Johnson & Johnson has officially submitted its Emergency Use Authorization request to the U.S. Food and Drug Administration (FDA) for consideration. This application is the same one Pfizer and Moderna requested, and got, during the Trump administration’s waning days. The request is yet another victory for Operation Warp Speed, delivering another vaccine in record time.
With that great news, the spotlight now shifts to the Biden administration. We’re in the middle of a pandemic. Another American company has proven they have a solution to help. Does the Biden help move mountains and get the FDA to approve Johnson & Johnson’s request rapidly, or are we due for more bureaucratic feet-dragging?
We know what the answer was from the Trump administration. Frustrated with the FDA’s slow approval pace, the Trump administration threatened to fire the head of the FDA on Dec. 11, 2020, unless the agency got the Pfizer vaccine approved by the end of the week. The FDA approved the Pfizer vaccine that same day.
Again, we’re in the middle of a pandemic. We’re a month away from hitting March of 2021. This isn’t a time for dragging feet, or for looking at bureaucratic red tape as usual and acceptable. This moment is a time for decisive action. The faster we can get Americans vaccinated, the faster we can re-open the economy and return to ordinary life.
It’s time for action. And the ball is in the Biden administration’s court. They have to act and speed the FDA up.
This isn’t an issue of product or medical safety. We know the vaccines work. We have Johnson & Johnson’s research. We know the results and more. The U.S. government has worked hand-in-hand with these companies to develop miracle cures, and it has happened in less than a year. It’s the most remarkable medical achievement in modern history.
Johnson & Johnson’s vaccine went through the same kind of multi-phase testing as Pfizer’s and Moderna’s. Those vaccines have helped single-handedly lead the charge to massively reduce new cases and the load on the American health care system. According to NBC News, Johnson & Johnson has said, “If the FDA grants the authorization…the company will be ready to begin shipping vaccines.”
“It is unclear how many doses would be prepared immediately; Johnson & Johnson has previously said it expects to supply 100 million doses to the U.S. by June,” NBC reported.
One hundred million doses of one vaccine, while Pfizer and Modern work to fulfill their promises of 200 million vaccines delivered on a similar timeline, is enough vaccines to get nearly every person in the United States a vaccine if they want by summer.
Remember, Johnson & Johnson is a single-dose vaccine. One hundred million doses means 100 million people vaccinated.
There are two reasons why this is an immediate action issue. The first is that Johnson & Johnson’s research showed:
The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.
That means if all 100 million doses were administered, the American health care system wouldn’t have to worry about an influx of COVID-19 cases. The stress this virus has placed on the system would evaporate, and we could start repairing the damage this virus has caused to our health care infrastructure. Not to mention, those doses will reduce the number of people dying from this awful virus unleashed on the world from China.
Second, the FDA is a federal agency. The president is the head of these agencies and can push them. In the middle of a pandemic, having politically elected leaders forcing these agencies to serve the people instead of miring themselves in the intricacies of bureaucratic red-tape is precisely what we need.
We know the safety of the vaccine. The FDA isn’t protecting anyone but itself. We need the vaccines on the market, and we needed them on the market yesterday.
As I wrote a couple of weeks ago, new variants to COVID-19 are popping up on a nearly weekly basis now. Combatting those variants requires getting solutions out to the people, reducing the load on hospitals, and supporting the health care system right now.
Meanwhile, COVID-19 case numbers are uniformly falling across the board. The more vaccine candidates we have active in the fight, the faster we can end this pandemic.
The Johnson & Johnson vaccine presents the Biden administration with its first challenge. Do they bow to red tape, or are they in this to win it? Journalists should enter the White House briefing room every day asking the same question: Why haven’t you granted Johnson & Johnson or AstraZeneca’s vaccines authorization for emergency use?
AstraZeneca has been used widely in the United Kingdom to drive down case numbers there. And it’s getting used widely across the European Union. The United States should be using it too. We could have four vaccine candidates in use immediately, but we’re waiting on federal agencies to do their jobs.
It’s time for swift federal action. These kinds of moments are why we give presidents the power they have over executive agencies.
Joe Biden needs to act now. If he can’t, he needs to answer for that failure of leadership.