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Pfizer and BioNTech announced this week that their vaccine is 90% effective in preventing symptomatic COVID-19 in clinical trials. The data is still preliminary and has not been reviewed by independent researchers, but this is good news for both this specific vaccine and other coronavirus vaccines in development – especially those based on the same genetic technology.
“This is extremely encouraging, in my opinion, not only for the Pfizer vaccine, but more broadly for the platform,” says Ross Kedl, an immunologist at the University of Colorado.
The Pfizer and BioNTech vaccine is made from genetic material called mRNA. MRNA carries instructions inside cells and tells them to build proteins. The vaccine includes a specific piece of mRNA that contains instructions on how to make the coronavirus spike protein, which is the small piece that allows it to bind to human cells. The vaccine prompts the human body to make copies of this protein. When the immune system encounters these spikes, it learns to recognize and block them.
Genetic vaccines are relatively simple to develop and manufacture. For years, they have been heralded as the future of vaccine development. However, so far they have been largely experimental. The Food and Drug Administration (FDA) has never approved one for use in humans. Rosemary Rochford, also an immunologist at the University of Colorado, says she was initially skeptical that they would work as well as other types of vaccines, such as those made from inactivated viruses. But Pfizer’s data – assuming it stands up to further evaluation by outside experts and the FDA – is strong proof of concept. “This mRNA platform looks very promising,” she says.
The Moderna vaccine candidate, which should to publish initial data soon, is also based on mRNA. “I guess their effectiveness will probably be similar,” says Drew Weissman, an immunologist at the University of Pennsylvania who has conducted research on mRNA vaccines. He is also an advisor for BioNTech, the company that has partnered with Pfizer on this vaccine.
Moderna and Pfizer / BioNTech have also achieved equivalent results in their Phase 1 and Phase 2 clinical trials, which are on a smaller scale, Kedl says. “You could almost overlap the two, or change the names and you’d cheat everyone.” They both really support each other in terms of strength of immunity. ”
Prior to the COVID-19 pandemic, there wasn’t a lot of research done on genetic vaccines for infectious diseases – much of the work focused on treating cancers, not viruses, Rochford says. Authorizing the first gene-based vaccine for something like COVID-19 would open up a new world of options for vaccine developers.
Pfizer’s vaccine has yet to be cleared or approved by the FDA, and there are still a few steps to go before it reaches this stage. The data released this week, however, points in that direction.
“I think that is a game changer,” Kedl says. “I wouldn’t be surprised if, over the next 10 years, we see this make its way into the flu vaccine.
Once these vaccines pass the initial hurdle of proving their effectiveness and safety, researchers can begin to study them more intensely. “Once we know it’s working, we’ll take the time to find out why,” Kedl says.
Rochford says she will monitor the duration of immunity provided by these mRNA vaccines and the duration of the antibody response generated by the vaccine. Research shows that, for people who catch COVID-19 and produce their own natural antibodies, the levels drop before they stabilize. But the antibodies generated by the vaccine are different. “Your body is not fighting an infection and a whole disease process,” she says. “I am more convinced that the durability will be better than what we see in a natural infection.”
Businesses and researchers will also be looking for ways to improve vaccines. Based on first reports, they cause more body aches and other mild side effects than other vaccines, for example. “There can be changes, we can start to change some things,” Kedl says.
A disadvantage of mRNA vaccines is that they must be stored at extremely low temperature, which makes them more difficult to transport. MRNA is an unstable compound, and keeping it cold ensures that it will not break down until it is injected into a patient’s arm. Weissman says teams at pharmaceutical companies are working on ways to keep these vaccines stable at higher temperatures, and he believes future generations of COVID-19 vaccines will be able to stay in refrigerators. Weissman is also working on a way to lyophilize genetic material, so that vaccines can be stored at room temperature. “I don’t think it’s going to be a big thing to worry about,” he said.
Having another proven way to make vaccines will help researchers prepare for the next pandemic. There is nothing unique about this specific coronavirus that makes mRNA vaccines work well – the platform could be just as effective for other viruses. “Let’s say we have a new coronavirus, or a new Ebola virus, or a new pathogen emerging,” Rochford says. “It would be pretty easy to generate them once you have the basic sequence and biology. Going forward, this gives us a very solid platform for a quick response.
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