A Texas Lab Conducts Critical Testing for Pfizer's COVID Vaccine
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According to the government, people who had been vaccinated against COVID-19 8 months ago will require a booster.
This decision was based in part upon blood tests showing that antibody levels in people who have been vaccinated decrease over time.
Some of these tests were performed at the University of Texas Medical Branch, Galveston Texas.
Why is that?
It's partly because of the special facility, partly because of a test that was developed there, and partly because of a personal relationship between a Pfizer executive and a professor at university.
Near the north end on Galveston Island, you will find the UTMB campus. It is a mixture of new and old buildings.
Pei-Yong Shi, Virologist, moved to Galveston six years ago after he left Singapore where he worked at Novartis. Galveston has a BSL-3 facility. This is a laboratory that allows researchers to safely tackle dangerous viruses.
Shi was working on the Zika virus at the beginning of last year. He asked the Centers for Disease Control and Prevention for a sample to help him study the coronavirus. The CDC was quick to respond.
Shi recalls receiving a phone call from a colleague.
"He said to me, 'The viruses are here.' Shi explains that this was the day we began the work. It was 5 o'clock on February 11.
Test speeded up by the Glowing Viral
Shi wanted to perform a neutralization test, which is a blood test that will determine if a drug or vaccine can stop the virus infecting the cells in the laboratory. The success of the test would not be a guarantee but a good indicator that the vaccine or drug could stop the virus infecting humans.
You take cells from the lab and mix them with coronavirus to run the assay. Next, you will add serum from people who have been vaccinated. The serum should contain antibodies that will stop the virus from infecting your cells. The virus will infect cells if it does not contain antibodies.
Shi used a technique to speed up the test by attaching a fluorescent tag with the virus. The cells would glow if they were infected.
As soon as the virus was discovered, Shi began working on his assay. He says, "We developed our system in just 42 days." "And then, I recall that March 26 was the first contact with Pfizer."
Pfizer and the German biotech company BioNTech had created a new type of vaccine. To test it, they needed an assay similar to the one Shi's lab had made.
Phil Dormitzer is chief scientific officer at Pfizer for viral vaccines. "The most important thing is that [the assay] requires BSL-3 containment." "At the time, we didn’t have it."
But Shi did.
There was also another factor that favored a collaboration. Dormitzer was previously employed at Novartis where he had been a part of Shi's work.
Dormitzer was thrilled to discover that Shi could perform the job and had the right assay.
Dormitzer states, "It's very beneficial to work with someone that you trust and know."
The helicopter transports the Pfizer team.
Pfizer was keen to see Shi's setup. Pfizer was set to test the vaccine in around 40,000 people worldwide, but scientists at Pfizer wanted to ensure that his assay was accurate.
In spring 2020, commercial travel was still difficult. The collaboration began. Shi recalled that a whole team from Pfizer arrived via helicopter.
He says, "They have their compliance personnel." They have their assayers. They have their virology. They have their vaccine people.
The Shi blood samples that Pfizer has sent are kept in a separate room from his office.
They take the samples to the BSL-3 facility located in a nearby building when they are ready to conduct an assay.
To reach the BSL-3 anteroom, you will need to go through two sets doors.
The negative pressure in the room means that air flows into it and not out.
For those who are going to the BSL-3 laboratory, the anteroom is available. Visitors are not allowed to enter. There are racks that can hold protective equipment such as face shields and gowns.
Because of safety precautions, the assay is performed in the facility to protect workers and prevent the virus from spreading to the rest of the world.
Encouragement for clinical testing
Pfizer used this facility in the spring to test the blood of its first volunteers for the experimental vaccine. Pfizer was so encouraged by the results, it began clinical trials to prove that the vaccine was safe. The Food and Drug Administration approved Pfizer's emergency vaccine by December and Pfizer could begin shipping it.
Pfizer was not the only company working on COVID-19 vaccines. Shi was also approached by several other companies. He says that he chose to work for Pfizer.
"We cannot spread our impact to 10 companies if we want to make an effect. Shi states that if this is the case, then you can't help anyone."
Shi is still working with Pfizer to test blood samples for antibodies to the new viruses.
To see if people's antibody levels change over time, he has also tested blood taken from them months after vaccination.
Shi has data that shows they are in decline. This evidence was part of what convinced federal health officials this week to recommend a booster shot.
Shi believes it would have been simpler to decide about boosters if there was a clear cutoff line. This is an antibody level that is too low to be considered protective.
"But, that cutoff line hasn’t been yet defined in the field. Shi says it is everyone's guess.
However, the government bets that Shi's results will tell us something.
