The Food and Drug Administration issued a press release on September 10, 2021 as US Schools open for in-classroom learning. The document attributes Acting FDA Commissioner Janet Woodcock, and director of FDA Center for Biologics Research and Evaluation Peter Marks. Hence, it is a reliable roadmap for the future US FDA strategy for childhood vaccines.
Food and Drug Will Follow the Tried and Trusted Path
US children younger than 12 years of age have benefited from vaccines and immunizations for over a century. Examples include Hepatitis A and B, Diphtheria, Tetanus, Measles, Mumps, Rubella and so on. Moreover, all vaccines trigger immune responses to particular diseases. And the technology is proven safe and effective.
There are of course occasional unfavorable reactions, although vaccinators have measures on standby to counter them. COVID vaccines follow the same approach. The US FDA strategy for childhood COVID-19 vaccines will follow this well-established path.
Unpacking the US FDA Strategy for Childhood Vaccines
1… First, allow current child trials to continue under controlled conditions based on past experience.
2… In addition, work closely with them to ensure the data is adequate and meets mandatory standards.
3… Then receive the vaccine makers’ reports, and approve (or disprove) them based on competent evaluation.
4… And finally, approve recommendations for emergency use for children provided all the boxes are ticked.
The Food and Drug Administration assures the reader there will be no cutting corners in the process. They will also continue to ensure the vaccine dosage and formulation strength is appropriate. And they will analyze the data coming in to ensure US child vaccinations deliver the promised results.
This approach has yielded impressive results among adults. The FDA recommends parents continue to protect their children until vaccine approval and administration. ‘Just like you,’ the authors say. ‘We are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible.’
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