When Pfizer’s COVID-19 vaccine was approved in August, it was only approved for ages 16 and older as a two-dose series. But since fully approved vaccines and drugs can be used “off the label,” many of us began to wonder if providers could do it. administer vaccinating children or giving impulses to people who otherwise could not get the condition. Unfortunately, this is not likely to be the case. The reason is related to some specific government formalities, but first let’s talk about what it means “off the label”.
What it does “Switched off label ”means?
Medications (and vaccines) are approved by the FDA for specific purposes. But providers can use their judgment to decide when and how to prescribe something. For example, a drug for chemotherapy may be approved for one type of cancer, but may be prescribed for a different type of cancer. This is one of the examples given by the FDA its off-label usage teller; there may be no medication approved for your condition, or you may have tried the approved medications and they have not worked.
Therefore, in theory, a provider can administer a vaccine to an age group or for a purpose for which it is not approved. This would not be advisable, but it would be legal.
Why the COVID vaccine is different
The way COVID vaccines are distributed in the US is different from most vaccines or medications. All doses of the vaccines were purchased by the federal government instead of ordered directly by suppliers. Providers must accept the terms of the document CDC COVID-19 Vaccination Program, which includes administering only vaccines as recommended.
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If a provider quit the vaccine however, they may be expelled from the program and be unable to administer future doses of the vaccine. They may also not be covered under the file Public Preparedness and Emergency Preparedness Act (PREP Act), which provides immunity from liability if something goes wrong.
There are also disadvantages from the patient’s point of view, as the CDC explains here. On the one hand, insurance may not pay the vaccine administration fee, leaving patients or parents with the bill. And if the person receiving the vaccine had adverse events caused by the vaccine, they would not be eligible for compensation as well as for other vaccine injuries.
He The American Academy of Pediatrics also discourages off-label use for children, noting that the doses being tested in vaccine trials for children are different from the vaccine for adults and that we do not yet have enough information about the safety of the vaccine in children. Pfizer says they expect to apply for emergency clearance for ages 5 to 11 by the end of September, so we may not be long in waiting. And if you’re waiting for a boost for you, these it could start coming (legally) as soon as September. 20, so you just have to sit strong.