Dear Alston & Bird Friends,
In the past week, President Biden signed the Executive Order on America’s Supply Chains, kicking off a comprehensive review of supply chain risks. Meanwhile, the FDA issued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine and allowed the Pfizer vaccine to be stored in pharmaceutical freezers. Please see details for these and other supply chain developments below:
- On February 22, the FDA issued a set of guidance documents to address emerging and future variants of SARS-CoV-2 in COVID-19 vaccine, test and treatment development, reviews, and approvals:
- Guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19 (superseding the guidance of the same title issued in October 2020).
- Guidance: Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests.
- Guidance: Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency.
- Guidance: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (superseding the guidance of the same title issued in May 2020).
- On February 24, President Biden signed the Executive Order on America’s Supply Chains, fulfilling his campaign commitment to comprehensively address supply chain risks and bolster more resilient supply chains.
- First, the order directs an immediate 100-day review across federal agencies to identify near-term steps the Administration can take, including with Congress, to address vulnerabilities in the supply chains of four key products. In particular, HHS is required to identify risks in the supply chain for pharmaceuticals and active pharmaceutical ingredients (APIs) and submit policy recommendations to address the risks.
- Second, the order calls for a more in-depth one-year review of a broader set of U.S. supply chains, with the “public health and biological preparedness industrial base” (to be determined by HHS) as one of the focus sectors. The order lists a set of risks and factors for agencies to consider in their assessments, and the agencies shall make specific policy recommendations to address risks, including, as listed in the order, sustainably reshoring supply chains and developing domestic supplies, cooperating with allies and partners to identify alternative supply chains, building redundancy into domestic supply chains, ensuring and enlarging stockpiles, developing workforce capabilities, enhancing access to financing, and expanding research and development to broaden supply chains.
- In addition, the order suggests the establishment of a quadrennial supply chain review.
- On February 25, the FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for up to two weeks. This is an alternative to the preferred storage in an ultra-low temperature freezer between -80°C to -60°C (-112°F to -76°F).
- On February 27, the FDA announced the issuance of an EUA for the Janssen COVID-19 vaccine for use in individuals 18 years of age and older, one day after its Vaccines and Related Biological Products Advisory Committee meeting for this product. This third COVID-19 vaccine is administered as a single dose. On February 28, the CDC Advisory Committee on Immunization Practices voted unanimously to recommend the use of the Janssen COVID-19 vaccine. Johnson & Johnson has begun shipping the vaccine and stated that it expects to deliver more than 20 million doses to the U.S. in March and 100 million doses in the first half of 2021.
Please do not hesitate to contact us if you have any questions about these developments.