Thoughts on the FDA delay of Covid vaccination authorization -- February 18, 2022
- bjmears1
- Feb 18, 2022
- 2 min read
The FDA has delayed authorization of the Pfizer Covid vaccine for children under age 5. Preliminary data seems to show that 2 doses seem effective against delta but may not be effective against omicron and regulators and the drug maker have chosen to finish testing first. It appears the FDA initially pushed Pfizer to prepare for release of this vaccine earlier than the company intended.
The numbers tested so far don’t appear to be enough to give good data on effectiveness. (There haven’t been enough cases in the study participants to avoid skewing results). Another factor, children between 2 and 4 years old don’t seem to have good antibody response while 6 to 24 month children had higher antibody response. Also, the studies use a lower dose than in older children (may not be a high enough dose)
There has been criticism of this decision. Younger children have a higher hospitalization rate than older children. There is no option for off label use of the vaccine in severely immunocompromised younger children. Should the FDA approve for the 6 -24 month group and delay for the 2-5 year group? The vaccine does appear to provide at least some protection.
I think you can effectively argue for either side of this argument. It would probably have been better if the FDA hadn’t pushed for an early approval.
Vaccines are a marvel but any medical intervention can have problems. Some show up fairly quickly. (The problems with one of the initial measles experimental vaccine, (see the history article-the first vaccine had lots of side effects). Some take longer. Consider the atypical measles cases that appeared after use of an inactivated vaccine (see the link to the Munoz article in Vaccine), and the intussusception cases that followed the 1999 Rotavirus vaccine. (MMWR article).
In this case, the problem seems to be not the risks of the vaccine but questions as to whether it will work adequately. In this situation, perhaps the goal is decreasing severity and hospitalization? The company and the FDA seem to think it is safer to wait for more robust data. Although I am not happy, I am inclined to not fuss too much. Perhaps they can separate the age groups and evaluate independently.
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