CDC’s Late October Timeframe for COVID-19 Vaccine Raises Concerns

On Aug. 27, 2020, the U.S. Centers for Disease Control and Prevention (CDC) provided all territories, 50 states, and five major cities — New York, Chicago, Philadelphia, Houston, and San Antonio — with information on the distribution of a COVID-19 vaccine by the end of October. The CDC estimates that if not at the end of October, the distribution would occur in early November. The vaccine would be distributed to health care workers and other high-risk groups first.

In the distributed documents, the CDC introduces two vaccines called “Vaccine A” and “Vaccine B”; each vaccine has a unique amount of shipments, storage, orders, and administration. Vaccine A is estimated to be available through two million doses toward the end of October, 10-20 million toward the end of November, and 20-30 million toward the end of December. On the other hand, Vaccine B will be available at a lower dosage. The second version of the vaccine may have an availability of one million doses toward the end of October, 10 million doses toward the end of November, and 15 million doses toward the end of December.

The real names of the vaccines have not been revealed. However, there are a small number of vaccines being developed that match the aforementioned timeline and production. The vaccines currently in Phase three trials are being developed by Moderna and National Institute of Allergy and Infectious Diseases, Pfizer and BioNTech, and AstraZeneca and the University of Oxford.

The CDC guidance was sent on the same day that President Trump gave his speech at the Republican National Convention, in which he claimed that a vaccine may arrive before 2021. To achieve this timeframe, the White House created “Operation Warpspeed,” a public-private partnership, to accelerate the development, testing, and manufacturing of a vaccine at a breakneck pace. However, in an NPR interview, Chief Scientific Adviser to this operation Moncef Slaoui said that an October vaccine is “extremely unlikely.” Even so, Slaoui also told NPR that having states prepared is “the right thing to do.”

A more realistic estimate for the vaccine, according to the Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci, is closer to the end of the year. “I believe that by the time we get to the end of this calendar year, that we will feel comfortable that we do have a safe and effective vaccine,” he said.

However, the Trump administration’s urgency in finding a vaccine has raised concerns over the possibility of premature and dangerous ramifications over the authorization of the vaccine; especially due to political forces such as the U.S. presidential election in November. CDC Director Dr. Robert Redfield asked states to speed through medical permits and waive any requirements that would hinder the vaccine’s distribution by November 1st — a date that’s much earlier than Dr. Fauci’s aforementioned realistic estimate but is before Election Day. Another area of concern is the Food and Drug Administration’s (FDA) approval process of vaccines. The process includes inspecting the manufacturing plants of the vaccine and usually takes one year, a timeframe that would not be finished until later on in 2021.

Concerns over the vaccine also stem from a historical precedent. In 1976, during President Gerald Ford’s term, a similar warp speed vaccine effort was spurred by a mysterious new strain of swine flu. Ford raced to find and implement a solution that resulted in a “fiasco.” The chaos that resulted included two million doses treating the wrong strain, the vaccine not working on children, paralysis, and deaths. This led to the inevitable shut down of the warp speed program.

Although it may seem that the Trump Administration is ignoring severe safety risks to ensure a normal upcoming election and a higher chance for victory, the Director of the National Institutes of Health Dr. Francis Collins believes that the aforementioned rush is just in case one of the vaccines indicates clear evidence to protect people. Furthermore, FDA officials claim that they have “unwavering regulatory standards” and that the acceleration relates to the finance portion of the development process, not safety. Peter Marks, the leader of the FDA division on the vaccine approval, has put his resignation on the line in case the Trump administration produces a vaccine that is not safe nor effective.