U.S. Calls For Pause Of J&J COVID-19 Vaccine Over Rare Blood Clot Concerns In Women

The Food and Drug Administration and Centers for Disease Control and Prevention surprised the country on Tuesday when the agencies announced that they were recommending a “pause” in the use of the Johnson & Johnson COVID-19 vaccine. Why? The vaccine has been linked to a rare form of blood clots in women.

According to a joint statement from the agencies, there have been six cases of a “rare and severe type of blood clot” called cerebral venous sinus thrombosis (CVST) out of more than 6.8 million doses of the vaccine that have been administered in the U.S. so far.

All six of the cases happened in women between the ages of 18 and 48. They developed symptoms happening six to 13 days after being vaccinated.

The CDC now plans to have a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to review the cases and determine how significant they are. The FDA will also review that analysis. Until that’s complete, the CDC and FDA are “recommending a pause in the use of this vaccine out of an abundance of caution,” the statement says.

There are two more vaccines currently available for use in the U.S.—Moderna and Pfizer/BioNTech—and they use different technology than the Johnson & Johnson vaccine.

But many questions still exist about the COVID-19 vaccines—especially about what life might look like in a post-COVID vaccine world.

Here’s everything we know about the COVID-19 vaccines, their ingredients, and the side effects they may carry:

How many vaccines are available in the United States?

The FDA has authorized three COVID-19 vaccines for emergency use. However, the agency—along with the CDC—just paused the use of one of them.

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. However, this vaccine is currently paused in the U.S. due to concerns about blood clots.

Some states have already leaped into action to ensure people with an appointment for a Johnson & Johnson vaccine will still get some form of the vaccine. In New York, for example, those who are scheduled to receive the Johnson & Johnson vaccine will get a Pfizer vaccine.

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 Centers for Disease Control and Prevention (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.

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.”

Will 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.

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.”

Can vaccinated people transmit the virus?

As COVID-19 vaccines become more widely available to the U.S. population, more and more data is emerging about just how much protection the vaccine offers against the virus.

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.

Since then, the CDC told The New York Times that Dr. Walensky was “speaking broadly.” A spokesperson for the agency clarified: “It’s possible that some people who are fully vaccinated could get COVID-19. The evidence isn’t clear whether they can spread the virus to others. We are continuing to evaluate the evidence.”

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 released CDC guidelines for fully vaccinated people are certainly something to feel hopeful about.

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

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

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