For the second Monday since the election there is encouraging vaccine news. The latest news comes from Moderna, which announced 95% success with its vaccine trials. The stock market responded with another great day.
The Moderna vaccine, like the one from Pfizer, is an mRNA vaccine. They reported 95 people in the study contracted the virus and 90 of those had received the placebo. These findings come from a 30,000 subject trial and moves the company closer to distribution of the vaccine. They only have to complete the safety data, which has been good thus far, at the end of this month.
Like the Pfizer vaccine, the Moderna vaccine requires two shots, approximately three weeks apart. Unlike the Pfizer vaccine, Moderna’s does not require refrigeration at extremely cold temperatures. They estimate, after thawing, it can remain stable in regular refrigerators for up to 30 days. This would greatly simplify distribution of the vaccine compared to the Pfizer vaccine.
You might expect this news to be greeted with enthusiasm by everyone. But there seem to be critics for every situation, no matter how much everyone benefits. Many have criticized the FDA for granting Emergency Use Authorization (EUA) this past summer for convalescent plasma to treat Covid. The Wall Street Journal reports more than a dozen studies showed benefits for this treatment. A Mayo Clinic trial that enrolled some 35,000 patients found seven-day mortality was 44% lower among non-intubated patients under the age of 80 who were treated within 72 hours of diagnosis with plasma containing high levels of antibodies versus lower levels.
These same critics claim the FDA jumped the gun by approving remdesivir and should have waited for supposedly more robust evidence of success. Some say the FDA should have consulted outside experts before granting EUA. By ignoring such naysayers, the Trump Administration has made possible effective treatments and new vaccines in record-breaking time.
The Wall Street Journal editorial board says, “Credit here goes to private drug investment and innovation, but also to the Trump administration for speeding up government approvals. The Administration pushed reforms in the Food and Drug Administration’s bureaucratic and risk-averse culture, even if it didn’t always succeed. Former FDA Commissioner Scott Gottlieb put a particular priority on speeding up drug approvals. New generic approvals increased to 107 last year from 73 in 2016.”
Unfortunately, some of these same critics now make up the Biden Covid task force. Ezekiel Emanuel, one of the notorious architects of the ObamaCare train wreck, was most noted for his creation of an Independent Payment Advisory Board (IPAB) which was designed to control Medicare spending. Thankfully, the IPAB has since been repealed by Congress. But Emanuel continues to be favored by Democrats who are more concerned with spending than taking care of people. He believes government needs to clamp down on doctors who prescribe treatments that incrementally help patients, especially the elderly with fewer years to live. In other words, he favors rationing of healthcare, like socialized medicine.
Another Biden Covid task force member is David Kessler, FDA commissioner under George H.W. Bush and Bill Clinton. The WSJ says Kessler let the agency be hijacked by trial lawyers and banned most silicone breast implants because of unascertainable risks, which many women were willing to bear. During his tenure, approvals of new medical devices ground to a halt. Kessler told Politico in August, “The FDA commissioner is to put their body on the line in between all the forces that want to influence the agency.” The WSJ says he meant the agency should ignore doctors and patients who want access to therapies that don’t pass this “expert” bureaucratic obstacle course.
The election results show many Americans voted for Biden believing he would do a better job than Trump on handling the Covid pandemic. Yet the Biden plan differed little from the Trump plan except for a national mask-wearing mandate. (Biden’s Covid Plan is Trump’s Plan)
But now it appears Biden may actually contribute to a worsening of the pandemic crisis. The WSJ editorial board summarizes their concerns: “The Trump FDA’s Covid innovation has been providing real-time feedback and clear guidance to drug and vaccine makers about its expectations. This has helped therapies and vaccines advance and cut Phase 3 trials from three years to three months. These reforms are one of the success stories of the federal Covid response. But there’s a serious risk that the Biden team will default to their instincts and reimpose a culture of bureaucratic control that restricts new medical advances.”
It’s easy to be a critic when you’re not in charge.