Top Stories for Week of January 11, 2021

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Pfizer/BioNTech vaccine appears effective against new coronavirus variants.

New research suggests Pfizer Inc.’s (NYC) COVID-19 vaccine can protect against a mutation found in the two more-contagious variants of the coronavirus that have erupted in Britain and South Africa, according to the Associated Press. The study was preliminary and did not look at the two other major vaccines being used in the West–Moderna Inc.’s (Cambridge MA) and AstraZeneca PLC’s (London).

But it was reassuring, given questions of whether the virus could mutate to defeat the shots on which the world has pinned its hopes.

There’s no reason to think the vaccines won’t work just as well on these strains,” said Dr. Frederic Bushman of the University of Pennsylvania, who tracks how the virus mutates.

The mutated version circulating in Britain has also been detected in the US and numerous other countries. That and the variant seen in South Africa are causing global concern because they appear to spread more easily–although how much more isn’t yet known. Bushman, who wasn’t involved with the Pfizer study, cautioned that it tested just one vaccine against one worrisome mutation.

But the Moderna and AstraZeneca vaccines are undergoing similar testing, and Bushman said he expects similar findings. That’s because all the vaccines so far are prompting recipients’ bodies to make antibodies against multiple spots on the spike protein that coats the virus. “A mutation will change one little place, but it’s not going to disrupt binding to all of them,” Bushman explained. While scientists did not expect that a single mutation would completely upend efforts to stop the pandemic, it is still an important area of study because the coronavirus, like all viruses, constantly evolves. This study marks just the beginning of continual monitoring to make sure that all the vaccines being rolled out around the world continue to work.

The study looked at one modification to the spike protein that both variants share, called N501Y, that is believed responsible for the easier transmission. Pfizer and researchers from the University of Texas Medical Branch in Galveston conducted laboratory tests to see if that mutation could thwart the vaccine. They used blood samples from 20 people who received the vaccine, made by Pfizer and its German partner BioNTech, during a large trial of the shots. Antibodies from those recipients fended off the virus in lab dishes, according to the study, posted late Thursday on an online site for researchers. The findings have not yet been reviewed by outside experts, a key step for medical research.

But “it was a very reassuring finding that at least this mutation, which was one of the ones people are most concerned about, does not seem to be a problem” for the vaccine, said Pfizer chief scientific officer Dr. Philip Dormitzer.

Viruses constantly undergo minor changes as they spread from person to person. Dr. Anthony Fauci, the top US infectious disease expert, told the Associated Press last week that the coronavirus variants don’t appear to block vaccine-induced antibodies but that testing to be sure of that is underway in the US and elsewhere. British scientists have likewise said the variant found in the UK which has become the dominant type in parts of England–still seems to be susceptible to vaccines.

According to Johns Hopkins Medical, as of Saturday, January 9, there were over 89 million global COVID-19 cases confirmed, and some 1.9 million deaths. Confirmed cases in the US totaled 22 million with nearly 370,000 deaths. The US figures comprise 25% and 19% respectively of the global totals. The US population comprises 4% of the global total. As of Saturday morning, about 28% of all the first COVID-19 vaccine doses have been administered in the US, according to the CDC.

COVID-19 Addenda: The US plans to start distributing COVID-19 vaccines through pharmacies around the country earlier than expected this week as states have struggled to use the supply they have been allocated, top health officials said last week. The partnership with 19 pharmacy chains will eventually let the Operation Warp Speed vaccination program deliver to as many as 40,000 locations around the country, OWS officials said, according to Reuters.

Pharmacies could provide a more efficient platform for distributing the vaccines than hospitals, they said. As of last Tuesday, more than 70% of the more than 17 million vaccine doses that have been delivered around the country since December were still sitting in freezers, according to data from the Centers for Disease Control and Prevention. US Health and Human Services Secretary Alex Azar also said that states should not let recommendations to prioritize certain groups like healthcare workers slow the pace of vaccinations. He said states should not keep vaccines sitting in freezers too long for distribution to healthcare workers and has encouraged governors to skirt CDC recommendations if it can speed inoculation.

Paramedics in Southern California are being told to conserve oxygen and not to bring patients to the hospital who have little chance of survival as Los Angeles County grapples with a new wave of COVID-19 patients that is expected to get worse in the coming days. The Los Angeles County Emergency Medical Services Agency issued a directive last week that ambulance crews should administer supplemental oxygen only to patients whose oxygen saturation levels fall below 90%, says NPR. In a separate memo from the county’s EMS Agency, paramedic crews have been told not to transfer patients who experience cardiac arrest unless spontaneous circulation can be restored on the scene.

Both measures, which were issued by the agency’s medical director, Dr. Marianne Gausche-Hill, were taken in an attempt to get ahead of an expected surge to come following the winter holidays. Many hospitals in the region “have reached a point of crisis and are having to make very tough decisions about patient care,” Dr. Christina Ghaly, the LA County director of health services, said. Los Angeles County remains the worst-hit county in the US for both confirmed COVID-19 cases and deaths.

Moncef Slaoui, the head of Operation Warp Speed, said on CBS’s “Face the Nation” that one way to speed up immunizations against COVID-19 was to give two half-volume doses of the Moderna Inc. (Cambridge MA) vaccine to some individuals.

“We know that for the Moderna vaccine giving half the dose for people between the ages of 18 to 55–two doses, half the dose, which means exactly achieving the objective of immunizing double the number of people with the doses we have–we know it induces identical immune response to the 100 microgram dose,” Slaoui said. “And therefore, we are in discussions with Moderna and with the FDA–of course ultimately it will be an FDA decision–to accelerate injecting half the volume,” he added.

The comments came in response to a question about why the US was not using the strategy of administering all available doses of vaccines now, even though the approved vaccines require a second round of shots to be fully effective. The United Kingdom has adopted this approach, with the hope that continued production will allow the second shots to be given in the future. Slaoui said he thought it would be a mistake to make a decision that was not supported by the trial data.

Fatigue, post-exercise malaise and cognitive dysfunction (or brain fog) are the most common symptoms reported by COVID long haulers 6 months after contracting the coronavirus, according to a new preprint study published on MedRxiv. Most people also experienced relapses, which were triggered by stress or exercise, and many were still unable to work at full capacity.

“We believe it’s vital at this time to collect and present a comprehensive dataset reflecting multifaceted long-COVID experiences reported by patients,” said Athena Akrami, the senior study author and a neuroscientist at University College London.

Most COVID-19 patients recover within a few weeks, but an increasing number of people have reported months-long symptoms that affect a number of organs. Published by the Patient Led Research for COVID-19, the study surveyed more than 3,700 people from 56 countries who contracted COVID-19 between December 2019 and May 2020. About 65% of respondents experienced symptoms for at least 6 months. They most often reported fatigue, post-exercise malaise and brain fog, but they also highlighted neurological sensations, headaches, memory issues, muscle aches, insomnia, heart palpitations, shortness of breath, dizziness, balance and speech issues.

And the FDA said on Friday genetic variants of COVID-19, including the one found in the UK, could lead to false negative results from some molecular COVID-19 tests, but the risk of the mutations affecting overall testing accuracy is low. The agency said it has alerted lab staff and healthcare providers to the possible false negative results and has asked them to consider such results in combination with clinical observations, and use a different test if COVID-19 is still suspected, Reuters reports. The more contagious variant of COVID-19 that has swept through the United Kingdom has been reported in at least five US states, National Institutes of Health Director Francis Collins said last week. Scientists have said newly developed vaccines should be equally effective against the new variant.

Still, Thermo Fisher Scientific Inc.’s TaqPath COVID-19 combo kit and Applied DNA Sciences Inc.’s Linea COVID-19 assay kit were found to have significantly reduced sensitivity due to certain mutations, including the B.1.1.7 variant or the so-called UK variant.

COVID-19 immunity robust eight months after infection, study says.

Certain antibodies and memory cells likely last more than 8 months after someone has contracted the coronavirus, especially if they have a strong immune response to COVID-19, according to a new study published last week in Science. Antibodies to the spike protein on the coronavirus were relatively stable after 6 months, and spike-specific memory B cells were higher at 6 months than the first month after infection. The number of memory T cells declined in about 4 to 6 months, but there were some that lasted.

“That amount of memory would likely prevent the vast majority of people from getting hospitalized [from] severe disease for many years,” Shane Crotty, the senior author and a virologist at the La Jolla Institute for Immunology, La Jolla, CA, told The New York Times.

The research team analyzed 254 blood samples from 188 COVID-19 patients across the country who had a range of disease, including asymptomatic, mild, moderate, and severe cases. Most had a mild case of COVID-19, and 93% were never hospitalized. Researchers also looked at 43 samples taken more than 6 months after symptoms started, up to 8 months post-infection.

The team found that neutralizing antibodies were stable between 1 to 8 months after infection and that these antibodies gradually declined over time but seemed to last longer. Memory B cells, which remember a virus to make antibodies, increased during the first 4 months after infection and then plateaued but lasted in nearly all of the cases after 8 months. Memory T cells, which recognize antigens on a virus and trigger an immune response, appeared within a month of infection and began a slow decline about 4 to 6 months after infection but also lasted. This is similar for other viruses that cause the flu and yellow fever. Specific “helper” T cells necessary for creating neutralizing antibodies and long-lasting immunity were present in nearly all of the samples analyzed and lasted for more than 6 months. Antibodies and memory B cells were higher in the patients who were hospitalized, which could mean that those with more severe COVID-19 may build up greater long-term immunity.

Overall, 64% of the cases had all five of the immune memory responses that were studied, appearing in the first or second month after infection. After 5 to 8 months, that dropped to 43%. However, 95% of the patients still had at least three of the five immunity categories after 5 months. Although researchers can’t make direct conclusions about COVID-19 immunity based on the levels of antibodies or memory cells in the samples, the findings seem promising. This might mean that an immune response could reduce reinfections, viral load, and disease severity in patients in the future. A few COVID-19 reinfections have been reported, but they tend to be asymptomatic or less severe, the authors wrote. “Durable immunity against secondary COVID-19 disease is a possibility in most individuals,” they wrote.

Just 150,000 people in the US have received both doses of a COVID-19 vaccine.

At least 151,000 people in the US have been fully vaccinated against COVID-19, according to a New York Times survey Saturday of all 50 states. Both of the vaccines being used across the country require patients to receive two doses spaced weeks apart, so the process of administering second shots to Americans has only just begun.

The Times sent surveys to state health departments, as well as health officials for territories and federal agencies that have received vaccine allotments from the Centers for Disease Control and Prevention. The tally of fully vaccinated people is an undercount because some states did not provide that information. The CDC, which is not yet reporting the number of people nationally who have gotten a second shot, said on Friday that about 6.7 million people had received a first dose of a vaccine. That falls far short of the goal federal officials set to give at least 20 million people their first shots before the end of 2020.

On Friday, the transition team for President-elect Joseph R. Biden Jr. announced a plan to accelerate vaccinations that includes reversing course and releasing nearly all available doses. That would provide more people with first doses but raise the risk that second doses would not be administered on time; however, ramped up vaccine production is expected to keep enough in the pipeline for timely second doses.

Officials from the Food and Drug Administration have spoken out strongly against changing the dosing schedule. Despite the slower-than-expected rollout, many states have started broadening the pool of people eligible to receive vaccines. After initially focusing on healthcare workers and people who lived or worked in long-term care facilities, some states are now offering shots to older adults or to people who have other high-risk jobs.

Indiana started offering vaccines to anyone over age 80. West Virginia said teachers over age 50 were now eligible. And the US Virgin Islands authorized grocery store workers, bus drivers and police officers to receive vaccines. After frictions with the mayor of New York City, Bill de Blasio, New York governor Andrew M. Cuomo expanded the groups eligible for vaccines to include three million more people, including those 75 and older. More states are expected to expand their vaccine programs in the coming days. The government says it has distributed about 22.1 million doses of COVID-19 vaccines to states and other jurisdictions.

Medical Stock Spotlight

Jaguar Health Inc. (NASDAQ:JAGX) led advancing issues, skyrocketing 391% over the week to $4.00, continuing the pharmaceutical company’s stunning gains since mid-November. Investors have bid up the healthcare stock after management announced its plan to develop and commercialize crofelemer, a new drug aimed at helping people with inflammatory diarrhea, including those who have recovered from COVID-19 but are still experiencing symptoms. San Francisco-based Jaguar Health said the plan could involve a potential merger of its operating subsidiary with Swiss Growth Forum, a sponsor of a special purpose acquisition company (SPAC). Preliminary terms of the deal include Jaguar receiving upfront cash payments of as much as $10 million and at least $20 million in clinical development funding, as well as an equity stake in the new company of 30% to 49.9%. Jaguar’s stock price surged recently, following the company’s announcement on Jan. 6 that it began a 28-day preclinical toxicology and safety study in dogs for lechlemer, a plant-based candidate for the relief of diarrhea from cholera.

Elsewhere, Chimerix Inc. (NASDAQ:CMRX) soared 74% to $8.42 on the news that the struggling biotech is acquiring a matching asset. Durham, NC-based Chimerix announced it has purchased Oncoceutics Inc., which like itself is a clinical-stage biotech actively developing cancer drugs. The price is $78 million, which will be divided evenly in a mix of cash and Chimerix stock. $25 million of the cash component was to be paid on the closing of the deal, with the remainder due one year thereafter. As with any respectable deal in the biotech space, Oncoceutics shareholders will be eligible to earn milestone payments if the company hits certain development, regulatory, and sales targets. They can also earn product royalties. Oncoceutics currently has five oncology therapies in its pipeline. Its lead product candidate certain is ONC201, an orally administered treatment that, according to Chimerix, has demonstrated efficacy in inducing cell death in several types of cancer. The drug candidate is currently in clinical trials for the treatment of glioma, an aggressive type of brain tumor.

And Arcturus Therapeutics Ltd. (NASDAQ:ARCT) surged 61% to $69.66 after Wells Fargo analyst Jim Birchenough initiated coverage on the stock with an overweight rating. He also set a $118 price target–a premium of 139% to Arcturus’s closing price last Wednesday. Arcturus’s shares plunged in December after the company announced updated results from a Phase 2 study of COVID-19 vaccine candidate ARCT-021 that disappointed investors. Birchenough thinks that ARCT-021 could be more successful than many expect. In particular, Birchenough still  anticipates that the experimental vaccine could be highly effective at a lower dosage than the leading coronavirus vaccines. The problem for investors is that there’s currently no way to know for certain if Birchenough will ultimately be proven right. However, if ARCT-021 does achieve high efficacy and a solid safety profile with a single dose, San Diego-based Arcturus could hit the analyst’s price target. A single-dose COVID-19 vaccine would be welcome to governments across the world.

But Calithera Biosciences Inc. (NASDAQ:CALA), a clinical-stage biotech company, plummeted 44% to $2.75 after reporting that telaglenastat, one of its leading pipeline candidates, flopped in a clinical trial. The clinical trial in question investigated the efficacy of the combination of telaglenastat, an experimental cancer treatment, and cabozantinib, a cancer drug marketed by Exelixis Inc., on patients with advanced or metastatic renal cell carcinoma (RCC). The primary endpoint of the study was improvement in progression-free survival (the amount of time during and after treatment the patient lives with cancer without experiencing worsening symptoms), compared to treatment with cabozantinib alone. Unfortunately, the combination of telaglenastat and cabozantinib didn’t meet the primary endpoint of the study. As a result of this outcome, South San Francisco-based Calithera Biosciences will cut its workforce by about 35% and focus its financial resources on other ongoing studies.

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