How they made the vaccine so fast

Vaccine development takes time. Previous tHis spring, we learned Previous record of vaccine development It was 4 years From sample to approval, and if any, the COVID vaccine may not be seen for years. But here we have just one year since the discovery of the new coronavirus and already have a vaccine approved in the United States.S. For emergency use, and some additions that have emerged from Phase 3 trials or are already in emergency use in other countries.

“Did you hurry?” This is a question I keep asking. I personally don’t say that. I have read the test data, listened to the FDA and CDC meetings, and carefully tracked the expert reactions. It doesn’t look like the corners are really sharpened. 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 break down some steps of vaccine development to see where the time went. We will focus on the mRNA vaccine, which is currently the leading candidate in the United States.S.: The FDA recently granted an emergency use authorization for the Pfizer / BioNTech vaccine and may grant another authorization for the Moderna version soon next week. The benefits described here also benefited many other vaccine candidates. At home and abroad.

Basic research on this type of virus dates back several years.

Before COVID was SARS.Mysterious respiratory disease at first People who got sick in China in late 2002 And thanks to careful quarantine and international cooperation, it began to spread around the world before it eventually became confused.

SARS was also caused by the coronavirus. The COVID virus is so similar to it that it was named like a sequel to the movie. The SARS virus is SARS-CoV and the new coronavirus is SARS-CoV-2.

The outbreak of SARS has spurred research into the deadly and contagious coronavirus. Another illness in this family, MERSPops up on MMiddle ETherefore, although the COVID virus is new, research into the prevention or prevention of pandemics caused by the coronavirus has a history of at least 18 years.

Research on basic molecular biology has also been more advanced over the years.Scientists are now very fast in sequencing viral RNA Coronavirus sequence published on January 10, 2020, Within a month after the virus was first discovered.

mRNA vaccines also have a long history

No mRNA vaccine has ever been approved for human use. Pfizer / BioNTech Vaccine (if fully approved as planned),will The first person. But researchers didn’t build technology from scratch this year.

The idea of ​​using RNA (a viral genetic material that does not contain the rest of the virus) in vaccines dates back to the early 1990s, and research into this technology has been around for nearly 30 Review published in 2018, MRNA vaccines have already been used to elicit immunity to influenza, Zika fever and rabies.

In the process, scientists have encountered problems such as the potential of mRNA vaccines to cause autoimmune conditions and have come up with ways to solve them. It is safe to chemically modify the mRNA and wrap it in a small bubble. In a 2018 review, “Recent technological advances have significantly overcome these problems, and multiple mRNA vaccine platforms for infectious diseases and some types of cancer have promising results in both animal models and humans. Nevertheless, this vaccine development method was highly regarded for its “rapid development capability.”

Know how to build what is given type The amount of vaccine can really accelerate the construction of the actual vaccine. In that sense, we have actually seen vaccines developed within a year. See flu shots. Annual flu shots are different from the previous year, but they are not made from scratch. Vaccine manufacturers have already set up laboratories and factories to produce influenza vaccines and only connect the specific influenza strains they need each year.

Do you remember how the viral genome was released in January?Moderna Told reporters Their lab was already set up to make an mRNA vaccine, so when I downloaded the data, I was able to prepare the vaccine. two days..

Vaccine testing usually involves a lot of waiting

Several vaccine trials began this spring around the United States.S. I was just starting to work on the blockade idea. Huge amounts of money have been poured from governments and other funders and donors from different countries. Everyone was ready to get the shit done.

Pharmaceutical companies wanted to make a vaccine as soon as possible.S. And other countries wanted the vaccine to be approved as soon as possible. There is usually a lot of waiting in court. Waiting for funding, paperwork, and review committees to discuss things at glacier pace. Once your trial is approved, you will need to recruit volunteers.

Vaccines usually take months or years to go through all this bureaucratic formalism. But this aspect of the timeline can be accelerated as people wish. For example, the FDA aims to process most applications for new drugs and vaccines. Within 10 months.. 6 “quick” reviews Moon. But what about the first COVID vaccine?They called an emergency meeting and were ready to approve it within 3 weeks.

As the pandemic worsened, the trial actually speeded up.

Vaccine trials were not scheduled to last for specific weeks or months. Rather, companies and regulators have decided in advance to continue until a certain number of COVID cases appear in volunteers.

The trial does not intentionally expose people to the virus. It is considered unethical. So all you have to do is vaccinate half of the participants and then wait. If the number of cases of illness in the area is small, it may not be possible to complete the study. That’s what happened before. However, for the Pfizer / BioNTech and Moderna exams, and many other trials, the pandemic actually speeded up during the Phase 3 trials. Cases accumulated quickly, studies could be completed sooner than anyone expected, and results could be analyzed.

Everything happened in parallel

In general, perform each step of vaccine development before performing the next step. If you’re not sure if the vaccine works, or even agrees that it’s worth FDA approval, it doesn’t make sense to make all these small liquid bottles and print the labels.

But here, everything happened at once. Vaccine companies began producing doses as soon as possible, even before the trial was completed. Government agencies, including the FDA and CDC, and the entire alphabet of committees and affiliates have begun to discuss potential vaccines even before certain applications were released.

For example, the Immunization Implementation Advisory Board, which recommends vaccines to the CDC, met several times this year to plan very meta-topics, such as how to make decisions about potential vaccines. Does COVID pose an sufficient risk to Americans that the vaccine is of total value? (Yes) By what criteria should a group of people be prioritized? (They have an overall framework that balances science, ethics, and practicality.) This committee usually meets at its own time after the FDA approves the vaccine. This time, they called an emergency meeting and were able to complete the recommendation within 24 hours of being approved by the FDA. Emergency permit..

Fast but not in a hurry

When wondering if a vaccine was in a hurry, we ask if the same vaccine would have been approved if the pandemic politics hadn’t surrounded it. However, it is difficult to distinguish between pandemic politics and its science.

Physicians, regulators, and individual humans all need to consider the risks and benefits when deciding whether to use medical interventions. Overwhelmingly, FDA and CDC advisors agreed that the known potential benefits of the vaccine outweigh the known potential risks. If COVID was a less fatal illness, the balance would have shifted and the unknown might have been much closer.

Imagine a COVID that is less deadly. Probably a cold. If I had a cold vaccine, would it have passed approval with just two months of follow-up and open questions? Whether to pose a risk to people with severe allergies?? Suspicious; the FDA must have told them to go back and do longer tests and collect more data to address some uncertainties.

However, if the stall is too long, it can be harmful in itself. CDC computer model shows The most life-saving way with a vaccine is to deliver the vaccine to everyone as soon as possible, rather than details such as giving this group or that group the first vaccine.

FDA in the name of transparency Announcing an emergency use authorization memorandum About recent Pfizer / BioNTech vaccines.. You can see all the scientific data and its summary, information about the manufacturing facility, and plans to collect safety data after the vaccine is launched.

And that is where we are. So far, vaccines are safe and effective. No one is forced to take it, so if you want to wait for unknown side effects to start appearing, sit down and take a look. Personally, when I live or work in a nursing home, I get shot with a heartbeat.I’m probably back quite far This lineOver time, we are curiously watching if we learn more about this vaccine, or about other vaccines.

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