Safe Vaccine Development Requires Orderly Process

The world is desperate for a vaccine against the coronavirus. Since the beginning of the pandemic in early 2020, at least 35 vaccines have been clinically tested worldwide, 11 of which are in the final stages prior to approval. We don’t have a vaccine yet.

It is not unusual. It takes a long time for a vaccine to be developed, tested and approved. The mumps vaccine took four years to develop, a short period of time compared to seven years for a polio vaccine and nine years for measles. The world was also desperate back then: before the polio vaccine became available in 1955, the disease beat like clockwork every summer and autumn. For example, in the United States in 1952, 21,000 people were paralyzed with polio

The wait goes on for a vaccine against HIV. In 1984 the head of the US Department of Health announced it would be ready in two years. that’s 36 years and it counts.

The search for a vaccine against the coronavirus began shortly after the pandemic spread. The Washington Post reports that 200 vaccines are currently being developed. The vast majority are in the pre-clinical stage, which means scientists are still working in the laboratory. (In contrast, the Food and Drug Administration (FDA) reports that 274 types of emergency diagnostic tests are currently approved.)

The vaccine discovery process is usually an orderly affair. It has to be how the FDA approval process insists. Each phase of the review must be completed before the FDA approves the beginning of a subsequent phase.

However, order is not a hallmark when looking for a coronavirus vaccine. A phase 1 study, which is normally only conducted to test drug safety, can quickly move on to a phase 3 study, which is normally not conducted until the dosage and safety results are confirmed. Anthony Fauci, MD, director of infectious diseases at the National Institutes of Health, told a US House of Representatives committee in July that no steps in the approval process would be skipped.

The financial help of their governments has driven many pharmaceutical houses to look for a vaccine. The hunters include Japan, the United States, Great Britain, China, Russia, India and even Cuba, reports the Post.

Like good hunters, pharmaceutical companies do not follow the same path to success. However, all investigational vaccines have one thing in common: They try to attract the attention of the body’s immune system.

Some researchers are pursuing vaccines that prevent the virus from entering a cell, which prevents it from replicating. Others pursue vaccines that work like the measles vaccine, in which a weakened but still living virus boosts the body’s immune system to defend itself against the intruder. Still others try to fight the virus from within the target cell, essentially creating a target that sits on the surface of the virus so the body’s immune system knows what to destroy.

One factor that has not affected the approval of previous vaccines in the US is the political interaction we see in Washington today.

In 1962, President Kennedy signed the Vaccination Assistance Act, authorizing the CDC to sponsor major vaccination campaigns and start maintenance programs.

In contrast, resentment grows between the White House and state health officials, namely the CDC and FDA, as the presidential election approaches. For example, the FDA recently tightened its rules for applying for an emergency permit, a move that President Donald Trump called a “political hit job.”

So will there be a COVID-19 vaccine sooner rather than later? We will see.