Many are eagerly awaiting the COVID-19 vaccine, especially now that the U.S. Food and Drug Administration approved emergency use authorization for Pfizer’s product late Friday night. While the vaccine will initially be rolled out to high-risk groups of adults, some parents may be wondering when their kids will be able to get vaccinated as well — particularly given the fact that coronavirus vaccine trials in young children have not started yet. Here’s what parents need to know.
What we know about the Pfizer vaccine so far
On Dec. 11, the FDA authorized Pfizer’s COVID-19 vaccine for emergency use. This followed the FDA’s vaccine advisory panel recommendation that the agency approve the Pfizer COVID-19 vaccine and the drugmaker requested emergency use authorization (EUA) at the end of November. EUA helps speed up the FDA approval process during a declared health emergency.
“Based on their recently published data in the New England Journal of Medicine and what was presented at the FDA Vaccines and Related Biological Products Advisory Committee Meeting on Thursday, Dec. 10, the Pfizer vaccine appears to be safe and efficacious for adolescents and adults 16 years of age and older,” Dr. Hayden Schwenk, a pediatric infectious diseases physician at Stanford Children’s Health, tells Yahoo Life. “By efficacious, we mean it appears to reduce the risk of developing symptomatic COVID-19 infection with onset at least seven days following the second dose.”
Schwenk says that the FDA and Centers for Disease Control and Prevention will be meeting over the next several days “to provide further guidance and recommendations, including the use of the vaccine in [younger] populations.”
Pfizer’s (and Moderna’s) vaccine candidate uses messenger RNA to trigger an immune response. Pfizer’s most recent analysis shows that its vaccine is 95 percent effective against the virus. Moderna, which also filed for EUA and is expected to get approval soon, is reporting a 94.5 percent efficacy rate against the virus. Both vaccines required two shots — for Pfizer, the shots are spaced three weeks apart, while Moderna’s are four weeks apart.
The newly approved Pfizer vaccine will be offered first to frontline healthcare workers and the mostly elderly residents living in long-term care facilities, per the CDC. The next groups most likely to follow are essential workers, people 65 and older, and those with health conditions that put them at higher risk for severe COVID-19 illness.
Who is the vaccine safe for?
Pfizer's vaccine candidate has been tested on older adolescents and adult men and women ages 16 and older. (Moderna's has been tested on adults 18 and over). The vaccines haven’t yet been tested on children and pregnant women. According to the CDC, “a COVID-19 vaccine may not be available for young children until more studies are completed.”
Patients who were pregnant, lactating or immunocompromised were not included in the study, “so there is insufficient data to support safety and/or efficacy in these groups,” notes Schwenk.
Dr. Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital, tells Yahoo Life that “testing first in adults” is standard, adding, “We want to make sure the vaccine is safe and it works” before testing younger and more vulnerable groups.
Why vaccine testing in kids has been limited
“It is not uncommon for vaccines to establish safety and efficacy in adults before enrolling children,” explains Schwenk. “Studying the COVID vaccine may be particularly challenging because COVID infection in children is often asymptomatic and, thus, harder to detect.”
Ramilo explains that there are also protocols that are specifically designed for children in studies. “Children are not small adults,” Ramilo tells Yahoo Life. “The liver and kidneys are different in children than adults, and the immune system is different. It’s still growing and developing, and sometimes they haven’t had the same levels of exposure as adults.”
With research showing the COVID-19 vaccine candidates to be safe and effective in adults, drugmakers are now starting to move forward on testing the vaccine in adolescents and children — which the American Academy of Pediatrics has been asking them to do for months. In a Dec. 10 statement, the AAP urged drugmakers for “continued, robust research” on coronavirus vaccines for children and adolescents “as soon as it is safe to do so.”
On Dec. 10, Moderna announced its COVID-19 vaccine trials would include adolescents 12 to 17 years old. And, according to a statement by Pfizer, which will continue its COVID-19 vaccine research, data on “adolescents 12 to 17 years of age will be gathered in the months ahead.” Pfizer also stated that “additional studies are planned to evaluate [the COVID-19 vaccine] in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.”
Schwenk says it’s “welcome news that several manufacturers are now collecting data in this vulnerable population.”
So when might testing on young children happen? Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a virtual discussion sponsored by Columbia University on Dec. 10 that coronavirus vaccine trials on young children and pregnant women may start in January, reports CNBC.
How COVID-19 affects children
As of Dec. 3, more than 1.4 million children have tested positive for COVID-19, according to the American Academy of Pediatrics. However, children appear to respond to the coronavirus differently than adults. “Although children can be infected with SARS-CoV-2 (the virus that causes COVID-19), get sick from COVID, and spread the virus, they seem to be less affected than adults,” explains Schwenk.
While some children can become severely ill, “the majority of children with COVID are asymptomatic or have mild symptoms only,” says Schwenk. “Since children can still spread COVID, the same basic principles of hand washing, social distancing, and masking — if 2 years of age or older — still apply.”
However, the CDC is investigating a “rare but serious” medical condition called Multisystem Inflammatory Syndrome in Children (MIS-C) that’s associated with COVID-19. MIS-C causes inflammation throughout the body, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs, according to the agency. If a child shows signs of MIS-C — which include fever, abdominal pain, vomiting, diarrhea, neck pain, rash, bloodshot eyes and feeling very tired, according to the CDC — seek emergency medical care immediately. “We do not yet know what causes MIS-C and who is at increased risk for developing it,” according to the CDC.
When parents can expect a vaccine
It’s not yet clear when the vaccine will become available to children. Experts advise being patient since several high-risk groups will go first.
“Particularly at the beginning, when the supply of COVID vaccine will be relatively limited, the focus will be on getting the highest-risk individuals vaccinated,” says Schwenk. That means health care personnel and residents of long-term care facilities will be offered the COVID-19 vaccine first. “Populations at high risk for severe COVID infection, including adults over 65 years of age, and essential workers are likely to be offered the COVID vaccine next,” says Schwenk. “The timing of vaccine availability will likely depend on the vaccine supply moving forward. The good news is, there are several promising vaccines in development, and as more data in children become available, we anticipate being able to start vaccinating children.”
Ramilo believes that the goal of many of the drugmakers is to continue moving forward with vaccine trials in children “so we can have data in the spring and summer,” with the hope that “by the time of the next school year, we would be able to implement something — that would be a dream.” He adds that there will likely be a “tremendous effort” to get kids vaccinated before school starts in the fall. “I’m optimistic that we should be able to do it,” says Ramilo.
He also points out that, as the adult population gets vaccinated, “it will decrease the amount of virus they can transmit, and the kids will have fewer opportunities to get infected.” In the meantime, Ramilo says, ”There is a light there at the end of the tunnel. There is an answer and we can get through this together. But we need to sit tight and be responsible.”
For the latest coronavirus news and updates, follow along at https://news.yahoo.com/coronavirus. According to experts, people over 60 and those who are immunocompromised continue to be the most at risk. If you have questions, please reference the CDC’s and WHO’s resource guides.
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