A conversation with Dr. Mike Ybarra on the current state of COVID-19

On May 11th of this year, the COVID-19 national public health emergency (PHE) officially ended, marking an incredible milestone in the fight against COVID-19. While the end of the PHE signals a new chapter in the fight against COVID-19, the biopharmaceutical industry’s work continues to ensure our health care system is well-prepared for any curve balls this virus might throw as well as staying ahead of the next pandemic.  

I recently had the opportunity to sit down with PhRMA’s Chief Medical Officer Dr. Mike Ybarra and get his perspective on the current state of COVID-19.

1. Just a little over three years ago, our industry made a commitment to lead the fight against COVID-19. Can you give us an update on where our industry focus is now?

MY: While we are in a very different place with respect to the pandemic, our industry remains focused on staying ahead of what might come next. This includes monitoring for new variants, engaging with regulatory agencies and governments to prepare updated vaccines to match circulating variants, continuing to research new anti-viral treatments, as well as researching possible medicines for treating those suffering from long COVID.  

2. What is the latest news on COVID-19 vaccines and what might be coming next?

MY: Individuals, depending on age, now have the option to receive a newly authorized bivalent booster. The bivalent boosters meet FDA’s rigorous safety and effectiveness standards for authorization and are designed to protect against the Omicron BA.4/BA.5 strains. To be up to date with vaccines, it is important that individuals receive the updated bivalent COVID-19 vaccine. Individuals ages 65 or older who have already received a single bivalent booster are now eligible for an additional booster four months following their initial bivalent dose.

Earlier this month, the FDA’s Vaccines and Related Biological Products Advisory Committee held a meeting where senior advisers provided input on which variants of COVID-19 will still likely be circulating this upcoming fall and made recommendations to update the formulations of the vaccines accordingly. As a result, the committee unanimously voted in favor of updating the vaccine to a new monovalent formulation that will target the Omicron XBB1.5 subvariant. Currently, manufacturers are submitting plans to the FDA to ensure that these updated vaccines are ready for the fall.

3. If you haven’t been vaccinated, is it still worth considering?

MY: Yes. One of the biggest changes to vaccine recommendations is the Centers for Disease Control and Prevention (CDC) and FDA are updating the vaccine schedule for most individuals. For those who are currently unvaccinated against COVID-19, the CDC and FDA now endorse a single bivalent mRNA dose as the initial series.  

4. What kind of policy or regulatory environment do we need to ensure that we are prepared for the next public health crisis? Are there any particular policies under consideration now that lawmakers should prioritize?

MY: While the pandemic spotlighted shortfalls in our health care system, it underscored the need for a robust policy and regulatory environment that enables biopharmaceutical researchers to meet the demands of patients and the world. To be prepared for what comes next, we need a clear commitment from our policymakers to continued innovation through strong intellectual property protections, regulatory predictability and a reimbursement system that rewards innovation.

In terms of a specific policy to solve an emerging threat, you may have seen in the news recently about the growing threat of antimicrobial resistance (AMR) — a phenomenon that occurs when harmful microorganisms develop the ability to resist antibiotics. One policy solution put forward in Congress is the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act. This bill would provide much needed incentives to ensure a robust pipeline of new antimicrobial products. I hope policymakers take this bill to the finish line.

Learn more about our industry’s fight against COVID-19 here.