American coronavirus: FDA advisers initially rejected Pfizer’s recall request – but then voted to recommend a third injection for some Americans


The vote came after the group voted for the first time and rejected a broader demand: to approve the third injection in all Americans 16 years and older six months after being fully immunized.

Dr Steven Pergam, medical director of infection prevention at Seattle Cancer Care Alliance, expressed concern that the recommendation approved by the counselors did not cover healthcare workers, who are at high risk of exposure. virus, even if they are not necessarily at high risk of serious illness.

But the FDA can make its own decision and has asked advisers to comment on possible changes to the wording of the emergency use authorization, said Dr. Peter Marks, who heads the vaccines arm of the FDA. . Committee members voted unanimously to informally advise the agency to include healthcare workers or other high-risk individuals in the authorization.

The most important message so far remains to get more Americans vaccinated, some experts say.

“I don’t think a booster dose is going to contribute significantly to controlling the pandemic,” said Dr. Cody Meissner, professor of pediatrics at Tufts University School of Medicine.

“It is very important that the main message that we are still sending is that we have to get two doses for everyone. Everyone has to get the primary series.”

More than 2 million Americans have received a booster dose of a Covid-19 vaccine, according to data released Friday by the U.S. Centers for Disease Control and Prevention.

Pfizer was strongly pushed back on Friday after saying it had data showing immunity wanes about six months after people were fully vaccinated with two doses, and adding that a third dose at six to eight months restores that immunity.

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 released on Wednesday supporting the argument that people might need a booster dose of Pfizer’s Covid-19 vaccine over time were among the data discussed by FDA vaccine advisers.
The meeting, broadcast online, began Friday morning.
Four days earlier, 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 mainstream at the moment.
The proportion of the population that is fully vaccinated – now at around 54.4% of the total population – is still far lower than where experts said it needs to slow or stop the spread, and cases are on the rise.

Disparity in the Covid-19 pandemic

The pandemic has affected different populations differently, and people of color bear a heavy burden, new research shows.

Blacks, those over 40, and people with pre-existing illnesses were most likely to suffer from long symptoms of Covid, which affected a third of Covid-19 patients, according to a Department of Health and Services study social networks in Long Beach, California. .

The most common widespread symptom was fatigue, followed by loss of taste and loss of smell, the team reported in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report. United.
There is no doubt about vaccine effectiveness, expert says as FDA assesses possible booster injection

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

Blacks had higher rates of difficulty breathing, joint pain, and muscle pain than other racial and ethnic groups. These results show the need to monitor demographic disparities in prolonged symptoms of Covid-19, the researchers said.

And an analysis released Thursday by the Kaiser Family Foundation found that racial disparities among children mirrored those among adults.

Compared to white children, children of color have had more cases, deaths, and more mental health and school issues related to the pandemic. Although they are the most vulnerable, they are also less likely to be vaccinated, according to the analysis.

While hospitalizations and deaths related to Covid-19 are rare in children compared to adults, hospitalized children were more likely to be black and Hispanic. Black and Hispanic children were also more likely to have a Covid-19-related illness called MIS-C – multisystem inflammatory syndrome in children – and black children were more likely to be admitted to intensive care for this.

Black, Hispanic, Native American and Native Alaskan children were more likely to die from Covid-19 than white children.

“Because children make up a significant portion of the population and are more racially diverse than the rest of the population, equitable immunization among this group is essential to achieve a high overall immunization coverage rate within the community. population and can help reduce disparities in immunization. rate more broadly, ”the report says.

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

Masks Help Block Airborne Transmission, Study Finds

Meanwhile, new research published this week indicates that the Alpha variant of the coronavirus spreads more easily when people breathe or speak, but has shown that even the simplest masks can significantly reduce transmission.

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

Local health departments are planning a potential Covid-19 booster rollout, but there is still

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

Loose masks kept about 50% of the virus-charged particles from coming out, the team found.

Milton said they are now testing to see what happens with the Delta or B.1.617.2 variant, which is much more transmissible than Alpha and now accounts for virtually all infections in the United States today.

But the implications of the findings for Alpha are clear.

“SARS-CoV-2 is moving towards a more efficient aerosol generation and loose masks offer important but modest source control. Therefore, until vaccination rates are very high, continuous diaper checks and properly fitted masks and respirators will be required. the team wrote.

“We know that the Delta variant that is currently circulating is even more contagious than the Alpha variant. Our research indicates that the variants keep getting better for air travel, so we need to provide better ventilation and wear masks well. adjusted, in addition to vaccination, to help stop the spread of the virus, ”Milton said in a statement.

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

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