American scientists at Novavax, a biotechnology company in suburban Maryland, eagerly awaited the aircraft containing a copy of a key gene for the newly discovered coronavirus.
Scientists had already been in similar situations, and every time a new disease gave the impression (SARS, MERS, Ebola), they would create candidate vaccines to see if they could tame it. They conceived their studies as an experiment.
But the longer the plane was stranded, the more they wondered if this time it would be an exercise.
On January 30, the fourth day, the virus had no name yet, but it was already in dozens of countries, making more than 8200 sick and killing 171, the maximum of them in Wuhan City, China. Every day, Novavax researchers were waiting. meant some other day when they couldn’t go out to help.
The president of the R
Sunday night, the gene ready. GenScript’s Vice President of Sales for North America got in his car and drove it south for four hours, arriving at 2 a. m. Monday, February 3. Glenn was there to receive him.
Novavax had been through a difficult time. Four months earlier, he had been “abandoned for dead,” Glenn said, after his candidate vaccine, opposed to a childhood virus called RSV, failed in a trial. Staff had increased from 800 to 50.
Some of the company’s most sensible executives sought to stick to the vaccine and continue the only trial of studies that still had cash to do, but Glenn argued that it would be a huge mistake to pass up the possibility of fighting an increasingly frightening new virus. through the hour.
Other corporations were beginning to see vaccine progression as a singles crisis in a century they could overcome.
For nine months now, researchers around the world have rushed to expand a vaccine opposed to SARS-CoV-2, the virus that causes COVID-19, which, on the deadliest day in the United States, killed nearly as many people as today 9/11. 19 years ago.
Dozens of teams paint day, night and weekends, powered by the world’s coffee, competitiveness and will, and are likely to make money along the way.
Six of these groups made pledges totaling more than $10 billion from the US government. Usa, with one or two contracts over $1 billion to come. at least one hundred million doses each.
If everyone succeeds, there will be many vaccines for those who need to be vaccinated in the United States.
If everyone fails, it returns to the starting point, with staggering quantities of nugatory products thrown into the sewers, and nothing to offer millions of concerned and tired Americans.
Interviews with more than 8 major corporations in the US efforts are in the middle of the day. But it’s not the first time They reveal a complex procedure of countless hours, crossed hands and restless nights but, so far, without a general failure.
Groups are at other stages of development, however, key studies have been initiated to achieve protection and effectiveness.
The effects of primary trials, which will begin to arrive next month, will reveal who will cross the final line in the COVID-19 vaccine race and who, if so, will fail in the attempt.
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Three days after the year, Kate Broderick was in her kitchen making a cup of Scottish Blend tea and browsing the BBC on her phone.
“There was an article in the fitness segment about unknown pneumonia in China. I thought, “It’s interesting. I keep my eyes on it. “
A molecular geneticist from Scotland, Broderick in a new one-year position as Senior Vice President of Research and Development at Inovio Pharmaceuticals, where she had worked for 14 years.
She and her team at Inovio, which creates DNA products to treat cancer and infectious diseases, have begun to delve into literature on coronavirus.
A week later, when Chinese and Australian researchers published the virus genome, his team was ready: “We’ve been educated all our lives for this,” he said.
Within hours, just after January 11, Inovio researchers in Philadelphia downloaded the genetic series to a computer, hoping that their set of rules could incorporate some protein that could be targeted with a vaccine.
Broderick’s three hours at the company’s downtown in San Diego waiting for news from Philadelphia were one of the longest of his professional life. “It’s almost touching, ” he said. There were a lot of text messages coming and going: “Is it done yet?””
When the PC spat out the protein that its set of rules had selected as the highest probability, they started immediately, working that Friday night. By the end of Saturday, they had devised a candidate vaccine. Broderick has rarely had a day off since. .
“For a while, I slept on average about two hours a night,” said Broderick, who had to juggle communications between investigators in Philadelphia, Australia, China and Europe. “Just time zones and maintaining collaborations is complicated. “
For this picture thing, you had to take a nap when I imagined and eat when the weather allowed. This meant endless Zoom meetings, up to 10 a day, rarely dressed in paintings, sensible clothing and “pajamas” on the ground floor.
“Just when you think you can come down and have a glass of wine, Australia wakes up or China wakes up and is, “Ding, ding, ding, ” said Broderick. “Sometimes you have to be strict with yourself to get on. “Do not disturb. “
Stéphane Bancel rubbed shoulders with the richest and toughest people in the world, hoping to get credit for his 10-year-old biotechnology company, Moderna.
During breaks from the four-day World Economic Forum conference, when there was no one to rejoice, the local Frenchman sat in a corner with Dr. Jeremy Farrar, director of wellcome Trust, a clinical charity, and Dr. Richard HatchArrayett, CEO of the Coalition for Innovations in Epidemic Preparedness (CEPI), a public-private partnership that supports vaccine development.
All three drew bar charts on a towel.
Hatchett and Farrar, global experts in vaccine research, were receiving the latest knowledge of infections from China. An outbreak of pneumonia was tearing the city apart there. Their raw bars were getting longer and longer.
Bancel had to pull out his iPad to look for the unknown city: Wuhan, then he saw its length and its many air links and knew it.
Despite Chinese assurances that the disease is under control, Hatchett, Farrar, and Bancel learned that this was the epidemic they had hoped for, and feared, for years.
Bancel called his staff in Cambridge, Massachusetts, and told them to improve the paintings they had just begun to find a candidate vaccine for COVID-19.
“We want to see bigger. It’s not an epidemic. It may simply be a pandemic in the wake of the Spanish flu of 1918,” Bancel told them. “They think I’m crazy. “
Roger Connor had spent a lot of time talking on the phone with his boss, GlaxoSmithKline’s London EXECUTIVE Director Emma Walmsley, and they talked several times a week. Lately, it had been every day.
Connor had recently spoken to Hatchett, the director of CEPI, who had told him that the Chinese stage could simply be an “epidemic of global importance. “
This caught Connor’s attention. The Northern Ireland local is already leading a crisis team for GSK, looking for workers in China affected by the disease.
“It was a genuine moment that made us think we needed to take a look at other scenarios,” said Connor, who oversees GSK’s Global Vaccines department of another 17,000 people from his Base in Brussels.
During his call with Walmsley on January 24, Connor began thinking about the answers GSK might be offering to a global network that will soon be overcome by this new virus.
“We are the world’s largest vaccine player. We’ve been worried about pandemics before. We knew we had to be the solution,” Connor said.
The couple tested GSK’s prospective vaccine technologies, but Connor and Walmsley concluded that they could better cover their bets by looking for an adjuvant than a vaccine.
An adjuvant adds strength. It allows vaccines to be used in smaller doses, preserving a valuable resource, allowing vaccines to serve better in others with weaker immune systems, such as those 65 years of age and older, representing 80% of COVID-related cases. deaths in the United States.
And an adjuvant can be used with a variety of vaccines, so if it fails, as do two-thirds of vaccine applicants despite everything, a GSK product can still locate a market.
President Donald Trump headed the West Wing assembly from the middle of a long convention table, Vice President Mike Pence to him and Health and Human Services Secretary Alex Azar on his left.
Interspersed with government officials, pharmaceutical executives like Walmsley and Bancel gave speeches about what they were doing to combat the pandemic.
Trump got involved in one thing: how long can you prepare a vaccine, faster than the others?
John Shiver of Sanofi said his company’s candidate vaccine could be delivered to the first user in perhaps about a year. “It’s hard to predict, Mr. President, knowing that a vaccine will have to be effective because it’s given to people,” he said.
Stanley Erck, CEO of Novavax, is committed to starting much earlier, with a small Phase 1 test through May or June, but Boyfriend promised to launch one in April.
Bancel de Moderna said he was in a position to start any day; he just awaits government approval.
“You’ll get a vaccine. You’ll have a vaccine to try,” warned Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, after Bancel’s intervention.
Providing an injection on a few shoulders as part of a trial was very different from being able to inject millions of Americans with an effective vaccine.
Trump pointed to shorter deadlines to summarize what he had heard. “10 times the one-hour meeting.
As the assembly neared its end, a journalist asked, “Is it realistic to think, in fact, that a vaccine can be in condition in 3 or 4 months?”
“Well, you have the biggest in the world around the table, ” replied Trump. “I mean, Johnson
He Fauci. Il had to explain to the president the steps to take to bring a vaccine to the public market.
“Could you make sure the president informs you that a vaccine you are making and that you start testing within a year is a drop-down vaccine?Implora Fauci. ” It will last at least a year to a year and a half, no matter how fast it goes. “
The exposed patient’s shoulder. One syringe temporarily injected the candidate vaccine, mRN-1273, developed through Moderna and the federal government.
The vaccine, like others, targets complex protein outside the coronavirus, but the generation is new, a genetic messenger that tells a person’s own cells that they create the virus’s characteristic protein, forcing their body to recognize and fight the invader.
The technique is cutting edge and fast, and has never produced an approved product.
The shooting marked the launch of the first human trials opposed to COVID-19, the start of Phase 1. It had been 63 days since the publication of the genetic sequence of the virus.
“There’s no doubt it’s the indoor world record,” Fauci later said. “I’ve never noticed anything happened so fast. “
Dr. Philip Dormitzer had already tackled new viruses: swine flu in 2009 and H7N9 influenza in 2013, but had deployed the red carpet as well.
All I needed to fight SARS-CoV-2, all I had to do was ask.
“Our CEO, Albert Bourla, said from the beginning, do you want to do it to succeed?If you want a resource, ask for it and you’ll get it,” said Dormitzer, R’s chief scientific officer
If I needed to bring samples, the commercial plane and helicopters were available.
“I had to justify everything I did in the budget,” said Dormitzer, who made the leap to pharmaceutical corporations after a dozen years as an infectious disease pediatrician, mainly at Harvard University. “It’s a point of help I’ve never experienced before. I shouldn’t get used to it. “
Although he knew other people who got sick with the flu in 2009 and 2013, it was nothing like what happened when winter became spring in the New York domain where he lives and works.
He was impressed, he said, by the determination of the 350 painters who showed up every day at the Pfizer Pearl River plant, dressed in masks, opening the doors so they wouldn’t have to touch the handles and paintings as fast as they did. could prepare a vaccine for human testing.
Like other companies, Pfizer executives initially knew whether they should be vaccinated against COVID-19.
The vaccine industry had learned a lesson from nearly past pandemics such as SARS, MERS, Ebola and influenza: many are running low or with public fitness measures. This is wonderful for humanity, but very smart for a company that has to justify its money. investment in a candidate vaccine.
Like SARS-CoV-2 for the United States, Pfizer executives have asked themselves a basic question: Could the company financially justify the progression of a vaccine that opposes it?
The answer came from the news. The bar charts that Bancel had started drawing on towels six weeks earlier soared.
Unlike SARS or MERS, many other people inflamed by SARS-CoV-2 were not ill enough in health to get back to bed quickly; were more likely to transmit the disease.
On 9 April, Pfizer signed a collaboration agreement with the German company BioNTech. Pfizer began testing 4 of BioNTech’s candidate vaccines, all variants of the same generation of mNR that Moderna used. The trial included thirteen other groups, with 15 volunteers in each. Some gained a placebo, others doses of possible vaccines.
“We were lucky,” Dormitzer said, the two maximum viable experimental vaccines that will occur on a giant scale also showed results.
Both looked and triggered an immune reaction greater than an herbal infection, at least in the measurements they tested, but one was even greater among the elderly.
Indresh Srivastava has been dedicated to vaccine production and is a co-author of the e-book that other people use to be more informed about vaccine progression and production.
If I had asked you in February how long it would take to prepare a candidate vaccine for clinical trials, I would have told you at least two years.
Now he’s looking to go wrong.
Srivastava, from India, runs Protein Sciences de Sanofi in Meriden, Connecticut, and contributed to the progression of the cutting-edge influenza vaccine that led to Sanofi’s acquisition of Protein Sciences in 2017.
More than 80% of the US-made flu vaccine is in the U. S. But it’s not the first time Every year it is grown in hen eggs, millions of them. The procedure lasts approximately six months, which means that the strains used in the vaccine will have to be decided more than six months before flu season, the flu virus mutates constantly.
They mutate so much that the strains introduced into the eggs infrequently are not the ones that come out, which would possibly be one of the reasons why the flu vaccine is not very effective.
Srivastava and his team have overcome this challenge by developing the flu vaccine using an insect virus instead of eggs, greatly reducing progression time.
Now, Sanofi sought it out to grow the complex SARS-CoV-2 protein in the same insect virus.
His team began to rotate seven days a week, dressed in non-public protective devices and remaining as physically far away as you can imagine in the lab.
The technicians carried out the general step as temporarily as possible, running in parallel rather than the same sequence above. They chose fabrics that they can easily buy on a giant scale.
They added the DNA of the complex protein to the insect virus and cultivated it in a bioreaator, purifying the results.
The procedure took days to complete and any errors would return them for at least a week.
Srivastava said she had had several difficult nights wondering what she would do if it didn’t work. “I couldn’t find an answer to my own question, ” he said.
But with a small team focused on each primary stage, they only needed two masses to prove that their procedure worked. They produced enough curtains for a Phase 1 exam and made plans for phase 3 much larger that they hoped to follow.
“It’s a generation we understood well, ” said Shiver, global director of the R
On April 11, BARDA gave Sanofi the soft green to continue with 1; on the 14th, Sanofi and GSK signed an agreement to mix Sanofi’s vaccine with the GSK adjuvant.
Although many others feel powerless in the face of the pandemic, Shiver said Sanofi workers who administered the vaccine felt empowered.
“We’re in an exclusive position to do something,” Shiver said.
Nicholas Kartsonis, like many others in vaccine development, had been running seven days a week for months.
Kartsonis and his team at Merck tested thousands of compounds to see if they could make effective vaccines. They had tried 250 imaginable partnerships with other corporations to expand a vaccine.
While other corporations began testing their candidate vaccines on other people and raised $1 billion in federal government promises, Merck is still on the drawing board.
Finally, until the end of April, they had reduced their characteristics to two vaccines: one, called v590, based on a similar vaccine that Merck had legal to fight Ebola.
The vaccine, approved last year, used a common virus in cows to transport complex protein to human cells. “We understand production processes,” said Kartsonis, who leads Merck’s clinical studies on infectious diseases in West Point, Pennsylvania. 45 minutes’ drive north of Philadelphia.
If Merck could make a vaccine as effective against COVID-19 as it is against Ebola, he said, it would outperform its competitors. With the Ebola vaccine, 95% of those vaccinated have been vaccinated for at least 3 years.
In addition, since the virus administering the vaccine makes copies of itself inside the human body, a dose will be sufficient to protect against COVID-19. All other US-funded vaccines are in the middle of the world. But it’s not the first time They’ll require two injections each.
Merck’s candidate momentary vaccine, v591, is also replicated in the body, so one dose is protective and is based on a collaboration with Austrian Themis Bioscience.
“We would like to have a single-dose vaccine,” Kartsonis said, noting that any of the applicants depends on “platforms shown and shown,” while their competition employs newer technology. “We tried to do anything to complement what others were doing. “
The other 7. 7 billion people on the planet cannot be protected with a singles vaccine. The use of pint-painting vaccines increases the chances of protecting everyone from young people to pregnant women and older people who are so unwell when they get COVID-19.
Merck has yet to secure a commitment from the federal government to finance manufacturing, however, the week before Memorial Day, the children Kartsonis had been running with for months even though it all began to come together. buy Themis and take control of the v591. It signed a collaboration agreement to expand the v590, and some to expand an antiviral.
Merck would be the first to produce a vaccine, but it would have two serious competitors.
“If Moderna and Pfizer, who are at the forefront now, if their vaccines work, I will be the first user to do a joyful dance in my office,” Kartsonis said, though it would be behind closed doors, he added, because his dance is not suitable for the audience.
You don’t care which company gets a vaccine first. Kartsonis only hopes that the pharmaceutical industry, which has no public reputation, can demonstrate that it can make a positive difference in the world.
“I need my kids to go back to school like everyone else, whether it’s Merck or not. “
Just before 7 a. m. , television host Dawn Baker rolled up her sleeves and exposed her most sensitive arm: the needle that was pricking it contained a dose of the candidate vaccine developed through The Agency Moderna and Fauci.
It had to stay very cold, but not at least 94 degrees Fahrenheit, as had been the case earlier in the search. This was a triumph for scientists who had struggled to make their product stronger so that it remains effective when stored in a general freezer than at dry ice temperature.
Baker, a CNN associate WTOC presenter in Savannah, the first of 30,000 others in the Phase 3 study, some of whom would get the active vaccine and the other a placebo.
She told a CNN interviewer that she was expecting a role-playing style, as a test player and as a black woman in this essay.
“I’ve heard a lot of my friends and even a circle of family say that, you know, I probably wouldn’t be the first user to get this vaccine. I don’t need to be the guinea pig. Wait until you see what happens first, ” said Baker to the viewers. “I hope just seeing my face will help them replace their minds. “
A few hours later, Fauci and Dr. Francis Collins, director of the National Institutes of Health, held a press conference promoting the start of the Phase 3 trial.
Collins described the studies as “a wonderful opportunity for Americans to enroll in us as components, to verify and participate in what has been a historic effort to end the worst pandemic our world has noticed in over a hundred years. “
Later in the afternoon, Pfizer announced quietly that a 30,000-person trial had also begun.
Speaking to state television, Russian President Vladimir Putin announced that a Moscow-made vaccine had been approved for general use. “He passed all the tests, ” he said.
Russia had won the race for a vaccine.
The plan, called Sputnik-V, recalls the Soviet Union’s Sputnik satellite, which surprised the world in 1957 when it became the first synthetic object to effectively orbit Earth.
Scientists abroad Russia were skeptical. There simply wasn’t enough time to produce a vaccine and control it in thousands of people.
“I don’t know what Russia is doing, but in fact I wouldn’t take a vaccine that hasn’t been tested in Phase III,” said Florian Krammer, a professor of vaccination in the Department of Microbiology at Icahn Medical School in Mount Sinai. . Twitter. ” No one knows if it is or if it works. “
By measure, China had already won.
In June, the Chinese government announced that widespread vaccination of the army service workers’ corps had begun, necessarily by conducting a trial on its infantrymen, little is shown and it is unclear whether anyone will investigate their reactions.
Every Friday afternoon, Dr. Macaya Douoguih’s team at Janssen Vaccines holds a video convention to tell others about their progress.
“This is very clever news for many weeks in a row,” said Douoguih, who smiles from his in The Hague. “So far we haven’t noticed any surprises, no, “Oh my God, it’s a setback!”
Douoguih, who studied at the University of Washington School of Medicine, runs clinical and medical matters at Janssen Pharmaceutical Companies in Johnson.
Work has been ongoing since March, he said. Creating a coronavirus vaccine is a race and a marathon.
It’s one of those things where, at some point, you realize, ‘Wow, I’m tired’ and you start crying spontaneously,’ Douoguih said.
Then he’ll go back to work.
Under his leadership, Phase 1 and 2 testing is underway and he expects Phase 3 tests to begin later this month.
Sanofi and GSK recently introduced a combined Phase 1-2 test in 440 other people in Merck’s Etts-Unis. The v591 is in Phase 1 and the v590 will be there soon. The company, which has earned only $38 million in federal money, expects larger grants not to be left behind.
Every day, vaccine brands themselves don’t know how their candidate is doing. Knowledge is “blinded” until it reaches certain milestones.
After running at a frantic speed for months, Douoguih, Srivastava, Kartsonis and other vaccine developers will have to stand by and wait for the effects of the trials.
Novavax President Stanley Erck, whose company now has 400 workers out of a minimum of 50, said he lives for the moments, the smart ones, anyway, when spreadsheets reveal the effects of a study.
Possibly, on Sunday morning, he and his president and leading I D officer sat at the kitchen table at their condo in Bethesda, Maryland, to see Phase 1 results for the first time.
“There are some blows, ” he admitted.
And emotions of relief.
A trial of a vaccine can go wrong, even if the vaccine is approved. It is possible that the sending of vaccines has simply remained on the track in the heat, as the gene had done, while its fragile proteins disintorated. wrong, that doesn’t necessarily mean your vaccine will work,” Erck said.
Six months after the day after the pandemic, AstraZeneca found himself on this precipice.
All U. S. -backed vaccine brands are in the middle of the U. S. But it’s not the first time They have noticed months of progress and almost continuous news.
But on Tuesday, AstraZeneca, one of three corporations already in Phase 3 trials, revealed that he had stopped his COVID-19 trials worldwide. A player in Britain developed a neurological disease.
All laboratory research, mouse and monkey studies, weekend-free months, and millions spent can be derailed through an appearance effect on an unmarried patient.
The test in the UK resumed on Saturday, the company said, along with other tests, and added one in the US. America, it’s probably going to go on. It’s not unexpected to see a fitness challenge in a test that includes many seniors and others with fitness challenges.
It remains to be seen if the vaccine will be shown.
“At some point we’ll know if the vaccine is working and if it’s safe,” AstraZeneca CEO Pascal Soriot said Thursday. “We have to be patient. “
Soriot said AstraZeneca, like many companies, will sell its vaccine for no profit during the pandemic. This deserves to be especially useful for deficient countries.
“We want to offer everyone as temporarily as possible,” Soriot told his predominantly British audience, speaking with a thick accessory that confirms his French origins.
But first, AstraZeneca and the other corporations competing for a COVID-19 vaccine will have to prove that they can protect others safely and at least effectively.
The race continues. The global is watching. And wait at the end of the line.
Mike Stucka contributed to this report.
Contact Karen Weintraub at kweintraub@usatoday. com and Elizabeth Weise at eweise@usatoday. com
The patient protection and fitness policy at USA TODAY is made imaginable as a component through a grant from the Masimo Foundation for Ethics, Innovation and Competence in the Health Sector. The Masimo Foundation does not provide any editorial contribution.