The FDA will decide in June on the future of COVID drugs

April 6, 2022 – A new generation of COVID -19 vaccines can fight a new disease and be delivered every year, a group of experts told the FDA on Wednesday.

But members of the class also realized that to reach that goal, the disease would change much faster.

Members of the Vaccines and Related Biological Products Advisory Committee said they wanted to find a balance that would ensure Americans were protected from serious illness and death but would not end them with constant recommendations for motivators.

“We’re not happy with high -intensity interventions every 8 weeks,” said committee leader Arnold Monto, MD, physician emeritus of public health at the University of Michigan. “We want to see an age -old vaccine like influenza but we know that the growth of the disease will dictate how we respond to the words of the new vaccines,” he said.

The disease itself will dictate vaccination, he said.

The government should also continue to make it clear to unaccompanied Americans to join the group, committee member Henry H. Bernstein, DO, said, ” giving “seems to be the most obvious of the best of those who are committed. There is no treatment. ”

The government needs to clearly communicate to the public about the goals of medicine, he said.

“I think our overall goal is to prevent serious illness, hospitalization, and death rather than preventing disease,” said Bernstein, a doctor of pediatrics at Zucker School of Medicine. at Hofstra / Northwell Health in New Hyde Park, NY.

The FDA has called a meeting of its advisors to discuss the overall vaccine and vaccine strategy, even though it has approved a fourth dose of Pfizer and Moderna for some parents who are immune and immune. for everyone over 50 years.

At the beginning of the daily meeting, interim committee member James Hildreth, MD, president of Meharry Medical College in Nashville, asked why that permission was given without the consent of the idea of ​​the class. Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the decision was based on data from the United Kingdom and Israel that believe the prevention from the third shot was over. .

Marks later said that “the fourth was allowed as a stopgap so we could have something else,” because the goal was to prevent the old Americans from dying somewhere. height of the young.

“I think we’re on a ship that we can’t inspire people like us,” Marks said.

There is not enough knowledge to make a comprehensive design

The meeting is expected to be a great conversation about continuing with the evolving disease and setting up a vaccine selection and developmental process to respond well and quickly to changes, as new trends. .

But committee members said they felt a lack of information. They want more information from medical trials of vaccine manufacturers. And they found that so far, for no apparent reason, lab-based studies have shown the effect of COVID-19 diabetes-known as a correlate of immunity. In particular, public health officials have looked at the numbers of hospitalizations and deaths to measure if the vaccine continues to provide protection.

“The question is, what’s the lack of protection?” Meissner’s place. “When do we say corn is not good?”

CDC officials have released data showing that a third shot is better than a two-shot program at preventing serious illness and death, and is more safe. three shots before being untrained.

In February, as Omicron’s rage continued, Americans undefeated at age 5 were nearly three times higher than testing well, and nine times higher. more deaths than those expected to be arrested, said Heather Scobie. PhD, MPH, member of the CDC COVID-19 Emergency Response Team.

But only 98 million Americans – about half of those aged 12 or over – have a third disease, Scobie said.

It was also not known how much safer the fourth shot would be, or how long it would take. The committee heard information about a published study of the fourth Pfizer vaccine given to about 600,000 Israelis during the Omicron wave from January to March. The COVID-19 risk factor was 3.5 times lower in the group that received the fourth stroke compared to those who received only three shots, and immunity remained for at least 12 shots. prayers.

However, researchers say, self -prevention is “short -lived.”

More like flu medicine?

Advisers discussed the possibility of developing COVID-19 disease as a standard procedure for chronic disease but noted several challenges.

The disease can be detected during the winter in any hemisphere and a global monitoring system has helped the World Health Organization (WHO) determine the number of cancers each year. The regulators and health officials of each state then select the risks for their shooting and the vaccine producers begin the usual 6 -month workforce.

COVID cases have been reported on a regular basis and are not always new in every country in the same way. The COVID patient was converted to five times the rate of disease progression-creating a new control model per year, compared to the 3-to-5-year requirement for chronic disease. patients do so, says Trevor Bedford, PhD, a professor in the field of cancer and pathology at the Fred Hutchinson Cancer Research Center in Seattle.

The WHO has not established a program to assist in the selection of patients for COVID-19 disease but is working on a process. Nowadays, vaccine manufacturers are more likely to choose the vaccine, said panellist Paul Offit, MD, a doctor of pediatrics at Children’s Hospital of Philadelphia. “I think sometimes businesses are directing the conversation,” he said. “It is not right from them. It’s for us, ”Offit said.

“Importantly, the public is aware of the complexity of this,” said volunteer committee member Oveta A. Fuller, PhD, professor of microbiology and immunology at the University of Michigan. “We haven’t known about influenza in 2 years,” he said. “It takes years to get an inefficient procedure but it has to be done with the disease.”

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