Pfizer became the first COVID-19 vaccine with “full approval”

All vaccines that are applied in the world have obtained timely emergency authorization in the context of the COVID-19 pandemic, which implies that although preliminary studies have shown their effectiveness and safety, phase III continued to be performed as she began to immunize the virus. population.

Now, as well as on December 2, 2020, Pfizer and BioNTech’s formulation against COVID-19 was the first to receive this emergency clearance and to begin enforcement in the United Kingdom, the US Food and Drug Administration. United (FDA, for its acronym in English) has just given full authorization to the United States.

“An Emergency Use Authorization (United States) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current pandemic. COVID-19, “they explained from the regulatory agency.

As, full approval implies that all the requirements demanded by the FDA, in particular those related to long-term studies to rule out harmful effects, have been met, in this case, by the Pfizer vaccine.

And although for many this is a formal procedure, the fact that the wording ceases to have “emergency use” status could make the difference in favor of many who have not yet been vaccinated decide to do so.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, FDA approval of a vaccine may now inspire additional confidence in getting vaccinated.”said Janet Woodcock, acting commissioner of the FDA.

To date, nearly 51% of Americans have been fully immunized, even as a recent outbreak of infections caused by the contagious Delta variant has afflicted areas of the country with low inoculation rates.

This is what they expect in the United States, where a recent survey found that three in ten unvaccinated adults said they would be more likely to be vaccinated if vaccines currently authorized for emergency use received full FDA approval.

On the other hand, for those for whom full approval is not the real reason but really wary of vaccines, the full authorization will give doctors more information to dispel the doubts that prevent people from getting vaccinated.

Likewise, the approval will allow more children to be vaccinated since, according to the authorities, people’s main objections stemming largely from mistrust of vaccines and concerns about side effects would be lifted with this green light from the regulator.

Full approval is “more psychological than anything else,” said Dr Paul Offit, a voting member of the agency’s advisory committee on vaccines and related biologics. And he added, “I mean he already has over 320 million administered doses that exist. Vaccines already have a huge safety and efficacy profile ”.

Before granting full approval, FDA scientists must carefully analyze the companies’ clinical trial data, including for any deviations or safety concerns.said Offit, who is also director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.

The next step is that Pfizer and BioNTech will ask the FDA to approve a third dose as a booster injection after full approval. Last week, Joe Biden’s administration planned to prepare to offer booster shots to all eligible Americans starting the week of September 20.

Three effects that the measure could cause

Almost as a result of full approval, experts believe a few more issues will arise:

1- Approval will provide longer term safety data. The reason is that for full approval, the FDA required an additional four months of safety data. The FDA has granted emergency use authorization for COVID-19 vaccines based on two months of safety data; With any vaccine, almost all potential safety concerns arise almost immediately after injection, which is why the FDA considered two months sufficient for emergency clearance. At least six months of safety data has now accumulated on these vaccines, making them eligible for full approval.

2- The approval will give employers greater authority to require vaccines. Many employers across the country were awaiting full approval before promulgating vaccine requirements, and it is expected that, as with other vaccines in school settings or that are required for travel to certain destinations, one intended to prevent COVID -19 be requested. in the works.

3- The approval will allow the prescription of vaccines for use “not indicated on the label”. When doctors talk about using “off-label” drugs, they mean using them for purposes other than those for which they were originally approved. Unauthorized prescribing is legal, but only when the drugs have received full FDA approval. Once that happens with the COVID-19 vaccines, doctors will be able to further study their use to treat various other diseases.

All vaccines have the same objective: to train the immune system to recognize the coronavirus and thus to raise its defenses in a preventive manner, in order to neutralize the real virus in the event of contagion.

With that of Pfizer and its German partner BioNTech, as well as that of the American company Moderna, strands of genetic instructions called messenger RNA, that is to say the molecule that tells our cells what to do, are injected into the body. Each cell is a mini-factory of proteins, according to the genetic instructions contained in the DNA of its nucleus.

The vaccine’s messenger RNA is made in the laboratory. Thanks to the vaccine, it is inserted into the body and takes control of this machinery to manufacture specific proteins or antigens for the coronavirus.: its “spicules”, these very characteristic points which are on its surface and allow it to adhere to human cells in order to penetrate them.

These proteins, harmless in themselves, will be released by our cells after receiving instructions for the vaccine, and the immune system in response will produce antibodies. These antibodies will remain on guard for a long time – as expected – with the power to recognize and neutralize the coronavirus in case it infects us.

KEEP READING