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FDA Booster Vaccine Meeting May Not Answer All Questions, Experts Say

by souhaib
September 17, 2021
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(Trends Wide) — The U.S. Food and Drug Administration (FDA) will meet this Friday on covid-19 booster vaccines, but the long-awaited discussion may not yield an answer on whether all vaccinated Americans will receive a third dose. experts said.

“What I think we’re going to hear from the FDA advisory committee is a go-ahead to give reinforcements to people over 60, probably because that’s where the data is most robust,” said Dr. Jonathan Reiner, medical analyst. from Trends Wide. “The question is what does this mean for younger people? Do we need to start reinforcing them now?”

Three reports released Wednesday that support the argument that people may need a booster dose of Pfizer’s covid-19 vaccine over time are part of a batch of data that will be discussed by FDA vaccine advisers at the consider a request from Pfizer to approve a third dose for most people six months after receiving their first two doses.

But there is no unanimity at this time. On Monday, a group of international vaccine experts, including some from the FDA and the World Health Organization, wrote in The Lancet that current evidence does not appear to support the need for booster vaccines in the general public at this time.

“Usually we have a pretty good idea of ​​how (these meetings) are going to play out ahead of time,” Trends Wide chief medical correspondent Sanjay Gupta said Thursday. “I have to say, I’m not so sure about this.”

Pending questions, Gupta noted, include: Is immunity waning? How serious are post-vaccination infections? How long does the effect of the boosters last? And how much do booster vaccines reduce transmission?

The questions are affected by the situation of the United States in the pandemic.

The proportion of the population that is fully vaccinated, now around 54.2% of the total population, is still well below where experts have said it needs to be to slow or stop the spread, and cases have been on the rise. increase.

The assessors will analyze the data to balance safety and efficacy with the rise in infections and serious illnesses facing the United States, Reiner said.

“We want them to do this, we welcome this. But I guess we are not going to hear some kind of general opening of reinforcements for the entire population,” Reiner said.

Disparity in the covid-19 pandemic

The pandemic has affected different populations differently, and people of color are bearing a heavy burden, according to new research.

Blacks, people over the age of 40, and people with pre-existing conditions were the most likely to suffer from prolonged covid symptoms, affecting a third of covid-19 patients, according to a study by the Department of Health and Safety. Long Beach Human Services in California.

The most common prolonged symptom was fatigue, followed by loss of taste and smell, the team reported in the U.S. Centers for Disease Control and Prevention’s (CDC) Weekly Morbidity and Mortality Report.

“The odds of experiencing symptoms 2 months after a positive SARS-CoV-2 test result were significantly higher among women, people with at least one pre-existing condition, and those ages 40 to 54,” they wrote.

Black people had higher rates of shortness of breath, joint pain, and muscle pain than other racial and ethnic groups. These results show the need to monitor demographic disparities in widespread covid-19 symptoms, the researchers said.

And an analysis published Thursday by the Kaiser Family Foundation found that race-based disparities among children mirrored those of adults.

Compared to white children, children of color have had more cases, deaths, and more academic and mental health problems related to the pandemic. While they are the most vulnerable, they are also least likely to get vaccinated, according to the analysis.

While COVID-19 hospitalization and death are rare among children compared to adults, children who were hospitalized were more likely to be black and Hispanic. Black and Hispanic children were also more likely to have a Covid-19-related condition called MIS-C (multi-system inflammatory syndrome in children), and black children were more likely to be admitted to intensive care for it.

Black, Hispanic, American Indian, and Alaska Native children were more likely to die from COVID-19 than white children.

“Because children make up a significant part of the population and are more racially diverse than the rest of the population, equitable vaccination among this group is key to achieving a high overall rate of vaccine coverage among the population and can help reduce disparities in vaccination rates more widely, “the report said.

Masks Help Block Airborne Transmission, Study Shows

Meanwhile, new research published this week indicates that the alpha variant of the coronavirus spreads more easily when people breathe or speak, but it showed that even the simplest of masks can greatly reduce transmission.

“Our latest study provides further evidence for the importance of airborne transmission,” said Dr. Don Milton, a professor of environmental health at the University of Maryland School of Public Health who worked on the study.

The intensive study, conducted at the University of Maryland, Walter Reed Army Research Institute, elsewhere, showed that people shed the virus in their breath and saliva, findings that support the now widely accepted idea that the virus it spreads in droplets of all sizes that fall to surfaces or float in the air. They measured RNA, the genetic material most used to detect viruses.

Loose-fitting masks prevented about 50% of the virus-laden particles from escaping, the team found.

Milton said they are now testing to see what happens to the delta or B.1.617.2 variant, which is much more transmissible than alpha and now accounts for virtually all infections in the US.

But the implications of the alpha findings are clear.

“SARS-CoV-2 is evolving into more efficient aerosol generation and loose fitting masks provide significant but only modest source control. Therefore, until vaccination rates are very high, continuous layered controls will be necessary. and tight-fitting masks and respirators, “the team wrote.

“We know that the delta variant that circulates now is even more contagious than the alpha variant. Our research indicates that the variants continue to improve to travel through the air, so we must provide better ventilation and wear tight-fitting masks, in addition to vaccination, to help stop the spread of the virus, “Milton said in a statement.

Virginia Langmaid, Jen Christensen, and Maggie Fox contributed to this report.

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