April 29: An official at the Food and Drug Administration (FDA) has shared that at least one of the two vaccine options for kids under age 5 could be available in June, meaning getting shots in arms for our youngest population could be just over one month away.
The news follows yesterday's announcement that Moderna has applied to the FDA for emergency use authorization (EUA) for its vaccine for kids ages 6 months to 6 years. Pfizer and BioNTech are expected to apply for authorization for a three-shot formula for kids under 5 in the coming weeks.
The agency has announced that it is holding the dates of June 8, June 21 and June 22 for meetings of its advisory committee to review the EUA applications.
The agency is under some pressure to move swiftly in its review without sacrificing rigor. The Washington Post reports that the agency understands the urgent need for vaccines for this age group, and that once complete data has been submitted, it will take action quickly, given that the data supports authorization.
When asked about the potential of overlapping reviews, The Post reports that Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, shared in an interview that the FDA would not delay progress on either vaccine to wait for the other, saying that the applications would each be considered as soon as they are ready.
Moderna asks FDA to authorize its pediatric vaccine
April 28: More than a month since Moderna announced its pediatric vaccine had trial reached an endpoint, the company has officially asked the Food and Drug Administration (FDA) to authorize its vaccine for kids ages 6 months to 6 years for emergency use.
The company says it has also asked the FDA for authorization of its vaccines for kids ages 6 to 11 and 12 to 18 and will submit more data on those age groups in the coming weeks.
At this time, the Pfizer-BioNTech Covid vaccine is the only one authorized for kids ages 5 and up, meaning that parents of kids under age 5 will hopefully have the ability to vaccinate their kids against the virus soon.
Moderna says that their vaccine for the 6 months to 6 years age group will be one-fourth the dosage of its adult vaccine, at 25 micrograms in two shots. In clinical trials, newly analyzed data show the vaccine was found to be 51% effective in preventing illness in kids ages 6 months to 2 years, and 37% effective in preventing illness in kids 2 to 5 years old.
The efficacy rates are relatively low compared to what we've seen in previous pediatric trials with the Pfizer vaccine, but the Moderna trials were conducted at the height of the Omicron surge, which was better able to skirt the body's defenses than previous variants, says Dr. Paul Burton, Moderna’s chief medical officer.
New data from the Centers for Disease Control and Prevention (CDC) released this week suggests that 75% of kids and teens have some evidence of virus antibodies at this point in the pandemic. But it's not currently known how long antibody protection will last, making vaccines still necessary to reduce the risk of infection—or reinfection. Boosters may also be part of the picture.
“We continue to believe those who are vaccinated and especially those who are boosted continue to have strong protection against severe disease even from BA.2.12.1,” says CDC Director Rochelle Walensky, MD, MPH.
Complete data is expected to be submitted to the FDA by May 9. The timeline for FDA authorization is still somewhat unclear, though experts say they believe the agency will move quickly while still providing a rigorous review, given the need for a vaccine for young kids.
“It’s difficult to put an exact timeline, but I believe they recognize there is an unmet need here. I think they’ll try and move quickly,” says Dr. Burton in an interview.
Moderna has announced it will seek FDA authorization of its vaccine for kids ages 6 months to 6 years
March 23: Moderna says it will seek approval from the Food and Drug Administration (FDA) for a low-dose pediatric Covid vaccine for kids ages 6 months to under 6 years. The company aims to apply for the FDA's emergency use authorization now that their pediatric trial has reached an endpoint, the company shares.
This news is keeping with the previously announced timeline for Moderna's pediatric vaccine, and if authorized, things could move quickly from here on out, meaning that shots may be available for our youngest population as soon as next month.
For parents who were floored by the FDA's recent reversal of its decision to authorize the Pfizer vaccine for kids ages 2 to 5, Moderna's news may provide a sense of relief.
That said, the Moderna vaccine's effectiveness is relatively low. In kids 6 months to 2 years, the vaccine showed an efficacy rate of 43.7%, and in kids 2 years to 6 years, an efficacy rate of 37.5.%. The Moderna trial looked at 6,700 kids who were given a two-dose regimen of 25 micrograms (mcg) each, which is 25% of the dosage of the company's adult vaccine. Moderna is currently studying the effectiveness of a booster shot in this age group, which the company says will be necessary to improve efficacy in the long term.
It's important to remember that the goal of vaccination is to protect against severe disease and hospitalization—and no severe cases of Covid were reported in the clinical trial. Though the results are still positive, they are consistent with the Omicron strain's ability to get past vaccine defenses. Results of the trial are consistent with the breakthrough cases seen with Omicron in adults and with the real-world data from the Pfizer vaccine in kids 5 to 12, which showed that vaccine protection dropped off after just a one month.
“What I will say is 37.5% and 43.7% are higher than zero,” says Dr. Jacqueline Miller, the firm’s senior vice president for infectious diseases, in The New York Times. “If I were the parent of a young child, I would want there to be some protection on board, especially if we see another wave of infections.”
The newest variant, BA.2, which is more contagious than Omicron, is poised to soon become the dominant strain. We could see another uptick in cases in the coming weeks.
In the clinical trial, adverse events after vaccination were mild or moderate, the company says, and more commonly seen after the second dose, given 28 days after the first. The most common side effect of the vaccine was fever over 100.4º, seen in 17% of kids in the 6 months to 2 years age group, and 14.6% in the 2 years to 6 years group. There were no signs of myocarditis.
FDA reverses course, postpones decision to authorize Pfizer's 2-dose vaccine for kids under 5
February 11: In a late-stage reversal, the Food and Drug Administration (FDA) has decided to postpone the advisory committee meeting set for Tuesday, Feb. 15, that would have reviewed study data and a potential authorization request for Pfizer's 2-dose vaccine for kids under age 5.
The agency had previously approached Pfizer-BioNTech (an unusual course of action) to apply for authorization for a 2-dose shot protocol even as the companies were undergoing clinical trials for a third dose.
But on Friday, the FDA released a statement saying it was notified by Pfizer that new data have emerged as part of its rolling submission of data from Pfizer's ongoing clinical trial on use of a third dose in the under-4 age group.
"Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the FDA announced.
A new advisory committee meeting has yet to be set, but a press release from Pfizer states that the company should have data on the third dose to present to the FDA again in April.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen," states Pfizer in the press release.
This new turn of events adds another two-month delay at minimum to vaccine distribution for the only population group that is still ineligible for the shots. The FDA's decision to stagger authorization, though unusual, would have at least offered partial protection for kids under 4.
Though Omicron cases are slowing down, another delay leaves our youngest kids unprotected against the rise of a new potential variant. And while the risk of severe disease from Covid in young children remains low, the most current state-level data from The American Academy of Pediatrics (AAP) shows that more than 12 million children under 18 have been infected. Nearly 400 kids under age 4 have died from Covid infection.
As we wait for more results, the FDA offers a note of assurance, stating that it will review all new data carefully, and will only authorize a vaccine if the data support both effectiveness and safety.
"The agency will ensure the data support effectiveness and safety before authorizing a COVID-19 vaccine for use in our youngest children. In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caregivers to get vaccinated or receive a booster dose when eligible," the agency says.
Pfizer asks FDA to authorize a 2-dose vaccine for kids under 5
February 2: Pfizer asked the Food and Drug Administration (FDA) on Tues., Feb. 1 to authorize its vaccine for kids under age 5 for emergency use. The company has applied for approval for their vaccine as a two-dose regimen, even as they continue to study the effectiveness of a three-dose regimen in kids ages 6 months to 4 years.
In December, the company announced that its vaccine for the 2- to 4-year-old age group did not produce a strong enough immune response to adequately defend against Covid. As clinical trials investigating the usage of a third low-dose shot are still underway, the previous timeline for that data was assumed to be sometime in March, putting actual shots-in-arm availability at a date in late spring.
But given the speed and duration of the spread of the Omicron variant, federal regulators "took the unusual approach of encouraging Pfizer to apply for authorization before that research was finished in hopes of protecting more children from the Omicron variant and other mutations that might follow,” reports The Times.
The current timeline puts initial shots in arms in mid-March, as it may take 4 to 6 weeks for the FDA to review the data, and then various advisory committees need to meet before the CDC makes the final decision, says Dr. Katelyn Jetelina in her newsletter Your Local Epidemiologist.
If the Pfizer vaccine is authorized for this age group, kids ages 6 months to 4 years can expect to receive two shots three weeks apart, and a third shot two months later.
The three-dose regimen is what the Centers for Disease Control and Prevention (CDC) already considers fully "up to date" for older kids and adults. Booster shots of the Pfizer vaccine are currently available for kids ages 12 and up.
More than 3.5 million Covid cases in children were reported in January 2022, and 11.4 million children have tested positive since the start of the pandemic, according to The American Academy of Pediatrics (AAP) data. Recent analysis from The Kaiser Family Foundation shows that only 28.1% of children in the 5 to 11 age group have received at least one dose of the Covid vaccine.
Pfizer's Covid vaccine for 2- to 5-year-olds did not produce a strong immune response
December 17: In clinical trial data released on Friday, a 3-microgram dosage of the Pfizer-BioNTech vaccine did not produce an adequate immune response in kids ages 2 to 5 to effectively defend against Covid. The companies announced they will now continue their clinical trials, testing a three-dose vaccine regimen for kids in the 6 months to under 5-years-of age group.
The trial results showed that after two doses of the 3 mcg shot, which is one-tenth of the adult dose, children between the ages of 6 months to 2 years had a robust immune response comparable to that of 16- to 25-year-olds. However, kids between ages 2 and 5 did not mount a similarly strong immune response.
This is certainly a setback for many parents who were hoping for streamlined access to vaccine protection for kids under 5, who are still vulnerable to the virus. Extending the trial could mean that shots may be further out than originally thought. The companies announced that they plan to seek FDA authorization in the first half of 2022.
Rather than testing a higher dose of the vaccine in the 2 to 5 age group, the companies will seek approval for the three-dose regimen, with kids receiving a third shot at least two months after their second shot. Whether kids ages 5 to 11 need a third dose is also being investigated.
Breaking News: Pfizer said its two-shot vaccine didn’t perform adequately in children 2 to 5, and it will test a three-dose series for official authorization. https://t.co/G8NhvNAhz8— The New York Times (@nytimes) December 17, 2021
Why are shots for kids under 5 taking so long?
What’s taking so long? Pediatric trials can happen only after a vaccine is already deemed safe and effective in the lab, then in animals and finally in adults, says Dr. Fataneh Majlessipour, a pediatric oncologist at Cedars-Sinai in a blog post. Pediatric trials are often the last to begin, after vaccines are determined to be safe and effective in adults and older children, and approved by various regulatory agencies.
One factor that has delayed the studies for children under 5 is that it takes time to deduce what dose will be safe and also produce a robust antibody response in younger kids, who tend to have a more powerful immune response in general. Some research points to stronger immune function being connected to the other routine childhood vaccines kids receive from a young age.
The FDA also asked both Pfizer and Moderna to expand their trials in order to account for concerns about myocarditis, a rare type of heart inflammation. In Pfizer’s trials in kids ages 5 to 11, no cases of myocarditis were found in the more than 2200 participants. According to the The American Academy of Pediatrics (AAP), myocarditis risk is 37 times higher in kids with Covid than in kids of the same age who haven’t been infected.
Kids still make up a large portion of Covid cases
Covid cases among children remain high. Kids under 5 are currently the only subset of the population who are still ineligible for vaccination, making them a primary target (along with anyone else who is unvaccinated) for the virus.
The Centers for Disease Control and Prevention (CDC) recently changed its language on booster shots, now recommending them for all people over the age of 12.
How to protect kids under 5 from getting Covid
There are more than 25 million children in the under-5 age group, which accounts for a large portion of the population that’s still highly susceptible to infection.
While we wait for vaccine trials to complete and agency approval to commence, here's what you can do to keep your kids safe:
- Keep up with kids' masking if they’re over 2
- Regular hand-washing
- Practice social distancing
- Avoid public places or large gatherings
- Utilizing frequent testing before and after events and if your child shows any symptoms of the virus.
These are all measures that can help curb the spread of the virus and protect your child. Additionally, keeping your child up to date on their other routine vaccinations and getting a flu shot can also help lend some immune benefits. But the most effective thing you can do? Encourage vaccination and booster shots for any and all teens and adults in your orbit.
A version of this post was originally published on Dec. 1, 2021. It has been updated.