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News Commentary
“It is your mission to make this vaccine. If you ask, we will give you the resources you need,” he said. Philip Drimitzer, the company’s head of vaccine research, remembers the Reuters interview.
The mission was exciting and difficult. Pfizer strongly backed the researchers for an unprecedented effort: create a vaccine to stop pandemics in one year.
“Bula doesn’t want to focus solely on the potential barriers we may face, instead, ‘It’s much better to defy the impossible, even if you don’t succeed. Still, I have accomplished great things, ”he said.
Once a “hipster idea”
Reuters interviewed six scientists who played a key role in Pfizer and Biontech’s new coronavirus vaccine development program. They began their efforts under the blockade of the new corona virus and incorporated the elements obtained from the ongoing research on influenza and cancer in their development. On November 9, the two companies announced the first promising interim analysis results in large-scale clinical trials conducted around the world.
On November 16, US Moderna, which received nearly $ 1 billion in research and development support from the US government, also announced good interim analysis results. The preventive effect of all candidate vaccines exceeded 90%. This is a higher number than expected and expectations of pandemic convergence are increasing.
The Physer / Biontech and Moderna vaccines induce immunity by delivering the genetic information of the virus to humans and causing the body to produce the virus protein. The idea of ”making the human body work like a vaccine factory” was once considered heretical. Biotech companies have proven it for years, and work from Pfizer / Biontech and Moderna has confirmed that this approach works.
In the case of Pfizer and Biontech, they made important decisions in just a few days, which would normally take months, including which version of the vaccine would be used in a large clinical trial involving about 44,000 people.
Research application on “influenza” and “cancer”
Pfizer’s Drimitzer has led vaccine research in Novartis, Switzerland, during the 2009 novel influenza pandemic. His project has created three vaccines as the fastest pandemic response in history.
At Novartis, Drimitzer has begun testing a new method for making vaccines using mRNA. While common vaccines use killed viruses and virus fragments, the mRNA-based approach does not involve the real virus.
The advantage of mRNA vaccines (which is also the key to “speed” of development) lies in plug-and-play. You just have to change the mRNA while maintaining the “vehicle” that carries the mRNA. Even if the virus is mutated, it can be treated by changing the mRNA accordingly.
At Pfizer, Drimitzer’s colleague Julia Lee has been looking for a partner in mRNA technology for several years. Among them, Lee turned his attention to Biontech, which was developing a drug for the treatment of cancer using mRNA technology. The company was co-founded by CEO Ugur Sahin and his wife, Medical Director Ozam Trija, but was not well known at the time.
“He wasn’t very interested. Why do we look for a company that makes cancer when we are studying viral infections?” Drimitzer looks back.
But Mr. Lee was different. Biontech had the ability to produce mRNA and had a strong team of scientists, so they wanted to work with them to study infectious diseases. “In the end, we went to Germany to meet with members of Biontech,” Drimitzer said. Then, in August 2018, the two companies began researching mRNA-based flu vaccines.
According to Catalin Calico, Senior Vice President of Biontech, Sahin, who was concerned about coronavirus panics, decided in January this year that Biontech should start developing vaccines. Sahin himself designed several candidate vaccines.
“Biontech is a small and flexible company, while large companies like Pfizer have the infrastructure and know how to scale and develop,” Cariko said. In early March, the two companies decided to expand their partnership and signed an agreement of up to $ 750 million.
Clinical trials with 4 prototypes
Both companies knew that the behavior of mRNA vaccines was very different between animals and humans. Therefore, after conducting preliminary animal experiments to confirm safety, animal experiments to narrow down the vaccine candidates to be advanced to clinical trials passed and multiple prototypes were transferred to clinical trials.
Phase 1 (P1) clinical trials began in Germany in April and in the United States in May, and both companies tested four candidate vaccines in these trials. “The goal was to quickly find out what works best for humans,” said Dormitzer.
On July 1, we published preliminary data from a P1 study of 45 adults in the United States. Of the four prototypes, the candidate vaccine named “B1” was shown to be the safest. At this time, scientists realized that the vaccine could induce a higher production of antibodies than those that recovered from the new coronavirus. On July 20, data from a German study also showed that the vaccine also elicited a T-cell response.
At this stage, the two companies were considering using “B1” for the P3 exam, which plans to enroll 44,000 people. However, on July 24, a few days before the start of the study, data came in for another candidate vaccine called “B2.” B2 showed the same immune response as B1, but had fewer adverse events in the elderly. The researchers soon switched to “B2” as the vaccine for the P3 trial.
Development proceeded at a rapid pace, with some researchers working for weeks without seeing their families. Dormitzer also said he has not seen his wife or children since March, except for a zoom dialogue. “Urgent, collaborative, focused … I have never felt them so strongly as this time.” Dr. Pay Yong Shi of the University of Texas School of Medicine, who has developed a new method to measure the strength of antibodies produced by vaccines, said:
At the same time, at Pfizer’s research center in Pearl River, New York, hundreds of workers were subject to strict infection prevention protocols. They were not allowed to touch the doorknobs and all the doors were left open. They were asked to register everyone they contacted on a daily basis so that they were immediately visible when an infected person emerged.
Enrollment of subjects for the P3 trial has also progressed rapidly, and Pfizer CEO Bula said he expects to have data on efficacy starting in October. Interim analysis took a bit longer, but didn’t take long. .
And on November 9, Pfizer made a shocking announcement based on 94 cases. Dormitzer learned of the results of the interim analysis a few hours before the announcement. He noted that the FDA has set a 50% preventive effect as an approval criteria, saying “no one would have expected an effectiveness of more than 90%.”
Meanwhile, Kariko was convinced of the effectiveness of the vaccine. “Previous studies have shown high levels of cellular immune response. I was not nervous, but rather confident.”
Er Michael Erman / Julie Steenhuysen ： 翻 訳 ： AnswersNews）
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