9 COVID-19 vaccine updates: FDA approvals, boosters for kids 5+ and more
We've compiled all recent vaccine developments in one place. A quick summary:
- Adults 50 years and older may get a fourth dose (second booster) of either Pfizer or Moderna vaccine
- COVID-19 vaccines for kids younger than 5 years are currently under FDA review. However, COVID-19 vaccines for kids 5 and up are FDA authorized, safe and effective
- Moderna vaccine is U.S. Food and Drug Administration (FDA) approved, along with the Pfizer vaccine
- To best protect yourself against COVID-19 complications, get your booster. A booster offers the best protection against omicron subvariant BA.2
"Getting more people who are 50 and older this additional booster dose will be a huge help in reducing hospitalization and death from the next COVID wave," says infectious diseases expert James Lawler, MD, MPH. "A booster gives you the best protection against omicron."
1. Second booster (fourth dose) authorized for 50 years and up
People 50 and older can now get a fourth dose of the COVID-19 vaccine, as of March 29.
Both the U.S. Food & Drug Administration and Centers for Disease Control and Prevention authorized a second booster of mRNA vaccines (Pfizer or Moderna) for people 50 years and up.
Older adults have a higher overall risk from COVID-19. People who are 55 and up account for 89.9% of COVID-19 deaths in Douglas County. A COVID-19 booster gives you additional protection against severe COVID-19 outcomes. Schedule your COVID-19 booster vaccine today.
2. Moderna vaccine gets FDA approval
In January 2022, the FDA fully approved the Moderna COVID-19 vaccine. Now there are two COVID-19 vaccines with full FDA approval: Moderna (ages 18 and up) and Pfizer (fully approved for ages 16 and up). Johnson & Johnson remains under emergency use authorization (EUA).
Moderna branded their FDA-approved vaccine with the name Spikevax. Spikevax and the Moderna vaccine have the exact same formulation and can be used interchangeably.
(Note: In August 2021, Pfizer branded their COVID-19 vaccine to the new name Comirnaty after the FDA approved the vaccine. Pfizer's EUA vaccine is biologically and chemically identical to the Comirnaty vaccine.)
3. How long between Moderna and Pfizer vaccines?
How long after the first mRNA COVID-19 shot can you get the second shot? The Centers for Disease Control and Prevention (CDC) updated their guidance. The CDC says a longer 8-week interval may be optimal especially for males ages 12 to 39 years. This scientific report explains the rationale behind the change.
While most people can follow the original guidelines of three weeks for Pfizer and four weeks for Moderna, others may benefit from a longer waiting period. Check with your primary care provider if you're not sure which interval is best for you.
4. Vaccine for kids under 5 waiting for FDA authorization
Moderna completed their phase 2/3 study for children 6 months to under 6. The press release (which is not peer-reviewed) claims that Moderna's pediatric vaccine can prevent symptomatic COVID-19 and is safe for kids. Moderna's two-dose primary series for children uses a dosage that's a quarter of the adult vaccine's dosage.
Moderna has submitted the data to the FDA, which may authorize the vaccine for kids if it's found safe and effective.
Pfizer's vaccine for children 6 months to 4 years is also awaiting FDA authorization. The dose is 3 mcg (which is 1/10th the dose for adults). There are two doses in the primary series.
5. Vaccines for children ages 5 and up available now
Children ages 5 to 11 can get vaccinated today. The Pfizer COVID-19 vaccine for children is over 90% effective at preventing COVID-19 in children ages 5 through 11 years. It's a two-dose primary series formulated especially for children. The lower dosage (compared to adults) is based on age, not weight.
On April 22, 2022, Moderna announced that it was submitting an application for Emergency Use Authorization for use of their COVID vaccine in children from 6 months through 5 years. With that submission, Moderna will have EUA applications under consideration by the FDA for all children down to 6 months of age.
Teens ages 12 to 17 years old can also get vaccinated with the adult Pfizer vaccine. Teens should receive their Pfizer booster shot at least 5 months after completing their Pfizer COVID-19 primary series.
As of May 19, 2022, the CDC recommends children ages 5 through 11 years receive a booster shot 5 months after their initial Pfizer vaccine. Moderna is currently studying third doses of vaccines (boosters) in children of all ages.
6. Fifth doses (second booster) for immunocompromised now available
Severe COVID-19 is a higher risk for people with weakened immune systems. As with all vaccines, you'll be best protected when you're up to date on the COVID-19 vaccination. If you're immunocompromised and at least 12 years old, you may receive a total of five doses of the COVID-19 vaccine. You can schedule your booster dose here.
It's a bit confusing, but a primary series for someone who is immunocompromised is defined as three doses. For other people, a primary series is only two doses. See the CDC's recommended vaccine schedule for people who are immunocompromised.
7. Omicron-specific vaccines in testing
Pfizer, Moderna and Johnson & Johnson are all currently testing omicron-specific vaccines. However, studies continue to show that the current vaccines developed against the original virus from early 2020 continue to perform well, although immunity wanes over time. Studies have yet to show a considerable advantage for vaccines derived from more recent variants.
8. Novavax vaccine waiting for FDA authorization
Another COVID-19 vaccine candidate, created by Novavax, is awaiting the FDA's decision. Instead of an mRNA vaccine (Pfizer, Moderna) or a viral vector vaccine (Johnson & Johnson), Novavax is a subunit protein vaccine.
The World Health Organization listed the Novavax vaccine for emergency use in December 2021. Since then, several countries have rolled out this vaccine, including Australia, Bangladesh, Canada, Great Britain, India, Indonesia, New Zealand, the Philippines and South Korea.
In the U.S., Novavax must be authorized for emergency use by the FDA before people can receive the shot. The FDA is currently reviewing the Novavax vaccine data.
9. Everyone ages 5 and up needs a booster
To be considered up to date, everyone 5 and up needs a booster. Boosters (third doses) are free to everyone living in the U.S.
Why is a booster necessary? Moderna and Pfizer's FDA-approved vaccines were created for the original COVID-19 strain in 2020. The incredible 94% and higher vaccine efficacy seen in the 2020 clinical trials tested vaccines against the original COVID-19 strain. As the virus mutates, the 2020 vaccines may be less effective. In fact, vaccine efficacy against the omicron variant is lower than for previous variants. It is also true that even without changes in virus variants, immunity from these vaccines decrease over time.
Data shows three doses are more effective than two against the omicron variant. That's why it's important to stay up to date with recommended COVID-19 vaccinations.
Per the CDC:
- Fully vaccinated means a person has received all recommended doses in their primary series of COVID-19 vaccine
- Up to date means a person has received all recommended doses in their primary series COVID-19 vaccine, and a booster dose when eligible
Schedule your COVID-19 booster vaccine today.
I have already been infected with COVID-19. Why do I need to get the vaccine?
Studies continue to demonstrate that immunity from prior infection (also called "natural immunity") decreases over time and may be significantly reduced when a person encounters a COVID-19 variant different from the one that caused their infection. Studies have shown that persons with documented prior infections and who also received the COVID vaccine have significantly more protection against COVID-19.
A recent study showed that person with previous infection but no vaccination had a higher rate of hospitalization from Omicron than persons who had previous infection plus vaccination.