At least half a dozen COVID-19 vaccine candidates are in clinical trials, with aggressive timelines and manufacturing plans that could result in multiple options available next year. But other parts of the medical supply chain could require a matched effort to produce enough component materials to package and distribute the finished products when the time comes, HRI found.
Unlike traditional vaccine manufacturing, in which companies await late-stage trials to bring commercial capacity online, these companies are preparing for manufacturing even as trials continue. Several have signed partnerships; not-for-profit collaborations are stepping up to enable swift manufacturing of millions of doses as clinical trials get underway (here, here and here). At the same time, HHS’ Office of the Assistant Secretary for Preparedness and Response has issued contracts for needles and syringes.
According to a whistleblower complaint filed early this month by Rick Bright, former BARDA deputy assistant secretary for preparedness and response, the US will need 850 million needles and syringes to deliver a vaccine but has only about 15 million in the Strategic National Stockpile.
According to Bright, there is also a global shortage of glass vials, and major suppliers are sold out of the borosilicate tubing required to manufacture enough supply. “It could take up to two years to produce enough vials for US vaccine needs,” he stated in his complaint.
The US experience with vaccine manufacturing during the H1N1 pandemic in 2009-10 could provide lessons for this pandemic.
During the H1N1 pandemic, a vaccine was manufactured within six months, but at first, the amount of vaccine produced failed to meet demand from the healthcare community. While the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) had expected 42 million doses available by the fall of 2009, only about 22 million doses were ready by the end of October, preventing healthcare providers from meeting demand even among the prioritized individuals such as children and pregnant women.
One of the challenges was that the manufacturing platforms relied on eggs, causing stakeholders to recommend that vaccine manufacturers move to new platforms, according to a workshop report issued after the pandemic subsided.
The most advanced vaccines in development for COVID-19 use different platform technologies, which could speed the manufacture, but the ancillary supplies could still be an issue.
At least two COVID-19 vaccine manufacturers have said they’re exploring multidose vials. A third vaccine candidate in the clinic relies not on needles or syringes for delivery but on electroporation—the use of an electrical pulse to open pores in the cell and allow the vaccine to enter. Scale-up of the delivery device has already started.