Biden Bolsters Vaccine Production in Pandemic Preparedness Plan

As part of a broad initiative to prepare for and prevent future global disease outbreaks, White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the United States and globally. This program is part of a broader $65 billion, 10-year pandemic preparedness plan announced Sept. 3, 2021 that also supports development of new therapeutics and diagnostics, as well as improved infectious disease surveillance, expansion of the national stockpile of critical medical supplies, and building regulatory oversight of these programs [see “American Pandemic Plan: Transforming Our Capabilities”.

The roll-out of the preparedness plan was an opening salvo in the administration’s heightened effort to increase vaccination rates and testing to keep schools open, strengthen the economy, and defeat the virus globally. In a national speech on Sept. 9, 2021, President Biden promised additional steps for providing protections for other countries and promised to release more details of his pandemic preparedness plan in coming weeks.

Meanwhile, the Biden administration looks to start the more targeted program to bolster vaccine production in the US by tapping an already approved $2.7 billion in funding authorized last March. This effort was announced by White House coronavirus response coordinator Jeffrey Zients at a press briefing on Sept. 2, 2021, called to provide an update on US efforts to ramp up production of COVID-19 vaccines for patients in the US and in other countries. Zients announced that the US has shipped more than 130 million doses to 90 countries, more than all other vaccine doses than all other countries in the world combined. However, even that greater volume of vaccines provided to the global community remains a fraction of the billions of doses that health officials say are needed.

Zients emphasized the importance of increasing vaccine manufacturing capacity at home and in other countries around the world by investing across the whole supply chain, from producing lipids to bioreactor bags to vials and syringes. He noted that the Biden administration has tapped funds already available to accelerate production “of critical vaccine manufacturing equipment, inputs and supplies” and to expand “fill/finish lines at factories” to get vaccine doses into vials faster and at a larger scale. The added $3 billion, he noted, will enable vaccine manufacturers to “add new production lines and facilities.” And this will create “thousands of good-paying American jobs” and “strengthen our long-term capabilities to respond to future threats.”

The White House unveiled its broader $65 billion pandemic preparedness plan the next day, as mentioned above, which lays out long-term strategies for expanding vaccine and drug manufacturing and for building a biomedical research pipeline as key components for quickly responding to future disease outbreaks. Described as similar to the Apollo mission to the moon, both public health and national security experts called for a “mission control” office to coordinate efforts by multiple government agencies to track and identify emerging disease threats and map strategies for combatting them. Administration officials proposed launching the program with an initial $15 billion budget as the debate over Biden spending proposals has stalled on Capitol Hill.

For the total program, more than half of the $65 million request would fund efforts to design and test new vaccines within 100 days after a pandemic threat appears and to speed production and distribution by eliminating the need for cold storage and replacing sterile injection with skin patches and nasal sprays. Rapid production of neutralizing antibodies would advance new antiviral therapeutics, and genome sequencing of patients with symptoms, wastewater sampling, and formation of early-warning data networks would enable earlier detection of viral outbreaks. The plan would expand the national stockpile to ensure access to next-generation personal protective equipment and testing equipment and build resilient supply chains for medical products, including active pharmaceutical ingredients.

The program also would support the efficient regulatory approval of new platform technologies and the establishment of “large, agile, and flexible clinical trials networks that can be rapidly ramped up for urgent needs.” Further information is presented in a “scientific appendix” to this 27-page plan, although many health experts maintain that a much more detailed program is necessary.

About the author

Jill Wechsler is Washington editor at Pharmaceutical Technology.