To capture the speed and audacity of its plan to field a coronavirus vaccine, the Trump administration reached into science fictions vault for an inspiring moniker: Operation Warp Speed.
The vaccine initiatives name challenges a mantra penned by an actual science fiction writer, Arthur C. Clarke: Science demands patience.
Patience is essential for those who ply the science of vaccines. But in that field, challenging economic conditions and a forbidding regulatory system converge with the immune systems complexity and the resilience of microscopic pathogens. Add in drug companies preference for big profits and the result is a trash heap of failed and abandoned efforts.
In the last 25 years, the U.S. Food and Drug Administration has approved new vaccines for only seven diseases. A vaccine to protect against the Ebola virus won approval just last year, three years after the epidemic in West Africa ended.
But in the midst of a COVID-19 pandemic that has killed more than 100,000 Americans and cratered the U.S. economy, Trump has shown little tolerance for sciences deliberate pace. And scientists, with fingers crossed, are falling in line.
Newsletter
Get our free Coronavirus Today newsletter
Sign up for the latest news, best stories and what they mean for you, plus answers to your questions.
Enter Email Address
Sign Me Up
You may occasionally receive promotional content from the Los Angeles Times.
The president declared that he wants 300 million doses enough to protect as many as 90% of Americans developed, manufactured and delivered by January 2021. He has ordered academics, government officials, private companies and the U.S. military to work together to make it so.
That means big and it means fast, Trump said. A massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project.
The new effort will demand the support, development, testing and assessment of several promising vaccine candidates by scientists at the National Institutes of Health, the FDA and companies and academic institutions across the world.
It will require the manufacture, procurement and storage of complex biologic medicines, as well as the vials, needles, syringes and storage equipment needed to deliver them. All will be needed on a massive scale.
And all that materiel will need to be transported, distributed and possibly administered by an army of logistics specialists.
Wherever possible, Operation Warp Speed envisions that many steps that have always followed each other in strict sequence clinical trials and production, for instance, or government approval and supply-chain development be done in parallel.
The program has already awarded a total of $2.16 billion to five companies with vaccine candidates at different stages of development.
To lead the effort, Trump tapped immunologist Moncef Slaoui, a pharmaceutical venture capitalist and former chairman of vaccines at the drug giant GlaxoSmithKline. The U.S. Armys most senior logistics and procurement specialist, Gen. Gustave Perna, will be the operations chief operating officer. Both expressed confidence in the operations success.
Perna called the project herculean. Slaoui, who has been criticized for holding a major stake in at least one of the vaccine makers that stands to benefit from Operation Warp Speed, told Trump we will do the best we can.
The time is short and the stakes are high. Just over four months after the coronavirus announced its presence inside the United States, President Trump is determined to send the country back to work.
With no effective treatment in sight, and no indication that the coronavirus would magically disappear, as Trump has frequently predicted, a vaccine will be the ultimate game changer in the pandemic, according Dr. Anthony Fauci, the nations leading expert on the outbreak.
Theres never a guarantee of success, Fauci said. But he added that he was cautiously optimistic that by winter, at least one of nearly a dozen promising vaccine candidates would have shown itself to be safe and effective in inducing immunity in humans.
Vaccine scientists are similarly cautious, especially of a testing schedule that will compress both the size and duration of safety and effectiveness trials and even overlap them in a bid to save time.
Its fine for politicians to say were going to have a vaccine next month, said Mayo Clinic immunologist Dr. Gregory Poland. But the literature is littered with false starts and unanticipated safety effects in vaccines.
Poland noted that a vaccines rarer side effects are often not recognized until its put into broad use. To ferret out an adverse outcome that only occurs in one person in 100,000, for instance, a company would need to test it in 384,250 people from broad backgrounds and with a variety of medical conditions, he said.
Such large trials are unlikely in the rush to field a vaccine, Poland said, and he fears the result could be a dangerous erosion of public trust. The yearly flu shot carries a risk of less than 1 in 1 million cases of the neurological complication Guillain-Barre syndrome, he said. And even with that low a risk, close to half of Americans refuse to get it.
You have a whole spectrum of people out there who wont be reassured by any amount of information, Poland said. If we dont pay strict attention to safety, this is going to backfire.
Money may help. Congress approved $8.3 billion in early March to fund federal agencies pandemic response. And scientists across the world have been scrambling to design vaccines to protect a population with no immunity to the deadly new pathogen.
Scientists in China, Kazakhstan, India, Russia, Germany, Sweden and the United States have brought 10 potential COVID-19 vaccines to the point where they are being evaluated in humans in some form. Another 115 are considered by the World Health Organization to be in the preclinical stage of development.
In some cases, these preclinical vaccine candidates are scarcely off the drawing board. In others, they are still being tweaked or tested in cells. Some are being tried in lab animals.
The prospective vaccines range widely in their design and novelty. There are those that challenge a persons immune system with a killed or attenuated virus, the traditional approach used by the polio vaccine and other immunizations. Others are products of genetic engineering and have never been tried in a vaccine before.
The vaccine candidates also vary in their ease of manufacture, the number of doses a patient needs to gain lasting immunity, and the way they are administered.
FDA Commissioner Dr. Stephen Hahn has said his agency evaluated about 10 vaccine candidates in early studies. By late May, it had narrowed its focus to five candidates that will begin a rapid and sometimes overlapping progression through human studies of safety and effectiveness.
Meanwhile, the groundwork for large-scale production is already being laid. Trump has said that the U.S. military may aid in the manufacture, and companies with the capability to produce vaccines will be recruited to do so.
Given the pressing urgency of the administrations deadline, vaccine candidates that can be produced fastest, transported most easily and administered to patients most efficiently will likely win the most and earliest support, experts said.
The redundancy built into Operation Warp Speed may also prove a vital safeguard against failure.
If the coronavirus shows signs that it is mutating in ways that could make one vaccine candidate ineffective, the scientific judges could swiftly shift their preferences toward a competitor that can be adapted more readily to changes in the virus. If rare but untoward effects show up with broader use, back-up vaccines could be brought on line. Some vaccines will be found to work better or worse in specific populations, and can be used accordingly.
The result will be an evolving panoply of vaccine choices, not only because some will be ready earlier than others, but because some will be more effective than others in certain populations.
There will be of necessity multiple types of vaccines, Poland said.
Michael S. Kinch, who directs the Center for Drug Discovery at Washington University in St. Louis, said that while there are pitfalls inherent to Operation Warp Speed, another pandemic offers comforting reassurance that in fielding the right drug, patience is an essential virtue.
In the early days of the HIV/AIDS epidemic, the first generation of drugs was mediocre at best, he said. As scientists learned more about the virus and the disease it causes, the medicines became more effective.
That may be a model for what were going to have here, Kinch said. We may not get the best vaccine up front. But hopefully it will be good enough and will be replaced later by better vaccines. We have may just have to live with that until we get a better one.
Read the original post:
Can Operation Warp Speed have a COVID-19 vaccine this year? - Los Angeles Times
- Biohackers Are on a Secret Hunt for the Coronavirus Vaccine - Reason [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- Can synthetic biology protect us from coronavirus? And the next one? - Big Think [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- When will there be a coronavirus vaccine and who will get it first? - Yahoo News [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- These nine companies are working on coronavirus treatments or vaccines heres where things stand - MarketWatch [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- Coronavirus Vaccine At Least a Year Away, But Treatment Could Be Here in Months - Newsweek [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- Coronavirus Drug and Vaccine Studies Are Recruiting Their First Volunteers - TIME [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- Brexit means coronavirus vaccine will be slower to reach the UK - The Guardian [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- First patient injected in trial of coronavirus vaccine - WCVB Boston [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- A coronavirus vaccine is in the making But you may have to check your pockets first - Duke Chronicle [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- Coronavirus vaccines and treatment: Everything you need to know - CNET [Last Updated On: March 16th, 2020] [Originally Added On: March 16th, 2020]
- Coronavirus outbreak: How much testing should we do, and where are we on developing a vaccine? - Economic Times [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- Coronavirus Vaccines Precision Vaccinations [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- How Long Will It Take to Develop a Vaccine for Coronavirus? [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- California lab says it discovered coronavirus vaccine in 3 hours [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- Coronavirus outbreak in Wuhan, China: Vaccine may be ready in ... [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- Everything You Need to Know About Canine Coronavirus Vaccine [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- CSU Researchers Are Working Full-Bore On The Mysteries Of Coronavirus And A Vaccine - Colorado Public Radio [Last Updated On: March 18th, 2020] [Originally Added On: March 18th, 2020]
- How soon will we have a coronavirus vaccine? The race against covid-19 - New Scientist [Last Updated On: March 18th, 2020] [Originally Added On: March 18th, 2020]
- Coronavirus trial vaccine participant says he wants to help the world - CNN [Last Updated On: March 18th, 2020] [Originally Added On: March 18th, 2020]
- Daily briefing: The five questions that scientists hunting a coronavirus vaccine must answer - Nature.com [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- Baltimore scientists to work on third experimental coronavirus vaccine - Baltimore Sun [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- The coronavirus could kill millions of Americans: 'Do the math,' immunization specialist says - CNBC [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- We're still in the early days of coronavirus vaccine research - Axios [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- Inoculating the Coronavirus Vaccine Against the Profit Pandemic - The New Republic [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- Wanted: People Willing to Get Sick to Find Coronavirus Vaccine - The Wall Street Journal [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- Coronavirus vaccine trial, Mars rover delay and a boost for UK science - Nature.com [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- Thousands of scientists are racing to find a vaccine for coronavirus. 41 possibilities are in the works. - The Californian [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- 'I Wanted To Do Something,' Says Mother Of 2 Who Is First To Test Coronavirus Vaccine - NPR [Last Updated On: March 21st, 2020] [Originally Added On: March 21st, 2020]
- Vaccine Trials To Fight Coronavirus Offer Hope, Could Be Harbinger Of New Technology - Outlook India [Last Updated On: March 23rd, 2020] [Originally Added On: March 23rd, 2020]
- Image of COVID-19 test kit shared as newly developed 'coronavirus vaccine' by Roche - Alt News [Last Updated On: March 23rd, 2020] [Originally Added On: March 23rd, 2020]
- A coronavirus vaccine is the only thing that can make life 'perfectly normal' again, former FDA commissioner says - The Week [Last Updated On: March 23rd, 2020] [Originally Added On: March 23rd, 2020]
- Johnson & Johnson CEO on potential coronavirus vaccine: 'I think we'll have important data by the end of the year' - Fox News [Last Updated On: March 23rd, 2020] [Originally Added On: March 23rd, 2020]
- As the First Coronavirus Vaccine Human Trials Begin, Manufacturer Is Already Preparing to Scale Production to Millions - TIME [Last Updated On: March 23rd, 2020] [Originally Added On: March 23rd, 2020]
- A coronavirus vaccine is the only thing that can make life 'perfectly normal' again, former FDA commissioner says - Yahoo News [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- This Vaccine Could Save Health Care Workers From the Coronavirus - Foreign Policy [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- Coronavirus vaccine must be affordable and accessible - The Conversation CA [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- Over 100 drugs are in testing in the race to treat coronavirus - Axios [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- This is when the first coronavirus drugs might actually be available - BGR [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- Another Day, Another Meme to Debunk: Vaccines for the Bovine Coronavirus Will Not Cure COVID-19 - Mother Jones [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- A Coronavirus Vaccine Could Be the First That Outwits Nature - Singularity Hub [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- Coronavirus treatment other than vaccines may be available soon - The Jerusalem Post [Last Updated On: March 25th, 2020] [Originally Added On: March 25th, 2020]
- Coronavirus: Vaccine hopes given boost as researcher says virus not mutating - The Independent [Last Updated On: March 27th, 2020] [Originally Added On: March 27th, 2020]
- Coronavirus Vaccine Is Critical, The Infection Could Become Seasonal, Researchers Warn - NDTV News [Last Updated On: March 27th, 2020] [Originally Added On: March 27th, 2020]
- A coronavirus vaccine from Virginia? These researchers are working on it. - The Virginian-Pilot - The Virginian-Pilot [Last Updated On: March 27th, 2020] [Originally Added On: March 27th, 2020]
- Scientists, under pressure, try to balance speed and safety on coronavirus vaccine research - NBCNews.com [Last Updated On: March 27th, 2020] [Originally Added On: March 27th, 2020]
- Should scientists infect healthy people with the coronavirus to test vaccines? - Nature.com [Last Updated On: March 27th, 2020] [Originally Added On: March 27th, 2020]
- Coronavirus Vaccines May Not Work for the Elderlyand This Lab Aims to Change That - Scientific American [Last Updated On: March 27th, 2020] [Originally Added On: March 27th, 2020]
- Vaccine Development Is Risky Business. Biotechs Are Tackling The Coronavirus, Anyway - WBUR [Last Updated On: March 29th, 2020] [Originally Added On: March 29th, 2020]
- Coronavirus vaccine: how soon will we have one? - World Economic Forum [Last Updated On: March 29th, 2020] [Originally Added On: March 29th, 2020]
- USC Working on Coronavirus Vaccine, Researchers Announce - NBC Southern California [Last Updated On: March 29th, 2020] [Originally Added On: March 29th, 2020]
- Tracking the development of coronavirus treatments - NBC News [Last Updated On: April 1st, 2020] [Originally Added On: April 1st, 2020]
- In the fight against coronavirus, antivirals are as important as a vaccine. Here's where the science is up to - The Conversation AU [Last Updated On: April 1st, 2020] [Originally Added On: April 1st, 2020]
- Johnson & Johnson Says It Could Have Coronavirus Vaccine Ready by Early 2021 - The Daily Beast [Last Updated On: April 1st, 2020] [Originally Added On: April 1st, 2020]
- Coronavirus: when will the vaccine be ready? - AS South Africa [Last Updated On: April 1st, 2020] [Originally Added On: April 1st, 2020]
- A Coronavirus Vaccine Is Coming, And It Will Work - City Journal [Last Updated On: April 1st, 2020] [Originally Added On: April 1st, 2020]
- With record-setting speed, vaccinemakers take their first shots at the new coronavirus - Science Magazine [Last Updated On: April 1st, 2020] [Originally Added On: April 1st, 2020]
- CDC: Coronavirus Vaccine Will Be Ready for Refusal By Anti-Vaxxers By 2021 - MedPage Today [Last Updated On: April 3rd, 2020] [Originally Added On: April 3rd, 2020]
- The race to find a coronavirus treatment has one major obstacle: big pharma - The Guardian [Last Updated On: April 3rd, 2020] [Originally Added On: April 3rd, 2020]
- Why A Coronavirus Vaccine May Be Years Away - The National Interest [Last Updated On: April 3rd, 2020] [Originally Added On: April 3rd, 2020]
- The race is on for coronavirus vaccines and treatments: current R&D status - The Pharma Letter [Last Updated On: April 3rd, 2020] [Originally Added On: April 3rd, 2020]
- Tests of potential coronavirus vaccine spur growth of virus-fighting antibodies - USA TODAY [Last Updated On: April 3rd, 2020] [Originally Added On: April 3rd, 2020]
- A 100-yr-old vaccine is being tested against the new coronavirus. Can it work? - Economic Times [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- Coronavirus Live Updates: Boris Johnson Moved to Intensive Care and the U.S. Death Toll Surpasses 10,000 - The New York Times [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- When will a coronavirus shot be ready? A look at the vaccine race. - WRAL.com [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- Hulk Hogan on coronavirus: Maybe we dont need a vaccine - Tampa Bay Times [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- White House advisor Fauci says coronavirus vaccine trial is on target and will be 'ultimate game changer' - CNBC [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- Coronavirus vaccine will take time, so researchers are hunting for and finding promising new COVID-19 tre - OregonLive [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- Chester County to begin testing for coronavirus antibodies; British prime minister moved to intensive care - The Philadelphia Inquirer [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- MAP: Where coronavirus treatments and vaccines are being tested on patients in the US - Business Insider - Business Insider [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- Coronavirus pandemic: Why it takes so long to make a vaccine - Business Today [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- A vaccine for coronavirus is the goal, but what does it take to get there? - ABC News [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- Trump says there's light at the end of the tunnel with coronavirus vaccine and treatment research - CNBC [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- Russia Ready to Start Testing Coronavirus Vaccines on Humans in June - The Moscow Times [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- Why a coronavirus vaccine takes over a year to produce and why that is incredibly fast - World Economic Forum [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- Pandemic expert calls for manufacturing coronavirus vaccines before they're proven to work - The Week [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- More Coronavirus Vaccine Efforts Move Toward Human Trials - The New York Times [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- A coronavirus vaccine is being developed in record time. But don't expect that technology to speed up flu vaccines yet. - USA TODAY [Last Updated On: April 8th, 2020] [Originally Added On: April 8th, 2020]
- A New Front for Nationalism: The Global Battle Against a Virus - The New York Times [Last Updated On: April 10th, 2020] [Originally Added On: April 10th, 2020]
- Here's how your body gains immunity to coronavirus - The Guardian [Last Updated On: April 10th, 2020] [Originally Added On: April 10th, 2020]
- Pfizer aims to create coronavirus vaccine by end of 2020 - MLive.com [Last Updated On: April 10th, 2020] [Originally Added On: April 10th, 2020]