursday criminalizing the falsification of vaccine records under state law.

“We want to make sure people go out and get vaccinated so we can hopefully reach herd immunity and put this [pandemic] behind us,” said State Senator Anna Kaplan (D.-Long Island), who introduced the bill in her chamber. “These vaccine cards really mean something, and we want to make sure we deter anyone who is thinking about putting fake cards out there.”

Following early reports of people selling fake vaccine cards, the FBI issued a warning in late March pointing out that the unauthorized use of an official government seal is a federal crime. COVID-19 vaccine cards carry the seal of the Centers for Disease Control and Prevention. But there’s no such seal on the Excelsior Pass, the digital vaccine passport created by New York State. The bill now heads to Governor Andrew Cuomo’s desk for his signature.

The state bill clarifies that falsifying a digital record of a COVID-19 vaccine constitutes computer tampering in the third degree, a class E felony that’s punishable by up to four years in prison. Make a fake paper card? That would be covered under the state’s forgery law, a class A misdemeanor. That crime could come with up to a year of jail time.

Blank vaccine cards have popped up for sale on Amazon, Etsy, and the encrypted messaging service Telegram, among other websites. Amazon already banned these fake IDs, but some vendors are apparently falling through the cracks.

In May, a 21-year-old CVS employee on Long Island, Zachary Honig, was arrested after he was found with a stack of 62 vaccine cards in his car. Eight were filled out with only the “name” section left out, while the others were blank. Honig reportedly told police he planned to share them with family members and friends.

Honig was charged with several counts, including criminal possession of a “forged instrument.” The new bill would eliminate any doubt that a falsified COVID-19 card falls into that category.

“We just wanted to make sure people understand that these CDC cards are really important and stress for everyone that it’s illegal to tamper with or make them,” Kaplan said.

https://gothamist.com/news/fake-your-covid-vaccine-card-ny-could-come-year-jail

American Society for Virology COVID-19 Vaccine Education Town Halls

 Scientific experts from major colleges and universities across the country are hosting a series of live town hall meetings to answer your questions about COVID-19 vaccination.

Please come and join us at no charge!

To register for a free town hall on COVID-19 vaccine education, click the button below!

REGISTER FOR TOWN HALLS

DONATE TO SUPPORT VACCINE EDUCATION

The Vaccine Education town halls are made possible by the partnership and support of the American Society for Microbiology.

The American Society for Virology is also grateful for the support of a number of individual donors.

https://asv.org/education/

26M Americans skipped routine vaccinations last year: Glaxo report

 Americans skipped a lot of vaccine appointments last year—and now GlaxoSmithKline has the numbers to prove it.

More than 26 million doses of recommended vaccines were missed from January through November. By age, adolescents missed 8.8 million vaccines and adults missed another 17.2 million, according to a claims analysis by Avalere Health commissioned by GSK.

Overall non-influenza vaccine claims dropped 13% to 35% for adolescents and 17% to 40% for adults.

“I was frankly surprised,” Thomas Breuer, chief medical officer for GSK Vaccines, said. “We knew it was happening, but to see the numbers right in front of you … essentially across a broad spectrum of vaccines was quite eye-opening.”

While media outlets and public health officials have been worried about vaccination rates dropping during the pandemic, the GSK study is one of the first to quantify the deficit in real-world numbers.

A smaller-scale study from the Centers for Disease Control and Prevention out Thursday found child and adolescent vaccinations dropped by as much as 70% during March, April and May 2020. The study of 10 jurisdictions across the country reported a rebound in kids' vaccinations from June through September, but not enough to make up for the earlier dropoff. 

In one example, HPV doses for children aged 9–12 years and adolescents aged 13–17 years fell by a median 64% and 72%, respectively, in the March-through-May 2020 period compared with the same timeframe in 2018 and 2019.

Now, GSK is focused on getting the data out to medical associations, public health officials, physicians and consumers. Even though vaccination rates are likely increasing now as physicians’ offices open more fully, the gap left by the pandemic needs to be addressed, Breuer said.

“Healthcare providers are one audience, but consumers, (like) mothers who are the chief executive officers of families and usually in charge of family vaccinations, should know and should be reminded. For example, before students go back to university,” he said.

Next week, Avalare will present the data at the Department of Health and Human Service’s National Vaccine Advisory Committee meeting.

The claims data also found that even though health officials warned about a potential “twindemic” of COVID-19 and influenza at the same time, flu vaccination rates were still lower than the previous year. Americans did get flu shots at a higher rate in August and September, but the insurance data shows the numbers leveling off in October and dropping in November.

As expected, the data showed a severe drop across all vaccinations in April 2020, with a steady increase across adolescents and adults since then. However, by November, the most recent claims data analysis, the number of claims still hadn't reached pre-pandemic January and February levels, according to Avalere charts.

One way GSK hopes vaccination rates will increase is through regular vaccinations given alongside COVID-19 vaccines.

The Centers for Disease Control and Prevention recently changed it guidance and now recommends that people get their regularly scheduled vaccines at the same time as the COVID-19 vaccines. That’s a change from earlier guidance, when the CDC advised giving COVID-19 vaccines alone, leaving a 14-day space before and after.

While the new data and public outreach from GSK and Avalere aims to educate people, GSK is also running separate vaccine awareness campaigns for shingles, meningitis B and hepatitis A.

During the pandemic, GSK created an umbrella campaign, “Brought to You by Vaccines,” reminding people of the good health they enjoy because of immunizations. However, the ad campaign, targeting the 50-plus crowd, will end this month.

https://www.fiercepharma.com/marketing/gsk-reveals-26-million-americans-skipped-routine-vaccinations-last-year-quantifying

EMA Recommends Change To Product Info For Gilead Remdesivir to Include Sinus Bradycardia As Adverse Reaction

 EMA SAYS PRAC RECOMMENDED CHANGE TO PRODUCT INFORMATION FOR REMDESIVIR TO INCLUDE SINUS BRADYCARDIA AS ADVERSE REACTION OF UNKNOWN FREQUENCY FOR MEDICINE

* EMA SAYS PRAC CONCLUDED THAT A CAUSAL RELATIONSHIP BETWEEN USE OF REMDESIVIR AND ADVERSE EVENT OF BRADYCARDIA IS AT LEAST A REASONABLE POSSIBILITY

* EMA SAYS DHPC IS INTENDED TO INFORM HEALTHCARE PROFESSIONALS ABOUT OUTCOME OF A SIGNAL PROCEDURE AND NEW RECOMMENDATIONS FOR USE OF XELJANZ

* EMA SAYS PRAC ADVISING XELJANZ BE USED IN PATIENTS OVER 65 YRS, CURRENT/PAST SMOKERS, OTHER CARDIOVASCULAR RISK FACTORS IF NO SUITABLE ALTERNATIVE AVAILABLE 

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-nbsp-EMA-Recommends-Change-To-Product-Information-For-Remdesivir-To-Include-Sinus-35584524/

FDA Approves Export of Covid-19 Vaccine Doses From Troubled Baltimore Plant

 The Food and Drug Administration is making millions of Johnson & Johnson Covid-19 vaccine doses available for export from a Baltimore factory that had been beset by contamination problems.

A review determined that two batches of vaccines produced at the Baltimore plant run by Emergent BioSolutions Inc. were suitable for use, the FDA said Friday.

The agency also said that it wasn't yet ready to designate the plant as an authorized manufacturing facility, and "continues to work through issues there" with J&J and Emergent.

The two batches cleared for use will provide about 10 million doses, according to people familiar with the situation. About 60 million doses were rejected for potential contamination, one of these people said, confirming a report in the New York Times.

With those rejections, there are about 120 million vaccine doses and unbottled substance made for J&J and AstraZeneca PLC at the Baltimore plant that could be cleared in coming weeks and be available for export, according to this person, a senior U.S. official.

The J&J shots are one-dose vaccines that can immunize about 10 million people. AstraZeneca's are part of a two-shot regimen, so those shots can immunize half as many people as doses available.

The Emergent plant made vaccine for J&J and for AstraZeneca, before an April 30 FDA inspection report concluded that the facility didn't take proper measures to avoid cross-contamination between the two companies' vaccine lines.

Kathy Wengel, chief officer of J&J's global supply chain, said in a statement that Friday's decisions "represent progress in our continued efforts to make a difference in this pandemic on a global scale."

Emergent said in a statement that it looks forward to "continuing to work with the FDA and Johnson & Johnson toward the release additional doses and resuming production at our Bayview facility."

The release of the vaccines will help advance President Biden's plan to export American-made vaccines to poor nations. In England ahead of the Group of Seven summit Thursday, Mr. Biden announced a plan to make 500 million doses of a third vaccine available to other countries. That vaccine, from Pfizer Inc. and BioNTech SE, also is given as a two-shot regimen.

Those donations are slated to take place over approximately the next 12 months. The doses of Pfizer/BioNTech vaccine will be provided through Covax, the global initiative to aid developing countries in their struggle against the Covid-19 pandemic.

Mr. Biden had previously committed to export a total of 80 million doses by the end of June in a bid to increase global vaccinations.

The White House said roughly 75% of those 80 million vaccine doses will be shared through Covax. The remaining 25% will be distributed to countries where cases are surging and to their neighbors, as well as to partners who requested assistance from the U.S. government.

The administration initially said 60 million doses would come from AstraZeneca following an FDA review, since the vaccine had not been authorized in the U.S., while the other 20 million doses would be a combination of vaccines from Moderna Inc., Pfizer and Johnson & Johnson, all of which are being administered domestically.

Under the Biden plan, the biggest chunk of the first batch of doses will go to South and Central American countries, including Brazil, Argentina, Peru, Ecuador and Guatemala; countries in Asia, including India, Nepal, Bangladesh, Pakistan and Sri Lanka; and to Africa, with countries that will be selected in coordination with the African Union.

Roughly six million doses will go to partners and regional priorities such as Mexico, Canada, South Korea, the West Bank and Gaza, and United Nations front-line workers.

White House press secretary Jen Psaki said earlier this week the administration still planned to export all 80 million doses by the end of the month.

"We remain committed to that. And obviously if the FDA approves AstraZeneca doses, then that will be a component of that supply," she said.

Mr. Biden has said the U.S. will be a global leader in vaccine diplomacy, which emerged as a top issue at the G-7 summit in Cornwall, England. British Prime Minister Boris Johnson, who had called on G-7 leaders to commit to vaccinating the rest of the world by the end of 2022, said the U.K. will donate more than 100 million surplus doses globally in the next year.

Some of the world leaders in attendance have disagreed with Mr. Biden's call to waive intellectual property rights for Covid-19 vaccines as a means of accelerating production in developing countries.

The U.S. has also faced criticism from some lawmakers and international aid groups for giving priority to the vaccinations of Americans and being slow to share its supply globally.

Mr. Biden's move to export doses comes as U.S. demand for the vaccine has waned following a mid-April peak of nearly 3.4 million doses administered daily. The number of daily doses administered over the past week averaged 1.1 million, according to the Centers for Disease Control and Prevention.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/FDA-Approves-Export-of-Covid-19-Vaccine-Doses-From-Troubled-Baltimore-Plan-Update-35585147/

Glaxo consumer arm confident that growth, cash flow will help with debt

 

Strong cash flow and growth will enable GlaxoSmithKline's consumer products business to cope with a higher debt load after its planned separation next year, the division's head of marketing told Reuters.

Tamara Rogers, Chief Marketing Officer for GSK Consumer Healthcare, said in an interview for the Reuters Marketing Interactive Week that the business would take the increased debt in its stride because of its cash flow prospects.

"As a consumer business we have a very good cash flow, so we're expecting - with the growth rates that we are anticipating - to be able to manage that burden," Rogers said.

This would enable the division to "make the choices we want to make around where to play. We are in sectors that are very high growth," Rogers added.

GSK is due to update investors on plans to split into two listed groups, one for pharmaceuticals and vaccines and another for consumer remedies, on June 23.

The consumer group has 10 billion pounds ($14.2 billion) in sales, about 30% of the group total, and as part of the separation slated for next year, GSK has said the unit will take on net debt worth 3.5 to 4 times its annual adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA).

That is up from 2 times for all of GSK currently.

The proceeds from recapitalising the consumer division will be paid out to help GSK's remaining pharmaceuticals and vaccines business cut net debt to a ratio below 2, as well as to Pfizer, which owns 32% of the entity.

Rogers said there was ample room for the consumer health business to grow from its number one position in the industry. Though ahead of Johnson & Johnson <J&J>, Sanofi and Bayer, it only commands a share of about 7% in the global market for over-the-counter remedies and vitamins.

For now, the group will focus on opportunities to grow in its established categories including oral care, pain killers as well as sprays and creams for allergy relief, both organically and via takeovers.

"It's a market that is more fragmented and we believe there is plenty of headroom for growth in the categories that we already play in," Rogers said.

"We are always looking at M&A opportunities but they have to be ones that are going to really align, augment and have a really strong fit with our business," said Rogers.Its vitamins and minerals for preventative healthcare, such as the Centrum brand, have seen a surge in demand during the coronavirus pandemic and Rogers said she expects preventative care to become an enduring trend even as COVID-19 cases drop.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/GSK-consumer-arm-confident-that-growth-cash-flow-will-help-with-debt-35560113/