On a call with BioPharma-Reporter this week, experts in biopharma, life sciences and regulatory matters, Winston Kirton and Reed Stephens from the global law firm of Winston & Strawn, weighed in on what the Biden led team can do under that legislative tool.
The lawyers also spoke about what is being done under the new US administration to cast the net wider in terms of having access to other COVID-19 vaccine candidates beyond those from Pfizer and Moderna, the only vaccines to date, granted emergency use authorization by the US Food and Drug Administration (FDA) for distribution in the US.
The Biden administration is looking to greatly enhance the US vaccination rollout, boosting deliveries to states for the next three weeks following complaints of shortages and inconsistent supplies. Yesterday saw the US President announce that his administration will soon “be able to confirm” the purchase of an additional 200m doses of COVID-19 vaccines - an extra 100m doses from Pfizer and the same from Moderna.
Pfizer and Moderna are working to ramp up production, reported CNN, and Biden said that the additional doses will be available this summer. The move would increase the COVID-19 vaccine order in the US by 50%, from 400 million to 600 million doses. With those additional doses, the new US leader said there would be enough to fully vaccinate 300 million Americans by the end of the summer or early autumn.
He also announced measures aimed at improving coronavirus vaccine allocation and distribution in the US.
“The Biden administration has made some aggressive promises in terms of increasing efficiency and availability of vaccines during its first 100 days, and because of that, they have had to completely rethink the prior administration’s vision. So we are seeing, overall, an effort to increase the US access to global resources; by the US rejoining the WHO, and becoming attached to the GAVI alliance, with its portfolio of vaccines that are globally under development through the COVAX initiative, we see the Biden administration is sending signals it is open to considering vaccines developed outside of the US,” said Stephens.
Raw material supplies
The other vital aspect of the Biden administration’s new rollout is their goal to increase the availability of all the components needed to manufacture and distribute vaccines.
And Kirton said it was obvious where “the squeaky wheels” were, when asked if the Biden team has been fully able to gauge the shortfalls in a US vaccine supply chain inherited from the Trump era.
“You have the syringes, the needles, the vials and the stoppers for those vials. The new administration is starting to look at the supply chain end to end, and this is a positive signal; by invoking the DPA, the plan, as stated, is to ensure those ancillary supplies are available in abundance so, as vaccine manufacturing increases, there won’t be any slowdowns in full production."
The vaccine makers have, to date, not actively flagged production bottlenecks due to a lack of components but Pfizer did indicate in December that building its raw material supply took longer than expected.
Germany’s Schott AG, the world’s biggest supplier of specialty glass for medical bottles and syringes, said last week that it didn't envisage any shortage of vials for bottling COVID-19 vaccines.
“The fact that the administration is focused on [component supply] would indicate that this is an area that needs to be addressed,” stressed Kirton.
The DPA is also going to be applied to personal protective equipment (PPE) production, boosting supplies of those materials also in the US, though shortages of these products are not quite as dire as they were early on in the pandemic.
“And then, of course, through invoking the DPA, the administration can also expand the different players in the manufacturing space, if you will, to ensure they can better predict and forecast how many supplies they will have on hand, including for stockpiling,” he continued, as, under the act, the US government can force companies to prioritize and accept contracts for raw materials and services necessary for the good of the nation.
Trump invoked the DPA a handful of times while in office, but commentators argue that he did not exploit it sufficiently to make real headway in the supply needs of the COVID-19 pandemic. “The Trump administration’s use of the DPA has been sporadic, vindictive and too late,” Scott Paul, president of the Alliance for American Manufacturing, told The New York Times last autumn.
Local rollout challenges
Stephens noted a lot of concern at the local level in the US, where the vaccines are actually being managed and administered, that there isn’t enough supply.
Indeed, according to an article in the New York Times, inoculation sites in the US are canceling thousands of appointments in one state after another as the vaccines roll out through a confusing patchwork of distribution networks, with local officials uncertain about what supplies they will have in hand.
There has been a disconnect between the demand and supply of vaccines in the US, said Stephens. “There are plenty of places in the US right now where the supply is sufficient but the demand does not meet the supply because of some messaging issues, but there are other places in the country where the demand is high but supply is not. That is the biggest challenge right now for the Biden administration, making the most efficient use of the existing supply.”
It is about optimizing supply forecasting and demand planning, commented Kirton. “Some of the supply forecasting has been spot on and some of it has, quite frankly, fallen short.”
Awareness raising is still a key issue. The Biden team is also paying attention to coordination, at the federal level, in terms of the communication strategy so that it is clear, succinct, and is not misinformed, said Kirton.
Communication with the leadership at state level is also a priority for Biden and his appointees. “That is very important as regards getting consistent messaging to communities that have been disproportionally affected by the virus, especially since there seems to be strong hesitancy still in those groups,” said Kirton.
There is an ongoing need for education around the vaccines themselves, their safety and efficacy, and in plain speak, he added.
Distribution timeline
Stephens, though, is relatively optimistic that the US could accomplish meaningful distribution progress by summertime, given the types of organization and logistical steps that are being taken now by the new administration. “As long as there is no disruption to the current plan that is being put in place then I think there is a good chance that we will see significant progress by the summer.”
However, the caveat is that the money has to be made available to fund all of the vaccine related initiatives proposed, and that is a political decision, with Congress making some procedural progress in recent days, he added. “The question of how the Senate, and the overall legislative program, is going to be organized over the next two years will have a measurable impact on the speed of progress in the COVID-19 pandemic.”
In terms of widening the net, they envisage that if Johnson & Johnson’s and AstraZeneca’s Phase 3 studies go well, and the data supports it, those vaccine makers can submit their requests to the FDA for emergency authorization thereafter, with potentially, their candidates becoming available for supply in the US by Q2 2021.
“There are also a number of therapeutics in development, and I would expect that we will be hearing more about the utilization of those in the conversation about effective treatments,” said Kirton.
