How quickly the COVID-19 vaccine was made without cutting corners

Still, more than one in five Americans Not vaccinated, According to a recent poll by the American Psychiatric Association.Some of the reasons for frequent pop-ups I’m worried that the vaccine will be developed too soon: Drug research usually takes years or even decades from idea to reality. The first vaccine against COVID-19 was developed, tested and granted an emergency use authorization in 11 months.

Boosted by global urgency and supported for decades Previous research on vaccine technology, Vaccine developers have found a way to truncate years from the timeline, not just days or months.What was dumped Not a science or safety testRather than waiting time built into the development process — waiting for results and waiting for regulatory approval.

By comparing the new vaccine with previous drugs that used the same technology under a more traditional research timeline, the approximate time taken from the development process after the shot was ready to enter the weapon. Can be calculated: about 4 years. Method is as follows.

Uncover the secrets of the coronavirus

To back up a bit at the beginning, the vaccine design started much earlier than the arm jab stage.It started with Decoding accurate gene composition Of SARS-CoV-2, the virus that causes COVID-19. By early January 2020, its genetic blueprint was at hand and the first vaccine to be tested was ready in just a few weeks.

From several perspectives, researchers first decoded or sequenced Whole human genome Over a span of almost 13 years, starting in 1990 and ending in 2003. Advances in computers have reduced the time required for the same task to just a few hours.

Most importantly, the researchers had the genetic instructions to make the peaplomers that the virus uses to invade cells. This is an important ingredient for making vaccines. These spelomers, which protrude from the surface of the virus, are easy targets for the immune system to recognize. Researchers knew that they would focus on these proteins, thanks to decades of research into the coronavirus. This includes the two that caused the outbreak of other human illnesses, SARS and MERS. The study also identified the best form of protein used, the stable form just before the virus fuses with the cells it is trying to infect.

Taken on January 11, 2021, this figure shows the vial and slinge in front of the Johnson & Johnson logo displayed. (REUTERS / DadoRuvic / Illustration / File photo)

Find a delivery system

These instructions can then be fed directly to a ready-made delivery medium that carries the genetic code to the cell to induce an immune response. Tom Denny, Chief Operating Officer of the Duke Human Vaccine Institute in Durham, North Carolina, said scientists have already created these rapid gene-based templates, primarily because of the ongoing fight against HIV. It states that it is.

“In the last 10 to 15 years, there have been major teams around the world … trying to understand what needs to happen to make a defensive HIV vaccine,” says Denny. These efforts “helped us in the fight against this current pandemic.”

These vehicles are like potato head toys in the world of vaccine development. Instead of exchanging different facial features, information specific to each virus is plugged in.

Denny calls it “plug and play” vaccine production. Decades of attempts to attack HIV have resulted in a library of safe weapons that can be used quickly against new virus looters. “We were lucky,” says Denny. The developed platform worked very well against this new deadly virus.

One of the templates carries a non-functional partial strand of viral mRNA directly to cells in the body, instructing them to make a copy of the protein that the immune system recognizes as a foreign body. That’s what Pfizer uses-a shot of BioNTech and Moderna.

The coronavirus peplomer mRNA is packaged in small bubbles of fat called lipid nanoparticles.These small fat bubbles have been around for decades and have been used safely for decades. Other medicinesSome have been approved, others are still in the pipeline. Therefore, only the internal orientation needed to be changed to target SARS-CoV-2.

Contents of Fat foam Known as the “payload,” says Vicki Stronge. She is Director of Product Management at Precision Nano Systems in Vancouver, where she manufactures equipment and compounds for the development of lipid nanoparticles. She explains why these fat bubbles are so important. When mRNA is injected alone out of the foam, it is quickly broken down into harmless pieces of biological raw material that are recycled by our body.

Benefits from past research

Two major therapies, one still working and the other approved, paved the way for COVID-19 vaccine developers to embark on using RNA-based templates.

One treatment, performed by Germany-based CureVac, is the first vaccine to reach human trials developed using mRNA to combat infections. It targets the rabies virus and has been injected into human volunteers since 2013. Decades ago, in 1971, researchers developed the first syringe that they thought was safe for humans, and first injected and tested it themselves. The first version of the mRNA-based rabies vaccine stimulated only a weak immune system response, but showed that the technique was safe. This new version of the rabies vaccine is beginning to show promising results in clinical trials. (CureVac too Development of mRNACOVID-19 vaccine,However Initial results I was disappointed. )

Another treatment is pachisilane, an RNA-based drug for the rare but often fatal hereditary disease in which amyloid proteins accumulate in nerves and some organs. It uses the same design as the mRNA-based COVID-19 vaccine based on lipid nanoparticles, but with a different payload inside.

Years of data from monitoring patients injected with these RNA fragments wrapped in lipid nanoparticles show that they are safe, and hematologists at the University of North Carolina at Chapel Hill-Tumors. Sascha Tuchman, a scholar who oversaw the location of Phase III Patisilane, says the trial.Patients who received Patisiran Low risk It has more side effects than those who have been injected with placebo saline. Regarding the long-term adverse effects of RNA and lipid nanoparticles, “we didn’t see any additional information showing that there were reasons to worry about safety,” Tuchman said.

Six years after the first shot began to be tested, FDA-approved Patisilane, A little faster than the standard pace of new treatments. This is a good comparison of where the COVID-19 vaccine could save time. We do not count decades of development research that has reached this point. Now let’s start the clock.

In this illustrated photo taken on March 14, 2021, you can see a vial and syringe labeled “Astra Zeneca COVID-19 Coronavirus Vaccine” in front of the displayed AstraZeneca logo. REUTERS / Dado Ruvic / Illustration

Volunteer recruitment

What from the timeline by cutting the long stretch of pure waiting that is incorporated in most human tests after the first syringe full of future COVID-19 vaccine emerged from the “Plug and Play” mRNA lab The year has also been deleted.Driven by the urgency of a pandemic, nearly 500,000 people in the United States alone Provided their deltoid muscles For the cause through COVID-19 Prevention Network Within months, often even before the first public success, according to the American Medical Association.

For example Recruit and register over 43,000 volunteers For the final stage of testing Pfizer vaccines.When volunteer recruitment begins Rabies mRNA vaccine clinical trial In 2013, it took 813 days for 101 participants to register. Based on this comparison, hiring alone can save about 730 days (about 2 years).

Get quick results

Another, more dire factor contributed to scientific speed. How fast the virus spreads.

Scientists can start calculations Vaccine efficacy When a sufficient number of people in the group receiving placebo rather than the vaccine become infected spontaneously. If an outbreak occurs, it will take some time to reach that threshold. The same is true if the virus spreads naturally and slowly. For example, HIV, herpes, human papillomavirus, HPV, and other viruses that are transmitted primarily through sexually transmitted infections. In contrast, SARS-CoV-2 can spread just by breathing or talking — And everyone does it.

A rough comparison of the COVID-19 vaccine test and the HPV vaccine test provides clues as to how many days may be delayed from the COVID-19 timeline due to the astronomical spread of the new virus. I will. The HPV trial took approximately 529 days, or 1.4 years, to reach a point at which efficacy could be calculated when the placebo group reached an infection rate of 3.8%.

In contrast, Pfizer’s Phase II / III coronavirus trials gave the first efficacy result of two doses in just 105 days when the infection rate reached nearly 2.4% in the placebo group. It was. This is 424 days faster than HPV. why? Only a few months after the pandemic occurred, SARS-CoV-2 infected hundreds of thousands of people worldwide each day.

Jump line

There was also a waiting time that was recovered from the US Food and Drug Administration review process. It usually takes 10 months for the FDA to review a new drug.

However, as the number of COVID-19 deaths increased, the FDA rushed all coronavirus vaccines to the forefront of the review line.The· Pfizer vaccine Received review and approval for emergency use only 21st After submission Modern vaccine Just 19th.. Compared to the more common 10-month waiting time, it saves about 283 days more.

In total, in 1,437 days, or 3.9 years, the normal timeline for new vaccines breaks. And this does not include other time savings, such as putting ethics reviews at the forefront. Adding that saved time to the 11 months it actually took to get the first COVID-19 vaccine totals nearly five years. This is very close to the 6 years required for testing and approval of Pachisilane.

In the final shock of speed, some pharmaceutical companies have increased doses during clinical trials, hoping that the vaccine will work, backed by large vaccine contracts and research funding from Operation Warp Speed ​​of the US government. I was producing. As soon as the company obtained an emergency use authorization, it was ready to ship the dose.

Decades of research combined with fast-moving viruses, public willingness to support, and elimination of waiting times have driven the rapid development of the COVID-19 vaccine. Stanley Plotkin, an emeritus professor of pediatrics at the University of Pennsylvania, best known for developing rubella vaccines, said he never skipped safety steps.

According to Plotkin, the rapid development of the COVID-19 vaccine is “a major change in the way vaccines are developed.” They are examples of what scientists can do when they are freed from waiting.

This story was originally published by Science news, A non-profit, independent news organization.