February 25, 2021
By Naomi Lopez
Barring any surprises, the U.S. will soon have another COVID-19 vaccine approved for use. While the approval of a third COVID vaccine will be cause for celebration, the process of getting to this point is a reminder that the U.S could—and should—be doing more to get medical innovations to the public more quickly.
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee meets Friday and is expected to recommend that the FDA authorize Emergency Use Authorization for the Johnson & Johnson COVID-19 vaccine, a one-shot vaccine that does not require frigid temperature storage. While the recommendation isn’t binding, it is usually followed and, at this point, seems to be a foregone conclusion. Emergency Use Authorization could happen almost immediately, meaning that Americans will likely have another vaccine options in mere days.
This is great news, without a doubt. Limited vaccine supply continues to hinder immunization rollout efforts across the country, as many Americans who are eligible for a vaccine struggle to get an appointment for the shot. More supply will help meet the high demand for vaccines, and should Emergency Use Authorization be granted, almost four million doses of the Johnson & Johnson vaccine are ready to be shipped out across the country, with an expected total of 100 million available by the end of June.
Even though the U.S. leads the globe in drug innovation and development, the risk-averse nature of the FDA means that we frequently lag other countries in granting approvals for potentially lifesaving treatments. That South Africa, which is ground zero for a very concerning COVID-19 variant, started immunizing with the Johnson & Johnson vaccine last week underscores the fact that the U.S. must do better. Since South Africa started immunizing with that vaccine, the U.S. surpassed the tragic benchmark of 500,000 deaths.
And make no mistake: This vaccine would save lives. The vaccine has an overall efficacy rate of 66 percent in preventing COVID-19. While less effective than the now-available Pfizer-BioNTech and Moderna vaccines, the lower efficacy of the Johnson & Johnson vaccine far exceeds the FDA’s desired benchmark of 50 percent efficacy, reduces illness severity, reduces risk of hospitalization and death, and is logistically simpler to administer due to its single dose and regular refrigeration requirements. And based on the preliminary trial data, the vaccine is 86 percent effective in severe COVID-19 illness and 100 percent effective in preventing hospitalization and death. For those with the most severe cases of the virus, having had access to the Johnson & Johnson vaccine could make the difference between being a COVID victim and a COVID survivor.
Even though the U.S. leads the world in the development of innovative treatments, it’s clear that we must act faster in deploying those treatments so we can save more lives. We must make a more robust effort to measure the potential impact of emerging vaccines—to capture and evaluate vaccine trial data faster, allowing for “rolling” evaluation of data so that the vaccine doses that now sit ready for shipment can be deployed weeks or, perhaps, months sooner.
The impending Emergency Use Authorization of the Johnson & Johnson vaccine is definitely a positive development in our fight against COVID-19, but it’s important to remember that too much red tape and risk aversion in the drug approval process can end up harming patients rather than helping them. There is no question that COVID-19 will continue to create a public health challenge, and the responses need to continue to focus on the most rapid evaluation and delivery possible.
[UPDATE: Saturday, February 27, 2021; 7:45PM ET]
Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 vaccine has been granted by the FDA. This is another important step in allowing the nation to return to health and economic activity.
Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.
