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
- Technion team discovers important adaptive strategy of the microbiome, impacting immune system - The Jerusalem Post - April 16th, 2024
- Targeting aging and age-related diseases with vaccines - Nature.com - April 16th, 2024
- Single cell analysis unveils B cell-dominated immune subtypes in HNSCC for enhanced prognostic and therapeutic ... - Nature.com - April 16th, 2024
- After the Smoke Clears: Scars on the Immune System - The Scientist - April 16th, 2024
- Exercise and the Immune System: What's the Latest Research? - Technology Networks - April 16th, 2024
- Analysis of immune cell infiltration characteristics in severe acute pancreatitis through integrated bioinformatics ... - Nature.com - April 16th, 2024
- Vaccination impairs de novo immune response to omicron breakthrough infection, a precondition for the original ... - Nature.com - April 16th, 2024
- Harnessing the power of the body's own cells to defeat cancer - Press Publications Inc. - April 16th, 2024
- Best Life: Immunotherapy targets brain cancer - Action News 5 - April 16th, 2024
- Dietary factors and their influence on immunotherapy strategies in oncology: a comprehensive review | Cell Death ... - Nature.com - April 16th, 2024
- New insights on B cells: Researchers explore building better antibodies and curbing autoimmune diseases - Medical Xpress - April 16th, 2024
- Immune cells' intense reaction to the coronavirus may lead to pneumonia - Science News Magazine - April 16th, 2024
- The telltale traces long Covid leaves in the blood - healthcare-in-europe.com - April 16th, 2024
- Overview of the Immune System - The Merck Manuals - March 18th, 2024
- SUNDAY Unraveling The Gut-Brain Connection: How Infant Gut Bacteria Shape Immune Resilience | TheHealthSit - TheHealthSite - March 18th, 2024
- Making drugs from T cells: The quantitative pharmacology of engineered T cell therapeutics | npj Systems Biology and ... - Nature.com - March 18th, 2024
- Study unlocks the mystery of neonatal neutropenia in newborns - News-Medical.Net - March 18th, 2024
- Vertebral Subluxation and Systems Biology: An Integrative Review Exploring the Salutogenic Influence of Chiropractic ... - Cureus - March 18th, 2024
- A new strategy to attack aggressive brain cancer shrank tumors in two early tests - ABC News - March 18th, 2024
- Turning on the Bat Signal - The Scientist - March 18th, 2024
- Power Foods That Can Support Your Immune System - Videos from The Weather Channel - The Weather Channel - March 18th, 2024
- Report: Aggressive brain tumors respond to new, immune-focused therapy - UPI News - March 18th, 2024
- Designer immune-cell therapy could shrink deadly brain tumors, early trials show - Livescience.com - March 18th, 2024
- 20.2: Introduction to the Immune System - Biology LibreTexts - February 27th, 2024
- Can one shot of yoghurt really boost your immunity and gut health? - Daily Mail - February 27th, 2024
- New cancer therapy approved by FDA supercharges bodys immune system - The Washington Post - February 27th, 2024
- How bubonic plague rewired the human immune system - BBC.com - February 27th, 2024
- Innovative therapy targets and destroys leukemia stem cells - News-Medical.Net - February 27th, 2024
- Participate in Our Study for $100; Open Slots This Week - University of Arkansas Newswire - February 27th, 2024
- Sexual dimorphism during integrative endocrine and immune responses to ionizing radiation in mice | Scientific Reports - Nature.com - February 27th, 2024
- Comprehensive pan-cancer analysis identifies the RNA-binding protein LRPPRC as a novel prognostic and immune ... - ScienceDirect.com - February 27th, 2024
- YOUR HEALTH: The HAMR fights cancer - WAFB - February 27th, 2024
- Cycles of a diet that mimics fasting can reduce signs of immune system aging, as well as insulin resistance and liver fat - News-Medical.Net - February 27th, 2024
- How the powerhouse of the cell could be cancers Achilles heel - Freethink - February 27th, 2024
- Food is medicine: The science behind zinc and other supplements for immune health - Healio - February 27th, 2024
- Unleashing Our Immune Response to Quash Cancer - Medscape - February 27th, 2024
- Tumor histoculture captures the dynamic interactions between tumor and immune components in response to anti-PD1 ... - Nature.com - February 27th, 2024
- Converging and evolving immuno-genomic routes toward immune escape in breast cancer - Nature.com - February 27th, 2024
- Sanjula Jain Urges a Comprehensive Approach in Address Alarming Rise in Cancer Cases Among Younger Populations - Managed Healthcare Executive - February 27th, 2024
- Cystic fibrosis breakthrough points to zinc as infection buster - New Atlas - February 27th, 2024
- Exploring synergies between B- and T-cell vaccine approaches to optimize immune responses against HIVworkshop ... - Nature.com - February 27th, 2024
- Is the 100-year old TB vaccine a new weapon against Alzheimers? - The Guardian - February 27th, 2024
- Immune system in the blood of Alzheimer's patients found to be epigenetically altered - News-Medical.Net - February 10th, 2024
- What impact does exercise have on your immune system? And how to stay well while cycling - BikeRadar - February 10th, 2024
- Had COVID recently? Here's what to know about how long immunity lasts, long COVID, and more - AAMC - February 10th, 2024
- Noor Momin harnesses the immune system to treat heart disease | Penn Today - Penn Today - February 10th, 2024
- Research reveals a process tumors use to induce immune suppressor cells and evade immunotherapy - Medical Xpress - February 10th, 2024
- Immune targeting of HIV-1 reservoir cells: a path to elimination strategies and cure - Nature.com - February 10th, 2024
- Preventing severe allergic reactions with nanoparticles - National Institutes of Health (NIH) (.gov) - February 10th, 2024
- Sugary handshakes are how cells talk to each other understanding these name tags can clarify how the immune ... - The Conversation Indonesia - February 10th, 2024
- Scientists have identified an immune cell that can cause allergies - EL PAS USA - February 10th, 2024
- Sickle cell and the importance of the immune system - Punch Newspapers - February 10th, 2024
- Which cancers can be treated with immune checkpoint inhibitors? - MD Anderson Cancer Center - February 10th, 2024
- How does waste leave the brain? Washington University School of Medicine in St. Louis - Washington University School of Medicine in St. Louis - February 10th, 2024
- Healthy Kids: Give your immune system a boost to stay healthy this winter - nbc16.com - February 10th, 2024
- The impact of prior exposure to hypoglycaemia on the inflammatory response to a subsequent hypoglycaemic episode ... - Cardiovascular Diabetology - February 10th, 2024
- Impact of Chronic Stress on Immune System and Depression | Health News - Medriva - February 10th, 2024
- I tried 'swamp soup,' the viral recipe that promises to boost your immune system - Yahoo News - February 10th, 2024
- Understanding Immune Checkpoint Inhibition Therapy: Challenges and Strategies - Medriva - February 10th, 2024
- One Simple Change May Dramatically Boost The Effect of COVID-19 Vaccines - ScienceAlert - February 10th, 2024
- The gut virome is associated with stress-induced changes in behaviour and immune responses in mice - Nature.com - February 10th, 2024
- Cancer vaccines are in the works to fight BRCA-linked gene mutations - The Philadelphia Inquirer - February 10th, 2024
- What are the organs of the immune system? - InformedHealth.org - NCBI ... - January 17th, 2024
- Novel insights into the immune response to bacterial T cell superantigens - Nature.com - January 17th, 2024
- FDA signs off on Takeda's HyQvia as maintenance therapy for CIDP - FiercePharma - January 17th, 2024
- CBDs Pobezinsky and Pobezinskaya Use Flow Cytometry to Determine How Tumor Cells Outwit the Bodys Immune ... - UMass News and Media Relations - January 17th, 2024
- Boosting. What To Do. - Science Based Medicine - January 17th, 2024
- Axelia Oncology takes its TLR2/6 agonist into the clinic to harness the innate immune system - BioWorld Online - January 17th, 2024
- Long COVID manifests with T cell dysregulation, inflammation and an uncoordinated adaptive immune response to ... - Nature.com - January 17th, 2024
- Opinion | Thanks to mRNA, Future Drugs Will Be Easier and Faster to Make - Mississippi Free Press - January 17th, 2024
- Elon research team models the COVID immune response, one equation at a time - Today at Elon - January 17th, 2024
- Are plant-based meals good for your immune system? 4 things to know about improving your health this week. - Yahoo Life - January 17th, 2024
- Scientists Find Key To Potential Breast Cancer Prevention, Treatment | Newsroom - UNC Health and UNC School of Medicine - January 17th, 2024
- What if every germ hit you at the exact same time? An immunologist explains - The Conversation - January 17th, 2024
- Why Don't We Have a Staph Vaccine? - Healthnews.com - January 17th, 2024
- Best ways to improve your immune system - The Business Standard - January 17th, 2024
- Stanford University researchers think future pandemics could be prevented with universal vaccines - KGO-TV - January 17th, 2024
- Why you may feel depressed and anxious when you're ill and how to cope with it - The Conversation - January 17th, 2024
- New mechanism with potential to boost checkpoint-blocking cancer immunotherapies identified - Medical Xpress - January 17th, 2024
- Battling Bugs and Blues: The Interplay of Infection and Emotion - News-Medical.Net - January 17th, 2024