Senior advisers for the US Food and Drug Administration gave their stamp of approval Tuesday night for use of the Pfizer coronavirus vaccine to inoculate children aged five to 11.
The committee said that the data that showed the Pfizer vaccine was effective in preventing symptomatic infection was convincing. The eight-hour discussion centered more on whether the benefits of vaccinating children outweighed the risks.
Seventeen out of 18 committee members voted in the affirmative that it is the right thing to give kids the jab. Only one member abstained.
Will the vaccine cause myocarditis?
“There is a small risk of heart inflammation,” Garty said. “From what we see in adolescents, it is very rare and usually very mild. When you compare the risks of inflammatory complications from the disease versus the vaccine, the benefits of vaccination completely outweigh the risks.”
An Israeli study that was published earlier this year reported the highest probability of any study to date on the subject: one in every 6,000 cases in males between the ages of 16 and 30. However, in August, when the Health Ministry published data specifically about how many cases of myocarditis it found in adolescents, the number was only 12 out of 250,000 vaccinated teens – and all of the cases were mild.
Could there be other vaccine side effects?
According to Garty, most of the side effects were mild, like pain in the arm, fever or weakness – the same symptoms that were seen in adults and teens.
The challenge, he said, is that the Pfizer study centered on a small cohort of kids, which means that rare side effects would likely not be found until the vaccine hits the market.
“It will be very important to closely monitor children getting vaccinated to see if any rare side effects appear,” Garty said. “This is something called post-marketing data, something that we do after every Phase III clinical trial for any drug or vaccine.”
He added that hundreds of millions of older people have already gotten the vaccine, so a huge amount of knowledge has been gained on side effects in general in the past year.
Should parents worry about the long-term effects of the vaccine?
“No one can be 100% sure that everything is going to be OK and that there will be no complications,” Garty admitted. “But we do have very good knowledge of how vaccines work, and immune response works, and in all vaccines known to mankind we do not have any side effects six or eight weeks after injection.”
The way these vaccines work is that you inject the mRNA into a person’s arm. The mRNA creates protein that triggers an immune response. Then, it degrades and nothing is left but immune memory and antibodies.
There is also, of course, a big question mark about the long-term impact of the virus, Garty said.
“Some viruses leave their mark behind,” he explained. “They infect people’s cells and change them a little, and only many years later do we see the consequences.”
He offered how in some cases people who contract measles end up with severe brain inflammation seven years later. Kids who have chickenpox can develop shingles as adults.
“This may not be the case, but it is not something we want to find out the hard way,” Garty said. “If you have to decide whether to get the vaccine or get the disease, the vaccine is definitely the better choice.”
Is PIMS also a real COVID risk?
PIMS stands for pediatric inflammatory multisystem syndrome. About one in every 3,000 children and adolescents who are diagnosed with COVID develop the syndrome, which is reminiscent of Kawasaki Syndrome and toxic shock, Garty said. The syndrome can be life-threatening.
How many children develop long COVID?
There are some studies that say as many as 30% of sick people develop long COVID. However, Garty said that these studies are often based on questionnaires that ask individuals how they feel a few weeks or months after getting the virus, so they may not be totally accurate. This is especially the case, since doctors are still determining what all the symptoms of long COVID really are.
How many Israeli children have died of the virus?
Around 10 children died.
If infection is down, should parents wait to vaccinate their children?
Garty said that the FDA addressed this question by modeling six scenarios looking back to times in which the COVID virus was peaking or on the decline. In all but one scenario it was clear that vaccination should happen immediately.
“If at the moment the infection rate is low, we know that it is only a matter of time before another wave appears,” Garty said. “If many people are unvaccinated, the next wave will come in and infect us again.”
Garty stressed that parents should get their news from confirmed sources and not from social networks, to ensure the information they receive is as accurate as possible.
He added that one in every 200 children who contract the virus ends up in the hospital.
“These are things we do not want our kids exposed to,” Garty said. “If we can prevent COVID, it is the best thing.”
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