Biden signs raft of coronavirus orders, pledges help is forthcoming.

President Joe Biden signed 10 additional executive orders on Thursday, summoning the Defense Production Act in a “wartime undertaking” to augment production of vaccine supplies while also requiring travelers to the US to get a test before flying. After attacking Donald Trump’s coronavirus response as a candidate and throughout the transition, Biden laid out in more detail what he’ll do differently as cases and hospitalizations continue to rise, with the US death toll expected to reach half a million people within weeks.

Biden said that the worst of the pandemic is yet to come and that it will take time for progress to be measurable. Politico reports that Biden’s plan aims to speed up vaccinations and testing and better protect workers. It also directs the Education and Health and Human Services departments to get schools guidance and resources they need to reopen safely. Further, it will reimburse states for the use of the National Guard in COVID-19 relief efforts, he said. He also said Thursday that his administration directed FEMA to have a COVID-19 liaison to help “maximize cooperation between the federal government and the states.”

“We’re in a national emergency. It’s time we treat it like one,” Biden said. “This is a wartime undertaking. The brutal truth is that it will take months for a majority of Americans to be vaccinated.”

He has pledged 100 million Vaccine shots in his first 100 days. Biden was testy when a reporter asked Biden if 100 million was high enough.

“When I announced it, you all said it’s not possible,” Biden chided. “C’mon, give me a break, man.”

This next wave of executive actions comes after Biden, hours after being sworn in, signed an order requiring face coverings and social distancing on federal property and canceled the Trump administration’s attempt to withdraw the US from the World Health Organization. But while many of the latest moves flex the executive branch’s power, several depend on cooperation from Congress or governors.

“We do need Congress to act and act quickly,” Jeff Zients, Biden’s coronavirus coordinator, said, calling for passage of the $1.9 trillion COVID relief bill Biden unveiled last week. “We will only overcome this pandemic together. It’s the only way out of the darkness.”

The order invoking the Defense Production Act is to increase the supply of all the materials needed to get the vaccines into arms and ramp up testing. The order covers N95 masks and other protective gear, testing machines, rapid test kits and syringes capable of maximizing the amount of COVID vaccine that can be extracted from vials. Tim Manning, a former FEMA official who will be Biden’s COVID-19 supply coordinator, said he sees the DPA as just one of many tools the new administration can use going forward.

“We’ll do whatever we need to do to ensure that we have an adequate supply of vaccine,” he said.

Biden also ordered the creation of a pandemic testing board, modeled on President Franklin Roosevelt’s War Production Board, that will be tasked with expanding testing capacity, particularly in schools. Officials said Biden will also “clarify” health insurance companies’ obligation to cover COVID-19 testing, a sign the new administration may reverse a policy that has allowed insurers to refuse to cover testing of asymptomatic individuals for public health surveillance or back-to-work programs.

According to Johns Hopkins Medical, as of Sunday January 24, there were 99 million global COVID-19 cases confirmed, and over 2.1 million deaths. Confirmed cases in the US totaled over 25 million with over 415,000 deaths. The US figures comprise nearly 25% and 20% respectively of the global totals. The 19 million doses of COVID vaccines administered to people as of Friday represent about 48% of the 39.8 million doses that have been distributed, according to the CDC. About 5% of the US population–roughly 16.2 million people–has received at least one dose of the vaccine, and 2.75 million people are fully vaccinated, according to CDC data updated Friday morning. The tally of vaccine doses are for both Moderna and Pfizer/BioNTech vaccines as of 9:00 a.m. ET on Friday, the agency said.

COVID-19 Addenda: The US will remain a member of the World Health Organization under President Joe Biden, Dr. Anthony Fauci said Thursday, and intends to join a global alliance that aims to deliver coronavirus vaccines to low-income countries. Speaking from Washington by videoconference one day after Biden was sworn into office, the US chief medical advisor told the WHO’s executive board: “

President Biden will issue a directive later today which will include the intent of the US to join COVAX and support the ACT-Accelerator to advance multilateral efforts for COVID-19 vaccine, therapeutic, and diagnostic distribution, equitable access, and research and development.” The US will also remain a member of the WHO and “fulfill its financial obligations,” Fauci said.

In May, then-President Donald Trump announced that the US would withdraw from the WHO, but the process wasn’t expected to be finalized until this July. Fauci said the Biden administration planned to work with the other 193 member states to help “strengthen and reform” the United Nations health agency.

President Biden signed an executive order to back up Centers for Disease Control and Prevention (CDC) guidelines recommending that international travelers quarantine for seven days after arriving in the US. Biden’s executive order says travelers must comply with CDC orders that require a negative COVID-19 test to get into the country as well as a quarantine period upon arrival to the states, according to The Hill. The CDC recently released a new mandate requiring international travelers to get a negative coronavirus test at least three days before their flight. The mandate is set to go into effect Tuesday.

Biden also signaled that he wants US agencies to talk with Canada and Mexico about COVID-19 protocols at ports of entry to the country. “The Secretary of State, in consultation with the Secretary of HHS, the Secretary of Transportation, the Secretary of Homeland Security, and the Director of CDC, shall immediately commence diplomatic outreach to the governments of Canada and Mexico regarding public health protocols for land ports of entry,” the order states. Those agencies have two weeks to return to Biden with a plan for health measures they recommend.

As AstraZeneca PLC (London) nears European authorization for its highly anticipated COVID-19 vaccine, the drugmaker has notified officials that initial shipments will come in lighter than originally expected. Two German-language publications, Bild and oe24, report that AstraZeneca notified EU officials last week that its first-quarter deliveries will come in lower than originally expected.

An AstraZeneca spokesperson attributed the dip to “reduced yields at a manufacturing site within our European supply chain.” She added, “We will be supplying tens of millions of doses in February and March to the European Union, as we continue to ramp up production volumes.”

The news comes after AstraZeneca applied for European authorization of its Oxford-partnered vaccine earlier this month. The company’s vaccine could win European authorization around the end of January, according to reports. So far, the Pfizer and Moderna mRNA vaccines have scored European green lights. In a Phase 3 trial, AstraZeneca’s vaccine was 70% effective overall, but a dosing error in some participants yielded a higher efficacy result. (Ref: FiercePharma)

Oxford University scientists are preparing to rapidly produce new versions of their vaccine to combat emerging more contagious COVID-19 variants discovered in the UK, South Africa and Brazil, The Telegraph reported last Wednesday. The team behind the vaccine from Oxford and AstraZeneca PLC (London) is undertaking feasibility studies to reconfigure the technology, the newspaper said, citing a confirmation from the Oxford University. The scientists were working on estimating how quickly they could reconfigure their ChAdOx vaccine platform, the report said.

A university spokesman told the newspaper that Oxford is carefully assessing the impact of new variants on vaccine immunity and evaluating the processes needed for rapid development of adjusted COVID-19 vaccines. Oxford did not immediately respond to a Reuters request for comment. Separately, British Prime Minister Boris Johnson said on Wednesday that the nation’s medicines regulator will be ready and able to give approval to new versions of COVID-19 vaccines designed to counter new variants of the coronavirus that may appear.

And three-quarters of patients hospitalized in China with COVID-19 were still experiencing at least one symptom of the infection six months after being discharged, according to a follow-up study involving 1,733 patients.

“Patients with COVID-19 had symptoms of fatigue, sleep difficulties, and anxiety or depression,” and those with “more severe illness during their hospital stay had increasingly impaired pulmonary diffusion capacities and abnormal chest imaging manifestations,” Chaolin Huang, MD, of Jin Yin-tan Hospital in Wuhan, China, and associates wrote in the Lancet.

Fatigue or muscle weakness, reported by 63% of patients, was the most common symptom, followed by sleep difficulties, hair loss, and smell disorder. Altogether, 76% of those examined six months after discharge from Jin Yin-tan hospital–the first designated for patients with COVID-19 in Wuhan–reported at least one symptom. Symptoms were more common in women than men: 81% vs. 73% had at least one symptom, and 66% vs. 59% had fatigue or muscle weakness. Women were also more likely to report anxiety or depression at followup: 28% vs. 18% (23% overall). (Ref: Reuters)

Lilly says antibody med shrinks COVID-19 risk for nursing home residents.

Eli Lilly & Co. (Indianapolis) announced Thursday that in a Phase 3 study, bamlanivimab was shown to significantly reduce the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The findings from the BLAZE-2 COVID-19 prevention trial suggest the risk was decreased by up to 80% in people administered the antibody therapy versus those in the same facility given placebo, according to FirstWord Pharma. The study enrolled residents and staff at skilled nursing and assisted living facilities across the US, with 965 people who tested negative for the SARS-CoV-2 virus at baseline randomized to receive either bamlanivimab or placebo. The trial’s primary outcome measure is cumulative incidence of COVID-19, defined as the detection of SARS-CoV-2 by RT-PCR and mild or worse disease severity within 21 days of detection. Meanwhile, additional endpoints include cumulative incidence of SARS-CoV-2 infection and moderate or worse disease severity within 21 days of detection.

According to Eli Lilly, participants who tested negative for SARS-CoV-2 at baseline, including 299 residents and 666 staff, were included in the analysis of primary and key secondary endpoints for assessing prevention, while 132 people, comprising 41 residents and 91 staff, who tested positive for the virus at baseline, were included in exploratory analyses for assessing treatment. Results demonstrated that after all participants reached eight weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 in the bamlanivimab treatment arm versus placebo, while this was also seen in the pre-specified subgroup of nursing home residents. The company added that all key secondary endpoints reached significance in both the overall and resident populations. Further, exploratory analyses showed that results for viral load in the treatment group were “consistent” with previously disclosed data from the BLAZE-1 study evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19.

Eli Lilly indicated that among the 299 residents in the prevention group, there were four deaths attributed to COVID-19, and all occurred in the placebo arm. Meanwhile, among the 41 residents in the treatment group, there were four deaths, all of which occurred in the placebo arm as well. Over the entire trial, there were a total of 16 reported deaths reported, including those not related to COVID-19. The drugmaker said that all of these deaths were in residents, with 11 in the placebo arm and five in the bamlanivimab arm. Bamlanivimab is currently authorized for emergency use in the US for the treatment of mild-to-moderate COVID-19 in high-risk patients. The drug, also known as LY-CoV555, is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2. Lilly shares closed the week up 8% at $206.14.

US coronavirus cases fall, but variants could reverse that hopeful trend.

The US is closely watching the more infectious variant of COVID-19 after British officials warned that it may also be more deadly, US National Institutes of Health Director Francis Collins said on Saturday. But Reuters reports that US health officials are even more worried about a separate variant from South Africa, although that one has not yet been identified among US cases of the novel coronavirus, Collins told MSNBC in an interview. Collins noted the UK’s data was preliminary, and said it was unclear why those with the UK variant faced a higher risk of death, whether by changes in the virus itself or other external causes such as pressures on the healthcare system.

“Let’s take this as something to watch closely,” he said.

Collins’ comments come as Democratic President Joe Biden takes the reins of the nation’s COVID-19 response, seeking to re-energize the fight against the highly infectious disease and urging a war-like stance. In a flurry of actions since taking office last Wednesday, Biden unveiled a new US strategic plan to curtail the outbreak and signed numerous executive orders to boost vaccines and increase mask use, among other measures.

The US is the nation hardest-hit by COVID-19, with nearly 25 million cases and 415,000 deaths by Sunday afternoon. Over the past week, 3,089 Americans have died of the disease on average, while 20 US states reported record deaths this month. British Prime Minister Boris Johnson on Friday warned that the UK variant was associated with higher level of mortality but said vaccines still appeared effective against it. The US Centers for Disease Control and Prevention last week warned the UK variant, already circulating in at least 10 US states, could become the dominant variant in the US by March.

The variant, known as B.1.1.7, is believed to be twice as contagious as the current version circulating across the US. Despite a subtle difference in the data, Collins said it showed current vaccines would still be very protective against the UK variant, so “at the moment we are not alarmed about that,” Collins said. “We are somewhat more concerned about a South African variant” that appears to be somewhat less protected against by vaccines, he added. No known cases, however, have been found in the US yet, he added.

Scientist magazine on Wednesday said the South African variant may reduce the efficacy of current vaccines, which also raises the prospect of re-infection. The United Kingdom has banned travelers from some African countries in an attempt to stop the spread of that strain in the British Isles and is weighing further restrictions. Pres. Biden has moved to impose a mandatory quarantine for air passengers arriving in the US. He is also requiring US-bound passengers to have a negative COVID-19 test starting on Tuesday.

Medical Stock Spotlight

Gritstone Oncology Inc. (NASDAQ:GRTS) led advancing issues, skyrocketing 355% over the week to $27.11 after the tiny cancer drugmaker received backing from an arm of the National Institutes of Health to begin testing a potential coronavirus vaccine that could fight off worrying mutations that have been found around the globe. The Emeryville, CA-based company entered into a clinical trial agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to test what the company is calling a second-generation vaccine that could protect against COVID-19 spike mutants. Gritstone CEO Andrew Allen said, “It’s a very natural extension of what we’ve been doing. At some level, we hoped that it would never be necessary [for coronavirus], but…we are now starting to see some resistant variants arising such that we may need alternative approaches such as ours.” Gritstone also received backing from the Bill & Melinda Gates Foundation to assist in preclinical evaluations of the potential coronavirus vaccine. Founded five years ago, the biotech created a solution to trigger the immune system to react to cancer cells.

Elsewhere, Obalon Therapeutics Inc. (NASDAQ:OBLN) soared 254% to $6.02 after the weight loss technologies company announced an agreement to merge with weight solutions company ReShape Lifesciences Inc. ReShape shares, which currently trade over the counter, rose 127% for the week to $9.09. When the merger is completed, ReShape shareholders will own 51% of the combined entity, and Obalon will be renamed Reshape Lifesciences Inc. and trade on the Nasdaq under the ticker symbol “RSLS.” Carlsbad, San Diego-based Obalon developed the first and only FDA-approved swallowable, gas-filled intragastric balloon system for the treatment of obesity. “We are excited with this opportunity to add Obalon’s FDA approved Balloon System to ReShape’s line of minimally invasive weight-loss solutions while also expanding our market reach,” said ReShape Chief Executive Bart Bandy. Obalon’s stock has now rocketed 621% over the past three months while ReShape shares have soared 246%.

And Aclaris Therapeutics Inc. (NASDAQ:ACRS) shot up 199% to $18.22. An investigational oral MK2 inhibitor from the Wayne, PA-based clinical-stage biopharmaceutical company was safe and associated with promising reductions in inflammatory markers in a 12-week, Phase 2a study of patients with moderate to severe rheumatoid arthritis (RA). Aclaris Therapeutics’ MK2 inhibitor candidate used in this study, ATI-450, was developed using the company’s KINect drug-discovery platform. The positive preliminary topline findings from the multicenter, placebo-controlled trial included data for 19 patients with moderate to severe RA who were randomly assigned to either twice daily 50 mg ATI-450 (n=16) or placebo (n=3) plus methotrexate. Treatment was administered for 12 weeks. Safety and tolerability comprised the primary endpoints, while secondary and exploratory endpoints were disease activity scores, DAS28-CRP and ACR20/50/70 as well as change from baseline in high sensitivity C-reactive protein (hsCRP) and endogenous cytokines.

But Cardiff Oncology Inc. (NASDAQ:CRDF) continued its slump for a second consecutive week, tumbling 44% to $10.90. It skidded 27% to $13.46 the week prior. The dive came after the San Diego-based company presented data from a Phase 1b/2 study of onvansertib in treating KRAS-mutated metastatic colorectal cancer (mCRC) at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. Biotech stocks don’t plunge when investors are happy with clinical trial updates. Motley Fool notes “it’s obvious that at least some investors were disappointed by Cardiff’s latest news.” Only 12 patients in the Phase 1b/2 study were evaluable in time to be included in the ASCO presentation. Five achieved a partial response (some tumor shrinkage) with four patients having confirmed partial responses. Eight demonstrated what Cardiff described as “durable responses” of at least six months. In addition, the company stated that onvansertib in combination with chemotherapy was found to be safe and well-tolerated. Cardiff said that 9% of adverse events reported in the study were grade 3 (severe) or grade 4 (life-threatening).