March 9, 2021

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How does the approval process work?


“The idea of ​​a vaccine (against Covid) being in someone’s arm by the end of October or beginning of November is ridiculous,” Bioethics professor Arthur Caplan told ABC News.

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Although many warn that the election season and US politics threaten to corrupt the process for the approval of a vaccine against Covid-19, specialists interviewed by ABC News have reiterated that the last stages of evaluation are progressing well.

One of them, the CEO of Pfizer, Albert Bourla, has reiterated that the final trials of the vaccine developed by his company are progressing smoothly, so it is possible that the pharmaceutical company will have enough data to determine its safety and efficacy at the end of the month of October.

If the results are positive, the company will send the data to the Food and Drug Administration (FDA), in an attempt to authorize the vaccines as soon as possible.

“We hope to have enough (data) by the end of October to say if the [vacuna] it works or it doesn’t, ”Bourla said during a digital event organized by the International Federation of Pharmaceutical Manufacturers and Associations.

However, submitting data does not mean that the vaccine will be ready for distribution, nor does it mean that Americans will be vaccinated immediately.

“The idea that a vaccine (against Covid) is on someone’s arm by the end of October or beginning of November is ridiculous,” said Arthur Caplan, professor of Bioethics and founding director of the Division of Medical Ethics at the Faculty of New York University Medicine.

Why?

For a vaccine to be approved, it must first undergo three phases of human clinical studies. In the first, the safety of the candidate vaccine is corroborated in a small number of people and in the second, this spectrum is greater.

Already in Phase III trials it is examined whether and to what degree the vaccine really protects against infection.

Pharmaceutical companies Pfizer, Moderna and other major vaccine manufacturers have already positioned themselves in this final stretch, which is why they seek to enroll 30,000 volunteers for their Phase III trials.

Pfizer already has 25 thousand interested people, however Moderna recently announced that it would reduce the speed of registration to ensure diversity in its test.

“If more people in the placebo group are infected and / or develop a serious disease, then the vaccine is considered effective,” said Dr. Paul Goepfert, professor of Medicine and Microbiology at the University of Alabama.

In other words, if they are successful, the group that receives the vaccine must have a disproportionately lower rate of infections than those that did not receive the vaccine.

The companies will then be able to submit their data to the FDA and, in turn, demonstrate whether their findings meet the safety and efficacy criteria required to authorize their use.

In June, the FDA said that to qualify for an Emergency Use Authorization, a coronavirus vaccine would have to protect at least 50 percent of vaccinated people.

But first, the data emerging from ongoing clinical trials must be evaluated by the Safety and Data Monitoring Board, an independent group of experts created by the National Institute of Health. This group has the authority to terminate trials early if the results are overwhelmingly positive or negative.

If the Phase III data shows efficacy and safety, then the vaccine manufacturer can submit an application to the FDA for an Emergency Use Authorization license.

Following that request, the data will be reviewed by the FDA’s 15-member Vaccine and Related Biologicals Advisory Committee, most of whom are active specialists at universities and research centers, with expertise in infectious diseases. .

The recommendation of that advisory committee is subsequently sent to the FDA’s Center for Biological Products Evaluation and Research, and then to FDA Commissioner Dr. Stephen Hahn.

The latter has promised that the FDA will rely on data and science to approve a vaccine. “I can promise you that when the data is available, the FDA will review it, using its rigorous and deliberative scientific process,” Hahn told the Journal of the American Medical Association.

Yet President Donald Trump has been promising a swift schedule for the vaccine for weeks – one that would presumably make it available by Election Day.

Meanwhile, health experts and politicians have expressed concern that Hahn, if he succumbs to political pressure, would prematurely authorize a vaccine.

Due to the degree of contagion and the number of victims of the pandemic in the United States – 199,000 as of last Tuesday, according to Worldometer – it is possible that the FDA will make the vaccine available in an emergency, instead of issuing a full approval.

This alternate regulatory pathway, called Emergency Use Authorization, has been activated only once for a vaccine. It happened at the beginning of this century, in response to the anthrax scare.



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