Imagine that you are generating a vaccine against the novel coronavirus from your immune system.
The virus that causes COVID-19 has caused around 1.3 million infections and 70,000 deaths worldwide by Sunday evening.A common vaccine can take a year or more to develop while a virus continues to rage.
This technique is faster than egg-based, which produces most of the annual flu vaccines, and caused delays in the distribution of a H1N1 vaccine during the 2009 pandemic.
And it enables the development of a possible vaccine for the new coronavirus in record time.
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“Getting started is faster,” said Clem Lewin, who is working on vaccine candidates for the manufacturer Sanofi Pasteur. “All you need is the blueprint for the protein.”
Testing will take some time. Scientists need to determine whether one of several vaccine candidates is fighting the virus effectively. In this case, you need to determine the correct dose. This crafting can take a year or more.
When the first potential vaccine from the manufacturer Moderna was injected into humans on March 16, Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, believed that the coronavirus vaccine would be developed at a record pace. It took 63 days to identify the genetic sequence of a virus and test a vaccine in humans.
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Scrambled egg-based production
A number of manufacturers tracking a vaccine against the latest corona virus have been supported by a technological innovation.
The method followed by Moderna, Sanofi, and others differs from conventional vaccinations, in which a weakened or dead version of the virus is introduced into the body, which triggers antibodies that attack the living virus when the person is exposed to it.
The new approach injects pieces of messenger RNA containing the chemical template of a spike protein from the SARS-CoV-2 virus into a human, said Mark Slifka, professor of viral immunology at Oregon Health and Science University in Portland. Oregon.
The tips are what the virus uses to bind to a human cell – the first step to making someone sick.
In response to the injection of these molecules, the cells in the body produce the spike protein encoded by this mRNA. This causes the body to develop an immune response to this viral protein, just like with conventional vaccines.
“Essentially, the patient makes his own vaccine,” says the narrator of a Moderna video about the vaccine. “That cuts out the middleman.”
According to Fauci, the volunteers would receive two injections of the potential coronavirus vaccine, the second after 28 days. The cans are 25 milligrams, 100 milligrams and 250 milligrams, he said.
“People are monitored for a year, both for security reasons and whether this is the type of response that we predict is protective,” said Fauci.
Moderna, the manufacturer who conducted the first tests, predicted the first commercially available vaccine in 12 to 18 months. According to a company registration on March 23, CEO Stephane Bancel told Goldman Sachs: “It is possible that in the fall of 2020 some people, possibly health professionals, will be able to get a vaccine in an emergency.”
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Why change the menu of reliable eggs?
Most flu vaccines are made from fertilized chicken eggs, a decades-old process that takes four to five months. The mRNA process is much faster.
According to a report by the Government Accountability Office, delays in the production of an H1N1 vaccine have prompted health authorities to push ahead with the development of other technologies.
“It’s state-of-the-art technology – for the 1950s,” said Luciana Borio, then director of medical and biological preparedness at the National Security Council, at a conference in 2018 to mark the 100th anniversary of the Spanish flu pandemic.
A review of the response to H1N1 by the New England Journal of Medicine found that 78 million doses of the vaccine were eventually made for 70 countries worldwide, but only after two waves of the disease worldwide.
“The most serious operational shortcoming … was the failure to distribute influenza vaccines in time,” the report said. The cause: distribution problems, “a lack of global vaccine production capacity and technical delays due to dependence on viral egg cultures for production.”
One step is to confirm that a possible vaccine will not cause bad reactions in patients. Scientists then investigate how much vaccine is required for an antibody response. And they need to check if the vaccine actually protects them from infection, which is why it’s ideal to test it during an outbreak.
All of these steps take place after scientists have identified the genetic sequence to be targeted by a vaccine.
“It’s like saying,” I have my architectural plans – my house needs to be ready, “said Fineberg.” There are a lot of things you have to do until you are ready to open the door. “
Manufacturers work with the government
Manufacturers using coronavirus vaccines 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 possible vaccines. Sanofi is working on two candidates: an mRNA candidate from Translate Bio and another option in collaboration with the Biomedical Advanced Research and Development Agency.
Other companies are pursuing other technologies. GlaxoSmithKline is working with Clover Biopharmaceuticals from China in another process to produce a cell-based vaccine.
Johnson & Johnson, which is working on several possible vaccines, announced last week that it would invest $ 1 billion in vaccine research, development and testing. The company said it could produce 1 billion doses of a vaccine in due course.
Senator Chris Coons, D-Del., Said that $ 3.5 billion in the coronavirus spending package will help develop manufacturing technologies to ensure a robust, agile supply chain of vaccines, therapeutics, and pharmaceuticals in the United States.
“The biggest challenge in the US is not to develop a vaccine, as difficult as this step is,” Coons said in a statement. “The fact is that we lack the domestic production capacity to quickly manufacture a vaccine once it is proven and deliver it to the American people.”
Lewin of Sanofi said the global health emergency has caused manufacturers to try different technologies.
“We and all 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’s not normal for anyone.”
What about changes to flu vaccines?
The technology used to develop a coronavirus vaccine does not affect the annual flu vaccine because it is a different virus that requires different approaches. But before the pandemic, steps were underway to speed up changes to the flu vaccine.
President Donald Trump signed an implementing regulation in September asking manufacturers to deviate from egg-based vaccines because of “critical deficiencies,” including the months it takes to make. The order provided for a pandemic that was more deadly than the 1918 Spanish flu that killed 675,000 Americans.
William Schaffner, professor of infectious diseases at Vanderbilt University, said one reason for the change in vaccine production was that growing the vaccine in eggs allows mutations that make it less effective.
“People have already worked on it,” said Schaffner. “This type of commitment, the President’s commitment and the money involved have really set the pedal for future research.”
The production of egg-based vaccines was reliable. Developing another process would require a multi-million dollar investment in a low-margin industry, Schaffner said.
“Moving away from egg-based production is not tantamount to flipping a switch,” he said. “I’m sure all manufacturers think about it, but how and how quickly they do it is another matter.”
Other options include cell-based and recombinant processes. A cell-based vaccine is grown in mammalian cells such as monkey or dog kidney cells and not in chicken eggs. A recombinant vaccine is made synthetically from the DNA or genetic instructions of a protein from the flu virus. The DNA is then combined with a baculovirus that infects invertebrates.
Other changes could relate to vaccine delivery, possibly from injections on pills or skin patches, Schaffner said.
A higher goal is the development of a so-called “universal vaccine”, which can take five years each. Such a vaccine could be given at any time of the year during a doctor’s visit, not just in the fall.
This would require changing how the vaccine attacks the flu virus, which is shaped like a ball with lollipops sticking out. So far, vaccines have directed the candy to the end of the lollipop, which changes every year.
A vaccine that targets the lollipop’s trunk could provide protection for years, Shaffner said. “If you are vaccinated, you will be vaccinated against a number of different influenza viruses,” said Schaffner.
The coronavirus pandemic has occurred during a severe flu season. This year’s vaccine is about as effective as usual by February 8, according to a study by the Centers for Disease Control and Prevention. The study found that the severity of people up to 49 years, including hospital stays, was worse than in other seasons in recent years, including the 2017-2018 difficult year.
“Current influenza vaccines offer significant public health benefits,” the CDC weekly report said of morbidity and mortality. “However, more effective vaccines are needed.”
Contributors: Elizabeth Weise