“The progress that is being made with vaccines during President Trump’s historic Operation Warp Speed is historic,” said Alex Azar.
But there has already been a setback. Just last week, the pharmaceutical company AstraZeneca stopped its vaccine trial after a participant allegedly developed a rare inflammatory condition.
“The news that there was a serious side effect that stopped the trial of one of the most promising vaccines that we heard a lot about is precisely why we need to take things carefully with vaccines. They are not toys,” the President said. and President of Access Health International William Haseltine.
SEE ALSO: Houston woman receives 2nd dose in final trial of COVID-1
At the same time, the CEO of nine pharmaceutical companies signed a pledge that promised high standards of safety and efficacy through phase three of the clinical trials. It shares the public’s concern that rushing could mean risks.
“We need to regain the trust of society when we say that something is safe and effective,” said Dr. Anthony Fauci.
According to the FDA, Phase 1 will typically include a group of up to 80 people to study the drug’s safety and side effects.
In phase two, a larger group of up to 300 people will further help determine safety, and in phase three, up to 3,000 people will be involved.
But in the case of COVID-19, the sample size is ten times as high with 30,000 participants. The larger the sample size, the faster experts can collect data to determine if the vaccine is working.
“If it were not a pandemic, if it were not a disease with almost catastrophic consequences for public health, we could so far give time to get to the results,” said Associate Professor of Molecular Virology and Microbiology and Medicine at Baylor Dr. Hana El Sahly.
Houston-native Christene Kimmel participates in one of the trials. The 46-year-old has received two injections, one last month and one late last week.
SEE ALSO: Oxford, AstraZeneca resume coronavirus vaccine trial after pause due to patient reported side effect
“I had a little bit of an injection on the spot, just like you would feel with a shot,” Kimmel said.
She said she was otherwise fine. She was not told if she received the vaccine or placebo.
Why she decided to attend, she said she did it in part for her two children. As a family, they have spent time together giving back to those in need.
“This is an unprecedented time,” she said. “I needed to show them that there is another way and that meant sticking my arm out and taking an injection,” she said.
Researchers said it could take ten or more years to develop vaccines. ‘Operation Warp Speed’, the government partnership with private producers, was set up to make the process much faster.
The operation was launched in May and aims to deliver 300 million doses of a vaccine by January 2021.
To make that happen, Congress has directed nearly $ 10 billion to the effort.
“I think by the end of the year we will have data on 30,000 personal tests for three of the Operation Warp Speed vaccines,” said the dean of Baylor National School of Tropical Medicine. Peter Hotez.
Dr. Hotez also says that while there has been a vaccine before election day, he does not see it happening, nor do other doctors.
“If it all looks really promising, we could potentially release vaccines early by the middle of next year,” Hotez said.
While some are concerned about a vaccine, Hotez says it’s all about the process.
“Any vaccine that undergoes the full approval process of the Food and Drug Administration, I will not hesitate to take that vaccine myself or give it to my family members,” Hotez said.
As part of ‘Operation Warp Speed’, manufacturers are already producing a vaccine, although tests have not yet been performed.
Secretary Azar assured ABC13 that the drug would only be distributed when the FDA gives the go-ahead.
“Only once the FDA has determined that these vaccines comply with the FDA for safety and efficacy will they be made available,” Secretary Azar said.
You can see comprehensive coverage of the efforts to create a COVID-19 vaccine on ABC13’s connected TV apps on Roku, Amazon Fire TV, Apple TV and Android TV.
Follow Marla Carter on Facebook, Twitter and Instagram.
Copyright © 2020 KTRK-TV. All rights reserved.