FDA Expands Authorization of Pfizer-BioNTech COVID-19 Vaccine to Those Ages 12 to 15
The U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include children ages 12 to 15. Previously, the two-shot Pfizer vaccine was authorized for people age 16 and older. The Moderna and Johnson & Johnson vaccines are authorized for use in people age 18 and older.
The U.S. Centers for Disease Control and Prevention (CDC) Wednesday officially recommended that the Pfizer vaccine be given to adolescents ages 12-15 following the FDA’s expanded EUA.
“For vaccination to do its job, we must do our critical part,” said CDC Director Rochelle Walensky in a statement. “That means vaccinating as many people as possible who are eligible. This official CDC action opens vaccination to approximately 17 million adolescents in the United States and strengthens our nation’s efforts to protect even more people from the effects of COVID-19.”
As a major factor in its decision, the FDA cited a new clinical trial involving 2,260 12-to-15-year-olds that found that Pfizer-BioNTEch vaccine’s efficacy to be 100 percent. Side effects were consistent with those among adults — mostly pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. Most of the side effects occurred after the second shot, which is administered three weeks after the first.
In its clinical study, an analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was conducted, the FDA said. “In this analysis, among participants without evidence of prior infection with (COVID-19), no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100 percent effective in preventing COVID-19.” The “placebo” recipients did not received a vaccine.
“With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a news release.
Current Vaccines Fare Well Against New COVID-19 Variants, Studies Indicate
Various studies seem to indicate that the vaccines available in the U.S. against COVID-19 work well again the growing threat of new variants — although booster shots will likely be needed to make them even stronger.
One study, conducted in Israel, showed that the Pfizer-BioNTech vaccine, widely available in the U.S., works most effectively after its recommended two doses. Being fully vaccinated provided greater than 95 percent from infection, severe illness and death, according to a report by the Israel Ministry of Health and colleagues published in the Lancet medical journal .
“Two doses are highly effective across all age groups in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalizations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant,” the researchers wrote.
The B.1.1.7 variant, which was first detected in the U.K., has spread widely and is now the most common new variant seen in the United States. The B.1.1.7 variant was also common in Israel when the study took place. The B.1.351 variant, first detected in South Africa, was also widely detected in Israel, but had not caused many infections at the time of the study. That’s why the study’s researchers were unable to determine if the vaccine worked effectively against the B.1.351 variant.
Separately, vaccine maker Moderna announced the initial findings of a new study. Moderna found that a single-shot booster of its vaccine sufficiently boosted antibodies in previously vaccinated individuals to fight off two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil).
“As we seek to defeat the ongoing pandemic, we remain committed to being proactive as the virus evolves,” said Stéphane Bancel, chief executive officer of Moderna, in a statement. “We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants.”
Pfizer-BioNTech and the U.S. Centers for Disease Control and Prevention (CDC) are also investigating the potential of booster shots in fighting COVID-19 variants.
“We are doing the studies on boosters to see if we will need them, and that is six months, one year, two years — we don’t really know,” said CDC Director Dr. Rochelle Walensky. “But we want to be prepared for them should we need them.”
CDC: Fully Vaccinated Can Go Maskless Indoors and Outdoors — Unless Regulations Require Them
Those who are fully vaccinated against COVID-19 “no longer need to wear a mask or physically distance in any setting” — except when required by federal, state or local laws, rules and regulations, says the U.S. Centers for Disease Control and Prevention (CDC) in its just-updated guidance on mask-wearing .
Masks are still required while traveling in airplanes, buses and trains — even if you’ve been fully vaccinated. Masks are also required in healthcare settings, correctional facilities and homeless shelters. (At all Baptist Health facilities, masks are still required to be worn by everyone at all times.)
The CDC says that it’s updated guidance also applies to children. “Unvaccinated people refers to individuals of all ages, including children, that have not completed a vaccination series or received a single-dose vaccine,” says the CDC.
The CDC adds that fully vaccinated people do not need to be tested following “a known exposure unless they are residents or employees of a correctional or detention facility or a homeless shelter,” the CDC adds. Nonetheless, fully vaccinated people should still get tested if experiencing COVID-19 symptoms, the agency said.
Under previous guidance issued last month, the CDC said fully vaccinated people must still wear masks outdoors during “a crowded, outdoor event, like a live performance, parade, or sports event.”
“Anyone who is fully vaccinated, can participate in indoor and outdoor activities, large or small, without wearing a mask or physical distancing,” said CDC Director Rochelle Walensky, M.D., said Thursday at a White House COVID-19 briefing. “If you are fully vaccinated, you can start doing the things that you had stopped doing because of the pandemic.”
As part of its update this week, the CDC cited three studies — one from Israel and two from the U.S. — that found vaccines to be highly effective at preventing both symptomatic and asymptomatic infections. The Israeli study, published in the Journal of the American Medical Association , concluded that vaccines were 97 percent effective against symptomatic COVID-19, and 86 percent effective against asymptomatic infection in more than 5,000 healthcare workers.