The F.D.A. Just Issued A New Warning For The J&J COVID-19 Vaccine

All people in the U.S. above the age of 12 are eligible to receive the COVID-19 vaccine.  The U.S. Centers for Disease Control and Prevention has eased mask-wearing requirements for vaccinated people. On Monday, the Food and Drug Administration (FDA) issued a warning that the Johnson & Johnson one-dose vaccine is linked to a very small incidence of a rare nerve complication, Guillain-Barré syndrome.

The more than 159 million Americans and counting who are fully vaccinated no longer need to wear masks inside most places and outside among crowds.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physical distancing,” CDC Director Dr. Rochelle Walensky told reporters at a press briefing in May. “If you are fully vaccinated, you can start doing the things that you had stopped doing because of the pandemic. We have all longed for this moment when we can get back to some sense of normalcy.”

People are considered fully vaccinated against COVID-19 two weeks after receiving the second dose in a two-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine like Johnson & Johnson.

All Americans over the age of 12 are eligible to receive the COVID-19 vaccine. Already, 67.7% of Americans over 18 have received at least one dose of the vaccine, and about 48% of the population have been fully vaccinated, according to data from the CDC.

If you’re not yet vaccinated, it’s understandable to have questions, including what’s in the vaccines. That’s especially likely if you’re interested in the Johnson & Johnson vaccine, which the Food and Drug Administration(FDA) now says is linked to a very small incidence of the rare nerve complication, Guillain-Barré syndrome.

Here's everything we know about the COVID-19 vaccines, their ingredients, and what life might look like once you're fully vaccinated:

How many vaccines are available in the United States?

The FDA has authorized three COVID-19 vaccines for emergency use.

On Friday, December 11, the FDA approved the COVID-19 vaccine from Pfizer/BioNTech. And exactly one week later, on December 18, the vaccine from Moderna/National Institutes of Health was given the official thumbs up. The breakthrough came after nearly a year of scientists racing to produce a safe and effective vaccine.

The Pfizer/BioNTech vaccine requires two doses, three weeks apart, and is said to be 95 percent effective at preventing symptomatic COVID-19.

The Moderna/National Institutes of Health vaccine also requires two doses, though they need to be given four weeks apart (not three). It’s said to have 94.1 percent efficacy.

On February 27th, a third shot, from Johnson & Johnson, was also granted emergency use authorization by the FDA. Johnson & Johnson announced that its single-shot vaccine is 66 percent effective in preventing moderate to severe COVID-19, 85 percent effective at stopping severe cases, and 100 percent effective against hospitalizations and deaths. This vaccine is now available for use again in the U.S. after it was on pause due to concerns about rare blood clots.

The Food and Drug Administration (FDA) approved the Pfizer-BioNTech vaccine for 12- to 15-year-olds. It’s the first vaccine to be approved for use in people under the age of 16—though Moderna, Johnson & Johnson, and AstraZeneca are in clinical trials now—meaning that hundreds of thousands of young people could be vaccinated in time for the 2021-2022 school year.

“We have safety, we got the immune response we wanted—it was actually better than what we saw in the 16- to 25-year-old population—and we had outright demonstration of efficacy,” Dr. Bill Gruber, a pediatrician and SVP at Pfizer told the New York Times.

How do these vaccines work again?

A quick primer: A vaccine is a substance that contains dead or weakened, disease-causing microbes. (For example, the measles vaccine contains measles microbes.) These microbes are inactive, which means they won’t make you sick—but they will stimulate your immune system to produce antibodies that will protect you from that disease in the future, according to the CDC.

“Vaccines fool the body into thinking it’s being attacked without actually giving you the virus,” explains Paula Cannon, PhD, professor of microbiology and immunology at the Keck School of Medicine at the University of Southern California. “Your body scrambles to make antibodies that are tailor-made to fight that virus, and you retain those antibodies for life.” (Antibodies are proteins your immune system makes to fight infections like coronavirus.)

In the case of COVID-19, the vaccines work in different ways but they all do the same thing: They trick your body into creating antibodies that fight COVID-19.

What’s in the COVID-19 vaccine?

“The Pfizer/BioNTech vaccine and Moderna vaccine don’t contain the whole virus,” says Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security. “They contain genetic material from the virus, known as mRNA.” When mRNA enters your body, your cells turn it into a protein called a spike protein, which your body recognizes as foreign and forms an immune response against.

“The mRNA is like an instruction manual,” explains Cannon. “It tells your body how to make the spike protein, which is a cool trick because normally it would need to be made in a lab.” (You know those images you’ve seen of the coronavirus? Those things sticking out of the microbe are the spike protein.)

Indeed, the use of mRNA in a vaccine is a huge scientific breakthrough. “It changes the entire way we respond to infectious disease emergencies and makes vaccine development much quicker, easier, and less costly,” says Adalja. “Not only are the Pfizer and Moderna vaccines a win against COVID-19, but they’re also a win for emerging infectious diseases as a whole.”

The Johnson & Johnson vaccine uses a different tactic to get spike protein into your body. “They also have the genetic instructions to make spike protein but instead of being written on a piece of mRNA, it’s contained within a harmless adenovirus, which normally causes the common cold,” says Cannon. The adenovirus has been weakened so it can’t infect you—it’s simply used to transport the genetic instructions for your body to make spike protein.

From there, the mechanism is the same as with the Pfizer/BioNTech and Moderna vaccine: Your body sees the spike protein as foreign and creates antibodies to fight against it.

What’s in the Pfizer COVID-19 vaccine?

Here is the full list of ingredients, according to the FDA:

mRNA

Lipids (including ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol)

Potassium chloride

Monobasic potassium phosphate

Sodium chloride

Dibasic sodium phosphate dehydrate

Sucrose

What’s in the Moderna COVID-19 vaccine?

These are the ingredients in the Moderna vaccine, per the FDA:

mRNA

Lipids

Tromethamine

Tromethamine hydrochloride

Acetic acid

Sodium acetate

Sucrose

What’s in the Johnson & Johnson COVID-19 vaccine?

The Johnson & Johnson vaccine contains these ingredients, according to the FDA:

recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein

citric acid monohydrate

trisodium citrate dihydrate,

ethanol

2-hydroxypropyl-β-cyclodextrin (HBCD)

polysorbate-80,

sodium chloride

Is the COVID-19 vaccine FDA-approved?

All vaccines must be approved by the Food and Drug Administration before they can be used in the United States. FDA scientists and medical professionals carefully evaluate all the available data about the vaccine to ensure its safety and effectiveness.

“Because of the urgency of the situation, the FDA has been fast-tracking the approval process,” says Jessica Malaty Rivera, MS, science communication lead at The COVID Tracking Project. “But that doesn’t mean the safety or efficacy has been compromised.”

In May 2021, the Pfizer-BioNTech vaccine was approved for use in 12- to 15-year-olds. Right now, the vaccine is currently in clinical trials for children ages 2 to 5 years old. Moderna, AstraZeneca, and Johnson & Johnson are currently in clinical trials for the teenage set, and have not yet been approved by the FDA.

Does the COVID-19 vaccine have side effects?

Like any vaccine, the COVID-19 vaccines do come with potential side effects. “Similar to the flu vaccine, the side effects are pretty mild, and the most common one is fatigue,” says Malaty Rivera.

Other potential side effects, which may last several days, include injection site soreness, muscle aches and pains, chills, joint pain, and a low-grade fever, according to the FDA. More people experience side effects after the second dose than after the first dose. The potential side effects of the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines are the same.

However, it’s now worth noting that the Johnson & Johnson vaccine comes with a very small risk of thrombosis with thrombocytopenia syndrome, which has happened in less than one in a million people—all women—who received the Johnson & Johnson vaccine.

And on July 12, the Food and Drug Administration (FDA) added a warning to the J&J vaccine, linking it to a very small incidence of the rare nerve complication Guillain-Barré syndrome.

The long-term side effects of the vaccines are unknown. That said, the risk of severe side effects such as heart issues is low. “Statistically, one in a million people will have serious vaccine side effects,” says Malaty Rivera. “The general burden of the disease far outweighs the potential risks of the vaccine.”

What is going on with the Johnson & Johnson vaccine?

The FDA announced on July 12 that the Johnson & Johnson vaccine will now carry a warning that it comes with a risk of Guillain-Barré syndrome, a rare autoimmune disorder where a person’s own immune system damages their nerves. Guillain-Barré syndrome can cause muscle weakness and sometimes paralysis, according to the Centers for Disease Control and Prevention.

Symptoms can last anywhere from a few weeks to several years and, while most people fully recover, some have permanent nerve damage or even die from the condition, the CDC says.

“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” the updated fact sheet for the Johnson & Johnson vaccine now reads.

“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.”

Dr. Adalja points out that Guillain-Barré syndrome is a known—and rare—risk factor in several vaccines, not just the COVID-19 vaccine. There’s “no specific ingredient” in the Johnson & Johnson vaccine that’s been flagged as problematic, Dr. Adalja says, “but it could be related to the adenovirus vector.” Similar cases also happened with the AstraZenca vaccine (which is not authorized for use in the U.S.), he points out.

Will I need to get a booster shot after I’m vaccinated?

The CEO of Pfizer, Albert Bourla, announced on April 15 that people will "likely" need to get a third dose of Pfizer/BioNTech's COVID-19 vaccine in the next 12 months.

"There will be likely a need for a third dose somewhere between six and 12 months and then from there would be an annual revaccination," Bourla said, as reported by CNBC.

Pfizer’s vaccine is not the only one that may require a booster. Moderna has also been monitoring those vaccinated with their vaccine and found that its vaccine maintained its effectiveness after six months. Moderna said on Tuesday, April 14, that the vaccine (which was found to be 95% effective in initial trials) was 94.5% effective at the six-month mark.

Dr. Anthony Fauci, the nation's top infectious diseases expert, also talked about the possible need for boosters to address COVID-19 variants on Monday, April 12. "We know for sure it's effective for six months and highly likely that it will be effective for considerably longer period of time," he said during an interview with MSNBC's Medhi Hasan. Dr. Fauci added that experts will "determine when that level of efficacy or protection diminishes.”

He also noted that monitoring will be ongoing, and "if it turns out [to last] a year or a year and a half, we very well may need to get booster shots to keep up the level of protection.”

Can vaccinated people transmit the virus?

People are considered fully vaccinated against COVID-19 two weeks after receiving the second dose in a two-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine like Johnson & Johnson.

Fully vaccinated people can now go unmasked almost everywhere inside and outside, according to new CDC guidance released May 13. It's a major step forward that will help reopen offices, schools, and other venues. The new guidance still calls for wearing masks in crowded indoor settings like buses, planes, hospitals, prisons, and homeless shelters. However, unvaccinated people still need to wear a mask at such gatherings.

In an interview on The Rachel Maddow Show, CDC director Dr. Rochelle P. Walensky stated that fully vaccinated individuals did not appear to transmit the virus to others. "Vaccinated people do not carry the virus, don't get sick, and that is not just in the clinical trials but it's also in real-world data," she said.

Will the COVID-19 vaccine be mandatory?

In general, vaccines can’t be mandated by the federal government; however, states and cities have the authority to regulate public health and they’ve mandated vaccines in the past.

The only people who may be required to get the vaccine are healthcare workers, which isn’t unusual. Hospitals frequently make staff get the flu or hepatitis B vaccine. Schools may make the same requirement. “There are vaccine requirements for school because you’re putting yourself in a public setting where there may be other people who are medically fragile,” explains Malaty Rivera. “Also: School is something you can do on your own if you don’t agree with the protocol.”

You may have heard rumors that companies like Ticketmaster or even your own employer could make the COVID-19 mandatory, but these claims are untrue. “No vaccines are mandatory for adults,” says Adalji. “There may be some employers who want that to be the case but it will be hard to do.”

What will life look like once you're vaccinated?

If you can't wait to resume your pre-COVID social life, the recently updated CDC guidelines for fully vaccinated people are certainly something to feel hopeful about.

Per the CDC, fully vaccinated individuals can now feel free to:

Resume indoor and outdoor activities without wearing a mask even in crowded settings and in most venues.

Visit with other vaccinated folks indoors (no masks or distancing required!).

If you travel in the United States, you do not need to get tested before or after travel or self-quarantine after travel.

Skip out on quarantining or testing after being exposed to someone with COVID-19 (as long as they remain asymptomatic).

However, there are still a few things that all of us need to do to stay safe (yes, including fully vaccinated people). These include:

High-risk individuals should consult their physician before shedding their masks.

Wearing a mask on planes, buses, trains, and other forms of public transportation as well as in hospitals and prisons.

Getting tested if experiencing COVID-19 symptoms.

Following guidance issued by individual employers.

Following travel guidelines and recommendations.

The F.D.A. Just Issued A New Warning For The J&J COVID-19 Vaccine