The Centers for Disease Control and Prevention approved the expanded use of the Covid-19 vaccine from Pfizer and BioNTech for children aged 12 to 15, clearing the way for pediatricians to fire the shots in the US as early as Thursday .
The recommendation of CDC Director Dr. Rochelle Walensky arrives hours after the Advisory Committee on Immunization Practices approved the change, adopted 14-0 with one abstention. Two days earlier, the Food and Drug Administration approved Pfizer and BioNTech’s motion to give young teenagers the opportunity to fire their shots in an emergency. Final approval by Walensky was expected imminently.
President Joe Biden called it “another big step in our fight against the pandemic”.
During the meeting on Wednesday, CDC officials said there were no serious adverse events related to Pfizer BioNTech intake in 12 to 15 year olds of more than 2,000 children in the company’s clinical study. Most vaccine recipients, 91%, experienced side effects.
The most commonly reported side effects were pain at the injection site, joints and muscles, fatigue, headache, chills and fever, said Pfizer scientist Dr. John Perez to the panel. With the exception of pain at the injection site, more teenagers reported side effects after the second dose than after the first. Side effects usually subsided within a day or two, he said.
The CDC panel’s approval comes ahead of the summer camp season and July 4th – a date the Biden government hopes will mark a turning point in the nation’s fight against the virus. According to the Johns Hopkins University, more than 3.3 million people have died of Covid-19 worldwide, almost 600,000 of them in the United States.
After Wednesday’s vote, several members expressed their excitement that members of their own families could now be vaccinated. Others noted that having access to the footage will help children return to normal after a year of psychological and social problems due to the pandemic.
“My husband and I are vaccinated. My 16-year-old is vaccinated. Now my 12- and 15-year-olds are in line,” said ACIP member Helen Keipp Talbot.
The panel’s recommendation will “help us close a difficult chapter for many children and families,” said Andy Slavitt, the White House’s top official on the country’s Covid-19 response plan, on Twitter.
Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.
According to the government, children make up around 20% of the total US population of 331 million. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots. However, other experts say that herd immunity becomes less likely as variants spread.
As of Tuesday, more than 150 million Americans ages 18 and older had received at least one dose, according to the CDC. According to the agency, around 115 million American adults are fully vaccinated. About 13% of adults say they definitely won’t get a vaccine, while 21% say they will “wait and see” or just get one if needed, according to the Kaiser Family Foundation.
CDC officials told the panel that research shows parents are hesitant about vaccines. Only about 46% to 60% said they wanted their children to be vaccinated. The reasons the shots weren’t fired included concerns about safety, the time it took to develop the vaccine and insufficient information, officials said.
Acting FDA Commissioner Dr. Janet Woodcock assured parents Monday that the US agency “did a rigorous and thorough review of all available data” before clearing it for use on younger teenagers.
CDC official Dr. Megan Wallace said Wednesday that serious adverse events were more common with vaccines than placebo participants, 0.4% versus 0.2%, but none of them were attributed to the shots.
Perez said one adverse event associated with the vaccine was lymphadenopathy, which is a swelling of the lymph nodes. In the clinical trial, there were nine cases in the vaccine group, seven of which were related to the shot. Two cases were in the placebo group, he said. There were no cases of anaphylaxis, according to a slide presented at the meeting. There were also no cases of Bell’s palsy – a rare problem that has occurred in some adult vaccine recipients – or blood clots, Perez said.
The vaccine was shown to be 100% effective in the clinical study involving 12 to 15 year olds. No deaths were reported. More serious side effects were more common in the vaccine group. About 11% reported pain at the injection site that prevented daily activity, severe fever, headache, or muscle pain.