4 things to keep in mind as COVID-19 vaccination efforts scale

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available.

Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to the New York Times vaccination tracker. “If you’re looking over the past 12 months, it doesn’t look like we’ve gotten very far,” said Reed Stephens, a partner at the global law firm Winston & Strawn.

But the rate of vaccination is picking up. The U.S. vaccination rate is now hovering between 1.5 to 2 million doses per day. Production is ramping up, and FDA will likely authorize additional vaccines in the coming months. Stephens said the goal of getting a large percentage of U.S. adults vaccinated by the end of summer seems within reach.

Since President Biden took office, the federal government seems poised to increase funding for the overall vaccination effort — with Congress moving forward on Biden’s $1.9 trillion COVID- 19 relief bill. Biden during a CNN town hall last night in Milwaukee promised 400 million doses available by the end of May — and 600 million by the end of July.

Other factors that could bode well for mass vaccination include the Biden administration’s focus on last-mile administration of vaccines, which had been a stumbling block in the past. “The current administration is taking a very active role to create standardization around the process and to give direction as to how states should go about distributing vaccines,” Stephens said.

Additionally, the current administration has taken a more end-to-end view of the COVID-19 vaccine supply chain. “This administration has determined that it’s just not about supplying just the vaccine,” said Winston Kirton, who is also a partner at Winston & Strawn. The administration is also focusing on safeguarding the supply of raw materials for vaccines, vials, stoppers and other goods needed for mass-vaccination. The federal government is also prioritizing creating a standardized data framework that extends across the federal and state governments. “We’re seeing evidence of better connectivity around data analytics,” Kirton said.

1. More vaccine options could bolster public acceptance of vaccines

The first two vaccines to win emergency use authorization from FDA rely on a relatively novel mRNA platform. In the future, however, there will likely be a growing number of options available. “Having more options for vaccines creates more opportunity for acceptance from the public,” Stephens said. While having several vaccine options available could also give rise to confusion, having multiple options available will provide more flexibility for the mass-vaccination effort.

2. EUAs are not full approval

As a growing number of COVID-19 therapies became available under emergency use authorization, FDA expects to see additional data related to product performance and manufacturability before it grants them full approval. Manufacturers that have won emergency use authorization should thus continue to be diligent in their efforts to document product performance as the pandemic evolves.

3. The pandemic could usher in a new era of government-industry collaboration

As recently as early 2020, the vaccine system had a reputation for being a niche part of the pharmaceutical industry. “It wasn’t deemed as a particularly robust area for business development among pharma companies,” Stephens said. “Now, that’s been completely turned on its head.”

Industrial countries across the globe are “pouring effort, money, investment and attention into vaccine business,” Stephens said. “I don’t think that’s going to change even once the COVID-19 situation has stabilized.”

The emergence of new SARS-CoV-2 variants could “keep this public–private partnership going fairly in a pretty robust way for years to come,” Stephens said.

While the pandemic has inspired pharmaceutical companies to find new ways to innovate, it is also forcing regulators like the FDA to evolve. “The public health emergency has arguably created some levels of innovation within the FDA,” Kirton said. Pharmaceutical companies should expect increased flexibility and collaboration from the agency. It’s plausible that the pandemic will drive changes in how the agency considers submissions and applications that “extend beyond COVID and into other areas,” Kirton said.

While drug approvals have traditionally relied on a linear model, “there may be opportunities to innovate around that process — especially in underserved or critical disease states,” Kirton added.

4. Education is a vital consideration for mass-vaccination

As mass-vaccination efforts ramp up to reach the broader public, providing clear information about vaccines becomes increasingly essential. “The Biden administration has said that they are going to commit more resources to education,” Kirton said.

Such educational efforts must reach underserved communities and communities that mistrust the government. “You need to partner with grassroots community-level efforts,” Kirton added. “In the Black community, the churches have always been at the forefront of getting messaging out. I think you have to consider non-traditional approaches.”

Educating the community about vaccines will require a multi-pronged approach that prioritizes equity of access to information. “Right now, there is an increase in messaging on YouTube and in electronic and social media in general,” Kirton said. But not everyone relies on those platforms. “People who are essential workers are out working, they’re usually not able to sit in front of a laptop,” Stephens said. “We need to take a broader look and increase our messengers, approaches and access points,” Kirton added.

The federal government has become more effective at educating the public about COVID-19 vaccination. “The Biden administration is sending consistent messages about the importance and the value of getting vaccinated,” Stephens said. “That in itself is a change from the last administration, which sent a lot of mixed messages.” The Biden administration is also working to ensure equitable access to broadband, which could lay the groundwork for educational efforts that translate into fairer vaccine access down the line.

Ultimately, focusing on equitable vaccine access could protect the broader population, Stephens said. “From a clinical public health standpoint, none of us are going to be safe until all of us are safe,” he added. “And that means folks who may not have easy access to knowledge about where to get vaccinated need to be reached.”