FDA advisers first rejected Pfizer’s booster application — but then voted to recommend a third shot for some Americans

That vote came as the group voted for the first time and rejected a wider application: to approve a third shot in all Americans 16 and older six months after they were fully vaccinated.

Dr. Steven Pergum, medical director for infection prevention at the Seattle Cancer Care Alliance, expressed concern that the advisory-approved recommendation does not cover health care workers who are at high risk of exposure to the virus, even though They should not be at a high level. risk of serious illness.

But the FDA can make its own decision and has asked advisers to look into possible changes to the wording for emergency use authorization, said Dr. Peter Marks, head of the FDA’s vaccine arm. Committee members voted unanimously to informally advise the agency to include high-risk healthcare workers or others in the authority.

Some experts say the most important message for now is to get as many Americans as possible to be fully vaccinated.

“I don’t think a booster dose will make a significant contribution to controlling the epidemic,” said Dr. Cody Meisner, professor of pediatrics at Tufts University School of Medicine.

“It’s very important that the main message that we still transmit is that we all have to get two doses. Everyone has to get the primary chain.”

More than 2 million Americans have received a booster dose of the COVID-19 vaccine, according to data published by the US Centers for Disease Control and Prevention on Friday.

Pfizer was hit hard on its request on Friday, saying it had data showing that immunity drops six months or so after people are fully vaccinated with two doses, and six That immunity is restored by adding a third dose every eight months.

Dr. Phil Krause, deputy director of the FDA’s Office of Vaccine Research and Review, noted that Pfizer was using data that had not been reviewed by experts.

Three reports published on Wednesday Supporting the argument that people may need a booster dose of Pfizer’s COVID-19 vaccine over time were part of the data discussed by the FDA’s vaccine advisors.
Four days ago, a group of international vaccine experts, including some from the FDA and the World Health Organization, The Lancet notes that current evidence does not appear to support Booster shots are needed in the general public right now.
Proportion of fully vaccinated population Now about 54.4% of the entire population – still far below where experts have said it needs to slow or stop the spread, and cases are on the rise.

Inequality in the Covid-19 pandemic

According to new research, the pandemic has affected different populations differently, and people of color are bearing the heavy burden.

According to a study by the Long Beach Department of Health and Human Services in California, black people, people over 40 and those with pre-existing conditions were most prone to chronic Covid symptoms, which accounts for a third of Covid-19 patients. used to influence. .

The most common extended symptom was fatigue, followed by loss of taste and loss of smell, the team reported in the weekly journal of the US Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report.
No question about vaccines' effectiveness, expert says, as FDA weighs potential booster shot

“The likelihood of experiencing symptoms 2 months after a positive SARS-CoV-2 test result was significantly higher in women, individuals with at least one preexisting condition, and those aged 40–54 years,” they wrote.

Black people had higher rates of difficulty breathing, joint pain, and muscle pain than other racial and ethnic groups. The researchers said these results reflect the need to monitor demographic disparities in extended COVID-19 symptoms.

And a Analysis published Thursday by the Kaiser Family Foundation found that race-based disparities among children mirror those in adults.

Compared to white children, children of color have had more cases, deaths, and more mental health and educational problems related to the pandemic. According to the analysis, when they are most vulnerable, they are also less likely to be vaccinated.

While Covid-19 hospitalizations and deaths are rare in 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 – multisystem 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.

“Since children make up a significant portion of the population and are more racially diverse than the rest of the population, equitable vaccination among this group is critical to achieving overall higher rates of vaccine coverage among the population and reducing inequalities in vaccination.” rates more widely,” the report said.

A syringe is prepared with Pfizer vaccine at a clinic in Reading Area Community College, Reading, Pennsylvania.

Masks help block airborne transmission, study shows

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

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

Local health departments are planning potential COVID-19 booster rollout, but still "There is some confusion."

In-depth studies conducted at the University of Maryland, the Walter Reed Army Institute of Research and elsewhere showed that people exhale the virus in their breath and saliva – findings that support the now widely accepted idea that viruses are all Disperses in droplets of sizes. that fall on the surface or float in the air. They measured RNA, the genetic material commonly used to detect viruses.

The team found that the loose-fitting mask blocked about 50% of virus-laden particles from exiting.

Milton said they are now testing to see what happens with the delta or version b.1.617.2, which is far more permeable than the alpha and which is now responsible for nearly all infections in the US. Is responsible.

But the implications of the findings about alpha are clear.

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

“We know that the delta version is now more contagious than the alpha version. Our research indicates that as variants are becoming better able to travel through the air, we should provide better ventilation and wear tight-fitting masks.” should be worn, in addition to vaccination, to help prevent the spread of the virus,” Milton said in a statement.

CNN’s Virginia Langmead, Jen Christensen and Maggie Fox contributed to this report.

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