In the past week, the FDA Vaccines and Related Biological Products Advisory Committee recommended authorization of the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The CDC formally endorsed the booster dose for the Moderna and J&J vaccines. President Biden met with Dr. Robert Califf for the top FDA post. Please see details for these and other supply chain developments below:
- On October 21, the CDC director endorsed the Advisory Committee on Immunization Practices (ACIP) recommendations for the Moderna and J&J booster doses. The decision comes after both vaccines were granted emergency use authorization (EUA) by the FDA. The indication for the Moderna booster is administration six months after completion of the initial two-dose vaccine regimen for people 65 years of age and older, those 18 to 64 years of age with risk factors for severe disease, and those whose occupations put them at risk of exposure. For the J&J booster, the indication is for administration two months following an initial vaccination for all individuals 18 years of age and older. The CDC also endorsed the FDA’s authorization of mix and match administration of doses from different manufacturers.
- On October 22, President Biden met with Dr. Robert Califf to discuss the possibility of leading the FDA. Califf previously served as the commissioner of the FDA from February 2016 to January 2017. Califf is the Donald F. Fortin M.D. Distinguished Professor of Cardiology in the Duke University School of Medicine. He is also the founding director of the Duke Clinical Research Institute and a member of the National Academy of Medicine. No official announcement has been made.
- On October 22, the Administration announced that investments have been made in the manufacturing supply chain to expand the availability and use of COVID-19 at-home tests, including rapid tests. Most recently, the FDA has authorized the Celltrion DiaTrust COVID-19 Ag Home Test, which is for use as a home test that can be used without a prescription. The FDA also reissued the EUA for the Quidel QuickVue At-Home OTC COVID-19 Test to include home use without a prescription. The Department of Health and Human Services and the Department of Defense have awarded over $500 million in contracts to companies dedicated to this effort. The Administration has committed to invest $3 billion by the end of the year. To date, 419 tests and sample collection devices have received an EUA; however, only 15 at-home tests have been authorized.
- On October 26, the FDA Vaccines and Related Biological Products Advisory Committee recommended granting an EUA for Pfizer-BioNTech’s COVID-19 vaccine for children 5–11 years of age. The two-dose regimen would consist of a smaller dose (10 micrograms per vaccine) than the vaccines used in persons 12 years of age and older. If the FDA amends the EUA for the vaccine, ACIP will vote on the recommendations during its meeting November 2–3, 2021.
- On October 27, the FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency jointly issued 10 guiding principles for the development of good machine learning practice (GMLP). The principles are intended to set forth cornerstones for international collaborative organizations (such as the International Medical Device Regulators Forum) to advance the maturation of GMLP.
Please do not hesitate to contact us if you have any questions about these developments.