In an article in Politico, the (somewhat) obvious point is made that the Biden administration is finally recognizing that there is not enough manufacturing capacity in the US to produce booster shots that will be needed to combat the new onslaught of variants coming out of Brazil, the UK, and even New York and California. The report states that “The United States has virtually no capacity to manufacture revised vaccines or booster shots alongside the original versions, according to a half-dozen vaccine experts and Biden administration health officials. Setting up additional facilities could take months or even years.”
The US vaccine solution is, in effect, solving the wrong problem. The Biden Administration has adopted a stance that essentially states “we take care of our own,” adopting the Defense Production Act to ensure that vaccine supplies are prioritized, and that the rest of the world is essentially on their own. This strategy doesn’t work when you are dealing with a virus such as SARS-COVID. The problem should be restated as “how do we ensure vaccines are available for the world, so that we can eliminate the likelihood of variants emerging that will render the current vaccines being distributed ineffective?”
Variants are going to continue to emerge until we can eliminate COVID globally through vaccination. Preliminary data on the vaccines now available in the United States, from Pfizer, Moderna and Johnson & Johnson, suggest that they can ward off the most worrisome known variants, although the shots are more effective against earlier forms of the virus. There is still a chance that an additional dose of those existing vaccines could provide all the protection against variants that people need.
Federal officials and outside vaccine experts say that Pfizer and Moderna shots are easy to modify and manufacture on a large scale, because the mRNA technology they use means very few changes need to be made to the original vaccine before plugging the formula back into the same manufacturing system. This is good news, and perhaps the greatest opportunity for us to understand how to expand manufacturing capacity. But it will also require new ways of thinking about the vaccine. Many large life science companies view their intellectual property as a profit-making machine, which can be extended over and over to cover new forms of variants that will continue to emerge. However, this overlooks the fact that, until COVID is eliminated, global economic growth will be put on hold. Many governments are also stating that they are willing to provide funding to low-cost countries to buy vaccines, but are refusing to license the technology to manufacturers in low-cost countries to enable them to be more self-sufficient. This is an old “colonial” perspective of wanting to keep these countries dependent on developed countries, and is not an effective way to deal with a virus that does not respect borders. In the era of air travel, we are all susceptible to variants that emerge in countries that cannot afford access to vaccines.
Meanwhile, manufacturing capacity of Johnson and Johnson and AstraZeneca vaccines are being constrained, due to the manufacturing quality issues at Emergent, a contract manufacturer in Baltimore. As I noted to a reporter for the Baltimore Sun, once the FDA goes into a facility and starts poking around on an investigation, they are likely going to be there for quite awhile, before they allow manufacturing of vaccines to proceed.
A new set of solutions is required to deal with this new pandemic problem that confronts us. New solutions demand new thinking. Our research team is engaged in many discussions with individuals worldwide to help drive this new way of thinking, and are hopeful that a more collaborative way of thinking about IP and licensing of vaccines is on the horizon.