The media warns of the issue at a time when the covid-19 epidemic in the United States is intensifying and when officials at the local, state and federal levels are looking for ways to speed up the immunization of the population. More than 160 million people in the country have already received some of the coronavirus vaccines, but tens of millions more are eligible to be vaccinated. They have various reasons for their approach, and research suggests that they include the absence of a full FDA screening of vaccines, which may have a touch of “experimental” products in the eyes of some members of the public.
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Pfizer filed its vaccine on May 7, followed by Moderna on June 1. The Washington Post reports that the FDA normally reviews such applications for at least a few months, but is faster expected for covid-19 vaccines. US President Joe Biden said last week that some of the substances could receive final approval from the beginning of autumn.
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In an effort to speed up the process, the FDA has decided to transfer some of its staff, strengthen the allocation of computers and provide additional resources. This was announced by Peter Marks, who heads the “biological assessment and research” department at the office, and thus oversees the assessment of vaccines. According to him, the authority is doing everything possible to make the evaluation of Pfizer vaccine data as fast as possible. According to WSJ, this company is so far the only one that has provided the FDA with all the necessary information.
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Bureaucratic sprint
The STAT website, which reports on the world of healthcare, again said, referring to an unnamed high-ranking source within the FDA, that the office plans to “lower the priority” of some other operations and launch some kind of bureaucratic “sprint.” Work on the assessment of the covid vaccine would be stepped up at the expense of unrelated negotiations with pharmaceutical industry representatives or factory inspections, the article said. STAT notes that vaccine approval requires the analysis of “millions of pages of complex data” as well as on-site inspections and negotiations with the manufacturer.
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Eric Topol, a professor of molecular medicine and director of the Scripps Research Institute in San Diego, is one of those calling for the speedy completion of a full-fledged review. In response to information about the FDA’s new approach, he said he was excited, but at the same time, he said, something similar should have happened much earlier. “We knew about the delta (a coronavirus mutation formerly known as the Indian) many months ago … and that was the moment when we had to strain our strength,” he said.
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“We would like it to be approved as soon as humanly possible,” adds Jim Malatras in an interview with WSJ. He is one of the leaders in the network of public universities of the State University of New York, which includes about 400,000 students. Malatras said that as long as covid-19 is vaccinated only on the basis of an “emergency permit”, it cannot demand vaccination from students due to state regulations.
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Many American schools and companies have already introduced compulsory vaccinations for staff and students, but many others are hesitant at present, according to WSJ. Similarly, there are individuals who, in many cases, want further reassurance that vaccines are safe and proven. In a June survey conducted by the nonprofit Kaiser Family Foundation, more than 30 percent of unvaccinated respondents said they would be more open to vaccination if the FDA granted full approval for some of the vaccines currently in use.
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Marks of the FDA is also aware of this potential, according to which a positive opinion “removes another layer” of skepticism. He did not want to speculate on when this break could occur. According to The Washington Post, some other officials have suggested that it is a matter of weeks, rather than months.
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