Top Stories for Week of January 4, 2021

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New Year arrives as US exceeds 20 million COVID-19 cases.

America just surpassed 20 million COVID-19 cases, nearly a year after a mysterious germ first revealed itself in Wuhan, China. That number is almost twice as many as in India, the second-worst-hit country, Bloomberg reports. New York state’s infections remained high, just below the record set last Wednesday, as the rate of positive tests in New York City rose toward 10%. California fatalities, on the other hand, reached a record. The pandemic arrived in 2021 with no signs of slowing.

Global daily deaths reached record highs last week. Countries from Germany to Japan to South Africa ended 2020 with record daily cases. Turkey, China and Brazil became the latest to report infections of the new, highly transmissible virus strain. Vaccines remained the best hope for 2021. The World Health Organization issued an emergency-use designation for Pfizer Inc.’s (NYC) jab, a move that could allow more countries to import and distribute the vaccine.

The US ended the year with records and milestones: New York state and Florida, each hit hard as the coronavirus ravaged across the nation, broke their previous daily records for cases. Texas reported a new high for hospitalizations. California became the third state to pass 25,000 fatalities, after New York and Texas. Virginia reported record infections as total fatalities surpassed 5,000.

New York City plans to speed up the slow start to vaccinations and inoculate 1 million residents in January, Mayor Bill de Blasio said. Governments across the globe urged people to celebrate the New Year at home. The new, highly transmissible virus strain was found in Colorado, California, China, Brazil and Singapore. Four nurses in the Netherlands were also diagnosed with the variant.

The new coronavirus variant that emerged in the UK is more transmissible and appears to affect a higher proportion of people under 20, according to a report from Imperial College London and other science groups. The mutation of concern has “a substantial transmission advantage” and is linked to “epidemic growth in nearly all areas,” the scientists wrote. It can raise the virus’s reproduction rate, which indicates how many people one patient infects, by as much as 0.7, the researchers found. “This will make control more difficult and further accentuates the urgency of rolling out vaccination as quickly as possible,” said Neil Ferguson, a professor at Imperial who has worked on modeling the outbreak.

Social distancing measures that worked against earlier strains of the virus were insufficient to control the spread of the new variant, the study found. The government had previously said the new strain was as much as 70% more transmissible than other versions, without providing documentation. The researchers used statistical tools to evaluate the link between transmission and frequency of the new variant across the UK. The data have informed the government’s pandemic planning in recent weeks, Ferguson said. It’s possible the new variant appears to infect the young the most because the research was conducted at a time when there were lockdowns but schools remained opened, the scientists said.

According to Johns Hopkins Medical, as of Saturday, January 2, there were over 84 million global COVID-19 cases confirmed, and some 1.8 million deaths. Confirmed cases in the US totaled 20.2 million with nearly 350,000 deaths. The US figures comprise 24% and 19% respectively of the global totals. The US population comprises 4% of the global total. As of Sunday morning, over 14 million vaccine doses have been distributed across the US, but only 4.2 million people have received shots, according to the CDC.

COVID-19 Addendum: Last week the leading US infectious disease specialist, Dr. Anthony Fauci, said he foresees America achieving enough collective COVID-19 immunity through vaccinations to regain “some semblance of normality” by autumn 2021, despite early setbacks in the vaccine rollout. Fauci made his remarks during an online discussion of the pandemic with California Governor Gavin Newsom, who announced at the outset that a more infectious coronavirus variant originally found in Britain has been detected in his state, a day after the first known US case was documented in Colorado.

Newsom said the coronavirus variant B.1.1.7 had been confirmed earlier in the day in a Southern California patient. He did not provide further details. But the California Department of Public Health said in statement later that the person, a San Diego County patient, has no known travel history, suggesting the variant is spreading within the community.

Fauci said, “It appears that this particular mutation does make the virus better at transmitting from one person to another.”

China approved its first COVID-19 vaccine for general public use on Thursday, a shot developed by an affiliate of state-backed pharmaceutical giant Sinopharm Group Co., Ltd., as it braces for greater transmission risks over the winter. No detailed efficacy data of the vaccine has been publicly released, but its developer, Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group (CNBG), said its vaccine was 79.34% effective in preventing people from developing the disease based on interim data.

The approval, announced by the National Medical Products Administration, comes after the United Arab Emirates last month became the first country to roll out the vaccine to the public, and as Pakistan announced a 1.2 million dose purchase deal with Sinopharm. While China has been slower than several other countries in approving COVID-19 vaccines, it has been inoculating some citizens for months with three different shots still undergoing late-stage trials.

Virginia state Sen. Ben Chafin died Friday from COVID-19 complications, the Republican senator’s office confirmed Friday night. Chafin had been hospitalized at VCU Medical Center for two weeks, according to a news release. The Russell County native represented the 38th District, which includes several Southwest Virginia counties. He first served in the Virginia House of Delegates in 2013 before being elected to the state Senate in 2014. Voters re-elected Chafin in 2019.

Separately, Luke Letlow, Louisiana’s incoming Republican member of the US House, died last Tuesday night from complications related to COVID-19 only days before being sworn into office. He was 41. Letlow spokesman Andrew Bautsch confirmed the congressman-elect’s death at Ochsner-LSU Health Shreveport. “The family appreciates the numerous prayers and support over the past days but asks for privacy during this difficult and unexpected time,” Bautsch said in a statement.

The European Union will buy an extra 100 million doses of Pfizer Inc. (NYC) and BioNTech SE’s (Mainz DEU) COVID-19 vaccine, bringing the total from the two firms to 300 million doses, European Commission President Ursula von der Leyen said.

“We decided to take an additional 100 million doses of the BioNTech/Pfizer vaccine, which is already being used to vaccinate people across the EU,” she said on Twitter. “We will therefore have 300 million doses of this vaccine, which was assessed as safe and effective,” von der Leyen added.

The plan comes after some of the vaccine candidates ordered by the EU faced unexpected delays in clinical trials, forcing the bloc and other wealthy nations to rely on shots from fewer manufacturers than initially planned. The Pfizer/BioNTech shot, the first COVID-19 vaccine to be approved by Western drugs regulators, is being rolled out in countries including Britain and the US. Under the EU contract, the two firms have committed to rapidly deliver 200 million doses after regulatory approval for 15.5 euros ($18.8) apiece, EU officials told Reuters in November.

And Senator Mitt Romney on Friday urged the US government to immediately enlist veterinarians, combat medics and others in a sweeping proposal to administer coronavirus vaccinations and slow the rising death toll. The 2012 Republican presidential nominee called for action after it emerged that just 2.8 million Americans had received their first dose, far short of the 20 million the Trump administration promised by the end of 2020.

“That comprehensive vaccination plans have not been developed at the federal level and sent to the states as models is as incomprehensible as it is inexcusable,” Romney said.

Nearly 350,000 people have died from COVID-19 in the US, equal to one in every 950 people. The country ranks 16th in per capita deaths in the world. With Democratic President-elect Joe Biden not taking office until Jan. 20, Romney is one of the few leading Republicans to openly criticize fellow Republican President Donald Trump.

Moderna’s COVID-19 vaccine 94.1% effective, New England Journal of Medicine confirms.

The recently authorized COVID-19 vaccine developed by Moderna Inc. (Cambridge MA) and the National Institute of Allergy and Infectious Diseases (NIAID) was 94.1% effective in preventing symptomatic COVID-19, according to Phase 3 trial results published December 30 in the New England Journal of Medicine. No cases of severe COVID-19 occurred among participants who received the vaccine, known as mRNA-1273, and there were no safety concerns Medscape reports.

The US Food and Drug Administration on December 18 issued an emergency use authorization for the vaccine, a lipid-nanoparticle-encapsulated mRNA vaccine expressing the prefusion-stabilized spike glycoprotein. The trial began in July and enrolled 30,420 adults in the US. Volunteers were randomly assigned in a 1:1 ratio to receive either two doses of the vaccine or two shots of saline placebo 28 days apart. The average age of the participants was 51 years. In all, 196 cases of symptomatic COVID-19 occurred at least 14 days after participants received their second shot–185 cases in the placebo group, and 11 in the vaccine group.

In a secondary analysis that included cases that occurred at least 14 days after the first shot, vaccine efficacy was 95.2%, study author Lindsey R. Baden, MD, of Brigham and Women’s Hospital, Boston, MA, and colleagues report. About half of the participants who received mRNA-1273 experienced moderate to severe side effects, such as fatigue, muscle aches, joint pain and headache, after the second dose. Most adverse events resolved within 20 days. Future studies will assess the vaccine’s effect on infectiousness.

Both the Moderna vaccine and the Pfizer-BioNTech vaccine “begin to protect recipients approximately 10 days after the first dose, with maximum protection after the second dose,” said Barton F. Haynes, MD, in an accompanying editorial. That both have “near-identical 94% to 95% vaccine efficacies–and that both vaccines were developed and tested in less than a year–are extraordinary scientific and medical triumphs,” said Haynes, director of the Duke Human Vaccine Institute, Durham, NC.

Continued safety monitoring and analysis of virus escape from protective immune responses will be important, Haynes added. Subgroup analyses by age, sex, race/ethnicity, and risk for severe COVID-19 showed “maintenance of efficacy across the board,” tweeted Medscape Editor-in-Chief Eric Topol, MD, leader of the Scripps Translational Science Institute in La Jolla, CA. Topol highlighted the absence of severe COVID-19 among participants who received the vaccine. All 30 participants in the trial who developed severe COVID-19 were in the placebo group. One death among those was attributed to COVID-19.

US vaccinations in 2020 fall far short of 20 million goal.

Only about 2.8 million Americans had received a COVID-19 vaccine going into the last day of December, putting the US way short of the government’s target to vaccinate 20 million people last month.

Simply put, the race to vaccinate millions of Americans is off to a slower, messier start than public health officials and leaders of the Trump administration’s Operation Warp Speed had expected. Overworked, underfunded state public health departments are scrambling to patch together plans for administering vaccines, says Medscape. Counties and hospitals have taken different approaches, leading to long lines, confusion, frustration and jammed phone lines.

A multitude of logistical concerns have complicated the process of trying to beat back the scourge that has killed over 340,000 Americans. Florida Gov. Ron DeSantis is asking for patience, noting the vaccine supply is limited. “It may not be today for everyone, may not be next week. But over the next many weeks, as long as we continue getting the supply, you’re going to have the opportunity to get this,” he said last Wednesday.

Dr. Ashish Jha, a health policy researcher and dean of the Brown University School of Public Health, said the main problem is that states are not getting adequate financial or technical support from the federal government. Jha said the Trump administration, principally the Department of Health and Human Services, has set states up to fail. “There’s a lot states still need to do,” he said, “but you need a much more active role from the federal government than what they have been willing to do. They’ve largely said to states, ‘This is your responsibility. Figure it out.’” Lags in reporting vaccination numbers explain in part why many states aren’t meeting their year-end goals, but officials blame logistical and financial hurdles for the slow pace. Many states lack the money to hire personnel, pay for overtime or reach out to the public. The equipment required to keep the vaccines cold complicates their distribution. Also, providers need to track vaccinations so they have enough to dispense the required second doses 21 days after the first.

Dr. James McCarthy, chief physician executive at Memorial Hermann in Houston, said the hospital system has administered about half of the roughly 30,000 doses that it has received since Dec. 15. The system had to create a plan from scratch. Among other things, administrators had to ensure that everyone in the vaccination areas could socially distance, and they had to build in a 15-minute observation period for each patient so that recipients could be watched for any side effects. “We can’t just hand it out like candy,” McCarthy said. Pasadena, CA, is vaccinating its firefighters in groups of 50 after their two-day shifts are over so they can recuperate during their four days off.

Medical Stock Spotlight

The 2020 stock market soared to new highs, and healthcare held its own with some jaw-dropping winners and just one bomb, all framed under the overhang of the pandemic and the everlasting war on cancer. Here they are, starting with the year’s top four victors.

Novavax Inc. (NASDAQ:NVAX) led the pack, skyrocketing 2,702% the past 12 months to $111.51. The Gaithersburg, MD-based vaccine maker last week said it’s commencing Phase 3 clinical trials for its Prevent-19 (NVX-CoV2373) novel coronavirus vaccine in the US and Mexico. The company submitted its Prevent-19 for a UK Phase 3 trial three months ago, so investors are likely expecting headlines pertaining to domestic efforts. Some of the problem here for Novavax is that it’s behind rivals such as Pfizer Inc. and Moderna Inc. Vaccines produced by those companies are already being administered across the US.

Elsewhere, Vaxart Inc. (NASDAQ:VXRT) blasted upwards 1,529% to $5.71. The South San Francisco-based company’s eye-popping rally rests squarely on the promise of an oral Covid-19 vaccine. “Most of us associate vaccines with needles,” said Andrei Floroiu, the biotech company’s CEO. “An oral vaccine would be the holy grail.” Timing is everything as Pfizer Inc. and partner BioNTech SE began rolling out their own shot with Moderna Inc. following soon thereafter. The company is targeting the start of a mid-stage study in the first quarter and plans to enroll patients in and outside of the US.

Cardiff Oncology Inc. (NASDAQ:CRDF) soared 1,351% to $17.99. The clinical-stage biotechnology company is developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia. Most recently, San Diego-based CRDF announced the presentation of updated data from its Phase 1b/2 study in relapsed/refractory acute myeloid leukemia (AML). The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML. Most impressive among the results was that nine of 45 (20%) patients achieved a complete remission with or without hematologic count recovery.

And Trillium Therapeutics Inc. (NASDAQ:TRIL) surged 1,342% to $14.71. The stock has seen highs and lows that would give most shareholders whiplash. Shares of Mississauga, ON, Canada-based Trillium sat at $0.24 last December before rocketing higher to $21 at the end of November. Trillium’s journey started last year with a new CEO and a doubling down on a potential treatment for blood cancers. The focus paid off. Early results from a Phase 1 study in January showed the company’s two drug candidates, TTI-621 and TTI-622, demonstrated the ability to block the signal that nearly all cancer cells use to cloak themselves from the immune system. That was enough to get Pfizer’s attention. The drug giant invested $25 million into Trillium in September.

But Aprea Therapeutics Inc. (NASDAQ:APRE) tanked 89% on the year to $4.92. The swan dive culminated last week after the Boston-based company announced its late-stage cancer combination treatment failed to meet its primary endpoint of complete remission rate. Aprea was investigating the combination of eprenetapopt and the chemotherapy drug azacitidine as a potential treatment for TP53 mutant myelodysplastic syndromes (MDS). The Phase 3 study assessed the combination against azacitidine alone in this indication. Aprea said the combination treatment appeared to demonstrate a higher complete remission rate than azacitidine alone, but the results did not reach statistical significance. Continued analyses of the trial data, including secondary endpoints, will be conducted as the patient follow-up lengthens.

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