CHICAGO / NEW YORK (Reuters) – Approximately one-fifth of the 11,000 people enrolled in a 30,000-volunteer U.S. trial of a Pfizer COVID-19 vaccine (PFE.N) and German partner BioNTech (22UAy.F) are Black as Latino, groups among the hardest hit by the coronavirus virus pandemic, said a top Pfizer executive.
PHILO PHOTO: People gather in downtown amid outbreak of coronavirus (COVID-19) in Chelsea, Massachusetts, US, May 20, 2020. REUTERS / Brian Snyder
“Between populations Latinx and black as well as African-American population, we run about 19 percent or so,” Drs. Bill Gruber, senior vice president of Pfizer for vaccine clinical research and development, told Reuters in an interview.
“We’re trying to push even higher.”
Black and Latino Americans are infected with COVID-19 at more than twice the rate of white Americans, with Native Americans infected at even higher rates, research has shown. The groups have historically been underrepresented in clinical trials.
The companies’ vaccines are rapidly advancing to late-stage testing, with some participants already receiving their second of two doses.
Doctors and scientists have called on companies to test coronavirus vaccines to include Black, Latino and Native Americans in COVID-19 vaccine tests in hopes of building trust among at-risk populations.
“We have a lot of campaigns to reach out to those communities because they are overrepresented in terms of COVID-19 disease, so we are very excited to have these individuals as part of our trial,” Gruber said on Thursday. “They have higher attacks and they are likely to benefit.”
According to a Reuters / Ipsos poll in May, only half of Black Americans said they were somewhat or completely interested in taking a COVID-19 vaccine.
Gruber revealed the number of Native Americans not enrolled in the trial, but said Pfizer plans to pull on tapes of its Prevnar 7 pneumococcal vaccine tests in the southwestern United States.
“I hope we can make further efforts in this community as well,” he said.
Pfizer and BioNTech expect to have enough data for an emergency use authorization (EUA) or to begin a full submission in October, according to Gruber.
The company does not have to finish recruiting the full 30,000 patients scheduled for the trial to have enough data to support an EUA, he said.
The US Food and Drug Administration (FDA) has stated that COVID-19 vaccine studies should have a safety database of at least 3,000 individuals for each of the younger and older populations in which it is tested.
Ultimately, the rate at which the vaccine can be approved depends on how quickly patients in the placebo arm become infected with the virus, starting about a week after the second dose is administered. That started this week.
“We will not really know until we get a little further,” Gruber said.
“We follow the rules that ensure rigor,” he added, saying the company did not take any discounts.
“I can not tell you what politics will happen,” Gruber said when asked about concerns that the Trump administration could pressure companies and regulators to announce progress ahead of the November election.
Gruber said the companies were now in talks with the FDA on how to begin testing the vaccine in children, a group that the regulatory agency itself is keen to gather data on.
Faxes work differently in children and adults.
Gruber said fax tests often progress in stages, first in older adolescents, then younger adolescents, and lastly in children. But there are already signs that younger adults have higher rates of reactions, such as fever and sore arms, to Pfizer vaccines than older adults do, Gruber said.
There is a risk that reactions may become even higher in younger populations, he added.
Roughly 75% of adults between the ages of 18 and 55 in the most recent trial of Pfizer had a fever after receiving the vaccine, most are mild, according to Gruber.
‘Younger children – maybe that’s not tolerated. Maybe we’ll have a bad fever, ‘he said. ‘That’s why we take a very thoughtful, graduate approach. Children are not just small adults. ”
Gruber said the company is submitting safety data to the FDA and developing a test plan for children, which he expects to begin soon.
Report by Julie Steenhuysen in Chicago and Michael Erman in New York
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