With COVID-19 still raging in the U.S. and the death toll approaching 200,000 Americans and 1 million people worldwide, a safe and effective vaccine is required to stop the spread of the disease and restart the economy.
All eyes are on the pharmaceutical industry, as leading companies have moved ahead to discover, test, and manufacture a vaccine faster than ever before. Many of the world’s best scientists are focused on this goal. To accelerate the availability of a vaccine in record time, the Trump administration launched Operation Warp Speed, funding multiple vaccine candidates through an accelerated development process and committing to purchase hundreds of millions of doses of approved vaccines.
Trying to speed up science carries many risks, especially for a novel virus like this one, which is not well understood nor easily characterized. Scientific discoveries cannot be driven by timetables like the upcoming Presidential election is.
To address these risks, the following questions must be answered:
1. Will there be safety issues not revealed in early clinical trials?
2. Will the vaccines be sufficiently effective to stop COVID-19’s spread?
3. Will the American people have enough confidence to get vaccinated?
4. Will there be sufficient quantities of vaccines available, and who gets priority?
5. If multiple vaccines are approved, how will people know which one to get?
6. Will political pressure influence the approval process?
Time pressure to complete the trials raises concerns that safety issues may appear only after millions of people have been vaccinated. Moncef Slaoui, head of Operation Warp Speed’s vaccine development arm, has said there is a “very, very low chance” of a vaccine being approved by election day, and that he will resign if he feels pressure to approve an unsafe vaccine.
On Sept. 9, clinical trials for AstraZeneca’s leading vaccine candidate were halted after a patient developed neurological symptoms, illustrating the care that must be taken in testing new vaccines. (Those trials have since resumed after a careful clinical review.) Learning of safety issues after millions of healthy people have been vaccinated would be devastating to the nation’s health and public confidence.
The Food and Drug Administration (FDA) has set the minimum threshold for a vaccine’s effectiveness at 50%, essentially the same bar as flu vaccines, but influenza has a far lower risk of death than COVID-19 does. With 50% effectiveness, will the public feel sufficiently confident to resume their normal lives—working in crowded spaces, attending concerts or sporting events, going into crowded bars and restaurants, or taking long airplane flights? Hopefully, pharmaceutical makers will be able to develop a vaccine with substantially more than 50% effectiveness.
A Sept. 10 Kaiser Family Foundation poll found that 54% of Americans would not want to receive a vaccine approved prior to election day on Nov. 3. Meanwhile, anti-vaccine activists are using COVID-19 to stoke fears about the safety of all vaccines. Thus, it is essential to build public confidence in the vaccine’s safety and effectiveness, so more people will volunteer to get vaccinated.
Once approved, a vaccine is unlikely to be widely available …read more