Researchers around the world have been working at record speed to develop vaccines to combat COVID-19. Less than a year after the start of the pandemic, that goal is now a reality. Three vaccines — one from Moderna, another from Pfizer-BioNTech and a third from Johnson & Johnson — are now being distributed in the U.S.
All three vaccines received an emergency use authorization (EUA) from the FDA. An EUA is a green light, of sorts. It is not the same as official approval.
During a public health emergency, such as the coronavirus pandemic, the FDA can authorize in a timely manner previously unapproved medical products to diagnose, treat or prevent the illness of concern when there are no other approved or available alternatives. The EUA process is faster than standard FDA approval, which can take six to 10 months. However, data proving safety and effectiveness are still required for authorization, and the FDA and an advisory committee of experts use this data to weigh the risks and benefits of the product in question.
What, exactly, is a vaccine?
A vaccine is something that helps a person build up immunity to an infectious disease. It works by intentionally introducing the body to an inactive form of a disease-causing germ, or something similar to it. This then stimulates the immune system’s production of antibodies, the proteins that help to protect the person from a future infection if he ever comes across the real germ.
Think of it like a workout for your immune system: You’re “sending it to the gym and preparing it to be able to do something when it encounters the real thing in the future,” says Tony Moody, associate professor of pediatrics and immunology at Duke University School of Medicine and a principal investigator at the Duke Human Vaccine Institute. “Essentially, what a vaccine is doing is teaching the immune system how to handle something before you actually encounter the real thing — so that, hopefully, when you do encounter the real thing, you’re able to deal with it quickly and get rid of it.”
In the case of the new coronavirus, a vaccine makes a person resistant to an infection from the virus and the illness it causes — COVID-19 — or, at least, enables a person who becomes infected to have “a shorter course [of disease] or not as many complications,” Moody adds.
What coronavirus vaccines are available now?
The three vaccines that have received EUAs - Pfizer-BioNTech, Moderna and Johnson & Johnson - are so far the only products available to Americans.
Pfizer’s vaccine was given emergency authorization by the FDA for use in people 16-years-old and older, making it the first coronavirus vaccine available to the American public.
Moderna and J&J's vaccines have now been authorized for people 18 and older.
The three vaccines have been found to be highly effective at preventing COVID-19 in clinical trial participants. Pfizer-BioNTech's two-dose vaccine is about 95 percent effective against COVID-19, regardless of age, race or other risks for severe illness from an infection, an FDA analysis shows. And Moderna’s proved to be about 94.5 percent effective against COVID-19 in people of all ages, genders and ethnicities. J&J’s product has been found to be 66 percent effective overall and 72 percent effective in the United States.
Are the vaccines safe?
Safety is a key concern among health officials and experts. Participants in the Pfizer-BioNTech, Moderna and Johnson & Johnson trials experienced side effects after vaccination, including injection-site pain, fever, chills, headaches, muscle aches and joint pain. These symptoms are temporary and are in line with side effects some people experience from other vaccines, including the flu shot and the vaccine to prevent shingles.
More serious reactions are rarer, but they do occur. On April 13, the CDC and FDA recommended that U.S. vaccination sites pause their use of the Johnson & Johnson vaccine while the agencies review data involving six reported cases of a rare but serious type of blood clot, called cerebral venous sinus thrombosis, in individuals after they received the vaccine. One case was fatal and one patient is in critical condition.
All six cases occurred in women between the ages of 18 and 48, six to 13 days after vaccination. People who recently received the Johnson & Johnson vaccine and develop symptoms of severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider, officials say.
Also, providers should be on the lookout for patients who present with these symptoms and be advised that “treatment of this specific type of blood clot is different from the treatment that might typically be administered,” according to a joint statement from the CDC and FDA. “Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”
On April 23, CDC’s Advisory Committee on Immunization Practices (ACIP) recommended to the CDC director that the pause be lifted. A notice to women age 50 and under would be added to the fact sheets the government provides to people getting vaccinated.
To date, no cases of cerebral venous sinus thrombosis have been linked to the Moderna and Pfizer-BioNTech vaccines. However, a small number of allergic reactions, including anaphylaxis, have been reported, according to early safety monitoring data from the CDC. Though an anaphylactic reaction is potentially life-threatening, it can be quickly halted as it was in these six cases, with medicines such as epinephrine. Because of this, the CDC is recommending that anyone who has ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine abstain from receiving it. If you have a history of severe allergic reactions to other vaccines, ask your doctor if you should get a COVID-19 vaccine, the agency advises.
After a vaccine is authorized, many vaccine safety monitoring systems watch for adverse events, according to the CDC. If one is discovered, “experts quickly study it further to assess whether it is a true safety concern” and then adjust vaccine recommendations as needed, the agency explains.
How are the vaccines being distributed?
The federal government is overseeing the distribution and tracking of coronavirus vaccines in the U.S., but state and local officials are prioritizing who gets the vaccine in their jurisdictions. The government is also partnering with private companies to ensure high-risk individuals can easily access a vaccine. Some states have started to open up vaccines to younger Americans, and the president says all American adults will be eligible for a vaccine beginning April 19.
Officials predict it will take several months to vaccinate everyone who wants a vaccine, even as production ramps up and more vaccine candidates clear authorization.
There are logistical considerations, including the need to ensure proper transportation and storage for the vaccines. Both the Pfizer and the Moderna vaccines require cold storage at specific temperatures, but the J&J vaccine is able to be shipped and stored at conventional refrigeration temperatures.
How much does the vaccine cost?
The federal government pre-purchased hundreds of millions of vaccine doses with taxpayer money, and Americans will not have to pay to receive them.
Vaccine providers are able to charge an administration fee for giving the shot, but this fee should be covered by public or private insurance, or by a government relief fund for the uninsured.
Can I still get COVID-19 after getting the vaccine?
A few cases of infection post-vaccine, called breakthrough cases, have been documented but are rare. “We see this with all vaccines in clinical trials. And in the real world, no vaccine is 100 percent efficacious or effective, which means that you will always see breakthrough infections regardless of the efficacy of your vaccine,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, explained in an April 12 briefing.
Breakthrough cases can happen when the body “doesn’t amount an adequate immune response,” or if immunity fades over time, Fauci explained. A vaccine may also fail if a person is exposed to a new or different variant.
“That’s something that the recipients will have to understand when they get the vaccine,” says William Schaffner, an infectious disease specialist and professor of preventive medicine at the Vanderbilt University School of Medicine. “The vaccine provides protection, but it won’t be like a suit of armor.”
Schaffner’s main message: Just because you roll up your sleeve and get the shot doesn’t mean you can throw away your mask and disregard other prevention efforts such as social distancing and handwashing. Those will be crucial “for quite some time” in order to get control over the virus, Schaffner says.
Are both doses really necessary?
Both the Pfizer-BioNTech and Moderna vaccines require two doses and following through with both doses is necessary to ensure effectiveness. The J&J vaccine only requires one dose.
According to the CDC, the first shot starts building protection, while the second shot “is needed to get the most protection the vaccine has to offer.”
Do I need the vaccine if I have already had COVID-19?
The verdict is still out when it comes to how long you are protected from COVID-19 after a previous infection — what's referred to as natural immunity. In fact, “early evidence suggests natural immunity from COVID-19 may not last very long,” the CDC explains. Because of this, “people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before,” the agency states.
Health officials will keep the public informed of any developments and recommendations as more is learned about the duration of natural immunity.
Is it good to have more than one vaccine available?
Absolutely. “In fact, it’s highly desirable,” Schaffner says, because that would mean “there would be more vaccine manufacturers working to actually produce the vaccine, and so we could more expeditiously try to vaccinate the population in the United States and beyond.”
Kathleen Neuzil, M.D., professor in vaccinology and director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, echoes Schaffner’s sentiment and points to the flu vaccine for comparison: There are multiple formulations on the market, including the injectable high-dose vaccine and the nasal spray vaccine, for example, which are recommended for different populations.
“We really need every person on Earth, theoretically, to be able to receive this vaccine. So, to me, [having more than one option] is a positive, because we need so much,” she adds.
Editor’s note: This article, originally published May 1, has been updated to reflect new information.