When millions are vaccinated, why has the FDA not approved a COVID vaccine

On August 11, the distance from the Food and Drug Administration (Food and Drug Administration) (Food and Drug Administration) Granted its first emergency use authorization (EUA) for the COVID vaccine.

Since December 11, 2020, 164.8 million U.S. citizens have received two doses of Pfizer or Moderna COVID vaccine, or a vaccine from Johnson & Johnson to help protect them from the disease.

However, the FDA has not yet approved the use of any currently available COVID vaccine. The introduction of vaccines in the United States relies and will continue to rely on the FDA’s rapid but temporary EUA procedures. EUA is a mechanism that the FDA can use to allow unapproved medical products to be used in a public health emergency (such as the COVID pandemic).

So why does it take so long for approval?

Approval is coming

Weekly newspaper Contact the FDA to ask if and when it believes that the COVID vaccine will be approved.

The agency pointed out Weekly newspaper In response to a series of tweets shared by FDA Acting Commissioner Dr. Janet Woodcock, she said that the FDA’s target date for approving Pfizer’s vaccine is January 2022, and that the agency intends to complete its review of Pfizer’s application, which is “far ahead”.

This Pfizer The vaccine is being reviewed as a priority, which means that a decision on its approval application is expected to be made six months or less after the application is accepted (in this case, July 16).

Herschel Nachlis, a policy researcher at the Rockefeller Center for Public Policy at Dartmouth College in New Hampshire, told Weekly newspaper: “Many people feel that it will take a long time for the FDA to fully approve the COVID vaccine.

“But it is worth acknowledging that most vaccines usually take many years or even decades to develop and obtain approval.”

FDA approval requires pharmaceutical companies to provide rigorous scientific data Support their approval application.

Nachlis said that for some people, the FDA’s approval process for the drug was too slow, while others actually thought it was too fast. But the FDA’s approval method is regarded as the gold standard internationally, and the agency hopes to get things done.

According to Adam I. Muchmore, Professor of Law at Pennsylvania State University Weekly newspaper:”There are many “I” points to be added and “no” lines to be drawn. These are not simple bureaucratic requirements.

“Generating and reviewing these data requires the work of multiple experts in a wide range of scientific fields.”

When will EUA be revoked?

In terms of their nature, EUA Just like those granted by the United States for COVID vaccines are temporary.

This means that the EUA will have to end at some point, which usually happens when the emergency that justifies their use (in this case the COVID pandemic) ends, or when the FDA approves the drug, making the EUA unnecessary.

Nachlis said that the FDA’s reason for withdrawing the EUA is not strict. If the FDA no longer believes that the drug is effective or the benefits no longer outweigh the risks, the agency can also withdraw the EUA-which is unlikely to be the result for the COVID vaccine.

Examples of drugs owned by the FDA Revoke EUA includes chloroquine phosphate and hydroxychloroquine sulfate as treatments for COVID.

The agency granted these drugs as EUAs for COVID-19 treatments in March 2020, but after deciding that they are “unlikely to be effective in treating COVID-19” and because their serious side effects mean that their benefits no longer outweigh the risks, It was cancelled in June 2020.

Expert told Weekly newspaper They do not believe that the FDA will cancel the EUA for the vaccine before its regular approval.

Susan S. Ellenberg, professor of biostatistics, medical ethics, and health policy at the University of Pennsylvania, said that “it is hard to imagine such a possibility.”

Muchmore responded to this, saying: “All the reports I have seen indicate that the safety and efficacy data that the FDA relies on in granting EUAs are very strong.

“I think that until the FDA regularly approves at least one of these vaccines, it is unlikely that the FDA will withdraw the EUA for any existing vaccine.”

What does this mean for the task?

Last weekend, the U.S. Centers for Disease Control and Prevention (CDC) Director Rochelle Varensky Forced to clarify The government’s position on federal vaccine regulations after she informed Fox News The Biden administration is “studying” a task that requires people to get an injection.Her comment is in the government trying to deal with The more communicative Delta variant This has become the main form of COVID in the country.

She later said that she “refers to the authorization of private agencies and parts of the federal government. There will be no federal authorization.”

So far, the US government’s strategy has been to try to persuade people to finish their injections and leave, requiring customers or employees to fully vaccinate private companies or institutions.

However, since less than half of the U.S. population is vaccinated, and indecision is a very real problem facing health agencies in the U.S. and elsewhere, will FDA approval speed up?

Naklis thinks so.He says Weekly newspaper“In my opinion, there are two groups of people who have not been vaccinated: one group may not be able to persuade them with carrots or sticks, but I think this group is not large.

“Once vaccination becomes easier, once there is more evidence of widespread use and safety and effectiveness, and once employers issue more instructions after the vaccine is fully approved, another larger group may eventually be vaccinated.”

For Ellenburg and Muchmore, full FDA approval may lead to more organizations Mandatory vaccination And further increase the acceptance of vaccines, thereby increasing the number of people vaccinated in the country.

Regarding the vaccine regulations, Ehrenberg said: “Those who are angry about restrictions on freedom don’t seem to remember that their freedom is restricted in many ways to protect others-they cannot drive under the influence, they must wear a seat belt. Many of their restaurants have to wear shirts or shoes, and they cannot buy and sell heroin. [There are] Many restrictive measures to protect public health. “