http://www.digitaljournal.com/life/health/there-s-a-second-covid-19-vaccine-problem-and-it-is-a-big-deal/article/571523

There's a second COVID-19 vaccine problem and it is a big deal

Posted May 11, 2020 by Karen Graham
As pharmaceutical companies around the world race to create a coronavirus vaccine, the alarm is being raised about a problem that may sound small but actually looms large: The world doesn't have enough glass vials to store a vaccine in.
Vaccines  as with all products regulated by FDA  undergo a rigorous review of laboratory and clinica...
Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products.
FDA
There are over 100 teams around the world working to create a vaccine for the coronavirus, however, even if a vaccine is approved for roll-out, there won't be enough vials to store it. And people on the front line of research have already spread the warnings about the problem.
Already, philanthropist Bill Gates, Dr. Rick Bright - who was ousted from his government post amid the coronavirus battle, and Professor John Bell of the University of Oxford have already sounded alarms over a vial shortage, according to Business Insider.
The thing is - even if millions of doses of a vaccine for the coronavirus are ready to go in January 2021, as the NIH’s Dr. Anthony Fauci a few weeks ago said could happen, Not only will there not be enough vials, but there will be a shortage of syringes and needles to administer the vaccine.
According to BioWorld, just as the shortage of swabs and reagents delayed testing for the coronavirus, the same could happen with the vaccination program.
The problem, in a nutshell, is not the science - but the manufacturing and supply chain. Vaccine vials are made from specialized glass. Companies like ThermoFisher Scientific and Schott trademark their glassware — and the vials usually hold between 2 ml and 100 ml of liquid. They measure, on average, 45 mm tall by 11.5 mm wide.
A healthy volunteer receives an experimental universal influenza vaccine known as H1ssF_3928 as part...
A healthy volunteer receives an experimental universal influenza vaccine known as H1ssF_3928 as part of a Phase 1 clinical trial at the NIH Clinical Center in Bethesda, Maryland.
NIH Image Gallery from Bethesda, Maryland, USA
Stoppers that go on top of the vials of vaccine are also specialized, to some extent. Manufacturers have to choose the right material, usually, rubber or latex, that will not interact with the sensitive chemicals inside the vial, reports Politico.
There is also an arduous process involved in getting the vaccine ready for shipment. The process of bottling vaccines is known in the industry as "fill-and-finish." Machines have to siphon fluid into millions of vials and syringes before each one is hand-checked for quality.
But it all winds down to be a glass shortage, and it began before the COVID-19 pandemic. There is a sand shortage in the United States, Evercore analyst Vijay Kumar wrote in an investor note. Desert sand is not acceptable because it is too smooth, and the necessary "angular" sand from rivers and mining is harder to obtain because of environmental laws and restrictions, he wrote.
Dr. Rick Bright and his team of vaccine experts estimated that between 650 million to 850 million needles and syringes would be needed to administer a vaccine in the U.S. alone. Currently, the Strategic National Stockpile (SNS) contains about 15 million needles and syringes, about 2 percent of what will be needed, according to Bright’s complaint.