Come Tuesday, November 3rd – Election Day – Americans will exist in one of two realities: One reality in which COVID-19 vaccines deemed safe and effective are available to the electorate, or a different reality in which vaccines are still unavailable. Biopharma companies are optimistic their COVID-19 vaccines could be available as early as the fall. At the same time, Congress is concerned political interference from the White House could result in the approval of substandard vaccines. This tension was on full display at yesterday’s House Energy and Commerce Subcommittee on Oversight and Investigations hearing featuring leaders from COVID-19 vaccine-makers AstraZeneca, Johnson & Johnson (J&J), Merck, Moderna, and Pfizer.
The prospect of political interference in COVID-19 vaccine availability
If all goes well, there could be millions of COVID-19 vaccine doses ready to be distributed to Americans this fall. AstraZeneca may have hundreds of millions of doses available as soon as September. Moderna has its sights set on having millions of doses produced by the fall. Pfizer could provide 100 million doses by the end of this year. These hopes are contingent on these companies’ vaccines proving safe and effective in phase three trials involving tens of thousands of people.
But what if US safety and efficacy standards are adjusted, or even disregarded, to serve political interests? That’s the concern Representative Frank Pallone (D, NJ-06), chair of the full committee, raised with the five officials from vaccine-making companies.
At the end of June, the Food and Drug Administration (FDA) established guidance for the approval of COVID-19 vaccines. The guidance states that any vaccine must prove at least 50 percent more effective for COVID-19 prevention when compared against placebo. (The flu vaccine varies between 40 and 60 percent efficacy from one year to another.) Efficacy of 50 percent or more for a COVID-19 vaccine must be shown in a clinical trial enrolling at least 30,000 people of all different races and ethnicities.
Chair Pallone raised the possibility that President Trump could pressure FDA to lower official COVID-19 vaccine standards to well below 50 percent efficacy, or to surreptitiously approve a vaccine even if a company’s internal data show it’s less effective than FDA’s public requirements. The Chair was looking for assurances from the vaccine-makers that they will help guard against possible political interference from the White House. Dr. Mene Pangalos, AstraZeneca’s executive vice president of biopharmaceuticals research and development, stressed that all his company’s clinical data will be published openly, and that since the vaccine will be marketed globally, it will be vetted by many countries’ regulators, in addition to FDA. Moderna’s president, Dr. Stephen Hoge, also committed to publishing his company’s data regardless of whether the vaccine succeeds in clinical trials, and added that independent investigators on a National Institutes of Health (NIH) Data Safety Monitoring Board are conducting oversight of Moderna’s trials. Even so, White House influence on FDA is expected to be monitored closely as the US heads toward Election Day.
The White House has not shied away from pressuring federal agencies responding to the COVID-19 pandemic. Earlier this month, President Trump undermined Centers for Disease Control and Prevention (CDC) guidelines for reducing the risk of spreading COVID-19 at schools. In May, the Administration shelved CDC recommendations “with step-by-step advice to local authorities on how and when to reopen restaurants and other public places.” In April, a research grant funding the study of coronaviruses’ transmission from bats to people was terminated because the White House told NIH to cancel it. And finally, FDA is not immune to pressure from the Administration: A whistleblower alleges the since-rescinded emergency use authorization permitting treatment of COVID-19 patients with hydroxychloroquine was granted as a result of political interference, and there is evidence FDA Commissioner Stephen Hahn took unusual steps to assist a New York medical doctor in obtaining the drug. Congress finds the possibility of political interference from the White House in FDA’s COVID-19 vaccine approval process very worrisome.
Keys to expediting vaccine-making
Vaccines are rarely developed in even less than five years. The development of a safe and effective vaccine and the beginnings of its distribution in less than a year since the emergence of a novel disease would be revolutionary. To expedite COVID-19 vaccine-making, three key tactics have been implemented.
For one, bureaucratic steps are being streamlined to move the vaccine testing process along faster. Unnecessary delays between trial phases have been eliminated, while rigorous studies on vaccine safety and effectiveness have been maintained.
Second, some “plug-and-play” technologies developed in prior vaccine work have been applied to SARS-CoV-2 (the coronavirus that causes COVID-19). For example, Moderna’s vaccine development platform had been used previously to produce influenza virus and Zika virus vaccine candidates, and during the hearing, J&J’s Janssen Vaccines head of clinical development and medical affairs, Dr. Macaya Douoguih, cited her company’s accelerated program that produced an Ebola vaccine as critical to J&J’s efforts to produce 100 million COVID-19 vaccine doses by March 2021.
And third, companies are already scaling up the manufacture of potential COVID-19 vaccines in parallel with the testing phases, so that if a COVID-19 vaccine candidate proves successful in trials, millions of doses will be immediately available. Called at-risk manufacturing – if vaccine candidates do not pass muster, millions of doses would be worthless – vaccine-makers are implementing this capital intensive tactic because of the urgent need for safe and effective COVID-19 vaccines to be available for protection of the public.
Vaccine-makers are optimistic that tens of millions of COVID-19 vaccine doses will be available by the end of this year; however, the US government’s plan for fair and equitable vaccine distribution is yet to be released. CDC has the lead on planning for COVID-19 immunization infrastructure and vaccine distribution to the American people, and the Department of Defense is supporting CDC on logistics. Ensuring all Americans can be vaccinated against COVID-19 demands intensive local-state-federal coordination, as well as cooperation between the public and private sectors. While biopharma companies continue their rapid pursuit of vaccines against COVID-19, there is good reason for both hope and vigilance.
To review the full House Energy and Commerce Subcommittee on Oversight and Investigations hearing, click here.