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This is how the safety of the COVID-19 vaccine will be checked before it is distributed

2020-11-22T07:32:23.156Z


For Dr. Fauci, the speed in the development of experimental vaccines "did not put their safety at risk" and is "a reflection" of scientific advances "that now allow us to do things in months that previously cost us years."


By Denise Chow - NBC News

The first experimental coronavirus vaccines will likely be available later this year.

While public health authorities have welcomed this news, polls show that people still have little confidence in these antidotes to COVID-19.

A Gallup poll conducted this month found that 58% of Americans said they would receive the vaccine,

a higher percentage than the 50% who said the same in September

.

But concerns remain that the rapid development and testing of these vaccines may compromise their scientific integrity.

Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, spoke at the White House on Thursday with the intention of answering questions about the safety of the first two vaccines from which the results of the phase 3 study have already come out. .

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"The speed of the process did not put safety or scientific integrity at risk at all," he said.

"It is a reflection of the extraordinary scientific advances in these types of vaccines, which now allow us to do things in months that previously took us years," he added. 

Fauci is confident in this development process, but what are scientists paying attention to to see if vaccines are safe?

The size of the sample in the trials and its design: the bigger the better

Clinical trials to test vaccines are usually made up of three phases.

Generally,

larger scale tests are better

.

In them the participants are of different ages and ethnic groups.

That will allow researchers to collect more data on how a potential vaccine works in different populations. 

Larger trials are also more likely to identify potential safety issues, according to Daniel Salmon, director of the Institute for Vaccine Safety at the Hopkins Bloomberg School of Public Health.

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"The question that must be taken into account is about the size of the sample, because it will indicate the frequency of a phenomenon that has been detected," says this specialist, who acted as director of vaccine safety in the Department of Health during the influenza A pandemic in 2009. 

The samples studied for the experimental vaccines that are currently in the final stages of testing in the United States - including those developed by Pfizer and Moderna -

are considered very large

, because they include an average of about 30,000 volunteer participants each.

Both companies also

recruited diverse population groups, incorporating people of different ages and medical histories

.

Moderna's trial, for example, includes 5,000 people with high-risk chronic diseases. 

"This is a big step," Fauci says of Moderna's announcement of vaccine advances.

Nov. 17, 202002: 30

To what extent does it protect

Pfizer and its German partner BioNTech released additional data on Wednesday after completing the phase 3 study.

Both companies announced that their vaccine had a 95% degree of protection in preventing COVID-19 symptoms, an improvement over the efficacy of more than 90% reported by Pfizer a week earlier based on preliminary information.

Moderna said Monday that initial results from phase 3 trials show that its experimental vaccine guarantees 94.5% efficacy.

Experts say that these results are encouraging, but that more data is needed to understand what they mean.

“95% efficiency is a great thing, but the question is: Effective for what?”;

Salmon argues.

"Does it prevent the possibility of suffering from COVID-19 in general?

Does it prevent the development of symptoms?

Does it prevent severe symptoms?

Does it prevent transmissibility?

These are all different questions, ”he added.

Food and Drug Administration (FDA) Commissioner Stepeh Hahn said the promising results revealed so far fuel hope that these vaccines are "a great medical achievement," but added that the agency you will need to carefully evaluate the still raw data from the trials.

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"We don't just look at a scientific article or a press release," he

said Thursday during a Facebook Live interview with John Torres, senior medical correspondent for NBC News, Telemundo's sister network.

Monitor side effects

The FDA requires vaccine developers to add two-month product safety monitoring data collected to applications for emergency use of their products.

This is

a key step in ensuring that drug companies can monitor trial participants

for any medical safety issues that may occur after vaccination.

Typically, most side effects appear within 60 days of receiving a dose, according to Grace Lee, a professor of pediatrics at Stanford University School of Medicine.

But rare problems may develop later, meaning that the FDA will need to weigh the potential benefits against the known risks before granting the emergency use authorization.

"We will have to accept that there will be risks - nothing we do in this world is without risk,"

said Lee, who is a member of the advisory committee on Immunization Practices at the Centers for Disease Control and Prevention (CDC). , for its acronym in English).

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If that authorization is granted, the advisory committee will then make recommendations on who should receive the vaccine doses first. 

"We could wait six months, a year or two to have enough data, but we should block access to the vaccine for the population for two years because we want perfect data," says Lee.

"Of course we want perfect data, but since we are in a pandemic right now, we have to balance the scale," he adds.

Still, there are likely to be more controls as both Pfizer and Moderna developed their vaccines with a new technology that uses messenger RNA, or mRNA (a component of cells).

So it is not yet known whether there may be unique side effects from these types of vaccines, although

neither company has reported serious safety problems in their trials so far

.

"We haven't had vaccines with those technologies before," Salmon said.

"When we use new technologies, we want to be more careful," he added.

One aspect that will be particularly important will be to differentiate medical safety problems associated with vaccines from health problems that occur after receiving them but are not related to them, according to Salmon.

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“If you vaccinate a lot of people, there will be a lot of bad things that will happen to those people but that only happen by chance,” he explains.

“This is especially possible in a mass vaccination program where many people are vaccinated quickly.

If we vaccinate 10 million people over 65, some of them will have a heart attack or stroke on the same day they receive the vaccine.

These are only fortuitous associations, but vaccination programs are liable to be undermined by them ”, he also assures.

There is a system in place to review vaccine data before it is released to the public

.

An application for authorization for emergency use will be reviewed by an independent group of FDA advisers known as the Advisory Committee on Vaccines and Related Biologics. 

The members of this committee include physicians, scientists, infectious disease specialists, and consumer representatives, and none of them are employed by the FDA itself or by vaccine developers.

After the committee presents its recommendations, the FDA will decide whether to grant authorization. 

Subsequently, the Advisory Committee on Immunization Practices will develop guidance for CDC on how to prioritize who gets the vaccine first.

The FDA and CDC advisory committees do not have decision-making authority, but the agencies typically follow the recommendations of both groups, according to Salmon.

And the committees will continue to monitor the vaccine's safety data over time

, according to Lee.

"The decision does not end at the time of recommendation";

ensures.

"We are going to incorporate new data whenever it appears, so it can change," he adds.

Transparency in the approval process

The public will be able to access trial data and observations on that information as soon as the Advisory Committee on Vaccines and Related Biologicals conducts its review in early December.

"It will include a public deliberation and that's good," Salmon maintains.

Pedestrians pass Pfizer's world headquarters in New York.

AP / Bebeto Matthews

You can see the process and if it is being reviewed by independent scientists

.

If people are aware of this later step and that there are independent scientists analyzing the data, they will probably be more confident, ”he adds.

Additionally, Salmon believes that this kind of transparency will be crucial to bolster public trust and combat misinformation.

This seems particularly important to him because the pandemic has become highly politicized and the government's initiative to invest resources in a vaccine development program known as Operation Warp Speed ​​may have cast doubt on the safety of a potential vaccine. against coronavirus.

"I think the name has caused a lot of concern," says Salmon, "people hear 'Warp Speed' and may have the perception that shortcuts are being taken that may affect safety.

But

if you look at the process so far, that's not the case

. "

Translation and editing by Francesco Rodella.

Source: telemundo

All news articles on 2020-11-22

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