What we know about vaccine safety for schoolchildren as California sets mandate

A masked student walks past a bulletin board at a school.

Oct. 1, 2021 Updated 3:59 PM PT

California is again on the leading edge of vaccine mandates, requiring all eligible public and private schoolchildren to be vaccinated against COVID-19.

The mandate could take effect for students between grades 7 through 12 as early as January if there is full federal approval before then for a COVID-19 vaccine for children age 12 to 15. Once it’s in effect, students will not be allowed to attend classes in person without being vaccinated or receiving an exemption.

But unlike other vaccine requirements for schoolchildren in California, the governor said parents will be able to cite personal beliefs in refusing to vaccinate their children against COVID-19, and still be allowed to send their children to class.

The personal belief exemption must be granted because the new vaccination requirement is being imposed through a regulatory process, rather than through the Legislature, officials said. State lawmakers can later decide to eliminate the personal belief exemption for the COVID-19 vaccine if they choose to do so.

Public health officials have said that the vaccine is perfectly safe for children and that getting them inoculated would help bring regions closer to herd immunity.

Here is a breakdown of what we know:

How long has the COVID-19 vaccine been available for children?

The Pfizer-BioNTech COVID-19 vaccine was authorized for emergency use in December for everyone 16 and older and began to be widely available in the spring.

Full approval from the U.S. Food and Drug Administration was granted for people 16 and older in late August.

The Pfizer shot was authorized for emergency use among adolescents 12 to 15 years old in May. Full approval is widely anticipated by November for this age group.

Vaccines for children 5 to 11 have not yet been made available. Pfizer is expected to apply for authorization imminently, citing evidence from trials indicating that the shots are safe and effective for children in that range. The shots could be available for that group, under an emergency-use authorization, around Thanksgiving, according to the Associated Press. But full approval for this age group would probably be many more months away, meaning it’s possible a vaccination requirement may not apply to elementary school children until next summer or later.

What’s the safety record of the Pfizer vaccine?

Experts call the Pfizer vaccine safe and effective for children.

Among all age groups, there have been 226 million administrations of the Pfizer-BioNTech vaccination in the U.S. since December, an astonishing mass rollout of vaccinations in a short time that has no parallel in U.S. history.

In that period, 54% of adolescents 12 to 15 have received at least one dose of vaccine, as have 62% of 16- and 17-year-olds. If there were a safety problem with the vaccine for adolescents, it probably would have surfaced by now, experts say.

What about reports of heart inflammation as a Pfizer side effect?

There were some early concerns about myocarditis — inflammation of the heart muscle — being a side effect following administration of the Pfizer-BioNTech vaccine, mostly among young males after getting a second dose.

But further study revealed that of 8.9 million adolescents in the U.S. aged 12 to 17 who had received the Pfizer-BioNTech vaccine through mid-July, cases of myocarditis were rare. There were fewer than 400 reports of myocarditis, the symptoms were generally mild and there were no related reports of death.

Even if myocarditis did occur following vaccination, usually aspirin or another common anti-inflammatory drug would resolve the symptoms, said Dr. Monica Gandhi, a UC San Francisco infectious diseases expert. After reviewing the data, she had her 13-year-old son get his second dose, and he was fine, she said.

The most common adverse pediatric events reported to officials were dizziness, headache and fainting, some of which is probably related to a history of anxiety around needles, according to a report published by the Centers for Disease Control and Infection. Fainting is common among adolescents after any vaccination, the CDC said.

Why is there a push to vaccinate children when hospitalization rates are so low in this group?

Children, indeed, have low rates of hospitalization and death from COVID-19.

Still, “the risk is not zero,” UCLA medical epidemiologist and infectious diseases expert Dr. Robert Kim-Farley said. More than 600 children under 18 in the U.S. have died after contracting COVID-19. Nearly 300 of them were between 12 and 17.

“This vaccine is safe and effective and will prevent needless suffering, disability and death in children. Any death in a child is to be regretted,” Kim-Farley said.

Children exposed to the coronavirus are also at risk of developing a rare but serious condition known as multisystem inflammatory syndrome in children, or MIS-C. The condition can cause the heart, lungs, kidneys, brain, skin, eyes or gastrointestinal organs to become inflamed, and is potentially deadly.

Nationally, there have been more than 4,600 cases of MIS-C, and 41 related deaths.

What are the risk to others when teens aren’t vaccinated?

Failing to vaccinate adolescents will only prolong the pandemic, putting other people at risk, epidemiologists say. In Los Angeles County, unvaccinated children 12 to 17 have the highest coronavirus case rate in the past month — 19% worse than among unvaccinated adults under 50 and 33% worse than among unvaccinated older adults.

It’s the older adults, however, who pay the price when coronavirus circulates at high levels in a community. Fully vaccinated grandparents, for example, are at higher risk for coming into contact with the virus, which in turn poses a greater risk of severe illness should they get a breakthrough infection from an unvaccinated grandchild.

“The Delta variant, unlike the Alpha variant, really is just so much more transmissible that children absolutely get it ... and they transmit it,” Gandhi said. “If you have all this virus around you, you’re still going to get breakthroughs. And who is going to be susceptible to severe breakthrough? Older people.”

Does the government have the authority to require vaccination for schoolchildren?

Yes, state governments have long required that vaccinations be a condition of entry to classrooms.

Shots in California that are needed for K-12 education include polio, measles, mumps, rubella, varicella, hepatitis B, diphtheria, tetanus and pertussis.

What have the courts said about government mandates for vaccinations?

The courts have previously upheld laws requiring compulsory vaccination: In 1905, the U.S. Supreme Court upheld state laws that require vaccination against communicable diseases. The case stemmed from a Massachusetts law that permitted city health boards to enforce mandatory, free vaccination requirements for adults over 21.

In a 7-2 decision, Justice John Marshall Harlan wrote that “the rights of the individual … may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.”

What determines how soon the new COVID-19 vaccine mandate could take effect?

The mandate would take effect for grades 7 through 12 as soon as the semester following the U.S. Food and Drug Administration’s full approval of the vaccine for children ages 12 and older, Newsom said, which will probably happen as early as January 2022, or perhaps as late as summer 2022.

Students in kindergarten through sixth grade would be phased in the semester after the vaccine is formally approved for younger children.

Even though the Pfizer vaccine has already been fully approved for everyone age 16 and above, Newsom’s plan does not require vaccinations for 16- and 17-year-old high school students until the shots have been fully approved for those age 12 to 15.

Even after the FDA fully authorizes the vaccine for adolescents and teenagers, the California Department of Public Health will need to begin a regulatory process that will address more details, including the scope of exemptions, and Californians will be able to provide formal public comment.

When will schoolteachers need to be vaccinated?

Once students must be vaccinated, the same rule will apply to workers. Currently, K-12 teachers and staff in California’s schools — public or private — must either be vaccinated or submit to a weekly coronavirus test.

Will the Legislature remove the ability of parents to cite personal beliefs in exempting their child from the COVID-19 vaccine?

It’s possible. A spokesperson for state Sen. Scott Weiner, who appeared Friday with the governor, said the San Francisco Democrat supports eliminating the personal belief exemption from the student COVID-19 vaccination mandate.

Newsom declined to directly call on state lawmakers to lift the personal belief exemption for the COVID-19 vaccine. He said he would work with state lawmakers “to figure out what’s best in terms of advancing our collective goals to keep people healthy and safe” and students in the classroom.

For other routine vaccinations required for school, are ‘personal belief exemptions’ allowed?

No, California allows only medical exemptions to other long-standing routine vaccines, such as measles, required for schoolchildren in K-12 schools who receive instruction in the classroom.

In 2016, California ended the practice of allowing parents of schoolchildren to seek an exemption from vaccinations due to the family’s personal beliefs.

Schools do not need to be immunized if they attend a home-based private school or learn through an independent study program and do not receive instruction based in a classroom.

Why did California end the practice of ‘personal belief exemptions’ for other routine vaccinations for schoolchildren?

A Disneyland measles outbreak in late 2014 and early 2015 spread to seven other states, as well as Canada and Mexico, which revealed the risks of declining childhood vaccination rates in California.

Vaccination rates had been declining as a result of a proliferation of myths that vaccines were unsafe, the result of misinformation that officials said endangered public health.

At the time of the strict 2015 vaccine law, two-thirds of California adults responding to a Public Policy Institute of California survey said unvaccinated children should not attend public school. Feelings were strong on both sides. Parents opposed to the law took part in large impassioned protests.

The state’s decision resulted in a big boost in vaccinations. In 2016, the vaccination rate for California’s kindergartners soared from the previous year, and resulted in the highest vaccination rate among kindergartners since at least 1998.

Times staff writer Maura Dolan contributed to this report.