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Why weren't booster shots for all adults approved earlier?

2021-11-20T13:45:49.898Z


Experts are divided on whether the FDA should have given the go ahead earlier, but agree that the message has been confusing and could lead to some people missing the boosters.


By Elizabeth Chuck -

NBC News

The authorization of the COVID-19 booster vaccine for all adults by federal authorities was applauded by public health experts.

However, some wonder why the Food and Drug Administration (FDA) did not adopt the measure earlier. 

Despite the Joe Biden government's plan to make the boosters available to nearly everyone in the country by the end of September, the FDA had so far only authorized the third injection of the Pfizer-BioNTech vaccine for certain population groups. such as those over 65 and people with underlying medical conditions.

With enough compelling data to demonstrate the safety of the vaccine in those groups, experts were frustrated by the fact that boosters from Pfizer-BioNTech and Moderna have been slow to authorize for everyone else.

"It's too late,"

said Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine and professor of infectious diseases.

"What is the problem so that the best treatment arrives quickly?" He asked.

[Specialist explains why booster doses of the COVID-19 vaccine are necessary]

FDA approval, followed by endorsement by the Centers for Disease Control and Prevention (CDC), formalizes what has emerged in many states in recent days.

From Massachusetts to California,

various governors have allowed those 18 and older to get the booster

.

Their decisions come before the Thanksgiving holidays, where indoor gatherings are expected to spike coronavirus cases.

"I have not seen people in the hospital who have the three reinforcements," says a doctor

Nov. 17, 202103: 43

"We've had evidence of the need to [administer] the boosters for several months," said Dr. Dorry Segev, professor of surgery at the Johns Hopkins University School of Medicine and professor of epidemiology at the Johns Hopkins University School of Public Health. University.

Segev added that he has heard of

people lying to get backup.

"When there are people who exaggerate their work situation or their medical risk situation or who feel that they have to lie to get the protection they need, that is a failure by the FDA and the CDC," he said.

[Pfizer asks the authorities to authorize its pill against COVID-19]

But others were not quick to pass judgment, arguing that the

FDA needed time to review safety data,

including the rare risk of myocarditis associated with the vaccine and a third dose of it.

If anything, noted Dr. Gregory Poland, director of the Mayo Clinic's vaccine research group, the

FDA was "working at record speed

,

"

given that Moderna only submitted its request for the expansion of the booster earlier this week. and Pfizer did so earlier this month.

Local authorities applaud the approval of the booster vaccine for all adults

Nov. 20, 202101: 41

"I think it would have been a public relations disaster to say: we are not going to review the data, we are just going to approve it," he said. 

Have Goodwin Veenema, a visiting professor and researcher at the Johns Hopkins Center for Health Security, agreed.

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“I don't think there is anything to be gained by looking back and criticizing what has happened.

We are still in the middle of a pandemic.

We are facing the possibility of a new increase in cases, "he said.

"We just have to get as many people vaccinated as possible, including children who are now eligible," he added.

The FDA has not responded to NBC News about the booster vaccination schedule.

In an interview Friday with The Associated Press, the agency's chief of vaccines, Dr. Peter Marks, said:

"We move as fast as we can." 

"We have to do the correct analysis to make sure that when we take action, we can stand behind it," he said.

"Our goal is to make sure that the person who is undecided, or who may be wondering whether to take the vaccine, feels confident enough about our decisions that they are willing to come in and take the vaccine or booster," she added.

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Will people really take the third dose?

It remains to be seen whether people will decide to get a third dose.

All experts agreed that allowing only part of the population to receive reinforcements at first likely created confusion.

"He's feeding the anti-vaccines

," Murphy said.

“It is not known whether to take the vaccine or not, whether it works or not.

This type of message does not help ”.

[Why do children need the COVID-19 vaccine?]

Although the FDA could have used more nuanced language - such as stating more strongly that its initial decision was based on the best data available at the time - the message problem was inevitable, Poland believes.

"We were doing it in real time

,

" he

said.

"If we had studied these vaccines and used them for low-grade outbreaks for five or ten years, like most other vaccines, we would have come up with a different set of recommendations, but the pandemic didn't allow us that luxury."

And it's unclear whether the general public will understand the evolutionary nature of the recommendations and the science behind them, Segev explained.

He worries that a lot of people "start to see the messages like: tomorrow they are going to tell me something different, so why should I listen to them now?"

The hope of the nation's leading infectious disease physician, Dr. Anthony Fauci, is that adults will listen.

Everyone 18 years of age and older "should get a booster dose" of the vaccine and the FDA is about to approve it

Nov. 17, 202102: 05

Noting studies from Israel, where many have received a third dose of the Pfizer vaccine, Fauci has repeatedly said in recent months that the boosters have been shown to be safe and effective. 

This week he argued that while vaccines continue to provide protection against serious illness and hospitalization, a third injection will provide benefits beyond that.

"I don't know of any other vaccine that we're just concerned about keeping people out of hospitals," Fauci said at a briefing at the White House on Wednesday.

"I think it is important to prevent people from contracting the symptomatic disease," he said.

Source: telemundo

All news articles on 2021-11-20

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