Biden announces bold plan to get America vaccinated.

President-elect Joseph R. Biden has unveiled a plan to jump-start the nation’s faltering COVID-19 vaccine effort that will include establishing mass vaccination sites and mobile vaccine clinics around the nation. Biden has repeatedly promised that his administration will vaccinate 100 million people during the first 100 days. “I’m convinced we can get it done,” Biden said in remarks on Friday.

“This is a time to set big goals and to pursue them with courage and conviction because the health of the nation is at stake,” he said.

The plan calls for a $20 billion investment in a national vaccination program Medscape reports. The funds are included as part of a $400 billion COVID response contained in the proposed $1.9 trillion COVID relief package that Biden hopes to get through Congress. His administration aims to ensure that all Americans can receive a vaccine with zero cost-sharing. According to the Centers for Disease Control and Prevention, 31 million COVID-19 doses have been distributed and 12.2 million have been administered thus far, including 1.3 million to residents of long-term care facilities. Some 1.6 million individuals have received 2 doses, and thus are considered fully vaccinated.

In the televised speech, Biden outlined five major goals:

1) Work with states to expand eligibility to anyone age 65 or older and to essential workers while continuing to vaccinate healthcare workers;

2) Set up thousands of new, federally supported mass vaccination centers at gyms, stadiums, and other locations–with 100 set up by the end of his first month in office; the sites would be supported by the Federal Emergency Management Agency (FEMA), which will mobilize thousands of clinical and nonclinical staff and contractors to work with state and local teams and the National Guard; Biden is seeking to have the federal government cover 100% of states’ National Guard deployment costs and fully cover the states’ costs for Medicaid recipients;

3) Deploy mobile vaccination clinics to hard-to-reach, underserved urban and rural areas, relying in part on community-based physicians;

4) “Jump-start” a federal partnership with pharmacies to increase capacity at chains and independent outlets; and

5) Use the full strength of the federal government to ramp up supply, which means using the Defense Production Act to help ensure the uninterrupted production and delivery of vaccine and vaccine supplies, with an aim of releasing most vaccine supply when available, while keeping a small reserve to cover unforeseen shortages or delays.

Increasing vaccination means expanding the workforce, which has been taxed by the ongoing COVID response. The Biden plan would encourage states to allow additional qualified professionals to administer vaccines and expand the scope of practice laws and waive licensing requirements as appropriate. Biden said he envisions using military clinicians, FEMA personnel, and staff from the US Public Health Service Commissioned Corps to help expand the number of vaccinators.

He also said he would seek a declaration to allow certain qualified professionals, including retired medical workers who are not licensed to administer vaccines, to be able to do so with appropriate training. The President-elect also promised to be transparent. “We’re going to make sure that state and local officials know how much supply they’ll be getting and when they can expect to get it so they can plan,” he said. He noted that officials have said they aren’t getting clear information from the current administration on vaccine supply. Biden said his administration would lead with science and that his agencies would be “free from political influence.”

According to Johns Hopkins Medical, as of Saturday, January 16, there were 94 million global COVID-19 cases confirmed, and over 2 million deaths. Confirmed cases in the US totaled nearly 24 million with over 394,000 deaths. The US figures comprise 25% and 20% respectively of the global totals. The US population comprises 4% of the global total.

COVID-19 Addenda: The SARS-CoV-2 variant first documented in Britain could become the primary strain in the US by March, researchers found. Despite only 76 infections with the variant, B117 or VOC 202012/01, detected in the US through Jan. 13, models predict it will crowd out other strains and become the most common cause of COVID-19 by March, according to Summer Galloway, PhD, of the CDC, and colleagues, writing in Morbidity and Mortality Weekly Report.

In addition to public health measures, they warned “enhanced genomic surveillance” will be necessary to track its spread. This variant is more transmissible, thanks to multiple genetic mutations, including in the S protein receptor-binding domain, they said. Not only is the virus more transmissible, but it may cause false negative results on COVID-19 diagnostic testing via PCR assays, and could be less susceptible to neutralizing antibodies, such as monoclonal antibody therapy and convalescent plasma. Last week, the FDA alerted clinicians to the possibility of false negative results on certain molecular tests targeting only a single region of the virus’ genome. (Ref: MedPage Today)

Moderna Inc. (Cambridge MA) is planning a new COVID-19 vaccine study in a familiar population. The company will offer a third shot to participants from its earliest Phase 1 trials, according to The New York Times, to determine whether repeated vaccinations or booster shots are needed, safe and effective. Those who received their last shots six to 12 months ago are in line to be offered the extra shot as Moderna continues looking at how long immunity might last in its authorized two-dose regimen.

Moderna also left the door open to see if boosters would be studied in people who took part in its Phase 3 Study of 30,000 participants, “if accumulating antibody persistence data indicate that this is warranted.” The FDA gave the emergency green light to the 100 μg dose of the mRNA-based vaccine, but Moderna had studied 25 μg and 250 μg doses in early-stage studies as well. In later studies, the company further examined a 50 μg dose and dropped the 250 μg regimen. Trial volunteers who received the lower doses might benefit more from a third shot, Yale immunologist Akiko Iwasaki told the NYT.

Norway has reported 23 deaths related to vaccination against the COVID-19 infection. 13 of the deaths have been assessed, with the results suggesting that common side effects may have contributed to severe reactions in frail, elderly people, according to the Norwegian Agency for Medicines said January 14. Over 25,000 people have been vaccinated in the country since the drive began on December 27 last year.  Pfizer Inc.’s (NYC) mRNA- based vaccines were used in the concerned cases.

The report cited of the 13 deaths, nine serious and seven less serious side effects were reported. The casualties were all among those with advanced heart conditions, dementia, chronic obstructive pulmonary disease and other serious diseases and aged at least 80 and some more than 90 years. Pfizer and BioNTech SE (Mainz DEU) are working with the Norwegian regulator to investigate the deaths in Norway. The agency found that “the number of incidents so far is not alarming, and in line with expectations,” Pfizer said. Pfizer also plans to reduce European vaccine deliveries as its upgrades production capacity.

Federal officials are urging healthcare professionals and patients to use monoclonal antibody treatments to help stave off more severe COVID-19 illness and have now set up three federally supported infusion sites. In its push, the government also has posted an online locator for sites offering the therapies and is encouraging use at long-term care facilities and other alternative locations. The US has spent $375 million on Eli Lilly & Co.’s (Indianapolis) bamlanivimab and $450 million on Regeneron Pharmaceuticals Inc.’s (Tarrytown NY) casirivimab plus imdevimab cocktail, and just agreed earlier this week to spend as much as $2.6 billion more on up to 1.25 million doses of that cocktail.

But almost 80% of the 660,000 doses that have been delivered by the two companies are still sitting on shelves, federal officials said in a press briefing Thursday. Doubts about efficacy, lack of resources to start up and staff infusion centers, questions on how to secure reimbursement, a lack of awareness, and no place to refer patients for infusions have all been barriers, said Janet Woodcock, MD, therapeutics lead on Operation Warp Speed.

And before boarding their flights, all international passengers headed to the US will first need to show proof of a negative coronavirus test, according to a new federal policy going into effect on Jan. 26.

“Testing does not eliminate all risk,” Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, said in a statement describing the new policy. “But when combined with a period of staying at home and everyday precautions like wearing masks and social distancing, it can make travel safer, healthier, and more responsible by reducing spread on planes, in airports, and at destinations.”

The new policy requires all air passengers, regardless of vaccination status, to get a test for current infection within the three days before their flight to the US departs, and to provide written documentation of their test results or proof of having recovered from COVID-19. Proof of immunization will not be sufficient, because the vaccines have only been shown to prevent serious illness. Vaccinated people may still become infected. (Ref: The New York Times)

Johnson & Johnson vaccine shows encouraging immune response in early trial.

Detailed Phase 1/2a study findings published in the New England Journal of Medicine last week showed that all volunteers given Johnson & Johnson’s (New Brunswick NJ) single-dose coronavirus vaccine Ad26.COV2.S had detectable neutralizing antibodies by day 57. In September, the company reported a preview of the interim results indicating that the vaccine, also known as JNJ-78436735, was “well tolerated and highly immunogenic” at the dose level of 5×1010 viral particles (vp), which was selected for further testing in the ongoing Phase 3 ENSEMBLE trial, where a preliminary data readout is anticipated by the end of this month. FirstWord Pharma reports that in the Phase 1/2a study, participants were randomized to receive Ad26.COV2.S at the 5×1010 vp and 1×1011 vp dose levels, or placebo. The vaccine was administered intramuscularly either as a single dose or two doses given eight weeks apart in healthy adults, with 405 enrolled in the 18-to-55 age group and another 405 who were over 65 years.

As previously reported, neutralizing antibody titers against COVID-19 were detected in over 90% of participants after a single vaccination at day 29. The new data showed that among younger adults aged 18 to 55 years, this increased to 100% at day 57, regardless of vaccine dose or age group, while titers then remained stable until at least day 71, which is currently the latest available time point in the ongoing study. Meanwhile, a second dose of Ad26.COV2.S provided an increase in the titer by a factor of 2.6 to 2.9, researchers said. Johnson & Johnson noted that data on durability of immune responses in trial participants aged over 65 years after day 29 will be shared in late January. The company previously reported that the vaccine had elicited T-cell responses as well. Operation Warp Speed chief advisor Moncel Slaoui expressed hope that Johnson & Johnson’s candidate would show effectiveness of 80% to 85%, a rate he said should be sufficient for the US regulator to give its okay.

According to the findings detailed in the NEJM, on day 14, CD4+ T-cell responses were detected in 76% to 83% of participants in the 18-to-55 age group and in 67% of those over 65, “with a clear skewing toward type 1 helper T cells,” researchers said. They noted that CD8+ T-cell responses were “robust” overall, but were lower in the 65-plus group. The interim analysis also revealed that local and systemic reactions to the vaccine either occurred on the day of immunization or the next day, and typically resolved within 24 hours, while the most common adverse events (AEs) were fatigue, headache, myalgia and injection-site pain.

However, there were five serious AEs in the study, including a case involving a volunteer who visited the hospital for a fever that was associated with vaccination, although the person recovered within 12 hours. The other AEs were deemed unrelated to Ad26.COV2.S. In the company’s $1-billion US contract, J&J pledged to have 12 million doses of its vaccine ready by the end of February, ramping up to a total of 100 million by the end of June.

Health officials reckon one in three LA County residents infected by coronavirus.

Los Angeles County scientists now estimate that 1 in 3 residents have contracted COVID-19 since the beginning of the pandemic, the Los Angeles Times reported on Thursday. That would mean at least 3 million of the county’s 10 million residents have been infected–more than triple the number confirmed through testing, according to the Times.

“Unfortunately, we are still engaging in behaviors that facilitate spread of the virus, so it is still able to find plenty of susceptible people to infect,” Roger Lewis, director of COVID-19 “hospital demand modeling” for the Los Angeles County Department of Health Services, told the newspaper.

In order for herd immunity through vaccination to become an effective strategy for controlling the virus, about 75% of the county’s residents would need to develop immunity, Lewis estimated. The county has become a hot spot for the coronavirus in a state that leads the nation in infection rates. As the virus continues to ravage the area, emergency room capacity has dropped to zero percent. Some hospital facilities have resorted to keeping patients in gift shops and other non-designated treatment areas.

Ambulances in Los Angeles County were even reportedly told not to transport patients who had a low chance of survival this month in order to conserve oxygen availability as the pandemic worsens.

“The high number of COVID-19 patients in our hospitals is distressing not only for those who have COVID-19, but for all others in the County who need acute care during this time,” the county health department said in a statement. “People who have a stroke or heart attack or who experience a traumatic injury from a car crash are finding it more difficult to access care compared to usual times.”

As of Jan. 4, the county health department reported that 7,697 people were hospitalized with coronavirus. In early November, that hospitalized figure was 791. By the end of December, the county had reached the grim milestone of 10,000 deaths as a result of the virus. (Ref: The Hill)

Medical Stock Spotlight

Iridex Corp. (NASDAQ:IRIX) led advancing issues, rocketing 117% over the week to $5.75. The catalyst could have been a favorable recommendation from Seeking Alpha (SA) saying that the Mountain View, CA-based company seems to be at the initial stage of a growth inflection that could drive the stock up 175-625%. SA notes that Iridex “has a commercial product which could revolutionize glaucoma treatment, with an addressable market of $1.2 billion+. IRIX is an ophthalmic medical technology company, at a growth inflection, that has developed what it terms ‘a revolutionary proprietary laser system’ to treat Glaucoma (Cyclo G6). The Cyclo G6 has significant advantages over competing treatments and is currently in the commercial ramp-up phase, with broad industry support and acceptance.” SA projects G6 will drive significant 25%+ growth for Iridex in revenues and cash flow for years to come. Due to IRIX’s small size, strong products, and undervaluation, SA believes the company is a prime acquisition target.

Elsewhere, Bionano Genomics Inc. (NASDAQ:BNGO) soared 79% to $8.43, following the conclusion of the biotech’s Next-Generation Cytogenomics Symposium. The final day of San Diego-based Bionano’s symposium focused on the ability of its Saphyr optical genome mapping (OGM) system to analyze the genomes of people with diseases resulting from so-called genomic repeats, or repetitive sequences that can alter the function of genes. Several researchers demonstrated how Saphyr could be used to study many parts of the genome that contain repeats that couldn’t be accurately assessed via other methods. Some of the doctors who presented their findings also noted Saphyr’s lower testing costs and faster results, as well as its improved quality control features.

And Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) surged 79% to $6.87 after the company issued a major positive regulatory update. The happy news is that Lexicon’s clinical-stage protein inhibitor sotagliflozin performed well enough in Phase 3 clinical trials to support a New Drug Application (NDA) from the Food and Drug Administration. This paves the way for sotagliflozin to win approval for treating patients at risk of heart failure. The Woodlands, TX-based company said that this “clears a key hurdle for partnership discussions around sotagliflozin…and enables a potential NDA filing in 2021.” It did not name any potential partners. Previously, Lexicon had partnered with global pharmaceutical industry giant Sanofi SA on developing sotagliflozin to combat diabetes. Disappointing clinical results prompted Sanofi to terminate the collaboration in 2019. Lexicon had received a $300 million up-front payment in that deal, but could have picked up $1.4 billion in milestone payments if the drug had advanced further as a diabetes treatment.

But Cardiff Oncology Inc. (NASDAQ:CRDF) skidded 27% to $13.46. 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).