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Eighteen months may sound long, but in the vaccine year, it happens very quickly. This is the long end of the time frame for the Trump administration to develop a coronavirus vaccine, and some leaders in the field say this is too fast and may come at the expense of safety.

Estimated time became headline last month mentioned by Trump TV Cabinet Meeting With pharmaceutical company executives, vaccines may be ready in “3-4 months”. So, in front of a television camera, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said that he poured cold water into Trump’s estimate, which is close to a year to a year and a half. .

Since then, that estimate of 12 to 18 months has become gospel and its appearance in media stories is everywhere. However, health professionals and scientists directly involved in vaccine development are skeptical.

“Tony Forch says it’s a year to 18 months. I think we’re optimistic,” said Dr. Peter Hotes. Leading experts About infectious diseases and vaccine development at Baylor College of Medicine. “If all the stars are aligned, it will probably be longer.”

Dr. Paul OfffitMore frankly, the co-inventor of a successful rotavirus vaccine.

“When Dr. Forch said 12 to 18 months, I thought it was tremendously optimistic,” he told CNN. “And I’m convinced he did too.”

Vaccine development is usually measured in years, not months

With more than 3,000 deaths from coronaviruses in the United States, the pressure on the scientific community to find vaccines is immense. In just a few weeks, the virus disrupted a powerful economic gear, Destroy 3.3 million jobs. Fear is off the chart, and with it comes pressure to find a fix yesterday.

Two weeks after the Cabinet meeting, on March 16, the first new federally funded test for coronavirus (formally known as SARS-CoV-2) was conducted at the Kaiser Permanente Washington Health Institute in Seattle. Started with On Friday, it expanded to Emory University in Atlanta. 45 volunteers from the Seattle and Atlanta communities participate in the first phase of the exam. “Released at record speed”. (Some vaccines are under development, but only one other clinical trial is ongoing in China.)

According to experts, the problem is that the timetables often said are ambitious at best.

“I don’t think this has ever happened on an industrial scale in 18 months,” said Dr. Ameshua Darja, a senior researcher focused on emerging infectious diseases in the United States. Health and safety center At Johns Hopkins University. “Vaccine development is usually measured in years, not months.”

Vaccine testing usually begins with testing on animals before embarking on a three-phase process. In the first phase, the vaccine is injected into a small number of people to assess safety and monitor the immune response. The second approach is to increase the number of people for randomized trials, often to hundreds, and often to members of risk groups. If the results are promising, the trial will move to an efficacy and safety phase 3 trial with thousands or tens of thousands, US Centers for Disease Control and Prevention.

Dr. Emily Abelding NIAID Infectious Disease Expert -This is part of the National Institutes of Health-states that the development of a typical vaccine will take 8-10 years. She is careful not to contradict her boss’s timeline, but said that “ 18 months will be as fast as I can think of it, ” but she says that the pace of acceleration is “ all data Not seeing “is included.

“ We are competing here to defeat this epidemic, and vaccines are so important that people may be willing to take the opportunity to move on to Phase 2 immediately, ” Erbelding said in CNN. Told. “Thus, 18 months will depend on speeding things up.”

According to Abelding, volunteers at each stage need to be monitored for safety. “I usually want to track the immune response for at least a year,” she said.

However, in ongoing research in Seattle and Atlanta, researchers test animals and humans in parallel, rather than in parallel. According to statistics, A health news website created by Boston Globe Media.

CNN contacted Kaiser about potential trade-offs related to shortening the timeline, but researchers in the organization could not comment.

Walt Orenstein, Emory Medical Professor Former director of the former US vaccination program said the trade-off was a difficult balancing act.

“If you want to scatter” i “beyond all” t “, how many more will die or suffer in Covid-19? “He said. “It’s not a simple decision, but a breakthrough speed to get things going.”

Orenstein said that although there may be lessons from past efforts to develop vaccines against SARS and MERS, it is difficult, but possible, to complete the process in 18 months .

“I think the reason it works so fast is because we have such a serious problem,” he said. “The disease is spreading like a wildfire.”

In rare cases, incorrect vaccine testing has proven to be harmful or even lethal to humans.

Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat that while recognizing the importance of animal testing, the urgency of current public emergencies is a trade-off. Was.

“If we hear that vaccines can take up to a year or a year and a half to become available, there is no way to approach these schedules without a new approach.” He told the site.

Coronavirus vaccine candidate uses a new technology that has never been approved

The vaccine under investigation was created using a new technology platform that could be innovative. However, technology Messenger RNA vaccine —Never approved as a product for distribution. This is the first.

Developed by scientists at NIAID and researchers at Moderna, a biotechnology company in Massachusetts, this product, unlike most licensed vaccines, does not use some of the live virus. Rather, researchers made vaccines from genetic information about the coronavirus provided by China. be called mRNA-1273Vaccines use messenger RNA (ribonucleic acid) to make proteins in the cells of the body and make proteins that stimulate an immune response that prevents or prevents disease.

“It’s a very sophisticated solution, and because we only need the viral sequence, that’s why we can go to vaccine testing right away,” said Adalja. “They don’t need to fiddle with the virus to make a vaccine candidate. They can make a vaccine candidate with the genetic sequence of the virus.”

Still, Adaliya said he believes the process will take longer than 18 months because of potential clinical trial or manufacturing issues.

At the White House briefing on March 26, Fouch stuck to his timeline and financially gambled the process by encouraging companies to start production even before the vaccine proved to work. He said he was going to promote it.

“Once you know it works, you can’t say,” Wonderful, it works. It takes another six months to manufacture it now, “he said.

Forch added that the federal government would help pass the bill.

“We have invested hundreds of millions of dollars in companies to make vaccines,” he said. “I will not hesitate to do it for a while now.”

Mr. Offito, head of the Vaccine Education Center at the Philadelphia Children’s Hospital, is concerned that pursuing quickly can do more harm than good.

“Remember, you’re probably giving this vaccine to healthy people. They’re not usually people who die from this infection,” he said. “So you should better make sure you hold it to a high standard of security.”

Forche, who did not respond to a request for comment on the story, acknowledged the importance of security in a statement on March 26.

“The worst thing you do is vaccinate someone to prevent the infection and actually make them worse,” he said.

Catastrophic vaccine failure

The World Health Organization estimates that vaccines save between 2 and 3 million lives annually. However, catastrophic failures are scattered throughout the history of vaccines, in which those who take them are much worse than those who did not.

In the 1960s, testing of RSV (human respiratory syncytial virus) vaccine Protection failed Many infants became ill and their symptoms worsened than usual. It was also associated with the death of two infants.

In 1976, President Geraldford’s administration responded quickly to the outbreak of the new flu and ignored the World Health Organization warning and the word v.To vaccinate “all men, women and children in the United States”. After 45 million people were vaccinated, the flu was found to be mild. To make matters worse, researchers have found that the total number of vaccinated patients is extremely high, around 450 in total, causing Guillain-Barre syndrome. In Guillain-Barré syndrome, the body’s immune system attacks nerves, causing paralysis. at least 30 people have died. The program ended in late 1976 due to the discovery of risks. A Litigation Continued against the federal government.

2017, Hurry campaign -WHO Approval-Immunization of approximately 1 million children with mosquito-borne dengue fever in the Philippines has been discontinued for safety reasons. The Philippine government has charged 14 state authorities in connection with the death of 10 vaccinated children, stating that the program was launched “in haste.”

Keymanthri Moodley, Professor of Bioethics at Stellenbosch University In South Africa, he said that accelerated trials increased the likelihood of failure to attract attention, which could have other unintended consequences.

“The risk of vaccine failure for other well-established vaccination programs is high,” Moodley wrote in an e-mail to CNN. “It will stimulate the agenda of the anti-Bax movement and deter parents from immunizing their children with other safe vaccines.”

How long did rotavirus, Ebola, measles and SARS take?

Historically, timelines for bringing vaccines to other pathogens have shown arcs much longer than 18 months.

In 2006, a vaccine co-developed by Offit was introduced for rotavirus, causing severe diarrhea in infants and significantly slowing the disease. The entire effort spanned 26 years. He told CNN that the trial took 16 years.

In November 2019, WHO pre-approved the Ebola vaccine. This means that health authorities can start using vaccines in countries at high risk, such as the Democratic Republic of the Congo, where hundreds of thousands of people are vaccinated. WHO has stated that this is the fastest pre-examination process ever undertaken. The story of vaccine development is complicated, but it took about five years to get a licensed product, said Seth Berkley, CEO of Gavi at the Vaccine Alliance. In a recent TED interview.

Even in the 1960s, when regulations were relatively lax, it took four years for mumps and measles vaccines to be approved, Offit said.

“The consent form is a 3 inch (5 inch) index card, and” I allow my child to participate in a blank trial. Then you sign it, “Offit said. . “It could never happen today, which is the fastest feasible.”

From time to time, promising vaccines can decline due to lack of public interest.

Although the SARS outbreak began in 2003, vaccines developed by the Hotez team in Texas were ready for clinical trials until 2016.

“It looked really good-it was protective and safe,” Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, told CNN. “But the problem was that we couldn’t raise money.”

He is looking for funding to restart it and says that the vaccine may partially protect against Covid-19, a disease caused by the current coronavirus belonging to the same virology as SARS. You.

“Because the investment has been made before, it may be possible to prepare the vaccine now,” Hotez told Congress last month.

Dr. Mike Ryan executive director The WHO Health Emergency Program states that testing new vaccines will take time.

“A lot of people are asking.” Why do we need to test vaccines? Why not just make a vaccine and give it to people? “Well, the world has learned many lessons about the high volume use of vaccines And there is only one thing more dangerous than a bad virus. That’s a bad vaccine. ” “We need to be very very careful when developing products that potentially inject into most of the world.”

Running a marathon at the forefront

Only one NIH-funded trial is ongoing, but involves dozens of companies and researchers from around the world. Researchers are doing their best to run the marathon.

Dr. David Dowling at Boston Children’s Hospital spends 17 hours caring for his wife and two infants who also work as scientists.

“I take a rest on Saturday,” he said. “But on Sunday, I’ll probably try 9 or 10 hours a day.”

Dowling Lab Project Manager It is working on the development of a new precision vaccine for coronavirus that protects the most vulnerable group, the elderly.

The role of this laboratory, led by Dr. Ofer Levy, in coronaviruses provides a glimpse of some of the federal government’s urgency.

Prior to the outbreak, the team was working on an influenza vaccine to protect the elderly using immune-enhancing molecules called adjuvants.

When a lab running at the Harvard Medical School building learned of a coronavirus outbreak in January, they sent an email to NIAID essentially asking if they could simply divert a coronavirus flu contract. Stated.

“They returned the email in about 30 seconds,” he said. “It’s ‘Yes. Do this as soon as possible.'”