Imagine generating a vaccine for the novel coronavirus from your immune system.
The virus that causes COVID-19 has swept the world with approximately 1.3 million infections and 70,000 deaths until Sunday evening.Development of a widely available vaccine can take a year or more while a virus continues to go wild.
The key to the race to develop a vaccine for the new coronavirus is technology that uses the virus’s genetic code to essentially persuade your body to make its own vaccine.
This technique is faster than egg manufacturing, which produces the majority of annual influenza vaccines and caused delays in the delivery of an H1N1 vaccine during the 2009 pandemic.
And this makes it possible to develop a possible vaccine for the new coronavirus in record time.
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“It’s faster to get started,” said Clem Lewin, who is working on vaccine candidates for the manufacturer Sanofi Pasteur. “All you need is the protein plan. “
The tests will still take time. Scientists need to determine whether more than one candidate vaccine is effective in fighting the virus. If so, they must determine the appropriate dose. This tinkering could take a year or more.
When people first injected the modern manufacturer’s vaccine Moderna on March 16, Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said he believed the coronavirus vaccine was growing at a record pace. It took 63 days to go from identifying the genetic sequence of a virus to testing a vaccine in humans.
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Interference from egg production
Several manufacturers looking for a vaccine against the latest coronavirus have been helped by a technological innovation.
The method followed by Moderna, Sanofi and others is different from traditional vaccinations, in which a weakened or dead version of the virus is introduced into the body, triggering it to create antibodies that would attack the live virus if the person were exposed to it. .
In the new approach, pieces of messenger RNA that contain the chemical matrix of a leading protein in the SARS-CoV-2 virus are injected into a human, said Mark Slifka, professor of viral immunology at Oregon Health and Science University in Portland, Oregon.
Spikes are what the virus uses to attach to a human cell – the first step in making someone sick.
In response to the injection of these molecules, cells in the body produce the advanced protein encoded by this mRNA. This triggers the body to mount an immune response to this viral protein, just like in traditional vaccines.
“Basically, the patient makes their own vaccine,” says the narrator. a Moderna video on the vaccine. “It removes the middleman. “
Fauci said the volunteers would receive two injections of the potential coronavirus vaccine, the second after 28 days. The doses are 25 milligrams, 100 milligrams and 250 milligrams, he said.
“The individuals will be followed for a year – both for their safety and whether it induces the type of response that we think would be protective,” said Fauci.
Moderna, the manufacturer performing the initial tests, screened the first commercially available vaccine in 12 to 18 months. A file filed on March 23 declared that CEO Stephane Banceltold Goldman Sachs “it is possible that in the event of an emergency, a vaccine will be available for certain people, including possibly health professionals, in the fall of 2020” .
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Why change the menu of reliable eggs?
Most flu vaccines are produced from fertilized chicken eggs, a decades-old process that takes four to five months. The mRNA process is much faster.
Delays in producing an H1N1 vaccine have prompted health officials to encourage the development of other technologies, according to a report from the Government Accountability Office.
“This is cutting-edge technology – for the 1950s,” said Luciana Borio, then director of medical preparation and biodefense at the National Security Council at a conference in 2018 on the 100th anniversary of the pandemic of Spanish flu.
A New England Journal of Medicine review of the H1N1 response found that 78 million doses of the vaccine were ultimately produced for 70 countries worldwide, but only after two waves of the disease worldwide.
“The most serious operational gap … has been the failure to deliver enough influenza vaccines in a timely manner,” said the report. The cause: distribution problems, “a lack of global vaccine production capacity and technical delays due to the dependence on viral egg cultures for production”.
Developing a vaccine is a painstaking process, said Harvey Fineberg, former president of the American Institute of Medicine and former dean of the faculty of public health at Harvard University.
One step is to confirm that a possible vaccine does not cause bad reactions in patients. Scientists then examine the amount of vaccine required for an antibody response. And they need to verify that the vaccine actually protects against infection, which is why it’s ideal to test during an outbreak.
All of these steps come after scientists have identified the genetic sequence to target for a vaccine.
“It’s like saying,” I have my architectural plans – my house must be ready to move in, “said Fineberg. “There are a lot of things you need to do between now and be ready to open the door.”
Manufacturers work with government
Coronavirus vaccine manufacturers work closely with the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Agency.
Moderna is working on 13 potential vaccines. Sanofi is working on two candidates: an mRNA candidate with the company Translate Bio and another option in collaboration with the Advanced Biomedical Research and Development Agency.
Other companies are chasing other technologies. GlaxoSmithKline is working with Chinese company Clover Biopharmaceuticals through a different process to produce a cell-based vaccine.
Johnson & Johnson, which works on several possible vaccines, announced last week that it would invest $ 1 billion in research, development and testing of vaccines. The company said it could produce 1 billion doses of the vaccine when the time came.
Senator Chris Coons, D-Del., Said $ 3.5 billion in coronavirus spending program will help develop manufacturing technologies to ensure a robust, agile, and US-based supply chain vaccines, therapeutic products and active pharmaceutical ingredients.
“The biggest challenge we face in the United States is not developing a vaccine, as delicate as this step,” Coons said in a statement. “It is that we do not have the domestic manufacturing capacity to quickly produce a vaccine once it is proven and deliver it to the American people. “
Sanofi’s Lewin said the global health emergency has prompted manufacturers to try different technologies.
“We and all the other manufacturers are working as quickly as possible to speed up these programs while ensuring that the vaccine is safe and effective,” said Lewin. “It is not as usual for anyone. “
What about changes to flu shots?
The technology used to develop a coronavirus vaccine will not affect the annual flu vaccine because they are different viruses that require different approaches. But even before the pandemic, measures were underway to speed up changes to the flu vaccine.
President Donald Trump signed an executive order in September calling on manufacturers to abandon egg vaccines due to “critical gaps,” including the months they take to produce. The order predicted a more deadly pandemic than the Spanish flu of 1918, which killed 675,000 Americans.
William Schaffner, professor of infectious diseases at Vanderbilt University, said that one reason for changing vaccine production is that the growth of the vaccine in eggs allows mutations that make it less effective.
“People were already working on it,” said Schaffner. “This kind of engagement, a presidential engagement, and the money that goes with it, really put the pedal to the plate for future research. “
The manufacturing of egg vaccines has been reliable. Developing another process would require a multi-million dollar investment in an industry with low profit margins, said Schaffner.
“Moving away from egg production is not like flipping a switch,” he said. “I’m sure all of the manufacturers are thinking about it, but how and how quickly they do it is another matter. “
Other options include cellular and recombinant processes. A cell-based vaccine is grown in the cells of a mammal, such as the kidney cells of monkeys or dogs, rather than in chicken eggs. A recombinant vaccine is created synthetically from DNA or genetic instructions from an influenza virus protein. The DNA is then combined with a baculovirus, which infects invertebrates.
Other changes could relate to the administration of vaccines, perhaps switching from injections to pills or skin patches, said Schaffner.
A higher goal is to develop what is called a “universal vaccine”, which could last five years at a time. Such a vaccine could be given at any time of the year during a doctor’s visit, rather than in the fall.
To do this, we would have to change the way the vaccine attacks the flu virus, which is shaped like a sphere with lollipops coming out of it. So far, vaccines have targeted candy at the end of the lollipop, which changes every year.
A vaccine that targets the lollipop stem could provide protection for years, said Shaffner. “If you get vaccinated, you get vaccinated against a whole host of different flu viruses,” said Schaffner.
The coronavirus pandemic occurred during a severe flu season. This year’s vaccine is about as effective as usual, according to a study by the Centers for Disease Control and Prevention on cases until February 8. severe year of 2017-2018.
“Current influenza vaccines have substantial public health benefits,” said the study in the CDC’s weekly morbidity and mortality report. “However, more effective vaccines are needed. “
Contributor: Elizabeth Weise