We have reached another pivotal moment in the fight against COVID-19: the Food and Drug Administration (FDA) has authorized Johnson & Johnson’s COVID-19 vaccine candidate for emergency use. With demand for vaccines currently outpacing supply, the addition of a third candidate is welcome news for Americans. Most importantly, a one-dose option that only requires refrigeration will provide greater flexibility in delivering vaccines to more individuals, including those in underserved and rural areas, with the ability to scale up production exponentially as we move into the spring and summer months.
HDA will be carrying forward the early lessons learned from COVID-19 pandemic and supporting response efforts in 2021, writes President and CEO Chip Davis in the January 4 issue of Chain Drug Review — particularly as distributors play a role in the largest public vaccination effort in recent memory. Davis provided his perspective on the year ahead, along with other healthcare trade association leaders, as part of the publication’s 2021 “Pharmacy Outlook” feature.
Since the enactment of the Drug Supply Chain Security Act in 2013, members of the pharmaceutical supply chain have undertaken efforts to meet each of the major milestones contained within the statute’s 10-year timeline to further secure the safety of the products being distributed. The industry’s progress to 2023 interoperability was top of mind as supply chain and other stakeholders came together at HDA’s recent Traceability Online Seminar.
While it has only been a few months since the first American was diagnosed with COVID-19, the scope of the pandemic is one which we have never experienced before. Throughout, it has become abundantly clear that our nation’s ability to effectively respond to this once-in-a-lifetime crisis depends on the public and private sectors joining forces, maintaining constant coordination, and working together to identify operational and regulatory barriers impeding access to medicines and medical supplies.
It has been clear for some time that the pharmaceutical supply chain has been concerned with meeting the November 27, 2019, saleable returns milestone. As the HDA’s Research Foundation’s annual Serialization Readiness Survey (conducted in May) notes, 79 percent of manufacturers have concerns with the viability of the Verification Router Service (VRS), while 82 percent of distributors are unsure about meeting the requirement.