- At a congressional hearing Tuesday, lawmakers pressed officials from five drugmakers developing vaccines for the new coronavirus — Moderna, AstraZeneca, Johnson & Johnson, Pfizer and Merck & Co. — on their push to make a shot available in record time.
- Legislators questioned the companies on whether they will profit from their vaccines, how they'll be distributed and what can be done to give a skeptical American public confidence that drugmakers aren't compromising safety and effectiveness for speed. AstraZeneca and J&J have promised not to profit from vaccine sales during the pandemic, while the others would not commit Tuesday to selling at cost.
- The hearing took place as Moderna preps to begin, next week, the first Phase 3 trial of a prospective coronavirus vaccine in the U.S. As many as five 30,000-volunteer studies could be underway by the fall, setting the stage for potential emergency authorization by early next year.
The developers of experimental coronavirus vaccines have a lot of questions ahead of them, and many of them have nothing to do with whether their shots can definitively prove, in clinical trials, that they can safely prevent infection or coronavirus disease.
The affordability of any vaccine successfully developed is a major concern, as are issues of access and who should be first in line. Lawmakers on a subcommittee of the U.S. House of Representatives Energy & Commerce Committee used a virtual hearing held Tuesday to seek answers.
Because of the urgency of the pandemic, vaccine developers, for example, are trying to accomplish in months what normally takes years, if not a decade or more. That means that any vaccine that becomes available within the next year would easily break the record for speed to approval, and come to market facing as much skepticism as any in history.
Drugmakers fought off repeated concerns from lawmakers that safety and effectiveness standards were being lowered to accommodate them.
Instead, they argued, scientific work is being done in parallel, rather than sequentially. Larger trials are being run before smaller ones wrap up. Billions of vaccine doses are being made "at risk," without proof they work. But the same quality of data will be accumulated, they contended.
AstraZeneca, for example, would have data from about 50,000 volunteers before it could be cleared for emergency use, a sample size comparable to several approved vaccines, said Mene Pangalos, AstraZeneca's head of R&D.
"We're neither cutting corners, nor are regulators lowering standards," he said.
Companies were not in agreement, however, when it came to their pricing plans. Each were asked whether they planned to sell their vaccines at the cost required to produce them. AstraZeneca has already committed to selling 300 million doses of its vaccine to the U.S. government at no profit, and has pledged not to profit on vaccine sales during the pandemic.
In written testimony before the hearing, Macaya Douoguih, the head of clinical development and medical affairs within J&J's vaccines division, said her company plans to provide more than 1 billion doses at a not-for-profit price during the pandemic.
Moderna and Pfizer, two leaders in the vaccine race, however, will take some profit, executives said. Merck plans to as well, though it is well behind the others. Julie Gerberding, Merck's chief patient officer and former Centers of Disease Control and Prevention head, noted her company doesn't expect for its shot to be available until late 2021 "at the earliest."
"We recognize that these are extraordinary times and our pricing will reflect that," said Pfizer chief business officer John Young. Unlike the others, Pfizer has chosen not to get financial support from the U.S. government to advance its vaccine, which is being developed through a partnership with German firm BioNTech. It's said it will spend more than $1 billion on the project this year.
Several of the companies involved, however, including Pfizer, said that the U.S. government would be in charge of distributing any vaccine that is granted emergency use. That drew criticism from legislators, citing issues the Trump administration has had in distributing COVID-19 tests and therapeutics. Some expressed concern that there wouldn't be equitable distribution of a vaccine, particularly to low-income communities and people of color who have faced disproportionately worse health outcomes from COVID-19.
Politicians and drugmakers did agree that likely the toughest task ahead is to convince Americans to get vaccinated, particularly given the first coronavirus vaccines that become available could rely on a previously unproven technology.
Moderna president Stephen Hoge, for instance, conceded that a "trust deficit" exists and that it will take a "broad effort" to ensure that coronavirus vaccines, if approved, will be widely adopted.
Correcting that deficit will require transparency with vaccine data and any potential side effects observed in clinical testing, as well as ensuring studies enroll diverse patient groups.
"Vaccine hesitancy is an increasingly bigger challenge over time and it certainly will be for COVID-19," said Douoguih, of J&J. "The outreach and discussions and educational materials, all of that needs to happen now."