Everything Parents Need to Know About the COVID-19 Vaccines

Learn about the COVID-19 vaccines available in the U.S. along with information about safety concerns and health updates—all in one place.

To date, three COVID-19 vaccines have rolled out in the U.S. The Pfizer-BioNTech COVID-19 vaccine is authorized for everyone ages 6 months and up—and the vaccine, now being marketed as Comirnaty, has full approval from the Food and Drug Administration (FDA) for those 16 and older. Moderna (now being marketed as Spikevax) can be given to kids 6 months and up under emergency use; adults 18 and older have full approval. Finally, Johnson & Johnson/Janssen COVID-19 vaccines can be given to anyone 18 and older. All available vaccines have been shown to reduce the risk of severe illness, hospitalization, and death from COVID-19.

On July 13, 2022, a COVID-19 vaccine from Novavax (a Maryland-based biotechnology company) received approval from the FDA after two years of manufacturing delays. The Centers for Disease Control and Prevention (CDC) must now meet to discuss the vaccine option. If the CDC recommends the Novavax vaccine, it can be given as a primary shot (instead of a booster) for those 18 years and older. Novavax requires two doses given three weeks apart, and it relies on "nanoparticles made up of proteins from the surface of the coronavirus that causes Covid-19," says The New York Times. This is different than Pfizer and Moderna, which use mRNA technology.

With all of the ongoing vaccine news, many parents are wondering what vaccines mean for their families. Here is the latest on vaccine development, safety concerns, what to expect once you've been fully vaccinated, and everything you need to know about COVID-19 vaccines.

Vaccine Safety and Regulations

The FDA has strict regulations that must be met before a vaccine can be distributed to the general public. To ensure the safety and effectiveness of a vaccine, it must go through three phases of clinical trial:

  • Phase 1: Early stage clinical trials on 20–100 healthy volunteers to test the safety profile, dose effects, and any adverse effects. If no serious side effects are discovered, the vaccine can move to phase 2.
  • Phase 2: Testing on hundreds of volunteers to determine any short-term side effects or dose effects on different categories of people. If deemed safe, the vaccine can move on to final trials.
  • Phase 3: Hundreds to thousands of volunteers are tested to evaluate the vaccine's effectiveness. This is where the FDA discovers if the vaccine prevents disease when compared to a placebo test and allows researchers to learn more about its safety and any common side effects.

Once this rigorous testing is complete and a vaccine is distributed to the public, phase 4—where the widespread effectiveness or long-term effects are tested on a greater population—will begin. To be considered effective, the FDA says that a vaccine should protect at least 50 percent of recipients.

"This unprecedented period has called for innovation, speed, and efficiency in vaccine production," says Mobola Kukoyi, M.D., MPH, an emergency physician at Carle Foundation Hospital in Urbana, Illinois who has seen both pediatric and adult COVID-19 cases in the emergency room. "Understandably, this comes with a concern for safety. However, given the different regulatory checkpoints in the phases outlined above, a product is only approved if it meets specific guidelines. My advice to all would be to follow the science."

The Vaccines Available in the US

With dozens of vaccines under development worldwide, a handful have shown promise and three are available in the U.S. either under emergency use authorization (EUA) or with full FDA approval. These are the ones to know about:

1. Pfizer-BioNTech (Comirnaty)

Pfizer—working with German company BioNTech and Chinese drugmaker Fosun Pharma—developed a COVID-19 vaccine that was approved for emergency use in the U.S. for people 16 years of age and older in December 2020.

In August 2021, it became the first COVID-19 vaccine to receive full FDA approval in America, after which it began to be marketed under the brand name Comirnaty. The full approval applies to use in people 16 years and up.

In May 2021, the EUA for the Pfizer vaccine was expanded to include children ages 12 to 15, and in October 2021, the FDA authorized the vaccine for use in children ages 5 to 11. Finally, in June 2022, kids ages 6 months through 4 years old got the go-ahead to get vaccinated with three doses of Pfizer. All groups receive a lower dose of the vaccine.

The Pfizer vaccine was the first vaccine authorized for use in children under the age of 18 in the U.S., and it remains available to those ages 6 months to 15 years old under EUA; it has not yet received full FDA approval for this age group.

The Pfizer-BioNTech vaccine is also authorized for use as a booster dose for certain people who have completed primary vaccination with the Pfizer vaccine or another COVID-19 vaccine.

2. Moderna (Spikevax)

Partnering with the National Institute of Allergy and Infectious Diseases (NAIAD), Moderna, a biotech company in Cambridge, Massachusetts, created the first vaccine to reach phase 3 testing. In December 2020, Moderna became the second drugmaker to receive emergency use authorization from the FDA for rollout to people ages 18 and up.

The Moderna vaccine then received full FDA approval for use in people 18 and older in January 2022, after which the company began marketing it under the brand name Spikevax. After receiving the initial emergency approval in 2020, Moderna started enrolling kids 6 months and older in clinical trials. In June 2022, children ages 6 months through 5 years old got approval for two low doses of Moderna's vaccine—and this was followed by approval for those ages 6 to 17. Note that those 12 and up get the same dosage as adults.

The Moderna vaccine is also authorized for use as a booster dose for people over 18 who have completed primary vaccination with the Moderna vaccine or another COVID-19 vaccine.

3. Johnson & Johnson/Janssen

In February 2021, the single-dose Johnson & Johnson (J&J)/Janssen COVID-19 vaccine was approved for emergency use authorization from the FDA for adults 18 years and older.

In April 2021, use of the Johnson & Johnson vaccine was temporarily paused after several women developed blood clots. Nearly 7 million people had received the vaccine in the U.S. at that time, and the FDA and CDC called for this pause out of an abundance of caution. After looking into the blood clot cases, use of the vaccine was restarted with a warning label about the rare clotting disorder. As of December 2021, nine people have died from these rare blood clots.

In July 2021, the FDA attached a different warning to the Johnson & Johnson vaccine, saying it could cause an increased risk of a neurological condition called Guillain-Barré syndrome. In May 2022, the FDA limited the use of the Johnson & Johnson vaccine to people 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or appropriate citing the risk of a rare but serious blood clot syndrome known as thrombosis with thrombocytopenia syndrome (TTS). The CDC also now recommends the Pfizer or Moderna vaccines over the Johnson & Johnson vaccine for most people.

4. Novavax

On July 13, the FDA approved a COVID-19 vaccine from Novavax (a Maryland-based biotechnology company. CDC advisors must now approve the shot; the organization is meeting next week to discuss it. If approved, Novavax will be given as a primary vaccine series, and the company has plans for boosters and pediatric vaccines in the future.

Although the Novavax vaccine received significant federal funding ($1.8 billion), it experienced manufacturing problems during its two-year development stage, which has delayed its release, according to The New York Times. It's already widely available in Europe. Early clinical trial data showed high effectiveness; however, the data was compiled before the Omicron variant.

The Novavax vaccine is protein-based, meaning it doesn't use mRNA technology like Pfizer and Moderna. This might appeal to vaccine-hesitant individuals who prefer a more conventional technology. The Biden Administration has already secured 3.2 million doses of Novavax.

FAQs

Did testing move too fast?

"The speed at which this vaccine was brought to market was unprecedented," says Kevin Kathrotia, M.D., neonatologist and COO of Millennium Neonatology in Charlotte, North Carolina who has cared for babies whose birth parents have tested positive for COVID-19. "This is a testament to the herculean effort of scientists and doctors at multiple companies, research facilities, and some of the world's greatest universities."

And while things are moving faster than usual—it usually takes years to develop and get approval for a vaccine, and COVID-19 vaccines were set to be distributed within 24 hours of FDA authorization—Dr. Kathrotia says that we should trust the clinical trial process and the fact that a drug is only brought to market if the FDA considered it safe and effective based on the clinical trial data. Although the COVID-19 vaccines are new, the CDC notes that "research and development on vaccines like the COVID-19 vaccines have been underway for decades."

Who should get a COVID-19 vaccine?

After undergoing a strategic rollout to the public—with doses available first to health care workers, high-risk adults, and residents of long-term care facilities—states began broadening eligibility. Now all Americans age 6 months and up are eligible to receive a COVID-19 vaccine. Parents can rest assured that vaccines authorized and approved by the FDA are safe.

Is it safe for pregnant people?

Organizations like the CDC and the American College of Obstetricians and Gynecologists (ACOG) recommend that pregnant people receive the COVID-19 vaccine, as the benefits of vaccination outweigh any possible risks.

More good news: There have been reports of babies born with coronavirus neutralizing antibodies after their birth parent received the vaccine during pregnancy. Early studies also point to protective antibodies being passed through the breast milk of those who have been vaccinated.

Is it safe for people with allergies?

Early Pfizer vaccine distribution in the U.K. sparked warnings that those with severe allergies should not receive the vaccine, but Americans with allergies have received the OK to get it—though they'll have to discuss with their doctors first and be monitored following vaccination.

"People that do report those types of anaphylactic reactions to other vaccines or injectables—they can still get the vaccine, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefit of vaccination," says Sarah Mbaeyi, a medical officer with the CDC's National Center for Immunization and Respiratory Diseases.

If you or your child have a history of allergic reactions, you should speak with your doctor before getting vaccinated.

How will I know if my family should get the COVID-19 vaccine?

According to the CDC, getting vaccinated may keep you from becoming seriously ill if you get COVID-19. It may also keep those around you from becoming sick. Health experts agree that families should let the vaccine data speak for itself. The FDA and government officials will share ongoing vaccination guidance, but you should check with local health officials and your doctor about your family's vaccine plan.

Note: The CDC has reported rare cases of myocarditis and pericarditis (inflammation of the heart) in people under 30 years old who received either the Pfizer or Moderna vaccine. Most cases—which come with symptoms like heart palpitations, chest pain, and shortness of breath—have occurred in males after their second dose in the initial two-dose series, and they usually resolve with treatment. The CDC is investigating further, and the FDA urged an expansion of pediatric trials to further evaluate this rare side effect, but the organizations still recommend that everyone 6 months and up get vaccinated.

What's the deal with booster shots?

As new variants spread across America, experts began seeing waning immunity from the COVID-19 vaccines. That's why booster shots have been approved for anyone 5 years and older.

If you received the two-shot series of the Pfizer or Moderna vaccine, you can get a booster five months after completing your primary vaccination series, as long as you're older than 5 years, according to the CDC. If you received the single-shot Johnson & Johnson, it's recommended that you get a booster at least 2 months after your initial shot.

Additionally, certain groups are eligible for two boosters, including:

  • Adults aged 50 years or older
  • People aged 12 years or older who are immunocompromised
  • People who received two doses (one primary and one booster) of the J&J vaccine

So which booster shot should you get? "You may choose which COVID-19 vaccine you receive as a booster shot," says the CDC. "Some people may prefer the vaccine type that they originally received, and others may prefer to get a different booster. CDC's recommendations now allow for this type of mix and match dosing for booster shots."

OK, I'm vaccinated—now what?

Finally, some good news: The CDC suggests that people who have been fully vaccinated can start to safely enjoy some of the things they've put on hold during the pandemic. And can do so with less worry about severe illness, hospitalization, or death related to COVID-19.

You're considered fully vaccinated two weeks after receiving the second dose of the Pfizer or Moderna vaccines or two weeks after receiving the single shot from Johnson & Johnson. You're considered up-to-date with COVID-19 vaccines after you have also received a booster when you become eligible.

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