The FDA and CDC are failing our country.

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.

CDC Director Walensky

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.

Data from states that are monitoring breakthrough infections show almost all current COVID-19 infections are in unvaccinated individuals.

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

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

13 thoughts on “The FDA and CDC are failing our country.

  1. its easy to be critcal of the FDA and CDC. I would discuss the lack of a permanent FDA head administrator more. In fact the previous Administration was hell bent on using “Acting” in many departments, undermining those departments effectiveness to address the issues at hand. We do not know how far this poor administration of the Federal Health systems has caused delay and implementation. Agree whole heartedly you comment on the administration of over a half billion vaccinations should provide the basis for FDA approval.

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    1. Agree the failure to appoint a permanent head for the FDA is a problem. Weird thing is that it seems out of place with all the other appointments that were quickly made by this admin. Not clear what the hold up involves or if there is some agenda here that I don’t understand.

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  2. Can you do a blog about whether people who have had Covid19 either before being vaccinated or after, should get the booster shot when it becomes readily available? I’ve heard one should wait 6 months because getting the vaccine (or a booster) can cause problems for people who had contracted the virus within the previous 6 months. Thank you,

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    1. Hi Ellen. Hope you are well!
      Most people are recommending 3 months before getting a booster after infection. This seems to optimize vaccine efficacy and minimize side effects. No one is currently suggesting a booster after breakthrough infection unless the individual is immuno-suppressed.

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  3. Currently, all the people I know right now who have tested positive for Covid have been vaccinated. Two people from our office, three people in a trade firm we use and another trades person, his wife and her 90+ parents who are hospitalized. Aside from one person mentioned who traveled to Disney, the other 8 people apparently were very careful with protocol. Very confusing.

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    1. While observations of small numbers of individuals may be confusing the overall data shows over 95% of infections are in the unvaccinated. Some just don’t tell people because they are embarrassed or don’t even bother to find out their status.

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  4. Great blog post! I agree that the CDC & FDA are failing at their job of protecting the public health. One note about the chart that the unvaccinated are driving the surge – this is a CDC talking point, but I believe misleading data (or purposefully obfuscated by the CDC). Most such reports I’ve seen analyze cumulative data from Jan 1 to July 31. However, vaccinations were not available in most states for months, and then uptake was gradual. Hence, “cases” are mostly in unvaccinated people over the cumulative time period.

    If you look at more recent data (i.e. last 3 weeks of infections), the % of cases in vaccinated vs. unvaccinated is markedly different.

    For example, article from PBS: https://whyy.org/articles/del-officials-emphasize-risk-among-unvaccinated-breakthrough-covid-cases-see-sharp-rise/

    This shows over the past few weeks, ~12%+ of cases in Delaware are breakthrough (in vaccinated folks) while year-to-date data is around 1%. This, coupled with the fact that vaccinated people are less likely to get tested (b/c they experience milder symptoms, or most falsely think “vaccine = no covid”, etc.) suggest that the underlying true % of breakthrough cases is likely even higher.

    Data from Israel or UK recently suggests that 40%+ of cases are breakthrough cases. If the CDC/FDA communicated this, the American public could be more careful, and vaxxed & unvaxxed alike could be exercising caution and limiting spread. Instead, it feels like the CDC and FDA are politicizing science as a religion (“Trust the science” = “do what I say!”), instead of thinking and searching for the truth. I fear this approach will continue to erode the public trust.

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  5. Do you agree with Dr. Segal’s statement here: https://www.wsj.com/articles/covid-19-herd-provincetown-mayo-delta-mask-mandate-vaccine-passport-cdc-mucosal-immunity-11629128219?mod=opinion_lead_pos6

    “Vaccine mandates for in-person interactions—whether imposed by governments, employers or businesses—should make exceptions for the previously infected, who thanks to natural mucosal immunity are likely at less risk than never-infected vaccinated people of spreading the virus to others.”

    If you don’t agree, is it because he’s wrong about the two different kinds of immunity?

    Thank you for this blog!

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    1. There is only one type of immunity, whether it is caused by infection or vaccine. Infection is equivalent to a single dose of vaccine. That is why most are recommending a dose of the vaccine after natural infection.

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