Finding a magic cure is a surefire way to get reelected in the middle of a global pandemic. The entire world is waiting for a reliable vaccine or an effective medication to treat Covid-19.
China and Russia have already approved the limited use of COVID-19 vaccines without clinical trial data. What is to stop President Donald Trump from setting up a perfect “made for television” moment by releasing a Covid-19 vaccine just before the election?
Donald Trump is likely to release a Covid-19 vaccine under the emergency use authorization (EUA) before completing phase 3 data indicating the vaccine is safe and effective. He is expected to release the vaccine in October.
An October surprise would look good on TV but not permit enough time to discover if the vaccine works or causes harm before we cast our votes.
What is the evidence for EUA vaccine release?
The Trump administration has tested the waters. Recent EUAs have been approved for Remdesir, Convalescent Plasma, and Rapid Antigen testing. The FDA revoked a previously EUA for Hydroxychoroquin after studies showed the benefits did not outweigh the risk.
An August 27th letter from CDC director Robert Redfield urges state governors to expedite “applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”
The US government has partnered with McKesson Corp. to distribute coronavirus vaccines to state and local health departments. We have also invested in eight different COVID-19 vaccines.
Stephen Hahn, the FDA director, published an article in JAMA stating a COVID-19 vaccine will be reviewed “under either the traditional Biologics License Application (BLA) review process or under the Emergency Use Authorization (EUA) program.”
The writing is on the wall for the Covid-19 EUA vaccine release.
How EUA works?
Countries like the United States create regulatory pathways for emergency use of vaccines and therapeutics outside of a clinical trial in the event of a public health, military, or national security emergency.
The EUA grants liability protection to pharmaceutical companies. The EUA also ends once the emergency or threat has resolved.
FDA director Stephen Hahn set the goals for a Covid-19 vaccine in a Washington Post Op-Ed stating, “any authorized or approved Covid-19 vaccine would need to show that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated.”
What is the harm with releasing a Covid-19 vaccine under the EUA?
Andy Slavitt, the former Medicare and Medicaid director for President Barack Obama summarized the issue stating, “Done right, vaccines end pandemics. Done wrong, pandemics end vaccines.”
Vaccines require trust. We rely on regulatory agencies to oversee the clinical trials to ensure a potential vaccine is safe and effective. If we can not trust our regulatory agencies to rely on science and protect the public from political pressure, we have a potential disaster recipe.
Various governmental agencies carefully govern clinical trials. Dating back to the infamous Tuskagee study in which black men were injected with syphilis without consent, strict guidelines were put into place for ethical clinical research.
Drug trials go through three phases:
- Phase 1 trials focus on safety and dosage.
- Phase 2 trials evaluate efficacy and side effects.
- Phase 3 trials are large trials seeking to prove a drug or vaccine works better than what is already available and to confirm efficacy and monitor for adverse reactions.
Releasing a vaccine without proving it does what it is supposed to do and does not cause harm is crucial to establishing trust. Without validation, we risk losing the public trusts in a Covid-19 vaccine as well as vaccines in general.
The World Health Organization (WHO) Solidarity Vaccines Trials Expert Group highlighted the dangers in an editorial published in The Lancet. An unproven or harmful vaccine could worsen the pandemic.
Vaccine makers pledge not to see FDA approval without data
In a bizarre twist, vaccine manufacturers have jointly pledged not to send a vaccine to the FDA approval without safety and efficacy data. Pfizer Inc., Moderna Inc., Johnson & Johnson, GlaxoSmithKline Plc, Sanofi, and potentially others are among the companies working together to avoid losing the public trust.
This joint pledge implies the vaccine manufacturers believe the FDA under the Trump administration can not be considered reliable to oversee the approval process.
Vaccine makers are taking a public stance against getting their own product to market.
Rushing medication to market can have grave consequences
The entire world waits on pins and needles for a magic bullet to stop COVID-19 dead in its tracks. We cheer on researchers working around the clock to find a solution, a vaccine, or a cure.
Despite our enthusiasm, we must take a cautious approach to medical research. We can not lose the public’s trust.
The FDA and CDC have made crucial mistakes cowering to political pressure. It is not too late to let the career scientists lead the way.