INDIA HEALTH MINISTER MANSUKH MANDAVIYA SAYS JOHNSON AND JOHNSON’S SINGLE-DOSE COVID-19 VACCINE IS GIVEN APPROVAL FOR EMERGENCY USE
Saturday, August 7, 2021
15 states are keeping COVID-19 breakthrough cases under wraps
State health departments across the country are taking various approaches to how they keep records on COVID-19 breakthrough cases, with 15 states deciding not to publish any data on the rare incidents.
An analysis by The Hill found that 35 states have disclosed some data on fully vaccinated people who later contracted COVID-19. The information ranged from a one-time percentage of residents who experienced a breakthrough infection to weekly detailed overviews broken down by demographics such as age, sex and race.
Figures on breakthrough cases are not available on the health department websites, social media or other publicly accessible sites for the other 15 states: Florida, Iowa, Kansas, Kentucky, Minnesota, Missouri, Nevada, New Hampshire, New York, North Dakota, Ohio, Pennsylvania, South Dakota, Texas and Wisconsin.
The Hill reached out to the health departments of all 15 states for comment. A handful of states, including New York, Texas and Wisconsin, provided the numbers upon request.
Alicia Shoults, a spokesperson for the Ohio Department of Health, told The Hill that the agency plans to publish a dashboard with breakthrough hospitalizations and deaths Friday.
Of the states already reporting data, Utah topped the list, with 0.36 percent or 5,265 breakthrough cases in its 1,462,313 fully vaccinated residents from Jan. 16 until this week. In that period, the state reported approximately 115,000 coronavirus cases.
The Centers for Disease Control and Prevention (CDC) stopped monitoring nonsevere breakthrough cases in May.
Some states have followed the CDC in publicly reporting breakthrough hospitalizations and deaths but not the total number of cases.
Tennessee’s Department of Health references the CDC’s policy in its critical indicator reports, where breakthrough cases with severe outcomes are regularly included. As of July 29, the state had reported 31 breakthrough deaths and 218 breakthrough hospitalizations.
Like many other states, Tennessee does not specify when it started collecting COVID-19 breakthrough data.
Illinois, too, only reports breakthrough infections that result in hospitalization or death. Its department of public health said the approach will “maximize the quality of the data collected on cases of greatest clinical and public health importance.”
On Wednesday, Illinois reported 714 breakthrough hospitalizations and 180 deaths, representing 2.58 percent of COVID-19 deaths since data collection began in January.
The state is one of a handful that feature breakthrough case data on their COVID-19 dashboards, joining Virginia, Maryland, Idaho, Indiana, Utah and the District of Columbia. Either through those dashboards or separate report summaries, 18 states publish data on breakthrough infections regularly. Although most updates are weekly, Idaho’s are the most frequent, revised every weekday, while Oregon publishes breakthrough numbers monthly.
The CDC announced in May it would only investigate and publish COVID-19 breakthrough cases that result in hospitalization or death. The change was intended to “help maximize the quality of the data collected on cases of greatest clinical and public health importance,” the agency said.
Nationally, an exceedingly low number of fully vaccinated people have contracted the virus. Out of the 101 million people vaccinated from January through April, the CDC reported 10,262 breakthrough infections in 46 U.S. states and territories. The agency’s latest update, on July 26, identified 6,239 hospitalizations and 1,263 deaths, about a quarter of which were asymptomatic or not related to COVID-19.
Across the board, the rate of breakthrough cases among those fully vaccinated was less than 0.5 percent for the 29 states that disclosed their full tallies, backing up the message from public health officials that COVID-19 vaccines are very effective at slowing infection.
One in three COVID-19 cases nationwide last week occurred in Florida and Texas, Jeff Zients, the White House's COVID-19 response coordinator, said at a White House briefing Tuesday. He emphasized that places with higher vaccination rates generally have lower COVID-19 case counts, including breakthrough infections.
“While vaccinated people can spread the virus if they get a breakthrough infection, the odds of them getting sick in the first place are far lower than those who are unvaccinated,” Zients said.
He added that the seven states with the lowest vaccination rates accounted for more than 17 percent of cases, despite representing only 8 percent of Americans. All of those states have put out reports on breakthrough infections.
But even when states do not release figures, some counties have tracked the cases themselves.
In Shawnee County, where Kansas’s capital is located, despite the weekly cases quadrupling in the past month, the local health department has documented only 91 breakthrough cases, just 0.1 percent of its 77,500 fully vaccinated residents.
On the flip side, Southern Nevada Health District’s weekly updates indicate that breakthrough hospitalizations in Clark County have steadily trended upward, from 30 in June to 178 in mid-July.
Many major cities have provided their own status reports as well.
New York City’s health department said July 14 that its breakthrough statistics show the vaccination campaign has proved successful. Just 1.1 percent of all 500,302 COVID-19 cases were in those who were fully vaccinated.
A total of 94 fully vaccinated New Yorkers died from the virus between January and mid-June, compared with 8,069 deaths, and 98.4 percent of hospitalizations were among the unvaccinated.
The Houston Health Department posted a graphic on Facebook that said 0.092 percent of fully vaccinated Houstonians developed breakthrough cases positive for COVID-19 as of July 23. It confirmed six breakthrough deaths, each in patients who were severely immunocompromised or had preexisting conditions.
After the Boston Herald used a Freedom of Information Act request to report there had been 3,907 infections and 71 deaths in fully vaccinated Massachusetts residents, Sen. Edward Markey (D-Mass.) urged the CDC to monitor all of these cases. Previously, the Department of Public Health had disclosed data on breakthrough cases only once, in a memo on the state website.
“As of May 24, 2021, there had been 3,343 instances of COVID-19 infection in over 2.9 million fully vaccinated individuals (a rate of 0.11%),” wrote Catherine M. Brown, the state epidemiologist, and the department’s medical director, Larry Madoff.
In a July 22 letter to CDC Director Rochelle Walensky, Markey asked why the agency announced “that it would no longer require states to report information to the CDC on breakthrough cases that do not require hospitalization,” and asked which states are still collecting data on such cases.
At a briefing the next day, White House press secretary Jen Psaki said the CDC actively tracks breakthrough cases through cohort studies, which involve “tens of thousands of people across the country” working in health care and long-term care facilities.
“CDC also collects what they call ‘passive surveillance,’ which is where hospitals provide CDC with data when they identify someone who is hospitalized but has been vaccinated,” Psaki said.
Due to inconsistent tracking and underreported asymptomatic breakthroughs, health experts caution that the breakthrough data publicly available is likely incomplete.
Still, Céline Gounder, a professor at NYU’s Grossman School of Medicine and a member of the Biden-Harris Transition COVID-19 Advisory Board, said studying breakthrough data helps us understand who is not responding as well to vaccines, which settings present a higher risk for infection, and what characteristics make certain variants more immune-evading.
She also said the new CDC guidelines, which recommend that even fully vaccinated Americans wear masks in areas with high transmission of the virus, are “partly a reaction to breakthrough infections.”
“The concern is that these people with breakthrough infections could be transmitting onward, could be contributing to community transmission,” Gounder told The Hill. “It’s not that that individual is going to get sick and die ... it's that we're worried what that infection could mean for others around them.”
Groups with weaker immune responses to the vaccine — organ transplant recipients, people receiving immunosuppressive therapy for cancer, or those over the age of 80 — are at a higher risk of developing a severe or deadly breakthrough case.
For the states that provided detailed demographic data, the median age of people who died from a breakthrough infection was 79 for Indiana, 81 for Ohio and 82.5 for Washington.
Robert Wachter, chairman of the Department of Medicine at the University of San Francisco, thinks some of the concern about contracting a breakthrough infection is valid and supports the CDC’s mask recommendations.
“Is it something that should cause you to worry that you're going to die? No, but concerned enough,” he said. “I think that for vaccinated people to go back to mask-wearing indoors is a completely rational response to the information as it’s played out over the last few weeks.”
Nahid Bhadelia, professor at Boston University’s Center for Emerging Infectious Diseases, said the CDC should test and track all symptomatic breakthrough cases, whether they lead to hospitalization or not.
But she also said the delta variant may have “changed the equation,” pointing to a new study in China that shows people infected with delta had about 1,000 times more virus in their bodies compared to the original strain.
“With the delta variant, you may get continued protection for severe disease, hospitalizations, and deaths, but you may get potentially more breakthroughs and more symptomatic breakthroughs,” she said. “The vaccines are still doing what they’re supposed to do.”
Leading Pfizer Scientist Answers Key Vaccine Questions
JOHN WHYTE: The COVID pandemic has infected more than 35 million Americans, resulting in over 600,000 deaths. The vaccines, developed in record time, are helping to curb the pandemic. And hopefully, we'll end it soon. Yet millions of Americans are skeptical. They seem to have been developed too fast. The side effects are serious, might be risky. Maybe you just don't know who to believe.
I had an opportunity to sit down with Dr. William Gruber -- he's Pfizer's senior vice president of vaccine clinical research and development -- to address these very issues, as well as answer the questions that are on your mind.
Dr. Gruber, thanks for taking the time today.
WILLIAM C. GRUBER: My pleasure to be here.
JOHN WHYTE: I want to start off with, why did Pfizer choose an mRNA technology for a vaccine development program, where history had shown that many vaccine development programs that used mRNA had failed? And we're talking about a pandemic.
WILLIAM C. GRUBER: Yeah. So it was clearly an ambitious undertaking. But it was driven by a need to develop a vaccine in record time. It was recognized at the time of the first wave of the pandemic that this would likely not be the last. And so speed was of the essence to deliver a vaccine in an unprecedented period of time, by December of the same year in which we started.
The relationship we established with by BioNTech and Pfizer occurred in March. And we were solving to develop a vaccine by the end of the year.
JOHN WHYTE: Did you consider other technologies, or pretty early on, you felt this was the way to go?
WILLIAM C. GRUBER: Yeah, pretty early on, we decided this is the fastest way to go. And it's really borne fruit. When you look at the other types of technologies out there, vector-based technologies also we're fairly rapid, but subunit or protein-based technologies have lagged. And we still don't have, at least in the United States, a licensed vaccine using that more conventional approach.
JOHN WHYTE: But Dr. Gruber, this should be a story of innovation in terms of how you brought a vaccine to market in record time. But many people are saying it's too fast. And that's contributed to vaccine hesitancy. So can you walk us through the steps that allowed you to develop it, as you describe, in record time?
WILLIAM C. GRUBER: Yes. I think it's important for the public to understand we took no shortcuts regarding our ability to demonstrate that the vaccine was likely to be safe and effective when applied to the population at large. What was really done was to remove a great deal of the white space that typically exists between each stage of development.
So we worked very deliberately in phase one to assure ourselves in small numbers of individuals about the safety of the vaccine and that we were getting the right sort of response that would be associated with protection. But we removed what typically are these intervening periods where we would go back and forth with regulatory agencies in decision-making and review of documents. It's a real credit to the regulatory agencies that they basically worked with us in real time, removing some of the typical periods that are required for that type of review.
So no shortcuts. We worked through deliberately until we were confident about the safety and immune response. And then we expanded quickly to a large-scale trial where we continued to collect safety information as well as information about the efficacy of the vaccine.
And I should say, we still do that. Post-licensure, we continue to look at information that we're getting from our trials and from the population at large to give us confidence and give the public confidence about the safety profile.
JOHN WHYTE: So these vaccines, as you know, are authorized by the FDA under an emergency use authorization, which is allowed under a public health emergency. You talk about the data and how the data has been convincing. Why aren't these vaccines fully licensed, a BLA [biologics license application], by the FDA? Some experts, such as Dr. Topol, have said it's contributing to vaccine hesitancy. I'm not sure if that's the case, if that's why people are holding out. But why aren't they fully approved?
WILLIAM C. GRUBER: Yeah. So I think the process of approval is a very deliberate one in which the FDA is obviously interested in gaining as much safety information as they can and as much efficacy. And of course, it probably makes some sense to talk to the FDA themselves about their perspective.
But it was quite clear that for essentially all vaccines, there is interest in having not only a large population for which you've got safety data, but also prolonged follow-up in that population. And so recognizing that we had to do things to solve for, one is getting a vaccine out to the public as soon as possible while still assuring safety.
The FDA reached a point where they recognized, OK, we will accept 2 months of follow-up for a significant proportion of the population for the safety assessment as a basis for emergency use. But as for other vaccines, we still want 6 months of follow-up to basically guarantee that there are really no longer-term effects.
Now, I think the data that we already have indicates -- and of course, this has now been submitted for the BLA -- is that, in terms of tracking for adverse events, the likelihood that you would see it only at 6 months and not see it at 2 months is very remote. But nonetheless, the FDA has chosen, and I think appropriately, to just provide the greatest confidence possible that they have followed both short-term and long-term to assure a safety profile. And I think we're confident with the data that's now been submitted for BLA, which the FDA now has under review, that the safety profile will be confirmed.
JOHN WHYTE: But can you see how it can contribute to vaccine hesitancy, because we're saying it's safe and effective, but then we're saying, oh, wait, we want to look at more data? Do you see the confusion that may result?
WILLIAM C. GRUBER: Well, I think the public should be reassured that it's not only the clinical trial data that's being examined. We've now, I guess across the world, across all vaccines, given over, I think, 3 billion doses and many hundreds of millions of doses now for the Pfizer vaccine itself. So that in itself lends itself to reassurance because the CDC, ourselves, other regulatory bodies, are basically monitoring that data in real time.
So now you've got hundreds of millions of individuals who have the opportunity to report back any sort of safety event. So you can look for those rare circumstances you otherwise can't pick up in clinical trials. And to this point, it's been clear that when one looks at all the potential adverse events associated with the vaccine versus the benefits, the CDC continues to come forward and recommend that everybody, at least in the case of the Pfizer vaccine, 12 years and above receive the vaccine.
JOHN WHYTE: Let's talk about some of those myths out there that are contributing to people's hesitancy. And two of the biggest myths -- let's start with the first one, is it changes your DNA. So Dr. Gruber, what can you say to people who believe it changes your DNA?
WILLIAM C. GRUBER: Yeah. So the first thing is that it does not change your DNA.
JOHN WHYTE: How do you know? That's what people are going to say: “How do you know?”
WILLIAM C. GRUBER: What evidence do we have for this? Well, first, mRNA basically is contained within the cytoplasm. So it doesn't get into the nucleus where the DNA resides. Secondly, there's no mechanism, either based on the host or the mRNA that's making its way into individual cells, for it to integrate.
So I think we have great confidence that there is no real risk there for integration. And we continue to obviously monitor populations for safety. There's been no evidence to suggest that there is a risk.
JOHN WHYTE: Let's talk about the other big myth: issues of fertility. And ACOG, or the American College of Obstetrics and Gynecology, put out a note that said women of reproductive age or even women that are lactating should not be denied access to the vaccine. Some people will say that's hard to understand exactly what that means. So what's the data that we have on issues of fertility and mRNA vaccination?
WILLIAM C. GRUBER: So to date, we've not identified, nor would we expect any impact on fertility. There's no basis in terms of our understanding of the construct that would be associated with a fertility risk. Some have pointed out that there may be some similarity between a protein that exists in the placenta versus the vaccine. But that similarity is small. And the peptide is very small. So there's no real even theoretical risk that should rise to the level of individual concern, in addition to which, we now know that, again, with the hundreds of millions of people that have been vaccinated, pregnant women have, in fact, been vaccinated.
The CDC has tracked that and has seen no evidence of either adverse outcomes of pregnancy associated with the administration of vaccine nor, in terms of the population at large, any evidence that fertility has been affected. And our own data reflects that. Pregnant women as well as women that are lactating after pregnancy should feel comfortable and reassured that the safety profile supports that they should be vaccinated, and particularly given that pregnant women have a likelihood of more severe disease if they get COVID-19.
JOHN WHYTE: For vaccines in general -- you've been studying vaccines for a long time. How much data is enough? You kind of referenced that normally, we like to see 6 months. But approval was based on 60-day fully immunized. Do we know how much data is enough?
WILLIAM C. GRUBER: Yeah. So I think the data that's been provided was enough for emergency use authorization. It will be enough for a BLA. But we will continue to be able to collect data to reassure ourselves and the public about the safety of the vaccine.
JOHN WHYTE: And in the history of vaccine development across different disease states, typically when we see serious adverse events, it is in those first 60 days, correct?
WILLIAM C. GRUBER: Yes. I think in most circumstances, we typically see them -- and in fact, many of them occur very proximate to vaccination, well before the 60-day period. So the likelihood, as I said before, that we would see anything that we have not picked up in the first 2 months, between 2 and 6 months, is remote.
JOHN WHYTE: Dr. Gruber, let's talk about what's on everyone's mind: boosters.
WILLIAM C. GRUBER: Yeah.
JOHN WHYTE: And there's been some conflicting information -- I'm just going to put it out there -- in terms of what we're hearing. But let's take a step back. I need to ask you: How long does immunity last from the vaccines?
WILLIAM C. GRUBER: Yeah, so we're still learning, frankly, how long immunity lasts. I think we can be reassured that in almost all circumstances, individuals that are hospitalized are in fact individuals that are unvaccinated. And the deaths almost exclusively seem to be occurring in individuals that are unvaccinated. And that's even in the setting of this new Delta variant that's created concern.
So I think the nature of the efficacy that we're seeing in the population at large provides some confidence that, in fact, the protection is durable. We have some data, in fact, that shows, even though antibody is declining, that the efficacy does not seem to decline at the same rate.
Now, how long that will continue is a reasonable question. So we need to answer it in two ways as to whether or not a booster would be required. First of all, can a booster restore a level of immunity like that seen after the first two doses? And so that's one of the things that we're exploring now actively with clinical trials, to look at a third dose to see what happens in terms of our ability to generate an appropriate immune response.
And can we do that safely? And I think we've reported publicly that, in fact, we are seeing a boost in that antibody response. And in fact, we are seeing that the safety profile looks very similar to what we saw after the second dose. So I think that's one piece. Can you do it?
Now the question is, when do you do it? And again, the data that we're hearing about, some of which I just referenced in terms of what's happening with the overall efficacy and where the breakthrough cases might be occurring, will help us learn better when an appropriate boost might occur.
And here again, we're not solely waiting for what occurs out in the population at large. We're also conducting a study of now 10,000 individuals, half of whom received the original two doses of the vaccine as part of our pivotal trial, and the other half will get a third dose. And we'll be able to compare those groups -- that group that's now farther and farther out from their original two doses of vaccine versus the newly third dose-vaccinated group -- and see: Is there really a benefit to be gained? And how much is it? And when does it occur in those that are vaccinated?
JOHN WHYTE: Do you expect that those persons that are immunocompromised will likely need a booster?
WILLIAM C. GRUBER: Yeah. I think if you were going to pick a population that would be most likely to fall in that category, it would likely be the immunocompromised because as you say, there is some data suggesting that two doses is not yielding the same level of antibody response, which again, we don't know that is the antibody itself that's so critical. But it does serve as a marker, along with all the other goodies -- the cell-mediated immune response, the memory that comes along with it -- to give us some indication of what might be required.
And so we're actually very much in support. And we've obviously communicated with the NIH [National Institutes of Health] about their plans. We have our own plan for studies looking at immunocompromised populations to better tease out what the best approach to those populations would be.
JOHN WHYTE: What do you say to those people that did get COVID, survived, and say, I don't need to get vaccinated, or maybe I just need one shot because we do know tens of millions of people have not come back for that second shot? What's your message to them?
WILLIAM C. GRUBER: Yeah. So again, there's data beginning to accumulate that I think supports that the level of efficacy seen with natural infection is well below that that's associated with vaccination. And I think that will help convince individuals.
But the CDC and others who have clearly recommended, whether or not you've had infection in the past, it's recommended that you receive the vaccine. And I think that's good advice.
JOHN WHYTE: What about this issue of interchangeability? We're not seeing it here in the United States. But some other areas of the world where there still are some shortages, even in Canada, you might get Pfizer the first time and Moderna the second time or vice versa. What are your thoughts on that?
WILLIAM C. GRUBER: Yeah. So from our perspective, of course, our emergency use authorization and what we're authorized to represent is two doses of the Pfizer vaccine. And we think that's important for protection. However, we welcome the fact that others are looking at the potential for interchangeability of vaccines to try to determine what might be the best regimens for the particular circumstances at hand in relationship to vaccine supply issues, et cetera.
So I think from our perspective, the best approach that we can stand behind now, based on the data that's available, is two doses of the mRNA vaccine where we have 95% efficacy.
JOHN WHYTE: But most experts don't recommend it. If it's something that has to be done, there's not objection to it, correct? But it's not something that should uniformly be done until we have more data, is that correct?
WILLIAM C. GRUBER: Right. I think the notion is, everything that we do -- and this is something I think we take great pride in at Pfizer -- everything that we do should be evidence-based. So you don't want to be too soon, nor do you want to be too late. You want to be able to gather the information as quickly as possible to make informed decisions and let that guide your judgment.
JOHN WHYTE: That's good advice. Dr. Gruber, thanks for taking the time today.
WILLIAM C. GRUBER: OK, thank you.
New Biomaterial Vaccines Aim to Ward Off Future Pandemic Threats
Find it. Kill it. This is the simple premise behind new biomaterial-based vaccines that experts are designing to fend off future pathogens, or germs that could threaten human health.
As they plan next-generation vaccines, scientists are banking on the idea that the structure of a future pandemic-scale pathogen will be like the ones they already know about.
The new class of vaccines are being developed to supercharge the immune system to help the body quickly respond to a range of pathogens.
The new biomaterial-based vaccines are also shelf-stable, meaning they wouldn’t have to be refrigerated like some the COVID-19 shots. This is encouraging news for faster vaccine rollouts, and it will help poorer countries that lack refrigeration for supplies.
New biomaterial vaccines tap into the body's natural immune response, explains Michael Super, PhD, from the Wyss Institute at Harvard University in Boston, who is first author on a new study exploring what the vaccines can do.
Previous research has shown that scientists can create a depository under the skin that acts like a protective lymph node, or a small bean-shaped structure that works as part of the body's immune system to help fight infection and disease.
Supercharging the Immune System
This opens the possibility that a biomaterial, such as silica, an important trace mineral already in connective tissues of the body, could be used to inject a pathogen to help the body produce antibodies to it and support how the immune system rallies, explains Super.
"We recruit the immune system to that site, and then the dendritic cells pick up the antigen you put in that biomaterial," he says. "That creates a danger signal that activates those dendritic cells in a very natural manner. The immune system doesn't overproduce, but it does respond, and we've found that it responds very quickly. We are essentially recapturing what the immune system normally does."
As cells mature at the deposit site, they learn what signals to send to the rest of the immune system so that it responds to the pathogen targeted by the vaccine. Those cells then travel through the body, stimulating other immune-responsive cells.
In their study, Super and his research team took this process a step further and used their biomaterial vaccine to introduce live attenuated pathogens into the body. This process kept the pathogen viable, but harmless.
This process is different from the recombinant spike protein vaccines used for COVID-19 that use genetically engineered agents to produce antibodies that target the coronavirus.
"We found we could take live pathogens and kill them with an antibiotic or something else and use that directly as part of the vaccine of our choice," says Super. "You don't have to do that complex manufacturing; you can simply take it, capture it, kill it, and mix it with the biomaterial and inject or implant it. We've seen that you've then got these native antigens to fight the pathogen."
The team used this process to target a form of E. coli, a type of bacteria that’s scientifically known as Escherichia coli that is particularly dangerous in livestock. They infected a pig and then gave it an antibiotic to kill the infection. They extracted that dead bacteria from the pig's blood and combined it with a biomaterial, in this case mesoporous silica, to create a vaccine.
After they gave this vaccine to mice, they exposed the mice to a different strain of E. coli, and the mice fought off the infection.
"It's not just the pig-to-mouse aspect that is exciting, it's that we were able to protect against a lethal challenge from a different strain," Super says. Results were similar when they tested the vaccine on mice infected with Staphylococcus aureus, he says.
Most of this study, which focused on immune responses to bacteria, was completed before the COVID-19 pandemic started. But the researchers say the work has important implications for preparing for future pandemics.
Stockpiling for Future Threats
"One of the problems is that, very often, you don't know what the pathogen is that you're dealing with, especially in the case of a biothreat," Super points out. But "we believe the structure of a microbial pathogen will be similar to the native, normal pathogens we already know about."
If that holds true — and the research suggests it will — then a vaccine for a little-studied pathogen could be created using pathogens that target structurally similar but well-studied bacteria.
Biomaterials can be made in bulk at low cost and dried for future use.
"We see this as something that could be made and stored and ready to use whenever it is needed," Super explains.
SOURCES:
Nature Biomedical Engineering: "Biomaterial vaccines capturing pathogen-associated molecular patterns protect against bacterial infections and septic shock."
Michael Super, PhD, lead senior staff scientist, Wyss Institute, Harvard University, Boston.
Why Aurinia Surged
- In January, the FDA approved Aurinia's first product, Lupkynis, to treat lupus nephritis.
- Independent new drug launches rarely live up to pre-launch expectations, so all eyes were on top-line sales of the drug.
- Second-quarter Lupkynis sales of $6.6 million didn't disappoint.
The stock of Aurinia Pharmaceuticals (NASDAQ:AUPH) was surging today after the company's second-quarter earnings call. A positive outlook for Lupkynis, its recently launched drug for lupus nephritis (LN), encouraged investors to drive the stock 21.5% higher as of 1:08 p.m. EDT on Friday.
All eyes were on Lupkynis sales when Aurinia reported second-quarter results after U.S. markets closed on Thursday. The company didn't disappoint, with product revenue that reached $6.6 million.
After first-quarter sales didn't even break $1 million, the uptick in the second quarter allowed Aurinia shareholders to breathe a sigh of relief. Despite today's gains, shares are still trading for a little less than their price over a year ago.
Systemic lupus erythematosus (SLE) is an autoimmune disorder that leads patients' immune systems to attack their own tissues. SLE affects around 300,000 Americans, and most go on to experience kidney damage, or lupus nephritis.
Lupkynis is the first oral treatment approved by the Food and Drug Administration to treat the underserved LN population, and this isn't the last surge in sales we're likely to see this year. Aurinia is predicting between $40 million and $50 million in Lupkynis sales for all of 2021. As the first available treatment for LN, Lupkynis could go on to generate blockbuster sales for Aurinia and send the biotech stock soaring much higher over the next few years.
https://www.fool.com/investing/2021/08/06/why-aurinia-pharmaceuticals-stock-was-surging-on-f/
Friday, August 6, 2021
Port area, supply chain can be source of virus transmission
An additional 23 members of the virus-hit Cheonghae, South Korea, naval unit tested positive for the new coronavirus, the defense ministry said Wednesday, raising the confirmed infection cases among the 301-member unit to 270.
According to virus tests conducted on all the members upon their return home from Africa the previous day, 270, or 89.7 percent, of them have tested positive for COVID-19, while 31 tested negative, the ministry said.
The unit on an anti-piracy mission in waters off Africa first reported six COVID-19 cases last week, and subsequent tests on the crewmembers aboard their destroyer, the Munmu the Great, confirmed a total of 247 cases as of Tuesday.
In the wake of the worst-ever mass outbreak among service members, the ministry brought them all home, weeks ahead of schedule, and sent them either to military hospitals or other facilities for treatment and necessary quarantine measures.
"Three of them showed moderate symptoms. We will continue to closely monitor the conditions of the crewmembers and take necessary steps," a ministry official said.
Their destroyer left an African port earlier in the day, after the ministry sent a team of crewmembers there Tuesday to pilot it back home.
The new batch of the Cheonghae unit arrived in the Gulf of Aden recently and is working to begin peacekeeping missions, according to officials.
Contact tracing is under way, but the outbreak appears to have begun after the destroyer was docked at an African port from June 28-July 1 to load supplies. One day after the vessel left the port, one officer first showed symptoms of a cold and dozen others complained of similar symptoms about a week later.
"When loading supplies, one civilian pilot got on the vessel. But the individual, as well as our service members, wore protective gear," Vice Defense Minister Park Jae-min told a radio program. "After crewmembers are in a stable condition, we will carry out inquiries into the situation."
The military has drawn criticism for its poor initial response to the outbreak and for not actively seeking ways to inoculate them. None of them had been vaccinated as they left South Korea in February, weeks before the country began the vaccination campaign.
Defense Minister Suh Wook apologized over the incident, and vowed to review and supplement antivirus schemes for troops overseas.
More Data Point to Lambda Variant’s Potential Lethality
Data show how the lambda COVID-19 variant could possibly elude vaccines. One of the lead researchers of a new study calls lambda “a potential threat to the human society.”
Scientific researchers continue to try and get a bead on the lambda variant of COVID-19, which initial and—as yet—not peer-reviewed research suggests might possibly be resistant to vaccines. That’s the conclusion reached by investigators with the University of Tokyo, in a study posted on bioRxiv, which has not yet been peer-reviewed. Their conclusions mirror those of a study released several weeks ago—also not peer-reviewed yet—by investigators in Chile.
The study by the University of Tokyo researchers states that two mutations in the lambda variant—T76I and L452Q—makes it more infectious than the variant that had health care systems throughout the world reeling this time last year—D614G, the so-called wild type. (It’s not yet known whether the lambda variant is more infectious than the Delta variant, which in many places in the world, including the United States, is now the dominant variant and also comes with a host of challenges to health care systems.) In addition, states the study, “the RSYLTPGD246-253N mutation, a unique 7-amino-acid deletion mutation in the N-terminal domain of the lambda spike protein, is responsible for evasion from neutralizing antibodies.” The investigators discovered the mutations in lab experiments.
The World Health Organization (WHO) says that the lambda variant—or C.37 variant—has been the COVID-19 carrier in about 81% of infections in Peru since April. The variant was first identified in Peru in August 2020. The WHO declared the lambda variant a variant of interest (VOI) on June 14, a designation that means that it could cause a greater risk than the wild-type variant.
That’s an understatement, according to the investigators at the University of Tokyo, who want the WHO to label the lambda variant a variant of concern (VOC) to put health care systems around the world on notice that this might be their next big challenge. They write that “because the lambda variant is a VOI, it might be considered that this variant is not an ongoing threat compared to the pandemic VOCs. However, because the lambda variant is relatively resistant to the vaccine-induced antisera, it might be possible that this variant is feasible to cause breakthrough infection.”
Kei Sato, PhD, a senior researcher at the University of Tokyo and 1 of the 2 lead authors of the study, tells Reuters that lambda “can be a potential threat to the human society.”
The study states that “since the Lambda variant has dominantly spread according to the increasing frequency of the isolates harboring the RSYLTPGD246-253N mutation, our data suggest that the insertion of the RSYLTPGD246-253N mutation is closely associated with the massive infection spread of the Lambda variant in South America.”
According to data-collecting organization GISAID Initiative, there have been 1037 cases of lambda in the US.
Pablo Tsukayama, PhD, is a molecular microbiologist at Cayetano Heredia University in Lima, Peru, and has been tracking lambda since its appearance. He told Al Jazeera on July 27 that “when we found it, it did not attract much attention. But we continued processing samples, and by March, it was in 50% of the samples in Lima. By April, it was in 80% of the samples in Peru…. That jump from [1%] to 50% is an early indicator of a more transmissible variant.”
https://www.infectioncontroltoday.com/view/more-data-point-to-lambda-variant-s-potential-lethality
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