No Off-Label COVID Vaccines

 

Aside from the few rabid “adults” who have childishly decided that protecting their notion of personal freedom is more important than protecting their own lives and livelihoods (not to mention, by the way, the lives and livelihoods of everyone around them) from a punishing global pandemic by getting vaccinated and wearing masks in schools, many parents have been anxiously asking pediatricians when a COVID vaccine will be available to kids younger than 12 years old. Kaiser Family Foundation predicts a mid-winter delivery date:

There are approximately 48 million children under the age of 12 in the United States. This group is not yet eligible for COVID-19 vaccination, though it is widely expected that a vaccine will be authorized for at least some children by the end of the year (clinical trials are currently underway among children between the ages of 6 months and 11 years old).

 

Some parents have reportedly insisted that their not-yet-eligible children be given the vaccine anyway, off-label. It’s entirely understandable why so many parents are anxious:

Although children have not borne the most severe brunt of COVID-19 relative to adults, some do become hospitalized, suffer long-term consequences, and even death from the disease. In addition, children can transmit to others, contributing to ongoing community transmission in the U.S., as the country continues to struggle to contain the virus in the midst of the much more transmissible Delta variant. Achieving a high rate of vaccine coverage among those under age 12, once eligible, is therefore important to protecting children and controlling continued spread of COVID-19 […]

 

The 2-dose Pfizer mRNA vaccine is the only one approved for use down to the age of 12. (The vaccine received full approval last month for ages 16 and older.) Studies testing efficacy and safety in youngsters are still underway with Moderna’s mRNA vaccine, and for the single-dose Johnson & Johnson vaccine. Both are now approved for emergency use in adults 18 and up. The American Academy of Pediatrics strongly discourages off-label administration of COVID-19 vaccines in children under 12:

“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” said AAP President Lee Savio Beers, MD, FAAP. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.

 

Feeling the urgency along with parents, the AAP advises patience:

Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases, urged physicians to wait until the clinical trials are complete in children to give the vaccine to those under 12.

“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Dr. Maldonado said. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

 

Frances Stead Sellers and Ariana Eunjung Cha found pediatricians coast-to-coast who are being peppered with parental requests for administering the vaccine off-label to their young patients:

Ilan Shapiro, a Los Angeles pediatrician, says he’s been bombarded by parents’ questions since the Pfizer-BioNTech shot secured full FDA approval Monday, including from roughly 20 who wanted their ineligible children to receive a jab off-label.

“I always let them know, ‘First of all, I’m a human. After that, I’m a father and husband, and after that I’m a doctor, and I wish I had a different answer, but we just need to wait a little bit,’ ” Shapiro said. “There’s sometimes frustration, but it’s a normal frustration. It’s like, ‘We are going back to school, and I want to give them the best tools to go back in a safe manner.’ ”

 

There are, of course, things all of us can do right now to reduce the risk to young children — and to everyone else — by preventing the transmission of COVID-19. The first thing we can do is vaccinate everyone 12 years and older. While more than 63% of American adults are fully vaccinated, we learned yesterday on The PediaBlog that kids are lagging behind:

As of last week, 47% of children between 12-15 years old had at least one Pfizer vaccine in their arms; 34% were fully vaccinated with both doses. The vaccine has been approved for older teenagers a little longer, so their vaccine uptake has been better: For 16-17 year-olds,  56% had at least one dose and 44% were fully vaccinated.

 

Wearing a mask in crowded indoor spaces like stores, restaurants, theaters, and schools has also been shown to be highly effective in reducing the spread of the respiratory virus responsible for the worst pandemic in over a century, the death of more than 4.5 million earthlings, including nearly 640,000 Americans, and ravaged economies the world over.

As adults, we all have a responsibility to protect ourselves and each other, especially those among us who are inevitably the most vulnerable: our children.

 

(Google Images)

 

source http://www.thepediablog.com/2021/08/31/no-off-label-covid-vaccines/