Rather than coordinate a coherent, science-based national strategy to combat the COVID-19 pandemic, Trump is hedging his bets solely on the quick release and acceptance of a vaccine (admittedly, a better strategy than some other ideas floating around his administration—like waiting for herd immunity to be achieved via infection, which would lead to an estimated 2 million additional U.S. deaths.)
The Trump administration plans to provide 300 million COVID-19 vaccinations by January 2021 through its vaccine program, Operation Warp Speed (OWS). But some are worried Trump will pressure the FDA to approve a vaccine as soon as late October as a campaign stunt to boost his reelection chances.
Despite some reassurances from federal officials, there are fears that the typical pathway for vaccine-approval of the COVID-19 vaccine will be impacted by potential political pressures.
“What I’m concerned about is there could be a gray zone where a vaccine looks partially protective and it goes on the market without a full formal review process,” said Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine.
There have been a ton of questions surrounding the potential of a COVID-19 vaccine (or vaccines), and some warranted concern for what to expect when options come along; so let’s tackle some of the most common ones.
How Far Are We From a Vaccine?
At the Republican National Convention, Trump touted Operation Warp Speed’s progress, promising during his acceptance speech, “[we] will produce a vaccine before the end of the year, or maybe even sooner.” Since then, the Trump administration has been prepping vaccine distribution partners to prepare by November 1.
To reassure some, and according to Massachusetts General Hospital, there are “approximately 135 vaccines now in development worldwide, moving at a pace that we have never seen before.” This speed and variety will help ensure that we have a selection of vaccines that will be effective for everyone.
At the same time, in a move widely condemned by health experts, the Trump administration has refused to join the COVID-19 Vaccine Global Access Facility (COVAX) global initiative, due to it’s being co-led by the World Health Organization (WHO). (Trump has an unexplained vendetta against the global health agency.)
The aim of COVAX is to “accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.” In the worst-case scenario, the U.S. could be left without a vaccine if none of our own vaccine candidates are proven to be safe and effective.
Meanwhile, Dr. Anthony Fauci—director of the National Institute of Allergy and Infectious Diseases and a highly trusted voice among the American public—said during a congressional hearing he is “cautiously optimistic” a vaccine will be ready by the end of this year or in early 2021. Currently, there are 37 vaccines undergoing clinical trials in humans.
Additionally, clinical trials could end early if there are overwhelmingly positive results.
But there’s another caveat: We don’t know how long COVID-19 immunity will last. If the coronavirus vaccine is ready in the coming months, it would be the quickest development of a vaccine ever. For a quick comparison, the mumps vaccine took over four years to develop before it was licensed in 1967.
Will the Vaccine Be Safe and Effective?
Public health officials are worried Trump will pressure the FDA to approve a vaccine without sufficient vetting of its safety and efficacy in order to improve his chances of reelection.
We’ve already seen Trump’s administration make hasty public health decisions—like when FDA commissioner, Stephen Hahn, approved hydroxychloroquine for emergency use against COVID-19 without review by an independent committee.
As of July, the FDA website advocates against the use of the drug, citing reports of heart rhythm problems, blood and lymph system disorders, kidney injuries, and liver failure—among other issues. Yet, in August, Trump was still pushing for its use.
As another example of politics influencing Trump’s pandemic response, Jared Kushner, the president’s son-in-law and White House adviser, reportedly had created a national testing plan early on, but suddenly scrapped it for political reasons.
“The political folks believed that because it was going to be relegated to Democratic states, they could blame those governors, and that would be an effective political strategy,” a public health expert linked to the official coronavirus task force told Vanity Fair.
Last week, in a decision made without approval from Dr. Fauci, the coronavirus task force pressured CDC officials to recommend those potentially exposed to COVID-19 do not need to be tested unless they are symptomatic—despite wide knowledge that asymptomatic transmission can occur.
All of this is to say that Trump’s handling of the pandemic hasn’t instilled confidence in health experts and the public that vaccine approval will be handled in good faith.
What’s Being Done to Ensure Public Trust in a Vaccine?
Recently released guidelines from the FDA on COVID-19 vaccine candidates indicate that no compromises will be made when it comes to evaluating safety and efficacy.
Yet, a major obstacle to a successful COVID-19 vaccine program persists: One-third of Americans say they would not get the vaccine once it’s available.
And unless a sufficient number of Americans are vaccinated, it is “unlikely” that we will achieve herd immunity—the point at which virus transmission becomes rare because a large majority of the population is immunized, according to Fauci.
“There is a general anti-science, anti-authority, anti-vaccine feeling among some people in this country—an alarmingly large percentage of people, relatively speaking.”
To be sure, Hahn has denied the FDA will make a decision concerning the vaccine’s release based on politics. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has also denied political pressure will influence his decision over a vaccine approval.
Fauci too assured the public a vaccine will not be rushed through the approval process: “The American public should be assured that in the process of determining the safety and efficacy [of the vaccine], the proper steps have been taken to determine that, and when a vaccine becomes available, it’s important for their own health and for the health of the country to take that vaccine.”
Still, for some member of Congress—and for a significant number of Americans—these promises simply aren’t good enough.
Chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, Rep. Raja Krishnamoorthi (D-Ill.) introduced a bill requiring the FDA to have an independent expert panel review and issue a recommendation on a COVID-19 vaccine before Hahn. However, there’s been no movement on the bill since August 7.
Additionally, nine top drug companies released a joint public pledge to “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
The statement, however, does not include a pledge to release data from the clinical trials, Rachel Sachs, an associate professor of law at Washington University in St. Louis, pointed out to Politico.
A lack of transparency surrounding the companies’ approval process will only worsen the public’s ability to trust a vaccine.
Will I Be Able to Get the Vaccine Once Approved?
The Centers for Disease Control sent documents to U.S. states and territories outlining protocols to prepare for vaccine administration. Vaccine shipment and deployment will be prioritized based on “current local spread/prevalence of COVID-19” in different regions.
Additionally, the vaccine will be first administered to “prioritized populations,” including health care workers, essential workers, national security professionals and residents and workers in long-term care facilities.
How Much Will This Cost Me?
Paul Mango, deputy chief of staff for policy at the U.S. Department of Health and Human Services (HHS), announced in mid-August the government will pay for the vaccine production and its distribution. However, providers may still charge an “administrative fee” to administer the vaccine to patients.
Mango said the administrative fee will be covered by Medicare and Medicaid. However, it’s unclear whether or not there will still be a copay for those insured by private companies. Mango said the government is working with insurance agencies to make sure consumers do not have to pay an administrative fee, and that some health insurance companies expressed “eagerness” to cover the cost of the copay.
Still, here at Ms., we’re skeptical of this holding true—given that many private health insurance companies are still making it hard to receive free COVID-19 testing, despite profiting more than ever during the pandemic.
Those who are uninsured may have to pay part or all of the administrative fee as well. Trump administration officials have said funds from the CARES Act Provider Relief Fund will be used to cover the cost, but coverage is “subject to available funding,” according to the HHS website. (In other words, the administrative cost may be shifted to the patient once funding runs out.)
The HEROES Act, passed by the Democratic-controlled House of Representatives includes coverage of immunization costs for the uninsured. However, the Republican-controlled Senate continues to refuse to vote on the bill.
If the vaccine is not free, it will potentially reduce the number of people who receive it, making it more difficult to safely achieve herd immunity.
“Reducing financial barriers is one critical element, as research shows that even small copayments can deter people from seeking needed care,” Harald Schmidt, a medical ethicist and vaccination researcher at the University of Pennsylvania, told Roll Call.
Regardless of when the COVID-19 vaccine becomes available, health care professionals are urging the public to get vaccinated against the annual flu.
Flu vaccinations are especially important this year in order to keep hospitals from becoming overwhelmed with patients and avoid a “twindemic” this fall. And because the symptoms of the seasonal flu and COVID-19 overlap, receiving the flu vaccination will reduce chances of misdiagnosis.
As always, continue to follow social distancing guidelines, wash your hands frequently and communicate with your health care provider if you are exposed to or having symptoms of COVID-19.
To keep up with our latest coverage of the pandemic and other health-related news, check out our Weekly Pulse column.