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The Pfizer vaccine gets full FDA approval, eliminating a primary argument for not getting it

Photo by Mika Baumeister on Unsplash, Andy Slavitt/Twitter

The FDA has given full approval for the Pfizer COVID-19 vaccine, marking a major milestone in the fight against the global coronavirus pandemic.

Since FDA Emergency Use Authorization was issued for the Pfizer, Moderna, and Johnson & Johnson vaccines earlier this year, some hesitant people have refused to get the vaccine, citing the fact that it wasn't fully approved by the FDA. Now that full FDA approval has been granted for the Pfizer vaccine (which is actually officially named Comirnaty—who knew?), that argument is moot. And with Moderna's approval submission clocking about a month after Pfizer, it's entirely likely we'll have two fully approved vaccines for COVID-19 in the coming weeks.

The big question now is—will it actually make that much difference?

On the hopeful side, the Kaiser Family Foundation found that 31% of unvaccinated Americans they surveyed last month indicated that they would be more likely to get vaccinated if the vaccine received full FDA approval. If all of those people changed their minds due to this approval, we'd have millions more Americans receiving the vaccine. With hospitals filling up with unvaccinated people across the country, putting a heavy strain on already burnt-out healthcare workers, getting more people vaccinated is imperative.

But even full approval doesn't seem to be budging the die-hard never-vaxxers.

A small-but-loud minority of Americans simply have a blanket distrust of the FDA (or any government regulatory agency), and this full approval is just seen as another untrustworthy move by an untrusted source. Social media today is filled with people asking how much the FDA was paid to give this full approval. Figuring out how to reach these people is an ongoing mystery.

Another minority of Americans are immersed in media that pushes misinformation about the vaccines and the pandemic in general, leading people to the erroneous belief that they're better off risking a COVID infection than getting the vaccine. Though COVID misinformation can be outright lies, more often it's studies or statistics or stories that are cherry-picked and used in misleading ways. (Watch the comments on this article if you read it on Facebook. There will be no shortage of such misinformation being shared. Happens every time.)

One example of such misleading information is reports of the number of vaccine reactions in VAERS, the U.S. government's Vaccine Adverse Events Reporting System. If a person were to just look at the numbers in that database (which is available for anyone to see) without proper analysis, they could easily believe that the vaccines were dangerous, leading to thousands of people's deaths and sickening thousands more.

However VAERS numbers have to be taken for what they are—self-reported, unverified reactions that 1) may not be real or accurate since anyone can submit to it, and 2) have not been demonstrated to actually be caused by the vaccine.

Here's one example of why raw VAERS numbers are essentially meaningless: When we're vaccinating more than 100 million people in a handful of months, basic statistics would tell us that a certain number of those people will die of out-of-the-blue heart attacks, strokes, aneurysms, or other sudden death events within a close window of receiving the vaccine, even though such events actually have nothing to do with the vaccine.

Here's how that math works: According to the American Public Health Association, around 2,200 Americans die each day of heart attack, stroke and other cardiovascular diseases every day. That's about one person every 40 seconds, and that's in years when there's not a mass vaccination effort happening. At the peak of vaccinations in April, the U.S. was administering over 1,300 vaccine doses every 40 seconds. Statistically, it's completely expected that some sudden deaths would coincide closely with a vaccine dose—but that doesn't mean that the vaccine caused them. Doctors investigate all reported deaths following vaccines, and there is simply no indication that vaccines are causing people to die or be severely impacted in any statistically significant way.

One might assume that the FDA's pause of the Johnson & Johnson vaccine for safety review when a correlation between the vaccine and a higher than normal incidence of rare, severe (but treatable) blood clots was discovered would have given people some faith that the safety monitoring systems work as they should. But memories are short and paranoia is high. Add in the fact that we're watching science happen in real-time, and that accurate information and guidance have changed many times as we've learned more, and it's not surprising that a lot of people simply don't know what to think anymore.

While this full FDA approval won't convince everyone who is hesitant to get the vaccine, hopefully it will convince some. (For those still on the fence, you can read the FDA insert that will now accompany the Pfizer vaccine here and an FAQ about the vaccine and the approval of it here.)

As always, look to the majority of experts in the epidemiology/virology/immunology fields for accurate information and ignore the handful of skeptics-with-credentials who thrive on social media attention and feed on people's distrust of institutions and authority. And for the love, run from anyone who says, "Do your own research," unless you actually have the expertise and ability to conduct clinical research. (For real, watching YouTube videos and searching hashtags on Twitter does not count.)

Let's celebrate the incredible medical feat of the world's top medical scientists during the pandemic, do our part to mitigate the spread of COVID-19, and get the free, widely available, and now fully FDA-approved vaccine as soon as possible.

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Family

Internet strangers are helping each other manage chronic illnesses. It's wonderful.

The web can't cure chronic illness, but it can help make it seem less daunting.

True
Seventh Generation

Being diagnosed with a chronic health problem can be terrifying and isolating — even more so if it means changing your diet, your lifestyle, and the products you bring into your home.

I know because it happened to me.

It was 2000, and I was 21 years old, broke, and sick when a new doctor diagnosed me with celiac disease. After a few visits, he told me I had celiac disease with lactose intolerance. If I wanted to start feeling better, I needed to cut out almost all grains and dairy products.

Just some of the enemies of my fragile digestive system.

Suddenly my entire world was different.

I couldn't eat any of my staple student foods anymore: Farewell, ramen. Adios granola. And I quickly learned that gluten was in almost everything — even products it has no reason to be in, like chewing gum. I was clueless and freaked out.

Thankfully, I had the internet — and so did dozens of other celiac sufferers. We congregated on forums, sharing stories, "safe" food recommendations, and strategies for eating in restaurants. My internet forum friends were my lifeboat, and I held on with both hands to the knowledge they shared.

Taking back control from a chronic illness requires compassion, understanding, and a lot of learning.

For people with chronic health conditions, the web can be an amazing resource to do that.

"Dear Internet: Today I learned licorice is made from wheat flour? Beware and learn from my sadness." — Me in 2002. Image by iStock.

Organizations like Beyond Celiac and The Celiac Foundation have hugely informative websites and vibrant online communities dedicated to helping people get a handle on their disease and access tools and information so they can recover and thrive.

Their online resources include food databases, grocery store apps, restaurant listings, message boards, information about political activism, even a gluten-free dating website. There are active blogger networks too, sharing personal stories, recipes, and motivation.

Resources for people with chronic illness — particularly those triggered by external factors — exist largely because there's nowhere else to turn.

A beautiful gluten-free restaurant meal — perfect for Instagram. Image by iStock.

For people with celiac disease, psoriasis, migraines, and asthma, knowing whether a product is safe to use or consume can be the difference between a normal day and a serious flare-up that might leave them bedridden or worse.

It's really only in the last five years that companies and government regulators started taking the requests of the growing ingredient transparency movement seriously. That spurred a huge increase in the number of products with detailed ingredients lists and more companies realizing that giving consumers access to information can help sales. Particularly for people with asthma, it is much simpler to avoid a common symptom trigger and find truly fragrance-free cleaning and personal care products. For others, change hasn't happened as quickly.

The U.S. Food and Drug Administration agreed to move forward on implementing rules for a gluten-free designation in 2004.

It didn't issue its final guidelines until 2013.

The new regulations allow companies producing gluten-free food products that contain less than 20 parts per million of gluten (a barely negligible amount, and generally not enough to cause a reaction) to label them as "gluten-free." While the FDA assures consumers it will be regularly testing products once they've arrived on store shelves, companies aren't required to submit proof they've tested their products for gluten before they go to market. The regulations also don't apply to food service establishments, personal care products, or medication. Those issues notwithstanding, it is a remarkable step toward complete ingredient disclosure.

Managed properly, people with celiac disease, psoriasis, asthma, and other chronic illnesses can live happy, wonderful lives. But it takes work, diligence, compassion, and support.

Pictured: four people who just learned their mobile phones are celiac-friendly. No, not really. Image by iStock.

Since my celiac diagnosis in 2000, gluten-free food and other products have become a billion-dollar industry. I have good days and bad ones, and sometimes even my best food plans go awry and knock me out of commission for a while. That's the nature of a lifelong illness, and I've come to terms with it. A lot of that acceptance comes from knowing I'm not alone in this.

In the absence of full, government-regulated ingredients lists on every product I eat, wear, or use — there are big-hearted, experience-sharing online communities ready to step in and help me navigate life with a chronic illness.

Family

Snake oil salesmen lying to us accidentally paved the way for a safer world.

The fascinating reason product labels are so boring.

True
Seventh Generation

When someone is selling a product that doesn't do what they say, they're often called snake oil salesmen.

The phrase brings to mind the old Wild West with shouty men waving little bottles of magical medicines that promise everything short of immortality but do absolutely nothing.

But snake oil's real history — and its legacy — is much more interesting.

A vintage bottle of Eclectric Oil promising to heal what ails you. Image by iStock.

In the 1860s, thousands of Chinese immigrants had come to America to work on the transcontinental railroad. After a hard day of work, they'd treat their aches and pains with a fatty salve containing oil from Chinese water snakes.


A small slithery swimming snake. Image by iStock.

Modern researchers know that Chinese water snakes contain lots of omega-3 fatty acids, which help soothe inflammation and reduce blood pressure. But 200 years ago, the health effects of snake oil salve were unexplainable — and quickly became legendary.

Everyone wanted it. That's when the capitalism kicked in.

Salesmen who'd previously purchased the salve from Chinese laborers realized that they didn't need to actually put snake oil in their product — they just needed to say they did. Most people had never taken the time to squeeze the oil (or venom, in some cases) out of a snake themselves and wouldn't know the difference if it were replaced with, say, red pepper flakes. When the U.S. government seized a shipment of the best-selling Snake Oil Liniment and studied its contents, they found it contained no snake oil whatsoever — only mineral oil, turpentine, camphor, red pepper, and a tiny amount of beef tallow.

This cartoon snake knows that selling snake oil isn't a problem itself; misleading consumers is. GIF via "The Simpsons"/20th Century Fox.

By 1906, the government had had enough. President Teddy Roosevelt signed the original Food and Drugs Act into law, banning the sale of falsely labeled foods, drinks, and drugs.

It was intended to prevent the kind of shady and dangerous behavior that led to the sale of fake snake oil.

Unfortunately, it wasn’t enough.

The label on a bottle of Sulfanilamide. Image by the Food and Drug Administration, used with permission.

In 1937, S.E. Massengill Co. launched a new product called Elixir Sulfanilamide. It was marketed to parents with young children as the first liquid antibiotic — which it was, but with one deadly caveat. Instead of suspending the antibiotic in alcohol or water, S.E. Massengill used diethylene glycol, a toxic solvent. More than 100 people died before the drug was pulled from shelves, most of them small children.

Afterward, the company admitted it had only tested Elixir Sulphanilamide for taste, smell, and appearance — never safety — because it wasn't legally required. It was "snake oil" all over again, but with horrifying deadly — and preventable — consequences.

This disaster prompted the government to massively expand its authority and pass 1938’s Food, Drug, and Cosmetic Act, giving it broad power to regulate the safety, marketing, and sale of food products, drugs, and cosmetics.

The FDA is by no means a perfect agency, but it has proved its value. In 1962, its rigorous testing procedures — led by bureaucratic superhero Frances Oldham Kelsey — prevented the sale of thalidomide in the United States. Advertised as a sleeping pill and targeted at expectant mothers, this drug caused more than 10,000 fetal deaths worldwide, but only a reported 17 in America.

Decades later, the FDA is keeping up with its work to protect Americans from harmful consumer goods with dangerous ingredients or false health claims.

Labeling requirements are a huge part of that.

Every company looking to sell new food products, cosmetic and cleaning products, or drugs must provide detailed information to consumers. While the rules differ between product groups, in general, most goods sold in the United States should show the following on their labels:

  1. The full product name, along with a detailed list of ingredients, including active and inactive ingredients.
  2. Instructions on how to safely store the product, whether it is a hazardous chemical, and how to dispose of it safely.
  3. Products containing chemicals proven to be irritants or hazardous need to display a detailed list of possible health risks, along with emergency treatment recommendations.
  4. The company should provide a phone number or website for consumers who want more information.

But disclosing information doesn't end there. There are also plenty of resources online to help consumers make smart choices about the cleaners, cosmetics, food, and pharmaceuticals they buy.

Image by iStock.

For people who want to know even more, there are mobile phone apps like OpenLabel, the Environmental Working Group, and Consumer Reports with detailed product information. Some companies are even considering smart labels, where a scan from a mobile phone can provide consumers with all kinds of extra information. It's all designed to help us know more than we ever thought we'd need to know about the products we buy.

More than 100 years later, we know that real snake oil is perfectly healthy. But what it represents — individuals and companies putting financial gain ahead of consumer safety and health — is still very dangerous.

He may be adorable, but this hissy little huckster may not have your best interest at heart.

Tough, thorough rules on what needs to go on product labels are just one way governments can hold companies accountable. They've made product labels informative, necessary, and, most of the time, totally boring. Exactly as safety should be.

Heroes

Environmentalists call these 12 chemicals the Dirty Dozen. Here's why.

Warning: Abbreviations ahead!

True
Seventh Generation

You may have heard of the Dirty Dozen — 12 chemicals that activists have identified as potentially harmful that we regularly come in contact with in our home, health, and beauty products.

Over the past decade, a lot of science and research has gone into figuring out the long- and short-term health effects of products we use in our homes and on our bodies. The jury is still out on most of them, but some of the findings are worth a closer look.

In 2010, Canada's David Suzuki Foundation did a study on the 12 chemicals and compounds they felt consumers should try to avoid. Since the study was published, some governments have banned some of the chemicals and some companies are reformulating their products so they don't contain them.

Are the Dirty Dozen hanging out in your home somewhere? Here's why these ingredients are on the list:

1. BHA (butylated hydroxyanisole) and BHT (butylated hydroxytoluene)

These two preservatives can be found in moisturizers and cream makeups. Image via iStock.

These two synthetic antioxidants are often used as preservatives in cosmetics (mostly lipsticks and moisturizers) and as food preservatives. They're also potentially allergenic, particularly on the skin.

The International Agency for Research on Cancer classifies BHA and BHT as possible human carcinogens, and the European Commission on Endocrine Disruptors lists BHA as a Category 1 priority substance, citing evidence that it interferes with hormone function in mice and rats.

Neither BHA nor BHT are restricted in the United States. California includes BHA on its list of chemicals that must be listed on product ingredient labels as potentially cancer-causing.

2. Coal tar dyes: p-phenylenediamine and colors listed as "CI" followed by a five-digit number

Coal tar (shown above) is a petroleum byproduct mixed with other chemicals. Image via iStock.

Coal tar dyes (chemical name p-phenylenediamine) are very popular in the cosmetic industry — particularly in hair dye — because they provide rich, long-lasting color. But, like a lot of petroleum-based products, some researchers and activists fear there may be health risks from exposure to them.

Research has linked coal tar dyes to tumors in laboratory mice, and other researchers may have found a connection between long-term use of hair dyes and non-Hodgkin lymphoma. The U.S. Food and Drug Administration (FDA) is unconvinced; it's waiting to see more research before making a firm decision on how to classify coal tar dyes.

The European Union (EU), by comparison, has taken a precautionary approach and classifies coal tar dyes as moderately toxic to humans.

Helpful hint: If you're looking at labels, you can tell if a coal tar dye is used in a product by looking for the the name p-phenylenediamine or the abbreviations FD&C or D&C followed by a five-digit color index number.

3. Diethanolamine (DEA), cocamide DEA, and lauramide DEA


Some shampoos get an extra kick from DEA. Image via iStock.

Consumers love creamy or sudsy personal care products. DEA helps with that. For personal care products, it's most common in moisturizers, sunscreens, and shampoos. As a cleaning product additive, it can be found in soaps and cleansers looking for an added bubbly kick.

Activists became concerned about DEA after some research found that DEA can cause skin and eye irritation, and some high doses have caused liver cancers in to laboratory animals. There are no restrictions on the use of DEA in the United States, but the EU does not allow its use in cosmetics, citing the risk of long-term exposure.

4. Dibutyl phthalate (DBP)

Some "no-chip" nail polishes may get their staying power from DBP. Image via iStock.

Dibutyl phthalate has lots of uses. It can keep nail polishes from chipping, help keep PVC flexible, and be a solvent for dyes or fragrances. The reason activists put it on the list of ingredients to keep an eye on is because in a laboratory study, researchers found it absorbs through the skin and can "enhance the capacity of other chemicals to cause mutations." Other research found it interfered with hormone function, maybe even for pregnant women. There's still a lot of research to be done, so the U.S. hasn't put any restrictions on DBP; the EU, though, does not allow it in cosmetic products.

5. Formaldehyde-releasing preservatives

These are medical sutures stored in formaldehyde, but lots of beauty and personal care products use chemicals that may release formaldehyde over time. Image via iStock.

Formaldehyde has a lot of uses in personal care, cleaning products, and industrial construction. It is found as a preservative in cosmetics and an active ingredient in some toilet bowl cleaners. It can also be released from a wide range of industrial products including some permanent-press fabrics and vinyl and wood-laminate flooring.

The U.S. Environmental Protection Agency (EPA) limits the amount of formaldehyde in some construction materials because on its own, formaldehyde is a carcinogen and is toxic to humans if ingested.

When personal care products or cosmetics are said to contain formaldehyde, what they usually contain are actually formaldehyde-releasers. It's unclear whether they are harmful; the FDA doesn't restrict the use of them in cosmetics or personal care products, preferring to require disclosure on ingredient labels instead. The EU has strongly restricted the use of formaldehyde in industrial and consumer products since 2014, citing its carcinogenic risk.

6. Parabens

Parabens help some cosmetics stay pretty longer. They may also be dangerous. Image via iStock.

If you drink fruit juices or use cosmetics or fragrance products, you likely have encountered parabens, an extremely popular preservative.

Some activists are concerned by parabens, citing research that it potentially has adverse health risks when it's absorbed through the skin. Some studies have shown that parabens can mimic the effects of estrogen, the female sex hormone which could lead to a possible increase to breast cancer risk or potentially interfere with male reproductive function. Despite activists' concerns, more definitive research is needed.

7. Parfum (aka fragrance)

Lots of products use the catch-all terms parfum and fragrance for the proprietary mix of chemicals that make up their signature scents. Image via iStock.

Since there are no regulations requiring companies to disclose the ingredient lists of their signature scents, many of them simply say parfum or fragrance on the label. This can be misleading because the smells that make up a fragrance can come from any number of essential oils or chemical compounds.

For people with chemical sensitivities, these unlisted ingredients can trigger allergic reactions, migraines, or cause asthma. Environment Canada has also found that some synthetic musks used in fragrances can build up in the fatty tissue of fish and other water-bound organisms. Other fragrance additives, like DEP (see #4 above) help scents stay in the air longer, but have been shown in laboratory environments to potentially interrupt hormone functions.

Unfortunately, it is hard to know whether a specific fragrance or parfum contains potentially unsafe ingredients. If companies say their product fragrance is a trade secret, they aren't required to list what's in it on the ingredient label.

8. Polyethylene glycol (PEG)

PEG compounds can be found in some cosmetic cream bases — and laxatives. Image via iStock.

Polyethylene glycols are petroleum compounds most often found helping makeup and face creams deliver moisture. If perfectly pure, they are considered generally safe, though they're not recommended for use on broken skin. In rare cases, polyethylene glycol compounds can become contaminated with ethylene oxide, and that's when activists get concerned. Ethylene oxide is a known carcinogen that has also been shown in some research environments to cause developmental problems. All of this considered, the Environmental Working Group rates the overall hazard of using polyethylene glycols as "low."

9. Petrolatum (aka petroleum jelly or Vaseline)

Some glossy lipsticks get their shine from petrolatum. Image via iStock.

Tyra Banks swears by mineral oil jelly as her holy grail makeup product. It's an excellent moisture barrier to keep skin hydrated and is often added to skin care and hair care products.

But, because it is petroleum-based, there's a risk it could be contaminated with polycyclic aromatic hydrocarbons. Research has shown a link between long-term exposure to these petroleum byproducts and cancer. Based on that evidence, the EU classifies petrolatum as a carcinogen and only allows its use "if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen." There are no such restrictions in the United States at the moment.

10. Siloxanes

Siloxanes are a group of chemical compounds based on silicone, a popular additive in many cosmetics and personal care products. Image via iStock.

If you like a clean windshield, dry underarms, or a smooth makeup base, you've probably used products containing siloxane. Two siloxanes in particular, cyclotetrasiloxane (D4) and cylcopentasiloxane (D5), have been studied by researchers in Canada and the EU extensively.

Environment Canada concluded that both D4 and D5 may build up in fish or other aquatic organisms but did not pose a threat to human health. The European study reached a similar conclusion, rating the chemicals as "high concern" but of no risk to human health.

11. Sodium laureth sulfate

Sodium laureth sulfate helps some shampoos stay foamier for longer. Image via iStock.

If you like lots of bubbles when you wash dishes or use shampoo, you may have sodium laureth sulfate to thank. It's a common foaming agent used in dish soaps, cleansers, and foamy beauty products. But, like polyethylene glycol (#8 on this list), sodium laureth sulfate can — on rare occasions — become contaminated with the known carcinogen ethylene oxide. Fortunately that's very unlikely to happen, so the Environmental Working Group rates the overall hazard of sodium laureth sulfate as "low."

12. Triclosan

Triclosan is an antibacterial chemical sometimes found in alcohol-based hand sanitizers. Image via iStock.

Triclosan is a very effective anti-bacterial chemical found in lots of common consumer products, including toothpaste, hand sanitizers, laundry detergent, and facial tissues, among others.

As we've written before, research has shown that triclosan sticks around in the environment long after we've finished using it, killing helpful algaes and even accumulating in the bodies of other organisms.

Triclosan was banned in personal care products ibanned in personal care products in the EU earlier this year. The EPA currently has it under review, and the FDA is reserving judgment until further research is done.

For a lot of these products, the research into their possible health impacts is still very new. Much is still to be done, and the definitive answers for what's safe and what's not may not be known for years — maybe even decades.

Until there is a scientific consensus, the smartest thing you can do for your health is what you're probably already doing: reading product labels, following warnings, and learning what companies are required to say (and sometimes don't say).

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