FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review – FDA.gov

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review – FDA.gov

COVID-19 vaccines and the LGBTQ+ community – Harvard Health Blog – Harvard Health

COVID-19 vaccines and the LGBTQ+ community – Harvard Health Blog – Harvard Health

April 30, 2021

I have a confession: in late 2020, when the first COVID-19 vaccines were approved by the FDA, I was hesitant to get one myself. Despite working in public health and believing strongly in vaccines to keep our community healthy, I was anxious about putting something in my body that seemed so new. I thought: What if the vaccine is dangerous? What about long-term side effects?

I am part of the LGBTQ+ community. Our history may help explain why I hesitated.

In March a New York Times article reported that LGBTQ+ people are more hesitant to get the COVID-19 vaccine. A research study from the Human Rights Campaign reported mixed findings: while LGBTQ+ people overall are more likely to get vaccinated, certain subgroups, such as LGBTQ+ people of color and bisexual women, are less likely to get vaccinated.

LGBTQ+ people have good reason to be hesitant about vaccines. Historically, this population has experienced and continues to experience discrimination in multiple settings, including in healthcare. At the same time, this population is more vulnerable to COVID-19 (see this study and an earlier blog post I wrote). LGBTQ+ people who are also people of color may be even more hesitant to get the COVID-19 vaccine, because of trauma and oppressions based on multiple intersecting marginalized identities that set the stage for mistrust in healthcare and medical research. We can include racism, transphobia, biphobia, and homophobia among such oppressions.

When I was trying to decide whether to get the vaccine, I began reading about the vaccine from trusted sources like the Centers for Disease Control and Prevention (CDC). I also talked to people I know and trust, like close friends, family members, and physician colleagues. I asked them: Will you get the vaccine when its offered to you? All of them gave me a resounding yes! Most shared this rationale: while we still dont know about long-term side effects, this vaccine is similar to other vaccines that have been around for a while, and the benefits of getting vaccinated far outweigh the risks of getting seriously ill or even dying from COVID-19.

When the vaccine was offered to me earlier this year, I booked my appointment immediately, without hesitation, and I havent looked back. As soon as I got the first shot, and certainly when I was fully vaccinated two weeks after my second shot, I felt a profound sense of relief. I also felt empowered about taking an important step toward keeping myself, my family, and my community safe from COVID-19. I now feel safer and freer in my daily life. I go into stores (wearing a mask) without feeling anxious, and I have been able to visit in-person with other fully vaccinated people, like my mom, without masks.

Numerous pandemics have already wiped out large numbers of the LGBTQ+ community: HIV/AIDS, violence, suicide. In addition, the COVID-19 pandemic has already disproportionately harmed LGBTQ+ people (see this study and this report). LGBTQ+ seniors and people of color are at greatest risk for serious, possibly life-threatening illness from COVID-19. If each of us takes steps to get vaccinated, we can prevent more deaths and negative health outcomes in our communities.


Read the original: COVID-19 vaccines and the LGBTQ+ community - Harvard Health Blog - Harvard Health
Covid-19 Vaccine, Variants and Cases: Live Updates – The New York Times

Covid-19 Vaccine, Variants and Cases: Live Updates – The New York Times

April 30, 2021

Heres what you need to know:The Narendra Modi Stadium in Ahmedabad, India, last month.Credit...Danish Siddiqui/Reuters

As plumes of smoke rose from cremation grounds, where bodies were arriving faster than they could be burned, teams of professional cricket players squared off under the lights of a cavernous stadium named for Indias prime minister, Narendra Modi.

The jarring scenes unfolded on Thursday in Ahmedabad, the capital of Mr. Modis home state of Gujarat and a hot spot in Indias spiraling coronavirus outbreak, which is claiming an average of nearly 3,000 lives a day nationwide.

For decades, cricket and its charismatic stars have commanded exalted status in India, where the once-genteel colonial game attracts its biggest and most passionate fan base. Now, public anger is growing at the sports marquee international product, the Indian Premier League, which is playing matches in a bio-bubble without spectators that has drawn criticism for diverting resources from the countrys wider coronavirus fight.

There is a lack of empathy for dead bodies lying in crematoriums surrounding your stadium, said Rahul Verma, a lawyer and die-hard cricket fan who said he had been a devoted follower of the cricket league since it started in 2008. This game, a gentlemans game, never was so grotesque.

India set another global record on Friday with nearly 383,000 new infections, the health ministry reported, pushing the global coronavirus case count to more than 150 million.

In India, with one in five tests coming back positive, experts fear the true toll is much higher. As the U.S. Air Force delivered the first shipments of oxygen cylinders, test kits, masks and other emergency supplies promised to India by the Biden administration, several Indian states said they could not fulfill the governments directive to expand vaccinations to all adults beginning on Saturday because they lacked vaccine doses.

As hospitals face shortages of intensive-care beds, relatives of the sick broadcast desperate pleas on social media for oxygen, medicine and other scarce supplies. Many Indians say they do not know if they are infected with the coronavirus because overwhelmed labs have stopped processing tests.

But one group that seems unaffected is the wealthy and powerful Board of Control for Cricket in India, the regulatory body that oversees the Indian Premier League, which was modeled on soccers Premier League in England and features players from around the world.

The board has kept ambulances fitted with mobile intensive-care beds on standby outside stadiums where matches are being played in case a player falls sick. It is testing players every two days and has created a travel bubble between stadiums in the six states hosting matches, including dedicated airport check-in counters for cricketers.

Meanwhile, some Indians say they cannot cross state lines to find hospital beds for Covid-19 patients.

Hemang Amin, the boards chief operating officer, said in a letter released this week that the health and safety of players and staff members were of paramount importance, and added that the matches, which conclude on May 30, were a needed distraction in a difficult time.

When you all walk out onto the field, you are bringing hope to millions of people who have tuned in, he wrote.

But the leagues safety protocols have only highlighted the gap between its star players who have said little publicly in the face of criticism and the rest of the country.

That ambulance outside that stadium could have saved at least ten lives a day, said Ishan Singh, a cricket fan in Delhi. These players are thieves. Given a chance, they will rob wood from the cremations and sell it in the market.

The New Indian Express, a daily newspaper, said in an editorial this week that it would suspend coverage of the cricket league until a semblance of normalcy is restored in the country.

This is commercialism gone crass, the newspaper wrote. The problem is not with the game but its timing.

The vaccine developed by AstraZeneca and the University of Oxford brought in $275 million in sales from about 68 million doses delivered in the first three months of this year, AstraZeneca reported on Friday.

AstraZeneca disclosed the figure, most of which came from sales in Europe, as it reported its first-quarter financial results. It offers the clearest view to date of how much money is being brought in by one of the leading Covid vaccines.

AstraZeneca, which has pledged not to profit on its vaccine during the pandemic, has been selling the shot to governments for several dollars per dose, less expensive than the other leading vaccines. The vaccine has won authorization in at least 78 countries since December but is not approved for use in the United States.

The vaccine represented just under 4 percent of AstraZenecas revenue for the quarter; it was nowhere near the companys biggest revenue generator. By comparison, the companys best-selling product, the cancer drug Tagrisso, brought in more than $1.1 billion in sales in the quarter.

AstraZeneca has said it is planning to seek emergency authorization for its vaccine to be used in the United States, even as it has become clear that the doses are not needed. The Biden administration said this week that it would make available to the rest of the world up to 60 million doses of its supply of AstraZeneca shots, pending a review of their quality.

If the company does win authorization from the U.S. Food and Drug Administration, it could help shore up confidence in a vaccine whose reputation been hit by concerns about a rare but serious side effect involving blood clotting. The F.D.A.s evaluation process is considered the gold standard globally.

Johnson & Johnson, whose vaccine was authorized for emergency use at the end of February, reported last week that its vaccine generated $100 million in sales in the United States in the first three months of the year. The federal government is paying the company $10 a dose. Like AstraZeneca, Johnson & Johnson has pledged to sell its vaccine at cost meaning it wont profit on the sales during the pandemic.

Vaccines from Pfizer and Moderna cost more, and neither company has said that it will forego profits. Pfizer has said that it expects its vaccine to bring in about $15 billion in revenue this year; Moderna said it anticipates $18.4 billion in sales.

Both companies are scheduled to report their first-quarter results next week.

Executives of Emergent BioSolutions, the vaccine manufacturer that was forced to discard up to 15 million doses because of possible contamination, reported a shake-up in leadership on Thursday and offered the most fulsome defense yet of the companys performance.

While announcing the high-level personnel changes and taking responsibility for the ruined doses, executives nonetheless forecast record revenues this year of nearly $2 billion.

Robert Kramer, the chief executive, speaking on a call with investors, said that one senior vice president overseeing manufacturing would depart the company while another executive would go on leave. A third official, Mary Oates, who recently joined Emergent after a long tenure at Pfizer, is now leading the companys response to a recent federal inspection that found serious flaws at the Baltimore facility that produced the vaccines.

The call on Thursday came at a tumultuous time for Emergent, a once-obscure federal contractor that has built a lucrative business selling biodefense products to the government. Production at the companys Baltimore plant was suspended this month after the discovery that workers had potentially contaminated millions of doses of the Johnson & Johnson vaccine.

Addressing these setbacks, Mr. Kramer offered a vigorous defense of the company on Thursday.

He took full responsibility for the manufacturing problems, acknowledging that the loss of a batch for a viral contamination is extremely serious, and we treated it as such, but he also said that Emergent had taken on a herculean task in a crisis.

GREENVILLE, TENN. This community and its surroundings in northern Tennessee are rural, overwhelmingly Republican, deeply Christian and 95 percent white. Polls show that resistance to the vaccine is most entrenched in such areas.

While campaigns aimed at convincing Black and Latino urban communities to set aside their vaccine mistrust have made striking gains, towns like Greenville will also have to be convinced, if the country is to achieve widespread immunity.

But a week here in Greene County reveals a more nuanced, layered hesitancy than surveys suggest. People say that politics isnt the leading driver of their vaccine attitudes. The most common reason for their apprehension is fear that the vaccine was developed in haste, that long-term side effects are unknown. Their decisions are also entangled in a web of views about bodily autonomy, science and authority, plus a powerful regional, somewhat romanticized self-image: We dont like outsiders messing in our business.

Still, conversations here show that for many people, resistance is not firm. Roiled by internet fallacies, many hunger for straightforward information from people they trust. Others have practical needs, like paid time off to recover from side effects, which the Biden administration has urged employers to offer, or the opportunity to get the shot from their own doctor.

GLOBAL ROUNDUP

Thousands of people letting loose on a nightclub dance floor. Hundreds of suited-up people gathering for a business conference. And none of them wearing masks.

As Britain slowly emerges from a lengthy lockdown, a flashback to life before the pandemic is taking place in Liverpool as part of a series of government-led experiments.

Liverpool on Wednesday hosted Britains first business conference since March 2020 and the northwestern English city will on Friday kick off a two-day nightclub event, the first in Britain in more than a year, and an outdoor music festival will take place on Sunday.

The events are part of a British government research project to see how mass gatherings can happen safely. Participants are asked to take a coronavirus test before events and are required to produce a negative result. Once they are inside the venues, social distancing and face coverings are not required.

The pilot events are taking place across England this month and next month, closely monitored by the health authorities. Some sports competitions with audiences have already been part of the program and thousands of people will gather in London next month for the Brit Awards music show, and soccers F.A. Cup final.

Every attendee will be asked to undergo a virus test after the event and the research gathered will shape the governments policy on bringing back large events.

England has set a provisional date of June 21 for all of its virus restrictions to be dropped, including those on mass gatherings, and scientists are hoping that the events that they are monitoring will provide insights into how to reduce the risk of the virus spreading.

Britain has in recent days reported its lowest number of infections since September and has given a first dose of a coronavirus vaccine to more than half its population.

In other updates from around the world:

Authorities at tollbooths and ports in Greece on Friday have turned back hundreds of people attempting to defy virus restrictions on travel between regions ahead of Orthodox Easter, the most important date in the religious calendar. Although cases have stabilized in recent weeks, deaths and hospitalizations remain high. Greece has gradually lifted restrictions in recent weeks, including ending quarantine requirements for visitors from dozens of countries, as it prepares to fully reopen its tourism sector next month.

While Spain is expected to lift its nationwide state of emergency on May 9, allowing for the return of tourists in June, some regional administrations are preparing to extend their own lockdown measures for longer. Cases are down, and more people are getting vaccinated. Reopening tourism is key to the economy, which contracted in the first quarter, the government said on Friday. Tourism arrivals dropped to 19 million last year, after seven years of growth, from 84 million in 2019.

In Portugal, Prime Minister Antnio Costa announced late Thursday that the countrys only land border with Spain would reopen on Saturday, having remained shut since January. Portugal is also fast-tracking the removal of lockdown restrictions after reducing significantly its coronavirus infection rate.

Raphael Minder and Niki Kitsantonis contributed reporting.

Before the pandemic, Googles sprawling campus of airy, open offices and whimsical common spaces set a standard for what an innovative workplace was supposed to look like.

Now, the company is creating a workplace for the Covid era, with a concept perhaps best described as Ikea meets Lego.

Instead of rows of desks next to cookie-cutter meeting rooms, Google is designing Team Pods. Chairs, desks, whiteboards and storage units on casters can be wheeled into various arrangements, and in some cases rearranged in a matter of hours. It is building outdoor work areas to respond to concerns about the coronavirus.

At its Silicon Valley headquarters, it has converted a parking lot and lawn area into a camp, with clusters of tables and chairs under open-air tents. The area is a fenced-in mix of grass and wooden deck flooring about the size of four tennis courts with Wi-Fi throughout.

David Radcliffe, Googles vice president for real estate and workplace services, said that while moving more than 100,000 employees to virtual work last year was daunting, now it seems even more daunting to figure out how to bring them back safely.

With vaccinations mounting in some of the worlds wealthiest countries and people envisioning life after the pandemic, the crisis in Latin America is taking an alarming turn for the worse, potentially threatening the progress made well beyond its borders.

Last week, Latin America accounted for 35 percent of all coronavirus deaths in the world, despite having just 8 percent of the global population, according to data compiled by The New York Times.

The length of the regions epidemic makes it even harder to fight. It has already endured some of the strictest lockdowns, longest schools closures and largest economic contractions in the world.

And if Latin America fails to contain the virus or if the world fails to step in to help it new, more dangerous variants may emerge, said Dr. Jarbas Barbosa of the Pan-American Health Organization.

This could cost us all that the world is doing to fight the pandemic, he said.

After being closed for more than a year, Disneyland reopens on Friday to California residents only. Travel advisers around the country said tickets sold out quickly, and people have been waiting online for hours to get a reservation to the Anaheim, Calif., theme park.

As more people across the United States are vaccinated and as summer approaches, theme park bookings are picking up, even though children are still not eligible for coronavirus vaccines. Greg Antonelle, the chief executive of MickeyTravels, a travel agency that helps plan Disney trips, said that if bookings keep up at the current pace, this will be the companys strongest year.

Walt Disney World in Orlando, Fla., opened in July and is operating at 35 percent capacity. At Disneyland, capacity is now capped at 25 percent, and officials have not said when restrictions would be eased or bookings would be opened to out-of-state visitors.

Getting in requires both a ticket and a reservation to the park. Park rules state that masks must be worn at all times, except when swimming or eating, even by those who have been vaccinated. The parades, fireworks, and nighttime spectaculars that are typical of the Disney park experience are still suspended, and character interactions are socially distanced.

But for Bethany Millar, an administrator at a medical school in St. Louis who visited Walt Disney World in April, it was worth it: Disneys staff did everything in their power to make you feel like you were having a safe Covid experience, she said.

A daughter holding her mothers hand. A son overcome that his 95-year-old mother had survived the pandemic. A stoic family patriarch, suddenly in tears.

After a year of excruciating lockdowns, these were the scenes at nursing homes and other long-term care facilities as they began to open up this spring. Before the arrival of vaccines, one in three coronavirus deaths in the United States had ties to nursing homes or similar facilities.

The New York Times sent photographers across the country to document reunions. For many family members, it was the first time they were able to be together, hold hands and hug in more than a year.

In interviews, which have been edited and condensed for clarity, families recalled a deep fear that they would never see their loved ones again. When the time finally came, they were flooded with a years worth of emotion in a single instant: joy, relief, love and grief for all the time that had been lost.

Con Yan Muy, 93, has been a resident at the San Francisco Campus for Jewish Living nursing home since 2019. Anita Li, 24, grew up with her grandmother and previously visited daily. For a year during the pandemic, she saw her grandmother only a handful of times through a window or at a distance. Even now, her visits remain limited, as is the case at many facilities.

ANITA LI: I was hiding in the bathroom when she came in. It was a surprise. She didnt recognize me initially because I had my mask on. I am going to be honest, I was kind of sad. I am one of the most involved persons in her life, and she couldnt recognize me. I immediately just started patting her legs and her arms for better blood circulation. I had brought some dumplings and also brought her some sesame balls that she really enjoys. We made a video for the rest of the family for her to say hi.

Its like a sigh of relief that we could finally be together, but also knowing that this was a one-time thing, and not really sure what the future holds. Am I going to see her every week face to face? Can I eventually take her out on walks where she can get some sun? What is the new normal, and how much can we be involved in her life postquarantine?


See original here:
Covid-19 Vaccine, Variants and Cases: Live Updates - The New York Times
US officials: Anxiety drove COVID-19 vaccine reactions in 5 states – KHOU.com
Michigan unveils reopening plan tied to COVID-19 vaccination rates – ABC News

Michigan unveils reopening plan tied to COVID-19 vaccination rates – ABC News

April 30, 2021

Michigan Gov. Gretchen Whitmer unveiled a reopening plan Thursday that will tie loosened restrictions to COVID-19 vaccination rate milestones, as the state starts to emerge from a surge in cases and hospitalizations.

So far, nearly half of residents ages 16 and up have gotten their first shots and about 36% are fully vaccinated, said the governor, whose goal is to reach 70% of the population fully vaccinated to near herd immunity.

Michigan will likely reach 55% of residents ages 16 and up receiving a first dose by the end of next week, Whitmer said. Two weeks after it hits that benchmark, under the new plan, in-person work for all businesses will be allowed.

Two weeks after 60% have gotten their first dose, sports stadiums and banquet halls can increase capacity to 25%, gyms can go up to 50% and an 11 p.m. curfew on indoor dining will be lifted.

Two weeks after hitting 65%, all indoor capacity limits will be lifted, and two weeks after reaching 70% -- about 5.6 million residents ages 16 and up -- the state's order on masks and gatherings will end.

"The vaccine remains the most effective way to protect you and your family from COVID and help us all return to normal sooner," Whitmer said at a press briefing Thursday. "We can all see the light at the end of the tunnel. ... But I want to remind you, we're still in the tunnel, and we have a lot of work to do."

Michigan had previously resisted tying its reopening to certain metrics, but now considers vaccines the "best tool that we have to get back to normal," the governor said.

"This is a creative way of challenging us to rise to this moment and to meet it," Whitmer said.

Second-year Michigan State University graduate student Genevieve Gottardo gets her Pfizer COVID-19 vaccination shot on April 14, 2021, at the student vaccination clinic at the MSU Pavilion in East Lansing, Mich.

She said it's a "real possibility" that Michigan could have normal gatherings by the Fourth of July, a goal previously stated by President Joe Biden.

The vaccination plan was welcomed by several Michigan business associations, including the Michigan Restaurant & Lodging Association.

"We applaud the governor for implementing what the MRLA has been requesting for months -- a metric driven plan that offers incentives rather than mandates to drive better outcomes and more opportunity for the imperiled hospitality industry," Justin Winslow, president of the association, said in a statement.

Dr. Ashish K. Jha, dean of the Brown School of Public Health, called the plan a "really innovative, smart strategy to tie loosening of public health restrictions to vaccination rates in Michigan."

"[Let's] hope this motivates folks to get the shot," he said on Twitter.

The vaccination plan comes as Michigan is starting to turn the corner on a surge in cases and hospitalizations, particularly among young adults. Health experts attributed the surge to the spread of more transmissible variants and a lack of mask and social distancing compliance.

A group of people walk wearing protective masks head to a restaurant as COVID-19 restrictions are eased in Ann Arbor, Mich., on April 4, 2021.

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said earlier this month that Michigan couldn't vaccinate its way out of its COVID-19 surge and needed to "close things down."

Other medical experts argued that vaccine supply should be ramped up to COVID-19 hotspots.

Michigan didn't issue any new restrictions, though Whitmer advised residents to avoid indoor dining and recommended a two-week pause on in-person learning for high schools and sports activities.

"Our seven-day case averages, hospitalizations and ICU numbers are all coming down," Whitmer said Thursday. "While the daily case count, test positivity and hospitalization numbers are still not where we want them to be, we're headed in the right direction."

The Michigan health department's latest weekly report, released Tuesday, showed that in the past week, new COVID-19 cases decreased 14%, COVID-19 hospitalizations dropped 16% and the testing positivity rate was down 14%. Still, the state has the highest seven-day case rate per 100,000 in the country, according to the CDC.


Originally posted here: Michigan unveils reopening plan tied to COVID-19 vaccination rates - ABC News
Hackers are attacking the COVID-19 vaccine supply chain – CBS News

Hackers are attacking the COVID-19 vaccine supply chain – CBS News

April 30, 2021

Hackers have targeted companies that distribute the COVID-19 vaccine to a degree previously unreported, according to research from IBM Security.

Starting last year, attackers attempted to access sensitive information about the vaccine's "cold chain" distribution system. IBM Security said the phishing attack targeted 44 companies in 14 countries across Europe, North America, South America and Asia.It is unclear if the hackers were successful in breaching systems. The hacking victims include high-ranking executives at a petrochemical firm, a solar energy manufacturer, several IT companies and a department at the European Commission.

The cyberattack was first discovered in late 2020. Researchers initially believed the hacking campaign targeted theGAVI alliance, a coalition of governments and companies that help developing countries distribute vaccines. At the time, it was unclear if the campaign was successful, according to IBM's global lead for threat intelligence, Nick Rossmann.

But the new IBM research shows the operation's scope was larger than previously thought, requiring significant "premeditated planning," Rossmann said. "This was a very well-calibrated, complex and precise campaign."

Although his team cannot conclusively attribute the cyberattack to a particular actor, Rossmann said "this operation has the hallmarks of nation-state activity. We're dealing with an adversary [that] has an acute understanding of [the vaccine] supply chain."

The ability to disrupt or destroy vaccine supplies amount to a form of saber-rattling, Rossmann said.

"We're far from over the COVID-19 crisis, and while the U.S. has turned the corner with its vaccination progress, many other countries continue to face significant challenges. As countries struggle to get access to vaccines, this type of adversarial activity illustrates a race for influence over the vaccine market," he said.

A range of health care firms were major targets of the hacking scheme. That includes biomedical research organizations, medical equipment manufacturers; pharmaceutical firms, surgical material makers, immunology experts and pharmacies distributing COVID-19 rapid tests.

Logistics and transportation were also heavily targeted in the cyberattack, including eight companies in the automotive, aviation, maritime and transport services sectors across Italy, Korea, Japan, Colombia and the U.S.

"Logistics firms are a particularly ripe target," Rossmann said. "They are moving the vaccine in different places around the world. You can imagine that a refrigeration company probably doesn't have the same security as one of the largest banks in the world."

This hacking group was capable of surreptitiously mining large amounts of data about how the vaccine is shipped, or even shutting down the company's operational systems. "Potentially [hackers] could spoil the vaccine batches that they have in refrigeration units," he said.

The attack was carried out in multiple stages. The hackers used highly customized spear-phishing emails to target companies in the cold chain. Phishing hacks are emails or text messages that appear to be sent from a legitimate source and are intended to steal a victim's username and password. Most phishing attacks, like spam, are imprecise and sent to thousands of recipients.

The cold chain hackers devised a clever cover story: They impersonated an employee of Haier Biomedical, one of the world's most respected cold chain providers and a client of one of the first targets.

Those targets were CEOs, product managers, sales managers and finance executives who anticipated an email requesting approval. The phishing message they received was so well-crafted that at least some of its recipients fell for the scam, Rossman said.

"The quote generally looked very good! And when you clicked on this email, a PDF popped up with a, 'Hey, can you please write your username, your password,' not typical for a PDF you would get from a supplier," Rossmann said.

Once inside the network, the hackers were able to steal important credential information, move to other parts of the network and send additional phishing messages by posing as executives from the company.

Harvested credentials are also often used to gain future unauthorized access to corporate networks and sensitive information. Researchers eventually discovered an additional 50 similar messages targeting the cold chain companies.

COVID-19 presented a huge opportunity for a wide spectrum of cybercriminals and malicious actors. The Department of Health and Human Services last month issued a phishing alert, warning: "Fraudsters are offering COVID-19 tests, HHS grants, and Medicare prescription cards in exchange for personal details, including Medicare information."

Email scams in particular are surging, according to the cyber defense firm Barracuda. A Verizon report last year found that phishing was responsible for almost 70% of data breaches.

"Cold chain companies are a piece of critical infrastructure and they're under attack," Rossmann said, noting that damaging these firms poses a major risk to public safety and national security.

The hackers' attempt to disrupt or destroy vaccine supplies was likely intended to undermine trust in the treatments, he said. If even a small percentage of COVID-19 vaccine doses were damaged, it could weaken trust in the entire system.

"This threat is very real, and our goal is to make sure anyone involved in any aspect of the supply chain is on high alert," Rossman said. "In the United States, Canada and Europe, where there is already doubt [about vaccine safety], sowing mistrust is a part of the arsenal of what some of these adversaries do."


Original post:
Hackers are attacking the COVID-19 vaccine supply chain - CBS News
Dallas mayor will host pop-up COVID-19 vaccination events starting Friday – The Dallas Morning News

Dallas mayor will host pop-up COVID-19 vaccination events starting Friday – The Dallas Morning News

April 30, 2021

In the latest effort to increase COVID-19 vaccine access in underserved communities, Dallas Mayor Eric Johnson is partnering with private providers to distribute doses.

Johnson announced the creation of the Neighborhood Vaccine Initiative Thursday. The initiative, which is separate from the city of Dallas efforts, will kick off with three upcoming pop-up vaccination events across Southern and West Dallas.

Johnson and the Caring Foundation of Texas will co-host the first event Friday at the Bishop Arts Theatre Center, 215 S. Tyler St., starting at 10 a.m.

The second will be Saturday at Pinkston High School, 2200 Dennison St., at 10 a.m. The third will be Tuesday at the Jubilee Park Community Center, 907 Bank St., at 1 p.m.

This is not the first time Johnson and the organization have worked together the two partnered to co-host a vaccination clinic at South Oak Cliff High School earlier in April.

It has never been easier to get a COVID-19 vaccine in Dallas, Johnson said in a press release. But we are still working hard to eliminate all remaining barriers to receiving these lifesaving vaccines.

Johnson said Dallas residents should get vaccinated when they have the opportunity to help the city reach herd immunity and end the pandemic.

People who would like to attend one of the pop-up vaccine events can register online. Find registration information about the Jubilee Park clinic here and the Pinkston event here.


See the original post: Dallas mayor will host pop-up COVID-19 vaccination events starting Friday - The Dallas Morning News
It’s time to start shunning the ‘vaccine hesitant.’ They’re blocking COVID herd immunity. – USA TODAY

It’s time to start shunning the ‘vaccine hesitant.’ They’re blocking COVID herd immunity. – USA TODAY

April 30, 2021

Michael J. Stern, Opinion columnist Published 4:00 a.m. ET April 30, 2021

Enough analysis of these human petri dishes. Everyone who wants a vaccine will soon have one, and proof should be required to work, play and travel.

Has-been rock star Ted Nugent told the world last week that he has COVID-19. Nugents announcement was an oddity because he previously called the viral pandemic a leftist scam to destroy former president Donald Trump.As I watched Nugents Facebook Live post, in which he repeatedly hocked up wads of phlegm and spit them to the ground, I got emotional when he described being so sick he thought he was dying. But when hetrashed the COVID-19 vaccine and warned people against taking it, I realized that the emotion I was feeling was not empathy, it was anger.

For the better part of a year, as the coronavirus racked up hundreds of thousands of American deaths, the flickering light at the end of the tunnel was herd immunity the antibody force-shield that comes when enough people have survived the illness or have been vaccinated against it. "Go get vaccinated, America," President Biden said inhis speech to Congress this week, referring to the shot as"a dose of hope.

Anthony Fauci, the nations top infectious disease doctor, suggested in December that if 75% to 85% of the population got vaccinated, we could reach herd immunity by June. And with herd immunity, wed return to a measure of normalcy, meaning indoor dining, movie theatersand hugs.

But herd immunity is slipping away because a quarter of Americans are refusing to get the COVID-19 vaccine.Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group recently said: There is no eradication at this point, its off the table. We as a society have rejectedherd immunity. Hmm, no! We have not rejected anything. A quarter ofthe country is ruining it for all of us.

Its not just wacky former rockers who have put herd immunity out of reach. It is white evangelicals(45% say they won'tget vaccinated).And it is Republicans (almost 50%are refusing the vaccine). In Texas, 59% of white Republicans have said no to the vaccine.You can slap the euphemism vaccine hesitancy on the problem, but in the end the G.O.P., and the children of G.O.D., are perpetuating a virus that is sickening and killing people in droves.

A big part of the problem stems from the cultish relationship many evangelicals and Republicans have with former President Donald Trump.Theyabsorbed his endless efforts to downplaythe danger of the virus and turn public health precautions into a political freedom movement. But the time for analyzing why these human petri dishes have chosen to ignore the medical science that could save them, and us, is over.We need a different strategy.I propose shunning.

COVID-19 vaccination site on April 27, 2021, in Los Angeles.(Photo: Frederic J. Brown/AFP via Getty Images)

Bidens wildly successful vaccine rollout means that soon everyone who wants a vaccine will have one.When that happens, restaurants, movie theaters, gyms, barbers, airlinesand Ubers should require proof of vaccination before providing their services.

And it shouldnt stop there.Businesses should make vaccination a requirement for employment.A COVIDoutbreak can shut down a business and be financially devastating.And failure to enforce basic health and safety measures is not fair to employees who have to work in offices, factories, and stores where close contact is required.Things should get personal, too:People should require friends to be vaccinated to attend thebarbeques and birthday parties they host.Friends dont let friends spread COVID.

Pro-life party: Where are the Republican COVID-19 heroes willing to risk their careers to save lives?

As Im writing this I can almost see the Twitter rebuttals:If peoplewant to risk being microchipped by the deep state, they can protect themselves by getting a vaccine without making me do the same. Nope.In its real life application, the vaccine is about 90% effective.Sure, thats impressive, but if the roulette wheels makes you one of the unlucky 10%, its little consolation.

There have already been several thousand documented breakthrough cases of COVID-19 infections in people who have been vaccinated.Some have died.And with coronavirus variants popping up across the globe, for which the vaccine is less effective, we should expect to see more infections in vaccinated people.

Unwilling to miss an opportunity to flout common sense, Republican leaders from Florida,Pennsylvania, Wisconsin, Arkansas and other states want toprevent businesses from requiring customers to be vaccinated.Florida Gov.Ron DeSantis has already issued an executive order prohibiting businesses from requiring patrons or customers to show vaccine documentation.

There are decades of state laws that require vaccination before children can attend schools.There are seatbelt and helmet laws, no-texting-while-drivinglaws, and countless other laws that restrict individual freedoms to ensure safety for the public at large.Despite this, vaccine requirements designed to curb a global pandemic that has cost us more than 570,000 American lives is the hill on which Republicans want to die.

Are we about to hit a vaccine wall?If you have doubts about getting the COVIDshot, reconsider.

When states pass these laws, designed to tell private companies how to run their businesses, there should be immediate legal challenges.Surely, if a bakery can refuse to provide its services to a gay couple getting married, they can refuse to bake a cake for people who choose to place themselves, the bakery staffand its customers at risk of contracting a deadly illness.

As a country, America has become too tolerant of half-witted individual autonomy that ignores the existential needs of the vast majority of its citizens.While writing this column I caught a TV promo for a new documentary in which Cher saves an elephant.It made me think of her performance in "Moonstruck." Vaccine hesitancy? We need Cher to slap us in the face and tell us to snap out of it.

Michael J. Stern, a member of USA TODAY's Board of Contributors,was a federal prosecutor for 25 years in Detroit and Los Angeles. Follow him on Twitter: @MichaelJStern1

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It's time to start shunning the 'vaccine hesitant.' They're blocking COVID herd immunity. - USA TODAY
The latest on Covid-19 and India’s worsening crisis: Live updates – CNN

The latest on Covid-19 and India’s worsening crisis: Live updates – CNN

April 30, 2021

Indian Prime Minister Narendra Modi called for people to continue to come out "in line with Covid-19 protocols" and vote during the last phase of West Bengal state elections.

Modi and hisBharatiya Janata Party(BJP) have come under fire for holding several rallies ahead of the elections in West Bengal, with thousands in attendance and failing to abide by social distancing guidelines.

Critics have accused the BJP of putting politics before public health. India is now facing a massive new wave of Covid-19 cases across the country and nationwide shortages of oxygen.

On April 22, the Election Commission of India tightened restrictions for the remaining phases of the West Bengal state assembly elections, banning road shows, vehicle rallies and large public meetings with more than 500 people after finding political parties and candidates were flouting Covid-19 guidelines.

However, political parties including the BJP continued to hold rallies throughout the week, even as India continued to record more than 300,000 cases per day.

Thursday is the last day of voting in West Bengal. The polls opened around7 a.m. local time (9:30p ET) and are expected to close at 6:30 p.m. local (9a ET).

Southern Tamil Nadu and Kerala states, West Bengal and Assam states in the east and the union territory of Puducherry went to the polls on March 27, with voting taking place across eight phases and ending on April 29. All votes are to be counted on May 2, with the results announced on the same day, though Indias Election Commission has banned victory procession.

On Thursday, the Election Commission also issued guidelines ordering all polling officials and candidates to provide negative Covid-19 test reports or to have had both doses of Covid-19 vaccine ahead of May 2.


See the article here: The latest on Covid-19 and India's worsening crisis: Live updates - CNN
(4) UK says it doesn’t have excess Covid-19 vaccine doses to send to India, but is providing them at cost – CNN International

(4) UK says it doesn’t have excess Covid-19 vaccine doses to send to India, but is providing them at cost – CNN International

April 30, 2021

The British health minister has said that the UK does not currently have any excess doses to send to India -- currently home to the world's worst coronavirus outbreak -- despite the country's ongoing vaccination rollout that has successfully vaccinated its priority groups and is now targeting younger ages.

In spite of mounting calls for rich nations to equitably distribute their surplus vaccines, Hancock said that they are providing India with the Oxford/AstraZeneca vaccine at cost and are also working closely with the Serum Institute of India (SII).

The SII are making and producing more doses of vaccine than any other single organization. And obviously that means that they can provide vaccine to people in India at cost, Hancock said.

We're leaning in, both on what we can provide and the material goods we can provide now like ventilators that we thankfully don't need any more here, he said.

India is in throes of a deadly second wave of the coronavirus which has seen cases surge above 300,000 for eight consecutive days, and a death toll that has surpassed 200,000 -- after the country reported 3,293 deaths on Wednesday.

Hancock's comments on vaccine exports come as a recent Ipsos MORI survey found that many people in the UK are keen to send vaccines to India.

The survey, which polled 1,016 adults aged 16-75 on Tuesday, found:

Over 33.9 million people in the UK have already received a first dose of a Covid-19 vaccine, with over 13.5 million now fully vaccinated, according to the latest government data.

On Wednesday, the UK Foreign and Commonwealth Office (FCO) announced that said it will be sending three oxygen factories to India, saying in a statement that the three oxygen generation units each the size of a shipping container - would be sent from surplus stock from Northern Ireland and would produce 500 litres of oxygen per minute each, which is enough for 50 people to use at a time.

The UK had already committed to providing India with 495 oxygen concentrators and 200 ventilators sent from surplus stock, the first batch of which arrived in India on Tuesday, the FCO statement said.

International collaboration is more essential than ever, and this additional UK support package will help meet Indias current needs, particularly for more oxygen, Foreign Secretary Dominic Raab said in a statement.

The FCO statement comes as the aid sector has heavily criticized the UK's plan to cut 85% of the aid it has pledged to the United Nations familyplanning program.

A top UN official on Wednesday called the move"devastating for women and girls and their families across the world."

"When funding stops, women and girls suffer, especially the poor, those living in remote, underserved communities and those living through humanitarian crises," Natalia Kanem head of the UNs sexual and reproductive health agency, said Wednesday in a statement.

This means that the UK's expected contribution of 154 million (approximately US $211 million) will be reduced to around 23 million (US$32 million).

Speaking about the cuts, Raab said it was part of the Foreign Offices efforts to ensure maximum strategic coherence, impact and value for taxpayers money.

Last year, the UK also garnered criticism from the humanitarian sector when it reduced its aid spending from 0.7% of the national income to 0.5%.


Originally posted here:
(4) UK says it doesn't have excess Covid-19 vaccine doses to send to India, but is providing them at cost - CNN International
Future COVID-19 vaccines might not have to be kept so cold – National Geographic

Future COVID-19 vaccines might not have to be kept so cold – National Geographic

April 30, 2021

The action was innocent: While cleaning the Veterans Affairs hospital in Boston this past January, a contractor knocked a loose freezer plug from its socket. This simple mistake resulted in the loss of nearly 2,000 doses of Moderna's COVID-19 vaccine that had been chilling inside the unplugged appliance. While that's a small hit on the grand scale of worldwide vaccination, it's emblematic of a much larger issue for many COVID-19 vaccines; they have to be kept frozen.

Two of the major coronavirus shots authorized for emergency use in the United Statesthe Moderna and the Pfizer/BioNTech vaccinesrely on a costly series of temperature-controlled shipments and storage, known as the cold chain, to get vaccines from manufacturers to muscle injection. Such stringent temperature requirements also pose an obstacle for equitable vaccine distribution, increasing the cost and difficulty of shipments and cutting off access to remote communities without reliable electricity or refrigeration.

The reason for these frigid conditions is that the key vaccine ingredienta molecule called messenger RNA (mRNA)is extremely fragile and storage at cold temperatures slows down the chemical reactions that can tear it apart. But promising efforts to reduce this frosty burden are already in the worksfrom tinkering with the mRNA structure to shipping the vaccine in solid form with a sugary protectant.

Such efforts are not just important for halting the current pandemic. Scientists see promise in mRNA vaccines for treating a wide variety of other diseases, since they can be readily tweaked for different viral variants as well as rapidly developed for new viruses.

"All those steps that are taken now will be really important in the coming years," says Rein Verbeke, a pharmaceutical scientist specializing in mRNA vaccines at Ghent University in Belgium.

The necessity for cold storage lies at the heart of how these vaccines work, which is mRNA. These strands of genetic code in the COVID-19 vaccine carry instructions that the human cell uses to manufacture the characteristic spike protein, which sits on the surface of SARS-CoV-2. This preview of the protein familiarizes the body's immune system with the virus so that it can recognize and fight future coronavirus invaders.

Messenger RNAis similar to a single strand of DNA, but its backbone carries one crucial difference: an additional chemical group made up of oxygen and hydrogen, known as hydroxyl.

If the RNA strand bends in just the right way, this hydroxyl group can interact with another part of the backbone sparking a reaction that severs the genetic chain, explains Hannah Wayment-Steele, a PhD student studying RNA structure at Stanford University.

"It cuts the message off," she says. And these shortened messages cannot build a complete protein. "Only one cut in your mRNA strand can be enough to lose your function," says Verbeke, the pharmaceutical scientist.

To slow degradation, companies keep the vaccines at low temperatures. The lower the temperatures, the slower the molecular movementsand the lower the chance of damaging reactions, Verbeke explains. The Pfizer/BioNtech vaccine must be shipped at temperatures colder than nearly 80 degrees below zero. It can be stored for up to two weeks in a standard freezer, up to five days in a fridge, and only six hours at room temperature. Moderna's vaccine is slightly more forgiving. It is stable for up to six months in a standard freezer, up to 30 days if refrigerated, and 12 hours at room temperature.

Vaccine storage is further complicated by another key component: fat. In both the Pfizer/BioNTech and Moderna vaccines the mRNA is encased in fat bubbles known as lipid nanoparticles. They serve as a delivery vehicle to shuttle the mRNA into cells where the cellular machinery can get to work producing the encoded spike protein.

Lipid nanoparticles also help with mRNA stability by shielding it from RNA-degrading enzymes that are abundant both within our bodies and throughout the environment. Yet over time, the lipid nanoparticles themselves can degrade or aggregate, and for a vaccine to work the structure of both fats and mRNA must be injected intact. "It's a difficult thing to accomplish," Verbeke says.

Some natural forms of RNA can survive within our bodies for more than 12 hours, says Rhiju Das, a computational biochemist at Stanford University. "They're these proofs of concept that the RNA should be able to last longer than it does in those vaccines," he says. And one thing these robust RNA molecules have in common are intricate structures that constrict the strand and prevent it from bending in a way in which it can cut itself in two.

"Industry folks had tried using a lot of other things," Das says. They tried tweaking the lipid formulas. They shifted the acidity of solutions. "They couldn't find a way to solve it," he says. But one avenue that was largely unexplored was these intricate folded RNA structures.

This is a potentially useful strategy for vaccine development because multiple mRNA sequences can code for the same proteinand each crumples up in a different way. So if scientists can identify the sequence that folds into the most stable shape, they can produce a vaccine with less stringent temperature requirements for shipping and storage.

The trick, however, is identifying the best genetic origami. "You have these astronomical numbers of possible sequences," says Wayment-Steele, which leads to whole galaxies of structures that a molecule could take. To narrow the possibilities, Wayment-Steele and her colleagues turned to an online game known as Eterna, which harnesses the power of crowds to assist in RNA design through puzzles.

Das and his colleague Adrien Treuille of Carnegie Mellon developed the game about a decade ago when they kept running into problems that AI couldn't solve. "Almost out of desperation we decided to try this sort of crowdsourcing approach," says Das, who is Wayment-Steele's graduate advisor. "Eternas ended up solving hard problem after hard problem."

Eterna users switch out units of the genetic code, called bases, and the game predicts the folded shape and estimates its stability. "Sometimes it will cause the whole [mRNA] structure to change by changing just that one base," says Amy Barish, a retired chemist and an Eterna player in Cumming, GA. The scientists then work with the players to develop AI, using their structures as examples to train a computer to predict the most stable RNA forms.

Through their work with Eterna players, the team developed a series of mRNA sequences that encode for the spike protein of SARS-CoV-2 variants B.1.351, P.1, and B.1.1.7, first identified in South Africa, Brazil, and the United Kingdom, respectively, that are potentially twice as stable as conventionally designed sequences. They are freely available online for vaccine developers, Das notes.

"Its just great that we can work on this fun, challenging game but yet were potentially helping the world," says Barish, who worked on some of the spike protein puzzles.

Much more work is required, however, before these so-called superfolder mRNAs can be injected into arms. One previous concern is that their structure would hinder cellular machinery, known as ribosomes, from reading and translating the mRNA instructions into proteins, explains Maria Barna, a geneticist at Stanford University. She teamed up with Das' lab to test superfolders translation using mRNA that codes for a set of easily analyzed proteins, including one that fluoresces green. They were surprised and delighted to find that ribosomes could not only unwind the superfolder structures to produce lots of protein, but the superfolders actually generated more protein than the less stable RNA structures.

"These superfolder mRNAs are not just a dream, they can actually work, and they work wellmore than we would have expected," Barna says.

Exactly how this will translate to COVID-19 vaccine stability remains uncertain, but Barna says they hope to produce vaccines that can be stored at room temperature for weeks at a time, if not longer. The team is now collaborating with a pharmaceutical company to test the superfolder spike protein structures in real world applications.

Another possibility for stabilizing the vaccines is drying or freeze drying so they can be stored at room temperature in solid form. But removing the water while keeping the RNA structure intact is no small feat. As the liquid freezes, the crystallizing ice can crush the molecule while whisking away water that can lead to structural collapse.

One way to avoid this damage is through the addition of sugar. Carlos Filipe, chemical engineer at McMaster University, and his colleagues have been testing sugary recipes for drying vaccines, and their current formulation relies on two different types of sugartrehalose and pullulan.

Trehalose helps fill the voids in the molecule as the water dries away, acting like scaffolding to prop up the structure. The sugar pullulan, which is the base of Listerine strips, encapsulates the molecule to keep it from twisting, which prevents the backbone from cutting itself apart.

"Its like Hans Solo when he was in the carbonite," says Filippe, posing frozen like the fictional Star Wars character with his hands held up, mouth agape.

Before the COVID-19 pandemic the team demonstrated the efficacy of this sugar treatment to dry out vaccines for the Herpes Simplex type 2 virus and the Influenza A virus and then tested the reconstituted vaccines in mice. Along with his colleague Robert DeWitte, Filipe co-founded a company Elarex to bring this technology to market. They're now working to test the mixture for drying mRNA encapsulated in lipid nanoparticles.

There are multiple different sugar combinations that might work, notes Daan Crommelin, a pharmaceutical scientist at Utrecht University, Netherlands. Yet even with sugar, drying may still have its challenges. For one, drying vaccines could increase the time and cost of production, Crommelin notes. But such costs could be greatly offset by elimination of the cold chain, says DeWitte, who is CEO of Elerax.

Most importantly, there are many options to investigate, or as Crommelin says, "There are several ways that lead to Rome." But he notes the old adage needs a tweak in this case since it's likely not just one road or another. A combination of efforts will be required to distribute COVID-19 vaccines to people no matter where they are in the world.

Versions of a more stable mRNA vaccine for COVID-19 seem to be on the horizon. Pfizer and BioNTech are currently recruiting participants for a phase 3 trial that will evaluate a freeze-dried version of their SARS-CoV-2 vaccine. They hope for results in the second half of 2021, after which they can submit the results to regulatory agencies for review.

Other companies also have new versions of a liquid mRNA COVID-19 vaccine that may be refrigerator rather than freezer stable. But scant details are available on the reasons behind the stability. Moderna initiated a Phase 1 trial for a version of their next-gen COVID-19 vaccine that they say is refrigerator stable. But after repeated requests the company did not answer questions about reasons behind stability of the new formulation.

The German companyCurevac also claims its vaccine is stable in a refrigerator for up to six months and at room temperature for 24 hours. Similar to other vaccines on the market, Curevacs is encapsulated in lipid nanoparticles (LNPs) and must be protected from cutting itself apart. We think we might have achieved this by having the mRNA tightly packed within the LNP, company spokesperson Thorsten Schller wrote in an emailed statement to National Geographic. Our theory is that the more compactly the mRNA is packaged, the less attack surface there is." When pressed for details the company responded: "it is hard to pin down differences in stability to just one aspect."

Still, the diversity of possibilities is an encouraging sign of potential improvements to mRNA vaccines already on the market. "This feat was tremendous," Verbeke says of the speedy delivery of a safe and effective vaccine against COVID-19. But he adds, "Im quite sure theres still a lot of room for improvement."


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Future COVID-19 vaccines might not have to be kept so cold - National Geographic