The Trump administration doubled its orders from Pfizer and Moderna this month to 200 million doses each. But both vaccines are given as two doses per person, meaning the U.S. supply will only cover 200 million of the nation's 250 million adults. Authorizing more vaccines for emergency use could immediately increase that stockpile, and also help ensure sufficient vaccine when inoculation is allowed for teens and children.
Johnson & Johnson is preparing to release the first efficacy data on its shot, which is given as a single dose, in January. AstraZeneca could also release more data as early as next month from its late-stage trials, officials with the federal government's Operation Warp Speed said recently. (The company said in a statement that it has "no further updates on the US specific trial.")
An early frontrunner in the global vaccine race, AstraZeneca has sold more shots worldwide than any other manufacturer. Between agreements with the World Health Organization, the Coalition for Epidemic Preparedness and Innovation and the Serum Institute, a mass manufacturer in India, the British drugmaker has promised nearly 1 billion shots to other countries not including the 300 million it pledged to the U.S.
AstraZenecas vaccine is vastly cheaper than others and much easier to ship and store than vaccines such as Pfizers, that require ultra-cold freezers or dry ice. That makes it an appealing option for hard-to-reach areas in the U.S., as well as lower-income countries with less advanced infrastructure.
But the outlook for the company's vaccine is hazy after AstraZeneca reported last month that nearly 3,000 trial volunteers in the U.K. were accidentally given a half-strength first dose. The regimen proved 90 percent effective in early data, beating the 62 percent efficacy of two standard doses. Some vaccine experts think the lower dose's success could be a statistical fluke, since 3,000 people is a small slice of the tens of thousands of people enrolled in the company's trials; others say it could indicate a clearly better option.
AstraZeneca would still have to fully test the lower dosing regimen before applying to the Food and Drug Administration for emergency-use authorization. The agency is also requiring that drug companies follow at least half the trial volunteers for two months after their last dose.
A company spokesperson said that there is "nothing to share on U.S. filing plans at this time."
But the FDA's minimum criteria for seeking authorization do not tell the full story of a vaccine's value, said Peter Hotez, a virologist and dean of the National School of Tropical Medicine at the Baylor College of Medicine.
Initial efficacy over the first two months is only one of several aspects that requires consideration," said Hotez, who is also developing a potential coronavirus shot with partners in India. Other vaccines may offer advantages in terms of durability of protection, tolerability, safety, suitability for children or adolescents, and for that well require additional vaccines.
Pfizer and Moderna only recently started studying their vaccines in children as young as 12 years old, and no manufacturer has begun trials in children even younger. Regulators have also called for more data in pregnant women and for certain risk factors like heart disease, diabetes and other illnesses that could affect the immune system. Health experts say that a vaccine that may only work moderately overall may be best for key subpopulations, such as pregnant women.
The latest news in health care politics and policy.
And some of the vaccines still in development may prove easier to manufacture, transport or administer than the Pfizer and Moderna shots.
Both of those authorized vaccines use relatively new messenger RNA technology to instruct cells to make a protein found on the virus, which revs up the body's immune system. J&J and AstraZeneca use a more traditional method, in which small bits of DNA from the coronavirus are edited into a weakened version of another virus called an an adenovirus. When the adenovirus enters cells, they read its DNA and produce a protein found in the coronavirus.
One theory about the AstraZeneca dosing confusion is that a full dose of the adenovirus triggered too big of an immune response so the body didnt have time to learn much about the coronavirus it was meant to protect against, said Rasmussen. There is still value in having that information, because maybe [AstraZeneca] can start assessing that half-dose regimen.
But the AstraZeneca data could present a quandary for FDAs independent vaccine advisory panel, which has been meeting publicly to discuss each candidate in a bid to boost transparency and public confidence. The company has said that combined results so far from its Phase III trials show its vaccine to be 70 percent effective. But the two dosing regimens tell different stories: 90 percent is basically comparable with the existing vaccines; 62 percent is not.
You cant reasonably combine data from two different dosing strategies, two different dosing intervals and two different placebo groups, Paul Offit, a vaccine expert at the University of Pennsylvania who sits on the FDAs expert panel, the Vaccines and Related Biological Products Advisory Committee.
It also presents a sticky situation for the largest national vaccination plan in history. While the two vaccines authorized now have nearly identical efficacy and safety profiles and use the same technology, having a more varied roster of vaccines would be harder to distribute fairly.
There are obvious ethical issues: If one vaccine is more effective than the others, who gets what, right? said Philip Landrigan, director of the global public health program at Boston College, who stressed the importance of clear federal planning if that happens. Transparency and openness have another benefit beyond just ensuring that the system works well it could persuade people who are reluctant to get the vaccine.
More here:
The first Covid vaccines were triumphs. What if the next are only OK? - POLITICO
- Systemic Lupus Erythematosus (Lupus) - Who gets it? | NIAMS - February 7th, 2025
- Systemic Lupus Erythematosus (Lupus) Basics - National Institute of ... - February 7th, 2025
- Long COVID: women at greater risk compared to men could immune system differences be the cause? - The Conversation - February 7th, 2025
- What is Pemphigus? Symptoms & Causes | NIAMS - February 7th, 2025
- How the immune system influences pancreatic cancer: New interactions provide therapeutic insights - Medical Xpress - February 7th, 2025
- Mitochondrias Secret Power Unleashed in the Battle Against Inflammation - SciTechDaily - February 7th, 2025
- WNT11 Promotes immune evasion and resistance to Anti-PD-1 therapy in liver metastasis - Nature.com - February 7th, 2025
- The role of the behavioral immune system in the expression of short and long-term orientation in young Chilean men during the COVID-19 pandemic - BMC... - February 7th, 2025
- Harvard nutritionist eats these 5 foods to keep her 'immune system strong' and 'energy high' - CNBC - February 7th, 2025
- Micro Immune Response On-chip (MIRO) models the tumour-stroma interface for immunotherapy testing - Nature.com - February 7th, 2025
- Personalized Therapeutic Vaccine Steers the Immune System to Fight Kidney Cancer | Newswise - Newswise - February 7th, 2025
- Identification of m6A methyltransferase-related WTAP and ZC3H13 predicts immune infiltrates in glioblastoma - Nature.com - February 7th, 2025
- Serotonin attenuates tumor necrosis factor-induced intestinal inflammation by interacting with human mucosal tissue - Nature.com - February 7th, 2025
- Identification of the immune infiltration and biomarkers in ulcerative colitis based on liquidliquid phase separation-related genes - Nature.com - February 7th, 2025
- FLASH radiation reprograms lipid metabolism and macrophage immunity and sensitizes medulloblastoma to CAR-T cell therapy - Nature.com - February 7th, 2025
- Young Innovators: U of S researcher uses bat immune systems to find next generation therapies - Saskatoon Star-Phoenix - February 7th, 2025
- World Cancer Day 2025: Chronic stress, immune system, and cancer risk- How are these connected? - The Times of India - February 7th, 2025
- New research unlocks key to long-lasting immune response in cancer and chronic diseases - The Peter Doherty Institute for Infection and Immunity - February 7th, 2025
- Microbial Dynamics and Immune Response to NTHi in COPD - Physician's Weekly - February 7th, 2025
- MHE Week in Review RFK Jr. Spotlight - Managed Healthcare Executive - February 7th, 2025
- Psoriasis Basics: Overview, Symptoms, and Causes - January 27th, 2025
- Vitiligo Symptoms, Treatment & Causes | NIAMS - January 27th, 2025
- The Surprising Connection Between Obesity, Parasites, and Your Immune System - SciTechDaily - January 27th, 2025
- Versatile 69p spice that boosts immune system can go in soups, smoothies and milk - Express - January 27th, 2025
- How the skins secret immune system could lead to needle-free vaccines - Gavi, the Vaccine Alliance - January 27th, 2025
- Fevers link with a key kind of immunity is surprisingly ancient - Science News Magazine - January 27th, 2025
- Immunology - The Scientist - January 27th, 2025
- Opinion: Immune System And Ageing Why We Get More Vulnerable As We Age - ABP Live - January 27th, 2025
- 'Forever chemicals' (PFAS) may weaken immune function in children, leading to more frequent infections - U.S. Right to Know - January 27th, 2025
- Cellular Signals That Wreak Havoc in Sepsis are Revealed - LabRoots - January 27th, 2025
- New Combination Immunotherapy Targets Melanoma and Breast Cancer with Promising Results - Inside Precision Medicine - January 27th, 2025
- New Research in The Journal of Poultry Science: Trained Immunity Offers Novel Poultry Disease Prevention Strategies - PR Newswire - January 27th, 2025
- Scientists uncover how cancer cells hijack T-cells, making it harder for the body to fight back - Medical Xpress - January 27th, 2025
- MiNK Therapeutics Targets Immune Reconstitution to Combat - GlobeNewswire - January 27th, 2025
- Mitochondria may be a promising therapeutic target for inflammatory diseases - Medical Xpress - January 27th, 2025
- Explainer: What is Guillain-Barr Syndrome and how it affects the immune system - Mathrubhumi English - January 27th, 2025
- Yes, Some Vaccines Contain Aluminum. Thats a Good Thing. - The New York Times - January 27th, 2025
- You Are What You Eat? MD Breaks Down The Science Of The Gut Microbiome - mindbodygreen - January 27th, 2025
- Potential gamechanger: Researchers discover basis for immunotherapy-induced myocarditis - Healio - January 27th, 2025
- Ozempic and Wegovy may boost health, from addiction to dementia - BBC.com - January 27th, 2025
- Neutrophil diversity and function in health and disease - Nature.com - December 6th, 2024
- Harnessing the Power of the Immune System for Breast Cancer Treatment - Breast Cancer Research Foundation - December 6th, 2024
- Study Examines Neoantigen Landscapes and Their Role in Immunotherapy Efficacy - Consult QD - December 6th, 2024
- The 5 Best Teas to Support Your Immune System This Cold & Flu Season - EatingWell - December 6th, 2024
- Engineered immune cells may be able to tame inflammation - Medical Xpress - December 6th, 2024
- Hybrid model of tumor growth, angiogenesis and immune response yields strategies to improve antiangiogenic therapy - Nature.com - December 6th, 2024
- Opioids interfere with cancer immunotherapy, but another type of drug could help - Medical Xpress - December 6th, 2024
- RANKL cytokine restores thymus cells in old mice, reducing tumor growth and improving T cell immune response - Fierce Biotech - December 6th, 2024
- Predictive role of neutrophil percentage-to-albumin ratio, neutrophil-to-lymphocyte ratio, and systemic immune-inflammation index for mortality in... - December 6th, 2024
- Immuno-Oncology Strategic Industry Research Report 2023-2024 & 2030: Approval of Pembrolizumab (Keytruda) and Nivolumab (Opdivo), which Target... - December 6th, 2024
- Study cracks the cold case of immunotherapy resistance - News-Medical.Net - December 6th, 2024
- New immune therapy improves survival and reduces tumor burden in glioblastoma - News-Medical.Net - December 6th, 2024
- Identification of immune-related hub genes and potential molecular mechanisms involved in COVID-19 via integrated bioinformatics analysis - Nature.com - December 6th, 2024
- Immune Cell Breakthrough: Scientists Discover a Hidden Ally in the Fight Against Cancer - SciTechDaily - December 6th, 2024
- Rising temperatures impact the immune system of wild monkeys - Earth.com - December 6th, 2024
- Study declaring Alzheimer's to be a "brain disease" proven to be fabricated - Earth.com - December 6th, 2024
- Warming temperatures impact immune performance of wild monkeys, U-M study shows - University of Michigan News - December 6th, 2024
- New study explores heart risks of cancer immunotherapy - News-Medical.Net - December 6th, 2024
- 'Incredible' way to boost your immune system naturally and ward of colds and flu this winter - The Mirror - December 6th, 2024
- Tis the Season to Boost Your Immune System - Mix93.3 - December 6th, 2024
- A mathematical model simulating the adaptive immune response in various vaccines and vaccination strategies - Nature.com - October 14th, 2024
- Fox Chase Cancer Center Researchers Find Gene That Triggers Immune Response in Treatment-Resistant Small-Cell Lung Cancer - Fox Chase Cancer Center - October 14th, 2024
- What Does It Mean to Be Immunocompromised? - The New York Times - October 14th, 2024
- Scientist hopes to cure Type 1 diabetes by disguising stem cells - The University of Arizona - October 14th, 2024
- Watching an infection unfold with a sphingolipid probe - Drug Discovery News - October 14th, 2024
- The cells that protect your brain against infection could also be behind some chronic diseases - BBC.com - October 14th, 2024
- On Nutrition: Foods that help strengthen the immune system - LimaOhio.com - October 14th, 2024
- An integral T cell pathway has implications for understanding sex-based immune response - Medical Xpress - October 14th, 2024
- Immune Response Linked to Lewy Body Formation - Neuroscience News - October 14th, 2024
- Are vaccines the future of cancer prevention? - Genetic Literacy Project - October 14th, 2024
- The Gut Microbiome and Autoimmunity - Inside Precision Medicine - October 14th, 2024
- Researchers discover how oral cancer cells may block the body's immune response - News-Medical.Net - September 21st, 2024
- Are Vaccines More Effective When You Believe in Them? - Greater Good Science Center at UC Berkeley - September 21st, 2024
- Researchers discover immune response to dengue can predict risk of severe reinfections - Medical Xpress - September 21st, 2024
- Texas Researchers Find Acid Walls That Shield Cancer Tumors from Bodys Immune System Response - DARKDaily.com - Laboratory News - September 21st, 2024
- Lysosomes in the immunometabolic reprogramming of immune cells in atherosclerosis - Nature.com - September 21st, 2024
- A new way to reprogram immune cells and direct them toward anti-tumor immunity - MIT News - September 21st, 2024
- Unravelling the many mysteries of the immune system - Cosmos - September 21st, 2024
- Long COVID patients maintain robust immune memory two years after infection - News-Medical.Net - September 21st, 2024
- Nutraceuticals and pharmacological to balance the transitional microbiome to extend immunity during COVID-19 and other viral infections - Journal of... - September 21st, 2024