The Food and Drug Administration (FDA) just granted an emergency use authorization (EUA) for the Johnson & Johnson (J&J) COVID-19 vaccine in the U.S., a move that puts us closer to ending the coronavirus pandemic that sadly has taken the lives of more than a half-million Americans.
A third vaccine option under EUA comes at a pivotal time when supply is the biggest barrier to vaccine administration.
This EUA renews our optimism that we just may be seeing some light at the end of this pandemic tunnel. Before we can truly all feel safe, there is some significant work that lays ahead. Two months into the vaccine rollout, we’ve vaccinated nearly 14 out of every 100 people – progress, yes, but speed needs to improve to get ahead of variants and achieve herd immunity by mid-summer.
Our member healthcare organizations tell us they have the capacity, capability and vigor to mass vaccinate; they just need more product to fulfill demand.
The addition of the J&J vaccine should provide much needed capacity.
As of mid-February, the Biden Administration has finalized deals to obtain another 200 million COVID-19 vaccine doses from Moderna and Pfizer by July 31, boosting the country's total supply to 600 million doses, enough to vaccinate every U.S. adult.
More supply can only be a good thing and estimates show that 3 to 4 million doses of the J&J vaccine could be available in the U.S. by March 6, 20 million by the end of March and 100 million by summer – joining the Pfizer and Moderna vaccines in the race to inoculate America.
Increased supply is just one advantage among many that the J&J vaccine offers healthcare providers.
The J&J vaccine cannot be compared apples-to-apples to Pfizer’s or Moderna’s. J&J’s trials included different patient populations, dosing regimens and time periods – and that’s good news for expanding our understanding of how vaccination can impact the trajectory of the pandemic.
From transportation and storage to administration, the J&J vaccine is different from what is already in the market.
It’s a single dose.
A one-shot regiment is exciting for a variety of reasons. A single-dose vaccine requires half the vaccination resources, including clinicians, syringes and personal protective equipment (PPE); inoculates people more quickly; and contributes to a faster rate of herd immunity.
For providers that may have more than one manufacturer of vaccine on-hand, they may choose to allocate the one-shot option toward patients who are unable to easily return for a second dose, whether due to work schedules, childcare or transportation. It may also be advantageous for rural areas and communities where people may have low access to healthcare facilities. And, it’s a potential positive for people with needle phobias; those who suffer from “white coat syndrome”; and individuals being discharged from a hospital and entering a nursing home, long-term care facility or rehabilitation facility.
It’s kept at standard refrigeration.
The J&J vaccine is stored in a refrigerator, easing the distribution process and making it more amicable to rollout in rural and remote areas that may lack cold-chain storage capabilities. A recent study published by the University of Pittsburgh observed large geographic variation in population access to potential COVID-19 vaccine administration facilities.
The flexibility of a refrigerated product versus a frozen product means states could distribute the J&J vaccine more widely, offering access for people who may otherwise have a longer wait, or be impacted by other healthcare and social disparities.
It’s effective against variants.
While scientists are just beginning to study whether the early high efficacy of Moderna and Pfizer (94-95 percent) will be sustained with more variants in the community, J&J’s vaccine was studied at a time when variants were circulating – and clinical trial data shows it exceeds World Health Organization (WHO) vaccine efficacy thresholds for protection.
With the increase in variants around the globe, it’s a benefit to have multiple vaccine options with different mechanisms of action that could be combined for improved efficacy. It’s also possible that more boosters of existing vaccines or variant spike protein-specific boosters could improve efficacy.
As distribution plans for J&J’s vaccine are made, there are a few important factors to consider.
Some entities may currently have more than one manufacturer of vaccine they will be administering. While jurisdictions are now receiving a three-week lookahead regarding their vaccine allocations, moving forward, it will be critical to also share the exact allocation of each vaccine manufacturer. This information will offer upfront communication and clarity to vaccination sites necessary to avoid confusion, target specific patient populations that may be better suited for one vaccine over another, populate appointment systems and appropriately staff clinics.
Accounting for health equity in the distribution methodology is also critical. Both federal and jurisdictional allocations should be dynamic to ensure vaccine is distributed to the areas and populations of greatest need first.
Finally, as we have seen with the Pfizer vaccine, the possibility of overfill and extra doses to be extracted with the right equipment provides an opportunity to reach the end zone sooner. The FDA, CDC and other federal partners need to be prepared to respond swiftly if it is found that an additional dose can be consistently extracted from the J&J vaccine. This would require updating FDA guidance, retooling the corresponding ancillary kits accompanying the J&J vaccine, updating the CDC reporting data infrastructure and more to accommodate the additional dose.
The addition of a third vaccine is a strong and necessary step in the right direction.
The U.S. vaccination rate will need to double or triple if we’re to have all adults who want a shot vaccinated by mid-summer. For this to occur, we’d need readily available vaccines, a centralized distribution and tracking system, and a massive public campaign to combat vaccine hesitancy.
Study data from the FDA indicates 85 percent effectiveness of the J&J vaccine against severe disease 28 days after vaccination and 100 percent effectiveness in preventing hospitalizations and death. This is good not only for vaccinated patients, but also for our healthcare system at large, as it decreases stress on providers and reserves capacity for severely ill patients.
In Premier’s recent letter to the Biden Administration, we offered recommendations on how to overcome these challenges and expedite the vaccination process across the country. The J&J vaccine will bring more product into the market, which is sorely needed for us to close the playbook on COVID-19.