CHICAGO/NEW YORK (Reuters)-Nearly one-fifth of the 11,000 registered US trials of 30,000 volunteers testing the COVID-19 vaccine from Pfizer and its German partner BioNTech have so far corona Viruses The group most affected by the virus, Pfizer’s chief executive, talked about the pandemic.
Photo of the file: On May 20, 2020, people with a coronavirus infection (COVID-19) gather in downtown Chelsea, Massachusetts, USA. Reuters/Bryan Snyder
“It operates at about 19% of the Latin American and black or African American population,” said Dr. Bill Gruber, senior vice president of vaccine clinical research and development at Pfizer. ..
“We are trying to push it further.”
Studies show that Blacks and Latin Americans are more than twice as likely to be infected with COVID-19 as White Americans, and Native Americans are even more prevalent. The group has historically been undervalued in clinical trials.
The company’s vaccine is rapidly undergoing late-stage testing, with some participants already receiving a second dose.
Doctors and scientists test coronavirus vaccines to include blacks, Latin Americans, and indigenous Americans in the COVID-19 vaccine trial, hoping to build trust among those at risk I’m asking the company.
“We have many campaigns to reach out to those communities because they are overrated on the disease of COVID-19. Therefore, we are bringing those individuals to our trial. We are very enthusiastic about welcoming them as part of it,” Gruber said Thursday. “They have a high attack rate and are most likely to benefit.”
According to a Reuters/Ipsos poll in May, only half of the Black Americans said they had some or very interest in vaccination with the COVID-19 vaccine.
Gruber said he did not reveal the number of Native Americans registered in the trial, but said Pfizer plans to use the Prebner 7 pneumococcal vaccine test relationship in the southwestern United States.
“We look forward to expanding into this community,” he said.
According to Gruber, Pfizer and BioNTech expect to have sufficient data to begin an emergency use permit (EUA) or full submission in October.
The company does not have to complete all recruitment of 30,000 patients planned for the trial to get enough data to support the EUA, he said.
The US Food and Drug Administration (FDA) states that the COVID-19 vaccine trial requires a safety database of at least 3,000 for each of the young and elderly populations it will be tested for.
Ultimately, the rate at which the vaccine will be approved depends on the time it takes for the patients in the placebo group to become infected with the virus approximately one week after the second dose. It started this week.
“We really don’t know until we go a little further,” Gruber said.
“We follow rules that guarantee rigor,” he added, saying the company wasn’t making a cut.
“I can’t say what happens politically,” when asked about concerns that the Trump administration might pressure businesses and regulators to announce progress before the November elections. Gruber said.
Gruber said the companies are currently negotiating with the FDA on how the regulators themselves will begin testing the vaccine on children, a group that is keen on collecting data.
Vaccines work differently in children and adults.
Gruber said vaccination testing often progressed in stages, first in the elderly, then in the younger, and finally in the child. But there are already signs that young adults are more likely to respond to Pfizer’s vaccine than older people, such as fever and arm pain, Gruber said.
He added that these reactions are at risk of being more likely to occur in younger populations.
According to Gruber, Pfizer’s latest study showed that approximately 75% of adults between the ages of 18 and 55 had fever after vaccination, most of which were mild.
“Younger children-maybe it won’t be forgiven. Maybe we’ll have a terrible fever,” he said. “That’s why we take a very thoughtful, step-by-step approach. Children are not just small adults.”
Gruber said the company has submitted safety data to the FDA and is developing a study plan for children.
Report by Julie Steenhuysen of Chicago and Michael Erman of New York
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