5 good reasons for the FDA to give full approval to COVID-19 vaccines: Analysis

iStock/rina Shatilova

(WASHINGTON) — The Biden administration announced on Wednesday that it will roll out COVID-19 booster shots for many Americans starting in mid-September. But there’s another date that many are anticipating.

As early as this coming week, according to The New York Times, the U.S. Food and Drug Administration is expected to give full approval to Pfizer-BioNTech’s coronavirus vaccine — the first COVID-19 vaccine expected to receive that endorsement.

The FDA’s approval might seem like a minor technical move to some. But full approval of all three COVID-19 vaccines is an important step that can make a difference in reducing COVID-19 infection and mortality rates, improving health care delivery and saving lives.

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.

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 the prescribing of vaccines for “off-label” use.

When physicians talk about using drugs “off label,” they mean using them for purposes other than those for which they were initially approved. For example, Metformin, which is approved for the treatment of type 2 diabetes, reduces appetite — so it’s often used to help patients who are trying to lose weight.

Off-label prescribing is legal — but only when drugs have received full approval by the FDA. Once this happens with COVID-19 vaccines, doctors will be able to further study their use in treating a variety of other illnesses.

Off-label use includes delivering booster shots outside of the FDA’s fully approved parameters — and while booster shots weren’t initially included in the COVID-19 vaccines’ application for full approval, companies can request an approved product be amended to include boosters. The FDA’s approval could thus make a third shot more palatable to the population.

Despite everything we know about the COVID-19 vaccines’ effectiveness and their ability to prevent serious illness and hospitalizations, just 60% of Americans ages 12 and up are fully vaccinated against the virus, according to data from the Centers for Disease Control and Prevention. The most recent model from the Institute for Health Metrics and Evaluation indicates grave consequences if Americans don’t continue to get vaccinated and follow mask guidance.

Given that the delta variant has led to an uptick in infections and deaths, it’s crucial that Americans use every tool at our disposal to convince every person to get vaccinated. If full FDA approval of vaccines is one of those tools, then the decision can’t come fast enough.

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