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What full FDA approval for Covid-19 vaccines really means

The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval.

Here’s why:

1. The approval will empower health care professionals to address the myth of “experimental vaccines.”

All three vaccines currently have what’s called “emergency use authorization” (EUA), which the FDA uses as a means to quickly give people access to potentially lifesaving medicines during a national crisis. Somehow, “emergency use” has been confused with “experimental.”

As physicians and epidemiologists who have treated COVID-19 patients, it’s frustrating that what amounts to a rather minor, somewhat bureaucratic detail is being used by people as justification not to get a vaccine that can save their lives and the lives of the people around them. More than 358 million doses of COVID-19 vaccines have been safely administered in the U.S. — and the incidence of complications as a result of the vaccines is minimal.

The good news: According to a recent Kaiser Family Foundation (KFF) study, three in ten unvaccinated adults say they’d be more likely to get vaccinated if the vaccines currently authorized for emergency use were to receive full approval from the FDA. So if full FDA approval is what it takes for millions of people to put away their skepticism and get vaccinated, we’re all for it.

Furthermore, for those for whom FDA approval isn’t the real reason but a convenient excuse, clinicians may uncover more information about what is holding individuals back from getting vaccinated.

2. Approval of the vaccines will get more kids vaccinated.

Schools across the country are open. Millions of school-age children are now learning indoors. According to another KFF study, about one-quarter of parents of kids aged 12-17 say they’ll “wait and see” how the vaccine works before getting their eligible child vaccinated. One in five parents say that their child will “definitely not” get vaccinated.

Again, people’s objections stem largely from distrust of the vaccines and concerns about side effects. To empower educators and health professionals to both counter myths surrounding side effects and confidently enact vaccine requirements in schools, it’s essential that the FDA give full approval to the vaccines. While authorization may initially only apply to those 16 and over, approval could provide reassurance to parents of all children currently eligible for the shot.

3. Approval will provide us with longer-term safety data.

What’s the difference between emergency use and full approval? The simple answer is that for full approval, the FDA will require an additional four months of safety data. The FDA granted the COVID-19 vaccines’ emergency use authorization based on two months of safety data; with any vaccine, nearly all potential safety problems crop up almost immediately after injection, which is why the FDA deemed two months sufficient for emergency authorization. We have now accumulated at least six months of safety data about these vaccines, making them eligible for full approval.MORE: Biden administration to begin rolling out booster shots the week of Sept. 20

For people with irrational fears of infertility, magnetism and other specious side effects of the vaccines, the extra data probably won’t mean much. But for people who really want to know more about the true long-term consequences of the vaccines, their reported diminished effectiveness over time, and common real-life side effects such as fevers and headaches, the extra information that goes into the full approval process will be yet another way to help them overcome hesitancy and get vaccinated.

4. Approval will provide employers with greater authority to mandate vaccines.

Many employers across the country have mandated that their employees get vaccinated. A number of these mandates have been challenged in court, and so far they’ve been upheld as legal. But Dr. Francis Collins, director of the National Institutes of Health, recently noted that if the vaccines receive full FDA approval, “then the legal ability to mandate becomes a lot stronger.”

No doubt many employers are waiting for full approval before enacting vaccine requirements, and the sooner they get the legal basis to do so, the better.

The idea of a workplace-based vaccine mandate may seem like a new concept, but these mandates are already common for other FDA-approved vaccines. For example, children are required to be vaccinated against diseases like measles and mumps before enrolling in public school. Travelers are required to be vaccinated against diseases like yellow fever before visiting countries where those illnesses are common. And health care workers are required to get annual flu shots to protect themselves and their patients.

5. Approval will allow colleges and universities to make the vacine mandatory

Most U.S. colleges already require vaccines for viral diseases like measles, mumps, and rubella. Some attorneys say universities have the same right to mandate COVID-19 vaccines, but none of the three COVID-19 vaccines currently used in the U.S. has full FDA approval.

As long as these vaccines were retaining emergency use authorization (EUA) status, the mandates were falling in a legal gray zone. Some colleges say they won’t issue a mandate without full approval. But now the vaccine is approved, it will be on firmer foundation for colleges and universities to mandate it.

“Campuses really want to get back to normal operations as quickly as possible,” says Chris Marsicano, an education professor and founding director of the College Crisis Initiative at Davidson College in North Carolina.

Now the COVID-19 vaccines has been approved, raises hope for a return to the traditional college experience, which means in-person lectures, study groups in the library, social gatherings and attendance at campus athletic events.

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