AJMC Staff

COVID-19 Vaccine Supply to Increase by 50%

A delivery of 200 million more coronavirus disease 2019 (COVID-19) vaccine doses by the summer, on top of the 400 million already manufactured, is in the works by the Biden administration, 

. In addition, as early as next week—and lasting for 3 weeks—states could see a 16% bump in doses, from 8.6 to 10 million. By the end of March, Pfizer is promising to deliver 120 million additional doses of its vaccine, and Moderna, 100 million. Both have raised their yearly target doses, by 35% and 17%, respectively. Meanwhile, data on Johnson & Johnson’s 1-dose vaccine are expected within the week, which could help alleviate some of the 

 by health officials about the current vaccine supply.

US Issues Alert on Hand Sanitizers From Mexico

Citing possible methanol, or wood alcohol, contamination, 

 on alcohol-based hand sanitizers manufactured in Mexico. The concern stems from products mislabeled as containing ethanol, or 

, when instead they test positive for the toxic and life-threatening agent methanol. According to FDA data, between April and December 2020, 84% of alcohol-based hand sanitizer samples for such products manufactured in Mexico failed to meet agency standards. Fourteen warning letters have been issued since June, with 

 going to Laboratorios Jaloma S.A. de C.V. on Monday.

BioNTech/Pfizer Receive Sanofi Production Boost 

Sanofi will give BioNTech production access to a Frankfurt, Germany, plant in order to boost the EU supply of its COVID-19 vaccine by over 125 million doses, 

. The move comes as Sanofi has pushed back the expected delivery date of its own vaccine to summer 2021. Other manufacturing partnerships are in the works, too. Lonza Group AG (based in Switzerland), which manufactures Moderna’s vaccine, has expressed its willingness to offer similar assistance, and JCR Pharmaceuticals is gearing up to increase Japan’s AstraZeneca vaccine stockpile by 90 million doses.

Articles

The Biden administration promises to increase vaccine delivery; the FDA issues an alert on alcohol-based hand sanitizers from Mexico; 3 pharma giants partner to speed EU vaccination efforts. 

What We’re Reading: Vaccine Delivery to Increase; FDA Issues Hand Sanitizer Alert; Sanofi, BioNTech/Pfizer to Partner

Biden Reportedly to Reopen ACA Insurance Marketplaces

This week, President Joe Biden plans to take executive action on health insurance as he moves to reopen federal marketplaces selling Affordable Care Act (ACA) health plans and lower barriers to joining Medicaid, according to a report Tuesday in 

Citing individuals inside and outside the administration, the effort is aimed at assisting Americans who lost their health insurance as a result of job losses or other factors stemming from the coronavirus disease 2019 (COVID-19) pandemic. Typically, open enrollment would not occur until a restricted 6-week period at the end of the year.

Moderna Developing Booster Shot to Combat COVID-19 Variants

 to manufacture a COVID-19 booster shot designed to be more effective against emerging variants of the coronavirus 

 against the variant identified in South Africa. Moderna will test 2 booster-shot options, with 1 targeting the South African variant and the other to fight new mutations. Notably, the company’s approved vaccine showed no reduction in producing neutralizing antibodies against the more contagious, and potentially more lethal, variant discovered in the United Kingdom.

First Case of Brazil Variant Found in United States

, the first US-reported case of the novel coronavirus variant identified in Brazil was found in an individual who recently returned from the country to Minnesota. The variant, known as P.1, has raised concern among researchers who say that people who have already been infected with COVID-19 may be at risk of being reinfected with the Brazilian variant. Although reinfection is reportedly rare, there is a confirmed case in Brazil of someone with the new variant who had been infected with a different virus strain several months earlier.

President Joe Biden reportedly will take executive action to reopen federal marketplaces selling Affordable Care Act (ACA) health plans; Moderna investigating booster shot designed to be more effective against emerging variants of coronavirus disease 2019 (COVID-19); Brazil coronavirus variant is found in Minnesota.

What We're Reading: Biden Reportedly Reopening ACA Enrollment; Moderna Developing COVID-19 Booster; Brazil Variant Now in US

The FDA late Friday approved voclosporin for the treatment of lupus nephritis (LN), a condition that is associated with kidney damage, kidney failure, cardiac events, and death.

Voclosporin, the first FDA-approved oral therapy for LN, will be sold as Lupkynis by 

 and is approved for use in conjunction with immunosuppressive treatment.

The approval is the second for an LN therapy recently; the FDA expanded the indication for belimumab to adults with LN last month. Belimumab was first approved in 2011 for systemic lupus erythematosus (SLE). LN affects about 40% to 50% of patients with SLE, which disproportionately affects Black, Hispanic, and Asian individuals; most patients are female.

 in people with a genetic predisposition. For the most part, clinicians use immunosuppressive drugs that limit immune system activity, including hydroxychloroquine—which experienced shortages last year when it was promoted as a possible treatment for coronavirus disease 2019, despite a lack of evidence.

The development of voclosporin stemmed from the AURORA phase 3 study and the AURA-LV phase 2 study. Over the course of 52 weeks, patients receiving voclosporin had vastly improved outcomes when taken in combination with standard-of-care therapy (SOC), mycophenolate mofetil (MMF), and low-dose steroids.

For both phase 2 and 3 studies, 533 patients with LN were given voclosporin 23.7 mg or a placebo twice a day in conjunction with SOC and a MMF target dose of 2 g daily. For the first 2 days, patients received intravenous (IV) methylprednisolone (up to 1 g), with a taper of oral corticosteroids after that. Oral prednisone dosage was 20 mg/day for patients weighing less than 45 kg and 25 mg/day for patients weighing at least 45 kg. By week 16, their target goal was a dose of 2.5 mg/day. Patients (with LN class III, IV, or V) were required to have baseline eGFR greater than 45 mL/min/1.73 m

The phase 3 study showed that voclosporin was twice as effective at achieving a complete renal response compared with SOC. Patients also obtained a 50% reduction in urine protein creatinine ratio twice as fast as those in the SOC group; in addition, a higher number of patients in the voclosporin group achieved a complete renal response by 24 weeks when compared with those in the SOC group.

Common adverse effects (>3%) included a decrease in glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain, dyspepsia, alopecia, renal impairment, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

Voclosporin, the first FDA-approved oral therapy for lupus nephritis, will be sold as Lupkynis by Aurinia Pharmaceuticals and is approved for use in conjunction with immunosuppressive treatment.



FDA Approves First Oral Therapy for Lupus Nephritis

In an effort to mitigate the spread of emerging variants of coronavirus disease 2019 (COVID-19), President Joe Biden plans to sign a travel ban today on most non-US citizens who recently visited South Africa, the 

, former President Donald Trump lifted international travel restrictions last week even as more contagious variants of COVID-19 were being reported worldwide. The travel ban comes as the nation’s top infectious disease expert, Anthony Fauci, MD, notes that current COVID-19 vaccines may be less effective against these more contagious variants, although they will still likely provide enough protection.

Vaccine Supply Garners Concern From Health Officials

As the Biden adminstration progresses toward its goal of administering 

100 million COVID-19 vaccine doses in 100 days

, top health officials have expressed concern about the current state of limited vaccine supplies. According to 

, state and local health officials nationwide have reported limited vaccine supply, which CDC Director Rochelle Walensky. MD, MPH, said will hopefully be increased after the first 100 days. Walensky further 

 that the federal government can't be certain of the current size of the vaccine supply, an issue she attributed to  challenges presented by the Trump administration’s vaccine rollout.


Merck Ends Development of COVID-19 Vaccines

Following poor results in early-stage studies, Merck has announced it will end its development of 2 potential COVID-19 vaccines and instead focus on assessing the efficacy of 2 treatments for COVID-19 not yet approved by regulators. Reported by 

, Merck said that although its vaccine candidates were well tolerated by patients, they provided an inferior immune system response compared with other vaccines. Notably, 1 of the treatments now being assessed, MK-7110, has the potential to minimize effects of an overactive immune response to COVID-19. The US government is paying Merck about $356 million to fast-track production of the potential treatment.

President to sign travel ban meant to contain more contagious variants of coronavirus disease 2019 (COVID-19); limited vaccine supply concerns top health officials; Merck ends COVID-19 vaccine development. 

AJMC Staff

Articles

What We’re Reading: Vaccine Delivery to Increase; FDA Issues Hand Sanitizer Alert; Sanofi, BioNTech/Pfizer to Partner

What We're Reading: Biden Reportedly Reopening ACA Enrollment; Moderna Developing COVID-19 Booster; Brazil Variant Now in US

FDA Approves First Oral Therapy for Lupus Nephritis

What We're Reading: Mitigating Variant Spread; Vaccine Supply Garners Concern; Merck Ends Vaccine Development