The Pfizer BioNTech coronavirus vaccine has been shown to be safe and highly effective in young children ages 5-11, the companies said early Monday morning. The news should help alleviate months of anxiety among parents and teachers about when children and their close contacts could be protected from the coronavirus.
The need is urgent: children now account for more than one in five new cases, and the highly contagious Delta variant has sent more children to hospitals and intensive care units in the past few weeks than ever before in the pandemic.
Pfizer and BioNTech plan to apply to the Food and Drug Administration for approval to use the vaccine in these children by the end of the month. If the regulatory review goes as smoothly as it does with older children and adults, millions of elementary school students could be vaccinated before Halloween.
Study results for children under 5 years of age are expected in the fourth quarter of this year at the earliest, according to Dr. Bill Gruber, senior vice president at Pfizer and pediatrician.
Pfizer and BioNTech released the results in a statement that did not include detailed data from the study. The results have not yet been peer-reviewed or published in a scientific journal.
But the new results are consistent with those seen in older children and adults, experts said.
“There will be a large number of parents who will breathe a sigh of relief when they hear this,” said Dr. Kristin Oliver, pediatrician and vaccine expert at Mount Sinai Hospital in New York. “We have been waiting for these children to be protected.”
Children have a much lower risk of Covid-19 than adults, even when exposed to the Delta variant. However, a few infected children develop a life-threatening condition known as Childhood Multisystem Inflammatory Syndrome, or MIS-C. Still others can have symptoms that last for months.
Almost 30,000 children were hospitalized for Covid in August; the least vaccinated states reported the highest rates. At Seattle Children’s Hospital, according to Dr. Danielle Zerr, a pediatric infectious disease expert at the hospital, told about half of the children admitted for Covid are over 12 years old.
“I was dismayed that the sickest children in our hospital with acute Covid-19 or MIS-C are children who could be vaccinated,” said Dr. Distort.
While ideological battles over masking and vaccine mandates are taking place in the communities, the reopening of schools has fueled the increase. In Mississippi, among the states without a mask requirement, almost 6,000 students tested positive for the virus in one week, and more than 30,000 students, teachers and staff had to be quarantined.
A county in South Carolina – where mask requirements are prohibited – had to quarantine more than 2,000 students in one day. Distance learning is not an option in many counties, so the safety of some medically vulnerable children in many parts of the country is subject to the actions of others.
Unvaccinated children, even if they do not get the disease themselves, can spread the virus to family members, teachers, and others with whom they interact regularly – including grandparents or those who are prone to serious illness or death.
9/20/2021, 6:45 a.m. ET
Wearing masks and having good air circulation can significantly reduce virus transmission. However, according to a recent review of the evidence by the Centers for Disease Control and Prevention, children are just as likely as adults to transmit the virus to others, and more likely than adults over 60.
Pfizer’s study enrolled 2,268 children ages 5 to 11, two-thirds of whom received two doses of the vaccine three weeks apart; the remainder were injected with two doses of saltwater placebo.
Given how rarely children become seriously ill, the study wasn’t large enough to draw meaningful conclusions about the vaccine’s ability to prevent Covid or hospitalization. Instead, the researchers relied on measurements of adolescents’ immune responses, assuming that the protective antibody levels seen in older people would be just as protective in younger children.
The children who received the vaccine produced a strong immune response that was comparable to the antibody levels seen in previous studies with participants aged 16-25 years. But children in the 5-11 year old group achieved this response with 10 micrograms of the vaccine, one-third of the dose given to older children and adults.
At higher doses, researchers observed more side effects, including fever, headache, and fatigue in younger children, although none were serious, said Dr. Gruber. With the 10-microgram dose, “we actually see less fever and less chills after the second dose than in 16-25 year olds”.
The immune defense becomes weaker with age and the side effects also become milder. This drop in potency is why most vaccines are given in childhood – and why a much lower dose is often enough for children, said Dr. Yvonne Maldonado, who led the study at Stanford University and chaired the American Academy of Pediatrics’ Infectious Disease Committee.
“You want to hit the sweet spot where you give the lowest dose that could cause reactions, but also high enough to get a good, sustained antibody response,” she said.
In children under 5, only three micrograms – one-tenth the adult dose – are tested in studies and seem likely to be enough, she said.
Understand US vaccination and mask requirements
- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, a reversal of the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
- College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. Both California and New York City have introduced vaccine mandates for educational staff. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students but are more likely to support masking requirements for students, teachers, and staff who are not vaccinated.
- Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
- New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13th. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, without the option of weekly testing. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.
The FDA’s full approval of the Pfizer BioNTech vaccine in August did not include children ages 12-15 still receiving the vaccine under emergency approval. As with young people, companies will also apply for emergency permits for children aged 5 to 11.
FDA scientists then have to weigh the vaccine’s benefits against the risk of side effects. On rare occasions, the vaccine has caused myocarditis, an inflammation of the heart, in young people.
But a large Israeli study based on electronic health records from two million people aged 16 and over found that Covid is far more likely to cause these heart problems.
To identify side effects in younger children, the FDA asked Pfizer-BioNtech and Moderna in July to expand their studies to 3,000 children. Based on the company’s discussions with the FDA, Dr. Gruber however, he believes the agency would give the vaccine the green light with the data so far available.
The discussions about the risks of the vaccine for children aged 6 months to 5 years are likely to be even more violent than the vehement disagreements about vaccinating healthy adults or adolescents.
“There are some people out there who don’t really feel that there is convincing data that children under the age of five need to be vaccinated,” said Dr. Maldonado.
Although most children are spared serious illnesses after infection, and pediatric hospitals and intensive care units are overcrowded, she added, “Why don’t you want to prevent an infection that could potentially bring your child to the intensive care unit?”