The track record of the FDA and CDC during the COVID-19 pandemic has been spotty at best. With new leadership at the CDC and the opportunity to advance effective COVID-19 treatments and vaccines at the FDA, we all had hoped that the performance of both these agencies would improve. Unfortunately, the recent performance of both agencies has been terrible.
The CDC’s recent actions have been particularly disastrous. Early in the pandemic I criticized them for recommendations for ridiculous activities like washing hard surfaces that detracted from the important message to wear a mask. Their initial flip-flop on masking undermined the public’s acceptance of this vital activity. Hope was that a new director (Dr. Rochelle Walensky) and a more consistent communication process would regain public trust. However, recently the CDC has again provided conflicting recommendations that have confused most people who are trying to do the right thing in the pandemic.
Most masks worn in public are only effective in preventing an infected person from spreading the disease to others.The CDC released everyone from wearing masks in the spring ignoring the fact that unvaccinated people (when infected) would easily spread the virus to others. This was apparent even before the more infectious variants arrived. No unvaccinated person should ever have been told to go out in public without a mask.
The CDC then announced that vaccinated people should also mask indoors, despite having almost no data on the likelihood they could be infected or infect others. They made this decision on an anecdotal report from a Provincetown, MA 40,000 person gathering based on PCR data. I have pointed out the problems with this data previously, so won’t reiterate here.
The reason there is no hard data on “breakthrough” infections in vaccinated individuals and their risk of COVID-19 transmission is because the CDC is not bothering to monitor them! We also lack data on the severity of Delta-variant infection in children and other potentially vulnerable populations. This is the CDC’s job, and they have failed miserably at providing the information that allows informed decision-making.
This data vacuum has allowed the spread of deceptive social media suggesting that the vaccines do not work and undermining the value of the vaccines. The data we do have concerning “breakthrough” infections in vaccinated individuals comes from some states (not the federal government) and clearly shows the current COVID-19 infection outbreak is in the unvaccinated.
Adding to this morass of communications, the CDC director recently blamed the problems with Americans following her recommendations on “politics!” Given the messy communications and poor data collection, Dr. Walensky should look in the mirror before blaming others.
In contrast, the FDA initially performed well in facilitating access to new drugs and vaccines for COVID-19 through their Emergency Use Approval (EUA) process. However, the final approval of the two RNA based vaccines seems to be in limbo, and this has seriously undermined efforts to vaccinate people. While there are individuals who won’t get vaccinated for COVID-19 under any circumstances, a significant portion of unvaccinated cite the lack of formal approval for refusal to take the vaccines.
The data packages for the final approval of the Pfizer and Moderna vaccines have been with the agency for almost two months. Importantly, most of the information surrounding efficacy was presented in the EUA approvals from December 2020. The large-scale toxicity data, the real concern about full approval, have been well defined as we have given these vaccines to over half a billion people.
Therefore, the failure to approve these vaccines by now is unreasonable. Some have argued the lack of a final full-time director for the FDA has inhibited this process. Regardless, the FDA needs to approve these vaccines and do it soon to facilitate vaccinating the entire country. That is the only way that these infections will finally be stopped