Executives of five firms working on COVID-19 vaccines briefed federal lawmakers on their timelines for potentially winning regulatory approvals and distributing these products, with Johnson & Johnson and Merck both having target goals for major data results next year. AstraZeneca has a more accelerated target for limited distribution of its vaccine.

But during a Tuesday hearing of the House Energy and Commerce Committee's Oversight and Investigations panel, representatives of all five drugmakers agreed on many points, particularly the need to begin immediately to build public trust in future COVID-19 vaccines.

At this hearing, Rep. Michael C. Burgess, MD, (R-TX) asked the representatives from AstraZeneca, Pfizer, Moderna, Merck, and Johnson & Johnson what Congress could do to help address the phenomenon of "vaccine hesitancy" that already has affected Americans' use of established products such as flu and measles shots.

Julie L. Gerberding, MD, MPH, who serves as Merck's chief patient officer, suggested outreach to physicians, as they likely will have more influence on their patients than do officials from pharmaceutical companies or government agencies.

Macaya Douoguih, MD, MPH, Johnson & Johnson's head of clinical development and medical affairs for vaccines, called for an immediate start to education campaigns and outreach about the COVID-19 vaccines now advancing in testing.

"All of that needs to happen now," Douoguih told the House committee.

Pharmaceutical executives and lawmakers at the hearing had delved into the many steps taken by the federal government to try to speed the development and distribution of a COVID-19 vaccine. These efforts will be undermined if many Americans avoid the vaccines because their concerns about these products have not been answered, she said.

"It's not only about access. It's about being willing to accept the vaccines," Douoguih said. "They need to have trust and confidence."

The rapid development cycles for COVID-19 vaccines may add to the public's concerns, said Mene Pangalos, PhD, executive vice president for biopharmaceuticals research and development at AstraZeneca. There needs to be a greater understanding of the efforts taken by the US Food and Drug Administration (FDA) to assure safety of these products while accelerating their development, Pangalos said.

In his written testimony for the hearing, Pangalos said AstraZeneca is finalizing an agreement for more than $1 billion with the Biomedical Advanced Research and Development Authority (BARDA) for development, production, and delivery of 300 million doses of a COVID-19 candidate, AZD1222, to the United States.

Under this agreement, AstraZeneca has a target of supplying the initial doses beginning in October 2020 and the remaining doses in 2021. The US government will own the doses of the vaccine produced and determine how they are distributed. The development program under this BARDA agreement includes a phase 3 clinical trial with 30,000 participants and a pediatric trial.

Current Status, Timelines

At the start of the hearing, Rep. Diana DeGette (D-CO), chairwoman of Energy and Commerce's Oversight and Investigations subcommittee, asked each witness to give a "quick and honest assessment" of their leading vaccine candidates. DeGette began her questioning with AstraZeneca, noting the company's Monday announcement of interim results from the ongoing phase 1/2 COV001 trial, led by Oxford University.

In a press release, AstraZeneca said results published in The Lancet confirmed that a single dose of AZD1222 resulted in a fourfold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants 1 month after injection.

At the hearing, DeGette directly asked Pangalos if AstraZeneca expects to have a vaccine available on an emergency basis by the end of the year in the United States.

"Yes, we do," he replied.

In his written testimony, Stephen Hoge, MD, president of Moderna, said his firm is set to begin a phase 3 trial this month of its COVID-19 vaccine candidate. About 30,000 participants are expected to enroll in a randomized and placebo-controlled study, conducted in collaboration with the National Institute of Allergy and Infectious Diseases.

"We, along with the rest of the world, will eagerly await the results from these trials," Hoge said. "If our vaccine is proven to be safe and effective, the Food and Drug Administration will be responsible for determining whether, when and under what conditions mRNA-1273 is approved."

In his exchange with DeGette, Hoge said Moderna might by the end of the year have data that they can submit to the FDA for them to make a determination about its distribution. Moderna also hopes at that time to "have millions of doses of vaccine available."

In his written testimony, John Young, Pfizer's chief business officer, said his firm is scaling up manufacturing capacity "at risk to be able to quickly supply a vaccine at scale if we are successful," with about $1 billion to be invested toward this goal this year. Pfizer to date has not accepted any federal government funding for this vaccine development program.

"If our clinical trials progress well, and we receive regulatory approval, we hope to be able to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses in 2021 globally, subject to final dose selection from our clinical trial," Young said.

In her written testimony, Douoguih said Johnson & Johnson will continue to work with the FDA, BARDA, and other global authorities to complete a phase 3 trial and "have results in-hand in early 2021."

"Based upon the safety, efficacy, and immunogenicity data from this trial and the cumulative data generated from our other trials, we would then enter into discussions with the FDA and other health authorities regarding regulatory authorizations for emergency use and licensure," Douoguih said.

Gerberding said at the hearing that Merck does not expect to have a licensed COVID-19 vaccine "until 2021 at the earliest."

During the hearing, Gerberding, who led the Centers for Disease Control and Prevention during the Clinton administration, acknowledged the contribution of the FDA and other federal agencies in seeking to speed the development of a COVID-19 vaccine.

Still, she cautioned against counting too heavily on predictions for when Americans would be able to get COVID-19 vaccines.

"That all assumes that things will go exactly as we planned and I think those of us who are experienced with vaccines know that that isn't always the case, so we don't want to overpromise on the timelines," Gerberding said. "That's one of the reasons why Merck is cautious about that."

Maintaining Standards

The federal government has sought to help pharmaceutical companies bring COVID-19 vaccines to market. The FDA last month, for example, issued a guidance document for development of COVID-19 vaccines. The FDA has said that companies need to run clinical trials large enough to demonstrate to the agency the safety and effectiveness of a vaccine. The FDA also said it expects that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated. The agency may also require postmarketing studies to further assess known or potential serious risks.

Rep. Brett Guthrie of Kentucky, the top Republican on the subcommittee, asked the panelists to explain how the safety of COVID-19 vaccines could be assured, given the accelerated pace of their development.

"Can you tell why you believe it's possible to bring a safe and effective COVID-19 vaccine to market in 12 to 18 months when currently the fastest vaccine to be developed was mumps and that took four years?" he asked.

AstraZeneca's Pangalos cited the extraordinary cooperation of regulators around the world, as well as long hours put in by AstraZeneca staff. "I don't think any of the regulatory bodies we've interacted with are lowering their standards," Pangalos said. "By the end of our pivotal studies, we'll have dosed nearly 50,000 people," which he says compares favorably with patient testing pools for already approved vaccines.

Douoguih said that the experience with the fairly rapid recent development of Ebola vaccines can serve as a model in this work. Johnson & Johnson won approval of its Ebola vaccine earlier this month by the European Commission.

"A lot needs to be done in parallel, but it can be done safely without compromising any of the standards that we usually undertake for any clinical trial," she said. "There may be a need to perform post-marketing surveillance and we're working on a plan there."

Published here.