How Did They Make the Vaccine so Quickly?

Vaccine development takes time. Earlier this spring, we learned that the previous record for vaccine development was four years from sample to approval, and that we might not see a COVID vaccine for years, if at all. But now it’s only a year after the discovery of the new coronavirus, and we already have a vaccine approved in the United States for emergency use, and several more vaccines that have emerged from phase 3 trials or are already in emergency use in other countries.

“Was it urgent?” this is a question I hear all the time. Personally, I would not say that. I read the test data, listened to the FDA and CDC meetings, and followed the experts’ reactions closely. It doesn’t really seem like the corners have been cut. Instead, the speed of this vaccine is due to a combination of luck, good planning, and unprecedented coordination between researchers, manufacturers and regulators.

Let’s take a look at some of the steps in vaccine development to see where it took. I will focus on the mRNA vaccines that are currently leading the way in the US: The FDA recently granted emergency use of the Pfizer / BioNTech vaccine and may issue another for the Moderna version as early as next week. The benefits I describe here have also helped many other vaccine candidates both here and abroad.

Fundamental research on this type of virus goes back several years.

Before COVID, there was SARS. The mysterious respiratory disease initially struck people in China in late 2002 and began to spread around the world before eventually disappearing due to careful quarantine and international cooperation.

SARS has also been caused by the coronavirus. The COVID virus is so similar to it that it was named as a sequel to the film: SARS virus – SARS-CoV, new coronavirus – SARS-CoV-2.

The SARS outbreak has spurred research into deadly infectious coronaviruses. Another disease in this family, MERS , originated in the Middle East in 2012. So while the COVID virus is new, research to stop or prevent a coronavirus pandemic goes back at least 18 years.

Research in fundamental molecular biology has also become more advanced over the years. Scientists are sequencing viral RNA so quickly that the sequence of the coronavirus was released on January 10, 2020 , less than a month after the virus was first detected.

mRNA vaccines also have a long history

There has never been a licensed mRNA vaccine for human use; The Pfizer / BioNTech vaccine, if fully approved under the plan, will be the first. But this year, researchers have not built the technology from scratch.

The idea of ​​using RNA (the genetic material of a virus without any other parts of the virus) in a vaccine originated in the early 1990s, so research on this technology has been carried out for almost 30 years. According to a review published in 2018 , mRNA vaccines have already been used to build immunity against influenza, Zika virus and rabies.

Along the way, scientists ran into problems – for example, the possibility that mRNA vaccines could cause autoimmune diseases – and figured out how to solve them. Chemically modifying the mRNA and enclosing it in tiny bubbles made it safe. A 2018 review states: “Recent technological advances have now largely overcome these challenges, and several mRNA vaccine platforms for infectious diseases and several types of cancer have shown encouraging results in both animal models and humans.” Even then, this way of developing vaccines was praised for its “ability to develop rapidly.”

Knowing how to create a specific type of vaccine can really speed up the creation of the vaccine itself. In that sense, we’ve already seen vaccines developed in less than a year: just look at flu shots. The annual flu shot is different from last year’s, but it is not created from scratch. Vaccine manufacturers already have laboratories and factories set up to make influenza vaccines, and each year they simply add the specific flu strains they need.

Remember how the genome of the virus was published in January? Moderna told reporters that their laboratories had already been set up to produce mRNA vaccines, so once they downloaded this data, they were able to create a vaccine in two days .

Vaccine trials usually require a long wait.

Several vaccine trials began this spring, around the time the US was just starting to fight the idea of ​​isolation. Huge sums of money came from governments of different countries, from other funding organizations and donors. Everyone was ready to end it.

Pharmaceutical companies wanted to produce vaccines as soon as possible, and regulators in the US and other countries wanted to be able to approve vaccines as soon as possible. Usually, during a trial, you have to wait a lot: waiting for funding, paperwork, meeting review boards and discussing issues at an icy pace. Once the challenge is greenlit, you must recruit volunteers.

Ordinarily, it would take months or years for a vaccine to get through all this red tape. But this aspect of the timeline is something that people can speed up just by wanting to. For example, the FDA aims to process most applications for a new drug or vaccine within 10 months . “Expedited” check – six months. But for the first COVID vaccine? They called an emergency meeting and were ready to approve it within three weeks.

The worsening pandemic actually sped up trials

The vaccine trials were not planned to last a certain number of weeks or months; rather, companies and regulators have determined in advance that they will continue until a certain number of COVID cases are detected in volunteers.

During the tests, people were not deliberately infected with the virus; it is considered unethical. Therefore, all you have to do is vaccinate half of the participants and then wait. If there are few cases in the area, it may not be possible to complete the trial; this has happened before. But in the case of the Pfizer / BioNTech and Moderna trials and many others, the pandemic actually picked up steam while the Phase 3 trials were in progress. Cases piled up quickly and the study could be completed and analyzed sooner than anyone expected.

Everything happened in parallel

Typically, you go through each stage of vaccine development before doing the next. It doesn’t make sense to manufacture all those little liquid bottles and print labels if you don’t already know if the vaccine will work and if the FDA will agree with its approval.

But here everything happened at once. Vaccine companies began producing doses as quickly as they could, even before the trial was complete. Government agencies, including the FDA and CDC, as well as a number of committees and related agencies, began discussing potential vaccines even before a specific application was proposed to them.

For example, the Immunization Practices Advisory Committee, which recommends CDC vaccines, has met several times this year to plan very meta topics like how they will make decisions about any potential vaccines. Does COVID pose enough risk to the American population for a vaccine to make sense at all? (Yes) On what basis should groups of people be given priority? (They have a whole structure that balances science, ethics, and practicality.) This committee usually meets in due course after the FDA has approved a vaccine; this time, they called an emergency meeting to finalize their recommendations less than 24 hours after the FDA granted an emergency clearance .

Fast, but not rushed

It seems that when we wonder if a vaccine was designed in a hurry, we ask if this vaccine would have been approved if it hadn’t been surrounded by a pandemic policy. But it is difficult to separate the politics of the pandemic from the science about it.

Physicians, regulators and individuals must consider the risks and benefits when deciding whether to use a medical intervention. The vast majority of FDA and CDC advisors agreed that the known and potential benefits of the vaccine outweigh the known and potential risks. If COVID had been a less deadly disease, the balance would have shifted and the uncertainty might have loomed more.

Imagine a less deadly COVID; a cold, perhaps. If there was a vaccine for the common cold, it would have been approved with just two months of follow-up and an open question as to whether it poses a risk to people with severe allergies ? I doubt; I bet the FDA would advise them to go back and do a longer trial and collect more data to clear up some of the uncertainties.

But seizing for too long is in itself harmful. CDC computer models have shown that the way to save most lives with a vaccine is not limited to details, such as giving a vaccine to a group first, but simply getting the vaccine to everyone as soon as possible.

In the name of transparency, the FDA recently issued an Emergency Use Memorandum for the Pfizer / BioNTech vaccine. You can view all the scientific data and its summaries, as well as the information it contains about the manufacturing facilities and plans for collecting safety data, even after the vaccine is deployed.

So this is where we are. So far, the vaccine looks safe and effective. No one will be forced to take it, so if you want to wait and see if the unknown side effects start to show, you can sit down and watch. Personally, if I lived or worked in a nursing home, I would get vaccinated right away. Since I will probably be quite far in the queue , I watch with interest if we learn more about this vaccine or others over time.