pandemic

CDC to re-evaluate Johnson & Johnson vaccine as halt due to cases of rare blood clots lingers on

Business

Elizabeth McLaughlin, Staff

AP Photo/David Zalubowski

The administration of the Johnson & Johnson COVID-19 vaccine was paused due to cases of rare blood clots associated with those who received the shot.

On April 20th, Johnson & Johnson announced that the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed the company’s vaccine and confirmed that the overall benefit-risk profile remains positive. 

In recent months, Johnson & Johnson’s vaccine has been linked to a small number of cases of blood clots in combination with low platelet counts. These cases, though small in number, were enough to draw international concern. The EMA made it clear on Tuesday that there is some validity to these links between Johnson & Johnson’s vaccine and blood clots. Moreover, in a press release, the EMA stated “that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen.”

The EMA relied on all available evidence, it said, which included eight U.S. reports of serious blood clot cases. As of April 7th, more than 7 million people had received the J&J vaccine in the United States.

The linkage between the vaccine and blood clots is not unique to Johnson & Johnson. In March, more than a dozen European countries halted the use of the AstraZeneca shot after some people who received the vaccine reported experiences of blood clots. 18 of these cases turned out to be fatal, compared to only one case of fatality linked to the Johnson & Johnson shot. The EMA stated that “unusual blood clots with low platelets” should be listed as “very rare side effects” for the AstraZeneca vaccine.

On Friday, April 23rd, vaccine advisers to the Centers for Disease Control and Prevention will meet to make recommendations regarding the use of the Johnson & Johnson vaccine. They will be meeting less than two weeks after the CDC and US Food and Drug Administration recommended a pause on the use of the Janssen vaccine. The pause gave experts time to work with doctors regarding the identification and treatment of these rare blood clots.

Moreover, ranking members at the CDC project said that “there will likely be more reports of blood clots connected to the vaccine” (Mascarenhas, CNN). Dr. William Schaffner, a non-voting member of the CDC’s Advisory Committee on Immunization Practices, stated that he and his colleagues need to understand the demographics of blood clot cases before they can move forward with a decision. Dr. Schaffner said that on Friday, the ACIP could give the all-clear for the vaccine, or it could recommend that the US stop using the vaccine entirely. Dr. Schaffner thinks it is likely that the ACIP will recommend the use continues with warnings about possible adverse side effects. Additionally, Dr. Schaffner says it is wise for high-risk people to avoid the vaccine altogether.

The chair of the ACIP, Dr. Jose Romero, who is also Arkansas’ secretary of health, says that the committee has reviewed enough data at this point to make a responsible decision. Although more data will be presented on Friday, Dr. Romero believes that the committee will likely affirm the vaccine’s legitimacy after estimating the risk-benefit analysis. However, there are currently so few cases of blood clots that it is hard to assess the entire picture of risk. For example, all but one case were in females; some members of the ACIP are concerned that cases among men or older people might arise in the near future. The ACIP would benefit from more data in the form of blood clot cases, but those looking to receive the vaccine might not benefit.

Dr. Romero stated, “I really hope that the American public will look at this pause and look at what we have done during this pause as an indication of how safe the vaccine system and the vaccine pipeline is in this country.”

mclaughline7@lasalle.edu

The overpromising and under-delivering of AstraZeneca

Business

Elizabeth McLaughlin, Staff

NBC News

Shares in AstraZeneca have dropped 8.1 percent in the last six months as the public loses confidence in the company’s COVID-19 vaccine.

We are now over a year into the COVID-19 pandemic and millions across the world are beginning to feel a little more at ease as countries ramp up their vaccination efforts. Those in the U.S. are familiar with the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines. On Monday, AstraZeneca released results of a large U.S. trial, claiming that the vaccine was shown to be safe and 79 percent effective in preventing symptomatic disease.

Meanwhile, regulators in Denmark, Germany and Norway identified reports of serious or fatal blood clots among young people who had been administered the AstraZeneca vaccine. Although the number of reported cases is small, regulators argue that it is statistically significant; Germany halted the distribution of AstraZeneca’s vaccine and most other countries soon followed suit. New Zealand decided to donate its supply to countries in need, opting for the Pfizer-BioNTech shot instead. South Africa sold its AstraZeneca doses. Confidence in the company’s vaccine is dropping and so is their stock price.

Angela Merkel, chancellor of Germany, instituted a lockdown that will not be lifted until at least April 18. Germany’s DAX, the blue-chip stock market index comprising the thirty largest actively traded companies on the Frankfurt Stock Exchange, was down 0.1 percent as of Tuesday. On top of that, “yields are falling as investors look to bonds for safety,” according to Al Root via Barron’s. The 10-year U.S. treasury yield dropped to 1.63 percent Tuesday. 

Moreover, U.S.-listed shares of AstraZeneca dropped two percent in premarket trading; shares in London fell more than one percent. Overall, AstraZeneca shares have dropped 8.1 percent in the last six months, compared to the Zacks Large Cap Pharmaceuticals industry’s gain of 4.8 percent. Although confidence in AstraZeneca’s vaccine is low, some of the company’s other drugs could pick up the slack. Cancer drugs Lynparza, Tagrisso and Imfinzi, according to the Nasdaq analysts, “should keep driving revenues”.

In December 2020, analyst Jim Crumly wrote on The Motley Fool that AstraZeneca was “one of the most attractive buys in the industry at the moment.” A Morgan Stanley analyst predicted that AstraZeneca’s 2021 profit could increase by 30 percent because of their COVID-19 antibody medicine.

But just last week, the president of the European Commission, Ursula von der Leyen, stated that “AstraZeneca has unfortunately underproduced and underdelivered.” If that weren’t enough, on Tuesday, the National Institute of Allergy and Infectious Disease reported more concerns about AstraZeneca’s efficacy from its vaccine trial. More specifically, the Data and Safety Monitoring Board (DSMB) as an independent expert group, “wrote a rather harsh note to [AstraZeneca]… saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit,” according to Dr. Anthony Fauci on Tuesday. Despite this, Fauci maintains that AstraZeneca has likely produced “a very good vaccine.”

A year in retail

Commentary

James LeVan, Staff

Five years ago, a week before “Star Wars: The Force Awakens” arrived in theaters, I had taken a job in a local grocery store pushing carts in the evening. It was during the holiday season, a time when grocery stores and other retail businesses hired anyone with a pulse. Pushing carts wasn’t a bad gig overall. When the weather was warm and they were constructing the overpass near my work, I loved watching the sunset in the parking lot and listening to the banging of metal in the night air. The work was simple and pleasant. Since then, I have been a cashier, janitor, seafood rep (that lasted a week) and now a floater (a fancier term for stock boy). Being a floater has never been an easy job. It is not just stocking cans of corn on the shelf with a bunch of teenagers and college students. Retirees, teenagers, other college students, people looking for a second chance, parents even college graduates (a coworker who worked overnight stocking shelves had a degree in Business from Temple) work in retail. It has become a major source of employment for the educated and the uneducated, the skilled and the unskilled alike. Regardless of race or creed, what unites us is our frustration for our work and since the pandemic that frustration has only exasperated.

When the pandemic first hit a year ago, our shelves were quickly depleted the weekend Pennsylvania began to shut down. Our freezers became barren, most if not all of our meats were sold, and, of course, we ran out of toilet paper. By the end of the day Saturday of the first weekend of the pandemic, all we really had were Little Debbie products and some sparkling cider left over from Christmas 2019 (that stuff sells poorly, even in the middle of a pandemic). It is hard to believe it has been a year since COVID-19 first hit — those months of March to maybe June of 2020 feel both distant and recent to me. I tried keeping a log back in April, but many of my notes were mundane. I did not record all that happened at work and when I was not working, I was at home puttering around my house. The supply chain did not collapse, but it was under pressure that had not been seen before in the recent history of the United States. 

Courtesy of James LeVan

Pictured above is a frozen food aisle in early April 2020.

It was hard telling people who were desperate for toilet paper that we did not have any. I tried directing them to the nearest small corner store or family-owned chain (in the beginning they maintained a better supply than we did). When people would ask me when we would get more stuff in, I would shrug my shoulders and tell them I did not want to lie to them. Some people would accuse us of hoarding supplies and truth be told, we were not. Some coworkers bought a pack of toilet paper together and divided the rolls amongst themselves. For me, my parents had to drive out to the rural parts of PA to find ground beef and toilet paper. We had plenty of Lysol spray and wipes left over from when I had the flu a month earlier (an odd stroke of luck when I think about it). At the beginning of the pandemic, a coworker gave me a can of Lysol and I felt bad taking it, so I took it back to the shelf and explained that we had plenty of it at home, and it felt like I was hoarding. A woman quickly came and picked it up from me and said thank you.

In normal times, delivery trucks come in the early evening, and the overnight crew comes in around 8 p.m. to break it down. However, during the summer, trucks became infrequent. I remember one time I had to come in early (5 a.m.) to help overnight unload a truck that had gotten there an hour earlier. Sometimes we would not get a truck for a day or so and then multiple loads in one day. It really depended on the luck of the draw that day. One surprising phenomenon was that at one point, just so we had stuff, we got stacks of toilet paper and flour that were originally meant for hotels. But since no one was travelling, it made more sense for us to stock shelves with it. Things are semi-stable now, though we still end up running short on supplies depending on what they are.

On social media and television, we were praised for continuing to come into work. That we were in a way heroes for making sure communities had food and supplies. The media certainly thought we were awesome, and we had some customers thank us for what we were doing. However, I do not think people realize just how bad it got on some days. The fear that your coworker sitting across from you had COVID in the breakroom, to customers who would lose control and act like a child having a tantrum in a toy store. One moment that stands out in my mind was the time me and my manager had to go over to our beer garden because an older white man was screaming at a co-worker and an African American customer. When we asked what was wrong, the old man started screaming at our manager claiming that a Black man was following him around the store (he was not, we checked the cameras). He spent 20 minutes screaming at us, telling us about how his wife left him in the store alone, that he thought we were discriminating against him because he was white and not questioning the Black man, he was accusing of following him, that he had PTSD and that if he did not yell, he would get violent. I honestly thought I was going to have to fight this guy who was twice my size at that moment and that I was going to end up on the news. The guy tired himself out and then proceeded to leave and went about our business.

We who work at stores like Acme, Giant, Walmart and Target have been through Hell this last year. We have gone home crying, scared and exhausted. I have broken down in tears personally three times this past year. Many of us did not choose to continue working during this pandemic because we were brave or had a sense of duty. We did it because we had bills to pay and mouths to feed. Our work was not a breeze to begin with and the pandemic only exacerbated our problems. Grocery stores face issues of sexual harassment, disrespect and abuse from the communities we feed. The latter is still being felt now as we struggle to get vaccines and the latest attempt for a minimum wage increase died with Senator Sinema’s obnoxious thumbs down. It is important to remember that behind that mask, the cashier that sounds like a robot reciting the “thank you for shopping with us,” the women in health and beauty care and the guys stocking the shelves are all human and we are so tired.

The upside of a year in isolation: Self-knowledge

Commentary

Elizabeth McLaughlin, Staff

As we round the corner on the first year of this pandemic, I can’t help but reflect on where we were 365 days ago. In the first week of March 2020, I went from attending a mock trial event with hundreds of people from across the country to throwing a 20th birthday party for one of my closest friends. I didn’t know it at the time, but the normalcy of handshakes and hugs would soon melt away with no promise of ever returning. Or so I thought. 

Fast-forward a year later, and we are certainly still in a pandemic but, with one-tenth of the country’s population vaccinated, this March feels more hopeful than the last. Last March was characterized by persistent changes to our everyday lives, forcing us to reevaluate nearly every facet of 21st-century life. Public health needed to be addressed, along with social justice and our relationships with our loved ones; lesson after lesson, ad nauseam. 2020 taught me that another thing needed to be addressed: my relationship with myself. 

I’m sure my fellow college students can relate; ours is a story of constant congregation that quickly turned into sorrowful exile. We are social creatures who were yanked from the most social environment we’ve ever experienced and sentenced to solitude. I quickly became too familiar with the walls of my childhood bedroom, wishing I could spend just one more night with my friends for old time’s sake. I had never been in a situation where I could not physically see anyone lest I risk contracting a deadly virus; none of us had any idea how to proceed. I quickly understood that this was uncharted territory for all of us. 

Fabrice Coffrini/Getty Images

On March 11, 2020, the World Health Organization (WHO) first characterized the coronavirus outbreak as a pandemic.

As the curious person I am, I wanted to chart that territory. I wanted to immerse myself in the idea of being alone so that I could better understand myself and those around me. Sure, loneliness sounds a little scary, but they say explorers are never lost, right? So I dove in.

I first had to understand where I was and how I was feeling. Then, I asked myself if that was where I wanted to be: the obvious answer was no, “Liz, you’d much rather be at a frat party with your roommates than stuck in this existentialist rut.” So, I had to bridge the gap between where I was and where I wanted to be. Not surprisingly at all, I found that this desire to bridge the gap was a common one; this experience was a tale as old as time, as Celine Dion would say.

A man born 125 years before coronavirus came about said that happiness is derivative. This man was named Jiddu Krishnamurti, and he argued that happiness is always a by-product of something else. You think you’ll be happy when you get that promotion. You get promoted, but you’re still not fully satisfied. Now, you think you’ll be happy when you get the girl. You’re in a relationship now, and guess what… you’re still not fully satisfied. There is a search for something permanent, within the self and things beyond the self; but happiness is never permanent.

Krishnamurti offered that instead of happiness, we should begin searching for something else: self-knowledge. There is an idea that you must first recognize what is; “you cannot imagine or have belief in something which you are not.” On top of that, you have to be real with yourself about your circumstances. To understand what is, there must be freedom from the fear of what is. This was really, really hard to put into practice considering, you know, everything going on in the world. It seemed hard, but not impossible.

My thought process went something like, “okay, I get the vibe that he’s saying happiness is tricky to pursue, but if I can understand myself, I think there’s some merit and pleasure in that.” So that’s what I tried to do (and I’m still trying). A global pandemic and all its associated isolation is, admittedly, a really convenient time to, if you’re able, parse through your own self-knowledge.

That isn’t to say a global pandemic isn’t tough; we all dearly miss the way things used to be. But those things aren’t reality anymore. Taking a look around my childhood bedroom, I reminded myself to stay grounded in the present because, as cliché as it sounds, the past and the future were either gone or uncertain. I was alone, and that was a fact; I was alone, and that fact didn’t have to be unfortunate. That is where self-knowledge comes in.

Understanding yourself is a lifelong task, the terms of which, I imagine, are always changing as you grow and evolve. But it doesn’t matter what the circumstances are, the following is true: everyone’s potential for self-knowledge exists within them. It cannot be explained by some self-help book or school newspaper article, but it is there. And it is worth exploring.

mclaughline7@lasalle.edu