The COVID-19 Pandemic: What We Need To Consider When Talking About Vaccines
“The 2020 Election is just days away. The President has repeatedly vowed that a vaccine would be available by Election Day, although prominent scientists within his administration have said it’s extremely unlikely… As HHS rolls out its vaccine distribution plan, the Indian Health Service and the Indian Health Care Delivery System has a responsibility to use sound judgement in determining when to administer a vaccine to our patients.”
The COVID-19 Pandemic has impacted nearly every aspect of our daily lives and shifted the focus of healthcare policy in a new direction. The latest dilemma forces us to examine safe and effective treatments and vaccines for COVID-19. Regrettably, the scientific community and government institutions that we rely on for clear and definitive solutions to address infectious diseases are being called into question due to political influence. Recent actions by the Trump Administration have undermined the public’s faith in these institutions. These actions include censoring the Centers for Disease Control and Prevention’s (CDC) Mortality and Morbidity Weekly Reports (MMWR), bypassing standard procedures for drugs and treatments to address COVID-19, and a pattern of mixed, misleading, and contradictory messaging from the CDC and Department of Health and Human Services (HHS).
The first sign of foul play came when President Trump’s political appointee, Michael Caputo demanded to revise, delay and even scuttle its most prestigious publication, the MMWR. The MMWR has long been the cornerstone of the CDC’s work and is used to inform doctors and researchers with the most up-to-date information regarding infectious diseases, including COVID-19. Mr. Caputo’s communication team openly complained to CDC Director Robert Redfield that the agency’s reports would undermine President Trump’s optimistic messaging about the outbreak. Mr. Caputo and his team were allowed to review and make changes to the MMWR and would sometimes delay information that was counter to Trump’s narrative that things were improving. That said, it is important to recognize the CDC worked with tribal epidemiology centers to release the MMWR that established COVID-19 rates are more than 3.5 times greater among AIANs than their non-Hispanic white counterparts. It should also be noted that California COVID-19 data was found to be unreliable for that MMWR and was excluded from the study.
Another way the Administration has undermined the public trust is by authorizing drugs and treatments for COVID-19 without going through the normal approval process. Earlier in the year, the President claimed at a campaign rally that Hydroxychloroquine and Chloroquine, a pair of drugs used to treat malaria, are safe and effective to prevent and treat COVID-19. The President began touting the efficacy of these drugs on the recommendation of Larry Ellison, a big-money fundraiser for the president. Shortly after a conversation with Mr. Ellison at one of his fundraisers, the White House pressured the Federal Drug Administration (FDA) to approve Hydroxychloroquine and Chloroquine through an Emergency Use Authorization (EUA). The EUA’s approval standard for prospective drugs are that the “potential benefits of the drug outweigh the risk.” On March 20, 2020, the FDA approved these drugs with an EUA. On June 16, 2020, the FDA was forced to rescind its approval after they were found to be unsafe and ineffective to treat COVID-19. The CDC delayed reporting that this pair of drugs was unsafe and ineffective for approximately a month after clinical trials concluded. The delayed response was at the direction of Mr. Caputo and his communications team.
Another example of the Administration playing politics with the public trust is the FDA’s issuance of an EUA for COVID-19 Convalescent Plasma (CP) just one day ahead of the Republican National Convention. This alone would not be cause for concern. However, during the press conference announcing the EUA for CP, President Trump and his team grossly overstated the efficacy of the treatment. Furthermore, the EUA for CP went against the recommendations of the scientific community, due to limited research on the treatment. President Trump’s announcement and the EUA approval was opposed by the National Institutes of Health who is calling for further studies of the treatment. In late September, Mr. Caputo left his role at CDC citing mental health issues. Shortly thereafter, the FDA announced continued clinical trials and studies regarding the effectiveness of CP as a treatment for COVID-19.
A primary concern moving forward is the public’s faith in the CDC’s ability to approve a safe and effective vaccine free from political influence. Regrettably, HHS appears to be priming the public to accept a vaccine before it has been thoroughly scrutinized. An email dated September 14, from HHS’s Director of Intergovernmental and External Affairs, Laura C. Trueman, oddly highlights an opinion piece that endorses an EUA for a COVID-19 vaccine. Ms. Trueman quotes the Op-Ed noting, “they say that an Emergency Use Authorization for a COVID-19 vaccine ‘isn’t a lower standard for FDA approval’ noting the EUA was designed for a public health emergency. They conclude that an EUA is ‘a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a COVID-19 vaccine.’” As noted above, the EUA is factually a lower standard of approval, where the “potential benefits of the drug outweigh the risk.” Additionally, the EUA approval process has been used on multiple occasions for political purposes.
COVID-19 as an infectious disease is easily one of the least understood diseases of our time. Guidelines to address the disease have frequently been revised. Guideline revisions have been contradictory in nature, and in at least one instance politically motivated. This alone has eroded the public trust in the CDC and other government institutions. In addition, the Trump Administration has a long track record of mixed, misleading, and contradictory messaging. The President has habitually worked to discredit those that disagree with him. His political strategy rests on invalidating any voice that is counter to his narrative. It is the reason Michael Caputo, a man without any prior experience in health care, was appointed to a position which oversees the communications coming from the CDC. We are living through a time when everything must be questioned, and the reliability and reputation of our most trusted institutions have been tarnished.
That being said, the FDA is working hard to salvage its integrity and the public trust. To support this effort the FDA developed stricter standards for the EUA process. These stricter standards cleared a review by the HHS and were expected to be approved by the White House. However, on Wednesday, September 23, the President said his Administration may not approve the tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines. Trump also suggested that the FDA’s decision to revise the standards, “was a political move more than anything else.”
The 2020 Election is just days away. The President has repeatedly vowed that a vaccine would be available by Election Day, although prominent scientists within his administration have said it’s extremely unlikely. President Trump is quoted saying a vaccine would be ready, “before the end of the year and maybe even before Nov. 1. I think we can probably have it sometime in October.” Although this political posturing is contradictory to what nearly all infectious disease experts and vaccine manufacturers have publicly stated, we must keep in mind that the President has pressured the FDA to use the EUA as a political tool in the past. As HHS rolls out its vaccine distribution plan, the Indian Health Service and the Indian Health Care Delivery System has a responsibility to use sound judgement in determining when to administer a vaccine to our patients.