To discuss this news, David Silverstein, partner in Axinn’s Intellectual Property and FDA Practice Groups, who has been following the rollout of the various COVID-19 vaccines closely, discusses what the approval process would look like should the administration receive approval for its plan to distribute booster shots to all individuals in the United States. With the full approval of the Pfizer vaccine, David weighs in on the broader implications this may have on the regulatory approvals moving forward.
Contract Pharma: With the full approval of the Pfizer-BioNTech vaccine, what questions remain and what’s likely to come next in the ongoing vaccine rollout?
David Silverstein: One of the biggest questions remaining, in the wake of Pfizer’s full approval for people 16 years and older, is how much longer it is going to take for FDA to grant emergency use authorization for young children. Since school year has now begun in most parts of the country, FDA is under a lot of pressure to grant full approval for administration to young children.
CP: What are the broader implications of the approval on the regulatory process for vaccine approvals moving forward?
DS: Other than serving as another example of FDA fully approving a drug that had been used under an EUA, not terribly much.
CP: What can we expect for other/new COVID vaccines and therapeutics in development going forward?
DS: It is looking as if SARS-Cov-2 is going to become endemic, and the transmission and mutation rates are such that we will face variant after variant. So we should expect a need for boosters, much like we do with the flu vaccine. The mRNA vaccine technology, thankfully, is very well suited to “updating” these already-approved vaccines by making minimal changes to the vaccines themselves. With the full approvals of Pfizer’s and Moderna’s mRNA vaccines as precedent, it will likely be much easier and faster to secure full approval for those boosters.
David Silverstein is a registered patent attorney with nearly twenty years of experience handling legal and regulatory matters, on the generic and the branded side, relating to pharmaceutical and biotech products. David has served as lead counsel in matters before the U.S. district courts, Patent Trial and Appeal Board, and U.S. Court of Appeals for the Federal Circuit. In addition, David’s practice includes performing due diligence, license negotiation, and counseling in connection with complex commercial transactions involving pharmaceutical and biotech products. David is frequently involved in FDA strategy and counseling, including filing or responding to citizen petitions, and coordinating FDA strategy with patent litigation strategy.