FREDERIC J. BROWN / AFP on photo shoots
In a lengthy virtual meeting, a panel of experts studying with the Food and Drug Administration emerged in strong support of efforts to develop new COVID-19 vaccines that are comparable to a variety of methods.
The committee was not asked to vote on the industry’s recommendations but discussed how to decide when to change the virus or the vaccines used for vaccines. to come, with motivators.
“I think we’re in an undiscovered country because with SARS-CoV-2 a lot of things haven’t been done before,” said Dr. Arnold Monto, professor emeritus at the University of Michigan and chairman of the committee.
It is expected that the board will meet again in May or June to consider a specific proposal for the revision of the COVID-19 models.
The procedure used to convert age-related coronary heart disease to circulating disease is a model that can understand the procedure for COVID-19, but much is not known about it. coronavirus mutation and significant differences between influenza virus and SARS-CoV-2.
Drop box for new booster type
The serious consideration is whether a different specific booster should be provided this fall. The rise of the omicron difference, which today is a subvariant called BA.2, raises the question. The drugs currently used in the U.S. are based on the treatment that is spread at the onset of the disease and are better for some patients later.
“While we have seen a significant decrease in the number of COVID-19 cases in the country, the disease continues and continues to work and could increase the number of cases,” said Drs. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, opened the meeting. “This is a big concern as we go into the fall and winter.”
Marks also noted that the coronavirus will have another opportunity to grow in the future in the US.
Earlier in the day, Israeli researchers released data on the prevention of a single Pfizer-BioNTech disease booster and the increase in the prevention of a second booster to fight infections, running faster, and serious illnesses, last longer. The rapid proliferation of the omicron type helped to reduce the resistance from resistance with a single stimulant.
Israeli officials approved a second booster in early January for people 60 or more and others in high -income or working health care. Israeli knowledge helped the FDA’s decision in late March to allow a double booster dose for 50 people or more for others with immune systems.
Predicting viral evolution is ‘extremely difficult’
Rapid genetic changes in the coronavirus lead to its ability to block the immune response and disease in the past. Changes that continue to make it difficult to make decisions about what types of materials to include in new varieties.
“In general, from everything we’ve seen, we need to consider how much evolution is going forward, and we need to find ways to continue this trend in terms of our medical program, ”said Trevor Bedford, who teaches viral development. at Fred Hutchinson’s Hospital in Seattle.
He said predicting where the disease would go was “extremely difficult.” Coronavirus infection is more rapid than coronavirus infection. New strains of the coronavirus have emerged in just months rather than years when the disease can make flies.
Given the current level of coronavirus development and uncertainty about what will happen in the future, Bedford believes a dangerous new species such as the omicron could emerge. of one year and a half or more than one year.
There isn’t much time to change the texture in time to intensify this fall. “If you’re not going to have a medical trial in early May, I think it’s very difficult to get products among manufacturers to meet the requirements,” said Robert Johnson, the vice president. assistant secretary of Federal Biomedical Advanced. Research and Development Power.
The FDA’s Marks confirmed there is a fixed timeline for deciding on how to add make-up, but there may be “some wiggle room” that could allow a decision in May or June.
Lots of decision making. “We can’t always encourage people like us,” Marks said, adding a second FDA -approved booster dose is now a “stopgap action” to help protecting the most vulnerable.
The goal for the revitalization sometime later this year, Marks said, is to “revitalize in order to avoid a future wave when we are in high crisis. “
In his closing remarks, commissioner Monto said, “We want to see an age group as a chronic disease but knowing that the growth of the disease will determine how we respond.”
Rob Stein gave this presentation.