Why it’s a big deal if the first Covid vaccine is ‘genetic’

On Monday in the morning, When representatives from the pharmaceutical company Pfizer said its Covid-19 vaccine appears to be more than 90 percent effective, the stock soared, White House officials rushed to (falsely) claim credit, and sighs of relief spread throughout the Internet. Dear world. We have a vaccine! The best news since January 10 ” tweeted Florian Krammer, a virologist and vaccinologist at Mount Sinai School of Medicine (who is also a participant in the Pfizer Covid-19 vaccine trial).

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But having a press release from a pharmaceutical company that says a vaccine works is very different from having a vaccine that works. Pfizer and its German vaccine partner BioNTech have yet to release any data from their phase III trial. This week’s findings are based on the trial’s first interim analysis, conducted by an external panel of experts after 94 of the 43,538 participants contracted the coronavirus. That analysis suggests that most of the people who got sick had received a placebo, rather than the vaccine. But it doesn’t say much beyond that. (More on why that matters, later.)

And logistically, there are still a lot That has to happen before non-study subjects can begin to roll up their sleeves. Pfizer researchers are now collecting safety tracking data for at least two months. If those findings don’t raise red flags, the company could apply for an emergency use authorization from the US Food and Drug Administration. Only then could executives begin distributing the 50 million doses they hope to make before the end. a year, a process complicated by the fact that until ready to be injected into someone’s arm, the Pfizer vaccine must be kept at low temperatures. -80 degrees Fahrenheit, which is much colder than the usual cold chain for vaccines. Completing the immunization also requires two doses three weeks apart. Oh yeah, and he claims that right now they are trying to do all the other things you have to do to prepare for such a complicated immunization campaign: hiring vaccinators, establishing digital records, deciding who will have vaccination priority, they are doing it without Extra money dedicated to the effort.

Those are a lot of caveats. But still, there are reasons to be hopeful. If the results hold up, a Covid-19 vaccine that is 90 percent effective will have far exceeded the efficacy bar set by the FDA. That level of protection would put it on a par with the measles vaccine, one of the most powerful vaccines developed to date.

The arrival of an effective vaccine to combat SARS-CoV-2 less than a year after the new coronavirus emerged would break all records ever set by vaccine manufacturers. “Historic isn’t even the right word,” says Larry Corey of the Division of Vaccines and Infectious Diseases at the Fred Hutchinson Cancer Center. Renowned virologist, Corey has spent the past three decades leading the search for a vaccine against the virus that causes AIDS. You have never seen a vaccine developed for a new virus in less than five years, let alone one. “It had never happened before, never, not even close,” he says. “It’s just an amazing achievement of science.”

And perhaps even more monumental is the kind of vaccine that Pfizer and BioNTech are bringing across the finish line. The active ingredient within your injection is mRNA, mobile chains of genetic code that contain blueprints for proteins. Cells use mRNA to pull those specifications out of hard DNA storage and into their protein production factories. The mRNA within the Pfizer and BioNTech vaccine directs any cell it reaches to run a coronavirus spike creation program. The viral proteins these cells produce cannot infect any other cell, but they are foreign enough to activate the body’s defense systems. They also resemble the real virus enough to train the immune system to recognize SARS-CoV-2, in case its owner finds the virus infectious in the future. Until now, this technology has never been approved for use in people. A successful mRNA vaccine will not only be a triumph over the new coronavirus, it will be a huge step forward for the science of vaccine manufacturing.